Meet Keith Wonnacott, PhD: ASGCT Volunteer Rockstar
February 24, 2023
In a February 2023 installment of our series highlighting ASGCT member volunteers, meet Keith Wonnacott, PhD, chair of the Society's Regulatory Affairs Committee Committee.
ASGCT is a volunteer-led organization, and it could not effectively pursue its mission and strategic vision without the commitment of its volunteers. The Society does so through 32 standing, scientific, and board committees supported by more than 400 member volunteers. We recognize our committee leaders for their time, commitment, and expertise, and appreciate their willingness to help ASGCT advance the field of gene and cell therapy in a unique and meaningful way.
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Keith Wonnacott, PhD, Regulatory Affairs Committee
Dr. Wonnacott has spent his entire career as a regulatory professional in the field of advanced therapies with extensive experience in both government and industry. He is currently the Vice President of Regulatory Affairs at Lexeo Therapeutics, a clinical stage gene therapy company focused on treating cardiovascular and CNS diseases. Previously, Dr. Wonnacott worked at Pfizer where he led regulatory efforts to aid the development of their divers AAV-based gene therapy portfolio. He also spent three years with Novartis Pharmaceuticals where he led the team responsible for developing the CMC module for the Kymriah (tisagenlecleucel) BLA, which became the first ever FDA approved gene therapy product in 2017. Prior to working in industry, Dr. Wonnacott was Chief of the Cellular Therapies Branch at the Center for Biologics Evaluation and Research (CBER). His branch was responsible for the CMC review of all cellular therapy products.
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Dr. Wonnacott leads the Regulatory Affairs Committee to educate members on the worldwide regulatory environment and to interact directly with the FDA regarding ASGCT initiatives. Dr. Wonnacott leads the committee in developing programming for the FDA Liaison Meeting, Policy Summit, and Annual Meeting, and undertakes other projects to address important policy issues.
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ASGCT thanks Dr. Wonnacott for his service on ASGCT’s standing committee. Our members serve as subject matter experts for Society-led projects, including Annual Meeting programming, through both our standing committees and scientific committees, and we could not do the work we do without them.
For questions on ASGCT committees or volunteer process, please contact Dani Gale (dgale@asgct.org).
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