Snehal Naik
Vice President, Science and Regulatory,
BIO
Snehal brings 18 years of pharmaceutical industry and biotech experience across regulatory strategy and policy, cross-functional project leadership, research, and new venture incubation, and has held roles at Pfizer, Johnson and Johnson and Spark Therapeutics. With her keen interest in influencing regulatory policy and shaping the evolving framework for cell and gene therapies, Snehal previously co-chaired the Regenerative Medicine Committee at BIO and was appointed past chair of the Regulatory Affairs Committee of the American Society of Gene & Cell Therapy, along with prior participation in the Bespoke Gene Therapy Consortium, Alliance for Regenerative Medicine, Innovative Medicines Initiative and Regenerative Medicine Forum of the National Academies of Sciences, Engineering and Medicine. Her current portfolio at BIO includes priority areas in cell and gene therapy, increasing efficiency of early drug development and Phase 1 testing in the US, and topics in preclinical development. She has experience establishing policy and regulatory intelligence as a function, supporting development of new modalities and serving as a global regulatory lead, including for a marketed gene therapy for a rare disease. Snehal graduated summa cum laude with an AB-MA in Biology from Bryn Mawr College and holds a Ph.D. in Molecular Genetics and Genomics from Washington University in St. Louis.
Sessions
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20-Jan-2027Mezzanine LevelRoundtable Discussions
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21-Jan-2027Theatre 4Session 8: Accelerated approval pathways: Do the benefits really outweigh the costs?