The US National Institutes of Health (NIH) on Friday introduced a new public-private partnership, which brings together more than a dozen biopharmaceutical companies and various government bodies, including the FDA and European Medicines Agency, to speed up a response to the COVID-19 pandemic. According to the NIH, the planned Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) partnership will work on building a framework to prioritise vaccine and drug candidates, streamline clinical testing, coordinate regulatory processes and leverage the use of assets among all partners in a bid "to rapidly respond to the COVID-19 and future pandemics."
"We will need to harness the best ideas from multiple stakeholders, including governments, regulatory authorities, academia, [non-governmental organisations] and industry to stop COVID-19," commented Paul Stoffels, chief scientific officer at Johnson & Johnson, one of the drugmakers taking part in the scheme. Other industry participants include AbbVie, Amgen, AstraZeneca, Bristol Myers Squibb, Eli Lilly, Evotec, GlaxoSmithKline, KSQ Therapeutics, Merck & Co., Novartis, Pfizer, Roche, Sanofi, Takeda and Vir Biotechnology.
The NIH said the research community is currently sifting through more than 100 potential preventives and therapeutics for COVID-19, and ACTIV will aim to "provide guidance [on] which can be used to prioritise the plethora of vaccine and therapeutic candidates in development and connect clinical trial networks to test new and repurposed candidates quickly and efficiently."
Specifically, ACTIV will have four fast-track focus areas with a dedicated working group consisting of senior scientists representing government, industry and academia. These include a group that will focus on speeding up clinical evaluation of therapeutic candidates "with near-term potential," in part by setting up an inventory of possible candidates with different mechanisms of action and acceptable safety profiles, and using single control arms to enhance trial efficiency.
For vaccine development, ACTIV will work on a framework to share insights into natural immunity and induced immune responses, in part by mapping epitopes and developing assays, collecting clinical data on immunological responses and endpoints, and talking to regulators about the use of surrogate endpoints. In addition, ACTIV will have groups focussed on standardising and sharing preclinical evaluation methods, as well as on how to maximise clinical testing capacity and effectiveness, with help from various existing NIH trial networks such as those for adjuvant development, HIV, acute lung injury and immunology.
Mikael Dolsten, chief scientific officer at Pfizer, remarked "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."
For related analysis, read ViewPoints: COVID-19 vaccines in focus, and listen to our latest podcast from FirstWord executive editors Simon King and Michael Flanagan, which includes a discussion of further potential treatment options and the politicisation of different approaches in the absence of meaningful data from controlled clinical studies.
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