NIH Ties Up with Top Pharma Companies for COVID-19 Drug Discovery

April 20, 2020 - The National Institutes of Health (NIH) and Foundation for the NIH recently announced it is joining forces with more than a dozen biopharmaceutical companies to boost COVID-19 drug discovery.  

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“This powerful public-private partnership will focus and expedite R&D activities required to combat COVID-19,” says Maria C. Freire, PhD, president and executive director of the Foundation for the NIH. “Working in lock-step, the public and private sectors will maximize the chances of success and provide a roadmap to pre-emptively manage future threats.”

The collaboration called the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) also includes government organizations such as Health and Human Services (HHS), CDC, FDA, and the European Medicines Agency.

Pharmaceutical companies signed up to join forces with NIH include AbbVie, Amgen, AstraZeneca, Bristol Myers Squibb, Evotec, GSK, Johnson & Johnson, KSQ Therapeutics, Eli Lilly and Company, Merck & Co, Novartis, Pfizer, Roche, Sanofi, Takeda, and Vir Biotechnology. 

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Together, the organizations plan to develop a successful framework for prioritizing vaccine and drug candidates, advancing clinical trials, coordinating regulatory processes, and leveraging assets among all partners to quickly respond to the COVID-19 and future pandemics. 

"We need to bring the full power of the biomedical research enterprise to bear on this crisis,” said Francis S. Collins, MD, PhD, director of NIH. “Now is the time to come together with unassailable objectivity to swiftly advance the development of the most promising vaccine and therapeutic candidates that can help end the COVID-19 global pandemic.”

Coordinated by the Foundation for the NIH, the extensive partnership is part of the “whole-of-government, whole-of-America” response the Trump administration has led to tackle COVID-19. ACTIV will provide infrastructure, subject matter expertise and funding, and prioritize and facilitate the entry of some of the most promising COVID-19 candidates into clinical trials, the announcement stated. 

Industry partners will also prioritize certain compounds and associated data to support the research for COVID-19. Leaders from NIH, FDA, and research and development organizations of the companies are helping to further develop the partnership.

“COVID-19 is the most significant global health challenge of our lifetime, and it will take all of us working together as a global community to put an end to this pandemic,” said Paul Stoffels, MD, vice chairman of the executive committee and chief scientific officer, Johnson & Johnson. 

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“We will need to harness the best ideas from multiple stakeholders, including governments, regulatory authorities, academia, NGOs and industry to stop COVID-19. At Johnson & Johnson, we are committed to working closely with FNIH, IMI and are part of other important consortia to speed solutions to stop this pandemic.”

Researchers continue to sift through over 100 potential preventives and  for COVID-19. ACTIV will provide guidance for prioritizing the vaccine and therapeutic candidates in development and advance clinical trials to uncover a treatment efficiently. 

“Using the most advanced clinical trial methods to rapidly test multiple interventions will help get the answers we need as soon as possible to expedite potential prevention and treatment approaches to fight COVID-19,” said FDA Commissioner Stephen M. Hahn, MD “Collaboration is a critical ingredient for success and the FDA will continue to use every tool possible under our Coronavirus Treatment Acceleration Program to speed the development of safe and effective medical countermeasures.”

The collaboration will have four focus areas, the announcement highlighted. Each area will be led by senior scientists representing the government, pharmaceutical industry, and academia. 

The first area will standardize and openly share a preclinical evaluation method that allows for comparison and validation. The collaborative will do this by establishing a central process and repository for sharing methods and evaluating models. It will also extend access to screening facilities to test all compounds that have been in human clinical trials to identify promising COVID-19 treatments.

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The area will also increase access to validated animal models and boost comparison of approaches to identify informative assays, the announcement stated. 

The second area will prioritize and accelerate clinical evaluation of therapeutic candidates with near-term potential. Experts will establish a steering committee with expertise to set criteria for and rank potential candidates, develop an inventory of candidates with different mechanisms and safety profiles, and design, launch, and open sharing master protocols with endpoints. They will also use a single arm control. 

To maximize clinical trial capacity and effectiveness, the third area will bring together existing networks of clinical trials by leveraging infrastructure and expertise from across NIH networks, and establish a mechanism across networks to expedite trials.

Finally, area four will advance drug and vaccine development as the COVID-19 outbreak worsens. Experts will create a framework to share insights into natural immunity and vaccine candidate-induced immune response by:

• Mapping epitopes and developing assays
• Establishing protocols for sampling and immunological analyses and reagents
• Collecting clinical data on immunological responses and endpoints, to enable meta-analysis of correlates of protection 
• Engaging with regulators on surrogate endpoints for clinical evaluation

“Battling the COVID-19 pandemic is far too great a challenge for any one company or institution to solve alone,” said Mikael Dolsten, MD, PhD, chief scientific officer and president, Worldwide Research, Development and Medical, Pfizer. “We are seeing an unprecedented level of collaboration across the innovation ecosystem to address this global health crisis, and this potentially powerful NIH initiative may allow us to further accelerate the delivery of much needed therapies to patients around the world.”