What is the MedCity INVEST Pitch Perfect experience like?

Finish line ahead

The INVEST Pitch Perfect contest is part of our INVEST conference April 19-23, which will be hosted online due to Covid-19, and includes five tracks for startups: biopharma, medical devices, diagnostics, health IT and health services. Read more on how to apply.

Prescient Healthcare Group to Partner with Bridgepoint Development Capital

The partnership will further enhance the depth, breadth and value of services for Prescient’s pharmaceutical and biotech clients.

LONDON, January 21, 2021: Prescient Healthcare Group (Prescient), a global product strategy advisory firm serving the pharmaceutical and biotech industries, announced today that Bridgepoint Development Capital, part of Bridgepoint, the international alternative asset management group, has agreed to invest in the business for an undisclosed sum, replacing current investor Baird Capital as the majority shareholder.

Founded in 2007, Prescient is headquartered in London and has offices in the US, India and China. The business provides product strategy services to help its clients make better clinical and commercial decisions, resulting in enhanced outcomes for patients. Prescient works with many of the leading multinational pharmaceutical companies, as well as a growing number of emerging biotech and specialty pharmaceutical organizations. Prescient has formed a partnership with Bridgepoint to support the continued scaling of its talent platform, client value proposition and global infrastructure.

“We are thrilled to be partnering with Bridgepoint, which has an impressive track record supporting the scaling of people-based businesses. Bridgepoint buys into our mission of becoming the biopharma strategy partner most respected for its people, expertise and impact,” said Jamie Denison-Pender, Prescient CEO. “I’m excited by the collaborative approach and hunger for excellence that Bridgepoint will bring to the boardroom and much look forward to our partnership as we continue to invest in our passion for helping our amazing clients develop and commercialize innovative treatments that bring such hope and relief to patients globally.”

“We’re delighted to partner with Prescient to help it drive growth and consolidate its market leadership and share management’s ambitions for the expansion of the Prescient platform. This will be achieved through a combination of investment to enhance scale and expertise, organic growth and selective M&A, with the aim of becoming the leading technology- and data-enabled strategic product partner of choice for decision support and advisory services to the large pharma industry,” said Stephen Bonnard, partner at Bridgepoint Development Capital.

Dr. Nick Edwards will remain Prescient’s Chairman. Baird Capital will be reinvesting in the company as a minority shareholder alongside Bridgepoint.

The post Prescient Healthcare Group to Partner with Bridgepoint Development Capital appeared first on .

Armed with $270M in capital, Scorpion Therapeutics aims to broaden the reach of precision oncology

bullseye, take aim

Founded in 2020, Scorpion is agnostic about the potential therapies and targets it will explore with what it describes as its drug-hunting engine. But the company is hoping to unveil its first drug candidate this year.

MedCity INVEST Precision Medicine spotlight: Building a BioInnovation Hub (video)

The panel, What It Takes To Build A Successful, Regional BioInnovation Hub (sponsored by Independence Blue Cross) focuses on Philadelphia — one of many cities seeking to support the continued growth of cell and gene therapy and connected health industries.

MedCity INVEST Precision Medicine spotlight: Pitch Perfect Life Science track (video)

A video from the conference spotlights startup pitches and Q&A with judges in the Life Science track of the Pitch Perfect contest.

Walmart pharmacies fueled opioid crisis, DOJ lawsuit claims

The Justice Department has sued Walmart for fanning the flames of the opioid crisis through its network of pharmacies, claiming that the retailer knowingly filled thousands of illegitimate opioid prescriptions. But Walmart says the lawsuit is “misguided.”

INVEST Precision Medicine Pitch Perfect winner spotlight: TrialSpark

Judges picked TrialSpark as the winner on the life sciences track of the pitch competition at MedCity’s virtual precision medicine conference. While the company is focused on improving clinical trials for others, it hopes eventually to bring drugs of its own to market.

FDA gives nod to Moderna vaccine for Covid-19

The company’s vaccine is the second approved for emergency use by the FDA. It is expected to pose fewer logistical challenges than the first, which was developed by Pfizer and BioNTech.

Precision measurement in 2021: Why accuracy is key to the vaccine ‘cold chain’ and disrupting the spread of Covid-19

By creating new networks for 24/7 temperature monitoring, alerts and reporting, the challenges of deploying transportation at ultra-low temperatures can be overcome. This also illustrates the crucial role that precision measurement will have to play.

Hospitals sue drug companies over discount program

The lawsuit follows action by at least a half-dozen drug companies to rein in what they see as waste and abuse in the program, overseen by the Department of Health and Human Services. Meanwhile, the Hospital plaintiffs have a potentially powerful ally in the person picked to head the department under the incoming Biden administration.

Immunai joins 10x Genomics program to boost drug development

Together, the two companies say can give drugmakers a better view at the cellular level of how a patient’s immune system is responding to a cerain therapy.

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

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

What You Should Know:

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

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


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

Why It Matters

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

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

SARS-CoV-2 IgG II Quant Antibody Test

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

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

Availability

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

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

Consumer awareness, needs generating shifts in precision medicine landscape  

Healthcare consumers are increasingly aware of specific therapies in development or on the market that can help treat the diseases they or their loved ones may be suffering from — and this growing awareness is changing the precision medicine arena.

How augmented intelligence and NLP can help clinicians, researchers identify rare diseases

To help clinicians diagnose rare disease more quickly and accurately, many healthcare organizations are embracing technology solutions like natural language processing (NLP) tools that can create augmented intelligence workflows that facilitate the rapid search of unstructured clinical data from multiple data sources.

Getting the right data to doctors is next hurdle for precision medicine

dna, genomics

The future of precision medicine will come only as quickly as doctors can pick out clinically useful information from the genetic data being gathered on their patients.

What’s coming up at MedCity INVEST Precision Medicine Day 3?

dna, genomics

The final day of the conference, Friday, December 11, includes a panel on precision medicine investment trends, a look at clinical trial design innovation and the life sciences track of our Pitch Perfect startup contest. Register now!

AI offers promise but faces barriers in drug development

Inertia is a barrier as is the traditional split between the clinical and the data-driven spheres of drug development. While smaller firms have an edge in bridging the gap, big pharma will eventually get there, said panelists at the INVEST conference session.

Which startups will present at MedCity INVEST Precision Medicine Pitch Perfect?

Finish line ahead

Among the areas of interest for companies presenting at Pitch Perfect at INVEST Precision Medicine are clinical stroke detection, making medical research more inclusive, using technology to accelerate the pace of clinical trials, developing more patient friendly drug delivery systems for reconstitutable drugs, and more.

Level Ex pitches gaming as a tool for reaching doctors

Interactive, cloud-based video games are designed to tackle pharma’s current challenge: engaging doctors virtually during a pandemic. But the tools are likely to outlive the circumstances in which they were born.

French startup lands $8.7M to advance microbiome therapies

money

Founded in 2014, MaaT Pharma is pushing two therapies through clinical trials that are designed improve survival for patients with blood cancers and other diseases. Despite high-profile hiccups, the field of microbiome therapy remains attractive to investors.

New study ties pharma payments to prescription practices

Recent efforts to improve transparency haven’t made much of a difference, one author noted. But earlier reforms made a dent the “most egregious” practices.

Mark your calendars for our virtual INVEST Precision Medicine conference, December 9-11

Here’s a preview of some of the panel discussions at INVEST Precision Medicine, including diagnostics, investment trends, and building a bioinnovation hub.

$200M investment to advance clinical programs for Ambrx

The San Diego-based biopharma firm has several oncology therapies in development and has partnered in the past with the likes of Astellas, BeiGene and Bristol-Myers Squibb.

AstraZeneca, Oxford are latest to unveil Covid-10 vaccine results

The partners pooled results from two trials and two different dosing regimens, one appearing to be more effective than the other. They hope to produce 3 billion doses in 2021 with an emphasis on serving poorer countries.

Imago raises $80M to further studies of its treatment for blood and bone-marrow disorders

money, dollar

The San Francisco-based company aims to complete at least one Phase III study by 2025, and it is weighing an IPO next year to fund more.

7 Best Practices for Third-Party Risk Management in the Pharmaceutical Industry

7 Best Practices for Third-Party Risk Management in the Pharmaceutical Industry
Dr. Aleksandr Yampolskiy, CEO of SecurityScorecard,

The globalization of the pharmaceutical industry has forced pharma companies to outsource, increasing their reliance on third-party vendors and suppliers. As this supply chain grows in complexity, companies find themselves grappling with a growing amount of cyber risk. 

A data breach in the pharmaceutical industry can cost companies upwards of $5 million and costs can rise significantly if a third-party vendor or supplier is the cause of a data breach. For this reason, organizations must ensure the third-parties that exist within their supply chain remain secure. 

Challenges in the Pharmaceutical Supply Chain

There are innumerable logistical, compliance, and cost-related issues that organizations must consider as they add third-parties and vendors to their supply chain. 

From a logistics view, a growing number of touchpoints between production and consumers, shipments that require refrigeration, packaging coordination, and shipment delays related to third-parties all may increase risk. 

This risk is compounded by compliance-related issues. The highly-regulated pharmaceutical industry must comply with a number of healthcare-related regulations, like HIPAA, and must also be sure that their third-party suppliers abide by rules set by supply regulations like Good Distribution Practice (GDP). If these companies and their third-parties do not comply, the organization becomes subject to costly fines – which can range between $10 million and $1 billion depending on various factors. 

Pharmaceutical businesses must protect their organizations in this challenging risk environment by working to mitigate third-party cyber risk as they also work to limit their own. 

Why Third-Party Risk Management is Critical for Pharma 

Due to the high value of the intellectual property they house, pharmaceutical companies are subject to a high-level of cybercrime. In fact, according to a study conducted by Deloitte, the pharmaceutical industry has become the number one target of cybercriminals at a global level, especially in relation to IP theft.

For a pharma organization, data breaches can be devastating, costing companies grief over lost or stolen data and large sums of money to remedy any business hindrances caused by the breach. According to Ponemon’s Cost of a Data Breach report, data breaches cost pharmaceutical companies an average of $5.2 million. When a third-party supplier or vendor causes a breach, the average cost rises by $370,000

In order to protect drug production and patient well-being, the industry must take care to minimize its cyber risk, specifically when it comes to third-parties. 

Best Practices for Third-Party Risk Management in the Pharmaceutical Industry

It is crucial that pharmaceutical organizations work to limit the third-party risk that may stem from vendors and suppliers. Use the following seven best practices for developing your third-party risk management (TPRM) strategy: 

1. Identify Your Suppliers

Pharmaceutical companies have a large, outsourced supply chain and it is imperative to understand exactly who your suppliers are at all points on the chain. Cyber risk can stem from any size or type of vendor, so make sure to list each third-party you work with – from small vendors who may work with only one department, to large vendors who develop drug labels and bottle caps. 

2. Understand and Qualify Potential Cyber Risks

Each third-party has the potential to introduce numerous risks that must be identified at the start of your business relationship. Make note of the types of software, networks, devices, and data that each of your third-parties access. Then, develop a risk inventory and map them against a standardized risk taxonomy, estimate the likelihood and severity of each risk, and rank each third-party in order of potential risk.  

3. Determine a Risk Rating

Once each third-party has been analyzed from a risk-perspective, assign a risk rating to each. Risk ratings generally range from low to high, meaning high-risk vendors receive the most attention when prioritizing risk monitoring strategies and determining your risk appetite. 

4. Define Controls

It’s important to make sure that third-parties have the same level of risk tolerance as your organization. When developing a TPRM policy, you need to define the types of controls your third-parties should be using like encryption, regular security patching, and data segregation. If possible, these controls should be worked into your business contracts. 

5. Measure Third-Party Compliance 

After setting controls, you must set metrics to measure third-party compliance. These metrics may include time to risk detection, time to risk remediation, or time to risk recovery. Monitoring third-party compliance regularly requires a review of security questionnaires or self-audits provided by the third-party. 

6. Align with a Risk Management Framework

In order to properly manage third-party risk, pharmaceutical organizations must develop a third-party risk management framework. Common frameworks like NIST and ISO help to identify which third-party vendors pose the greatest risk and require an immediate response.  

7. Continuously Monitor Third-Parties

In order to ensure security, pharmaceutical companies must continuously monitor their third-party business partners. Many organizations incorporate platforms that can monitor ecosystem risk, providing real-time visibility into the complex IT risks associated with the rapidly expanding pharmaceutical attack surface.

Final Thoughts

The supply chain for the pharmaceutical industry is increasing in regulatory complexity, logistics, and costs. Globalization has expanded the threat landscape, leaving many companies forced to upgrade their risk-management capabilities. Now is the time to adopt the best practices highlighted above to protect drug IP and patient lives. 


About Dr. Aleksandr Yampolskiy, CEO of SecurityScorecard

Dr.Aleksandr Yampolskiy is a globally recognized cybersecurity innovator, leader, and expert. He is co-founder and chief executive officer of SecurityScorecard and strives to create a new language for cybersecurity by enabling people to work collaboratively across the enterprise and with external parties to build a more secure ecosystem. 

Important questions about Pfizer’s Covid-19 vaccine

News of positive results from Pfizer’s Covid-19 vaccine is heartening but historically, important scientific announcements about vaccines are made through peer-reviewed medical research papers that have undergone extensive scrutiny about study design, results and assumptions, not through company press releases.

With 90% efficacy against Covid-19, Pfizer/BioNTech’s vaccine jumps ahead in global race

Finish line ahead

The news sent the stock market soaring as it represents a key milestone in developing and distributing a vaccine for the virus. Still public confidence in vaccines need to be boosted, an expert noted.

Merck paying $2.75B for cancer therapeutics firm VelosBio

The deal will broaden Merck’s oncology portfolio as it picks up an antibody-drug conjugate, a class of biological drugs that target tumor cells even as the pharma giant jettisons other parts of its business

String of FDA approvals gives momentum to liquid biopsies

Following years of research and investment, liquid biopsies are steadily accumulating FDA approvals. The tests are being used in molecular profiling of solid tumors and as companion diagnostics for targeted cancer therapies.

Why prioritizing health equity in the Covid-19 vaccine distribution is not just right, but necessary

Even though Covid-19 is distinct from any health crisis the country has previously faced, assessing U.S. public health strategies during past crises can provide insight into what has contributed to a more or less equitable response.

Purdue to plead guilty, pay $8.3B deal to resolve opioid charges

In addition to monetary damages and the guilty pleas, the government is seeking to transform the maker of OxyContin into a public benefit company that would fund efforts to curb opioid abuse and give away drugs to prevent overdose deaths.

Ori Biotech Lands $30M for Cell and Gene Therapy Manufacturing Platform

Biotech Startup Ori Biotech Lands $30M for Cell and Gene Therapy Manufacturing Platform

What You Should Know:

– Biotech startup Ori Biotech raises $30M in Series A
funding to scale its cell and gene therapy (CGT) manufacturing platform.

– Ori Biotech helps pharmaceutical and biotech companies
develop and manufacture cell and gene therapies. Its patented technology aims
to reduce the manufacturing cost of these life-saving treatments by up to 80%,
allowing them to be more widely accessible for patients.


Ori Biotech Ltd (Ori),
a leading innovator in cell and gene therapy (CGT) manufacturing, today
announced the successful close of a $30 million Series A financing round,
bringing the company’s total funding to date to $41 million. The Series A round
was led by the experienced life sciences investment team at Northpond Ventures, a leading global
science, medical, and technology-driven venture fund, alongside Octopus Ventures, a leading European
venture fund. Northpond and Octopus invested alongside significant support from
Ori’s existing institutional investors, Amadeus Capital Partners, Delin Ventures, and Kindred Capital.

The Future of Cell and Gene Therapy Manufacturing

Founded in 2015 by Dr. Farlan Veraitch and Professor Chris Mason, Ori Biotech is a London and New Jersey-based cell and gene therapy (CGT) manufacturing technology company. Ori has developed a proprietary, flexible manufacturing platform that closes, automates, and standardizes manufacturing allowing therapeutics developers to further develop and bring their products from pre-clinical process development to commercial-scale manufacturing. The mission of the Ori platform is to fully automate CGT manufacturing to increase throughput, improve quality, and decrease costs in order to enable patient access to this new generation of life-saving treatments.

The new funding will be used to help bring Ori’s innovative
manufacturing platform to the market. The Ori platform delivers scalable
solutions to flexibly address the critical clinical and commercial
manufacturing needs of CGT developers.

“Closing a significant Series A round, during these uncertain times, further validates Ori’s disruptive approach to fully automating cell and gene therapy manufacturing to increase throughput, improve quality, and decrease costs,” said Jason C. Foster, CEO of Ori Biotech. “We are excited to work with our top tier investors and development partners to bring our platform to market as fast as possible to achieve our mission of enabling patient access to life-saving cell and gene therapies.”

Takeda strikes $1B RNAi deal with Arrowhead Pharmaceuticals

The companies will partner on development and commercialization of ARO-AAT, Arrowhead’s Phase II RNA-interference drug for alpha-1 antitrypsin-associated liver disease, a rare genetic disorder. An analyst wrote that the deal makes sense given Takeda’s position in the AAT-augmentation therapy market.

CRISPR gene-editing discoverers awarded Nobel Prize in chemistry

The prize went to Jennifer Doudna of the University of California Berkeley and Emmanuelle Charpentier of the Max Planck Institute. Charpentier published her research on the biology behind the technology in 2011 and collaborated with Doudna. The two discovered it was possible to control the mechanism.

Lilly seeks emergency clearance for Covid-19 monoclonal antibodies on Phase II data

The company announced data on the combination of two antibodies against the SARS-CoV-2 virus, showing significant reductions in viral load compared with placebo. The company has applied for an EUA for LY-CoV555 and will seek an authorization for the combination of that drug with LY-CoV016 next month.

FDA issues Covid-19 vaccine guidance as White House reportedly relents

The guidance calls for a median two months’ worth of follow-up safety data from well-designed Phase III studies as a precondition for a vaccine receiving an EUA. The Wall Street Journal reported that the White House had backed down in its opposition to the guidance, which pushes the date of an EUA past Election Day.

Amgen announces ‘positive’ Phase II lung cancer results for cancer drug with hard-to-reach target

The company did not provide data, but said results for patients who received sotorasib at the 960mg dose were consistent with those seen in the Phase I portion of the Phase I/II study, which showed an overall response rate of 35.3%. ……

BMS acquires MyoKardia, maker of drugs for cardiovascular disease, for $13.1B

heart, doctor, cardiac

The companies expect the deal to close in the fourth quarter. MyoKardia’s lead drug candidate is mavacamten, which it is developing for hypertrophic cardiomyopathy and plans to submit to the FDA in the first quarter of next year.

Amid mixed messages about his Covid-19 diagnosis, Trump looks like a one-man clinical trial

While the White House and doctors at Walter Reed have sought to reassure the public that Trump’s condition is improving, he has received numerous drugs for Covid-19, including the steroid dexamethasone, which is typically administered only to those who are critically ill.

Gilead takes over distribution of Covid-19 antiviral drug from federal government

The company said it was meeting real-time supply demands for Veklury (remdesivir) in the U.S. and anticipated meeting global demands for the drug worldwide. AmerisourceBergen will continue acting as sole U.S. distributor.

Ovid drug reduces seizure frequency in two rare forms of epilepsy, according to early Phase II data

The data from a Phase II pilot and an extension study of soticlestat, also known as OV935 or TAK-935, showed short- and long-term reductions of seizure frequency in patients with CDKL5 deficiency disorder and Dup15q syndrome.

Report: FDA takes closer look at adverse event that occurred in AstraZeneca Covid-19 vaccine study

Reuters reported Wednesday that U.S. regulators would look at data from previous clinical trials that came from the same scientists who created the vaccine, AZD1222, which originated at the University of Oxford and is also known as ChAdOx1 nCoV-19.

Moderna’s Covid-19 vaccine shows antibody, T-cell responses a month after second dose in interim Phase I data

The company published interim data from the Phase I study of mRNA-1273 in 40 older and elderly adults, showing responses comparable to those seen in younger adults. The vaccine is being tested in a 30,000-participant Phase III trial.

Policy makers should ‘set their sights higher’ on U.S. drug pricing regulations, researchers say

Money pile and medicine pills representing medical expenses

A review published in JAMA found that bills introduced into the House and Senate don’t go nearly as far as existing drug pricing regulations other countries. The researchers listed eight key lessons from six nations.

Triumvira Immunologics raises $55M in Series A funding round for new form of cancer cell therapy

The company hopes to use the money to bring its T-cell antigen coupler cell therapy technology – currently in preclinical development – into human clinical trials. German drugmaker Bayer’s venture capital arm led the round.

Generic drugmaker Teva indicted in alleged price-fixing conspiracy leading consumers to be overcharged by $350M

Money pile and medicine pills representing medical expenses

The charges, filed in Philadelphia federal court, allege that Teva conspired with four other generic drug companies to fix prices, rig bids and allocate customers. Teva – which the Justice Department and New York’s state government also sued this month for unrelated allegations – said it rejected the allegations.

AstraZeneca starts Phase I study of long-acting double-antibody cocktail for Covid-19

The drug, AZD7442, is designed to potentially provide at least six months of protection from Covid-19. The trial, which is funded by federal defense and health authorities in the U.S., is enrolling up to 48 healthy volunteers in the U.K. AstraZeneca’s double-antibody approach is similar to that of Regeneron and Roche with their drug, REGN-COV2.

Study uses genomic data to trace Covid-19 ‘superspreader’ event linked to February Biogen exec meeting

The study, by researchers at Harvard, MIT, The Broad and other institutions, used genomic analysis of cases linked to the Biogen meeting, linking much of the community transmission in the Boston area to a European genetic variant of SARS-CoV-2 that first appeared at the meeting.

Aetion completes $82M Series B round with $19M extension

The healthcare analytics company said it had raised the extension funding from three new investors and would use it to accelerate development of its real-world evidence technology.

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

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

Stephen Hahn and the terrible, horrible, no good, very bad FDA weekend

The FDA commissioner took to Twitter Monday night to defend his performance at the agency, which came under sharp criticism amid accusations that the authorization of a plasma treatment for Covid-19 was politically motivated and that he stood by while President Trump unfairly maligned FDA staffers, prompting calls for his resignation.

FDA’s emergency authorization for convalescent plasma in Covid-19 sparks controversy

While the emergency use authorization granted Sunday was not seen as scientifically unwarranted, it drew concerns from some experts that it could hinder enrollment in clinical trials, while the timing and circumstances of the FDA’s move fueled suspicions that political pressure – rather than science and data alone – may have played a role.

Kronos Bio raises $155M in private financing to advance lead leukemia drug into registration study next year

venture capital,money,business,Investor

The company has raised $148 million so far and plans to raise the remaining $7 million by next month. Its lead candidate is entospletinib, a SYK inhibitor acquired as part of a deal with Gilead Sciences last month, under development for patients with biomarker-defined acute myeloid leukemia.

Trump launches baseless attack on FDA; agency controversially authorizes plasma treatment for Covid-19

Over the weekend, Trump called the agency, without evidence, part of a “deep state” that was slow-walking vaccines and drugs for Covid-19. The next day, the agency authorized convalescent plasma despite having turned it down shortly before due to insufficient evidence.

Astellas’ Audentes Therapeutics discloses third patient death in gene therapy trial

dna, genomics

The clinical trial had already been placed on hold in connection with the two prior patient deaths, which were linked to the higher dose of 300 trillion viral vectors per kilogram, while no deaths have been reported among those receiving the lower dose of 100 trillion vectors.

UK Cancer Diagnostics Startup Biofidelity Raises $12M

UK Cancer Diagnostics Startup Biofidelity Raises $12M

What You Should Know:

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

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


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

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

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

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

Recent Traction

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

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

Report: FDA halted move to authorize convalescent plasma for Covid-19 over evidence concerns

The New York Times reported that the FDA was prepared to issue an emergency use authorization for the treatment last week, but NIH Director Francis Collins and NIAID Director Anthony Fauci intervened, arguing that data were too weak.

J&J to buy Momenta Pharmaceuticals for $6.5B

The drugmaker emphasized the full global rights it would acquire to Momenta’s lead asset, nipocalimab, which it is developing for several autoantibody-driven diseases and that in certain indications could have peak sales of more than $1 billion.

FDA rejects BioMarin’s hemophilia A gene therapy in ‘massive surprise’

In a CRL issued for valoctocogene roxaparvovec, the FDA told BioMarin that differences between its Phase I/II and Phase III studies limited the ability to rely on the earlier trial to support durability of effect, which an analyst said likely referred to a product comparability issue.

FDA issues surprise rejection of Gilead, Galapagos rheumatoid arthritis drug

While there had been some risks to filgotinib’s approval cited before, analysts expressed surprise at the decision, with one writing it would likely delay approval by at least a year. Shares of both companies fell sharply on the news.

Gilead invests another $145M into expanded oncology pact with Tango Therapeutics

The update to the partnership includes opt-in rights for Gilead on 15 drug targets, up from five under the original 2018 deal. Gilead will pay $125 million upfront and make a $20 million equity investment in Tango, which focuses on synthetic lethality.

Gilead got a boost from a newly approved PrEP drug. Now, a major insurer is dropping coverage

UnitedHealthcare sent a notice to plan members stating that it would no longer cover Descovy to prevent HIV, while Truvada – after it goes generic next month – will be covered for free. Gilead reported that Descovy for PrEP had offset a second-quarter fall in product sales.

Reify Health Raises $30M to Fix The Broken Clinical Trial Ecosystem

Reify Health Raises $30M to Fix The Broken Clinical Trial Ecosystem

What You Should Know:

– Reify Health, a clinical trial software provider
that digitizes and accelerates clinical trials is announcing a $30 million
series B funding round to support the company’s ambitious mission to fix the
broken clinical trial ecosystem.  

– The company’s platform, StudyTeam systematically
eliminates redundant work across the clinical trial process while generating
novel insights that speed up trials.

StudyTeam harmonizes biopharma and research site
workflows, introducing a new paradigm for clinical research that brings
therapies to patients sooner.


Reify Health, a
Boston, MA-based provider of leading cloud-based solutions that connect and
empower the clinical trial ecosystem, today announced a $30 million Series B funding
round led by Battery Ventures with
participation from previous investors including Sierra Ventures and Asset Management Ventures. The funding will
drive the continued expansion of Reify’s StudyTeam enrollment solution and
accelerate additional platform solutions.

Solutions to Accelerate Clinical Trial Enrollment

Founded in 2012, Reify Health works with an impressive
client roster including half of the top-20 biopharmaceutical companies,
including Eli Lilly and Amgen and has developed its platform, StudyTeam,
to upgrade the systems that healthcare staff at clinical research sites depend
on to run trials. By bringing them onto a shared platform with biopharma
sponsors, Reify has helped the industry dramatically
accelerate clinical trial enrollment and reduce workloads for
stakeholders across the ecosystem.

“The life science industry spends over four billion dollars
every year on technologies aimed at making clinical trials more efficient,”
said Ralph Passarella, CEO and co-founder, Reify Health. “Yet, very
little of that investment goes towards technology that helps the frontline
healthcare staff who enroll and care for patients. If we want to make clinical
trials faster, cheaper, and more predictable, the industry can’t keep building
technology that increases efficiency for some but decreases efficiency
for those working directly with patients. We decided that we needed to change
that.”

StudyTeam systematically eliminates redundant work across
the clinical trial process while generating novel insights that speed up
trials. For example, staff at research sites spend hours each week manually
copying information about patient recruitment and enrollment from their own
systems into sponsor logs so that sponsors have the insights they need to
manage and optimize enrollment.

With StudyTeam, this hours-long task takes just a few
minutes, enabling site staff to spend more time with patients. At the same
time, sponsors gain better insights for making real-time enrollment decisions.
As a result, StudyTeam accelerates enrollment, on average, by 6 weeks per
trial. When 80 percent of trials fail to recruit enough patients on time, this
improvement can be seismic.

Patient Recruitment and Enrollment

Reify’s StudyTeam platform is used by 1,800 research sites across 26
countries
and by half of the top-20 global biopharma companies, including
Eli Lilly and Company and Amgen. The platform has been so effective in
improving enrollment dynamics between research sites and sponsors that several
top-20 biopharma companies are in the process of implementing the product
across their global research portfolios.

“The COVID pandemic has shed light at a global scale how much clinical trial speed matters. While the world sits and waits for COVID-19 vaccines and treatments, we should also remember that patients suffering from numerous conditions such as Alzheimer’s and late stage breast cancer have been waiting on clinical trials for years,” said Michael Lin, co-founder and executive chairman, Reify Health. “At Reify we’ve made it our job to build solutions that streamline work for both research sites and biopharma sponsors so that patients get access to therapies sooner. Doing so has required us to overhaul how we think about solution categories, software business models, and the relationships across the entire clinical trial ecosystem.”

Trials of Gilead’s remdesivir in Covid-19 not diverse enough, experts write

In a commentary, physicians and pharmacists wrote that percentages of Black, Latino and Native American patients in two Phase III studies of the drug that the company is using for FDA approval were disproportionate to Covid-19’s incidence in those communities.

Reify raises $30M in Series B round for clinical trial cloud computing system

The company’s software system is designed to streamline the work done by staff at clinical trial sites, such as manually copying information about patient recruitment and enrollment.

Moderna secures more than $1.5B federal government deal to provide Covid-19 vaccine

The agreement, which includes 100 million doses of mRNA-1273 and an option to acquire 400 million more, brings the total amount of money the biotech company has received from the federal government for its vaccine efforts to nearly $2.5 billion.

Report: Russia says its Covid-19 vaccine ready for market despite no Phase III data

Russian President Vladimir Putin said a vaccine developed at a Moscow research institute that appears to still be in Phase I development among fewer than 100 participants had undergone all necessary tests.

Why MedCity News should be your go-to advertising partner

MedCity News has the most engaged healthcare business audience in the industry. We can collaborate with you to develop customized content or provide a platform for your business to present sponsored thought leadership content highlighting from executives in healthcare and life sciences.

Big Pharma plays CMO as Pfizer signs on to produce Covid-19 drug remdesivir for Gilead

Gilead Sciences had said in its second-quarter earnings that it would partner with companies in North America, Europe and Asia to manufacture the antiviral drug, which received an emergency use authorization from the FDA in May.

Biogen to get speedy FDA review for Alzheimer’s drug despite not using voucher to request it

Dementia or brain damage and injury as a mental health and neurology medical symbol with a thinking human organ made of crumpled paper torn in pieces as a creative concept for alzheimer disease.

Biogen and Eisai said the FDA had accepted and given priority review to their application for aducanumab. The drug will undergo an advisory committee meeting at an undisclosed date. Biogen’s stock rose 10%, but analysts had mixed opinions.

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

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

What You Should Know:

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

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

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


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

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

Accelerating Development of Messenger RNA Medicines to Prevent
and Fight Diseases

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

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

AWS/Moderna Integration Benefits

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

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

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

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

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

GSK nabs FDA approval for first-in-class multiple myeloma drug

Blenrep, an antibody-drug conjugate, is the first drug approved for multiple myeloma that targets the antigen BCMA. Several other companies are also developing BCMA-targeting therapies for the blood cancer, including CAR-T cells and bispecific antibodies.

Novartis plans to seek approval for CAR-T in slow-growing lymphoma after Phase II success

The company said the study of Kymriah in follicular lymphoma met its primary endpoint, though it did not disclose the trial data. It plans to submit approval applications to the FDA and EMA next year.

J&J in $1B supply pact with federal government for one-shot Covid-19 vaccine

Under the agreement with BARDA and the Department of Defense, the drugmaker would supply 100 million doses of its vaccine, for which it published preclinical data last and is currently running a first-in-human clinical trial.

Platform study designed to rapidly screen potential Covid-19 drugs enrolls first patients

Three of the companies making drugs used in the Phase II I-SPY COVID-19 study – Amgen, AbbVie and Takeda – announced the patient enrollments Monday. The study, which will enroll up to 1,500 critically ill patients, could test around 10 drugs.

INVEST Pitch Perfect winner spotlight: Pleiogenix eyes road ahead for liver disease drug

The company is hoping to close its seed funding round in the next six months and aims to be in a position to seek regulatory approval for its lead asset, PLX888, in acute alcoholic hepatitis in 2023.

FDA approves MorphoSys, Incyte’s drug for vulnerable lymphoma population

The FDA approved Monjuvi for second-line diffuse large B-cell lymphoma. Though the drug has the same antigen target as approved CAR-T cell therapies, it is designed for patients unable to tolerate such intensive treatments.

Pfizer, BioNTech score deal to supply 120M Covid-19 vaccine doses to Japan

Financial terms of the deal were not disclosed, but it follows a $1.95 billion contract between the two companies and the U.S. government. Assuming clinical trial success and regulatory approval, they would supply the vaccines in early 2021, ahead of the rescheduled Tokyo Olympics.

Sanofi, GSK nab $2.1B deal from federal government to provide Covid-19 vaccine

The companies will provide 100 million doses of their jointly developed vaccine. But with a Phase I/II study planned in September, it is behind in development compared with those of Moderna and Pfizer and BioNTech, which have already started late-stage clinical testing.

Alexion drops kidney disease program for drug that was part of $930M Achillion buyout last year

The company said in its 2Q earnings that it would halt development of ALXN2040 for C3 glomerulopathy, or C3G, citing the drug’s lack of potency. However, it may develop a second, more potent drug from the Achillion acquisition, ALXN2050, in the same disease.

BMS, bluebird refile FDA approval application for CAR-T therapy in myeloma

The companies’ resubmission of their application Wednesday seeking approval for idecabtagene vicleucel was in line with the timeline they provided in May, when the FDA sent a refuse-to-file letter in response to their initial submission.

Who won the MedCity INVEST Pitch Perfect competition?

Question mark heap on table concept for confusion,

Healthcare startups across health services, health IT, medical devices, biopharma and diagnostics tracks took part in the week-long competition at the conference July 20-24. Here are the winners for the five tracks.

AstraZeneca, Daiichi Sankyo sign $6B deal for antibody-drug conjugate

The companies will share development and commercialization of DS-1062 in solid tumors. They already have a similar deal in place, the $6.9 billion agreement signed last year for another ADC, the HER2-positive breast cancer drug Enhertu.

Moderna snags another $472M from BARDA, launches Phase III Covid-19 vaccine trial

The company had received $483 million from BARDA in April to fund the development of the vaccine, mRNA-1273, through Phase III, but that amount was based on a smaller anticipated number of participants than the 30,000 it now plans to enroll into the trial, named COVE.

Prescient Announces Recent Appointments to the Senior Advisory Team

Prescient hires two new senior members to support its fast-growing Advisory business

LONDON, July 20, 2020—Prescient, a biopharma product and portfolio strategy firm, announces the recent appointment of two new senior members, Peter Donachie and Dr. Haroon Khan, to its Advisory business. They join our specialist team focused on helping clients develop and commercialize assets and brands that resonate in the market and differentiate from the competition.

Peter joins as a Director in our London office supporting both the Advisory and Intelligence & Insight business units. After earning a degree in life sciences, he gained a first-class Master’s degree in business at Edinburgh Napier University and a postgraduate qualification in health economics at Aberdeen University. He brings experience in drug development and commercialization from his CRO and biopharmaceutical leadership roles at Charles River Laboratories, Kyowa Kirin and Ablynx NV. Peter’s advisory expertise includes commercial launch strategy, R&D portfolio and project management, pricing and market access, competitive strategy and opportunity assessment across various therapeutic areas.

Haroon joins as an Associate Director in our London office. He holds a doctorate in biochemical engineering from University College London, where he also gives guest lectures on the financial assessment and valuation of biotech start-ups. He brings experience in supporting value creation within global pharma and healthcare deals from his time in PwC’s M&A Advisory practice. He joined PwC from PharmaVentures, a corporate advisory firm focused on the life sciences sector, where he worked on a wide range of transactions covering different disease areas and product types. Haroon’s advisory expertise includes corporate strategy synthesis, product valuation and business development.

“As we continue to expand our presence and bring the best of product strategy advisory to biopharma clients, we are delighted to welcome Peter and Haroon to our rapidly growing team,” said Dr. Debasish Talukdar, Vice President and Head of Prescient Advisory. “Their combination of scientific expertise with commercial savviness and biopharma experience with core consultancy skills makes them an invaluable asset to the Advisory team as we bring expertise, experience and evidence together to partner with our clients to co-create winning strategies.”

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