Dr. Brandon Salke, PHARM.D, Pharmacist-in-charge, Optime Care
One of the biggest challenges for biopharmaceutical companies of rare and orphan disease patient populations is optimizing disease management in a way that enhances the patient journey and improves outcomes. As these companies seek innovative solution partners, a patient-first approach that offers specialty Rx pharmacist expertise is critical for securing insurance coverage, coordinating care, ensuring compliance, and, ultimately, minimizing the daily impact of rare and orphan diseases.
In today’s challenging healthcare environment, biopharma companies need to feel confident that their products are properly and promptly distributed, and reimbursements processed quickly and correctly. The best approach is to partner with a pharmacy, distribution, and patient management organization that offers a patient-first strategy for rare and orphan disorders, as well as personalized care programs designed to maximize the benefit of the therapies prescribed for patients. The goal is to improve the quality of life for both patient and caregiver with a dedicated support system for positive outcomes and long-term well-being.
The right patient-first partner can tailorIT, technology, and data-based upon client needs, combined with a high-touch approach designed to improve patient engagement from clinical trials to commercialization and compliance.
High Touch Meets Technology
Rare and orphan disease patients require an intense level of support and benefit from high touch service. A care team, including the program manager, care coordinator, pharmacist, nurse, and specialists, should be 100% dedicated to the disease state, patient community, and therapy. This is a critical feature to look for in a patient-first partner. The idea is to balance technology solutions with methods for addressing human needs and variability.
With a patient-first approach, wholesale distributors, specialty pharmacies, and hub service providers connect seamlessly, instead of operating in siloes. This strategy improves continuity of care, strengthens communication, yields rich data for more informed decision making, and improves the overall patient experience. It manages issues related to collecting data, maintains frequent communication with patients and their families, and ensures compliance and positive outcomes. A patient-first model also hastens time to commercialization and provides continuity of care to avoid lapses in therapy – across the entire life cycle of a product.
Key Components for Effective Patient-First Strategy
A patient-first strategy means that the specialty Rx pharmacist works directly with the patient, from initial consultation, and across the entire patient journey, providing counseling, guidance, and education-based upon individual patient needs. They also develop an individualized care plan based on specific labs and indicators related to patient behavior to help gauge the person’s level of motivation and identify adherence issues that may arise.
The best patient-first partners enable patients to contact their pharmacist 24/7 and offer annual reassessments that ensure that goals of therapy are on track and every challenge is addressed to improve the patient’s quality of life. These specialty pharmacists also play a critical role on behalf of biopharmaceutical partners, providing ongoing regulatory and operations support and addressing each company’s particular challenges.
Telehealth
As the COVID-19 pandemic wanes on, it’s also important to find a patient-first partner that offers a fully integrated telehealth option to provide care coordination for patients, customized care plans based on conversations with each patient, medication counseling, education on disease states, and expectations for each drug.
A customized telehealth option enables essential discussions for addressing patient challenges and needs, a drug’s impact on overall health, assessing the number of touchpoints required each month, follow-up, and staying on top of side effects.
Each touchpoint should have a care plan. For example, a product may require the pharmacist to reach out to the patient after one week to assess response to the drug from a physical and psychological perspective, asking the right questions and making necessary changes, if needed, based on the patient’s daily routine, changes in behavior and so on.
Capturing information in a standardized way ensures that every pharmacist and patient receives the same assessment based on each drug, which can be compared to overall responses. Information is gathered by an operating system and data aggregator and shared with the manufacturer, who may make alterations to the care plan based on the patient’s story.
Ideally, one phone call with a patient can begin the process of optimizing medication delivery, insurance reimbursement, compliance, and education based on a plan tailored for each patient’s specific needs.
About Dr. Brandon Salke, PHARM.D
Dr. Brandon Salke serves as the pharmacist-in-charge and General Manager at Optime Care in Earth City, MO. He previously served as a team pharmacist for Dohmen Life Science Services, where he helped launch several new care programs and assisted in the management of clinical trial activities.
He is specialized in specialty pharmaceuticals, particularly ultra-orphan, orphan, and rare disease. Dr. Salke has been involved in all aspects of operations (planning, process integration, project management, etc.) for pharmaceutical manufacturers. This includes clinical trials to commercialization and assisting in commercial launches (and relaunch) of specialty pharmaceuticals.
Tiziana has completed its clinical study in Brazil assessing nasally administered Foralumab either alone or in combination with orally administered dexamethasone in COVID-19 patients
The study enrolled 39 patients with mod. to sev. COVID-19 who did not require the use of a ventilator at the beginning of the study with anticipated results available in Jan’2021
The 1EPs of the study was safety of the treatment while the 2EPs were to evaluate the effect on disease severity symptoms, nasal tolerance, sense of smell, and biomarkers for disease progression. Anecdotal feedback from Foralumab-treated patients was positive suggesting that the treatment was well-tolerated
Click here to read full press release/ article | Ref: Tiziana | Image: Share Talk
As we close out the year, we asked several healthcare executives to share their predictions and trends for 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
– Philips and BioIntelliSense has been selected by the
U.S. Army Medical Research and Development Command (USAMRDC) to receive nearly $2.8M
from the U.S. Department of Defense (DoD) to validate BioIntelliSense’s
FDA-cleared BioSticker device for the early detection of COVID-19 symptoms.
– Working with the University of Colorado Anschutz
Medical Campus, the clinical study will consist of 2,500 eligible participants
with a recent, known COVID-19 exposure and/or a person experiencing early
COVID-19 symptoms.
Royal
Philips and BioIntelliSense,
Inc., a continuous health monitoring and clinical intelligence company, today
announced they have been selected by the U.S. Army Medical Research and
Development Command (USAMRDC) to receive nearly $2.8M from the U.S. Department
of Defense (DoD) through a Medical Technology Enterprise Consortium (MTEC)
award to validate BioIntelliSense’s FDA-cleared BioSticker device for the early
detection of COVID-19
symptoms. The goal of the award is to accelerate the use of wearable
diagnostics for the benefit of military and public health through the early
identification and containment of pre-symptomatic COVID-19 cases.
Medical-Grade Wearable for Early COVID-19 Detection
As millions of individuals have been screened and tested, the emerging research on traditional screening methods is revealing how challenging it is to detect the risk of COVID-19 infections early. Temperature checks have proven to be unreliable and even amplified testing (PCR) has proven to be ineffective in identifying the virus in the early days of infection.
The FDA-cleared BioSticker is an advanced on-body sensor
that allows for effortless continuous monitoring of temperature and vital signs
combined with advanced analytics, enables the BioSticker to identify
statistically meaningful trends and screen for early potential COVID-19
infection.
“The medical-grade BioSticker wearable, combined with advanced diagnostic algorithms, may serve as the basis for identifying pre- and very early symptomatic COVID-19 cases, allow for earlier treatment for infected individuals, as well as reduce the spread of the virus to others,” said James Mault, MD, Founder and CEO of BioIntelliSense.
Clinical Trial Details
Working with the University of Colorado Anschutz Medical Campus, the
clinical study will consist of 2,500 eligible participants with a recent, known
COVID-19 exposure and/or a person experiencing early COVID-19 symptoms.
Individuals may learn more about the study eligibility and enroll online
at www.BioStickerCOVIDstudy.com.
The research will focus on the validation of BioIntelliSense’s BioSticker for
early detection of COVID-like symptoms, as well as assessment of scalability,
reliability, software interface, and user environment testing.
Turning Data into Actionable Insights
While previous studies have shown potential using consumer wearables in relation to COVID-19, this study will leverage BioIntelliSense’s medical-grade wearable, the BioSticker, which enables continuous multi-parameter vital signs monitoring for 30 days and captures data across a broad set of vital signs, physiological biometrics and symptomatic events, including those directly associated with COVID-19. With its integration into Philips’ remote patient monitoring offerings, this is another example of how cloud-based data collection takes place seamlessly, across multiple settings, from the hospital to the home. Allowing data to be turned into actionable insights and care interventions, while providing connected, patient-centered care across the health continuum.
Dr. Vik Bebarta, the Founder and Director of the CU Center for COMBAT Research and Professor of Emergency Medicine on the CU Anschutz Medical Campus added: “The University of Colorado School of Medicine and the CU Center for COMBAT Research in the Department of Emergency Medicine are excited to be a lead in this effort that will change how we care for our service members in garrison and our civilians in our communities. The COMBAT Center aims to solve the DoD’s toughest clinical challenges, and the pandemic is certainly one example. With this progressive solution, we aim to detect COVID in the pre-symptomatic or early symptomatic phase to reduce the spread and initiate early treatment. This trusted military-academic-industry partnership is our strength, as we optimize military readiness and reduce this COVID burden in our community and with frontline healthcare workers.”
AstraZeneca and Amgen looked on course to cruise to approval of their severe asthma drug tezepelumab with a pair of positive clinical trials, but the failure of a third threatens to derail the programme.
The new study – called SOURCE – was supposed to back up the encouraging readouts from the phase 3 NAVIGATOR trial and phase 2b PATHWAY, which found that the antibody benefited asthma patients whose symptoms were so bad they needed oral corticosteroid (OCS) therapy.
SOURCE has changed the script however by missing its primary objective, proving unable to significantly reduce the daily dose of OCS needed by patients in the 150-subject trial, although AZ and Amgen still think the drug is approvable based on the “totality of evidence”.
AZ and Amgen have only released the top-line data, so it could be a while before an explanation for the failure emerges, although AZ’s head of biopharmaceuticals R&D Mene Pangalos suggested it may have resulted from flaws in the trial design.
Just a month ago, AZ and Amgen trumpeted the result of the NAVIGATOR trial of tezepelumab, a first-in-class inhibitor of the cytokine thymic stromal lymphopoietin (TSLP) that analysts have said could have blockbuster potential if approved, perhaps reaching as much as $2.5 billion in annual sales.
NAVIGATOR found that the antibody reduced the asthma exacerbations compared to placebo when added to standard care, and crucially also seemed to have a positive impact on patients with low levels of white blood cells called eosinophils.
Biologics like GlaxoSmithKline’s Nucala (mepolizumab) and AZ’s Fasenra (benralizumab) – both IL-5 inhibitors – and Sanofi/Regeneron’s IL-4 and IL-13 blocker Dupixent (dupilumab) are already approved to treat severe eosinophilic asthma but treatment options are limited for patients with non-eosinophilic forms.
Tezepelumab claimed a breakthrough designation in non-eosinophilic asthma from the FDA in 2018, on the promise that it could provide an option for these patients, who account for around a third of all severe asthma cases.
The drug acts further upstream in the inflammatory cascade than its rivals and so could be effective for a broader range of patients, according to its developers.
AZ and Amgen say they still plan to press ahead with plans for regulatory filings for tezepelumab next year, and will prevent detailed results from NAVIGATOR and SOURCE at a future medical conference.
The two partners started working together on tezepelumab in 2012, and was one of five drugs covered by that alliance. It has previously failed a mid-stage study in atopic dermatitis, but is still in development for that indication as well as chronic obstructive pulmonary disease (COPD).
– H1, the largest database of information on every doctor
in the world raises $58M in Series B funding, just six months after raising its
Series A round during the pandemic.
– H1 is the largest database in the world connecting that
provides comprehensive in-depth profiles of more than 9 million healthcare
professionals and 16,000 institutions in 70-plus countries, all of which are
kept up-to-date weekly.
H1, a global
platform for the healthcare ecosystem, announced today that it has closed a $58
million Series B round of funding co-led by IVP and Menlo Ventures, which led
the Series A round in April 2020. Transformation Capital, Lux Capital, Lead
Edge Capital, Novartis dRx and YC also participated.
Over 9 Million Healthcare Professional Profiles
Co-founded by Ariel Katz and Ian Sax in 2017, H1 is a developer of a healthcare data analytics platform intended to help companies make smarter scientific decisions. H1 has created the largest healthcare platform to forge connections in the healthcare ecosystem. The H1 team has taken a unique approach to building the platform that combines AI, human-powered engineering, third-party data sources, and government partnerships, to create the largest platform of healthcare professionals, currently spanning over 9 million healthcare professions around the globe.
The company specializes in providing real-time data to support the end-to-end therapeutic development process from fundraising to product development to product launch, thereby providing the healthcare industry, organizations, and professionals with on-demand, live insights from across the data universe to accelerate the discovery and development of therapies to fight diseases.
Traction/Milestones
H1 has enjoyed tremendous growth in 2020, surpassing
projections and proving the need for its platform of doctors is stronger than
ever. Following its Series A announcement in April 2020 of $12.9 million, the
company has grown from approximately 100 employees globally to nearly 250 and
anticipates expanding its headcount significantly over the next year, including
further expansion into Europe and Asia.
With over 50+ customers to date and growing rapidly, H1 is
slowly becoming the standard that companies think about when they want to find
the right Key Opinion Leading Doctors to collaborate with for Clinical Trial
Activity, Medical Activity, and Educational Activity.
The platform has been a unique and powerful resource for
global pharma companies, including those working on COVID-19 vaccines and
therapeutics. In fact, 13 of the top 20 pharmaceutical companies are currently
using the platform for research and insights.
“We have created a platform for the healthcare ecosystem to connect in the same way Linkedin connected professional workers in the early 2000’s. There hasn’t been a global platform like H1 before that has connected industry to the right doctors the way H1 does,” said H1 co-founder and CEO Ariel Katz. “This next round of funding, with our excellent investment group, including Menlo who has been a great partner for us, will help us continue to become the largest healthcare professional platform and ultimately create a healthier future.”
– 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.
– Lightspeed Venture Partners, the VC behind Nest and GrubHub, is leading a $10 million round for Freespira, an FDA-cleared digital therapeutic proven to significantly reduce or eliminate panic attacks and PTSD symptoms by training users to normalize respiratory irregularities.
– In 28 days, Freespira can reduce or eliminate panic
attacks and PTSD symptoms from home with just a tablet, sensor, and custom app.
There’s no medicine with possible side effects and no need to see a doctor or
therapist in person.
Freespira, Inc.(formerly
Palo Alto Health Sciences, Inc.), a Kirkland, WA-based maker of the first
FDA-cleared digital therapeutic that significantly reduces or eliminates
symptoms of panic attacks, panic disorder and post-traumatic stress disorder
(PTSD) in only 28 days, announced it has completed a $10 million capital raise led
by Lightspeed Venture Partners. Joining
the financing round, the largest in the company’s history, were previous
investors Aphelion Capital, Medvest Capital, and Freespira Chairman,
Russell Siegelman.
Free from Panic Attacks & PTSD in 28 Days
Founded in 2013, Freespira® is the only FDA-cleared digital therapeutic proven
to significantly reduce or eliminate Panic Disorder and PTSD symptoms by
training users to normalize respiratory irregularities in just 28 days. This
4-week medication-free program can be done from the comfort of your home for 17
minutes, twice daily. Treatment is authorized and completed under the
supervision of a licensed healthcare provider and is clinically proven to
reduce or eliminate panic attacks and other symptoms of panic disorder. Freespira
uses a custom sensor to train patients to stabilize their respiration rate and
exhaled carbon dioxide levels, thereby reducing or eliminating panic attacks
and PTSD symptoms.
Recent Peer-Reviewed Studies
Numerous peer-reviewed studies have demonstrated the
clinical effectiveness and cost savings of the Freespira solution, including:
– A clinical trial conducted at the VA Palo Alto Health Care
System in Palo Alto, Calif. demonstrated the efficacy of Freespira for veterans
and non-veterans suffering from PTSD. Significant reductions in measures of
PTSD severity were achieved by 85% of subjects post-treatment, with half of
subjects reporting remission scores six months post-treatment. Patient
satisfaction was 84% at six months post-treatment, and mean patient adherence
to the treatment protocol was 77%.
– A large multi-center trial conducted by David Tolin, PhD,
Director of the Anxiety Disorders Center at The Institute of Living, and Adjunct
Professor of Psychiatry at Yale University School of Medicine, found that
Freespira produced a clinically significant reduction in panic symptoms 12
months post-treatment in 82% of subjects, with 84% adherence and 88% patient
satisfaction.
– A study led by Alicia Kaplan, MD at the Allegheny Health
Network in Pittsburgh found that use of Freespira not only resulted in 91% of
patients reporting significant reduction in symptoms at 12-months but also
significant cost savings for the patients’ insurance provider, Highmark Blue
Cross Blue Shield. These included a 65% reduction in emergency department
costs; a 68% reduction in pharmacy costs; and a 35% reduction in total medical
costs for treatment of the study subjects.
“We’re honored that Lightspeed, one of Silicon Valley’s premier venture firms, has joined our existing investors to help speed the commercialization of Freespira to benefit the millions of people who suffer from panic attacks and PTSD, including veterans, first responders, and increasingly, frontline healthcare workers,” said Dean Sawyer, Chief Executive Officer of Freespira. “Now that we have accumulated overwhelming evidence of the clinical and cost effectiveness of Freespira and achieved FDA clearance for its use treating both panic disorder and PTSD, we believe health plans and employers across the country will support the use of Freespira for their members and employees.”
– Cerner announced a strategic investment in Elligo
Health Research, a leading research organization that enables clinical trials
with nationwide community-based health care practices.
– Cerner plans to expand the data and tools available in
the Cerner Learning Health Network to offer additional clinical trial resources
to community and rural hospitals and physician practices.
– Financial terms of strategic investment were not disclosed.
Cerner Corporation today announced an undisclosed strategic investment in Elligo Health Research, a leading integrated research organization that enables clinical trials with nationwide community-based health care practices. As part of the strategic investment, Cerner will enter into a commercial agreement to expand the data and tools available in the Cerner Learning Health Network to offer additional clinical trial resources to community and rural hospitals and physician practices.
Single Platform to Accelerate Clinical Research
Founded by John Potthoff, Ph.D., and Chad Moore in 2016, Elligo
Health Research Since 2016, Elligo Health Research, founded by John Potthoff,
Ph.D., and Chad Moore, has accelerated the development of new pharmaceutical,
biotechnology, medical device, and diagnostic products using its novel clinical
technology and its Goes Direct® approach. As one of the largest health networks
for clinical research, Elligo works to bring research as a care option to as
many participants as possible by offering innovative, patient-centric solutions
within the practices of trusted physicians.
Collaboration Will Accelerate Clinical Research
Timeframes
Health systems face significant obstacles such as patient recruitment, costs, and access to clinical trial resources. Today, for example, the drug development process takes more than 17 years and costs approximately $2.5B. Cerner and Elligo will focus on helping reduce those obstacles health systems face to make clinical trials become more of a reality – no matter the size, location, or academic standing.
Additionally, most clinical trials are executed in large,
urban areas with homogenous trial populations, which offer insights that may
not be broadly applicable to all patients in need of the therapies. Clinical trial
resources can offer funded research opportunities for health care organizations
as well as access to trial therapies for patients who need it most, including
those in minority populations and rural communities. This could result in
outcomes that are more representative of diverse populations and a potential
increase in drug safety through post-market surveillance capabilities.
This collaboration is expected to help accelerate clinical
research timeframes, make clinical trials more broadly and easily accessible
and reduce the costs associated with bringing a therapy to market. In addition,
Cerner representatives will also join Elligo’s board of directors.
“At the beginning of the year, we launched a bold push with our provider clients to change the pace and cost of clinical trials. Today, 51 health systems are part of our Learning Health Network,” said Donald Trigg, president, Cerner. “Elligo shares our passion for making clinical trial opportunities accessible to every provider and patient. Our collaboration will accelerate that shared mission in the quarters ahead.”
– Ro announced it has acquired Workpath, a technology
platform that powers on-demand, in-home healthcare and diagnostics services
nationwide.
– Through this acquisition, Ro’s platform will now
uniquely bring together a patient’s doctor, pharmacy, and
diagnostics/lab–offering a personalized, end-to-end experience with no
insurance required.
– Ro is also announcing a partnership with Quest
Diagnostics, which operates more than 2,200 locations nationwide, to process
its lab tests.
Ro, the healthcare technologycompany, today announced it has acquiredWorkpath, a software platform that enables healthcare companies to offer on-demand, in-home care, and diagnostic services with a simple API. The acquisition will enable Ro to seamlessly integrate virtual and in-person care on its own platform and offer these in-home capabilities to other healthcare companies. The ability to send healthcare professionals to, and conduct diagnostic tests in, a patient’s home significantly expands the scope of Ro’s vertically-integrated platform and advances the company’s strategy of becoming a patient’s first call for all of their healthcare needs.
End-to-End In-Home Care Solution
Founded in 2015, Workpath is a technology platform that powers on-demand, in-home healthcare services nationwide. Workpath’s API enables healthcare companies to dispatch phlebotomists and other providers to perform services ranging from blood draws to vaccinations, all from the comfort of a patient’s home. The company’s full-service platform includes scheduling and dispatch software, a nationwide network of healthcare professionals, diagnostic processing and reporting, and more. Workpath is available to 95% of patients across the country and facilitates in-home healthcare services for clinical trial operators, Fortune 100 companies, and the nation’s largest diagnostic laboratories.
Acquisition Creates A New Paradigm for
Patient-First Healthcare
As part of the acquisition, Workpath will
continue to operate independently as an autonomous entity. Workpath and its API
will continue to be available to other healthcare companies, enabling them to
dispatch healthcare professionals to perform services ranging from blood draws
to vaccinations and other primary care services, all from the comfort of a
patient’s home. The company’s full-service platform includes scheduling and
dispatch software, a nationwide network of healthcare providers, diagnostic
processing and reporting, and more. Ro’s offering of Workpath’s platform will
position the combined company as an integral part of the healthcare industry’s
transition to connect the best of virtual and in-person care.
Enabling End-to-End Care
Ro-affiliated providers will leverage Workpath’s
API to order in-home care or diagnostic services for patients, greatly
expanding the scope of conditions that can be treated or managed through Ro’s
platform. In doing so, Ro will seamlessly connect a patient’s doctor, pharmacy,
and lab on its vertically-integrated platform, enabling end-to-end care from
diagnosis to the delivery of medication to ongoing care. Given that seven of
every ten healthcare decisions require blood work, Ro will start by offering in-home
phlebotomy (blood test) services with results directly delivered through Ro’s
platform.
Zachariah Reitano, Co-Founder and CEO of Ro, said: “Ten years from now, more healthcare services will be delivered online or in-home than in every hospital, doctors office, or pharmacy combined, and this acquisition will help accelerate that change. The powerful new platform we’re creating enables Ro, and countless other healthcare companies, to deliver care whenever and wherever patients need it. We look forward to welcoming Workpath to the Ro family and together setting a new standard for vertically integrated healthcare delivery.”
Financial details of the acquisition were not disclosed.
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.
The companies initiated the P-II study of their COVID-19 vaccine in China. The trial will generate data to support the BLA filing for approval of the vaccine in China
The study will be conducted by Jiangsu Provincial Center for Disease Control and Prevention. The study will commence with the recruitment of 960 patients aged b/w 18-85yrs.
In an ongoing P-III study, it met all 1EPs with an 95% efficacy rate in preventing symptomatic COVID-19 infection. The data supports the submission of an EUA to the US FDA on Nov 20, 2020
Click here to read full press release/ article | Ref: BioNTech | Image: World Pharma Day
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.
Frank McGillin, CEO at The Amwell/Cleveland Clinic Digital Health Company
Egbert van Acht, Executive Vice Chairman to the Board of Directors, Amwell/Cleveland Clinic Digital Health Company
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.
Cory L. Haynes, VP, Financial Services Strategy at Talkdesk
Greg Miller, Vice President Industry Strategy, Healthcare & Life Sciences
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.
Just over a year after its first phase 3 trial of its Engensis gene therapy for painful diabetic peripheral neuropathy (DPN) bombed, Helixmith has started dosing patients in a new study.
The South Korean biotech says the DNA plasmid-based therapy has been administered to a patient at Innovative Research of West Florida. The aim is to enrol 152 DPN patients at 15 clinical sites across the US in the study, called REGAiN-1A.
Helixmith has previously suggested that if positive, the new study could support marketing applications for Engensis. It is due to generate results in December 2021, which could lead to filings in 2022.
While most gene therapies in late-stage development target rare diseases, DPN is a relatively common condition and is likely to become even more prevalent as diabetes is becoming more common around the world. It has a lifetime prevalence of around 50% in people with diabetes, with around half of these having pain.
In DPN, prolonged exposure to higher than normal blood sugar levels damages nerves, most commonly in the legs and feet but also in the arms and hands.
At the moment treatment is limited to drugs like gabapentin and pregabalin, which are only palliative and don’t tackle the underlying cause of the condition.
Engensis – also known as VM202 – is a DNA plasmid-based gene therapy that is administered as an intramuscular injection into the calves, delivering a gene coding for human hepatocyte growth factor (HGF).
The hope is that delivery of Engensis to the lower limbs might promote nerve system regeneration and alleviate the pain that often accompanies DPN, whilst also promoting blood vessel growth in the extremities.
In its first 500-patient phase 3 trial, called DPN 3-1, Engensis was no better than placebo at reducing pain scores over the first 90 days of the trial. However Helixmith (formerly known as ViroMed) said that was due to a major mix-up in the study protocol, which undermined the results.
Analysis of samples taken from patients in the placebo group found traces of the VM202 plasmid, suggesting that clinicians may have inadvertently administered the gene therapy to the control group.
There was also a wide variation in the amount of plasmid DNA among the treatment group, which might suggest inaccuracies in the administration of the gene therapy. On the plus side, safety results were in keeping with a benign profile seen in earlier-stage clinical trials.
Helixmith then started a phase 3 extension study in 101 subjects from DPN 3-1 – conducted under a separate protocol – to look at long-term safety and efficacy at 12 months.
That backed up the safety data for the therapy, and also found significant pain reductions compared to placebo after six, nine and 12 months, as well as a trend towards reduced pain at three months.
The primary measure in REGAiN-1A will be a comparison of the average daily pain scores from seven days prior to the first injection, to seven days prior to the six-month visit between both the Engensis and placebo groups.
Secondary efficacy measures include pain reduction at six months compared to placebo, as well as the proportion of patients experiencing a 50% reduction in pain at six months. The therapy will be administered by injection into the calf at day zero, 14, 90 and 104.
– New study out from Propeller and Chicago’s NorthShore
University HealthSystem shows that asthma patients maintain higher medication
adherence and decrease their rescue inhaler use when using a digital health
platform.
– The study looked at 100 patients recruited from
NorthShore practices, half of whom used Propeller to manage their condition and
half of whom did not.
– The treatment group maintained their high medication adherence at 68%, while the control group experienced a 17% decline in adherence over the course of the study. The treatment group also increased days without needing their rescue inhaler by 19%, 13% more than in the control group.
Poor adherence to asthma medication and overuse of rescue
inhalers have both been associated with increased asthma morbidity in previous
research. Studies reveal that patients often overestimate their level of
adherence to their clinician, leading to costly treatments that may not be
appropriate or necessary to curb symptoms.
Randomized Clinical Trial Details
The published study features a randomized controlled trial
that enrolled 100 patients with uncontrolled asthma, 25 to 65 years of age.
Patients were recruited between April 2018 and 2019 from allergist and
pulmonologist practices at NorthShore University HealthSystem in Chicago. Treatment
and control group participants were both attached a small sensor to their
controller and rescue inhalers. The treatment group received insights on their
medication use in the Propeller app, including reminders to take missed or late
doses and reports on their usage and possible triggers.
Utilizing Propeller’s digital health platform, clinicians
had had access to the treatment patients’ controller and rescue medication
data. If patient utilization indicated poor adherence or worsening control,
patients were contacted to address adherence and review asthma control status. The
control group’s medication use was remotely monitored, but they did not receive
insights in the app or outreach from providers.
Clinical Trial Outcomes/Results
The study’s treatment group maintained its high medication adherence at 68%, while the control group experienced a 17% decline in adherence over the course of the study. In addition, Propeller users’ days without needing their rescue inhaler increased 19% in the treatment group, 13% more than in the control group.
“Increasing adherence and reducing rescue use are critical to improving the health and well-being of asthma patients,” said Giselle Monsaim, MD, lead author of the study and attending physician in the Departments of Medicine, Division of Pulmonary, Critical Care, Allergy and Immunology at NorthShore University HealthSystem. “We’re pleased to add to the body of research that shows digital health can play an important role in maintaining high adherence rates and increasing days without symptoms for people with asthma.”
CMS will cover monoclonal antibody treatments for Medicare beneficiaries with Covid-19. Though this is a step forward in increasing access to these treatments, there are still hurdles to its widespread use.
J&J has resumed recruitment, enrolment, and vaccination in all studies of its COVID-19 vaccine across the EU, after a temporary pause. Trials in the US, South Africa, and some Latin American countries are already ongoing
Clinical trials to be resumed are the P-IIa studies in Germany, the Netherlands, and Spain and P-I/IIa study in Belgium
The company is preparing for the initiation of a second P-III study of the COVID-19 vaccine candidate. The trial will evaluate a 2-dose regimen and is anticipated to start later this month across the EU. The study follows positive interim results of the P-I/IIa study, showing the safety profile and immunogenicity of the COVID-19 vaccine was supportive of further development
Click here to read full press release/ article | Ref: Janssen | Image: Law.com
– The FDA just extended its research collaboration
agreement (RCA) with COTA, specifically looking at how COVID-19 is affecting
cancer.
– With this expanded agreement, COTA and the FDA will use real-world data to explore the impact of COVID-19 and the pandemic on cancer treatment, with the opportunity to expand into other oncology questions in the future.
COTA, Inc., a healthcare technology
company that uses real-world data to bring clarity to cancer care, today
announced it has extended its Research Collaboration Agreement (RCA) with the
U.S. Food and Drug Administration (FDA) for an additional three years. This
renewed RCA will expand on the objective to explore the applications of
real-world data in oncology, including the impact of COVID-19 and the
pandemic on cancer treatment. As the project advances, the research will
broaden to study other oncology care delivery questions.
Real-world data can provide critical insights into the
delivery of cancer treatment in the routine practice setting, as well as
potential long-term effects post-COVID-19 recovery. The expanded focus of this
RCA will enable the exploration of important research questions to help support
FDA’s understanding of how the COVID-19 pandemic continues to impact patients
with cancer.
Why It Matters
With over 8 million cases of COVID-19 in the United States,
there is a significant need to understand the pandemic’s impact on oncology
care. Additionally, an increasing body
of research has shown that oncology patients may be particularly
susceptible to harm during this pandemic – both in contracting the
condition itself or experiencing care delays.
Cancer patients are particularly at risk of severe complications with COVID-19, and there is currently no understanding of how this can affect their oncology care or progression. Through real-world data, we can begin to understand if COVID-19 should be considered as comorbidity – particularly around clinical trial criteria.
The digital health startup released the results of a 599-person randomized clinical trial on Tuesday. It found a statistically significant reduction in participants’ weight and hemoglobin A1c levels.
– FDA awards AppliedVR Breakthrough Device designation for
treating treatment-resistant fibromyalgia and chronic intractable lower back
pain
– AppliedVR’s EaseVRx program helps patients learn self-management skills grounded in evidence-based cognitive-behavioral therapy (CBT) principles and other behavioral methods.
AppliedVR,
a pioneer advancing the next generation of digital medicine, today announced
its EaseVRx product received Breakthrough Device designation from the U.S. Food
and Drug Administration (FDA) for treating treatment-resistant fibromyalgia and
chronic intractable lower back pain. EaseVRx is now one of the first virtual
reality (VR) digital therapeutics to get breakthrough designation to treat
conditions related to chronic pain.
What is the FDA Breakthrough Device Program?
The FDA Breakthrough Device Program helps patients receive more timely access to breakthrough technologies that could provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions.
Clinical Trial Results/Outcomes
AppliedVR achieved this milestone after successfully
completing the first randomized controlled trial (RCT), evaluating VR-based
therapy for self-management of chronic pain at home. The RCT, which was
published in JMIR-FR,
found that a self-administered, skills-based VR treatment program for treating
chronic pain was feasible, scalable and was effective at improving on multiple
chronic pain outcomes – each of which met or exceeded the 30-percent threshold
to be clinically meaningful. On average, participants noted:
AppliedVR’s EaseVRx program helps patients learn self-management skills grounded in evidence-based cognitive-behavioral therapy (CBT) principles and other behavioral methods. The program was designed by AppliedVR, in partnership with the top pain experts and researchers, to improve self-regulation of cognitive, emotional, and physiological responses to stress and pain. AppliedVR has already been shown to be an effective treatment for acute pain in hospital settings.
Why Virtual Reality Is An Effective Approach for Pain
Management
Lower back pain is one of the most common
chronic conditions that people face worldwide and represents one of the top
reasons why people miss work. Additionally, it’s an extremely
costly problem for insurers, especially as they look to cut costs related to back surgery. Recent research indicated that, when combined with neck pain,
lower back pain costs nearly $77 billion to private insurance, $45 billion to
public insurance, and $12 billion in out-of-pocket costs for patients.
Chronic pain more broadly also is a difficult and costly
problem that has contributed to many other major health problems in the U.S.,
including the opioid epidemic. A previous Johns Hopkins study in the Journal of
Pain found that chronic pain can cumulatively cost as high as $635 billion a year — more than the annual costs of
cancer, heart disease and diabetes — and lower back pain has been one of the most common reasons for prescribing opioids.
Cognitive behavioral therapies like VR are now seen by many providers as an
effective alternative or complement to pharmacological interventions that can
support their larger treatment tool belts.
“Since 1980, the American Chronic Pain Association has advocated a multidisciplinary approach to pain management—using a combination of medical and behavioral techniques to address pain,” said Penny Cowan, founder and CEO of the American Chronic Pain Association. “Virtual reality has the potential to be an important resource in this approach, helping people with pain to think differently about their conditions and learn strategies to reduce suffering and improve quality of life.”
Future Clinical Trials
AppliedVR is currently engaged in many other trials,
including feasibility studies with multiple well-known payers and with the
University of California at San Francisco (UCSF) to study how digital therapeutic platforms, including
virtual and augmented reality, can be used to improve care access for
underserved populations. AppliedVR also is advancing two clinical trials with
Geisinger and Cleveland Clinic to study VR as an opioid-sparing tool for acute
and chronic pain – specifically the company’s RelieVRx and EaseVRx platforms.
The National Institute on Drug Abuse (NIDA), part of the National Institutes of
Health (NIH), recently awarded $2.9 million grants to fund the trials.
The P-II ROCCELLA is a dose-ranging trial involves assessing GLPG1972/S201086 (PO, qd) in three different doses vs PBO in 932 patients with knee OA for 52wks. across 12 countries including EU, Asia, North and South America. Galapagos is responsible for ROCCELLA in the US, where 326 patients were recruited while Servier will be solely responsible for trial in 11 countries where 606 patients were recruited
The trial failed to meet its 1EPs as the change from baseline to 52 in cartilage thickness in mm (SD) is {-0.068 (0.20), -0.097 (0.27) & -0.085 (0.22)} vs -0.116 (0.27) for the low, medium & high dose respectively
No difference in 2EPS including clinical outcomes, the therapy was generally well-tolerated by patients in the P-II study
Click here to read full press release/ article | Ref: Globe Newswire | Image: Servier
– Virta is expanding its suite of treatment options to
include prediabetes reversal, obesity reversal, and type 2 diabetes management.
– By making this crucial expansion, Virta can scale its
treatment to support the tens of millions of additional patients with
prediabetes and obesity, as provide an on-ramp to reversal for those with T2D
that aren’t yet ready to reverse.
Virta Health, the
leader in type 2 diabetes reversal, today introduced the addition of new
services including prediabetes reversal, obesity treatment, and provider-led
management for type 2 diabetes. The expansion provides payers and covered
beneficiaries a single, full-service virtual clinic that offers
industry-leading outcomes for the most critical needs in metabolic health.
Virta’s fully-virtual, high-touch model demonstrates hope
for change, and stands in stark contrast to approaches that only slow the
diabetes downward spiral, as opposed to reversing it. Virta provides
individualized guidance from medical providers and behavioral specialists,
whenever and wherever it is needed. Patients interact with their dedicated
clinical team often multiple times per day. This novel telehealth
approach—called Continuous Remote Care—ensures successful adoption of Virta’s
individualized medical nutrition therapies and long-lasting results.
Why It Matters
Nearly half of adults in the United States suffer from obesity,
prediabetes, or type 2 diabetes. Thirty people die per hour of diabetes-related causes. The
economic burden continues to grow, and people with diabetes incur nearly $17,000
in medical expenses per year. They are also at high risk for severe illness
from COVID-19, and risk of dying from the disease is twice as high compared to
those without diabetes.
Obesity and prediabetes patients will benefit from the same
treatment that delivers the sustained type 2 diabetes reversal outcomes in Virta’s
clinical trial and commercially-covered population. Patients receiving type 2
diabetes management will receive support from a provider-led care team, with
personalized guidance and an option for a seamless transition to Virta’s
reversal treatment. All patients will receive individualized care via Virta’s
provider-led Continuous Remote Care platform.
Virta Type 2 Diabetes Reversal Results
Virta’s results in type 2 diabetes reversal have fueled continued triple-digit year-over-year growth for the company while creating strong demand to bring Virta’s evidence-based approach to other metabolic conditions. In Virta’s peer-reviewed clinical trial results, 60% of people at one-year reverse type 2 diabetes, and 94% reduce insulin use or eliminate it altogether.
Additionally, patients completing one year of the Virta
Treatment experience 14% weight loss. This figure exceeds the goal of the
National Diabetes Prevention Program and the FDA benchmark for weight loss
drugs by nearly 200%.
“This expansion provides our commercial partners and patients with the transformational outcomes they’ve come to expect from Virta, but don’t receive from other solutions on the market,” said Sami Inkinen, CEO & co-founder of Virta Health. “We can now meet every patient wherever they are on their metabolic health journey, while uniquely offering a path to reversing their chronic disease.”
The multiple expansion cohort will assess the safety, tolerability, drug levels, molecular effects, and clinical activity of MRTX849 in patients with advanced solid tumors harboring a KRAS G12C mutation
Strata Oncology will identify patients to be considered for enrollment into Mirati’s P-I/II study. The Strata Trial provides tumor molecular profiling for patients with advanced cancer paired with a portfolio of biomarker-guided clinical trials
Strata Oncology utilizes StrataNGS which is a molecular profiling test optimized for performance on tumor tissue samples as small as 0.5mm2 surface area. MRTX849 is a novel KRAS G12C selective inhibitor
Click here to read full press release/ article | Ref: PRNewswire | Image: Strata Oncology
The P-I study will evaluate the safety and immunogenicity of the vaccine as well as confirm dose selection in ~144 healthy subjects aged 18-55 and >55 yrs. As part of the two-dose cohort design, subjects will receive two injections (prime-boost), 21 days apart BNT162b1 vs PBO
The dose range was determined based on early data from clinical trials conducted in Germany and the US. The participants will be dosed in Taizhou clinical P-I center, Jiangsu province
BioNTech will provide the clinical supply of the vaccine from its GMP-certified mRNA manufacturing facilities in EU while Fosun Pharma will exclusively commercialize the vaccine in Mainland China, Hong Kong, and Macau Special Administration Regions and in Taiwan if received approval in China
Click here to read full press release/ article | Ref: GlobeNewswire | Image: PharmaShots
First dose of ETC-159 administered in Phase 1B of clinical trials, advancing the development of this drug to treat solid tumours Made-in-Singapore cancer drug, ETC-159, has achieved a new developmental milestone in achieving “First Patient First Visit[1]” in Phase 1B. The first dose of ETC-159 has been administered to patients in this new phase of
An app combining physical therapy, relaxation exercises and medical education developed by Kaia Health has been shown to improve physical and mental symptoms in people with chronic lower back pain.
The iOS and Android app was put through its paces in a 1,245-patient study reported in the Journal of Pain Research that, according to its developer, is the largest ever trial of a digital therapy against chronic pain.
It features computer-vision technology that locks onto 23 key points on the body to track movements accurately, allowing the app to provide advice on the correct movements and exercises.
The Kaia app reduced pain levels, anxiety, depression and stress, and improved patient-reported wellbeing and body functionality compared to standard treatments left to the discretion of doctors, which could include painkillers, surgery and physical therapy.
It was used as part of an intervention called Rise-uP, which was delivered by GPs and included the use of electronic health records, an algorithm for guideline-based treatment decisions, and teleconsultation between GPs and pain specialists for patients at risk for development of chronic back pain.
The Rise-uP group showed a significantly better pain reduction compared to the control group after three months, with 33% reporting an improvement compared to 14% of a control group that according to the study authors received “relevant active treatment” from their doctors.
Among a group of high-risk patients who received a teleconsultation, there was also a larger decrease in pain intensity for the Rise-uP group – a drop of 43.5% – than control patients who saw a 14.3% reduction.
Lower back pain is one of the top causes of disability around the world, and according to a 2018 report in The Lancet accounts for 189 million lost working days and $62.4 billion in lost productivity in a year.
“This large-scale study demonstrates the significant benefits for people managing low back pain when using Kaia to deliver a multimodal treatment through a digital device, such as a smartphone,” commented Thomas Toelle, head of the pain centre at the Technical University Munich, Germany, and lead author of the study.
“These results add to the growing body of medical evidence that supports the use of digital multimodal treatments for chronic conditions, such as back pain,” he added.
New York City-based Kaia Health raised $18 million last year from investors to develop its app, and recently announced a $26 million second-round financing, which included new investment from lead backer Optum Ventures as well as world number one ranked golfer Rory McIlroy.
We’re pleased to welcome @McIlroyRory, world No. 1 golfer, as an investor in Kaia Health. Rory believes in Kaia’s holistic and innovative approach. He praised the importance of strengthening core muscle groups, which guided his success as a professional golfer. #BackPainpic.twitter.com/KKQWkA8oO1
France’s Genfit has said its elafibranor drug as a treatment for non-alcoholic steatohepatitis (NASH) was unable to improve patient outcomes in a phase 3 study, which has now been terminated.
Genfit took the “highly disappointing” decision after taking a look at interim data from the RESOLVE-IT study, said the company’s chief executive Pascal Prigent. Those results were first disclosed two months ago and wreaked havoc with the biotech’s share price.
In the study, PPAR agonist elafibranor was unable to hit the primary objective of resolving NASH without worsening fibrosis (scarring) compared to placebo, and also flunked its secondary targets.
At the time Genfit said it wasn’t calling time on the drug yet, as it was examining an unexpectedly high response rate in the control group. Now, elafibranor joins a lengthening list of drugs that have failed to hit the mark in the fatty liver-disease, which still has no approved treatments despite billions of dollars in R&D investment by the biopharma industry.
Genfit will switch its attention to developing elafibranor in primary biliary cholangitis (PBC) and a NASH diagnostic tool called NIS4 as part of a new corporate strategy that will also allow it to rein in costs.
Biopharma companies have piled into the NASH space in recent years, lured by the promise of big rewards for the first drugs to treat a disease that afflicts millions of people around the world and is becoming more common.
Elafibranor joins Gilead’s selonsertib, Novartis’s/Conatus’s emricasan, and Cymabay’s seladelpar among candidates that have failed in the latter stages of clinical testing.
Meanwhile, Intercept Pharma’s obeticholic acid – which cleared phase 3 testing and reached the stage of being filed for approval with the FDA – was rejected by the regulator last month on the grounds that it needed more evidence for its safety and efficacy.
Genfit says that elafibranor’s failure in NASH shouldn’t read through to its potential in PBC – a chronic, autoimmune disease in which bile ducts in the liver are gradually destroyed causing cirrhosis – because the two diseases have very different pathologies.
However, PBC is a much smaller indication than NASH, affecting around 1 in 1,000 people – mainly women – over the age of 40.
The PPAR agonist generated positive results in a phase 2 trial in PBC reported at the end of 2018, but in this indication it will be playing catch-up with Intercept’s drug, which is already approved for the disease under the Ocaliva brand name.
Data from more than 1,000 healthy volunteers dosed with a coronavirus vaccine developed at Oxford University and AstraZeneca suggest the shot is safe and stimulates an immune response against the virus.
The first phase 1/2 results with the ChAdOx1 vaccine – also known as AZD122 – were published today in medical journal The Lancet and bode well for the outcome of much larger phase 2 and 3 trials that are already underway in the UK, Brazil and South Africa, say the investigators, led by Prof Andrew Pollard of Oxford University.
The data reveal that ChAdOx1 generated antibodies that were able to neutralise the SARS-CoV-2 virus in more than 90% of subjects aged 18 to 55 after a single dose, and 100% after two doses.
All vaccinated patients also showed increases in white blood cells (T cells) that can fight the infection and are thought to be an important factor in limiting the severity of COVID-19-related illness.
There were minimal side effects such as headache and fever, which could be prevented with paracetamol, according to the researchers.
AstraZeneca’s share price ticked up by almost 2% following the announcement.
ChAdOx1 is based on an adenoviral vector based on a weakened version of the adenovirus that causes a common cold-line illness in chimpanzees, containing the genetic material of SARS-CoV-2 spike protein.
“The immune responses observed following vaccination are in line with what we expect will be associated with protection against the SARS-CoV-2 virus, although we must continue with our rigorous clinical trial programme to confirm this,” commented Prof Pollard.
Meanwhile, The Lancet also carries a 500-patient, phase 2 study from researchers in China on another adenoviral vector-based vaccine developed by CanSino Biologics, which also generated antibody and T cell responses and appeared to be safe.
An editorial accompanying the studies by Naor Bar-Zeev and William Moss at Johns Hopkins Bloomberg School of Public Health in the US notes that the results of the two trials “are broadly similar and promising”.
They add however that “much remains unknown about these and other COVID-19 vaccines in development, including longevity of response and immunogenicity in older adults or other specific groups.”
At the moment the follow-up period in both studies is vanishingly short in the context of typical vaccine studies, but it’s nevertheless encouraging that in the Oxford study the data show sustained immune responses for up to 56 days.
Some scientists estimate that vaccine protection for just six months or more could be enough to have an impact in controlling the coronavirus pandemic.
Larger studies are needed to conform these early findings and answer other key questions, such as how the vaccines perform in older people, those with concomitant illnesses and other high-risk individuals, and children.
Meanwhile, there have also been calls for so-called “challenge studies”, which would involve deliberately infecting subjects with SARS-CoV-2 after a vaccine to test directly the level of protection it confers.
Oxford University has partnered with AZ to produce the ChAdOx1 vaccine, and the UK government has already placed an order for 100m doses, with other big orders also received from the US, German, France and others.
The UK government has also just ordered 90 million doses of two other COVID-19 vaccines – from BioNTech/Pfizer and Valneva – plus an option for another 40 million doses.
Pfizer and BioNTech also announced further clinical data from the most advanced from a group of four vaccines they are developing, with data collected in Germany supporting findings of a US trial arm published earlier this month.
According to the latest estimates from the World Health Organization there are 23 potential vaccines in clinical trials and 140 in preclinical development.
– 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.”
– 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.
– 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.
The second P-III LIBRETTO-531 involves assessing of selpercatinib vs physician’s choice of cabozantinib or vandetanib in 400 patients in ratio (2:1) with advanced or metastatic RET-mutant MTC who have received no prior systemic therapy for metastatic disease
The study will have efficacy endpoints as progression-free survival (PFS), treatment failure-free survival (TFFS), overall survival (OS), overall response rate (ORR), and duration of response (DoR)
LOXO-292 is an oral investigational new medicine targeted to inhibit native RET signaling as well as anticipated acquired resistance mechanisms and has also received Breakthrough Therapy designation in RET fusion-positive NSCLC, RET-mutant medullary thyroid cancer (MTC) and RET fusion-positive thyroid cancers
Click here to read full press release/ article | Ref: PRNewswire | Image: Twitter
