Individualized therapies: CBER director discusses challenges, regulatory approach
The FDA’s Center for Biologics Evaluation and Research (CBER) is looking for ways to facilitate the development of more products intended to treat individual or small groups of patients, including cell and gene therapies, antisense oligonucleotides and phage therapies.
At a workshop at the FDA’s headquarters in Silver Spring, MD on Tuesday, CBER Director Peter Marks addressed some of the barriers to developing individualized therapies such as “customized products” with a single indication and a mode of action that are tailored to individual patients, or “created products” that could target different indications via different modes of action.
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