National Institutes of Health (NIH) Director Francis Collins co-wrote an article in the Journal of the American Medical Association (JAMA) that a swift, coordinated effort across many sectors of society is necessary to respond to the COVID-19 pandemic.
The article – co-written by Collins and Johnson & Johnson Chief Scientific Officer Paul Stoffels, — outlines the innovative efforts of Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV), a public-private initiative organized by NIH.
ACTIV’s partners, which include biopharmaceutical companies, U.S. federal agencies, and the European Medicines Agency, are developing an international strategy for an integrated research response to COVID-19. Drs. Collins and Stoffels said never has a public-private biomedical research effort of this scope come together so quickly.
In the article, they wrote about how ACTIV has established a collaborative framework to prioritize therapeutic and vaccine candidates, streamlined human clinical trials, and coordinated regulatory processes.
They said ACTIV’s industry partners have taken unprecedented steps to support the prioritization of therapeutic and vaccine candidates. Further, they have indicated a willingness to contribute their respective clinical trial capacities, irrespective of the agent to be studied.
ACTIV has established four working groups, each with a co-chair from NIH and industry. The four working groups are:
• The Preclinical Working Group, which is charged with standardizing and sharing preclinical evaluation resources and methods, and with accelerating testing of candidate therapies and vaccines to support entry into clinical trials;
• The Therapeutics Clinical Working Group, which prioritizes and accelerates clinical evaluation of a long list of therapeutic candidates for COVID-19 with near-term potential;
• The Clinical Trial Capacity Working Group, which is charged with assembling and coordinating existing networks of clinical trials to increase efficiency and build capacity to test potential therapies and vaccines for COVID-19; and
• The Vaccines Working Group, which works to accelerate the evaluation of vaccine candidates to enable rapid authorization or approval.