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Aligning With the FDA on a Regulatory Pathway To Avoid Decision Day Surprises
During the past seven months, biopharma companies have had to contend with unprecedented change within the upper echelons of the FDA. Among other challenges, executives at small and medium companies have reported communication issues, misaligned expectations and media leaks while attempting to get their products across the regulatory finish line.
Notably, many of these investigational therapies have targeted rare diseases affecting primarily children—products that FDA Commissioner Marty Makary and Center for Biologics and Research Director Vinay Prasad have vowed to expedite to the market.
At the same time, the FDA has outlined its commitment to aligning with drug sponsors on the regulatory approval process, with Makary and Prasad stating in a JAMA article published in June that they intend to provide “the regulatory navigation that [small] companies may lack internally.”
It’s clear that both the FDA and biopharma companies developing medicines for rare diseases want the same thing but there remains a disconnect. This panel discussion will look at how to leverage FDA frameworks, define expectations and adopt modern technologies, including AI and in silico models, to increase the likelihood of success.
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