Peter Marks, the FDA's director of the Center for Biologics Evaluation and Research (CBER), recently resigned, prompting significant industry concern. Marks, who advocated for the advancement of vaccines and therapies for diseases, had led CBER since 2016 during a transformative period for cell and gene therapies. His exit may hinder the regulatory guidance essential for developing new biologic medicines. While his tenure featured regulatory flexibility, which resulted in controversial approvals, Marks was also a prominent figure in Operation Warp Speed, staunchly defending vaccines against skepticism in his farewell.
The loss of Peter Marks could impact guidance for novel biologic medicines, particularly amid emerging therapies like cell and gene treatments.
Marks's leadership was marked by regulatory flexibility, allowing the FDA to approve treatments with limited data, recently drawing both praise and criticism.
In his resignation, Marks defended vaccines against skepticism, underlining his belief in the importance of scientific truth and transparency.
The FDA's exploration of new therapeutic modalities under Marks was crucial for fostering innovations in the treatment landscape for rare diseases.
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