Biden administration – What can the healthcare industry expect?

As Joe Biden takes the reins at the White House, pharmaphorum asks experts how his presidential tenure may influence the global healthcare industry.

“I think the Biden administration will have only an incremental impact on the healthcare industry as a whole,” said Maxim Jacobs, CFA, managing partner and director of research at Edison Group.

“With a slim majority in the House and an evenly divided Senate it will be tough for him to get anything radical through Congress.  He ran on protecting and expanding Obamacare and I think that is probably what he will try to do. He’ll be able to protect it but I’m not sure about his ability to expand it or enact things like the public option.”

Given other challenges in the US that need to be dealt with first – such as the COVID-19 response, additional Medicaid funding and economy and tax reform – dramatic changes are unlikely, said Mark Brewer, life sciences research director for finnCap.

“Sweeping healthcare reform, in the way that it was prioritised in the Obama administration, is unlikely to be top of the agenda, partly also due to the narrow majority that the Democrats have in the House of Representatives and the Senate and the time/effort that would be required to try and push through such legislation without any guarantee of success. We don’t believe there will be draconian price cuts, for the same reason.

“The Biden administration could put additional scrutiny on drug prices, but more drastic measures, such as allowing Medicare to negotiate with pharma companies directly, are still unlikely.”

“The industry should continue to prosper with innovation driving new product introductions and consequently valuations. Post-COVID recovery in global healthcare systems should also drive the broader healthcare sector, which should benefit device companies and those focused on elective surgery rates,” said Brewer.

Biden could put additional scrutiny on drug prices but more drastic measures, such as allowing Medicare to negotiate with pharma companies directly, are still unlikely, according to Tim Xu, investment associate at Boston, US-based Arix Bioscience.

“Policy-wise, President Biden will aim to protect and restore Obamacare, which to many remains a band-aid solution to the US’ healthcare problem. It is quite likely that cornerstones of the Affordable Care Act will be found unconstitutional by the Supreme Court, such as the individual mandate.

“As ever, it takes a “supermajority” of over 60 votes to get any major legislation through the Senate, so longer-term Democratic wishlist items like a public option or single payer are unlikely. What this means for the pharma industry is likely business as usual, at least until the midterm elections in 2022.”

Generic and opioid-alternative companies could benefit from expanded coverage, if Biden changes policy, according to analysts at Jefferies. In the EU, pharmaceutical companies like Roche could have the largest exposure to Medicare Part B drug reforms due to the proportion of its products that are either IV infused or administered in the physician’s office.

“Some of this apparent threat is already de-risked, given biosimilar erosion of Rituxan, Herceptin and Avastin which have wider pricing disparities ex-US than the newer launches at more competitive prices such as Ocrevus, Hemlibra and Tecentriq. Ex-US stocks with less Part B exposure are Novo Nordisk, Novartis and GSK,” said Jefferies’ Peter Welford.

One area where Biden might be able to make a big difference is pandemic preparation, according to Jacobs. “COVID has been a global disaster and unfortunately there are other pathogens that can be as or more deadly. He’ll probably want greater investment in biodefense so the country can increase its stockpile ahead of the next pandemic event, which may increase industry focus on vaccines, antivirals and antibiotics.”

Science first

While Donald Trump had a strained relationship with the scientific community, Biden is keen to strengthen its position.  This support could help the US preserve its reputation for being at the forefront of research, science and innovation. “It is very clear that Biden is using science and not public opinion to drive change,” ImaginAb CEO, Ian Wilson told pharmaphorum.

“He has publicly stated he expects newly appointed presidential science adviser and the director of the Office of Science and Technology Policy (OSTP), Eric Lander and his team to address questions about the future of science and technology and recommend how his administration can combat public health threats, mitigate the impact of climate change, keep the country a world leader in innovation, use science to improve social equity, and strengthen the US research enterprise.

“This is the first time in history the science adviser will be a cabinet-level position. That, along with the 100 day promise to immunise 100 million people, increased stimulus packages to ensure biotech companies and smaller businesses can ride out the pandemic, and a focus on making the US a leader once again in medical science, gives hope for a new beginning.”

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Therma Fisher Acquires Rapid COVID-19 Test Provider Mesa Biotech for $450M

Therma Fisher Acquires Rapid COVID-19 Test Provider Mesa Biotech for $450M

What You Should Know:

Thermo
Fisher Scientific Inc.
has entered into a definitive agreement to acquire
Mesa Biotech, Inc., a San Diego,
CA-based molecular diagnostic company, for approximately $450 million in cash.
Under the terms of the agreement, Thermo Fisher will pay up to an additional
$100 million in cash upon the completion of certain milestones following the
close of the transaction.

– Mesa Biotech designs, develops, manufactures, and commercializes next generation Rapid PCR tests, bringing the superior diagnostic performance of nucleic acid PCR amplification to the point-of-care (POC).

– Mesa Biotech’s Accula™ SARS-CoV-2 test was among the first
POC tests to obtain Emergency Use Authorization, providing results within 30
minutes, with higher accuracy than other rapid tests on the market.

– The company has approximately 500 employees and reported
$45M in revenue in 2020.

Uber, Moderna Partner to Increase Access to COVID-19 Vaccines

What You Should Know:

Moderna and Uber announced a partnership to work together initially to provide accessible, credible information on COVID-19 vaccine safety through Uber’s in-app messaging.

– The two companies will also work with public health and
other organizations to identify additional opportunities to support ongoing
efforts to broaden access to COVID-19
vaccines.

– Additional options being evaluated include incorporating
ride scheduling directly into the immunization appointment process, and
possibly integrating with vaccine providers’ systems to text reminders and
enable patients to book rides in advance of their first or second immunization
appointments.

– While initially targeting Uber users in the United States,
the companies anticipate expanding this partnership globally in the coming
months alongside ongoing immunization efforts.


CVS Health to Provide In-Home Chemotherapy with Cancer Treatment Centers of America

CVS Health to Provide In-Home Chemotherapy with Cancer Treatment Centers of America

What You Should Know:

– Today, CVS Health announced a collaboration with Cancer
Treatment Centers of America (CTCA) to provide in-home chemotherapy for
clinically eligible and fully insured patients.

– The program, which leverages CVS Health’s home infusion
service, Coram, and CTCA’s expertise as a top oncology care provider, aims to
minimize immunocompromised patients’ exposure to COVID-19 by offering an
alternative to inpatient or in-office cancer care.

– Through this program, patients will begin their first
cycle of infused chemotherapy in the hospital or outpatient care center.


CVS Health announced
today it is working with Cancer
Treatment Centers of America® (CTCA)
to increase access to chemotherapy at
home
for eligible, fully insured patients. Together, the companies are
focused on minimizing patient exposure to COVID-19 from
inpatient or hospital outpatient settings during the ongoing pandemic while
ensuring continuity of critical cancer care. The program leverages Coram’s home
infusion capabilities, coupled with training in chemotherapy administration
based on Oncology Nursing Society guidelines, harnessing CTCA’s expertise as a
top oncology care provider to give patients who may have delayed their care due
to COVID-19 the flexibility to receive treatment from the safety and comfort of
home.

Why It Matters

Clinically eligible and fully insured CTCA patients with a
range of cancers, including breast cancer, lung cancer,
prostate cancer, colorectal cancer, head and neck cancers, and some
genitourinary cancers on particular chemotherapy/immunotherapy
medications, will begin their first cycles of infused chemotherapy in the
hospital or outpatient care center, and, if tolerated over a number of months,
can be transitioned home for continued infusions. Once home,
patients will receive in-home Coram nurse visits to administer the
therapy, paired with regular telehealth visits and digital therapeutic
check-ins with their CTCA clinician, care team, pharmacists and other clinical
staff as needed.

In collaboration with CTCA and their approach to
quality, safe care, coupled with more than 35 years of infusion expertise,
Coram has the ability to reach 97 percent of the U.S. population. The program
is being piloted in the Atlanta market and will expand to other
geographies over the next few months to help increase access to important home-based cancer care
during and beyond the pandemic. 

“Putting patients first has been our philosophy for over 30 years, and working together with CVS is an extension upon in which we can better meet their needs, especially in light of a pandemic. For a variety of reasons, COVID-19 has caused far too many people to skip or delay treatments. We’re seeing a 50% reduction in infusions, and, while a slight delay in treatments may have been appropriate at the pandemic’s onset, data is now pointing to increased mortality risk with every month of delayed care,” said Dr. Chevon M. Rariy, M.D., CTCA telehealth program director. “We’re proud to be working with Coram to provide home infusion of cancer treatment that prioritizes the safety of patients, their families and health care workers.” 


Komodo Health Acquires Cloud-Based Life Sciences Platform NEVIS- M&A

Komodo Health Acquires Cloud-Based Life Sciences Platform Nevis

What You Should Know:

– Komodo Health announces the acquisition of Nevis, a cloud-based platform for life sciences to expand its software capabilities.

– The acquisition of NEVIS offers customers a cloud-based
platform with a suite of software that ends reliance on fragmented data
and expensive single-point solutions.


Komodo Health today announced its acquisition of NEVIS, a leader in cloud-based technology solutions for the life sciences. The acquisition will enable Komodo Health to expand its cloud-based platform with a suite of software and applications that will help life sciences companies seamlessly integrate critical insights and data into their enterprise workflow applications. Financial terms of the deal were not disclosed.

NEVIS sells patient and medical software products and
provides deep industry expertise at more than 60 life sciences companies. The
company brings more than 130 industry experts with world-class expertise in
cloud software and technology integration. The acquisition also accelerates
Komodo’s global expansion as Nevis currently operates in the U.S., U.K. and
India.

“We are excited to join forces with Komodo Health to create a next-generation solution for the industry,” said Prasad Kanumury (PK), Founder and CEO of NEVIS. “Together, we will transform the way life sciences companies put life-saving therapies in the hands of patients that need them most, ultimately reducing the burden of disease across the globe. This raises the bar and changes the expectations of the entire healthcare ecosystem.”

Acquisition Creates Data-Driven Enterprise Platform for
Life Sciences

Together, Komodo and NEVIS will expand their software
capabilities, infused with insights from Komodo’s Healthcare Map™ — which
leverages the patient journeys of more than 320 million de-identified
individuals. As the industry shifts toward a patient-centered model, enterprise
healthcare companies can end their reliance on legacy data aggregators and better
connect workflows to the primary objective of meeting the needs of patients.

“This acquisition disrupts the status quo, unlocking a fundamentally different opportunity for life sciences companies to access differentiated insights,” said Arif Nathoo, MD, CEO and co-founder of Komodo Health. “Purchasing fragmented and costly data assets, custom solutions and expensive consulting projects will be a thing of the past as Komodo Health delivers a seamless, data-driven platform across R&D, Commercial, Medical Affairs and Patient workflows.”

Verily, Broad, Microsoft Partner to Expand Life Sciences Research with Azure Cloud

Verily, Broad, Microsoft Partner to Expand Life Sciences Research with Azure Cloud

What You Should Know:

– Verily and The Broad Institute have partnered with
Microsoft to expand health and life sciences research utilizing the Microsoft
Azure cloud.

– The new partnership brings together Microsoft’s cloud, data, and AI technologies, and a global network of more than 168,000 health and life sciences partners to accelerate the development of global biomedical research through the Terra platform, provide greater access and empower the open-source community.


Broad Institute of MIT and Harvard, Verily, an Alphabet company, and Microsoft Corp. announced a
strategic partnership to accelerate new innovations in biomedicine through the
Terra platform. Terra, originally developed by
Verily and the Broad Institute, is a secure, scalable, open-source platform for
biomedical researchers to access data, run analysis tools and collaborate.
Terra is actively used by thousands of researchers every month to analyze data
from millions of participants in important scientific research projects.

Importance
of Open-Source Biomedical Data

Biomedical data are being generated and digitized at a historic rate and are expected to reach dozens of exabytes by 2025 — including data from genomics, medical imaging, biometric signals, and electronic health records. Coupled with powerful research and analysis tools, these datasets can provide lifesaving insights into some of the world’s most pressing health issues. But making use of these important datasets remains difficult for researchers who face huge, siloed data estates, disparate tools, fragmented systems and data standards, and varying governance and security policies.

Partnership
Objectives

The new partnership aims to break through those barriers by bringing together Microsoft’s cloud, data, and AI technologies, and a global network of more than 168,000 health and life sciences partners to accelerate the development of global biomedical research through the Terra platform, provide greater access and empower the open-source community. Building on the open-source foundation of Terra, the new collaboration will advance the ability of data scientists, biomedical researchers, and clinicians around the world to collaborate in tackling some of the most complex and widespread diseases facing society today.

The Broad-Verily-Microsoft partnership brings together leading genomics and computer science researchers, data scientists, and technology experts to jointly deliver on the vision of the Terra platform.

Partnership
Benefits for Health & Life Sciences Research

Through collaboration with Microsoft, the companies will accelerate Terra’s vision for health and life sciences research by:

– Expanding
on Terra’s open, modular and interoperable research platform, with the addition
of the Microsoft Azure cloud, data and AI technologies, and global capabilities

– Increasing
Terra’s accessibility to the more than 168,000 health and life sciences
organizations partnering with Microsoft around the world

– Enabling
secure and authenticated access to distributed data stores via collaborative
workspaces

– Allowing access to a rapidly growing portfolio of open and proprietary standards-based tools, best practices workflows, and APIs

– Enabling
federated data analysis to uncover insights and build novel analytical and
predictive models while ensuring patient privacy

– Creating
a seamless and secure flow to speed the delivery of data and insights between
research and clinical domains

– Using
open APIs and modular components to advance the standards-based biomedical data
ecosystem in line with the open, compatible and secure approach to data
developed by the Data Biosphere and the responsible
policies and technical standards established by the Global Alliance for Genomics and Health

20 COVID-19 Predictions and Trends for 2021 – Executive Roundup

Dr. Justin Graham, Chief Medical Officer, GYANT

The rapid development of a COVID-19 vaccine is a monumental achievement, but it does nothing to address our extremely fragmented healthcare system. In 2021, policymakers must create and extend incentives to providers to work together to keep patients healthy rather than maximize profit. The pandemic has devastated the traditional fee-for-service budgets of many healthcare systems, and it isn’t clear they will ever be able to catch up without additional federal or local funding, or succeeding with radically different business models. Fortunately, this time of difficult budget decisions and value-based care models coincides with an explosion in growth of digital health tools that are being readily embraced by patients that are happy to see healthcare providers adopt technology familiar to them in other settings. This convergence of demand for technology and innovation by health systems and patients will enable providers to be able to reach new populations while continuing to serve their communities that have been impacted by the pandemic.


COVID-19 Trends and Predictions

Peter S. Tippett, MD, PhD, Founder & CEO, careMESH

In 2020, COVID exposed significant gaps in interoperability
and patient data exchange between and among healthcare providers and public
health agencies. As 2021 arrives, I expect to see renewed vigor for tackling
this challenge since it has hamstrung efficiency and the quality of patient
care for a long time. I am optimistic that the Centers for Medicare &
Medicaid Services (CMS) Interoperability and Patient Access Final Rule
requiring admission and discharge summaries be sent to primary care providers,
as well as a renewed focus on electronic referrals under the Promoting
Interoperability program, gives hospitals the incentive to share patient
information and medical records with the entire patient care team. I believe
lessons learned from 2020 have set a determination across the industry to
finally break down these communications barriers.


Chris McCann, CEO, Current Health

With the second surge of COVID-19 underway, hospitals are
quickly reaching capacities that exceed the numbers we saw at the onset of the
pandemic. In the coming year, we will see an increase in home-based care models
propelled by remote patient monitoring (RPM), a technology that has proven to
be indispensable in aiding hospital staff to best allocate their current,
limited resources. Just recently, the Centers for Medicare & Medicaid
Services announced steps to increase the capacity of healthcare systems to provide
acute care outside a traditional hospital setting. Similar to the telehealth
waivers we saw at the onset of the pandemic, this new program will serve as a
sandbox for health systems to explore new clinical pathways for patients in
their own home, which will look quite different than within the hospital.
Reimbursement will allow these models to scale; and with scale, we’ll be able
to explore how data can move beyond just supporting care at home to actually
predicting future risk and enabling preventive care.


Doug Cusick, CEO of TransformativeMed

As the pandemic intensified, many health IT companies were
able to adapt and create COVID-19 specific solutions. The critical hospital and
frontline clinician needs that presented early in the virus’s outbreak revealed
many communication problems within health systems and between care team
members. What became abundantly clear early on was that a lot more needed to be
done to help these healthcare workers to collaborate and communicate to
effectively track and care for their patients.

Health IT companies are taking a very close look at their solutions and asking themselves how they can be improved to better support clinical collaboration and decision making across the entire care team. Advancements in these areas can create usability and efficiency gains through specialty-specific views of information and by supporting care team collaboration by coordinating the distribution of critical and routine notifications, tasks and to-dos between mobile and desktop, and then sharing the information across various members of a multidisciplinary care team.

Moving forward, these innovations will help hospitals and health systems to maximize the ROI that would be expected from their technology investments, recover from the pandemic and support coordinated care delivery well into the future.


Siva Namasivayam, CEO of Cohere Health

COVID-19 has dramatically reinforced the need to fix the basic healthcare infrastructure including helping patients get faster access to needed medical care and moving through the system with less friction. The American Medical Association has outlined the benefits of reducing the volume of medical services and drugs requiring prior authorizations. Regulatory bodies have stated the value of prior authorization, and they also know it’s essential to alleviate the burden the current process puts on providers. Because of regulatory pressures and provider workflow issues, health plans need better technology that ties clinical guidelines and recommendations to a complete care plan, easily approves that care plan, and supports physicians in providing high-quality care to their patients.


Sean Carroll, CEO of Arcadia

In the early stages of the COVID-19 pandemic, many health systems rapidly accelerated existing plans for virtual care delivery or made brand new investments in this space.  As the pandemic continues to ravage our communities and put our health care systems under strain, healthcare leaders will accelerate investments in curated data at scale to support population health initiatives across their entire covered population.  With systems facing staffing and budgetary crises, it will be critical for them to understand the needs of the community at large and allocate those scarce resources where they can offer maximum benefit to patients.


Omri Shor, CEO of Medisafe

COVID-19: The pandemic will continue to dominate our lives
throughout 2021. I don’t anticipate a vaccine to be readily available to the
masses until mid-2021. There will likely be competition on single vs. multiple
doses, and stricter guidelines are to be expected (at least in other countries)
as we head into the flu season. I don’t anticipate a vaccine to be readily
available to the masses until mid-2021. According to Medisafe survey findings,
60 percent of respondents say they don’t expect a vaccine to be available
before the end of 2020. Additionally, 54 percent of respondents will wait to
receive a vaccine until either their doctor prescribes it, or enough have received
it to know it works.

Expect to see more widely available drugs to support the
treatment of COVID-19, in addition to the vaccine, such as steroid medications
and antibiotic drugs. COVID-19 will drive drug companies to devote more
research into pandemic treatment and monitoring of patients’ post-treatment.


David Lareau, CEO of Medicomp Systems

Once the COVID crisis is under control, expect to see
attention turn to innovation in the management of patient health status.
Current HIT systems were designed for transaction-based reimbursement, but the
industry must make the shift to condition-based reimbursement. This will
require systems to provide better tools for clinicians to manage patient
conditions at the point of care. I expect to see advances in this area start to
make their way into the marketplace by the end of 2021.


Post COVID-19: Medical Billing Finally Realizes the Value of Text-to-Pay

Bird Blitch, CEO at Patientco 

Economic and health equity gaps exposed by COVID-19 will be
addressed: As we head into 2021, organizations will commit more resources and
collaborate with others within the healthcare community to support better
health equity and ensure every patient can reach their full health potential.


Daniel Kivatinos, COO and Co-Founder of DrChrono

The Pop-Up Testing Clinic

COVID-19 has ushered in a new way of testing that has never
been seen before across the country. The white tents scattered around parking
lots and connected to medical facilities have proven that this new way of
testing is working. Furthermore, the data that is being collected, stored, and
reported at the pop-up testing clinics and then shared with various local,
state, and federal public health databases is critical. Companies are creating
integration tools to help share and analyze this data.


Lisa Romano, RN, Chief Nursing Officer, CipherHealth

Hospitals will need to counter the staff wellness fallout

The pandemic has placed unthinkable stress on frontline healthcare workers. Since it began, they’ve been working under conditions that are fundamentally more dangerous, with fewer resources, and in many cases under the heavy emotional burden of seeing several patients lose their battle with COVID-19.

The fallout from that is already beginning – doctors and nurses are leaving the profession, or getting sick, or battling mental health struggles. Nursing programs are struggling to fill classes. As a new wave of the pandemic rolls across the country, that fallout will only increase. If they haven’t already, hospitals in 2021 will place new premiums upon staff wellness and staff health, tapping into the same type of outreach and purposeful rounding solutions they use to round on patients.


Ryan Van Wert, MD, Intensive Care Physician, Clinical
Assistant Professor at Stanford University and CEO and co-founder of Vynca

The realities of COVID-19 have thrown into stark reality the need for improved advance care planning in 2021. According to many surveys and studies, few Americans would choose to die on a ventilator in an ICU. Instead, the overwhelming preference is to pass away peacefully and avoid aggressive interventions at the very end.

In 2021, more and more patients and healthcare providers will realize the importance of having a clear advance care plan that is digitally accessible and actionable. By educating and empowering healthcare providers to have advance care planning conversations with their patients, they can ensure goal-concordant care can be provided to every patient. Advance care planning is increasingly being included as a quality measure in value-based initiatives, which ties this critical activity directly to success in these programs.


Bill Paschall, VP at Vivify Health (part of Optum)

COVID-19 descended on us in 2020 like a terrible wave and
continues to swirl around the globe despite social distancing, masking, and the
drowning of economies. Vaccines promise to dilute and dry up this scourge on
mankind, but who will have access and when? Working in conjunction with the
World Health Organization, organizations like COVAX
endeavor to ensure equitable distribution in early 2021 so that all nations can
provide vaccines for up to 20% of their population. It is very likely that only
some countries will be able to vaccinate their entire population in 2021, so we
may see COVID and its impact lingering well into 2022 or even 2023.

Does this mean that the Tsunami of Telehealth in the US
enabled by CMS waivers in early 2020 will wane when the Public Health Emergency
expires? Although some services will again become more restricted, we will
likely see only a short-term dip in these services. Patient acceptance of and
engagement with telehealth has been proven, and provider willingness to invest
in and utilize technology has been demonstrated.  Providers continue the move from Fee for
Service to Value-Based care models, and health plans will support the use of telehealth
and remote patient monitoring to wider populations, lowering the overall cost
of care and improving outcomes.


Paul Jensen, President, Novarad

The global COVID-19 pandemic and its various, and often inaccurate, testing methods have led many organizations to turn to technologies like AI and AR, which are giving radiologists a better sense of how to proactively provide for their patients and predict both outcomes and how they’ll respond to various therapies.

As the medical imaging industry continues to feel the surmounting pressures from the virus, AI, when coupled with CT scans, is and will continue to play a vital role in the diagnosis and management of COVID-19. While medical imaging continues to catch up with more modern, consumer technology, leveraging AI in the fight against COVID to reduce patient vulnerability and improve medical image processing is just the beginning.


Rob Cohen, President of Appriss Health

The COVID-19 pandemic has fueled a resurging U.S. opioid
crisis that some argue has worsened in part because of the stress and anxiety
we are collectively experiencing. One bright spot is that physicians and
hospitals have greater access to in-workflow tools to not only help identify
patients at risk for opioid use disorder or overdose but also to connect
patients with behavioral health resources that can provide them with needed
treatment. This access will continue to expand to more physicians and hospitals
in 2021 – and it will help save lives.


Sara Radkiewicz, Head of Product, CarePort

The ongoing COVID-19 pandemic has exacerbated existing operational issues within the US healthcare system and has also made exceedingly apparent the need for increased interoperability and streamlined care coordination. Better communication, collaboration, and transparency across the care continuum is the best way to ensure safe patient transitions between different levels of care and optimal patient outcomes.

Looking ahead to 2021, we expect increased provider communication, collaboration and transparency to be made a priority, particularly under CMS’s new patient event notification Condition of Participation (CoP) requirements, which go into effect on May 1, 2021, as part of the Interoperability and Patient Access final rule. Though COVID-19 has highlighted the need for real-time data and alerts regarding patient status, increased visibility into patient utilization history, and streamlined data-sharing between disparate providers, this actionable information will remain critically important long beyond the pandemic.


Mike Hoxter, Chief Technology Officer, Lightbeam Health
Solutions

In 2021, I think COVID-19 will eventually diminish with the
distribution of a vaccine, but efficiently delivering care without coming
face-to-face will not. The healthcare industry will continue to streamline
current processes that improve care quality through more remote and electronic
means. We have learned a lot about doing things differently and safely for
high-risk populations through virtual care, and I do not think it will be going
anywhere in the new year.


Theresa Kushner, Senior Director of Data Intelligence and
Automation, NTT DATA Services

COVID-19 will continue to compromise patient data,
setting back efforts to fight the virus

COVID-19 is an assault on privacy in the absence of data
governance. Privacy regulations and protections of personal health data have
been thrown out the window, along with the pandemic response playbook, as the
public sector and healthcare industry scramble to aggregate as much data as
they can on COVID-19 through personal health records and contact tracing –
rendered as public information. Similar to other crises in history, regulation,
privacy and governance fall by the wayside during reconnaissance. I believe the
lack of regulation and governance around healthcare data will result in
setbacks to overcoming the virus in the next several months, not to mention
that it’s compromising patient data.


Kevin Phillips, VP of Product Management and Product Marketing
at Capsule Technologies

The Coronavirus pandemic and accompanying stress on the healthcare system have shown the need for new technology that can help clinicians be more efficient and effective at delivering care, and proactively identify patients at risk.  Our caregivers are healthcare’s most precious resource, and in many cases, they are overwhelmed with the sheer volume of raw data, alarms and alerts around them.  The onslaught has forced many into reactive care. 

As we look to a new year, however, there has been a change in mindset about which alarms equate to emergent patient safety events requiring clinical intervention.  Single threshold device alarms are not actionable, and therefore, of no practical benefit.  What’s required are intelligent alerts and surveillance tools that track patient deterioration, explain the ‘how’ and ‘why’ such events occur, and detect them before they occur – all toward eliminating patient safety risks and preventable deaths. 

While machine learning and artificial intelligence have great potential, in 2021 we’ll start to see more immediate, practical examples of “augmented intelligence,” where technology is used to quickly analyze reams of live, streaming patient data to identify the relevant trends and insights that can then be used to provide the best possible treatment; all based on established, evidence-based care practices.  By focusing on these areas, hospitals and health systems will see clear benefits that can help them transition from reactive care delivery to more insight-driven, proactive care.


Kris Fitzgerald, CTO, NTT DATA Services

Technology’s Obligation in the COVID-19 Vaccine
Distribution

Healthcare workers and pharmaceutical companies have been in
the trenches the past several months treating COVID-19 patients and conducting
research to develop a vaccine. As the healthcare industry, and tangential
industries, work tirelessly to mitigate the virus and work to eradicate it, the
technology industry has an obligation to contribute to this cause, as well. The
tech sector is comprised of some of the most innovative and powerful companies
in the world, and they have a responsibility to leverage their resources to
remove technical barriers and help secure the supply chain to ensure the
vaccine can be distributed successfully and without delay.

COVID-19-specific data is being generated at incredibly high volumes and speeds – from symptoms, to contact tracing, infection and recovery rates, and more. However, the governance around this data is severely lacking. By creating one centralized data management, analytics, and governance repository, government officials, and healthcare professionals overseeing distribution of the vaccine can better analyze the data available to them to generate more accurate real-time decisions.

This allows them to move swiftly and efficiently on in-the-moment insights, such as geographical case spikes or rural areas with a lack of resources to properly store the vaccine, to increase agility and respond to constantly changing consumer and supply chain needs. Real-time, trustworthy, and transparent data management, as well as consulting from technology and data experts, has never been more important. As we learn more about the virus and how to prevent it, data will be the key that unlocks critical information around flattening the curve and efficiently and strategically distributing the vaccine.


12 Telehealth & Virtual Care Predictions and Trends for 2021 Roundup

Dr. Paul Hain, Chief Medical Officer of GoHealth

Telehealth is Here to Stay in 2021

Prior to the pandemic, telehealth was a limited ad-hoc service with geographic and provider restrictions. However, with both the pandemic restrictions on face to face interactions and a relaxation of governmental regulations, telehealth utilization has significantly increased from thousands of visits in a week to well over a million in the Medicare population. What we’ve learned is that telehealth allows patients, especially high-risk populations like seniors, to connect with their doctors in a safe and efficient way. Telehealth is valuable for many types of visits, mostly clearly ones that involve mental health or physical health issues that do not require a physical exam or procedure. It’s an efficient modality for both the member and provider.

With the growing popularity of telehealth services, we may see permanent changes in regulatory standards. Flexible regulatory standards, such as being able to use platforms like FaceTime or Skype, would lower the barrier to entry for providers to offer telehealth and also encourage adoption, especially among seniors. Second, it’s likely we’ll see an emergence of providers with aligned incentives around value, such as in many Medicare Advantage plans, trying very hard to encourage utilization with their members so that they get the right care at the right time. In theory, the shift towards value-based care will allow better care and lower costs than the traditional fee for service model. If we are able to evolve regulatory and payment environments, providers have an opportunity to grow these types of services into 2021 to improve patient wellness and health outcomes.


12 Telehealth & Virtual Care Predictions and Trends for 2021

Dr. Salvatore Viscomi, Chief Medical Officer, GoodCell

2021 will be the year of patient controlled-health

The COVID-19 pandemic brought the realities of a global-scale health event – and our general lack of preparedness to address it – to the forefront. People are now laser-focused on how they can protect themselves and their families against the next inevitable threat. On top of this, social distancing and isolation accelerated the development and use of digital health tools, from wellness trackers to telehealth and virtual care, most of which can be accessed from the comfort of our homes. The convergence of these two forces is poised to make 2021 the year for patient-controlled health, whereby health decisions are not dictated by – but rather made in consultation with – a healthcare provider, leveraging insights and data pulled from a variety of health technology tools at people’s fingertips.


Bullshit Metrics: Is Patient Engagement Real?

Anish Sebastian, CEO of Babyscripts

Beyond telemedicine

Telemedicine was the finger in the dyke at the beginning of pandemic panic, with healthcare providers grabbing whatever came to hand — encouraged by relaxed HIPAA regulations — to keep the dam from breaking. But as the dust settles, telemedicine is emerging as the commodity that it is, and value-add services are going to be the differentiating factors in an increasingly competitive marketplace. Offerings like remote patient monitoring and asynchronous communication, initially considered as “nice-to-haves,” are becoming standard offerings as healthcare providers see their value for continuous care beyond Covid.


Rise of the "Internet of Healthy Things"

Daniel Kivatinos, COO and Co-Founder of DrChrono

Telehealth visits are going to supersede in-person visits as time goes on.

Because of COVID-19, the world changed and Medicare and Medicaid, as well as other insurers, started paying out for telehealth visits. Telemedicine will continue to grow at a very quick rate, and verticals like mental health (psychology and psychiatry) and primary care fit perfectly into the telemedicine model, for tasks like administering prescription refills (ePrescribing) and ordering labs. Hyperlocal medical care will also move towards more of a telemedicine care team experience. Patients that are homebound families with young children or people that just recently had surgery can now get instant care when they need it. Location is less relevant because patients can see a provider from anywhere.


12 Telehealth & Virtual Care Predictions and Trends for 2021

Dennis McLaughlin VP of Omni Operations + Product at ibi

Virtual Healthcare is Here to Stay (House Calls are Back)

This new normal however is going to put significant pressure on the data support and servicing requirements to do it effectively. As more services are offered to patients outside of established clinical locations, it also means there will be more opportunity to collect data and a higher degree of dependence on interoperability. Providers are going to have to up their game from just providing and recording facts to passing on critical insight back into these interactions to maximize the benefits to the patient.


Sarahjane Sacchetti, CEO at Cleo

Virtual care (of all types) will become a lasting form of care: The vastly accelerated and broadened use of virtual care spurred by the pandemic will become permanent. Although it started with one-off check-ins or virtual mental health coaching, 2021 will see the continued rise in the use and efficacy of virtual care services once thought to be in-person only such as maternity, postpartum, pediatric, and even tutoring. Employers are taking notice of this shift with 32% indicating that expanded virtual health services are a top priority, and this number will quickly rise as employers look to offer flexible and convenient benefits in support of employees and to drive productivity.


12 Telehealth & Virtual Care Predictions and Trends for 2021

Omri Shor, CEO of Medisafe

Digital expansion: The pandemic has accelerated patient technology adoption, and innovation remains front-and-center for healthcare in 2021. Expect to see areas of telemedicine and digital health monitoring expand in new and novel ways, with increased uses in remote monitoring and behavioral health. CMS has approved telehealth for a number of new specialties and digital health tools continue to gain adoption among healthcare companies, drug makers, providers, and patients. 

Digital health companions will continue to become an important tool to monitor patients, provide support, and track behaviors – while remaining socially distant due to the pandemic.  Look for crossover between medical care, drug monitoring, and health and wellness – Apple 

Watch has already previewed this potential with heart rate and blood oxygen monitoring. Data output from devices will enable support to become more personalized and triggered by user behavior. 


Kelli Bravo, Vice President, Healthcare and Life Sciences, Pegasystems

The COVID-19 pandemic has not only changed and disrupted our lives, it has wreaked havoc on the entire healthcare industry at a scale we’ve never seen before. And it continues to alter almost every part of life across the globe. The way we access and receive healthcare has also changed as a result of social distancing requirements, patient concerns, provider availability, mobile capabilities, and newly implemented procedures at hospitals and healthcare facilities.

For example, hospitals and providers are postponing elective procedures again to help health systems prepare and reserve ICU beds amid the latest COVID-19 resurgence. While level of care is always important, in some areas, the inability to access a healthcare provider is equally concerning. And these challenges may become even more commonplace in the post-COVID-19 era. One significant transformation to help with the hurdle is telehealth, which went from a very small part of the care offering before the health crisis to one that is now a much more accepted way to access care.
As the rise in virtual health continues to serve consumers and provide a personalized and responsive care experience, healthcare consumers expect support services and care that are also fast and personalized – with digital apps, instant claims settlements, transparency, and advocacy. And to better help serve healthcare consumers, the industry has an opportunity to align with digital transformation that offers a personalized and responsive experience.


12 Telehealth & Virtual Care Predictions and Trends for 2021

Brooke LeVasseur, CEO of AristaMD

Issues pertaining to the COVID-19 pandemic will continue to be front-and-center in 2021. Every available digital tool in the box will have to be employed to ensure patients with non-COVID related issues are not forgotten as we try to free up in-person space and resources for those who cannot get care in any other setting. Virtual front doors, patient/physician video and eConsults, which connect providers to collaborate electronically, will be part of a broadening continuum of care – ultimately aimed at optimizing every valuable resource we have.


12 Telehealth & Virtual Care Predictions and Trends for 2021

Bret Larsen, CEO and Co-Founder, eVisit

By the end of 2021, virtual care paths will be fairly ubiquitous across the continuum of care, from urgent care and EDs to specialty care, all to serve patients where they are – at home and on mobile devices. This will be made possible through virtualized end-to-end processes that integrate every step in patient care from scheduling, waiting rooms, intake and patient queuing, to interpretation services, referral management, e-prescribe, billing and analytics, and more.


12 Telehealth & Virtual Care Predictions and Trends for 2021

Laura Kreofsky, Vice President for Advisory & Telehealth for Pivot Point Consulting

2020 has been the year of rapid telehealth adoption and advancement due to the COVID pandemic. According to CDC reports, telehealth utilization spiked as much as 154% in late March compared to the same period in 2019. While usage has moderated, it’s clear telehealth is now an instrumental part of healthcare delivery. As provider organizations plan for telehealth in 2021 and beyond, we are going to have to expect and deliver a secure, scalable infrastructure, a streamlined patient experience and an approach that maximizes provider efficiency, all while seeing much-needed vendor consolidation.


12 Telehealth & Virtual Care Predictions and Trends for 2021

Jeff Lew, SVP of Product Management, Nextech

Earlier this year, CMS enacted new rules to provide practices with the flexibility they need to use telehealth solutions in response to COVID-19, during which patients also needed an alternative to simply visiting the office. This was the impetus to the accelerated acceptance of telehealth as a means to both give and receive care. Specialty practices, in particular, are seeing successful and positive patient experiences due to telehealth visits. Dermatology practices specifically standout and I expect the strong adoption will continue to grow and certainly be the “new normal.” In addition, innovative practices that have embraced this omni-channel approach to delivering care are also establishing this as a “new normal” by selectively using telehealth visits for certain types of encounters, such as post-op visits or triaging patients. This gives patients a choice and the added convenience that comes with it and, in some cases, increases patient volume for the practice.


2020’s Top 20 Digital Health M&A Deals Totaled $50B

Teladoc Health and Livongo Merge

2020’s Top 20 Digital Health M&A Deals Totaled $50B

The combination of Teladoc Health and Livongo creates a
global leader in consumer-centered virtual care. The combined company is
positioned to execute quantified opportunities to drive revenue synergies of
$100 million by the end of the second year following the close, reaching $500
million on a run-rate basis by 2025.

Price: $18.5B in value based on each share of Livongo
will be exchanged for 0.5920x shares of Teladoc Health plus cash consideration
of $11.33 for each Livongo share.


Siemens Healthineers Acquires Varian Medical

2020’s Top 20 Digital Health M&A Deals Totaled $50B

On August 2nd, Siemens Healthineers acquired
Varian Medical for $16.4B, with the deal expected to close in 2021. Varian is a
global specialist in the field of cancer care, providing solutions especially
in radiation oncology and related software, including technologies such as
artificial intelligence, machine learning and data analysis. In fiscal year 2019,
the company generated $3.2 billion in revenues with an adjusted operating
margin of about 17%. The company currently has about 10,000 employees
worldwide.

Price: $16.4 billion in an all-cash transaction.


Gainwell to Acquire HMS for $3.4B in Cash

2020’s Top 20 Digital Health M&A Deals Totaled $50B

Veritas Capital (“Veritas”)-backed Gainwell Technologies (“Gainwell”),
a leading provider of solutions that are vital to the administration and
operations of health and human services programs, today announced that they
have entered into a definitive agreement whereby Gainwell will acquire HMS, a technology, analytics and engagement
solutions provider helping organizations reduce costs and improve health
outcomes.

Price: $3.4 billion in cash.


Philips Acquires Remote Cardiac Monitoring BioTelemetry for $2.8B

2020’s Top 20 Digital Health M&A Deals Totaled $50B

Philips acquires BioTelemetry, a U.S. provider of remote
cardiac diagnostics and monitoring for $72.00 per share for an implied
enterprise value of $2.8 billion (approx. EUR 2.3 billion). With $439M in
revenue in 2019, BioTelemetry annually monitors over 1 million cardiac patients
remotely; its portfolio includes wearable heart monitors, AI-based data
analytics, and services.

Price: $2.8B ($72 per share), to be paid in cash upon
completion.


Hims & Hers Merges with Oaktree Acquisition Corp to Go Public on NYSE

Telehealth company Hims & Hers and Oaktree Acquisition Corp., a special purpose acquisition company (SPAC) merge to go public on the New York Stock Exchange (NYSE) under the symbol “HIMS.” The merger will enable further investment in growth and new product categories that will accelerate Hims & Hers’ plan to become the digital front door to the healthcare system

Price: The business combination values the combined
company at an enterprise value of approximately $1.6 billion and is expected to
deliver up to $280 million of cash to the combined company through the
contribution of up to $205 million of cash.


SPAC Merges with 2 Telehealth Companies to Form Public
Digital Health Company in $1.35B Deal

2020’s Top 20 Digital Health M&A Deals Totaled $50B

Blank check acquisition company GigCapital2 agreed to merge with Cloudbreak Health, LLC, a unified telemedicine and video medical interpretation solutions provider, and UpHealth Holdings, Inc., one of the largest national and international digital healthcare providers to form a combined digital health company. 

Price: The merger deal is worth $1.35 billion, including
debt.


WellSky Acquires CarePort Health from Allscripts for
$1.35B

2020’s Top 20 Digital Health M&A Deals Totaled $50B

WellSky, global health, and community care technology company, announced today that it has entered into a definitive agreement with Allscripts to acquire CarePort Health (“CarePort”), a Boston, MA-based care coordination software company that connects acute and post-acute providers and payers.

Price: $1.35 billion represents a multiple of greater
than 13 times CarePort’s revenue over the trailing 12 months, and approximately
21 times CarePort’s non-GAAP Adjusted EBITDA over the trailing 12 months.


Waystar Acquires Medicare RCM Company eSolutions

2020’s Top 20 Digital Health M&A Deals Totaled $50B

On September 13th, revenue cycle management
provider Waystar acquires eSolutions, a provider of Medicare and Multi-Payer revenue
cycle management, workflow automation, and data analytics tools. The
acquisition creates the first unified healthcare payments platform with both
commercial and government payer connectivity, resulting in greater value for
providers.

Price: $1.3 billion valuation


Radiology Partners Acquires MEDNAX Radiology Solutions

2020’s Top 20 Digital Health M&A Deals Totaled $50B

Radiology Partners (RP), a radiology practice in the U.S., announced a definitive agreement to acquire MEDNAX Radiology Solutions, a division of MEDNAX, Inc. for an enterprise value of approximately $885 million. The acquisition is expected to add more than 800 radiologists to RP’s existing practice of 1,600 radiologists. MEDNAX Radiology Solutions consists of more than 300 onsite radiologists, who primarily serve patients in Connecticut, Florida, Nevada, Tennessee, and Texas, and more than 500 teleradiologists, who serve patients in all 50 states.

Price: $885M


PointClickCare Acquires Collective Medical

2020’s Top 20 Digital Health M&A Deals Totaled $50B

PointClickCare Technologies, a leader in senior care technology with a network of more than 21,000 skilled nursing facilities, senior living communities, and home health agencies, today announced its intent to acquire Collective Medical, a Salt Lake City, a UT-based leading network-enabled platform for real-time cross-continuum care coordination for $650M. Together, PointClickCare and Collective Medical will provide diverse care teams across the continuum of acute, ambulatory, and post-acute care with point-of-care access to deep, real-time patient insights at any stage of a patient’s healthcare journey, enabling better decision making and improved clinical outcomes at a lower cost.

Price: $650M


Teladoc Health Acquires Virtual Care Platform InTouch
Health

2020’s Top 20 Digital Health M&A Deals Totaled $50B

Teladoc Health acquires InTouch Health, the leading provider of enterprise telehealth solutions for hospitals and health systems for $600M. The acquisition establishes Teladoc Health as the only virtual care provider covering the full range of acuity – from critical to chronic to everyday care – through a single solution across all sites of care including home, pharmacy, retail, physician office, ambulance, and more.

Price: $600M consisting of approximately $150 million
in cash and $450 million of Teladoc Health common stock.


AMN Healthcare Acquires VRI Provider Stratus Video

2020’s Top 20 Digital Health M&A Deals Totaled $50B

AMN Healthcare Services, Inc. acquires Stratus Video, a leading provider of video remote language interpretation services for the healthcare industry. The acquisition will help AMN Healthcare expand in the virtual workforce, patient care arena, and quality medical interpretation services delivered through a secure communications platform.

Price: $475M


CarepathRx Acquires Pharmacy Operations of Chartwell from
UPMC

2020’s Top 20 Digital Health M&A Deals Totaled $50B

CarepathRx, a leader in pharmacy and medication management
solutions for vulnerable and chronically ill patients, announced today a
partnership with UPMC’s Chartwell subsidiary that will expand patient access to
innovative specialty pharmacy and home infusion services. Under the $400M
landmark agreement, CarepathRx will acquire the
management services organization responsible for the operational and strategic
management of Chartwell while UPMC becomes a strategic investor in CarepathRx. 

Price: $400M


Cerner to Acquire Health Division of Kantar for $375M in
Cash

Cerner announces it will acquire Kantar Health, a leading
data, analytics, and real-world evidence and commercial research consultancy
serving the life science and health care industry.

This acquisition is expected to allow Cerner’s Learning
Health Network client consortium and health systems with more opportunities to
directly engage with life sciences for funded research studies. The acquisition
is expected to close during the first half of 2021.

Price: $375M


Cerner Sells Off Parts of Healthcare IT Business in
Germany and Spain

2020’s Top 20 Digital Health M&A Deals Totaled $50B

Cerner sells off parts of healthcare IT business in Germany and Spain to Germany company CompuGroup Medical, reflecting the company-wide transformation focused on improved operating efficiencies, enhanced client focus, a refined growth strategy, and a sharpened approach to portfolio management.

Price: EUR 225 million ($247.5M USD)


CompuGroup Medical Acquires eMDs for $240M

2020’s Top 20 Digital Health M&A Deals Totaled $50B

CompuGroup Medical (CGM) acquires eMDs, Inc. (eMDs), a
leading provider of healthcare IT with a focus on doctors’ practices in the US,
reaching an attractive size in the biggest healthcare market worldwide. With
this acquisition, the US subsidiary of CGM significantly broadens its position
and will become the top 4 providers in the market for Ambulatory Information
Systems in the US.

Price: $240M (equal to approx. EUR 203 million)


Change Healthcare Buys Back Pharmacy Network

2020’s Top 20 Digital Health M&A Deals Totaled $50B

Change
Healthcare
 buys
back
 pharmacy unit eRx Network
(“eRx”),
 a leading provider of comprehensive, innovative, and secure
data-driven solutions for pharmacies. eRx generated approximately $67M in
annual revenue for the twelve-month period ended February 29, 2020. The
transaction supports Change Healthcare’s commitment to focus on and invest in
core aspects of the business to fuel long-term growth and advance innovation.

Price: $212.9M plus cash on the balance sheet.


Walmart Acquires Medication Management Platform CareZone

2020’s Top 20 Digital Health M&A Deals Totaled $50B

Walmart acquires CareZone, a San Francisco, CA-based smartphone
service for managing chronic health conditions for reportedly $200M. By
working with a network of pharmacy partners, CareZone’s concierge services
assist consumers in getting their prescription medications organized and
delivered to their doorstep, making pharmacies more accessible to individuals
and families who may be homebound or reside in rural locations.

Price: $200M


Verisk Acquires MSP Compliance Provider Franco Signor

2020’s Top 20 Digital Health M&A Deals Totaled $50B

Verisk, a data
analytics provider, announced today that it has acquired Franco Signor, a Medicare Secondary Payer
(MSP) service provider to America’s largest insurance carriers and employers.
As part of the acquisition, Franco Signor will become part of Verisk’s Claims
Partners business, a leading provider of MSP compliance and other analytic
claim services. Claims Partners and Franco Signor will be combining forces to
provide the single best resource for Medicare compliance. 

Price: $160M


Rubicon Technology Partners Acquires Central Logic

2020’s Top 20 Digital Health M&A Deals Totaled $50B

Private equity firm Rubicon Technology Partners acquires
Central Logic, a provider of patient orchestration and tools to accelerate
access to care for healthcare organizations. Rubicon will be aggressively driving Central Logic’s
growth with additional cash investments into the business, with a focus
on product innovation, sales expansion, delivery and customer support, and
the pursuit of acquisition opportunities.

Price: $110M – $125 million, according to sources


CIO: 3 Rules for Meeting ONC/CMS Interoperability, While Improving Cybersecurity

Healthcare data security has been a growing concern for CIOs for the last year or so, as hackers are increasingly targeting health information. Now, with a global pandemic forcing a shift to telemedicine and remote work, and new rules from the ONC and CMS introducing more regulatory burden, healthcare CIOs have more to manage than ever. Fortunately, it is possible to roll out new capabilities while simultaneously improving cybersecurity by following these three rules:

Rule 1: Think Like an Attacker

The coronavirus pandemic has forced healthcare providers everywhere to roll out new capabilities, processes, and workflows, such as telemedicine systems and new patient check-in procedures. These measures are being taken in addition to the necessary work being done to comply with the new mandates from ONC and CMS regarding patient data accessibility. Though these changes need to be implemented quickly, it’s important to follow cybersecurity best practices to avoid providing new openings for attackers. 

When a hacker sees new systems and processes being implemented, they are thinking about:

– What software is being introduced? Are there known vulnerabilities or frequently unpatched exploits associated with it?

– How are new endpoints being added and are they secure?

– Since the new ONC and CMS rules require publicly exposed FHIR APIs, how can those be attacked? Are there social engineering exploits that can provide a way around security?

– Are there ways to perpetrate identity fraud if a patient does not need to be physically present to receive healthcare?

This approach should lead to a cybersecurity plan that puts measures in place for each identified risk. By thinking like the adversary, it is possible to identify and lock down the possible attack vectors. 

Rule 2: Minimize the Attack Surface

Every way into an organization’s network needs to be secured, monitored, and maintained. The best way to make this process as efficient and fool-proof as possible is to minimize the number of ways into the network. 

This is especially difficult in light of the ONC and CMS rules, which require that clinical systems must share data through publicly available FHIR APIs. At first, this seems like a mandate to radically expand the organization’s attack surface. Indeed, this is precisely what happens if the straightforward approach of exposing every clinical system through public APIs is followed. 

A different approach, which provides the same capabilities and compliance with the rules, would be to route all API traffic through a central hub. Attaching all the clinical systems to a single point of API access provides a number of benefits:

– Most importantly, compliance is achieved while minimizing the new attack vectors.

– All traffic between clinical systems and the outside world can be monitored from a single place.

– The API hub can act as a façade that makes legacy systems compliant with the new rules, even if those systems lack native FHIR API capabilities.

The API hub need not be an expensive new component of the network architecture. Most healthcare organizations are already using a clinical integration engine to move HL7, XML, and DICOM traffic among their internal systems. The same technology can serve as an API hub. This is especially effective if a new instance of the integration engine is placed in an isolated part of the network without full access to other systems. 

Rule 3: Have an Expert Review the Defenses

Even for healthcare organizations with cybersecurity experts on staff, it can be worthwhile to bring in a cybersecurity consultant to cross-check new implementations. Novel threats are constantly shifting and emerging, making it nearly impossible for internal IT staff to keep up with the looming threats of ransomware hacks, while also adequately carrying out the day-to-day responsibilities of their jobs. For that reason, it makes sense to bring in a professional who focuses exclusively on security. It is also often useful to have an independent review from someone who is looking at the implementation from an outsider’s perspective. Independent consultants can provide the necessary guidance, risk assessments, and other security support, to set healthcare organizations up for success and operate more securely. 

Expanding an organization’s IT capabilities often means more exposure to risk, especially when implementations are subject to time constraints. However, given the value and importance of the data that’s being generated, transmitted, and stored, it is imperative not to let cybersecurity fall out of focus. By following best practices around design, implementation, and testing healthcare organizations can rise to meet the current challenges of the pandemic, address the mandates of the interoperability rules, and simultaneously improve data security measures. 


About Scott Galbari, Chief Technology Officer

As Chief Technology Officer for Lyniate, Scott leads the development and delivery of all products and services. Scott has been in the healthcare IT domain for the past twenty years and has experience in developing and delivering imaging, workflow, nursing, interoperability, and patient flow solutions to customers in all geographies. He was most recently the General Manager for multiple businesses within McKesson and Change Healthcare and started his career as a software developer.

About Drew Ivan, Chief Product & Strategy Officer

Drew’s focus is on how to operationalize and productize integration technologies, patterns, and best practices. His experience includes over 20 years in health IT, working with a wide spectrum of customers, including public HIEs, IDNs, payers, life sciences companies, and software vendors, with the goal of improving outcomes and reducing costs by aggregating and analyzing clinical, claims, and cost data.


30 Executives Share Top Healthcare Predictions & Trends to Watch in 2021

As we close out the year, we asked several healthcare executives to share their predictions and trends for 2021.

30 Executives Share Top Healthcare Predictions & Trends to Watch in 2021

Kimberly Powell, Vice President & General Manager, NVIDIA Healthcare

Federated Learning: The clinical community will increase their use of federated learning approaches to build robust AI models across various institutions, geographies, patient demographics, and medical scanners. The sensitivity and selectivity of these models are outperforming AI models built at a single institution, even when there is copious data to train with. As an added bonus, researchers can collaborate on AI model creation without sharing confidential patient information. Federated learning is also beneficial for building AI models for areas where data is scarce, such as for pediatrics and rare diseases.

AI-Driven Drug Discovery: The COVID-19 pandemic has put a spotlight on drug discovery, which encompasses microscopic viewing of molecules and proteins, sorting through millions of chemical structures, in-silico methods for screening, protein-ligand interactions, genomic analysis, and assimilating data from structured and unstructured sources. Drug development typically takes over 10 years, however, in the wake of COVID, pharmaceutical companies, biotechs, and researchers realize that acceleration of traditional methods is paramount. Newly created AI-powered discovery labs with GPU-accelerated instruments and AI models will expedite time to insight — creating a computing time machine.

Smart Hospitals: The need for smart hospitals has never been more urgent. Similar to the experience at home, smart speakers and smart cameras help automate and inform activities. The technology, when used in hospitals, will help scale the work of nurses on the front lines, increase operational efficiency, and provide virtual patient monitoring to predict and prevent adverse patient events. 


30 Executives Share Top Healthcare Predictions & Trends to Watch in 2021

Omri Shor, CEO of Medisafe

Healthcare policy: Expect to see more moves on prescription drug prices, either through a collaborative effort among pharma groups or through importation efforts. Pre-existing conditions will still be covered for the 135 million Americans with pre-existing conditions.

The Biden administration has made this a central element of this platform, so coverage will remain for those covered under ACA. Look for expansion or revisions of the current ACA to be proposed, but stalled in Congress, so existing law will remain largely unchanged. Early feedback indicates the Supreme Court is unlikely to strike down the law entirely, providing relief to many during a pandemic.


30 Executives Share Top Healthcare Predictions & Trends to Watch in 2021

Brent D. Lang, Chairman & Chief Executive Officer, Vocera Communications

The safety and well-being of healthcare workers will be a top priority in 2021. While there are promising headlines about coronavirus vaccines, we can be sure that nurses, doctors, and other care team members will still be on the frontlines fighting COVID-19 for many more months. We must focus on protecting and connecting these essential workers now and beyond the pandemic.

Modernized PPE Standards
Clinicians should not risk contamination to communicate with colleagues. Yet, this simple act can be risky without the right tools. To minimize exposure to infectious diseases, more hospitals will rethink personal protective equipment (PPE) and modernize standards to include hands-free communication technology. In addition to protecting people, hands-free communication can save valuable time and resources. Every time a nurse must leave an isolation room to answer a call, ask a question, or get supplies, he or she must remove PPE and don a fresh set to re-enter. With voice-controlled devices worn under PPE, the nurse can communicate without disrupting care or leaving the patient’s bedside.

Improved Capacity

Voice-controlled solutions can also help new or reassigned care team members who are unfamiliar with personnel, processes, or the location of supplies. Instead of worrying about knowing names or numbers, they can use simple voice commands to connect to the right person, group, or information quickly and safely. In addition to simplifying clinical workflows, an intelligent communication system can streamline operational efficiencies, improve triage and throughput, and increase capacity, which is all essential to hospitals seeking ways to recover from 2020 losses and accelerate growth.


30 Executives Share Top Healthcare Predictions & Trends to Watch in 2021

Michael Byczkowski, Global Vice President, Head of Healthcare Industry at SAP,

New, targeted healthcare networks will collaborate and innovate to improve patient outcomes.

We will see many more touchpoints between different entities ranging from healthcare providers and life sciences companies to technology providers and other suppliers, fostering a sense of community within the healthcare industry. More organizations will collaborate based on existing data assets, perform analysis jointly, and begin adding innovative, data-driven software enhancements. With these networks positively influencing the efficacy of treatments while automatically managing adherence to local laws and regulations regarding data use and privacy, they are paving the way for software-defined healthcare.

Smart hospitals will create actionable insights for the entire organization out of existing data and information.

Medical records as well as operational data within a hospital will continue to be digitized and will be combined with experience data, third-party information, and data from non-traditional sources such as wearables and other Internet of Things devices. Hospitals that have embraced digital are leveraging their data to automate tasks and processes as well as enable decision support for their medical and administrative staff. In the near future, hospitals could add intelligence into their enterprise environments so they can use data to improve internal operations and reduce overhead.


30 Executives Share Top Healthcare Predictions & Trends to Watch in 2021

Curt Medeiros, President and Chief Operating Officer of Ontrak

As health care costs continue to rise dramatically given the pandemic and its projected aftermath, I see a growing and critical sophistication in healthcare analytics taking root more broadly than ever before. Effective value-based care and network management depend on the ability of health plans and providers to understand what works, why, and where best to allocate resources to improve outcomes and lower costs. Tied to the need for better analytics, I see a tipping point approaching for finally achieving better data security and interoperability. Without the ability to securely share data, our industry is trying to solve the world’s health challenges with one hand tied behind our backs.


30 Executives Share Top Healthcare Predictions & Trends to Watch in 2021

G. Cameron Deemer, President, DrFirst

Like many business issues, the question of whether to use single-vendor solutions or a best-of-breed approach swings back and forth in the healthcare space over time. Looking forward, the pace of technology change is likely to swing the pendulum to a new model: systems that are supplemental to the existing core platform. As healthcare IT matures, it’s often not a question of ‘can my vendor provide this?’ but ‘can my vendor provide this in the way I need it to maximize my business processes and revenues?

This will be more clear with an example: An EHR may provide a medication history function, for instance, but does it include every source of medication history available? Does it provide a medication history that is easily understood and acted upon by the provider? Does it provide a medication history that works properly with all downstream functions in the EHR? When a provider first experiences medication history during a patient encounter, it seems like magic.

After a short time, the magic fades to irritation as the incompleteness of the solution becomes more obvious. Much of the newer healthcare technologies suffer this same incompleteness. Supplementing the underlying system’s capabilities with a strongly integrated third-party system is increasingly going to be the strategy of choice for providers.


Angie Franks, CEO of Central Logic

In 2021, we will see more health systems moving towards the goal of truly operating as one system of care. The pandemic has demonstrated in the starkest terms how crucial it is for health systems to have real-time visibility into available beds, providers, transport, and scarce resources such as ventilators and drugs, so patients with COVID-19 can receive the critical care they need without delay. The importance of fully aligning as a single integrated system that seamlessly shares data and resources with a centralized, real-time view of operations is a lesson that will resonate with many health systems.

Expect in 2021 for health systems to enhance their ability to orchestrate and navigate patient transitions across their facilities and through the continuum of care, including post-acute care. Ultimately, this efficient care access across all phases of care will help healthcare organizations regain revenue lost during the historic drop in elective care in 2020 due to COVID-19.

In addition to elevating revenue capture, improving system-wide orchestration and navigation will increase health systems’ bed availability and access for incoming patients, create more time for clinicians to operate at the top of their license, and reduce system leakage. This focus on creating an ‘operating as one’ mindset will not only help health systems recover from 2020 losses, it will foster sustainable and long-term growth in 2021 and well into the future.


30 Executives Share Top Healthcare Predictions & Trends to Watch in 2021

John Danaher, MD, President, Global Clinical Solutions, Elsevier

COVID-19 has brought renewed attention to healthcare inequities in the U.S., with the disproportionate impact on people of color and minority populations. It’s no secret that there are indicative factors, such as socioeconomic level, education and literacy levels, and physical environments, that influence a patient’s health status. Understanding these social determinants of health (SDOH) better and unlocking this data on a wider scale is critical to the future of medicine as it allows us to connect vulnerable populations with interventions and services that can help improve treatment decisions and health outcomes. In 2021, I expect the health informatics industry to take a larger interest in developing technologies that provide these kinds of in-depth population health insights.


30 Executives Share Top Healthcare Predictions & Trends to Watch in 2021

Jay Desai, CEO and co-founder of PatientPing

2021 will see an acceleration of care coordination across the continuum fueled by the Centers for Medicare and Medicaid Services (CMS) Interoperability and Patient Access rule’s e-notifications Condition of Participation (CoP), which goes into effect on May 1, 2021. The CoP requires all hospitals, psych hospitals, and critical access hospitals that have a certified electronic medical record system to provide notification of admit, discharge, and transfer, at both the emergency room and the inpatient setting, to the patient’s care team. Due to silos, both inside and outside of a provider’s organization, providers miss opportunities to best treat their patients simply due to lack of information on patients and their care events.

This especially impacts the most vulnerable patients, those that suffer from chronic conditions, comorbidities or mental illness, or patients with health disparities due to economic disadvantage or racial inequity. COVID-19 exacerbated the impact on these vulnerable populations. To solve for this, healthcare providers and organizations will continue to assess their care coordination strategies and expand their patient data interoperability initiatives in 2021, including becoming compliant with the e-notifications Condition of Participation.


30 Executives Share Top Healthcare Predictions & Trends to Watch in 2021

Kuldeep Singh Rajput, CEO and founder of Biofourmis

Driven by CMS’ Acute Hospital at Home program announced in November 2020, we will begin to see more health systems delivering hospital-level care in the comfort of the patient’s home–supported by technologies such as clinical-grade wearables, remote patient monitoring, and artificial intelligence-based predictive analytics and machine learning.

A randomized controlled trial by Brigham Health published in Annals of Internal Medicine earlier this year demonstrated that when compared with usual hospital care, Home Hospital programs can reduce rehospitalizations by 70% while decreasing costs by nearly 40%. Other advantages of home hospital programs include a reduction in hospital-based staffing needs, increased capacity for those patients who do need inpatient care, decreased exposure to COVID-19 and other viruses such as influenza for patients and healthcare professionals, and improved patient and family member experience.


30 Executives Share Top Healthcare Predictions & Trends to Watch in 2021

Jake Pyles, CEO, CipherHealth

The disappearance of the hospital monopoly will give rise to a new loyalty push

Healthcare consumerism was on the rise ahead of the pandemic, but the explosion of telehealth in 2020 has effectively eliminated the geographical constraints that moored patient populations to their local hospitals and providers. The fallout has come in the form of widespread network leakage and lost revenue. By October, in fact, revenue for hospitals in the U.S. was down 9.2% year-over-year. Able to select providers from the comfort of home and with an ever-increasing amount of personal health data at their convenience through the growing use of consumer-grade wearable devices, patients are more incentivized in 2021 to choose the provider that works for them.

After the pandemic fades, we’ll see some retrenchment from telehealth, but it will remain a mainstream care delivery model for large swaths of the population. In fact, post-pandemic, we believe telehealth will standardize and constitute a full 30% to 40% of interactions.

That means that to compete, as well as to begin to recover lost revenue, hospitals need to go beyond offering the same virtual health convenience as their competitors – Livango and Teladoc should have been a shot across the bow for every health system in 2020. Moreover, hospitals need to become marketing organizations. Like any for-profit brand, hospitals need to devote significant resources to building loyalty but have traditionally eschewed many of the cutting-edge marketing techniques used in other industries. Engagement and personalization at every step of the patient journey will be core to those efforts.


Marc Probst, former Intermountain Health System CIO, Advisor for SR Health by Solutionreach

Healthcare will fix what it’s lacking most–communication.

Because every patient and their health is unique, when it comes to patient care, decisions need to be customized to their specific situation and environment, yet done in a timely fashion. In my two decades at one of the most innovative health systems in the U.S., communication, both across teams and with patients continuously has been less than optimal. I believe we will finally address both the interpersonal and interface communication issues that organizations have faced since the digitization of healthcare.”


Rich Miller, Chief Strategy Officer, Qgenda

2021 – The year of reforming healthcare: We’ve been looking at ways to ease healthcare burdens for patients for so long that we haven’t realized the onus we’ve put on providers in doing so. Adding to that burden, in 2020 we had to throw out all of our playbooks and become masters of being reactive. Now, it’s time to think through the lessons learned and think through how to be proactive. I believe provider-based data will allow us to reformulate our priorities and processes. By analyzing providers’ biggest pain points in real-time, we can evaporate the workflow and financial troubles that have been bothering organizations while also relieving providers of their biggest problems.”


Robert Hanscom, JD, Vice President of Risk Management and Analytics at Coverys

Data Becomes the Fix, Not the Headache for Healthcare

The past 10 years have been challenging for an already overextended healthcare workforce. Rising litigation costs, higher severity claims, and more stringent reimbursement mandates put pressure on the bottom line. Continued crises in combination with less-than-optimal interoperability and design of health information systems, physician burnout, and loss of patient trust, have put front-line clinicians and staff under tremendous pressure.

Looking to the future, it is critical to engage beyond the day to day to rise above the persistent risks that challenge safe, high-quality care on the frontline. The good news is healthcare leaders can take advantage of tools that are available to generate, package, and learn from data – and use them to motivate action.


30 Executives Share Top Healthcare Predictions & Trends to Watch in 2021

Steve Betts, Chief of Operations and Products at Gray Matter Analytics

Analytics Divide Intensifies: Just like the digital divide is widening in society, the analytics divide will continue to intensify in healthcare. The role of data in healthcare has shifted rapidly, as the industry has wrestled with an unsustainable rate of increasing healthcare costs. The transition to value-based care means that it is now table stakes to effectively manage clinical quality measures, patient/member experience measures, provider performance measures, and much more. In 2021, as the volume of data increases and the intelligence of the models improves, the gap between the haves and have nots will significantly widen at an ever-increasing rate.

Substantial Investment in Predictive Solutions: The large health systems and payors will continue to invest tens of millions of dollars in 2021. This will go toward building predictive models to infuse intelligent “next best actions” into their workflows that will help them grow and manage the health of their patient/member populations more effectively than the small and mid-market players.


Jennifer Price, Executive Director of Data & Analytics at THREAD

The Rise of Home-based and Decentralized Clinical Trial Participation

In 2020, we saw a significant rise in home-based activities such as online shopping, virtual school classes and working from home. Out of necessity to continue important clinical research, home health services and decentralized technologies also moved into the home. In 2021, we expect to see this trend continue to accelerate, with participants receiving clinical trial treatments at home, home health care providers administering procedures and tests from the participant’s home, and telehealth virtual visits as a key approach for sites and participants to communicate. Hybrid decentralized studies that include a mix of on-site visits, home health appointments and telehealth virtual visits will become a standard option for a range of clinical trials across therapeutic areas. Technological advances and increased regulatory support will continue to enable the industry to move out of the clinic and into the home.


30 Executives Share Top Healthcare Predictions & Trends to Watch in 2021

Doug Duskin, President of the Technology Division at Equality Health

Value-based care has been a watchword of the healthcare industry for many years now, but advancement into more sophisticated VBC models has been slower than anticipated. As we enter 2021, providers – particularly those in fee-for-service models who have struggled financially due to COVID-19 – and payers will accelerate this shift away from fee-for-service medicine and turn to technology that can facilitate and ease the transition to more risk-bearing contracts. Value-based care, which has proven to be a more stable and sustainable model throughout the pandemic, will seem much more appealing to providers that were once reluctant to enter into risk-bearing contracts. They will no longer be wondering if they should consider value-based contracting, but how best to engage.


30 Executives Share Top Healthcare Predictions & Trends to Watch in 2021

Brian Robertson, CEO of VisiQuate

Continued digitization and integration of information assets: In 2021, this will lead to better performance outcomes and clearer, more measurable examples of “return on data, analytics, and automation.

Digitizing healthcare’s complex clinical, financial, and operational information assets: I believe that providers who are further in the digital transformation journey will make better use of their interconnected assets, and put the healthcare consumer in the center of that highly integrated universe. Healthcare consumer data will be studied, better analyzed, and better predicted to drive improved performance outcomes that benefit the patient both clinically and financially.

Some providers will have leapfrog moments: These transformations will be so significant that consumers will easily recognize that they are receiving higher value. Lower acuity telemedicine and other virtual care settings are great examples that lead to improved patient engagement, experience and satisfaction. Device connectedness and IoT will continue to mature, and better enable chronic disease management, wellness, and other healthy lifestyle habits for consumers.


Kermit S. Randa, CEO of Syntellis Performance Solutions

Healthcare CEOs and CFOs will partner closely with their CIOs on data governance and data distribution planning. With the massive impact of COVID-19 still very much in play in 2021, healthcare executives will need to make frequent data-driven – and often ad-hoc — decisions from more enterprise data streams than ever before. Syntellis research shows that healthcare executives are already laser-focused on cost reduction and optimization, with decreased attention to capital planning and strategic growth. In 2021, there will be a strong trend in healthcare organizations toward new initiatives, including clinical and quality analytics, operational budgeting, and reporting and analysis for decision support.


Dr. Calum Yacoubian, Associate Director of Healthcare Product & Strategy at Linguamatics

As payers and providers look to recover from the damage done by the pandemic, the ability to deliver value from data assets they already own will be key. The pandemic has displayed the siloed nature of healthcare data, and the difficulty in extracting vital information, particularly from unstructured data, that exists. Therefore, technologies and solutions that can normalize these data to deliver deeper and faster insights will be key to driving economic recovery. Adopting technologies such as natural language processing (NLP) will not only offer better population health management, ensuring the patients most in need are identified and triaged but will open new avenues to advance innovations in treatments and improve operational efficiencies.

Prior to the pandemic, there was already an increasing level of focus on the use of real-world data (RWD) to advance the discovery and development of new therapies and understand the efficacy of existing therapies. The disruption caused by COVID-19 has sharpened the focus on RWD as pharma looks to mitigate the effect of the virus on conventional trial recruitment and data collection. One such example of this is the use of secondary data collection from providers to build real-world cohorts which can serve as external comparator arms.

This convergence on seeking value from existing RWD potentially affords healthcare providers a powerful opportunity to engage in more clinical research and accelerate the work to develop life-saving therapies. By mobilizing the vast amount of data, they will offer pharmaceutical companies a mechanism to positively address some of the disruption caused by COVID-19. This movement is one strategy that is key to driving provider recovery in 2021.


Rose Higgins, Chief Executive Officer of HealthMyne

Precision imaging analytics technology, called radiomics, will increasingly be adopted and incorporated into drug development strategies and clinical trials management. These AI-powered analytics will enable drug developers to gain deeper insights from medical images than previously capable, driving accelerated therapy development, greater personalization of treatment, and the discovery of new biomarkers that will enhance clinical decision-making and treatment.


30 Executives Share Top Healthcare Predictions & Trends to Watch in 2021

Dharmesh Godha, President and CTO of Advaiya

Greater adoption and creative implementation of remote healthcare will be the biggest trend for the year 2021, along with the continuous adoption of cloud-enabled digital technologies for increased workloads. Remote healthcare is a very open field. The possibilities to innovate in this area are huge. This is the time where we can see the beginning of the convergence of personal health aware IoT devices (smartwatches/ temp sensors/ BP monitors/etc.) with the advanced capabilities of the healthcare technologies available with the monitoring and intervention capabilities for the providers.


30 Executives Share Top Healthcare Predictions & Trends to Watch in 2021

Simon Wu, Investment Director, Cathay Innovation

Healthcare Data Proves its Weight in Gold in 2021

Real-world evidence or routinely stored data from hospitals and claims, being leveraged by healthcare providers and biopharma companies along with those that can improve access to data will grow exponentially in the coming year. There are many trying to build in-house, but similar to autonomous technology, there will be a separate set of companies emerge in 2021 to provide regulated infrastructure and have their “AWS” moment.


Kyle Raffaniello, CEO of Sapphire Digital

2021 is a clear year for healthcare price transparency

Over the past year, healthcare price transparency has been a key topic for the Trump administration in an effort to lower healthcare costs for Americans. In recent months, COVID-19 has made the topic more important to patients than ever before. Starting in January, we can expect the incoming Biden administration to not only support the existing federal transparency regulations but also continue to push for more transparency and innovation within Medicare. I anticipate that healthcare price transparency will continue its momentum in 2021 as one of two Price Transparency rules takes effect and the Biden administration supports this movement.


30 Executives Share Top Healthcare Predictions & Trends to Watch in 2021

Dennis McLaughlin VP of Omni Operations + Product at ibi

Social Determinants of Health Goes Mainstream: Understanding more about the patient and their personal environment has a hot topic the past two years. Providers and payers’ ability to inject this knowledge and insight into the clinical process has been limited. 2021 is the year it gets real. It’s not just about calling an uber anymore. The organizations that broadly factor SDOH into the servicing model especially with virtualized medicine expanding broadly will be able to more effectively reach vulnerable patients and maximize the effectiveness of care.


30 Executives Share Top Healthcare Predictions & Trends to Watch in 2021

Joe Partlow, CTO at ReliaQuest

The biggest threat to personal privacy will be healthcare information: Researchers are rushing to pool resources and data sets to tackle the pandemic, but this new era of openness comes with concerns around privacy, ownership, and ethics. Now, you will be asked to share your medical status and contact information, not just with your doctors, but everywhere you go, from workplaces to gyms to restaurants. Your personal health information is being put in the hands of businesses that may not know how to safeguard it. In 2021, cybercriminals will capitalize on rapid U.S. telehealth adoption. Sharing this information will have major privacy implications that span beyond keeping medical data safe from cybercriminals to wider ethics issues and insurance implications.


30 Executives Share Top Healthcare Predictions & Trends to Watch in 2021

Jimmy Nguyen, Founding President at Bitcoin Association

Blockchain solutions in the healthcare space will bring about massive improvements in two primary ways in 2021.

Firstly, blockchain applications will for the first time facilitate patients owning, managing, and even monetizing their personal health data. Today’s healthcare information systems are incredibly fragmented, with patient data from different sources – be they physicians, pharmacies, labs, or otherwise – kept in different silos, eliminating the ability to generate a holistic view of patient information and restricting healthcare providers from producing the best health outcomes.

Healthcare organizations are growing increasingly aware of the ways in which blockchain technology can be used to eliminate data silos, enable real-time access to patient information, and return control to patients for the use of their personal data – all in a highly-secure digital environment. 2021 will be the year that patient data goes blockchain.

Secondly, blockchain solutions can ensure more honesty and transparency in the development of pharmaceutical products. Clinical research data is often subject to questions of integrity or ‘hygiene’ if data is not properly recorded, or worse, is deliberately fabricated. Blockchain technology enables easy, auditable tracking of datasets generated by clinical researchers, benefitting government agencies tasked with approving drugs while producing better health outcomes for healthcare providers and patients. In 2021, I expect to see a rise in the use and uptake of applications that use public blockchain systems to incentivize greater honesty in clinical research.


30 Executives Share Top Healthcare Predictions & Trends to Watch in 2021

Alex Lazarow, Investment Director, Cathay Innovation

The Future of US Healthcare is Transparent, Fair, Open and Consumer-Driven

In the last year, the pandemic put a spotlight on the major gaps in healthcare in the US, highlighting a broken system that is one of the most expensive and least distributed in the world. While we’ve already seen many boutique healthcare companies emerge to address issues around personalization, quality and convenience, the next few years will be focused on giving the power back to consumers, specifically with the rise of insurtechs, in fixing the transparency, affordability, and incentive issues that have plagued the private-based US healthcare system until now.


Lisa Romano, RN, Chief Nursing Officer, CipherHealth

Hospitals will need to counter the staff wellness fallout

The pandemic has placed unthinkable stress on frontline healthcare workers. Since it began, they’ve been working under conditions that are fundamentally more dangerous, with fewer resources, and in many cases under the heavy emotional burden of seeing several patients lose their battle with COVID-19. The fallout from that is already beginning – doctors and nurses are leaving the profession, or getting sick, or battling mental health struggles. Nursing programs are struggling to fill classes. As a new wave of the pandemic rolls across the country, that fallout will only increase. If they haven’t already, hospitals in 2021 will place new premiums upon staff wellness and staff health, tapping into the same type of outreach and purposeful rounding solutions they use to round on patients.


30 Executives Share Top Healthcare Predictions & Trends to Watch in 2021

Kris Fitzgerald, CTO, NTT DATA Services

Quality metrics for health plans – like data that measures performance – was turned on its head in 2020 due to delayed procedures. In the coming year, we will see a lot of plans interpret these delayed procedures flexibly so they honor their plans without impacting providers. However, for so long, the payer’s use of data and the provider’s use of data has been disconnected. Moving forward the need for providers to have a more specific understanding of what drives the value and if the cost is reasonable for care from the payer perspective is paramount. Data will ensure that this collaboration will be enhanced and the concept of bundle payments and aligning incentives will be improved. As the data captured becomes even richer, it will help people plan and manage their care better. The addition of artificial intelligence (AI) to this data will also play a huge role in both dialog and negotiation when it comes to cost structure. This movement will lead to a spike in value-based care adoption


Gladskin’s President Skyler Stein Talks Endolysin Technology – Q/A

Gladskin’s President Skyler Stein Talks Endolysin Technology
Skyler Stein, President of Gladskin

We recently spoke with Skyler Stein, President of Dutch biotechnology company Gladskin to learn more about its global endolysin technology that uses its science to improve inflammatory skin conditions by rebalancing the skin microbiome. Gladskin’s parent company, Micreos, raised about $36.7M in funding last year for its endolysin technology that is poised to replace many antibiotics and overcome some of the challenges of antimicrobial resistance.

HITC: Skyler, can you speak more
about endolysin technology? Can you share the results of clinical trials
related to AD (Atopid Dermatitis) with us?

Stein: Endolysin technology is cutting edge science, but actually it is based on three billion years of nature’s evolution to keep our skin healthy. Our endolysin is so targeted – it only targets a single bacterial species that is causing the problem, and it keeps the rest of your skin’s microbiome healthy. Based on the data from studies we’ve performed, resistance is not expected, making it a safe option to use daily. It doesn’t have the treatment limitations, side effects, or withdrawal symptoms that you can have with immunosuppressants, antibiotics, and steroids.

Micreos launched its double-blinded placebo-controlled Phase I/2A trial for the treatment of mild to moderate Atopic Dermatitis in September 2020.

HITC: Can you talk more about the
endolysin trials you are doing and can you share results?

Stein: We have performed various studies with our endolysin technology. The two summary charts that tell the story the best are the two below. In the chart on the left, you can see that the endolysin is specific to reducing S. aureus (the known trigger for eczema flares) and saving S. epidermis, which is a naturally protective bacteria that helps maintain microbial balance. In the chart on the right, you can see the Staph resistance developing against two common topical antibiotics, while no resistance develops against the use of the endolysin. 

Gladskin’s President Skyler Stein Talks Endolysin Technology - Q/A

 HITC: As 2020 comes to a close, have
dermatologists found new, more effective ways of treating eczema?

Stein: There is a tremendous amount of research happening supporting the fact that eczema is a bacterial driven disease. We know that the vast majority of people with eczema have Staph aureus on their skin and that it is causing itch, redness, and inflammation, even if it does not present clinically as a full-blown Staph infection. However, dermatologists have been trained to only use antibiotics in severe cases where there is clear evidence of infection. Endolysins represent a novel and safe opportunity to address the problem-causing Staph in a safe way, without having to use resistance-creating antibiotics. 

HITC: What is the correlation between
staph and eczema?

Stein: Dermatologists have always known that staph is opportunistic but physicians now know for sure that for eczema sufferers, staph is causal for flares. There has been clear evidence for quite some time that there is a very high correlation of Staph overgrowth with eczema. The chart below is from a study published by Heidi Kong from the N.I.H. that shows the direct correlation of Staph with eczema flare-ups. In September, a study was published in the Journal of Allergy and Clinical Immunology that provides evidence that Staph bacteria is a direct cause of (not just correlated with) eczema flare-ups, via the inflammation caused by its Second Immunoglobulin-Binding Protein.

Gladskin’s President Skyler Stein Talks Endolysin Technology - Q/A

HITC: Congratulations on your license agreement with L’Oreal. Is there some data you would like to share with us that you haven’t shared anywhere else yet?

Stein:
Thank you! We are very excited about our partnership with L’Oreal. By combining
our platform technology expertise with their global distribution capabilities,
together we will be able to help millions with inflammatory skin conditions
globally.


Vaccine Safety Expert Shares 5 COVID-19 Vaccine Facts to Protect 2021

Vaccine Safety Expert Shares 5 COVID-19 Vaccine Facts to Protect
Dr. Noam Tau of Sheba Medical Center

Now more than ever, public confidence is key. It’s our job as medical professionals, the FDA’s job, and public figures’ job to convince the population to vaccinate by presenting the real results of studies.

The current vaccine hesitancy, which might result in a large proportion of people refusing vaccination, will leave us with an ongoing global crisis, even with the best vaccines ever made. A vaccine only works if it is actually administered.

Five Vaccine Facts to Protect 2021:

1. Although Pfizer and Moderna’s COVID-19
vaccines utilize a technology not used in vaccines before, it is in no way new.
Studies on this type of vaccine have been conducted for the last 10 years, and
even earlier.

2. The approval studies conducted by Pfizer and Moderna included
more than 70,000 participants in both, compared to 4,000 participants in a
“regular” vaccine trial.

3. The FDA did not allow any shortcuts in the approval process. The main thing that sped up the proceedings was faster and more efficient bureaucracy and obtaining funding.

4. Now that the Pfizer vaccine has received an FDA emergency use
authorization, hundreds of thousands of people have already been vaccinated,
with a remarkable safety profile.

5. In vaccines, if side effects do appear, they mostly do so in the first 28 days. The studies by Pfizer and Moderna followed patients for more than 2 months and found that the vast majority of side effects were mild and short-lived.


About Dr. Noam Tau

Sheba Medical Center’s Dr.
Noam Tau was the lead researcher of a recent study assessing the safety of all
U.S.-approved vaccines over a twenty-year period. Dr. Tau’s study reviewed
57 FDA approved vaccines between 1996-2015, showing that an overwhelming
majority were safe to use on a large scale. 


Verily Nabs $700M to Expand Baseline, Verily Health Platforms

Verily Nabs $700M to Expand Baseline, Verily Health Platforms

What You Should Know:

Verily, a subsidiary of
Alphabet focused on life sciences and healthcare announced it has raised $700M
from current investors, including Alphabet, Silver Lake, Temasek, Ontario Teachers’ Pension Plan and others.

– The company plans to use the capital to support rapid
expansion of some of Verily’s leading commercial businesses including Baseline, an end-to-end ecosystem
designed to make clinical research more efficient; and Verily Health Platforms,
which supports population health, clinical care delivery and chronic disease
management through programs like Healthy
at Work
Onduo and Coefficient.

– In addition, the company plans to expand several of its
life sciences programs across surgery, pathology and immunology.

– Verily has seen accelerated growth and commercial interest
in 2020, spurred by its significant contributions to public health efforts to
combat the COVID-19
pandemic.

– “We’re humbled and excited about the opportunity to
expand the scope and rapidly scale our products and services. With this new
round of funding from our largest investors, they are strengthening their
commitment to help expedite our original vision,” said Andrew Conrad, CEO and
founder at Verily. “2021 will be a year of significant and focused growth for
Verily’s operations as we continue to drive innovation in our core programs,
launching more studies and study tools on Baseline to support decentralized
research, and expanding our Health Platforms product offerings and services for
employers, providers and patients.”

Cerner to snap up Kantar’s health division for $375M

The EHR giant is planning to buy Kantar Health, which provides data, analytics and research to the life sciences industry. Through the acquisition, Cerner aims to provide its clients with more access to data analytics and research expertise and engagement with life sciences companies.

How Hackers Are Targeting COVID-19 Vaccine Distribution Chain – Q/A

COVID-19 Vaccine Cyber Attacks

With the US and other major countries poised to begin national
distribution of multiple FDA-approved COVID-19 vaccines, the cybersecurity threats
to secure COVID19
vaccine distribution is imminent. Earlier this month, IBM released a report on malicious cyber actors targeting
the COVID-19 cold chain—an integral part of delivering and storing a vaccine at
safe temperatures.

Impersonating a biomedical company, cyber actors are sending phishing and spear-phishing emails to executives and global organizations involved in vaccine storage and transport to harvest account credentials. The emails have been posed as requests for quotations for participation in a vaccine program. In the report, IBM urges companies in the COVID-19 supply chain — from research of therapies, healthcare delivery to the distribution of a vaccine — to be vigilant and remain on high alert during this time

We recently sat down with Nigel Thorpe, Technical Director, SecureAge, an enterprise data security and encryption company to talk about the cybersecurity risks involved with COVID-19 vaccine distribution.

HITC: What type of information are hackers trying to
seize to disrupt the vaccine distribution process?

Thorpe: Hackers will try to obtain all the data they can muster, but specifically, they are looking for data around the distribution logistics together with details of the vaccine and its packaging. Using this they could attempt to replicate and profit from a counterfeit vaccine. In addition, cybercriminals are looking for all sorts of personal information about people involved in the vaccine distribution process, plus members of the public, so they can attempt identity theft and phishing attacks.

What are the dangers and implications if foreign actors
weaponize this information?

Thorpe: One of the biggest problems that already exist is an apprehensive public who is concerned with taking the vaccine because of fears that the approval process has been rushed and circumvented. These fears can be exploited by cybercriminals simply through the use of disinformation. In terms of cybersecurity, any attack on the distribution chain feeds into the fear of those already uncertain about the whole program.

In addition, bad actors could launch ransomware and spear-phishing attacks to get into the corporate network. Here, they can steal information concerning the “cold chain” and use this to build an illegal channel for counterfeit vaccine delivery. Not only would this result in unauthorized, unsafe vaccines being distributed but also reinforce fears of vaccines that many Americans already have. Any data, no matter how small or seemingly innocuous, could be used and exploited by cyber attackers.

How can health facilities remain protected?

Thorpe: The most important aspect is to ensure
that data is encrypted at all times so even if it is stolen, hackers won’t be
able to access this scrambled information. In addition, organizations should
make sure that unauthorized processes don’t run. This can be done by blocking
any application that attempts to execute, but which is not on an authorized
list. These measures will stop the problems of both phishing messages and data
theft – even by insiders.

What other information do you think hackers will target
in the future as we head into 2021?

Thorpe: Outside of exploiting the vaccine distribution network, hackers will attempt to capitalize on the continued remote working situation that is likely to last for most of 2021. Cybercriminals will try to exploit a situation where workers are not all using secure devices, resulting in data being stolen and exploited by bad actors.

In addition, we can expect combination attacks, where
something technical and something human will be combined in ways that the
confines and physical security of office spaces would have prevented. Notices
sent by mail to homes, phone calls, and possibly even personal visits by repair
technicians will be facilitated through stolen information and credentials
online, upping the ante of the scams and other illegal shenanigans.

M&A: Cerner to Acquire Health Division of Kantar for $375M in Cash

M&A: Cerner to Acquire Health Division of Kantar for $375M in Cash

What You Should Know:

 – Cerner announces it will acquire Kantar Health, a leading data, analytics, and real-world evidence and commercial research consultancy serving the life science and health care industry.

– This acquisition is expected to allow Cerner’s Learning
Health Network client consortium and health systems with more opportunities to
directly engage with life sciences for funded research studies. The acquisition
is expected to close during the first half of 2021.


Cerner today announced an agreement to acquire Kantar Health, a division of Kantar Group, a leading data, analytics, and real-world evidence and commercial research consultancy serving the life science industry for $375 million in cash, subject to adjustment.

Acquisition Will Create Leading Data Insights and Clinical
Research Platform

With this acquisition, Cerner plans to harness data to improve the safety, efficiency, and efficacy of clinical research across life sciences, pharmaceuticals, and health care at large. This acquisition is expected to allow Cerner’s Learning Health Network client consortium to more directly engage with life sciences for funded research studies.

The Cerner Learning Health Network offers health systems complimentary access to a network of bi-directional, de-identified data resources. This access helps advance research efforts and provides opportunities to generate revenue with funded research studies from life science companies. Kantar Health’s proprietary syndicated data products including CancerMPact, Claritis, National Health & Wellness Survey, and its broader oncology, rare disease, and multi-therapeutic expertise are used today by all of the top 20 life science companies to further their real-world evidence, commercial and clinical research efforts.

The combination of Cerner and Kantar Health is expected to
enable a two-sided collaboration between providers and the pharmaceutical
industry, where researchers can generate insights and use differentiated
real-world data assets and expertise to address the most complex clinical
research questions.

“Cerner launched the Learning Health Network with our provider clients to advance a shared vision: treat global diseases more effectively through an acceleration of clinical research,” said Donald Trigg, president, Cerner. “Kantar Health has incredible health economics and medical affairs expertise, differentiated real-world data assets and strong relationships with the world’s leading life science companies. It offers us an amazing opportunity to drive cross-industry collaboration that can change health outcomes around the world.”

Acquisition Reflects Cerner’s Strategic Focus on Clinical
Research

This is the second announcement in this month expanding upon
Cerner’s commitment to improving the safety and efficiency of clinical research
in life sciences and health care. Last week we announced a relationship with
Elligo which broadens the clinical trial resources available to rural and
community hospitals and physician practices. This is significant to help
broaden the diversity of individuals involved in clinical research, including
those in minority populations and rural communities.

The acquisition is anticipated to close in the first half of 2021, subject to regulatory approval, employee consultations, and other conditions, and is not expected to have a material impact on Cerner’s earnings in 2021.

FDA Authorizes First Fully Over the Counter COVID-19 Home Test

FDA Authorizes Ellume COVID-19 Home Test as First Over-the-Counter Fully At-Home Diagnostic Test

What You Should Know:

– FDA grants Emergency Use Authorization for Ellume
COVID-19 Home Test for non-prescription home use in symptomatic and
asymptomatic individuals

– The first fully over-the-counter COVID-19 Home Test
demonstrated 96% accuracy in a multi-site US clinical study of both adults and
children 2 years and above

– Ellume is ramping up manufacture, with production on
track for over 100,000 tests per day in January 2021

Ellume, a
digital diagnostics announced its rapid, at-home COVID-19 antigen test has been
granted Emergency Use Authorization (EUA) from the U.S. Food and Drug
Administration (FDA). The test will be available for non-prescription home use
for the detection of active COVID-19 in individuals with or without symptoms,
and in adults and children aged 2 years and above. The Ellume COVID-19 Home Test is the first of its kind to be granted
an EUA and provides an essential new tool to help combat the COVID-19 pandemic.

How It Works

The test includes a sterile Nasal Swab, a Dropper,
Processing Fluid, and a Bluetooth® connected Analyzer for use with an app on
the user’s smartphone. Utilizing the dedicated app, the user follows
step-by-step video instructions to perform the test including a self-collected
mid-turbinate nasal swab. The sample is analyzed, and results are automatically
transmitted to the user’s smartphone via Bluetooth® in 15 minutes or less.
Results can be shared with healthcare professionals to enable optimal therapy.

Through a secure cloud connection, Ellume’s COVID-19 Home
Test can provide real-time reporting of test results to health authorities,
employers, and educators, for efficient COVID-19
mapping.

Safe & Accurate

In data submitted to the FDA from an independently run,
simulated home-setting clinical study of 198 subjects ranging in age from 2
years to 82 years, the Ellume COVID-19 Home Test demonstrated 96% accuracy,
with an overall sensitivity of 95% (positive percent agreement) and specificity
of 97% (negative percent agreement) when compared to an emergency
use-authorized RT-PCR laboratory test.

In individuals presenting with COVID-19 symptoms, the Ellume
COVID-19 Home Test demonstrated a sensitivity of 96% and specificity of 100%,
and in asymptomatic individuals, the test demonstrated a sensitivity of 91% and
specificity of 96%.

Manufacturing Scale-Up

Ellume has been able to fast-track the development of its
range of COVID-19 diagnostic tests with the support of a $30 million WP-2 grant
from the U.S. National Institutes of Health (NIH)’s Rapid Acceleration of
Diagnostics (RADx) initiative.

In order to meet anticipated demand, Ellume has expanded its
manufacturing facility in Brisbane, Australia, the largest of its kind in the
Southern Hemisphere, and is rapidly expanding its manufacturing efforts and
supply chain within the U.S. Production has already commenced and Ellume will
be shipping over 100,000 tests per day from next month. Ellume plans to
manufacture and deliver 20 million Ellume COVID-19 Home Tests to the U.S.
within the first half of 2021.

“As COVID-19 case numbers hit record highs, the world needs access to fast, affordable, easy-to-use home testing,” said Ellume founder and CEO, Dr. Sean Parsons. “Ellume’s COVID-19 Home Test delivers this important first line of defense – it can be widely available without the need for a prescription, enabling the U.S. to respond to the pandemic in its most urgent stage.”

Abbott Receives CE Mark for its COVID-19 IgG Quantitative Antibody Blood Test

Abbott Receives CE Mark for its COVID-19 IgG Quantitative Antibody Blood Test

What You Should Know:

– Abbott Receives CE Mark for its COVID-19 IgG Quantitative Antibody Blood Test that specifically detects levels of IgG antibodies that attach to the virus’ spike protein, which can be helpful to evaluate a person’s immune response to vaccines.

– Abbott plans to submit its test for the U.S. Food and Drug Administration (FDA) emergency use authorization soon.


Abbott, today
announced it received CE Mark for its new quantitative SARS-CoV-2 IgG
(Immunoglobulin G) lab-based serology test. IgG antibody testing that gives a
quantitative result (measuring the amount of antibodies) provides important
insights to people as they recover from COVID-19 and
helps evaluate a person’s immune response to a vaccine.

Why It Matters

Countries around the world are preparing for the
authorization and the distribution of COVID-19 vaccines. As these vaccines
become available, healthcare professionals and researchers will need to assess
how individuals and communities are responding.

The quantitative IgG antibody test is the latest in Abbott’s
broad portfolio of tests to support the global healthcare community in the
fight against COVID-19. Abbott’s COVID-19 test portfolio includes molecular,
antigen and serology tests. These tests can help healthcare professionals
detect the virus at all stages of its life cycle, including tests that are done
in the lab as well as rapid tests done at the point of care.

SARS-CoV-2 IgG II Quant Antibody Test

Abbott’s quantitative IgG antibody test is designed to
detect levels of IgG antibodies that attach to the virus’ spike protein on the
virus surface in serum and plasma from individuals who are suspected to have
had COVID-19, or in serum and plasma of subjects that may have been infected by
SARS-CoV-2.

A study to determine the clinical performance of Abbott’s
SARS-CoV-2 IgG II Quant test on its Alinity i instrument found it had 99.60%
specificity (ability to exclude false positives) and 99.35% sensitivity
(ability to exclude false negatives) in patients tested 15 days or more after
symptoms began.

Availability

The quantitative IgG test will be available on both the
Abbott ARCHITECT and Alinity i platforms. Abbott is also developing a test and
plans to submit for U.S. Food and Drug Administration (FDA) emergency use
authorization soon.

“Testing will continue to help both identify those who are infected as well as determine whether people have had a natural or vaccine-induced immune response,” said John Hackett, Ph.D., divisional vice president of Applied Research and Technology for Abbott’s diagnostics business. “Quantitative antibody testing can help provide greater understanding of a person’s immune response.”

Amazon Launches HealthLake for Healthcare Orgs to Aggregate & Structure Health Data

AWS Announces Amazon HealthLake

What You Should Know:

– Amazon today announced the launch of Amazon HealthLake,
a new HIPAA-eligible service enables healthcare organizations to store, tag,
index, standardize, query, and apply machine learning to analyze data at
petabyte scale in the cloud.

– Cerner, Ciox Health, Konica Minolta Precision Medicine,
and Orion Health among customers using Amazon HealthLake.


Today at AWS re:Invent, Amazon
Web Services, Inc. (AWS),
an Amazon.com company today announced Amazon HealthLake, a
HIPAA-eligible service for healthcare and life sciences organizations. Current
Amazon HealthLake customers include Cerner, Ciox Health, Konica Minolta
Precision Medicine, and Orion Health.

Health data is frequently incomplete and inconsistent, and is often unstructured, with the information contained in clinical notes, laboratory reports, insurance claims, medical images, recorded conversations, and time-series data (for example, heart ECG or brain EEG traces) across disparate formats and systems. Every healthcare provider, payer, and life sciences company is trying to solve the problem of structuring the data because if they do, they can make better patient support decisions, design better clinical trials, and operate more efficiently.

Store, transform, query, and analyze health data in
minutes

Amazon HealthLake aggregates an organization’s complete data across various silos and disparate formats into a centralized AWS data lake and automatically normalizes this information using machine learning. The service identifies each piece of clinical information, tags, and indexes events in a timeline view with standardized labels so it can be easily searched, and structures all of the data into the Fast Healthcare Interoperability Resources (FHIR) industry-standard format for a complete view of the health of individual patients and entire populations.

Benefits for Healthcare Organizations

As a result, Amazon HealthLake makes it easier for customers to query, perform analytics, and run machine learning to derive meaningful value from the newly normalized data. Organizations such as healthcare systems, pharmaceutical companies, clinical researchers, health insurers, and more can use Amazon HealthLake to help spot trends and anomalies in health data so they can make much more precise predictions about the progression of the disease, the efficacy of clinical trials, the accuracy of insurance premiums, and many other applications.

How It Works

Amazon HealthLake offers medical providers, health insurers,
and pharmaceutical companies a service that brings together and makes sense of
all their patient data, so healthcare organizations can make more precise
predictions about the health of patients and populations. The new
HIPAA-eligible service enables organizations to store, tag, index, standardize,
query, and apply machine learning to analyze data at petabyte scale in the
cloud.

Amazon HealthLake allows organizations to easily copy health
data from on-premises systems to a secure data lake in the cloud and normalize
every patient record across disparate formats automatically. Upon ingestion,
Amazon HealthLake uses machine learning trained to understand medical
terminology to identify and tag each piece of clinical information, index
events into a timeline view, and enrich the data with standardized labels
(e.g., medications, conditions, diagnoses, procedures, etc.) so all this
information can be easily searched.

For example, organizations can quickly and accurately find
answers to their questions like, “How has the use of cholesterol-lowering
medications helped our patients with high blood pressure last year?” To do this,
customers can create a list of patients by selecting “High Cholesterol” from a
standard list of medical conditions, “Oral Drugs” from a menu of treatments,
and blood pressure values from the “Blood Pressure” structured field – and then
they can further refine the list by choosing attributes like time frame,
gender, and age. Because Amazon HealthLake also automatically structures all of
a healthcare organization’s data into the FHIR industry format, the information
can be easily and securely shared between health systems and with third-party
applications, enabling providers to collaborate more effectively and allowing
patients unfettered access to their medical information.

“There has been an explosion of digitized health data in recent years with the advent of electronic medical records, but organizations are telling us that unlocking the value from this information using technology like machine learning is still challenging and riddled with barriers,” said Swami Sivasubramanian, Vice President of Amazon Machine Learning for AWS. “With Amazon HealthLake, healthcare organizations can reduce the time it takes to transform health data in the cloud from weeks to minutes so that it can be analyzed securely, even at petabyte scale. This completely reinvents what’s possible with healthcare and brings us that much closer to everyone’s goal of providing patients with more personalized and predictive treatment for individuals and across entire populations.”

Kleva Health Launches FDA Authorized Saliva At-Home COVID-19 Test Kit for $149

Kleva Health Launches FDA Authorized ‘Saliva At-Home COVID-19 Test Kit’ With $1.8M in Seed Fundraising

What
You Should Know:


Digital health startup Kleva Health launches FDA authorized saliva at-home
COVID-19 test kit and raises $1.5 million in seed funding.


Kleva Health’s At-Home COVID-19 Saliva Test Kit will be available for orders on
its website, klevahealth.com, and will retail for US$149. Test results will be
reported on klevahealth.com and available within 48 hours after the test has
arrived at the lab.


Kleva Health, a San Francisco, CA-based digital health company, today announced the availability of its FDA Authorized at-home COVID-19 testing kits to offer Americans the choice to self-administer COVID-19 tests. In addition to the launch of at-home COVID-19 test kits, the company is also announcing $1.8M in seed funding from VCs including IMO Ventures, Human Longevity, and Performance Impact Venture Fund and Zenni Optical.


At-Home COVID-19 Saliva Test Kit

Kleva Health Launches FDA Authorized Saliva At-Home COVID-19 Test Kit, Raises $1.8M

Kleva Health’s At-Home COVID-19 Saliva Test Kit uniquely
includes a Kleva Health saliva DNA/RNA collection device. This enables Kleva
Health to rapidly scale up its supply, without being dependent on distributors.
But a saliva test also enables the company to offer the ability to test for a
wider assortment of diseases and viruses – not just COVID-19.


Availability

Kleva Health Launches FDA Authorized Saliva At-Home COVID-19 Test Kit, Raises $1.8M

Kleva Health’s At-Home COVID-19 Saliva Test Kit will be
available for orders on its website, klevahealth.com, and will retail for US$149. Test results
will be reported on klevahealth.com
and available within 48 hours after the test has arrived at the lab.


Kleva Health Background

Kleva Health is founded by Harvard Business School
classmates and medical industry executives, David Yu, Bernie Siu and Kai Lim.
But the company started following a familiar story. Bernie Siu (Kleva Health’s
Chief Medical Officer and Doctor of Medicine from Stanford University’s School
of Medicine) had fallen ill from contract COVID-19 but discovered that getting
access to testing solutions ahead of his family reunion was easier said than
done. Not qualified for immediate testing at the time, Bernie believed that
there had to be a better solution. But he’s not alone. As many as 55.1% of
people do not know that at-home COVID-19 testing is an option for Americans,
according to the survey.


Responding to the New Normal

Fortunately, Kleva Health’s launch comes at an opportune
time. 55.4% of Americans are prepared for COVID-19 to be around longer than one
year. An additional 31.7% believe that COVID-19 will be around until a vaccine
is available. Not surprisingly, respondents overwhelmingly believe that
COVID-19 has made them realize the need for maintaining healthy habits,
including regular testing. As a digital health tracking company, Kleva Health
encourages healthy habits by offering Americans the convenience of at-home
tests, amid this new normal, and an online platform for keeping track of their
biomedical health.

 “With COVID-19, many of us have a heightened awareness for not only our personal well-being, but also for those family members and friends around us. As the holidays are fast approaching, Kleva Health’s FDA authorized saliva-based COVID-19 self-testing kit, offers Americans the convenience and assurance that they can spend time with loved ones with peace of mind,” said David Yu, CEO and co-founder of Kleva Health. “But this product and the Kleva platform is just the start for us. Supported by our investors including IMO Ventures and the Human Longevity Fund, we plan to scale and introduce additional products that will make biomedical testing as easy and common as brushing one’s teeth.”


Future Plans

In addition,
Kleva Health will introduce in January 2021 a patent-pending and FDA authorized
next-generation COVID-19 saliva rapid testing kit that enables Americans to
self-test for the virus at home and read the results in just minutes.


PRISYM 360 Achieves SAP® Certification as Integrated with Cloud Solutions from SAP

PRISYM 360 Achieves SAP® Certification as Integrated with Cloud Solutions from SAP

The latest version of the PRISYM 360 intelligent data import connector now has SAP-certified integration using SAP Cloud Platform Integration Suite

Wokingham, United Kingdom — 7 December 2020 — PRISYM ID, a leading provider of regulated content and label management solutions for the life sciences sector, announced today that PRISYM 360 version 1.10 has achieved SAP® certification using SAP Cloud Platform Integration Suite. The integration helps organizations to transfer labeling data from SAP technologies into the PRISYM 360 label management platform, easing the process of producing compliant labels and booklets for clinical trials, medical devices and other life sciences organisations.

The new interface supports cloud-based SAP applications as well as on-premise components. It is available as a standard product for PRISYM 360 deployments and its SAP-certified integration with cloud solutions from SAP offers businesses assurance that they are safely integrating the two systems in an approved way.

PRISYM 360 and SAP technologies communicate through a web service using standard SAP components with no intermediate stages.  This helps to eliminate the need for manual data transfers and reduce the risk of human error, providing certainty while streamlining the process.

The SAP® Integration and Certification Center (SAP ICC) has certified that PRISYM 360 version 1.10 leverages SAP Cloud Platform Integration Suite for integration to SAP.

“PRISYM ID has achieved SAP-certified integration with SAP solutions before, helping to ensure that accurate data is used automatically for labeling purposes,” said Chris Lentz, VP SaaS and SAP Business Development at PRISYM ID. “This latest intelligent data import connector for PRISYM 360 delivers enhanced capabilities, enabling customers to transfer their clinical or medical device labeling data into PRISYM 360 using the latest cloud and on-premise components from SAP and eliminating the need for manual transfer of data. This SAP certification of PRISYM 360 gives users continued peace of mind that their systems are integrated using the latest protocols and following recommended procedures.”

– Ends –

About PRISYM ID
PRISYM ID provides regulated content and label management solutions designed specifically for life science companies and medical device manufacturers, improving patient safety and health outcomes whilst ensuring regulatory compliance. PRISYM ID’s unique products and technologies are used to assure compliance globally, for 10 million+ medical device, clinical trial and pharmaceutical products annually. www.prisymid.com

Any statements in this release that are not historical facts are forward-looking statements as defined in the U.S. Private Securities Litigation Reform Act of 1995. All forward-looking statements are subject to various risks and uncertainties described in SAP’s filings with the U.S. Securities and Exchange Commission (SEC), including its most recent annual report on Form 20-F, that could cause actual results to differ materially from expectations. SAP cautions readers not to place undue reliance on these forward-looking statements which SAP has no obligation to update and which speak only as of their dates.

SAP and other SAP products and services mentioned herein as well as their respective logos are trademarks or registered trademarks of SAP SE (or an SAP affiliate company) in Germany and other countries. See https://www.sap.com/corporate/en/legal/copyright.html for additional trademark information and notices. All other product and service names mentioned are the trademarks of their respective companies.

For more information:

Andrew Baud, Distil

[email protected]

+44 (0) 7775 715775

 

 

The post PRISYM 360 Achieves SAP® Certification as Integrated with Cloud Solutions from SAP appeared first on .

NLP is Raising the Bar on Accurate Detection of Adverse Drug Events

NLP is Raising the Bar on Accurate Detection of Adverse Drug Events
 David Talby, CTO, John Snow Labs

Each year, Adverse Drug Events (ADE) account for nearly 700,000 emergency department visits and 100,000 hospitalizations in the US alone. Nearly 5 percent of hospitalized patients experience an ADE, making them one of the most common types of inpatient errors. What’s more, many of these instances are hard to discover because they are never reported. In fact, the median under-reporting rate in one meta-analysis of 37 studies was 94 percent. This is especially problematic given the negative consequences, which include significant pain, suffering, and premature death.

While healthcare providers and pharmaceutical companies conduct clinical trials to discover adverse reactions before selling their products, they are typically limited in numbers. This makes post-market drug safety monitoring essential to help discover ADE after the drugs are in use in medical settings. Fortunately, the advent of electronic health records (EHR) and natural language processing (NLP) solutions have made it possible to more effectively and accurately detect these prevalent adverse events, decreasing their likelihood and reducing their impact. 

Not only is this important for patient safety, but also from a business standpoint. Pharmaceutical companies are legally required to report adverse events – whether they find out about them from patient phone calls, social media, sales conversations with doctors, reports from hospitals, or any other channel. As you can imagine, this would be a very manual and tedious task without the computing power of NLP – and likely an unintentionally inaccurate one, too. 

The numbers reflect the importance of automated NLP technology, too: the global NLP in healthcare and life sciences market size is forecasted to grow from $1.5 billion in 2020 to $3.7 billion by 2025, more than doubling in the next five years. The adoption of prevalent cloud-based NLP solutions is a major growth factor here. In fact, 77 percent of respondents from a recent NLP survey indicated that they use ​at least one​ of the four major NLP cloud providers, Google is the most used. But, despite their popularity, respondents cited cost and accuracy as key challenges faced when using cloud-based solutions for NLP.

It goes without saying that accuracy is vital when it comes to matters as significant as predicting adverse reactions to medications, and data scientists agree. The same survey found that more than 40 percent of all respondents cited accuracy as the most important criteria they use to evaluate NLP solutions, and a quarter of respondents cited accuracy as the main criteria they used when evaluating NLP cloud services. Accuracy for domain-specific NLP problems (like healthcare) is a challenge for cloud providers, who only provide pre-trained models with limited training and tuning capabilities. This presents some big challenges for users for several reasons. 

Human language very contexts- and domain-specific, making it especially painful when a model is trained for general uses of words but does not understand how to recognize or disambiguate terms-of-art for a specific domain. In this case, speech-to-text services for video transcripts from a DevOps conference might identify the word “doctor” for the name “Docker,” which degrades the accuracy of the technology. Such errors may be acceptable when applying AI to marketing or online gaming, but not for detecting ADEs. 

In contrast, models have to be trained on medical terms and understand grammatical concepts, such as negation and conjunction. Take, for example, a patient saying, “I feel a bit drowsy with some blurred vision, but am having no gastric problems.” To be effective, models have to be able to relate the adverse events to the patient and specific medication that caused the aforementioned symptoms. This can be tricky because as the previous example sentence illustrates, the medication is not mentioned, so the model needs to correctly infer it from the paragraphs around it.

This gets even more complex, given the need for collecting ADE-related terms from various resources that are not composed in a structured manner. This could include a tweet, news story, transcripts or CRM notes of calls between a doctor and a pharmaceutical sales representative, or clinical trial reports. Mining large volumes of data from these sources have the power to expose serious or unknown consequences that can help detect these reactions. While there’s no one-size-fits-all solution for this, new enhancements in NLP capabilities are helping to improve this significantly. 

Advances in areas such as Named Entity Recognition (NER) and Classification, specifically, are making it easier to achieve more timely and accurate results. ADE NER models enable data scientists to extract ADE and drug entities from a given text, and ADE classifiers are trained to automatically decide if a given sentence is, in fact, a description of an ADE. The combination of NER and classifier and the availability of pre-trained clinical pipeline for ADE tasks in NLP libraries can save users from building such models and pipelines from scratch, and put them into production immediately. 

In some cases, the technology is pre-trained with tuned Clinical BioBERT embeddings, the most effective contextual language model in the clinical domain today. This makes these models more accurate than ever – improving on the latest state-of-the-art research results on standard benchmarks. ADE NER models can be trained on different embeddings, enabling users to customize the system based on the desired tradeoff between available compute power and accuracy. Solutions like this are now available in hundreds of pre-trained pipelines for multiple languages, enabling a global impact.

As we patiently await a vaccine for the deadly Coronavirus, there have been few times in history in which understanding drug reactions are more vital to global health than now. Using NLP to help monitor reactions to drug events is an effective way to identify and act on adverse reactions earlier, save healthcare organizations money, and ultimately make our healthcare system safer for patients and practitioners.


About David Talby

David Talby, Ph.D., MBA, is the CTO of John Snow Labs. He has spent his career making AI, big data, and data science solve real-world problems in healthcare, life science, and related fields. John Snow Labs is an award-winning AI and NLP company, accelerating progress in data science by providing state-of-the-art models, data, and platforms. Founded in 2015, it helps healthcare and life science companies build, deploy, and operate AI products and services.

Recent Executive Hires: CVS Health New President, Cleveland Clinic/Amwell Joint Venture Leadership, Others

Neela Montgomery, EVP & President at CVS Pharmacy/Retail

CVS Health Corporation names Neela Montgomery Executive Vice President and President of CVS Pharmacy/Retail, effective November 30, 2020. Montgomery will oversee the company’s 10,000 pharmacies across the United States. Montgomery, currently a Board Partner at venture capital firm Greycroft, most recently served as chief executive officer of furniture retailer Crate & Barrel and has nearly 20 years of global retail experience.


The Cleveland Clinic and Amwell joint venture appoint Egbert van Acht as Executive Vice Chairman to the Board of Directors and Frank McGillin as CEO. Formed one year ago as a first-of-its-kind company to provide broad access to comprehensive, high-acuity care via telehealth, the company has made great progress scaling digital care through its MyConsult® offering. With an initial focus on clinical second opinions, the organization also offers health information and diagnosis on more than 2,000 different types of conditions including cancer, cardiac, and neuroscience issues.


Dana Gelb Safran, Sc.D., SVP at WELL Health

Healthcare industry veteran Dana Gelb Safran, Sc.D. has joined Well Health Inc. as Senior Vice President, Value-Based Care, and Population Health. In her new role, Dr. Safran will expand WELL’s uses to improve healthcare quality, outcomes, and affordability through partnerships with payers and Accountable Care Organization (ACO) providers.


Talkdesk®, Inc., the cloud contact center for innovative enterprises appoints Cory Haynes to lead Talkdesk’s strategy for the financial service industry and Greg Miller to lead the strategy for healthcare and life sciences. Haynes and Miller are key members of the Talkdesk industries team led by Andrew Flynn, senior vice president of industries strategy for Talkdesk.


Mark McArdle, SVP Products & Design at Imprivata

Imprivata appoints Mark McArdle to Senior Vice President of Products and Design. Mr. McArdle has more than two decades of experience in software development, Software-as-a-Service (Saas), in Cybersecurity, and advanced products for the enterprise, SMB, and consumer markets.


Jack Stoddard, Executive Chairman at Eden Health

Eden Health names Jack Stoddard as executive chairman of its board of directors. Formerly serving in COO roles for Accolade and Haven, Stoddard brings two decades of healthcare innovation and operating experience to the board position, providing leadership, wisdom, and counsel during a time of monumental growth and adoption for the company. 


Saurav Chatterjee, PhD., CTO at Augmedix

Augmedix names Saurav Chatterjee Chief Technology Officer. Prior to joining Augmedix, he most recently served as Vice President of Engineering at Lumiata, Inc., where he led the engineering team that built a leading AI platform, focusing specifically on transforming, cleaning, enriching, featurizing, and visualizing healthcare data, and on building, deploying and operationalizing machine learning and deep-learning models at scale.


Philip Vecchiolli, Chief Growth & Strategy Officer, Tridiuum

Tridiuum, the nation’s premier provider of digital behavioral health solutions names Philip Vecchiolli has joined the company as Chief Growth and Strategy Officer. Vecchiolli, who brings over 30 years of experience to the new role, has a successful track record of leading business development for large and mid-size healthcare companies.


Janet Dillione, CEO of Connect America

Connect America appoints Janet Dillione as its new chief executive officer (CEO). Prior to joining Connect America, Dillione worked in the healthcare information services industry as CEO of Bernoulli Enterprise, Inc., GM of Nuance Healthcare, and CEO of Siemens Healthcare IT.


Health Catalyst, Inc. announces that current Chief Financial Officer Patrick Nelli has been named President, effective January 1, 2021. Following Nelli’s promotion to the President role, Health Catalyst has named Bryan Hunt, current Senior Vice President of Financial Planning & Analysis, Chief Financial Officer, also effective January 1, 2021.

Two additional promotions, also effective January 1, 2021, include Jason Alger, Senior Vice President of Finance, to Chief Accounting Officer, and Adam Brown, Senior Vice President of Investor Relations, to Senior Vice President of Investor Relations and Financial Planning & Analysis. 


Rick Howard, Chief Product Officer at Apervita

Apervita hires health IT veteran Rick Howard as Chief Product Officer. In his role, Rick will oversee product vision, innovation, design, and delivery of Apervita’s digital platform, which enables digital quality measurement, clinical intelligence, as well as value-based contract monitoring and performance measurement.

Roberto Simon

Conversion Labs, Inc. appoints Roberto Simon to its board of directors and as the chair of its audit committee. Following his appointment, the board now has eight members, with six serving as independent directors. Mr. Simon currently serves as CFO of WEX (NYSE: WEX), a $6+ billion fintech services provider.


Dr. Isaac Rodriguez-Chavez, Ph.D., MHS, MS.

PRA Health Sciences, Inc. appoints senior FDA official Isaac Rodriguez-Chavez, Ph.D., MHS, MS, as Senior Vice President, Scientific and Clinical Affairs. He will lead the company’s Global Center of Excellence for Decentralized Clinical Trial (DCT) Strategy. Dr. Rodriguez-Chavez’s responsibilities will involve the continued growth and development of PRA’s industry-leading decentralized clinical trial strategy, regulatory framework creation, and clinical trial modernization.


Proprio appoints three global thought leaders to its Medical Advisory Board. Dr. Sigurd Berven, Orthopedic Surgeon and Professor at the University of California, San Francisco, Dr. Charles Fisher, Professor and Head of the Combined Neurosurgical & Orthopedic Spine Program at Vancouver General Hospital and the University of British Columbia, and Dr. Ziya Gokaslan, Professor and Chair of the Department of Neurosurgery at Brown University and Neurosurgeon-in-Chief at Rhode Island Hospital and The Miriam Hospital will apply their globally respected surgical and research expertise to the development of the Proprio navigation platform.


Andrew Bindman, MD, EVP & Chief Medical Officer at Kaiser Permanente

Kaiser Permanente names Andrew Bindman, MD Executive Vice President and Chief Medical Officer.  In this role, Dr. Bindman will collaborate with clinical and operational leaders throughout the enterprise to help lead the organization’s efforts to continue improving the high-quality care provided to members and patients throughout Kaiser Permanente. Dr. Bindman will report directly to Kaiser Permanente chairman and CEO Greg A. Adams.

Dr. Michael Blackman, Chief Medical Officer at Greenway

Greenway names Dr. Michael Blackman Chief Medical Officer at Greenway. Dr. Blackman will further support the company’s ambulatory care customers, ensuring providers are equipped with the solutions and services they need to improve patient outcomes and succeed in value-based care.


Suki expands its leadership team with six key hires to support the company’s rapid commercial growth. Tracy Rentz, formerly Vice President of Implementation at Evolent Health, joins Suki as the Vice President of Customer Success and Operations to lead all customer operations, with a particular focus around deploying new Suki customers. Brian Duffy brings over 20 years of sales experience to Suki, joining the team as Director of Sales-East, after having most recently served as Regional Director at Qventus, Inc. Brent Jarkowski will also join Suki’s sales team this November as the Director of Sales-West, bringing over 15 years of experience in strategic relationship management. Brent joins Suki after serving as Senior Client Development Director at Kyyrus. Together, Brian and Brent will head the company’s efforts in building new partnerships across the country. And Josh Margulies, who previously served as the Director of Integrated Brand Marketing for the Jacksonville Jaguars, will serve as Suki’s new Senior Director of Field Marketing.

UCB Taps Medisafe to Develop Branded Digital Drug Companions for Antiepileptic Medications

UCB Taps Medisafe to Develop Branded Digital Drug Companions for Antiepileptic Medications

What You Should Know:

– UCB has selected Medisafe to develop branded digital
drug companions for antiepileptic medications, marking the company’s official
entry into the digital therapeutics space.

– The initial collaboration will primarily be focused on their antiepileptic medications, but they are exploring its use for additional brands. 


Medisafe,
a leading digital
therapeutics
company specializing in digital companions, has been selected
by UCB to develop branded digital drug
companions for its antiepileptic medications, with greater capabilities to
expand across additional brands. The digital companions streamline support for
patients to access financial assistance, patient diaries, and doctor discussion
guides throughout their treatment journey.

UCB is launching both digital companions in November in
support of National Epilepsy Awareness Month and the more than 3.4 million
patients in the US who live with the neurological condition. 1 in 26 people in
the US will develop epilepsy at some point in their lives and UCB wants to make
managing medication therapies easier through new digital companions from Medisafe. UCB
is a leader in antiepileptic medications commonly used to treat epilepsy and
the new digital experience for users will deliver condition-specific
content to help support patients through any medication challenges. To
date, nearly 7MM users rely on Medisafe’s digital therapeutics platform,
which applies real-world evidence to build connected medication management
programs and influence patients’ behavior on therapy. 

The collaboration will raise awareness and drive engagement
with a content-rich digital experience for patients to gain support and
community throughout the course of their treatment. The Medisafe app
is available to Android and iPhone users through both the Google play and Apple
app stores. Patients can experience the antiepileptic medication resource
centers within the Medisafe app, unlocking a world of advanced
patient support and guidance as a result of this collaboration. 

“At UCB, we focus on fostering collaborations that deliver a purposeful impact to people living with epilepsy. As part of our ongoing digitalization efforts, the Medisafe app will allow us to continue supporting patients with new, innovative ways of navigating their health,” said Anita Moser, Head of Assets and Optimization for U.S. Neurology, UCB. “During the COVID crisis, the ability to support patients digitally is more important than ever, and we are pleased to deliver personalized and immediate support directly to epilepsy patients and their caregivers.”

COTA Lands $34M to Drive Innovation in Oncology Using Real-World Data

COTA Lands $34M to Drive Innovation in Oncology Using Real-World Data

What You Should Know:

– COTA, Inc., a healthcare technology company that uses
real-world data to bring clarity to cancer care, has secured $34M in funding.

– Access to over one million patient data records and additional
funding support enhanced real-world data and analytics services in oncology.


COTA, Inc., a Boston, MA-based healthcare technology company that uses real-world data to bring clarity to cancer care, today announced it has raised $34 million in Series D funding led by Baptist Health South Florida and ONC Capital with participation from EW Healthcare, Horizon BCBS and other existing investors. This also includes a $20M investment from Varian, who negotiated an option to acquire COTA at a later date.

Bringing Clarity to Cancer

COTA was founded in 2011 by a team of doctors, engineers,
and data scientists to create clarity from fragmented and often-inaccessible
real-world data. The company organizes fragmented, often hidden data from the
real world to provide clarity in cancer care. Combining clinical expertise in
cancer with proprietary technology and advanced analytics, COTA’s platform
helps inform decisions and action in oncology. COTA partners with
providers, payers, and life science companies to ensure that everyone touched
by cancer has a clear path to the right care.

COTA offerings include:

Providers: Curate EHR data that can be
used to drive research and standardization in order to improve patient outcomes
while also reducing costs at your institution.

Payers: Make clinical sense of claims data, providing
insight into performance and related outcomes across sites in order to support
value-based payment models.

Life Sciences: Deeplycurated real-world data accelerates drug development informing the decisions and actions that will deliver the best drugs to patients faster and at a lower cost.

Recent Traction/Milestones

The company will use the latest round of funding to expand
its data access by over 300%, which now well exceeds one million oncology
patient records. This growth will support the company’s commitment to
accelerating the use of real-world data to improve patient outcomes and
increase efficiency in oncology drug development. data helps life science
partners answer key research questions, and in 2020 alone, COTA is projected to
double its life science customers, growing from 8 to 16.

“COTA is proud to receive this validation from leading institutions across the oncology ecosystem.” said Michael Doyle, President and CEO of COTA. “The additional capital combined with our increased data access positions COTA for tremendous growth and enables us to drive innovation in oncology using real-world data. Our high-quality data and technology solutions will improve how cancer is treated and provide much needed clarity to patients as they navigate their cancer journey.”

FDA Authorizes First At-Home COVID-19 Test, Results in 30 Mins or Less

FDA Authorizes First At-Home Molecular COVID-19 Test

What You Should Know:

– FDA approves emergency use authorization (EUA) for Lucira
Health’s all-in-one-test kit for COVID-19 self-testing at home.

– The streamlined Lucira COVID-19 All-In-One Test Kit,
which fits in the palm of a hand, extracts genetic material from the virus and
amplifies it. This process takes up to 30 minutes, but a positive test result
can be generated in as few as 11 minutes.


On late Tuesday, the Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the first COVID-19 diagnostic test for self-testing at home and that provides rapid results. The Lucira COVID-19 All-In-One Test Kit is a molecular (real-time loop-mediated amplification reaction) single-use test that is intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19.

Why It Matters

By current national estimates, up to 50 to 100 million COVID-19 tests may need to be conducted each month in the United States, with as many as 900 million totals possible through 2021. If all U.S. airline passengers were also tested, that would require one billion tests annually. Likewise, if the country’s health care workers were tested weekly for a year, that would also require around one billion tests. A variety of tests have been developed to help meet this need, with Lucira being the latest and first to get FDA authorization for prescription self-testing at home molecular diagnostic test.

Authorized for Prescription Use Only

The Lucira COVID-19 All-In-One Test Kit test has been authorized for home use with self-collected nasal swab samples in individuals age 14 and older who are suspected of COVID-19 by their health care provider. It is also authorized for use in point-of-care (POC) settings (e.g., doctor’s offices, hospitals, urgent care centers, and emergency rooms) for all ages but samples must be collected by a healthcare provider when the test is used at the POC to test individuals younger than 14 years old. The test is currently authorized for prescription use only.

How It Works

The streamlined Lucira COVID-19 All-In-One Test Kit, which fits in the palm of a hand, extracts genetic material from the virus and amplifies it. This process takes up to 30 minutes, but a positive test result can be generated in as few as 11 minutes. The Lucira COVID-19 All-In-One Test Kit comes with everything needed to perform a single COVID-19 test. Users open the box containing the test device, sample vial, swab, and simple instructions. Two AA batteries are inserted in the device and the sample vial is placed in the test unit.

Next, the user opens the test swab packet and rotates the swab in each nostril five times. The swab is then stirred in the sample vial and then pressed down in the test unit to start the test. The “ready” light will blink until a “positive” or “negative” green light is illuminated within 30 minutes. For guidance on care and public health reporting, patients will report their test results to the medical office that prescribed the test

Availability

The Lucira ™COVID-19 All-In-One Test Kit is expected to be
available to patients served by Sutter Health in Northern California, and
Cleveland Clinic Florida in Miami-Ft. Lauderdale, in the near future. By early
spring 2021, it is expected to be available nationally through health care
providers and is expected to cost around $50.

By the second quarter of 2021, Lucira Health plans to amend
its EUA or file a new EUA so people who think they’re infected with COVID-19
can communicate with a medical professional online through a dedicated website
to arrange a prescription and overnight delivery of the test kit, if approved.
Follow-up monitoring will be available for public health reporting so people
can get additional guidance and information if needed.

Change Healthcare Unveils Social Determinants of Health Analytics Solution

Change Healthcare Acquires Credentialing Tech Docufill to Improve Administrative Efficiency

What You Should Know:

– Change Healthcare launches national data resource on
social determinants of health (SDoH) for doctors, insurers and life sciences
organizations to better understand the connection between where a person lives
and how they live their life to the care a patient receives and their health
outcome.

– 80% of U.S. health outcomes are tied to a patient’s
social and economic situation, ranging from food, housing, and transportation
insecurity to ethnicity.


Change Healthcare, today announced the launch of Social Determinants of Health (SDoH) Analytics solution that will serve as an innovative national data resource that connects the circumstances of people’s lives to the care they receive. The SDoH Analytics solution is designed for health systems, insurers, and life sciences organizations to explore how geodemographic factors affect patient outcomes.


Understanding Social Determinants of Health

SDoH includes factors such as socioeconomic status, education, demographics, employment, health behaviors, social support networks, and access to healthcare. Individuals who experience challenges in any of these areas can face significant risks to their overall health.

“All the work I do—for Mayo Clinic, the COVID-19 Healthcare Coalition, and The Fight Is In Us— is predicated on equity,” said John Halamka, president, Mayo Clinic Platform. “The only way we can eliminate racism and disparities in care is to better understand the challenges. Creating a national data resource on the social determinants of health is an impactful first step.”

The SDoH Portrait Analysis includes financial attributes, education
attributes, housing attributes, ethnicity, and health behavior attributes.

3 Ways Healthcare Organizations Can Leverage SDoH
Analytics

Healthcare organizations can now use SDoH Analytics to
assess, select, and implement effective programs to help reduce costs and
improve patient outcomes. Organizations can choose one of three ways to use
SDOH Analytics:

1. Receive customized reports identifying SDoH factors that
impact emergency room, inpatient, and outpatient visits across diverse
population health segments.

2. Append existing systems with SDoH data to close
information gaps and help optimize both patient engagement and outcomes.

3. Leverage a secure, hosted environment with ongoing
compliance monitoring for the development of unique data analytics, models, or
algorithms.

Why It Matters

Scientific research has shown that 80% of health outcomes
are SDoH-related. Barriers such as food and housing availability,
transportation insecurity, and education inequity must be addressed to reduce
health disparities and improve outcomes. Change Healthcare’s SDoH Analytics
links deidentified claims with factors such as financial stability, education
level, ethnicity, housing status, and household characteristics to reveal the
correlations between SDoH, clinical care, and patient outcomes. The resulting
dataset is de-identified in accordance with HIPAA privacy regulations.

“Health systems, insurers, and scientists can now use SDoH Analytics to make a direct connection between life’s circumstances and health outcomes,” said Tim Suther, senior vice president of Data Solutions at Change Healthcare. “This helps optimize healthcare utilization, member engagement, and employer wellness programs. Medical affairs and research are transformed. And most importantly, patient outcomes improve. SDoH Analytics makes these data-driven insights affordable and actionable.”

8 Ways Advanced Analytics Can Help You Decide If Telehealth Should Be Temporary or Permanent

8 Ways Analytics Can Help You Decide If Telehealth Should Be Temporary or Permanent
Prasad Dindigal, Vice President, Healthcare & Life Sciences, EXL.

Over the past few months, primarily as a result of the COVID-19 pandemic, telehealth has gone from a “nice-to-have” to a “must-have” for healthcare providers. The surge of COVID-19 patients in the spring, coupled with “stay-at-home” orders in many states, meant that many patients in need of care for chronic conditions and other non-emergent health issues were unable to visit their providers face-to-face. 

Telehealth became the emergency solution, aided by relaxation of government regulations and improved reimbursement from health payers, led by the U.S. Centers for Medicare and Medicaid Services (CMS). But then a funny thing happened. 

As COVID-19 restrictions eased, many patients and providers found they liked telehealth and wanted to keep it around. Patients liked it because they didn’t have to take hours out of their day to travel to an appointment, go through COVID-19 protocols, wait to be called, wait to see their provider, then travel home again.

Providers liked it because they could work more efficiently and, if they were incorporating remote patient monitoring, obtain a more complete view of their patients’ day-to-day health. Both sides also liked telehealth because, quite frankly, it helped them reduce their risk of contracting a highly contagious virus. 

While we are not out of the woods yet – many experts are predicting a fall and winter surge that will make the spring surge look like a warm-up act – there are already discussions about whether telehealth was simply a stopgap measure in a crisis or should be viewed as a standard option for care going forward.  In order to make telehealth permanent, however, healthcare organizations will want to know exactly what it can contribute once it’s safe to venture to the office once again. 

Advanced analytics can help. They can show what worked, and what didn’t, so providers can make data-driven decisions about where, how, and whether to continue using telehealth. The following are eight ways analytics can contribute to present and future telehealth success. 

1. Find the patients for whom telehealth visits offer the greatest benefits. Normally, these will be patients who can be diagnosed or assessed without direct laying-on of hands. They may have a condition such as a rash that can be inspected visually or may be able to use consumer-grade devices to take and report biometric readings. Advanced analytics can help discover them, enabling providers to close care gaps while improving Star ratings and HEDIS scores. 

2. Prioritize patients by need. Analytics can help identify patients who are most at-risk of deterioration if they do not follow-up after preventive or elective procedures or are not closely monitored. They can also help providers make the appropriate adjustments to those priorities as patient health changes. 

3. Get ready for additional surges. The next surge has already begun, and there are likely to be others before the pandemic is fully behind us. Providers need to have measures in place to keep staff safe and avoid the risk of more lockdowns or other changes that will disrupt their operations. Analytics can help them determine how much to invest in additional telehealth equipment and training to ensure uninterrupted service to their patients. 

4. Measure telehealth’s impact on patient outcomes and reimbursement. Telehealth is so new, and the pandemic has caused so many shifts in reimbursement, that it can be difficult to determine exactly what effect it has had on outcomes and revenue. Analytics can uncover which changes have been positive and should be continued, and which should either be discontinued or adjusted to produce better health and/or financial result. 

5. Uncover and rectify possible coding errors. As the pandemic took hold in March, CMS launched its “patients over paperwork” initiative. The goal was to ensure providers focused on care rather than worrying about coding accuracy, especially as the path to telehealth opened up. At some point, however, accurate coding will again be required. Analytics can help providers uncover and rectify any coding issues to ensure claims are paid fairly and completely. 

6. Enable more effective remote patient monitoring. The presence of a global pandemic doesn’t halt chronic or other conditions affecting patient health. These conditions must continue to be managed to prevent them from deteriorating, which will place more of a health burden on patients while increasing long-term costs. Remote patient monitoring delivers the day-to-day data on these conditions. Analytics use that data to spot trends and update providers on the condition of all those patients, making it easier to ensure successful treatment for all of them. 

7. Manage timed events more effectively. Risk-adjustment capture of previously documented conditions, which comes through CMS sweeps, retrospective reviews, and other means, can be disruptive to provider operations. Analytics can take the burden off an already exhausted staff by automating and simplifying the process. 

8. Use trend and outcome data to inform the future. There is still much we don’t know about the effectiveness – and cost-effectiveness – of telehealth. This type of forward-looking analysis can be used to deliver policy and regulatory guidance for permanent reimbursement and best practices for telehealth-related visits. 

As we continue to battle the global pandemic, telehealth does more each day to demonstrate its value. But what happens when the battle is finally won? Should it go back to the background or become fully integrated into a healthcare organization’s standard offerings? 

Advanced analytics can be used to answer these questions and many others, helping providers make the decision that best fits their organization. 


About Prasad Dindigal 
Prasad Dindigal serves as Vice President, Healthcare & Life Sciences, with EXL, a leading operations management and analytics company that helps our clients build and grow sustainable businesses.

AstraZeneca, CCT Partner to Conduct COVID-19 Vaccine Clinical Trials in Arizona

AstraZeneca, CCT Partner to Conduct COVID-19 Vaccine Clinical Trials in Arizona

What You Should Know:

– AstraZeneca and CCT announce a partnership to conduct
COVID-19 vaccine clinical trials in Arizona with 1,500 participants.


CCT Research (CCT), a leader in community-based, embedded clinical research, today announced its partnership with AstraZeneca to advance COVID-19 research. Together with local healthcare providers, CCT will facilitate clinical trials for the AZD1222 COVID-19 VACCINE, an investigational vaccine for the prevention of COVID-19.

CCT is recruiting eligible study participants who
are 18 years of age or older, not pregnant, in good general health, and have
not been previously diagnosed with COVID-19. The study takes place at Bayless Integrated Healthcare’s
downtown Phoenix location at 3620 N 3rd St. in Phoenix.

Eligible
study participants must be 18 years of age or older, not pregnant, in good
general health, and have not been previously diagnosed with COVID-19. Participants are reimbursed for
expenses related to the study. This study compares an investigational vaccine against a placebo to see if the vaccine can prevent COVID-19.

Why
It Matters

“COVID-19 has been and continues to be devastating to our world. Finding a vaccine is one tool that will help us return to our new normal,” said Thomas Fiel, D.O., family practice physician and Arizona principal investigator. “I understand the need for clinical trials, as well as the anxiety they can bring to study participants. By conducting this trial through local medical practices like ours, CCT and AstraZeneca can build on an existing foundation of trust, ultimately improving the patient experience. It is another way that, as a community physician, I can help fight this battle.”

Peregrine Ventures Launches $300M VC Fund for Late-Stage Life Science Companies

Peregrine Ventures Launches $300M VC Fund for Late Stage Life Science Companies

What You Should Know:

– Israeli-based Peregrine Ventures launches a new $300 million venture capital fund named Peregrine Growth to focus on late-stage life science companies.

– Peregrine Growth will invest $20 to $30 million per funding round, with a strong emphasis on companies that are on the verge of an IPO or M&A. 


Peregrine Ventures, one of Israel’s premier venture capital firms focused on the life sciences, today announced the launch of a new growth fund, Peregrine Growth, focused on late-stage life science companies. Peregrine closed $101 million of the planned $300 million fund, with the participation of leading Israeli institutional investors and is currently aiming to raise additional funds from institutional investors and family offices worldwide.

Peregrine Growth Fund Investment Thesis

Peregrine Ventures Launches $300M VC Fund for Late Stage Life Science Companies

Peregrine Growth will invest $20 to $30 million per funding round, with a strong emphasis on companies that are on the verge of an IPO or M&A.  Peregrine invests in sectors such as medical devices, pharma, and digital health. Peregrine Growth is Peregrine Ventures’ fifth fund, and first growth fund, and follows Peregrine IV, which closed in December 2019 after raising $115 million. The performance of Peregrine’s portfolio places the firm in the upper quartile of IRR results for all venture capital firms in global benchmarks.

“We’re very excited to launch this new fund and believe that late stage life science companies present an excellent investment opportunity,” said Eyal Lifschitz, managing partner and co-founder at Peregrine Ventures. “This new fund focusses Peregrine’s nearly 20 years’ experience in life science investing at all stages, on companies that are at an incredibly exciting time: on the cusp of an  IPO or M&A. Our deep familiarity with the life science industry and close ties with strategic partners, allow us to know which late stage company to support and the exact timing of the investment that will yield the best returns for our partners.”

Portfolio Companies & Successful Exits to Date

Peregrine’s portfolio companies completed exits totaling
more than $2 billion to date, among them Valtech and Neovasc, among the largest
exits in the field of medical devices in Israel’s history. Additionally,
Peregrine’s portfolio includes mature growth companies worth hundreds of
millions of dollars. The fund has invested in and helped develop numerous
successful companies in the medtech field, including medical devices, biotech,
pharma, esthetics, and digital health, such as Memic, CartiHeal, Cordio and
Magneto. 

A number of Peregrine’s current portfolio companies have
pivoted to use their technologies to combat the coronavirus. Among them, Cordio’s noninvasive
technology is able to remotely monitor and diagnose the status of COVID-19
patients based on the analysis of their speech pattern sampled with the use of
a cellular application.

Peregrine Background

Peregrine was founded in 2001 by serial entrepreneurs Eyal
Lifschitz and Boaz Lifschitz. In the 1990s, the two brothers had co-founded the
biomedical device companies Visioncare Ophthalmic Technologies and BioControl,
and also led the business development efforts of companies such as PharmaSys
(acquired by Elan Corp. NYSE:ELN) and ECR (acquired by AVX Corp. NYSE:AVX).
After the establishment of Peregrine, the co-founders were joined by partners
Tamir Tal Lior Shahory, David Eldar and Tal Carasso. The firm has become a
prominent investor in Israel’s medical, life science and biotech sectors with a
specific focus on medical devices.

Cytek Biosciences Raises $120M To Expand Spectral Cell Analysis Systems

Cytek Biosciences Raises $120M To Expand Spectral Cell Analysis Systems

What You Should Know:

– Cytek Biosciences raises 120M in Series D funding –
underscoring the company’s growing momentum and significant contributions to
the field of cell analysis.

– Cytek, whose innovative flow cytometers represent the
first big technological leap in flow cytometry in decades, is currently
transitioning into a complete solution provider for the cell analysis market.

– This most recent funding round accelerates this transition and helps the company expand support for key areas of study including immunotherapy, immuno-oncology, and infectious diseases such as COVID-19.


Cytek Biosciences Inc., a Freemont, CA-based provider of cell analysis instrumentation and solutions, today announced that it has closed a $120 million Series D funding round, co-led by RA Capital and Hillhouse Capital, with OrbiMed and LYFE Capital also participating. The investment will be used to expand Cytek’s global infrastructure, sustain its growth momentum, and enable the company to deliver on its robust technology platform.

Reimagining Cell Analysis to Fuel Scientific Discovery

Cytek Biosciences Raises $120M To Expand Spectral Cell Analysis Systems

Founded in 1992, Cytek Biosciences Inc. is a leading flow
cytometry solution provider that develops compact, affordable instruments with
high multiplexing capability and a wide range of services to support scientists
and clinicians.

Representing the first big technological leap in flow cytometry in decades, Cytek’s cell analysis systems contain unique architectures that detect the full spectrum of the many fluorescent particles labeled on each cell. This technology enables the Cytek® Aurora to run beyond 40 color panels, a significant increase in the number of colors per sample, which in turn offers a much more complete picture of all the different cellular players in the immune system.

With the recent unveiling of a new
family of proprietary cFluor™ reagents, Cytek is transitioning into a
complete solution provider for the cell analysis market – inclusive of clinical
diagnostics. The company’s Series D funding round will help accelerate this
transition and offer expanded support for key areas of study such as
immunotherapy, immuno-oncology and infectious diseases such as COVID-19.

Additionally, RA Capital and Hillhouse Capital have joined Cytek’s board of directors. Said Andrew Levin, managing director of RA Capital, “The investments we make are evidence-based, and we are particularly focused on finding novel capabilities that address unsolved challenges. Cytek is ushering in flow cytometry’s next chapter with its proven, unique combination of innovative technologies. We are excited to join them on their mission to advance cancer and cell biology research.”

Kyowa Kirin backs €125m life science fund closed by Fountain Healthcare

Ireland-based Fountain Healthcare Partners has raised another €125 million ($131 million) for its third life sciences fund – 25% ahead of its target – and says it will pump most of the money into European therapeutics and medical device companies.

The latest cash injection adds to the €118 million initially raised by Fountain Healthcare for the fund in May 2019, and brings the total value managed by the company above the €300 million mark. The third fund is now closed.

The specialist life sciences venture capital shop – which has offices in Dublin and New York – said Japanese drugmaker Kyowa Kirin took part in the latest funding round, joining domestic and international institutional investors.

Three companies have already received investment from Fountain Healthcare’s third fund. That includes include France’s Inotrem, which is developing nangibotide in phase 2 testing for septic shock, and Dublin-based Priothera, which is developing immuno-oncology drug mocravimod in phase 2b/3 for acute myeloid leukaemia (AML) in partnership with Kyowa Kirin.

Another beneficiary is Dublin biotech Mainstay Medical, which recently claimed FDA approval for its ReActiv8 device for chronic lower back pain.

All told, Fountain Healthcare expects to make up to 10 investments in “predominantly private life science companies” with its third fund, mainly in Europe but also in the US.

The VC’s first two funds supported early-round financings some prominent emerging biotechs, including inflammatory disease biotech Inflazome, which was sold to Roche in September in a €380 million deal. Inflazome’s lead drugs inzomelid and somalix – both NLRP3 inhibitors – have cleared phase 1 testing.

Others included UK women’s health player KaNDy – snapped up by Bayer for $425 million upfront a few weeks ago – as well as drug delivery specialist Chrono Therapeutics and Opsona, focusing on autoimmune and inflammatory diseases, solid organ transplantation and oncology.

Dr Manus Rogan, co-founder and managing partner at Fountain Healthcare and a former executive at GlaxoSmithKline and Elan, said the company’s investment strategy “focuses on building a balanced portfolio of companies with complementary risk and return profiles within the life science sector.”

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Mammoth Lands 2 Major Partnerships to Use CRISPR to Solve COVID19 Testing Shortage, At Scale

Mammoth Lands 2 Partnerships to Use CRISPR to Solve COVID19 Testing Shortage

What You Should Know:

– Mammoth Biosciences signs agreements
with MilliporeSigma and Hamilton company targeting commercialization of high-throughput
CRISPR-based SARS CoV-2 Test.

– These partnerships will help Mammoth bring a turnkey CRISPR-based sample-to-answer solution for commercial laboratories to enable a multi-fold increase in a testing capacity.


Mammoth
Biosciences
, Inc., announced that it has signed agreements with
MilliporeSigma and Hamilton Company targeting commercialization of a
high-throughput CRISPR-based SARS CoV-2 test. The test leverages Mammoth’s DETECTR BOOST™ platform and
will provide a sample-to-answer turnkey solution for commercial laboratories to
enable a multi-fold increase in testing capacity. 

As laboratories nationwide face limited capacity and testing supply shortages amid the pandemic, Mammoth Biosciences is poised to help reduce the backlog by working with leading manufacturing and automation vendors for its CRISPR-based SARS-CoV-2 molecular assay. The high-throughput systems will be compatible with both nasal swab and saliva samples and are targeting 1500 tests per 8-hour shift with minimal user interaction. Mammoth Biosciences plans to submit the assay for FDA Emergency Use Authorization later this year.

“In order to begin reopening more aspects of society, we’ll need a robust testing infrastructure that can rapidly scale up capacity as needed,” said Trevor Martin, Ph.D., co-founder and CEO of Mammoth Biosciences. “By combining CRISPR-based diagnostics with the proven manufacturing and product leadership of MilliporeSigma and Hamilton Company, we’re confident this solution will be a game-changer for labs.” 

Mammoth’s DETECTR BOOST™ SARS-CoV-2 assay reagent kits,
which will be contract manufactured by MilliporeSigma, rival PCR in sensitivity
while being less prone to supply chain risk. The testing system will also
leverage standard, automated liquid handling equipment such as those from
Hamilton Company to enable rapid processing of patient samples. By implementing
this unique offering, CLIA laboratories will be able to significantly improve
their capacity to regularly test communities and businesses in need. 

“This collaboration will allow us to help Mammoth with the development and production of their new SARS-CoV-2 test, which, once approved by the FDA, will increase testing capacity here in the U.S. at the scale needed to combat this pandemic,” said Jean-Charles Wirth, head of Applied Solutions at MilliporeSigma. “MilliporeSigma is helping to advance the future of testing at scale. This is an important step in detecting Covid-19 quickly.”

Mission Bio Launches Single-Cell Multi-Omics System for Precision Cancer Therapies

Mission Bio Launches Single-Cell Multi-Omics System for Precision Cancer Therapies

What You Should Know:

– Mission Bio launches industry’s first and only
single-cell multi-omics platform, is announcing the launch of its most
comprehensive instrument to-date, to save the industry billions of dollars in
drug development costs and bring life-saving treatments to market at least six months
faster.

– Mission Bio’s Tapestri Platform, the first single-cell platform capable of detecting DNA and protein changes simultaneously, gives a profound insight into the mutations that drive disease to enable faster, more successful development of precision cancer therapies.

– Spun out of the lab at UCSF and since led by a former
Berkeley engineer, the company has caught the attention of strategic investors
like Mayfield and Agilent, who see it as one to rival 10x Genomics.


Mission Bio, Inc., a South San Francisco, CA-based
company announced the launch of a complete Tapestri® Single-cell Multi-omics
Solution, the most comprehensive single-cell multi-omics platform on the
market. With a new instrument, single-cell
multi-omics reagent kits, TotalSeq-D™ antibody content from BioLegend, and
visualization software, the complete package provides layered insight into
multiple analytes across all blood cancers, reducing drug development time and cost by at least half.
The company is partnering with BioLegend, a global leader and provider of
world-class, cutting-edge antibodies and reagents, to develop antibody panels
for single-cell protein detection with the new device.

Why
Single Cell for DNA and Protein?

The
complexity of cancer cannot be overcome without
comprehensive tools. Running a large-scale clinical study costs around $40
million, and the pharmaceutical industry is losing $50 billion a year on failed
clinical trials and ineffective drugs. It is essential to identify precision
biomarkers and characterize resistance mechanisms — both DNA mutations and
protein expression– to minimize losses, maximize treatment efficacy, and
accelerate time to market.

“With
our technology, you can unlock the ground truth of cancer:
our DNA-Protein kit offers, for the first time, the
ability to understand the communication pathway all the way from the blueprint
of life in the center of the cell — DNA — to the exterior of the cell via
surface proteins, without inference or conjecture,” explained Nigel Beard,
Ph.D., Chief Technology Officer and SVP of Operations of Mission Bio. “It’s a product builders’ dream to deliver a disruptive
technology that truly empowers our customers with the potential to unravel the
many connected threads that make up the complexity of cancer.”

Uniquely Detect DNA & Protein Simultaneously from the Same Cell

Mission Bio’s new solution
can uniquely detect DNA and protein simultaneously from the same cell and is
already adopted by marquee NCI Cancer Centers,
including MD Anderson Cancer Center, Memorial
Sloan Kettering Cancer Center, University of
Texas, Southwestern Medical Center, and the University of California, San
Francisco. The offering sets a new standard for
comprehensive single-cell multi-omics, providing:

2x Faster Analysis – The new Tapestri
Instrument uniquely enables a simpler workflow for faster time-to-data.
By integrating both genotype and phenotype data on a single Tapestri run,
researchers save weeks in processing and analysis time in
running a single multi-omics workflow.

Get More Out of Your Sample – Save precious
samples by utilizing new reagent kits for a single
workflow to obtain both mutation data and protein expression.

– New Tapestri Cell Protein Staining Reagent Kits from Mission Bio are optimized with a fully developed protocol and compatible with new TotalSeq-D kits from BioLegend and existing Tapestri Core Reagent Kits.

– The 45-plex TotalSeq-D Heme Oncology Cocktail is the first catalog panel in partnership with BioLegend for single-cell surface protein detection with the Tapestri Platform. The panel is pre-mixed, titrated, and lyophilized and consists of antibodies applicable to various hematological malignancies.

Visualization Tools for
Integrated Insights
 – From novice users to savvier bioinformaticians, the
updated Tapestri Pipeline and Insights software provide publication-ready
visualization tools that make it easier to understand data — from raw
sequencing files to multi-dimensional cluster plots.

“The value of connecting the mutations in single-cells with their immunophenotypes directly has been a game-changer in allowing us to discover cell surface markers that identify disease stem cells. Merging multiple assays saves us a tremendous amount of time and allows for better insights into disease biology so that we can develop more precise and effective therapies,” said Stephen Chung, M.D., University of Texas, Southwestern Medical Center.

CVS Health Adds 1,000 COVID-19 Rapid-Result Testing at Retail Pharmacy Locations

CVS Health Adds 1,000 COVID-19 Rapid-Result Testing at Retail Pharmacy Locations

What You Should Know:

– CVS Health announced plans to expand COVID-19 testing
services by offering rapid-result testing at select CVS Pharmacy locations and
through the company’s return to work COVID-19 testing solution, Return Ready.

– Rapid-result tests can help to slow the spread of the virus, especially when combined with other preventive measures including social distancing and “mask-wearing” because it provides patients with the opportunity for a quick diagnosis, appropriate treatment, and care which can help minimize community spread.


As part of CVS Health’s
ongoing effort to increase access to COVID-19 testing
and help slow the spread of the virus, the company today announced plans to
expand COVID-19 testing services currently offered at select CVS Pharmacy
locations to include rapid-result testing at nearly 1,000 sites by the end of
the year.

Rapid-result COVID-19 diagnostic tests are available at no cost to patients who meet the Centers for Disease Control and Prevention criteria. In addition, rapid-result tests may also be available as a testing option for eligible employees or students affiliated with an organization that has adopted CVS Health’s Return Ready™ return-to-work COVID-19 testing solution.

“Access to rapid-result tests enables us to help minimize community spread of COVID-19 by being able to more quickly identify active COVID-19 infection,” said David Fairchild, MD, Chief Medical Officer, MinuteClinic. “In addition, we can test and treat symptomatic patients who test negative for COVID-19 for seasonal illnesses such as flu or strep and provide appropriate treatment and care.”

How It Works

Patients must register in advance at
CVS.com
to schedule an appointment. Testing is also available for patients
ages 12 to 17; a parent or legal guardian must complete the online registration
and must accompany minors ages 15 and younger for testing.

When arriving for testing, patients are asked to follow
signage or the instructions of the staff onsite. Procedures vary by location
and patients may be directed to stay in their vehicle and proceed to a
designated testing structure located in the parking lot or, in very limited
locations, to enter a CVS store through a doorway specifically allocated for
this purpose.

Patients will be provided with a test kit, given
instructions, and a CVS Health team member will observe the self-swab process.
Patients will be directed to wait outside the store in their vehicle for
results. The process, from the collection of the swab to the delivery of the
results, will generally take approximately 30 minutes.

Patients who access rapid-result testing and receive a
negative COVID-19 result will have the opportunity to schedule an appointment
at the on-site MinuteClinic for further assessment and to determine if a rapid-result
test for flu and strep would be appropriate. The MinuteClinic provider will
then be able to provide counsel on a treatment plan and prescribe medications
if clinically appropriate.


Availability

Nearly 100 of the planned rapid-result test sites will be
operational at select CVS Pharmacy locations in 22 states as of this
week. States include Arizona, California, Connecticut, Florida, Georgia,
Illinois, Indiana, Kansas, Massachusetts, Maryland, Michigan, Minnesota,
Missouri, North Carolina, New Jersey, New Mexico, Ohio, Pennsylvania, Rhode
Island, South Carolina, Texas, and Virginia. Patients seeking a COVID-19 test
at CVS Pharmacy can find a complete list of locations and options
offered here.


Medidata Acquires Digital Biomarker Business of MC10 / Clinical Trials & Wearable Sensors

Medidata Acquires Digital Biomarker Business of MC10 / Clinical Trials & Wearable Sensors

What You Should Know:

– Clinical trials technology company Medidata has
acquired the digital biomarker business of MC10.

– MC10’s offerings will bring novel clinical analytics
and biosensor capabilities to Medidata’s existing technology solutions,
enhancing Medidata’s capabilities to integrate data from wearable sensors –
including clinical grade metrics – in clinical trials.

– With this acquisition, Medidata’s integrated offering
will help provide life sciences companies and device developers with greater
understanding of diseases, transformational therapies, and novel endpoints.


Medidata,
a Dassault Systèmes company, the global leader in creating end-to-end solutions
to support the entire clinical development process, acquired
the digital biomarker business of MC10. MC10’s offerings will bring novel
clinical analytics and biosensor capabilities to Medidata’s existing Patient Cloud solutions
in ePRO (patient-reported outcomes), eCOA (clinical outcome assessments), and
biomarker discovery. This will enhance Medidata’s capabilities of integrating data from
wearable
sensors – including clinical grade metrics – to help
customers successfully virtualize clinical trials.

MC10 Background

MC10 is a Lexington, MA-based privately held
company focused on improving human health through digital solutions. The
company combines conformal BioStamp sensors with clinical analytics to unlock
novel insights from physiological data collected from the home or in clinical
settings. The company flagship product, BioStamp nPoint, is intended for the
clinical research community.

Why It Matters

Remote, patient-centered technologies have become
an essential part of clinical research, especially in the age of COVID-19; the
physical restrictions placed on patients and clinical sites caused by the
pandemic can interfere with launching a clinical study and carrying it to
completion. Wearable sensors are used in about 15 percent of studies, and the
use of sensors is expected to grow to approximately 70 percent by 2025.* 

Medidata leads the industry in building and integrating new technologies to revolutionize clinical research in pursuit of patient-centric therapy development. MC10’s focus on clinical-grade data capture and novel digital biomarker development represents an important next chapter – advancing the understanding of disease progression and treatment effect in the home. 

“Medidata is excited to add the pioneering work at MC10 to our ongoing efforts in building a new platform for ingestion and analytics across a wide array of mobile sensors,” said Anthony Costello, senior vice president, Mobile Health, Medidata. “Incorporating remote biometric data capture and analysis that includes the MC10 nPoint Biostamp, alongside other leading mobile devices, will further strengthen the Medidata platform and help propel the digital transformation of life sciences.”

Acquisition Builds Integrated Offering

An integrated Medidata offering will provide research companies and device developers new and innovative ways to collect, normalize, and analyze data in pursuit of new therapy development. This enhanced capability will also create a closer connection between patients and the ecosystem of trailblazing researchers, practitioners, and life science companies committed to deepening a shared understanding of the disease, transformational therapies, and novel endpoints.

“Medidata is an exceptional fit for MC10. Our combined expertise will help customers and partners take a more data-driven approach to bringing targeted therapies to patients,” said Ben Schlatka, co-founder and CEO, MC10. “We are looking forward to moving ahead together, accelerating the development and deployment of new innovative offerings for our customers and ultimately transforming therapy development to improve the lives of patients.”

Press Ganey Acquires Doctor.com, Acquires Majority Stake in Binary Fountain

Press Ganey Acquires Doctor.com, Acquires Majority Stake in Binary Fountain

What You Should Know:

– Press Ganey advances the healthcare consumerism movement with acquisitions of Doctor.com and a majority stake in Binary Fountain.

– Expanded technology platform enables industry-leading
management of providers’ online brand and seamless Web-wide patient acquisition
and loyalty strategies.


Press Ganey today
announced the expansion of its market-leading health care consumerism platform
with the acquisitions
of Doctor.com and a majority equity stake
in Binary Fountain. These acquisitions create the largest health care
consumerism platform in the industry that offers an unmatched opportunity for
health systems and providers to drive digital patient acquisition, retention,
and reputation management strategies that will deliver new levels of growth and
loyalty.


Set Up Your Virtual Practice in 5 Minutes or Less with
Doctor.com’s Turnkey Solution

Founded in 2013, Doctor.com provides the critical
infrastructure and integrations necessary to enable modern digital experiences
for patients. Doctor.com clients benefit from best-in-class provider data,
robust physician and patient engagement tools, and seamless integrations with
the most prominent health care directories, search engines, social media
platforms, and EHR/PM systems. As a result, thousands of clients, including
200+ leading hospitals and health systems, 30,000+ private practices, and
leading brands in the life sciences industry, have been empowered by Doctor.com
to enhance their digital presence and credibility, increase patient trust, and
grow their business.


Why It Matters

The COVID-19 crisis radically disrupted the health care
industry and altered consumer behavior. The result was massive growth in
telehealth services, with Press Ganey administering more than 15 million
telemedicine surveys year to date. Coupled with more than 71% of patients
seeking physician reviews online and 70,000 health-related Google searches each
minute, these fundamental shifts have escalated the need for health care
providers to enhance and streamline the online healthcare customer experience.

“This acquisition is game-changing for the industry. By pairing data and insights from Press Ganey’s 472 million consumer surveys a year with next-generation technology, health care organizations can finally unite their patient experience and patient acquisition efforts within one powerful platform. This unified solution drives performance improvement, accelerates transparency initiatives, and improves the patient experience,” said Andrei Zimiles, co-founder and CEO, Doctor.com. “As patients continue to ‘shop’ for care in increasingly competitive digital channels, this groundbreaking new platform from three pioneers in the consumerism space gives health care organizations the edge they’ve been looking for.”

Financial details of the acquisition were not disclosed.

How Low-Code Solutions Reduce Headaches for Healthcare CIOs

How Low-Code Solutions Reduce Headaches for Healthcare CIOs
Ruby Raley, VP of Healthcare and Life Sciences at Axway

Twenty years ago, technology consultants started advising CIOs to build less. That’s when the movement towards Commercial Off the Shelf (COTS) began. 

Today, there are many shops, especially those in small and medium-sized organizations, with few programmers who build new applications from scratch.  

Yes, they have programmers who configure, script, and integrate various applications but very little is built. For the provider community, we have a habit of either sourcing our needs from our Electronic Health Records (EHR) application vendor or buying a “best of breed” application from a niche vendor.

Moving to Software as a Service (SaaS) has even reduced the dread of upgrades. No doubt buying commercial software has enabled all of us to have access to better solutions and in some cases, may have reduced the ongoing run rate. Still, it means technology costs have gone up and a lot of our technology goals have not been achieved. 

For example, interoperability remains a point to point problem. ONC and CMS are still pushing to remove barriers to interoperability and have mandated data exchange with penalties.  

CIOs are struggling with the realities of constraint budgets where new programs are starving while dollars go to pay maintenance, integration costs associated with prior purchases (e.g. tech debt).

New Challenges

Then, in a year of the normal pull-and-tug between maintaining current and delivering new systems, COVID-19 arrived and our planning fell short. Technology teams were challenged as never before. They suddenly needed to:

– Enable teams to work from home – even teams who have never worked remotely.

– Stand up telehealth solutions in days – not months.

– Find a good external data source with statistics to integrate and then discover a newer, better source days later.

– Provide real-time updates on the availability of hospital rooms to leadership.

– Provide rapidly evolving guidance to patients on admissions changes, new requirements for entrance to facilities reduced access to admitted patients.

– Be a trusted, consistent source of guidance to reduce the spread of the disease.

Unplanned work

This was all new, unplanned work. Work that took resources from other budget areas and other teams. Work that didn’t always meet our aim for better patient care or patient experience.

For example, we saw some providers advertising the availability of telehealth services but requiring a patient to call their primary care doctor to schedule instead of requesting an appointment online. Then due to staff shortages, the patient would land in voice mail, further delaying access to care. 

Patients needing tests have been told to get an order from their physician. The truth is telehealth isn’t integrated and isn’t part of our daily processes.  

Unsung hero

The story here is the emergence of an unsung hero you can’t find on the nightly news: our IT Teams. We need to arm this group of heroes with better tools.  Tools where delivery of new programs, updates to existing processes and integrating new data from external sources can be done in days, not months. 

Did your clients link to external data sources such as John Hopkins? Did they need to enable test sources from new partners? Did they need to build new mobile applications to integrate workstations in parking lots and third-party locations?

New approach – Low-Code

Today’s challenges require a new approach that is “low-code.” Low-code is shorthand for an application development environment that is primarily visual and uses simple declarative statements to create applications. The primary goal of low-code is to accelerate program delivery.  

This is surely a goal for every healthcare technology team. As enterprise clients embrace low-code, they can ensure readiness by putting these building blocks in place so clients can realize the promised value:

– Authentication Management through APIs (OAuth)

– Standardized access through APIs

– Management and Monitoring

Preparation

In preparation for the adoption of a low-code application platform (LCAP), it is essential to assess the adoption of authentication best practices. 

The technology landscape now spans on-prem, private cloud, and public cloud solutions requiring a standardized, tokenized approach to authentication. Without this, security processes will inevitably fall short of the CISO’s goals or will require additional manpower to monitor and maintain.  

OAuth is the building block

Given the number of vendors, environments, and the velocity of human interactions (non-employee clinicians, temporary resources of all types, patients, etc.), OAuth is the building block for scalable secure authentication. OAuth is a delegated authentication framework that replaces the need to send credentials in program calls (APIs). 

It has been required by CMS for the interoperability rule as a foundation for data sharing. If you haven’t, invest in a centralized identity management system and move to use OAuth to authenticate service and access requests. Standardizing authentication is foundational. Do it before selecting a low-code vendor.

LCAP platforms deliver a variety of methods to access data from other applications. Typical integration patterns include files, database calls (ODBC, JDBC, etc.), and scripting.  

Now is the time to adopt API-First and design thinking. Stop building point-to-point integrations – the velocity of LCAP will result in a proliferation of connection methods if interfaces are not standardized.

Using APIs – fast delivery

Using APIs will enable faster delivery and better performance.  Providing a set of standardized interfaces that meet the needs of consumers (a fundamental goal of API-First) will reduce test time, production breakage, and upgrade complexity. Don’t wait.  

Doing APIs right requires a culture shift – slapping an API on an enterprise application is not the goal. Delivering APIs that drive consumption and adoption by citizen developers and go-to-market programs will power user experiences that truly do more with less.  

Management and monitoring 

Last but not least is the management and monitoring of your new agile applications, especially the application interactions with your core enterprise applications and external integrations. We have all seen it, a new program or upgrade is delivered, and performance slows to a crawl. 

Monitoring and metering access (limited access to X number of calls per time period) is essential to proactively prevent coding errors and shield your client from bad actors. Knowing who is accessing what, and how the load varies, is necessary to achieve the goals of delivery velocity and efficient use of resources.

API Management vendor leaders include policy engines, management, and embedded analytics in their gateways to protect and scale service integrations.  

Better, faster, cheaper is our mantra (once again, some of us mutter under our breaths). Adopting low-code will accelerate delivery and help us meet the demands of the new normal.  

LCAP demands standardized authentication, application program interfaces (APIs), and secure, monitoring gateways to accelerate adoption while protecting and securing enterprise resources. 


About Ruby Raley

Ruby Raley is VP of Healthcare and Life Sciences at Axway. Axway empowers customers to compete and thrive in dynamic marketplaces using hybrid integration solutions to better connect their people, systems, businesses, and digital ecosystems. More than 11,000 organizations in 100 countries rely on Axway to solve their data integration challenges. 

Complimentary trend analysis report: Emerging trends in pancreatic cancer research

Pancreatic cancer sadly remains one of the most deadly cancers in existence, partly because it often goes undiagnosed until it has already metastasized. Finding new and better therapies to fight pancreatic cancer means accelerating the research. A new report just released from Elsevier’s Professional Services Group, titled Text mining to identify emerging trends in the pancreatic cancer literature, shows how that is possible.

Elsevier Life
Sciences consultant Eric Gilbert authored the report, utilizing Elsevier’s text
mining tool to zero in on trends published in the scientific literature over
the last couple years. Accomplishing this involved a sophisticated process –
facilitated by Elsevier’s Natural Language Processing engine – of identifying
trending taxonomy terms and filtering to get the most relevant results. (While
the method was used here specifically for pancreatic cancer, it is flexible and
can capture trending terms for any subject.)

As the report’s
Executive Summary shows, key findings include:

  • The upregulation of two long non-coding RNAs (lncRNA) XIST and linc00511 in pancreatic tissue were correlated with poor patient outcomes.
  • Higher levels of the methyl transferase METTL3 and lower levels of the demethylase ALKBH5 resulted in higher levels of methylated m6A RNA and poorer prognosis.
  • The induction of ferroptosis, a type of regulated cell death, is being looked at as a potential treatment for pancreatic cancer.
  • New insights into the mechanisms of pancreatic cancer’s ‘immune evasion’ are being reported.
  • There is increasing evidence that propofol has biological effects that may alter the progression of pancreatic cancer.

These findings
reflect a number of really intriguing and promising developments in the world
of pancreatic cancer research. And keeping on top of advances and insights like
these is vital for the Life Sciences community in order to stay at the leading
edge of research and discovery.

To learn more about these and other emerging trends in pancreatic cancer research, please download the full report here.

Feel free to contact us if you want to find out more about Elsevier’s text mining tool or how the Professional Services Group can help you with your own custom research reports.

J.P. Morgan on the state of life sciences and strategies to fuel innovation [Sponsored]

In an interview, Peter Meath, J.P. Morgan’s co-head of Healthcare and Life Sciences, Middle Market Banking & Specialized Industries, says the Covid-19 pandemic has cast a bright light on the life sciences industry with startups raising venture funding at record levels as the virus has transformed the way people usually do business in the sector. 

KPMG Launches COVID-19 Convalescent Plasma Donor Matching Solution

KPMG Launches New COVID-19 Convalescent Plasma Donor Matching Solution

What You Should Know:

– KPMG offers its data & analytics capabilities to
address emerging challenges tied to matching recovered patients with those in
clinical trials to receive convalescent plasma.

– KPMG’s capabilities can make the plasma donation process easier
and more efficient by automating the complex tasks and logistics associated
with the data collection, qualification and matching process by performing
statistical analytics, and using artificial intelligence (AI), virtualized
data, and blockchain to trace the plasma from donor to clinical trial
patient.  


Recognizing the need for technologies to help advance the
response and recovery to the COVID-19
pandemic, KPMG LLP has built the technology
architecture for a solution that can match patients in clinical trials for
convalescent plasma therapy to recovered patients willing to donate their
antibodies.

Simplifying The Plasma Donation Process

Data & analytics can simplify the process of matching
patients who have recovered with patients that are undergoing clinical trials.
According to media
reports
, the FDA paused the use of
convalescent plasma therapy for emergency cases, citing inconclusive data.
federal
registry for clinical trials
 lists
54 U.S. studies of convalescent plasma therapy for treating COVID-19, with a
majority of them still recruiting patients. 

KPMG’s capabilities can make the plasma donation process easier
and more efficient by automating the complex tasks and logistics associated
with the data collection, qualification and matching process by performing
statistical analytics, and using artificial intelligence (AI), virtualized
data, and blockchain to trace the plasma from donor to clinical trial
patient.  KPMG’s framework is designed to integrate third-party data
from blood banks, hospitals, and diagnostic labs and work with data backbones
and existing technology applications that are already in place, such as IT
infrastructure owned by governments and hospitals.

The technology can also be deployed for contact tracing or
monitoring vaccine use to help policy makers with population health and social
distancing decisions. KPMG introduced this technology as part of its
recently announced “Restarting America” initiative
to help organizations safely reopen workplaces.

“This solution is designed to help ease the burden on plasma donors, accelerate the COVID-19 plasma donation process and provide better visibility to health authorities, while helping facilitate the study of convalescent plasma,” said Bharat Rao, PhD, principal and leader of Data and Analytics for healthcare & life sciences at KPMG. “With the use of a mobile app, the data is better organized in a secure format, and reduces the duplication of requests and administrative overhead among healthcare organizations.”

UK Cancer Diagnostics Startup Biofidelity Raises $12M

UK Cancer Diagnostics Startup Biofidelity Raises $12M

What You Should Know:

– UK-based Biofidelity raises $12 million in Series A funding to accelerate the launch of disruptive cancer diagnostic technology.

– The funding will be used to bring technology to market,
enabling a dramatic simplification of precision genetic testing to ensure many
more cancer patients receive optimal diagnosis and therapy.


Biofidelity Ltd, a Cambridge,
UK-based cancer diagnostics company, today announced it has raised $12 million
in Series A funding led by BlueYard Capital and backed by experienced investors
including Longwall Ventures and Agilent Technologies, a global leader in life
sciences and diagnostics.

Founded in 2019, Biofidelity is initially focusing on the diagnosis of non-small cell lung cancer, with potential across a broad range of cancers as well as applications in the detection of resistance to therapy and disease recurrence.

Biofidelity’s disruptive technology combines fast, affordable, easy to interpret results, in order to dramatically simplify genetic testing while providing all the key benefits of next-generation sequencing (NGS). The Company estimates that 95% of cancer patients are currently excluded from NGS due to high cost, complexity, and slow turnaround times.

Biofidelity provides clinically actionable data based on ultra-sensitive detection of the markers recommended in cancer treatment guidelines, enabling oncologists to prescribe the right cancer drug at the right time to many more patients. Straightforward adoption of existing infrastructure is expected to greatly increase the number of laboratories able to offer superior cancer diagnostics.

Recent Traction

In January, Biofidelity announced the successful completion of a study to detect key lung cancer mutations in collaboration with Agilent Technologies. The collaboration, using an assay developed by Biofidelity, demonstrated an improvement in sensitivity of 50 times that achieved with current FDA-approved PCR-based diagnostics. This matched the sensitivity of specialized NGS assays, which require error-correction technology while providing a dramatic simplification of workflows from more than 100 steps to just four. Assays were performed using standard laboratory instrumentation, demonstrating the potential for straightforward adoption of Biofidelity’s panels in decentralized testing laboratories around the world.

The company plans to use the funding to accelerate the development and clinical validation of oncology panels for treatment selection and patient monitoring in oncology, and to bring these assays rapidly to market through direct sale, partnering, and collaboration.

emids Acquires Payer IT Consulting Firm FlexTech

emids Acquires Payer IT Consulting Firm FlexTech

What You Should Know:

– emids – a leader in digital engineering and
transformation solutions for the healthcare and life sciences industries –
today announced the acquisition of Nevada-based FlexTech, a payer IT consulting
firm recognized by KLAS as a category leader.

– The FlexTech deal will drive expanded channel
partnership opportunities for emids among leading core platform vendors and
position emids as the go-to partner for advancing adoption of new digital
business models.


emids, a Nasvhille, TN-based provider of digital engineering
and transformation solutions to the healthcare and life sciences industry, today
announced it has acquired FlexTech, an Incline Village, NV-based
information technology
consulting company with deep expertise in leading payer core administration and population health platforms, in a deal that closed late last month. The partnership, driven by heightened urgency for health
plans to adopt breakthrough digital-based strategies, enhances emids’ ability
to help its clients accelerate their digital transformation journeys.

Acquisition Benefits for emids

The acquisition is part of emids’ purposeful growth plan and comes on the heels of a strategic equity investment earlier this year from the Blue Venture Fund, a majority investment last fall from New Mountain Capital. The FlexTech deal will drive expanded channel partnership opportunities for emids among leading core platform vendors and position emids as the go-to partner for advancing the adoption of new digital business models. FlexTech, a KLAS 2020 category leader in payer IT consulting services, brings a proven and experienced team of 120+ subject matter experts, each with an average 20 years of experience in managed care, core administration and population health platforms, and strong partner relationships with the leading healthcare payer technology vendors.

“The need for deep domain expertise combined with digital transformation capabilities is vital as our payer and ‘payvider’ clients expand their government-sponsored business lines, and we’re excited to bring our clients the proven payer platform expertise that FlexTech has built over 30+ years, delivering more than 250 core platform implementation programs,” said emids Founder and CEO Saurabh Sinha.

Financial details of the acquisition were not disclosed.

Castor Raises $12M to Advance COVID-19 Research Through Clinical Trial and Data Automation

Castor Raises $12M to Advance COVID-19 Research Through Clinical Trial and Data Automation

What You Should Know:

– Castor raises $12M in Series A funding to further their
support for COVID-19 research through clinical trial and data automation.

– With 4,000 live studies and 2,000,000 enrolled patients
across 90 countries, Castor will use the funding to further invest in enabling
patient-centric, data-powered clinical trials.


Castor, a Hoboken,
New Jersey startup using automation and data reuse to simplify the entire
clinical trial process, announced $12M in Series A funding led by Two Sigma
Ventures with participation from Hambrecht Ducera Growth Ventures and existing
investor INKEF Capital. Castor will use this new funding to further strengthen
its support for patient-centric, remote trials and to enable customers to
maximize value from existing and newly generated data throughout the clinical
trial process.

Based in the United States and The Netherlands, Castor is an international health-tech company founded by CEO Derk Arts, MD, PhD. Their cloud-based clinical data platform simplifies the clinical trial process, from recruitment to analysis, for researchers worldwide. Castor’s leading cloud-based clinical data platform is used by 50,000 researchers globally to run remote clinical trials and capture data from patients, physicians, EHR systems, and wearables. The platform transforms this data into a machine-readable format that facilitates the use of AI and makes large scale sharing and reuse of clinical trial data possible for the first time.

Powering COVID-19 Clinical Research Across The Globe

The company is at the forefront of fighting COVID-19 – the
first to make its platform freely available for non-profit COVID-19 vaccine
research. Over 200 COVID-19 projects across 33 countries are currently running
on the platform, including the World Health Organization’s global Solidarity Trial. To date, Castor is powering 4,000+
studies with 2M+ patients across 90 countries and counts 192 medical device,
biotech, and pharmaceutical companies and contract research organizations
(CROs) as customers.

“There are three key challenges that need to be addressed in the clinical trial space: making research more patient-centric, maximizing the impact of data on human lives, and better addressing the needs of underserved communities,” said Derk Arts, MD, PhD, CEO & Founder of Castor. “With this new investment, we will be able to make significant progress in all three areas by continuing to deliver user-friendly, accessible technology that can support remote trials, while ensuring machine-readable output that allows for trial automation and data reuse. In the next 18 months we intend to support our customers with patient recruitment and synthetic control arms, through better use of their data. We are excited to partner with Two Sigma Ventures, who bring extensive experience in leveraging the power of data and AI to disrupt incumbent industries.”

THREAD Lands $50M for Decentralized Clinical Trial Research Platform

THREAD Lands $50M for Decentralized Clinical Trial Research Platform

What You Should Know:

– THREAD receives an additional $50 million capital commitment from Water Street and JLL Partners to expand its decentralized clinical trial research platform

– THREAD is an innovative technology and service
provider that increases participant engagement by enabling pharmaceutical
companies and contract research organizations to remotely capture data from
participants and sites during, in between and in lieu of in-clinic
visits. 

– This major investment comes at a time of incredible
growth for the company, which has expanded its footprint to 40 countries in the
past year. Further, its cutting edge, virtual approach has allowed
pharmaceutical companies and researchers alike to continue with critical
clinical trials throughout the pandemic.


 THREAD, an innovative technology and service provider that enables
decentralized clinical research, announced today that it’s accelerating the
company’s expansion after receiving an additional capital commitment of up to
$50 million from strategic healthcare investors, Water Street Healthcare
Partners and JLL Partners.  In 2019, Water Street and JLL Partners
invested in and acquired THREAD to further develop and expand THREAD’s offering on a global
scale. The company’s latest capital infusion builds on a year of
significant growth and investments in its platform and services to advance
decentralized research approaches for large-scale, Phase Ib – IV global
clinical trials.

Decentralized Clinical Trial Research Platform

THREAD is a leading provider of a proprietary, decentralized research platform and suite of supporting services used by biopharma, CROs, and life science organizations to remotely capture data from participants and sites during, in-between, and in lieu of in-clinic visits. THREAD’s platform and supporting services are helping customers to reduce study launch timelines, reduce study budgets with Virtual Visits, and bring studies from the clinic to patients’ homes. THREAD provides key platform features such as eConsent, eCOA/ePRO, sensors, reminders, and telehealth Virtual Visits to support remote data capture, hybrid virtual studies, and fully decentralized studies in key therapeutic areas.

Recent Traction/Milestones

Over the past year, THREAD has leveraged the healthcare firms’ combined pharmaceutical expertise, a network of industry resources and capital to:

– expand its global footprint to more than 40 countries;

– add new features to its proprietary, configurable decentralized research platform;

– enhance its capabilities and provide 24×7 global, multilingual customer support;

– rapidly develop and implement COVID-19 clinical trial risk mitigation tools to advance critical research during the pandemic;

– ultimately support customers with virtual visits, hybrid decentralized studies

– fully decentralized studies customized to their individual study needs in key therapeutic areas.

To
date, THREAD has supported more than 100 decentralized studies.  The
company will continue to invest in expanding and enhancing its innovative
platform and supporting services as a growing list of the world’s leading
pharmaceutical and life science organizations engage the company as their
partner for their clinical research studies.  

Bayer, Verizon Partner to Build Next-Gen Global Network Infrastructure

Bayer, Verizon Partner to Build Next-Gen Global Network Infrastructure

What You Should Know:

– Bayer announced that it has chosen Verizon
Business to build a next-gen global network infrastructure to support the
pharmaceutical giant’s global business operations. 

– Verizon will enhance Bayer’s existing network
capabilities to enable easier and more cost-effective network management and
will deploy next-generation network technologies, such as software-defined
networking (SDN), to further improve resilience, flexibility, and
scalability. 

– Through this five-year contract
partnership, Verizon Business will deliver managed network services to
over 700 sites in 91 countries around the world.  


Pharmaceutical giant Bayer
announced it has selected Verizon Business
to build a next-generation global network infrastructure to underpin the
company’s global business operations. As part of the five-year contract, Verizon Business will
enhance Bayer’s existing network capabilities to enable easier and cost-effective
network management, and will also deploy next-generation network technologies,
including software-defined networking, to further improve resilience,
flexibility and scalability. 

Outsourcing Global Network Environment

As Bayer continues to move to a cloud-first,
digital business model, the company decided to outsource management of the
majority of its global network environment to a single service provider.
The objective was to free up its own resources to focus on supporting its core
crop science, pharmaceutical and consumer health business activities, while
also further developing a secure, stable but flexible network platform to
improve connectivity and collaboration around the globe, and support ongoing
digital business transformation. 

Delivering Managed Network Services to Over 700 Sites

Verizon Business will deliver managed network services to
over 700 sites in 91 countries around the world. This includes a managed global
Private IP network, a managed software-defined Wide Area Network, and
Professional Services support and governance. Verizon Business was chosen for
the strength of its expertise and experience, its position as a global leader
in network delivery and its proven track record in delivering efficient
networking services for global clients. 

“Our network is foundational to our future business success,
and Verizon has the global technology and innovation capabilities and expertise
to support us as we continue to digitally transform our company. Most
importantly, with our network management safe in Verizon’s hands, we are able
to focus our internal IT competencies on generating value for our core Life
Science businesses,” said Bijoy Sagar, Chief Information Technology and Digital
Transformation Officer, Bayer.

The five-year contract is effective immediately and has an
additional two-year extension.

Moderna Leverages AWS Cloud Platform to Develop New Class of Vaccines and Therapeutics

Moderna Leverages AWS Cloud Platform to Develop New Class of Vaccines and Therapeutics

What You Should Know:

– Moderna, Inc., a biotechnology company pioneering a new
class of messenger RNA (mRNA) medicines, has selected Amazon Web Services
(AWS) as its preferred cloud provider, as well as its standard for
analytics and machine learning workloads.

– By building and scaling its operations on AWS, Moderna
is able to quickly design research experiments and uncover new insights,
automate its laboratory and manufacturing processes to enhance its drug
discovery pipeline, and more easily comply with applicable laws and regulations
during production and testing of vaccine and therapeutic candidates.

– Leveraging its mRNA platform and manufacturing facility
with the AWS-powered research engine, Moderna delivered the first clinical
batch of its vaccine candidate (mRNA-1273) against COVID-19 to the NIH for the Phase
1 trial 42 days after the initial sequencing of the virus.


Amazon Web Services, Inc.
(AWS)
, an Amazon.com company, announced that Moderna, Inc., a biotechnology company
pioneering a new class of messenger RNA (mRNA) medicines, has selected AWS as
its preferred cloud provider, as well as its standard for analytics and machine
learning workloads. Leveraging its mRNA platform and manufacturing facility
with the AWS-powered research engine, Moderna delivered the first clinical
batch of its vaccine candidate (mRNA-1273) against COVID-19 to the
NIH for the Phase 1 trial 42 days after the initial sequencing of the virus.

By building and scaling its operations on the world’s
leading cloud, Moderna is able to quickly design research experiments and
uncover new insights, automate its laboratory and manufacturing processes to enhance
its drug discovery pipeline, and more easily comply with applicable laws and
regulations during production and testing of vaccine and therapeutic
candidates.

Accelerating Development of Messenger RNA Medicines to Prevent
and Fight Diseases

Researching and developing new drugs can be complex and
expensive. Scientists have to conduct years of basic research to understand how
new diseases act at a molecular level in the human body and need to screen
thousands of different molecular compounds (the basis for many drugs) to assess
their safety and efficacy as potential treatments. After they narrow down the
pipeline, researchers perform multiple rounds of testing in the laboratory
before advancing the most promising drug candidates for further study.

In addition, because the manufacturing requirements for
these drugs can be highly variable, pharmaceutical companies may also need to
build expensive new infrastructure or redesign existing facilities in order to
produce them. Moderna is managing these challenges, leveraging the breadth and
depth of AWS services to simplify the research and manufacture of a
new class of drugs, based on mRNA, to treat a wide range of diseases.

AWS/Moderna Integration Benefits

Moderna has invented proprietary technologies and methods
that run on AWS to create mRNA constructs that cells recognize as if
they were produced in the body. This invention has empowered Moderna to
experiment rapidly on virtually any mRNA sequence, easily shifting between
research priorities, without investing in new technology. Moderna runs its Drug
Design Studio on AWS’s highly scalable compute and storage infrastructure
to quickly design mRNA sequences for protein targets.

It then uses analytics and machine learning to optimize
those sequences for production so that the company’s automated manufacturing
platform can successfully convert them into physical mRNA for testing. In
addition, by leveraging Amazon Redshift – AWS’s fully managed data
warehousing service – Moderna’s scientists and engineers aggregate results from
dozens of experiments that are running in parallel and can easily query and
share insights to refine their design and production cycle quickly. 

Moderna runs all of its SAP S/4HANA workloads on AWS,
including manufacturing, accounting, and inventory management, which enables
the company to achieve greater efficiency and visibility across its
operations. AWS also powers Moderna’s highly automated production
facility, which runs AWS IoT services to connect the manufacturing
instruments, robotics, and other critical systems that quickly deliver the mRNA
constructs for experimentation.

Integrating its systems on AWS provides Moderna
with the ability to trace its manufacturing process, facilitating industry best
practices in its supply chain, manufacturing, and quality control processes.
Moderna also used AWS to essentially copy and paste its digital
manufacturing model onto its partner’s facilities for technology transfer,
giving Moderna rapid access to the additional production capacity it needs to
address global demand.  

“The science behind mRNA medicines is advancing at a rapid pace, and building Moderna’s technology platform on AWS gives our scientists the insights, agility, and security they need to continue to lead in the industry,” said Stéphane Bancel, Moderna’s Chief Executive Officer. “With AWS, our researchers have the ability to quickly design and execute research experiments and rapidly uncover new insights to get potentially life-saving treatments into production faster. AWS’s breadth and depth of services are supporting our mission to create a new generation of medicines for patients and are instrumental in our quest to develop a vaccine for COVID-19 and other life-threatening diseases.”

Talis Awarded $25M NIH Contract for Point-of-Care COVID-19 Testing

Talis Awarded $25M NIH Contract for Point-of-Care COVID-19 Testing

What You Should Know:

– Today, Talis Biomedical Corporation announced it has
been awarded a $25M contract from the National Institutes of Health (NIH) as
part of Phase 2 of its Rapid Acceleration of Diagnostics (RADx) initiative as
well as another $100 million in additional financing.  

– The new funding will be used to scale manufacturing for
the launch of the Talis One™ diagnostic platform that provides rapid and highly
accurate detection of COVID-19 at points-of-care in 30 minutes or less.

– The Talis One System is a fast, easy-to-use, solution
that brings testing out of the lab and to the point of care. The technology
provides healthcare professionals with an entire clinical lab in the palm of
their hand and is intended for use in non-laboratory settings, such as
physicians’ offices, urgent care clinics, elder care/assisted living
facilities, cancer treatment and dialysis centers, and potentially the
workplace.


Talis Biomedical Corporation,
a company dedicated to developing high-performance point-of-care diagnostic
tests for infectious diseases, today announced that it has secured a $25
million contract from the National Institutes of Health (NIH) for Phase 2
of its Rapid Acceleration of Diagnostics (RADx) initiative. Additionally, the
company has completed an additional financing of $100 million to scale
manufacturing for the launch of the Talis One™ diagnostic platform, which
provides rapid and highly accurate detection of COVID-19 at the
point-of-care. 

Accurate Point of Care COVID-19 Testing

 Today, patients are
often forced to endure days of waiting for lab results.  As a result, doctors may initiate unnecessary
isolation or empirical treatment based on incomplete information. This approach
is costly and can be harmful to patients. With COVID-19 cases
on the rise in many areas across the country, there is a tremendous need for
access to testing, especially in vulnerable populations where the spread of
COVID-19 infection can be devastating.   The Talis One System is a molecular diagnostic
platform developed to enable rapid, highly accurate point-of-care testing for
infectious diseases such as COVID-19.

Talis One COVID-19 Assays

The Talis One assays are based on a proprietary, highly
optimized nucleic acid isothermal amplification chemistry to achieve
exceptional test performance much faster than traditional PCR. The system is
designed for use in non-laboratory settings, such as physicians’ offices,
urgent care clinics, elder care/assisted living facilities, cancer treatment
and dialysis centers, and potentially the workplace.

COVID-19 is the first infectious disease that the Talis One
System will support. Future infectious disease indications may include assays
for other respiratory infections, such as influenza, as well as sexually
transmitted infections (STIs) and other infections impacting women’s health.
The Talis One instrument can be managed remotely and sends test results to a
cloud database for secure transmission, storage and review. Results are
available in 30 minutes or less.

“We are extremely proud that the NIH selected Talis,
out of a field of 600 applicants, to be among the first teams to move to the
final phase of the RADx initiative. This important funding will accelerate the
commercialization of our Talis One System for the detection of COVID-19.
Additionally, we are pleased to have the continued support of our investors,
who share our excitement about the significant impact the Talis One System can
deliver as a fast and reliable diagnostic testing platform for life-threatening
and life-altering infectious diseases,” said Brian Coe, Co-Founder and
Chief Executive Officer of Talis.

“In response to the significant need for rapid, highly
accurate testing solutions to help combat the pandemic, we were able to utilize
our Talis One System, which we have been developing for clinical use in women’s
health, to quickly develop an assay for SARS-CoV-2, the novel coronavirus that
causes COVID-19. We are particularly focused on serving vulnerable populations,
such as those in elder care facilities or patients with impaired immune
systems. With the support of the NIH RADx program and proceeds from the new
financing, we are confident that we will be able to accelerate our goal of
making rapid diagnostic testing widely available,” added Coe.

NIH Support

The Talis One COVID-19 assay project is supported by the
RADx program and has been funded in whole or in part with Federal funds from
the National Institute of Biomedical Imaging and Bioengineering, National
Institutes of Health, Department of Health and Human Services, under Contract
No. 75N92020C00010.

Super-Spreading of COVID-19 Co-Infections Reveals a Deadly Diagnostics Gap

Super-Spreading of COVID-19 Co-Infections Reveals a Deadly Diagnostics Gap
Oliver Schacht, PhD, CEO of OpGen

Secondary bacterial or fungal co-infections in COVID-19 patients have received inadequate attention from the public. For most, co-infections pose little to no risk according to reports that an estimated 8% of patients are found to experience this during hospital admission – a relatively low number compared to the global impact of the virus. However, once a patient enters a hospital for care or becomes ventilated while in the ICU, the risk for acquiring and spreading a deadly secondary bacterial or fungal infection drastically increases and patients have to battle for their life with not one, but two potentially fatal diseases. 

Preliminary results from a study performed by the Karolinska Institutet in Stockholm, Sweden found that 25% of hospitalized COVID-19 patients in the ICU have a bacterial co-infection. Similarly, other studies have reported that patients hospitalized with COVID-19 have acquired a dangerous secondary bacterial infection, and 50% of patients who have died had such infections. Consequently, these infections become just as significant a threat as the virus itself once a patient enters the hospital. Hospitals have an inherent responsibility to not only slow the spread of COVID-19 but also to diligently diagnose and treat these secondary infections. 

As doctors prioritize the identification and treatment of COVID-19, instances of patients ‘super spreading’ bacterial or fungal infections through hospitals reveal a dangerous gap in our healthcare system’s ability to quickly and precisely identify these other infectious diseases. To adequately evaluate COVID-positive individuals under their care and fill this gap, hospitals should be aware of the availability of rapid multiplex PCR diagnostic panels for lower respiratory tract infections such as pneumonia and deploy them as part of the diagnostic assessment of patients in whom bacterial or fungal infections are suspected.  

The Need for Rapid yet Comprehensive Diagnostics 

Hospitals are already in a fight against time when patients are admitted for COVID-19. Doctors have to quickly determine how long the patient has had the virus, what the impact is on their respiratory system and what other diseases they may be battling in order to create a strategic treatment plan customized to each patient. Complicating diagnosis and treatment even further, COVID-19 patients can be exposed to dangerous and sometimes drug-resistant bacterial and fungal co-infections during any step in the treatment process. From the use of ventilators to their close proximity to infected individuals being treated by the same staff, the risk is heightened the longer a patient’s stay. 

Fast identification of specific pathogens and antibiotic resistance markers benefits hospitals in two specific ways – First, it provides a clearer view of a patient’s health for a more precise and customized treatment. In knowing which antibiotics a patient has developed a resistance to or understanding the select pathogen strain within a patient’s system, doctors can more strategically administer customized treatment and preserve limited antibiotic resources.  

The second and most important benefit is enhanced infection control by minimizing the transmission risk, or “super spread” of bacterial and fungal infections, such as pneumonia, C. Auris, and more.  Super spreading is not new, in fact, a study observing the SARS I outbreak in 2003 found that 76% of SARS-CoV infections were acquired in healthcare facilities, and hospitalized patients with bacterial co-infections were sources of super-spreading. In some cases, one single patient could infect more than 10 additional persons. 

Historically, traditional microbiological culture has been the most reliable option for testing, offering a high degree of specificity with pathogens. These cultures, while effective, can take days or even weeks to return full results – time that doctors and patients alike do not have. During that time, empiric and preventative use of frontline antibiotics in these patients without any diagnostic insight can exacerbate the issue. To adequately treat COVID-positive individuals under their care, healthcare facilities should consider the use of rapid multiplex PCR diagnostic panels capable of detecting common AMR pathogens in order to provide earlier and more targeted antibiotic treatment insights in just a few hours instead of days. 

Broader Diagnostics Help Create a Treatment Roadmap

Innovation in the diagnostics space for common COVID-19 secondary infections like pneumonia has proven to be effective. The available technologies have been able to quickly identify, with a high degree of sensitivity and specificity, a comprehensively broad range of pathogens and antibiotic resistance markers all in approximately five hours with only two minutes of hands-on time needed. Using this data, doctors are able to create an antibiotic treatment roadmap that is more effective for patients to reduce the risk before super spreading occurs. 

As doctors create this roadmap, antibiotic use and stewardship must be delicately balanced with rapid testing and treatment. In cases without rapid diagnostic panels capable of identifying AMR markers, doctors have to decide whether or not to use broad-spectrum antibiotics as a preventative action to stop or slow the spread of infections in patients – a route chosen in up to 80% of all COVID-19 patients on ICUs

This overuse has contributed to the growth of antibiotic-resistant “superbugs” which cause more than 2.8 million infections and 35,000 deaths in the United States each year. Advancements in available FDA-cleared rapid multiplex PCR diagnostic panels are encouraging antibiotic stewardship and guiding treatment to help determine if and when antibiotics are necessary.  Doctors don’t need to delay treatment for diagnostic results or move forward with broad-spectrum antibiotics; they can identify and provide effective treatment on the same day.  Additionally, with only a couple of minutes of hands-on time to perform such tests, more tests can be processed and more roadmaps for recovery can be created to stop the spread of drug-resistant co-infections. 

Secondary co-infections in COVID-19 patients may carry a low risk outside the hospital, but once admitted, rapid diagnostics become the frontline defense to protect patients against these life-threatening diseases.  With high levels of specificity for both pathogens and antibiotic resistance markers, and testing capabilities in mere hours instead of days, hospitals stand to benefit from incorporating rapid multiplex diagnostic panels into their care practices for hospitalized COVID-19 patients. Only in doing so, can they fill this gap in the care for secondary bacterial co-infections. 


About Oliver Schacht

Oliver Schacht is the CEO of OpGen, Inc., a pioneering informatics and genomic analysis company providing complete solutions for patient, hospital, and network-wide infection prevention and treatment. 


W2O Acquires Discern Health to Strengthen Value-Based Care Capabilities

W2O Acquires Discern Health to Strengthen Value-Based Care Capabilities

What You Should Know:

– W2O announced today the acquisition of Discern Health, a leading healthcare consultancy based in Washington, DC, and Baltimore, to strengthen its strategic capabilities in assisting clients with critical healthcare policy trends and value-based reimbursement models.

– Discern Health brings experts with decades of experience in quality, health care measurement, and payment models to W2O’s analytics-driven, technology-enabled marketing and communications solutions. Leaders from Discern come from companies and organizations like the Centers for Medicare & Medicaid Services (CMS), National Quality Forum (NQF), and the National Committee for Quality Assurance (NCQA). 


W2O, the leading independent provider of analytics-driven, technology-enabled marketing, and communications solutions to the healthcare sector, today announced the acquisition of Discern Health. This health economics and outcomes research (HEOR) consulting firm provides strategic direction and policy solutions to life sciences companies, government and nonprofit agencies, and health insurers.  Financial details of the acquisition were not disclosed.

Discern Health Background/Capabilities

Discern Health counsels leading healthcare organizations on
the performance measures and innovative payment models that shape the market
for their products and services. Discern Health also works closely with
organizations to strengthen and quantify clinical and real-world evidence
strategies that inform ongoing market access and commercialization initiatives.
Discern Health’s staff previously held roles within leading organizations
including the Centers for Medicare & Medicaid Services (CMS), the National Quality
Forum (NQF), and the National Committee for Quality Assurance (NCQA). Discern
has offices in Baltimore and Washington, D.C., further expanding W2O’s presence
with now nearly 100 people dedicated to these increasingly important health
policy arenas.  

Value-based
care
is a key driver of health system change,” said Guy D’Andrea, Founder
and Managing Partner of Discern Health. “To be successful, health care
companies need to integrate value-based strategy into each level of their
organization and each stage of product development.”   

Today’s announcements marks the sixth acquisition W2O has
completed since the company announced its partnership with New Mountain Capital
just over a year ago. W2O’s approach to growth is to add experts and
capabilities that its clients recommend. This approach continues to strengthen
W2O’s offerings and positions the company as a go-to partner of choice to help
clients accelerate clinical trials, achieve commercial success, and navigate
and engage all their stakeholders in an increasingly virtual, social and
digital post-COVID-19 pandemic reality. 

 Why It Matters

“Value-based metrics, the continued need for real-world data integration, and the changing landscape of federal, state and international health policy in the face of the COVID-19 crisis are impacting healthcare faster than ever before,” said Rita Glaze, Practice Leader, Commercial Strategy and Market Access at W2O. “Our clients need ongoing evidence-generation strategies that mirror the market dynamics they are facing, along with up-to-the-minute insights and counsel. This information is vital to guide policy positions and commercial decisions that will unlock maximum value for their products, solutions and services. With Discern Health as part of our organization, we will continue to raise the quality and depth of our data and analytics offering, to ensure it stands up to the scrutiny of peer and government review. We will truly be #BetterTogether.”  

Post-Acquisition Plans

The Discern team will operate under W2O’s single, integrated
profit and loss (P&L) operation, with access to all of W2O’s proprietary
data models and tools as well as its 1,400 person strong multidisciplinary team
– including data analysts, scientific strategists, branding experts,
communications specialists and creatives – to build unfair advantage for
clients and their brands. Additionally, the Discern leadership team will remain
the same.  

Virtual Behavioral Health Could Reduce Costs, Improve Patient Outcomes, Report Finds

What You Should Know:

– A new Accenture report called “Breakthrough Behavioral
Health Access: Think Virtual” finds that the use of virtual behavioral health could
expand care for more than 53 million Americans facing these conditions.

– Demand for behavioral health specialists significantly outweighs current availability; in addition to severe wait times of 25 days for first clinical appointments, we are projected to have a shortage of 250,000 behavioral health and mental health professionals by 2025.

– Just a 1% increase in treatment for these disorders would save $2.4 billion annually and could yield as much as $2.4 billion in medical cost savings annually.


The use of virtual delivery channels could expand treatment
to 53 million Americans suffering from behavioral health issues, according
to a new report from Accenture. The
report, “Breakthrough Behavioral Health Access: Think Virtual,” is
based on a survey of more than 3,400 people in the U.S. diagnosed with or
having symptoms related to specific behavioral health conditions such as
anxiety, depression, post-traumatic stress syndrome, attention deficit disorder
or reported themselves as having addiction or substance abuse issues.

Access to Behavioral Healthcare Barriers

Access to behavioral healthcare is especially challenging.
Beyond the burden on individuals, the challenges of accessing and delivering
behavioral health services have a ripple effect across healthcare. Payers,
providers, employers, government and life sciences companies are all impacted
differently.

“The behavioral health crisis in the U.S. isn’t new, but the pandemic is clearly exacerbating it,” said Rich Birhanzel, a senior managing director at Accenture who leads the company’s Health practice globally. “The rapid expansion of virtual care models during lockdown in the current pandemic created new expectations for effective and reliable healthcare at a distance. While our research found that only 38% of respondents hadn’t been widely using a virtual channel for such treatment in the prior three years, they’re now overwhelmingly willing to do so.”

Virtual Health Can Shatters Barriers

Virtual Behavioral Health Could Reduce Costs, Improve Patient Outcomes, Report Finds

Current data indicates that nearly 58 million adults and
8 million youth between the ages of six and 17 in the U.S. have mental
health and/or substance use disorders, yet only 43% of affected adults are receiving
treatment for them. Four in five respondents (81%) of the Accenture survey said
they would either definitely or probably engage in a virtual channel to manage
their behavioral health condition. Applying this finding to the 66 million
adults and youths impacted by these disorders suggests that virtual channels
could expand care to approximately 53 million people. Furthermore, the number
of people with such conditions is likely to rise due to the current environment
of COVID-19, record unemployment, and widespread social unrest.
 
Among the channels respondents said they’d be willing to use include on-demand
videos (cited by 55%), webchat (63%), individual therapy via voice (59%) and
individual therapy via voice plus video (56%).

The research shows younger patients are much more likely
than older ones to engage in virtual behavioral health services. The report
notes that this is critical insight for employers as they develop their
workforce and talent strategies, particularly since millennials comprise the
largest percentage of the U.S. labor force, followed by Gen Zers.

In addition to improving people’s lives, better access to
care and treatment is a potential breakthrough in terms of overall outcomes and
medical spending as behavioral health patients typically have co-occurring
medical conditions and as a result, can have two to three times the amount of
associated health expenditures. Related Accenture analysis shows that even a 1%
increase in treatment for behavioral health disorders in the U.S. could yield
as much as $2.4 billion in medical cost savings annually, due largely to the
fact that individuals with behavioral health conditions often have other
medical conditions.

From Tipping Point to Transformation

The report notes three fundamental factors that healthcare
providers should consider to remain relevant and responsive to consumers’
needs:

· Control the personal cost. Four in 10 respondents
(44%) said they would only use such channels if the services are provided at
low or no cost to them. Public and private organizations sponsoring these
solutions will need to think through how to lower costs to
consumers—particularly those in need. 

· Orbit around experience. Beyond cost, consumers want convenience and positive user experience. While consumers are hungry for behavioral health services through virtual channels, the design of the programs and consumers’ experiences will make or break adoption no matter the demand.

· Make all the connections. Coordination and integration of care with a whole-person approach is critical. Services should be offered in the context of individuals’ physical health, and data-sharing and interoperability among different healthcare stakeholders are critical to providing the most effective care.

Report Background/Methodology

For the Accenture 2020 Behavioral Health Consumer Survey,
Accenture surveyed 3,448 US consumers ages 13 and over to better understand
attitudes and behaviors related to virtual health options for treating mental
health conditions and substance abuse issues. All survey respondents were
either diagnosed with and/or had symptoms related to specific mental health
conditions such as anxiety, depression, PTSD, ADD/ADHD, or reported themselves
as having addiction issues. Survey respondents received anonymity and
represented a cross-section of the population based on age, location,
ethnicity, insurance coverage, gender and income. The survey was conducted by
Dynata in May and June 2020.

Fujifilm Sonosite Unveils Next-Gen Point-of-Care Ultrasound System for Frontline Clinicians

Fujifilm Sonosite Unveils Next-Gen Point-of-Care Ultrasound System for Frontline Clinicians

What You Should Know:

– FUJIFILM Sonosite, Inc. launches its next-generation point-of-care (POCUS) ultrasound system – designed specifically for the clinicians on the front lines of medicine to treat patients more effectively. 

– The
product is expected to commercialize in the US, Australia and New Zealand in
July 2020, and in the UK, Spain, Germany and France this August. Sonosite has
received nearly 600 leads (and counting) from healthcare providers and medical
facilities in the U.S. [and ANZ].


FUJIFILM Sonosite, Inc., specialists in
developing cutting-edge point-of-care
ultrasound (POCUS) solutions
, and part of the larger Fujifilm Healthcare
portfolio, has announced the launch of the new Sonosite PX ultrasound system.
Sonosite PX is the next generation in Sonosite POCUS, with the most advanced
image clarity ever seen in a Sonosite system, a suite of workflow efficiency
features, and an adaptable form factor. 

Designed Specifically for Front-Line Clinicians

Fujifilm Sonosite Unveils Next-Gen Point-of-Care Ultrasound System for Frontline Clinicians

The ultrasound system and the new family of transducers are drop-tested to one meter and the work surface is sealed to the edge for simplified cleaning and disinfection.  When mounted on the specialized stand, Sonosite PX has an adaptable worksurface position for optimal clinician ergonomics while a small footprint and adjustable height allow for closer bedside access. Information essential to completing an exam including patient information, reports, and worksheets, is intuitively placed in one location, saving clinicians time and effort when navigating the ultrasound system user interface.

Recognizing the importance of efficient documentation to the
electronic health record
(EHR),
Sonosite PX has been designed for onboard documentation of ultrasound
findings at the bedside. Sonosite PX integrates seamlessly with the
company’s Sonosite Synchronicity solution, a workflow manager for
POCUS that supports seamless credentialing, quality assurance, and billing
across departments and institutions.

An overview of the system’s competitive features
include: 

Exceptional Imaging Clarity – as a result of advanced
speckle reduction technology. Seeing anatomy more clearly provides clinicians
with an unparalleled level of confidence for diagnostic and procedural
applications.

Suite of Workflow Efficiency Features – the
streamlined user interface improves workflow, allowing even novice clinicians
to find controls quickly with fewer touches.

Adaptable Form Factor – designed to optimize
clinician ergonomics and improve efficiency, the system has an adaptable work
surface that can be used in a horizontal or vertical position based on the
situational needs of the exam.

Why It Matters

Today, POCUS is quickly emerging as a reliable and critical tool to diagnose, monitor, and manage patients in emergency departments and those admitted to inpatient services. Sonosite’s newest bleeding-edge system presents a new world where POCUS is no longer looked at as a device- but rather a partner for clinicians.

“Every aspect of Sonosite PX was designed specifically for the clinicians on the front lines of medicine. We designed Sonosite PX as a tool to help clinicians in all fields of medicine to treat patients more effectively where it matters most – at the point of care.” said Rich Fabian, President and Chief Operating Officer of FUJIFILM Sonosite, Inc. “To optimize clinician ergonomics and improve efficiency, the system has an innovative and adaptable work surface that can be used in a horizontal or vertical position based on the situational needs of the exam. The exceptional image clarity is the result of a new proprietary imaging technology – seeing anatomy more clearly with Sonosite PX provides an unparalleled level of confidence for diagnostic and procedural applications.”

Commercial Roll-Out Plans

The product is expected to commercialize in the US,
Australia and New Zealand in July 2020, and in the UK, Spain, Germany and
France this August. Sonosite has received nearly 600 leads (and counting) from
healthcare providers and medical facilities in the U.S. [and ANZ].

Activ Surgical Raises $15M Advance Autonomous and Collaborative Surgery

Activ Surgical Raises $15M Advance Autonomous and Collaborative Surgery

What You Should Know:

– Digital surgery pioneer Activ Surgical raises $15M in funding led by ARTIS Ventures to accelerate U.S. commercialization and European expansion efforts for its ActiveEdge platform, which enables existing surgical systems, from scopes to robots, to visualize, characterize and track tissue, in real-time beyond today’s human capability. 

– ActivSight, is an easy-to-adapt, connected imaging module that seamlessly attaches to today’s laparoscopic and arthroscopic systems so outcomes can be improved immediately, providing real-time, on-demand insights, integrated into standard monitors.

– The company is aiming for FDA clearance in Q4 this year
and already has eight hospital systems in the US signed up for pilot programs.


Activ Surgical™, a Boston, MA-based digital surgery pioneer, today announced the close of a $15 million venture round led by ARTIS Ventures, a venture firm focused on pioneering investments at the intersection of life sciences and computer sciences. LRVHealth, the “Inside Healthcare” venture capital platform, joined the round, along with participation from existing investors DNS CapitalGreatPoint Ventures (GPV)Tao Capital Partners, and Rising Tide VC. To date, Activ Surgical has raised a total of $32 million.

ActivSight: Reveal Game-Changing Visual Data During Surgery

Founded in 2017, Activ Surgical is building a
hardware-agnostic platform to enable autonomous and collaborative surgery
through the integration of computer vision, artificial intelligence and
robotics. The company’s first product in the portfolio, ActivSight, is an
easy-to-adapt, connected imaging module that seamlessly attaches to today’s
laparoscopic and arthroscopic systems so outcomes can be improved immediately,
providing real-time, on demand insights, integrated into standard
monitors. The company’s second product currently in development,
ActivInsight will transform massive amounts of surgical data into intelligent,
real-time guidance for surgeons over the next 12 months.

Preventable medical errors are the third leading cause of
death after heart attack and cancer, with preventable surgical errors costing
U.S. health care $36B+ and 400k+ deaths every year. Activ Surgical’s
patent-protected surgical software platform reduces unintended and preventable
surgical complications by enhancing a surgeon’s intra-operative decision
making. In 2018, Activ Surgical completed the world’s first fully autonomous
minimally invasive robotic surgery of soft tissue.

Expansion Plans

Activ Surgical will use proceeds of the latest financing round to accelerate U.S. commercialization and European expansion efforts for itsActivEdge™ platform, which enables existing surgical systems, from scopes to robots, to visualize, characterize and track tissue, in real-time beyond today’s human capability. The company is aiming for FDA clearance in Q4 this year and already has eight hospital systems in the US signed up for pilot programs.

“Activ Surgical is poised to play a leading role in the democratization of surgical care, extending insights from experienced surgeons to surgical systems all over the globe, and ensuring world-class care for all, regardless of location,” said Todd Usen, CEO, Activ Surgical. “We welcome the guidance and support from our new and current investors and Board members as we accelerate our efforts to commercialize our first product, ActivSight. 2020 will be pivotal for our business with committed pilot projects with major hospital systems slated to launch by the end of this year.”

Paige Lands Additional $15M for AI-Native Digital Pathology Ecosystem

Paige Raises $45M to Expand AI-Native Digital Pathology Ecosystem

What You Should Know:

– Paige secures an additional $15M from Goldman Sachs for a total Series B funding round of $70M for its AI-native digital pathology ecosystem.

– The company’s continued product portfolio of innovation in telepathology and digital diagnostics accelerated by further investment.


Paige, an NYC-based leader in computational pathology transforming the diagnosis and treatment of cancer, today announced it received an additional $15M from Goldman Sachs Merchant Banking Division, totaling $20M from the firm. The funding will be added to previously announced Series B financing, bringing the total round to $70M, including an additional investment from Healthcare Venture Partners of $5M on top of their previous $10M investment. The funding brings the Company’s total capital raised to over $95M.

Transforming Diagnosis & Treatment of Cancer

Founded in 2017 by Thomas Fuchs, Dr.Sc., Paige’s mission is
to revolutionize the diagnosis and treatment of cancer by providing
pathologists, clinicians and researchers with insights drawn from decades of
data diagnosed by world experts in cancer care.​ Spun out of Memorial Sloan
Kettering, Paige builds powerful, clinical-grade computational technologies to
transform the diagnosis, treatment and biomarker discovery for cancer. With AI
positioned to open a new future of pathology, Paige has created an AI-native
digital pathology ecosystem that enables the Pathologist to achieve higher
quality, faster throughput, and lower cost diagnosis and treatment
recommendations.  Additionally, Paige
accelerates new biomarker discovery and is built to generate new insights into
pathways and drug efficacy.

Paige will use this new capital to further accelerate its global leadership position in transforming pathology workflows in the field of cancer while working closely with biopharma companies to create custom diagnostic and clinical trial solutions to improve patient care.

“We appreciate the continued recognition and support we’ve received from Goldman Sachs as we gain traction and prove early results in the clinical and biopharma space,” said Leo Grady, Ph.D., CEO of Paige. “This new funding will help ensure that the Paige Platform and our advanced computational pathology products will drive the next generation of pathology and improve cancer care globally.”

COVID-19 Has Permanently Shifted Patient Behavior Towards Virtual Care

Report: How COVID-19 Has Permanently Changed Patient Behavior Towards Virtual Care

What You Should Know:

– The COVID-19 crisis has significantly impacted the
patient care paradigm, and the ripple effects have altered patient behaviors
and expectations, requiring a significant change in how life sciences companies
engage with and support patients

– Accenture surveyed 2700 patients about changes in care
during COVID-19 and found a major shift to virtual care, which patients
embraced.

– Virtual care is here to stay and can be an integral
part of the patient experience with health care providers and as part of
clinical trials.

– With 70% of patients deferring or canceling treatment, virtual tools were widely adopted as an essential lifeline for continuing care.


The COVID-19 pandemic has permanently shifted patient behavior towards virtual care, according to a new survey from Accenture. The Accenture COVID-19 Patient Survey conducted in May across China, France, Germany, Japan, the U.K., and the U.S. asked 2,700 oncology, cardiology, or immunology patients globally how patient care has changed during COVID-19. The survey revealed patients have embraced virtual care and communications at very high rates as a result of COVID-19 and nine out of 10 reported the quality of care was as good or better than before.

Patients Chose to Defer and Change their Care

As restrictions came into effect, patients faced difficult choices about whether and how to continue their treatments. Many healthcare providers canceled appointments, and transportation options were shut down. Patients were afraid to risk exposure to COVID-19 by going to their healthcare providers for regular treatment, and many (70%) deferred or canceled at least some elements of their treatment.
 
But nearly half of all surveyed patients also started getting some treatment at home instead of going to their healthcare provider’s office and they began using virtual tools such as video conference calls, online chat, and apps. 1 out of 5 patients switched to a different therapy due to COVID-19, while nearly half considered making a change. Patients were concerned about how treatment might affect their risk of COVID-19, and about the method and timing required for specific treatments.

Sixty-three percent of those who used video conferencing
said it was very good or excellent, an impressive response given 70% were using
video conferencing for treatment for the first time. By using technology to
support communication and care, healthcare providers were largely able to
maintain or even improve on the patient experience.

Other key findings of the survey include:

Trust in the Healthcare Ecosystem Increased

 Forty-seven percent of respondents said they received better, more personalized responses; 41% said quicker responses and 40% said it was more convenient to access through new communications channels.
 
In addition, the overall trust in the healthcare system has increased. Sixty percent of patients surveyed said their trust in healthcare providers has increased, and 45% said their trust in pharmaceutical and medical device companies has increased.

Virtual care helped keep some clinical trials going

Worryingly, many clinical trials were disrupted by COVID-19.
Seventy-seven percent of patients said their clinical trials were suspended or
delayed, which could have a knock-on effect on the speed in which new
treatments come to market.
 
However, for trials that continued, the use of virtual care was critical for
consultations, treatment, and monitoring. Consider that 61% of patients whose
trials continued used some form of virtual communication or care.

Using virtual technologies as a regular part of the clinical trial process would not only improve resilience to disruptions but would help to improve the patient experience.
 
Patients said they want to be consulted more, but they are currently far from the center of the clinical trial design process. As decisions were being made on how to modify clinical trials due to COVID-19, only 14% of surveyed patients were asked about what changes would work for them. This held true across all therapeutic areas and geographies.
 
“Increasing virtual communication and treatment options offers multiple benefits for clinical trials, as one-third of all patients in trials reported that even before COVID-19, they had difficulty making appointments or physically getting to clinics for treatment,” said Michel. “Patients want more video conferencing and fewer clinic visits, which would make clinical trials more convenient and accessible.”

For more information, the full report is available for
download here.

Scripps Research, Repurpose.AI Partner to Develop COVID-19 Therapeutics

Scripps Research, Repurpose.AI Partner to Develop COVID-19 Therapeutics

What You Should Know:

– Repurpose.AI, has partnered with Scripps Research to
discover drug candidates that may be repurposed to treat COVID-19. 

– The partnership will leverage Repurpose.AI’s ActivPred
AI Drug Discovery Platform, an unbiased drug, target, and disease agnostic
digital chemistry engine, to discover drug candidates to treat COVID-19. 


Scripps Research is
teaming up with Repurpose.AI, an AI
drug discovery company to develop COVID-19 therapeutics. The partnership will
leverage Repurpose.AI’s ActivPred AI Drug Discovery Platform, an unbiased drug,
target, and disease agnostic digital chemistry engine, to discover drug
candidates to treat COVID-19. Previously, the company has successfully utilized
the platform to discover REP-001, REP-002, and REP-003 – three Phase II/III
ready small molecule assets for the treatment of gastric, neurological, and
weight disorders, respectively.

Partnership Details

Scripps Research scientists together with Calibr,
its drug development division, will leverage its COVID-19
screening models and commitment to drug repurposing as part of the partnership.
Calibr previously established the ReFRAME collection, the world’s leading
collection of known drugs, comprising over 14,000 compounds that have been
approved by the FDA for other diseases or have been extensively tested for
human safety, which it is bringing to bear on the current pandemic. The
collaborative work with Repurpose.AI will augment this effort by characterizing
compounds not identified to date using conventional repurposed drug screening
approaches.

 “We could not be more excited about our partnership with Scripps Research and Calibr. Like Repurpose.AI, Calibr is committed to ending the scourge of the global COVID-19 pandemic. Our goal is to move therapeutics from the computer to the clinic in a fraction of the time typically required to discover and bring new drugs to market and alleviate the suffering of patients afflicted by COVID-19. Creating therapeutics to treat COVID-19 also allows the global community to go back to work and for children to go back to school. Repurpose.AI and Calibr are committed to doing our part to ensure that happens sooner rather than later,” said Dr. Daniel Haders II, Ph.D., Executive Chairman at Repurpose.AI.

AI-Driven Drug Discovery

Repurpose.AI, a Nex Cubed digital health
portfolio company, has harnessed the predictive prowess of artificial
intelligence and machine learning with its ActivPred AI Drug Discovery Platform
to discover drugs that may be repurposed to serve as therapeutics to treat
patients suffering from COVID-19. The drugs that Repurpose.AI discovers for
COVID-19 can enter clinical trials in as little as several months.

Repurpose.AI’s Drug Library

Repurpose.AI’s Drug Library is comprised of approximately
4,000 drug compounds that have been approved for commercial use by the U.S.
FDA, or similar agencies, and 20,000+ drug compounds that are known to have
successfully navigated a Phase I (human safety) clinical trial. All drugs have
a full pre-clinical program, an existing or legacy supply chain, and are known
to be safe and well-tolerated in humans.

New Lighthouse Initiative to Provide De-identified Patient Data for VIRUS COVID-19 Registry

New Lighthouse Initiative to Provide De-identified Patient Data for VIRUS COVID-19 Registry

What You Should Know:

– PointClickCare introduces
the Lighthouse initiative, which will provide de‐identified
data on COVID‐19 diagnosed patients, including demographics, vitals,
medications and health‐related outcomes, in order to better understand health
outcomes post‐ICU. 

– Comprehensive data sets are especially critical tools
in responding to crises like the current COVID-19 pandemic, and this initiative
is one example of PointClickCare’s efforts to arm frontline workers with
the tools they need to keep vulnerable populations safe during this time.


PointClickCare,
the leading cloud-based software platform for the senior care market has been
selected by the Society of Critical Care
Medicine (SCCM)
to launch the Lighthouse initiative to
provide de-identified patient data for the Discovery Viral Infection and
Respiratory Illness Universal Study (VIRUS) COVID-19 Registry.

VIRUS Overview

Created by SCCM’s Discovery, the Critical Care Research Network,
VIRUS tracks ICU and hospital care patterns in near real-time to enable
evaluation of safety and observational effectiveness of COVID-19 practices and
to determine practice variations across hospitals. VIRUS is a cross-sectional
observational study and registry of eligible adult and pediatric patients
admitted to a hospital. There is no intervention or patient interaction and
only data, de-identified in accordance with HIPAA, will be used for analysis.
The registry features a dashboard which tracks data on trends including length
of stay in the ICU and mechanical ventilation duration. The registry will also
study mortality and health impact post-ICU.

Lighthouse Initiative Background

VIRUS will partner with Lighthouse, PointClickCare’s newly
formed internal group, with a mission to provide healthcare organizations,
government agencies and life sciences companies with de-identified data from
older adults. The goal of providing data that specifically represents seniors,
a population often considered to be at higher risk for severe illness, is to
support research by expanding drug discovery and development. Lighthouse will
provide the VIRUS COVID-19 Registry with de-identified data on COVID-19
diagnosed patients, including demographics, vitals, medications and
health-related outcomes to help better understand their health post-ICU.
PointClickCare will continue to deliver relevant data on COVID-19 patients
throughout the study period.

“Lighthouse builds on PointClickCare’s commitment to sharing data and insights that drive action for better care, thereby accelerating innovation designed to protect vulnerable populations. We are honored to partner with SCCM and committed to helping shed light on trends in COVID-19 care around the world,” said Mike Wessinger, Founder and Chief Executive Officer, PointClickCare.

The Lighthouse project is just one example of
PointClickCare’s efforts to fight COVID-19 and arm frontline workers with the
tools they need to keep vulnerable populations safe. Additional innovations
include the Infection
Prevention and Control (IPC) solution
, a clinical
workflow and intelligence solution that helps care teams achieve ongoing
resident surveillance focused on infection prevention at the facility or
enterprise level. PointClickCare has also deployed a Crisis Response and
Readiness solution, broadening access to telehealth services for all customers,
and enabling a HIPAA-compliant dialogue between staff and physicians.

Cleveland Clinic Florida Opens Florida Research and Innovation Center

Cleveland Clinic Florida Opens Florida Research and Innovation Center

What You Should Know:

– Cleveland Clinic Florida opens Florida Research and
Innovation Center that will advance innovative translational research, focused
on immuno-oncology and infectious diseases, including COVID-19.

– The 107,000-square-foot, state-of-the-art research facility features modern laboratory space, biosafety level 3 facilities for work with infectious agents, and office space for support services on eight acres of land. 


 Cleveland
Clinic Florida
 announced the open of the Florida Research and
Innovation Center in Port St. Lucie, Florida that will advance innovative
translational research, focused on immuno-oncology and infectious diseases,
including COVID-19. The Florida Research and Innovation Center will be
closely integrated with Cleveland Clinic’s new Center
for Global and Emerging Pathogens Research
 established in April 2020,
which has brought together some of the world’s top research experts in
virology, immunology, genomics, and population health to broaden understanding
of emerging pathogens – ranging from the Zika virus to SARS-CoV-2 (which causes
COVID-19) – and to expedite critically needed treatments and vaccines. The
researchers will also collaborate with drug developers at Lerner Research
Institute’s Center for Therapeutics Discovery to more rapidly move discoveries
out of the laboratory and into the clinic for patient care. 

State of the Art Research Facility

Cleveland Clinic Florida Opens Florida Research and Innovation Center

The 107,000-square-foot, state-of-the-art research facility features modern laboratory space, biosafety level 3 facilities for work with infectious agents, and office space for support services on eight acres of land. Cleveland Clinic has recruited a team of renowned scientists to the Florida Research and Innovation Center to launch scientific programs that address both local and international health challenges, including cancer and emerging pathogens. The facility will additionally provide an exceptional training environment for researchers. Philanthropic funding of this research program will support the new center’s efforts to explore new treatments and technology.

Leadership

The Florida Research and Innovation Center is headed by
Scientific Director Michaela Gack, Ph.D., who joined Cleveland Clinic Florida
in July 2020. Previously, she was a professor in the Department of Microbiology
and chair of the Committee on Microbiology at The University of Chicago in
Chicago, Ill. Gack, a renowned virologist, has an extensive background in
microbiology and infectious disease. Her research focuses on the immune
system’s response to viruses, an essential step in developing safe and
effective antivirals and vaccines. She has also done extensive research on
immune evasion by Dengue, Influenza and Zika viruses. 

Research Expansion

The Florida Research and Innovation Center will complement
and expand research underway at the Florida health system’s five hospitals and
the Lerner Research Institute,
which is home to 190 laboratories on Cleveland Clinic’s main campus in
Cleveland, Ohio. The scientific teams will closely collaborate, tapping into
resources at both facilities to develop new treatments for patients around the
globe.

“We are pleased to be moving forward with our vision to
create a world-class research program in Florida,” said Joseph
Iannotti, M.D., Ph.D
., Interim CEO and President of Cleveland Clinic
Florida and Chief Academic and Innovation Officer. “We are confident that the
collaboration between our scientists and partners will ultimately result in the
development of therapies that address some of the most challenging medical
conditions we face.”  

“Cleveland Clinic’s robust research infrastructure will be further expanded with the opening of the Florida Research and Innovation Center,” said Tom Hamilton, Ph.D., vice chair of Cleveland Clinic’s Lerner Research Institute. “Through team-based discovery, forward-thinking science, translational research, clinical trials and innovation, our vision is to bring together a world-class team of experts within a leading-edge research facility.” 

Propeller Health, Novartis Co-Package Asthma Medication in Europe for Prescription

Propeller Health, Novartis Co-Package Asthma Medication in Europe for Prescription

What You Should Know:

– Propeller Health announced
it will co-package a new asthma medication from Novartis, which was
approved by the European Commission this week for use in the EU.

– Enerzair®
Breezhaler® plus Propeller Health sensor is the first asthma medication to be
co-packaged and co-prescribed with a digital health platform.

– Propeller’s solution
works by attaching a sensor to the Enerzair® Breezhaler® inhaler, which then
delivers objective data on medication use to the Propeller app on the patient’s
smartphone


Propeller Health today announced a collaboration with Novartis to co-packaged the Propeller digital health platform with Enerzair® Breezhaler® (QVM149; indacaterol acetate, glycopyrronium bromide and mometasone furoate [IND/GLY/MF]), a recently approved Novartis medication developed to treat uncontrolled asthma. Propeller previously announced a collaboration with Novartis to develop a custom add-on sensor for the Breezhaler® inhaler, a device used for the company’s portfolio of COPD treatments (Ultibro® Breezhaler®, Onbrez® Breezhaler®, and Seebri® Breezhaler®), connecting these medications to Propeller’s digital health platform. The same sensor will be co-packaged with Enerzair® Breezhaler®.

Why It Matters

This collaboration marks the first time a digital health tool will be packaged and prescribed alongside an inhaled asthma medication. Enerzair® Breezhaler® and Propeller sensor and app received approval from the European Commission in July and will launch across Europe starting in 2020. Healthcare professionals in Europe will have the option to prescribe Enerzair® Breezhaler® with or without the companion digital health platform. The medication is not available in the U.S.

Enerzair® Breezhaler® was approved as a maintenance treatment of
asthma in adult patients not adequately controlled with a maintenance
combination of a long-acting beta2-agonist
(LABA) and a high dose of an inhaled corticosteroid (ICS) who experienced one
or more asthma exacerbations in the previous year.

Impact of Uncontrolled Asthma

Asthma affects an estimated 358 million people worldwide and can cause a significant personal, health, and financial burden when not adequately controlled. Despite current therapy, over 40% of patients with asthma at Global Initiative for Asthma (GINA) Step 3, and over 45% at GINA Steps 4 and 5 remain uncontrolled. Patients with uncontrolled asthma may downplay or underestimate the severity of their disease and are at a higher risk of exacerbation, hospitalization, or death. Barriers, such as less than optimal adherence, incorrect inhaler technique, treatment mismatch, safety issues with oral corticosteroids, and ineligibility for biologics, have created an unmet medical need in asthma.

Enerzair Breezhaler 

Enerzair Breezhaler is provided in a transparent capsule that allows patients to see that they have taken their medication and will be administered via the dose-confirming Breezhaler® device, which enables once-daily inhalation using a single inhaler. The digital companion includes a sensor that attaches to the Breezhaler device and can be linked to the Propeller Health smartphone app, providing patients with inhalation confirmation, medication reminders, and access to objective data that can be shared with their physician in order to help them make better therapeutic decisions.

Propeller’s solution works by attaching a sensor to the
Enerzair® Breezhaler® inhaler, which then delivers objective data on medication
use to the Propeller app on the patient’s smartphone. The app also sends the
patient reminders to take their prescribed dose and keeps a record of adherence
data over time. The patient can share that data with their clinician to help
inform the patient’s treatment plan.

In previous clinical studies unrelated to this collaboration, the Propeller platform has been shown to increase asthma control by up to 63 percent, increase medication adherence by up to 58 percent, and reduce asthma-related emergency department visits and hospitalizations by as much as 57 percent.

“Our collaboration with Novartis to co-package Propeller with Enerzair® Breezhaler® is the first time a pharmaceutical company and digital health company have worked together to package a digital health platform with an asthma medication,” said David Van Sickle, co-founder and CEO of Propeller Health. “The ability to prescribe a maintenance medication with Propeller will make it easier for healthcare professionals to engage their patients in self-management.”