Volunteer Rockstars

Meet Kristin Van Goor, PhD: ASGCT Volunteer Rockstar

Dr. Van Goor leads the Regulatory Affairs Committee - February 09, 2024

Dr. Van Goor is passionate about working closely with regulatory strategists and development teams to anticipate, mitigate, and overcome regulatory hurdles to the efficient development of transformative therapies.

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.

Kristin Van Goor, PhD is currently Executive Director, U.S. Head, Global Regulatory Policy and Innovation at Takeda. At Takeda, she leads the US Regulatory Policy Team with a focus on therapeutics for GI and inflammatory diseases. Prior to Takeda, Dr. Van Goor led US Regulatory Policy and Intelligence at Vertex Pharmaceuticals, focusing on a wide range of modalities from small molecules to cell therapy to in vivo and ex vivo editing technologies. She previously led Global Regulatory Policy at BioMarin and U.S. Regulatory Policy at Biogen. At Biogen, she served on the R&D Transformation Team, a special assignment to transform the R&D organization – from improving team health and effectiveness to increasing the probability of success of the early pipeline and optimizing external innovation integrations. After receiving a PhD in genetics from Yale University and doing a postdoc at the National Human Genome Research Institute at NIH, Dr. Van Goor led science and regulatory advocacy at PhRMA. During this time, she developed initiatives that resulted in significant changes to FDA’s policy regarding acceptance of novel biomarkers, use of real-world evidence in regulatory decisions, patient-focused drug development, creation of expedited programs, and benefit-risk assessment.

Dr. Van Goor is passionate about working closely with regulatory strategists and development teams to anticipate, mitigate, and overcome regulatory hurdles to the efficient development of transformative therapies. She believes in strength-based leadership and cultivating teams that thrive with shared purpose, meaningful work, and collaboration. Dr. Van Goor lives in Amherst NH. She spends her free time enjoying the outdoors, gardening, dancing, singing, and supporting the work of the Trevor Project.

Dr. Van Goor leads the Regulatory Affairs Committee to educate members on the worldwide regulatory environment and interact directly with the FDA and CMS regarding gene and cell therapy. The committee also provides Society representation to entities developing gene and cell therapy standards. Dr. Van Goor supports the development of new policy positions at ASGCT, and develops programming for the Policy Summit and FDA Liaison Meeting. Her committee is focused year-round on addressing regulatory hurdles to CGT development.

ASGCT thanks Dr. Van Goor for her service on ASGCT’s Regulatory Affairs 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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