Recording of a Learn and Connect event sponsored by Children's Hospital of Philadelphia Research Institute's Innovation Ecosystem
The FDA approval process can be a significant and necessary hurdle to bringing novel medical products and devices developed in research laboratories to patients in our hospitals.
This FDA Roundtable aimed to jumpstart and centralize efforts among CHOP faculty and staff who must navigate the FDA approval process. This session focused on novel drugs and biologics, and provided time at the end to network and connect with colleagues.
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.
This Event took place on May 11, 2022 at the Children’s Hospital of Philadelphia.
Dr. Chip Smith, DVM, MS Technical Director of the Comparative Medicine Services Core
Dr. Stephan Grupp, PhD, MD, Director of Translational Research in the Center for Childhood Cancer Research
Sarah McCague, MS, Clinical Research Program Manager Clinical In-Vivo Gene Therapy Team
Each presenter’s video and the Q&A session are listed below:
Kymriah with Dr. Stephan Grupp
Luxturna with Sarah McCague, MS
Q&A With Dr. Chip Smith, Dr. Stephan Grupp and Sarah McCague, MS
Gooneratne, N. (2019). Overview of Drug Development. In Academic Entrepreneurship for Medical and Health Sciences. https://doi.org/10.21428/b2e239dc.84c3ee98
Srivastava, G., & Winslow, A. (2019). Orphan Drugs: Understanding the FDA Approval Process. In Academic Entrepreneurship for Medical and Health Sciences. https://doi.org/10.21428/b2e239dc.381f7d37
Park, S. E., & Schaer, T. P. (2019). Preclinical Animal Models. In Academic Entrepreneurship for Medical and Health Sciences. https://doi.org/10.21428/b2e239dc.034dc5a5