The National Institutes of Health and the Foundation for the NIH (FNIH) are 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 to develop an international strategy for a coordinated research response to the COVID-19 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. 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.
ACTIV will have four fast-track focus areas:
- Standardize and share preclinical evaluation methods in an open forum that allows for comparison and validation by:
- Prioritize and accelerate clinical evaluation of therapeutic candidates with near-term potential by:
- Maximize clinical trial capacity and effectiveness by:
- 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.”