The National Institutes of Health (NIH) is taking an “all hands on deck” approach to fighting COVID-19. The Foundation for the NIH (FNIH)—a branch of the NIH that creates and manages alliances with public and private institutions in support of the mission of the NIH—is developing an international strategy for a coordinated research response to the COVID-19 pandemic.
To do this, the organization is bringing together more than a dozen leading biopharmaceutical companies, the Health and Human Services Office of the Assistant Secretary for Preparedness and Response, the Centers for Disease Control and Prevention, the U.S. Food and Drug Administration, and the European Medicines Agency.
“We need to bring the full power of the biomedical research enterprise to bear on this crisis,” said NIH director Francis S. Collins, MD, PhD. “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.”
The planned Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) partnership will develop a collaborative framework for prioritizing vaccine and drug candidates, streamlining clinical trials, coordinating regulatory processes, and/or leveraging assets among all partners to rapidly respond to the COVID-19 and future pandemics.
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.
The industry partners that will join in the endeavor are AbbVie, Amgen, AstraZeneca, Bristol Myers Squibb, Evotec, GlaxoSmithKline, Johnson & Johnson, KSQ Therapeutics, Eli Lilly and Company, Merck & Co., Novartis, Pfizer, Roche, Sanofi, Takeda, and Vir Biotechnology. These industry partners 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 research community is currently striving to sift through more than 100 potential preventives and therapeutics for COVID-19. ACTIV will aim to provide guidance that 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.
“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 CSO, 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.”
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, and advance vaccine development.
“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, CSO 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.”
“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.”
“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, 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.”