The FDA is undergoing a major transformation in its drug approval processes, regulatory oversight and transparency initiatives. This webinar explores the implications of these reforms and what they mean for innovation, compliance and strategy in the biopharma industry.
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From Commissioner’s National Priority Vouchers to a push to move away from animal studies to new guidances for oncology and vaccine approvals, the FDA is making considerable changes to its drug approval pathways and standards. The agency is also adjusting how it conducts its regulatory oversight, including promising to make complete response letters available in real time and report adverse events daily, launching a series of expert panels while considering pulling back from advisory committees and, importantly, implementing an AI tool called Elsa to help its staffers conduct their work. Through it all, Health Secretary Robert F. Kennedy Jr. has emphasized the department’s goals of “radical transparency” and a return to “gold-standard science.”
Watch this webinar as we dive into what this all means for biopharma companies working to bring innovative treatments to market.
Featured Guests
Evan is consistently recognized as a top research analyst and leading voice on the sector. Among his achievements, he hosted the first obesity and metabolic disease focused investor conference in 2024. In 2021, he was named a Rising Star of Equity Research by Business Insider. He is regularly a guest on CNBC’s Fast Money, Squawk Box, and Power Lunch; Yahoo Finance and Canada’s BNN Bloomberg. He is also frequently quoted in The Wall Street Journal, The Financial Times, The New York Times, and industry trade publications. Evan holds a BBA in Finance and Accounting and BA in Spanish, both from the University of Michigan.
Mr. Grossman co-founded and later served as Executive Director of the Alliance for a Stronger FDA. This multi-stakeholder coalition has helped grow the FDA’s appropriated budget from $1.6 billion to $3.5 billion. Mr. Grossman’s advocacy is rooted in public service, having spent six years as counsel and Health Staff Director on the Senate HELP Committee and four years as a Deputy Assistant Secretary for Health at HHS. While working in the Senate, he was one of the chief Senate negotiators on the Orphan Drug Act (ODA) and the Drug Price Competition and Patent Term Restoration Act (known as Hatch-Waxman). In recognition of his advocacy and policy leadership, he has been honored by the Reagan-Udall Foundation for the FDA with its Innovations in Regulatory Science Award.
