The National Institutes of Health (“NIH”) and the Foundation for the NIH recently announced a public-private partnership, named the Accelerating COVID-19 Therapeutic Interventions and Vaccines (“ACTIV”) partnership. The ACTIV partnership consists of a number of entities, including the NIH, the Department of Health and Human Services (“HHS”), the Centers for Disease Control and Prevention (“CDC”), the US Food and Drug Administration (“FDA”), and the European Medicines Agency (“EMA”) together with 16 biopharmaceutical companies, and is intended to develop and implement an international strategy for a coordinated research response to the pandemic.
The ACTIV partnership will focus on the following areas:
Standardize and share preclinical evaluation methods in an open forum that allows for comparison and validation: The activities here include establishing a centralized process for harmonizing and sharing methods, and evaluating models. There will also be a centralized repository for these methods and models. In addition, the partners will extend access to high-throughput screening facilities to test potential COVID-19 treatments, and increase access to validated animal models.
Prioritize and accelerate clinical evaluation of therapeutic candidates with near-term potential: The partnership will establish a steering committee to develop criteria for ranking potential therapeutic candidates for priority evaluation, and create an inventory of potential candidates with different mechanisms of action and acceptable safety profiles. They will also design, launch and share protocols with agreed upon sampling, endpoints and analysis for evaluation of therapeutic candidates.
Maximize clinical trial capacity and effectiveness: The partners here will connect existing networks of clinical trials to build capacity, with a particular focus on different populations and disease stages, leverage infrastructure from multiple NIH networks, as well as establish a coordination mechanism across the networks to expedite trials.
Advance vaccine development: This area will involve creating a collaborative framework to share insights into natural immunity and candidate-induced immune response by mapping epitopes and developing assays, establishing protocols for sampling and analysis, collecting clinical data on immunological responses and endpoints, and engaging with regulators to identify appropriate surrogate endpoints.
NIH Directors, Dr. Francis Collins commented on the ACTIV partnership, noting that “[w]e need to bring the full power of biomedical research enterprise to bear on this crisis. 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.”
Dr. Paul Stoffels, Vice Chairman of the Executive Committee and Chief Scientific Office at Johnson & Johnson, also struck a hopeful tone, saying “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. We will need to harness the best ideas from multiple stakeholders … to stop COVID-19 … we are committed to working closely with … consortia to speed solutions to stop this pandemic.”