FDA Leadership Change Raises Concerns Among Biopharma Industry Over Future Collaboration

The recent removal of Peter Marks from his position at the U.S. Food and Drug Administration (FDA) has sparked concern within the biopharmaceutical industry, which had viewed him as a key ally. Marks, who led the FDA’s Center for Biologics Evaluation and Research (CBER), played a significant role in regulatory oversight for biologics, including vaccines and gene therapies. His departure has prompted questions about how the industry will navigate its relationship with the Trump administration moving forward.

Marks was widely regarded as a collaborative figure by many in the biopharma sector, known for fostering dialogue between regulators and companies developing innovative treatments. His leadership at CBER was seen as instrumental in advancing regulatory frameworks that supported innovation while maintaining safety standards. Industry stakeholders are now closely watching to see how this leadership change might impact ongoing projects and future engagements with the FDA under new direction.

Date: March, 2025

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Author

Mark Chiang

紐約 NYU Computer Science 碩士 紐澤西 UMDNJ Biomedical Informatics 博士 中研院博士後 台灣大學博士後