Jennifer Swisher

Jenni Swisher is a Review Chief in the Office of Biotechnology Products (OBP) in FDA/CDER. She joined OBP in 2006 as a researcher/reviewer in the Division of Monoclonal Antibodies, then joined the full-time review staff in OBP in 2016. In her current role, she oversees CMC assessment of therapeutic proteins, including both new molecular entities and biosimilars. As a team lead, her experience with highly potent, low-dose biologics led her to convene a working group to develop expectations for the assessment of compatibility studies to support first-in-human dosing for these products.