A Champion Departs: Peter Marks’ Resignation and Biotech’s Crossroads

When Dr. Peter Marks walked out of the FDA’s headquarters for the last time this week, it sent a tremor through the U.S. biotech community. Marks – a name that rarely graced headlines outside scientific circles – had quietly become a linchpin in America’s biomedical innovation engine. For nine years he led the FDA’s Center for Biologics Evaluation and Research (CBER), shepherding the approval of 22 gene therapies and other cutting-edge treatments. His sudden resignation, tendered “with a heavy heart” and under protest of what he called an assault on scientific truth, has left scientists, investors, and policymakers alike asking: What now?

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