FDA’s plan to move away from animal toxicity testing could expedite INDs and cut costs for biopharma companies, while helping the U.S. maintain its position as a clinical research hub. On the latest BioCentury This Week podcast, BioCentury’s editors discuss the agency’s new three-year road map to reduce animal safety studies for mAbs. The editors then discuss the deepening morale crisis at FDA after HHS Secretary Robert F. Kennedy Jr. accused the agency of corruption, encouraged staff to report supervisors over approval decisions they oppose, and endorsed conspiracy theories about the “deep state.” They assess the impact of whipsawing tariff policies and turmoil at FDA on biotech indexes — and why the sky isn’t falling just yet for biotech’s specialist investors. The editors also highlight recent stories on base editors’ efficiency boom and how exosomes are finding new life. This episode of BioCentury This Week podcast was sponsored by RemeGen.

View full story: https://www.biocentury.com/article/655622

00:01 - Sponsor Message: RemeGen Co.
02:38 - Replacing Animal Models
09:40 - RFK Jr. & FDA
19:36 - NIH
30:02 - BioPharma Market Pulse
33:23 - Innovation Highlights

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