As the COVID-19 pandemic surpasses one million cases in the United States, Research!America brought together experts to discuss the R&D landscape for vaccines and treatments. The webinar was moderated by Research!America board member, former FDA Commissioner Dr. Mark McClellan, Director of the Duke-Margolis Health Policy Center and featured Dr. Stefano Bertuzzi, CEO of the American Society for Microbiology, and former CDC Director Dr. Julie Gerberding, Executive Vice President and Chief Patient Officer, Strategic Communications, Global Public Policy and Population Health at Merck.
Dr. McClellan noted that FDA staff are taking on new challenges as collaboratively and with as much communication as possible right now in executing their important role in the development of safe and effective new therapeutics and diagnostics. Kicking off the discussion, Dr. Gerberding explained why it takes time to demonstrate vaccines are effective and safe and that large scale manufacturing is challenging. She emphasized, “there are no shortcuts to vaccine development.” She is hopeful antiviral therapies will prove effective for COVID-19, enabling patients to avoid entering intensive care or dying of the disease.
Dr. McClellan then turned to Dr. Bertuzzi who explained clinical trial work on COVID-19 has moved so far, so quickly because of the powerful body of science we are standing on. Basic research is essential and now more than ever we need to continue science funding. Dr. Bertuzzi said, Dr. McClellan then turned to Dr. Bertuzzi who explained clinical trial work on COVID-19 has moved so far, so quickly because of the powerful body of science we are standing on. Basic research is essential and now more than ever we need to continue science funding. Dr. Bertuzzi said, “the fact that we were able to develop, so fast, therapeutics repurposed to develop vaccines and all that is because we're building on all that body of research that has happened over time.”
Dr. Gerberding thanked Research!America and all of the alliance members who have continuously pushed for robust science funding. McClellan also noted the importance of research advocacy in this critical time, saying, “If anybody had any doubts about the value of research, basic research, translational research, clinical research to take these products through more efficient testing, where they really work in people, and then applied research, including in manufacturing and even in related issues like real-world evidence and ways to improve the distribution of medical products, If anybody had doubts about the value of those investments, it's really clear here.”
Dr. Bertuzzi then spoke about the current therapies being tested, such as Emory Institute for Drug Development compound 2801 (EIDD-2801), which he explained is a promising orally administered drug candidate. He shared that ASM.org has generated a valuable registry on its website to ensure rapid acceleration and synergy of ideas. Dr. Bertuzzi also emphasized the value of serology testing and stressed the importance that these tests be FDA approved and/or generated in a CLIA laboratory.
As the panel closed, both speakers expressed that we are far from returning to our normal lives. Gerberding stated that, at this time, “[she does not] see that a positive antibody test right now tells anyone that they're safe.” She further explained that scaling up viral and serology testing is crucial but also a great challenge. Both panelists were hopeful that breakthroughs in therapeutics and widespread testing will allow us to safely begin to reopen the United States. Bertuzzi ended the meeting on a positive note by saying there are, “several new things that are being tested out, like stem cells for example … I think there is a very composite landscape that gives us a lot of hope.”