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FDA Roundtable: Demystify the FDA for Biologics Development



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May 11, 2022 ‐ 4:00 pm
End Date/Time-NEW
Location - People View
Room 2170

2716 South Street
Philadelphia, PA 19146
United States

A major hurdle to bringing novel medical products and devices developed in CHOP’s research laboratories to the bedside is the FDA approval process. Let’s demystify the FDA, from preclinical trials through full FDA approval and commercialization.

We aim to jumpstart and centralize efforts among CHOP faculty and staff who struggle with the FDA approval process, focusing on novel drugs and biologics, followed by networking and connecting with colleagues.

Moderator: Dr. Chip Smith, Technical Director of the Comparative Medicine Services Core

Dr. Stephen Grupp, Director of Translational Research in the Center for Childhood Cancer Research
Ms. Sarah McCague, Clinical Research Program Manager in the Clinical In Vivo Gene Therapy Team

Our panelists played vital roles in CHOP’s efforts to achieve FDA approval of two groundbreaking biologic therapeutics, Kymriah and Luxturna. Kymriah is the first FDA-approved CAR-T therapy, and Luxturna is the first FDA-approved in vivo gene therapy.

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