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BY KAREN TKACH TUZMAN, ASSOCIATE EDITOR | MAR 25, 2020 | 7:24 PM EDT
BIO’s virtual summit on biotech’s response to the COVID-19 pandemic generated a wish list of resources to support development of therapeutics, vaccines and diagnostics, with appeals to both government agencies and industry peers.
The online meeting, which took place Tuesday and Wednesday, gathered representatives from 45 member companies developing products to take on COVID-19. Leading the discussion were Biotechnology Innovation Organization President and CEO Jim Greenwood and George Scangos, president and CEO of Vir Biotechnology Inc. (NASDAQ:VIR).
Also participating were White House Coronavirus Task Force Response Coordinator Deborah Birx, HHS Assistant Secretary for Preparedness and Response Robert Kadlec and other government officials including representatives from FDA.
In a briefing after the meeting, Greenwood said the summit’s COVID-19 therapeutics task force called for adaptive clinical trial designs and study plans that accounted for variations in treatment standards. The vaccines and diagnostics task forces pointed to their needs for scaled up manufacturing capacity and FDA guidelines on point-of-care tests, respectively.
Scangos said companies are constrained by limited access to key reagents, such as recombinant SARS-Cov-2 spike protein, and to biosafety level 3 (BSL-3) facilities. On the manufacturing front, he said companies are in the unprecedented situation of having to commit to scaling up capabilities before knowing they have a viable product, all while facing constraints on cash flow.
Government can fill some of these gaps, said Phyllis Arthur, BIO’s VP of infectious diseases & diagnostics policy. She said the summit highlighted government funding opportunities for both early- and late-stage product development, as well as ongoing discussions about HHS investing in fill and finish capabilities and making those resources available to industry.
Last week, HHS launched a public-private partnership, Rapid Aseptic Packaging of Injectable Drugs (RAPID), to enable the Strategic National Stockpile to quickly fill and finish “hundreds of millions of prefilled syringes” for rapid response to widespread health emergencies such as COVID-19 (see “Jefferies Joins RAPID Push”).
Scangos said the meeting included discussions on reagent sharing among companies, and that BIO has set up a website to connect companies that have relevant resources to those that need them.
The three task forces will continue to meet and issue reports on their progress, Greenwood said.
Further analysis of the coronavirus crisis can be found at https://www.biocentury.com/coronavirus.