"We need to bring the full power of the biomedical research enterprise to bear on this crisis," said NIH Director Francis S. Collins, M.D., Ph.D. "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 FNIH, ACTIV government and industry partners will provide infrastructure, subject matter expertise and/or funding (both new and in-kind) to identify, prioritize and facilitate the entry of some of the most promising candidates into clinical trials. Industry partners also will make available certain prioritized compounds, some of which have already cleared various phases of development, and associated data to support research related to COVID-19. The partnership is being developed with input from a steering committee managed by the FNIH which includes leaders from NIH, FDA and the research and development organizations of the companies.
"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, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson. "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."
"Battling the COVID-19 pandemic is far too great a challenge for any one company or institution to solve alone," said Mikael Dolsten, M.D., Ph.D., 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."
The research community is currently striving to sift through more than 100 potential preventives and therapeutics for COVID-19. ACTIV will aim to provide guidance which can be used to prioritize the plethora of vaccine and therapeutic candidates in development and connect clinical trial networks to test new and repurposed candidates quickly and 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, M.D. "Collaboration is a critical ingredient for success and the FDA will continue to use every tool possible under our Coronavirus Treatment Acceleration Program(link is external) to speed the development of safe and effective medical countermeasures."
ACTIV will have four fast-track focus areas, each of which will be led by a highly motivated working group of senior scientists representing government, industry and academia:
- Standardize and share preclinical evaluation methods in an open forum that allows for comparison and validation
- Prioritize and accelerate clinical evaluation of therapeutic candidates with near-term potential
- Maximize clinical trial capacity and effectiveness
- Advance vaccine development
"This powerful public-private partnership will focus and expedite R&D activities required to combat COVID-19," says Maria C. Freire, Ph.D., President and Executive Director, FNIH. "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."
About the Foundation for the National Institutes of Health
The Foundation for the National Institutes of Health creates and manages alliances with public and private institutions in support of the mission of the NIH, the world’s premier medical research agency. The Foundation, also known as the FNIH, works with its partners to accelerate biomedical research and strategies against diseases and health concerns in the United States and across the globe. The FNIH organizes and administers research projects; supports education and training of new researchers; organizes educational events and symposia; and administers a series of funds supporting a wide range of health issues. Established by Congress in 1990, the FNIH is a not-for-profit 501(c)(3) charitable organization.
About the National Institutes of Health (NIH)
NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases.