Cartier Esham, EVP of Emerging Companies at BIO spoke with FDA Commissioner Dr. Stephen M. Hahn to discuss collaboration and COVID-19 response efforts.
“There is an extraordinary amount of collaboration, scientific endeavors, and work happening in the medical research community with patient organizations, doctors, clinicians, government, biopharmaceutical companies, all resulting in over 500 unique compounds under development working to bring forward vaccines and treatments for COVID,” said Esham to start the discussion.
And Dr. Hahn agrees: “There’s no question. This is unprecedented. I know we use that term a lot but what’s been remarkable about this is the speed with which this pandemic came upon us and the significant number of unknowns, but how remarkable the response has been from the biopharma community in collaboration with regulators and the FDA."
"It shows what we can do and really is a roadmap for some of the things we can do together moving forward in a non-COVID environment," he continued.
On the development of therapeutics, Dr. Hahn touches on the FDA’s expedited approval process and efforts to prioritize science-based solutions with a “rolling” approach.
“We engaged early with developers and manufacturers, and did a serial process of exchange of information so that when the final application came in, there had been already a lot of input [allowing us to] easily, readily, and quickly look at that application and make decisions.”
To meet the demands of a pandemic like COVID-19, public-private partnerships are important.
“It’s been truly an all-of-America approach,” said Dr. Hahn.
“There has been incredible alignment, collaboration, and cooperation among...the private sector. This is usually a very competitive environment but what I’ve seen is a really significant lean-in of industry to work together in sharing information."
Post-COVID clinical development will be “very different.”
We should consider domestic manufacturing for medical products, said Dr. Hahn. To do that, “we must understand what the supply chain looks like, and we can only do that by working hand-in-glove with industry.”
Dr. Hahn also calls attention to the effect COVID-19 has on existing clinical trials. “We can do all the regulatory flexibility we want in the middle or backend, but if we can’t get the clinical trials done because we don’t have the flexibility around how those visits occur, we’re not going to be able to move things forward.”
The takeaway: trust the expertise and approach the FDA has used in the past.
There is an enormous amount of pressure to operate in this new territory, bringing many changes and developed process. Dr. Hahn emphasized the FDA “will continue to prioritize data and science.”
– Cassie McKay and Andrew Segerman