Regulatory learnings for the next wave of cellular immuno-oncology agents
Cell & Gene Therapy Insights 2022; 8(6), 663–670
Published: 25 June 2022
Dr Pietrusko currently serves as Chief Regulatory and Quality Officer at Vor Biopharma in Cambridge, MA and leads the Regulatory strategy for engineered hematopoietic stem cell therapy for hematologic malignancies including AML. He has directed the worldwide approval of more than 30 new products in multiple therapeutic areas. As an early team member at Voyager Therapeutics, Dr Pietrusko pioneered regulatory strategies to translate gene therapies from research into the clinic. Prior to Voyager, he was Vice President of Global Regulatory Affairs & Quality and Executive Officer at ViroPharma, Inc. He also served as Senior Vice President of Regulatory Affairs at Millennium Pharmaceuticals, spearheading the accelerated approval of Velcade® in the US and in more than 90 countries worldwide. Earlier in his career, he was Vice President of Regulatory Affairs at SmithKline Beecham (now GSK). He has played a key role in shaping US regulatory policy for cutting edge medicines, such as recently pioneering the concept of an expedited pathway to approval for cell and gene therapies that led to the Regenerative Medicine Advanced Therapy (RMAT) designation process that was included in the United States 21st Century Cures Act. He currently serves as Chair of the Regulatory Affairs Committee of the Alliance for Regenerative Medicine (ARM) and is an appointed member of the Regulatory Affairs Committee of the American Society of Gene and Cell Therapies (ASGCT). Dr Pietrusko holds a Bachelor of Science degree in biology, a Bachelor of Pharmacy degree from Rutgers University, and a Doctor of Pharmacy degree from the Philadelphia College of Pharmacy and Science. He completed his residency training in hospital pharmacy at Thomas Jefferson University Hospital and is the author or co-author of over 50 scientific publications.