Bob Pietrusko, PharmD has directed the worldwide approval of more than 30 new products. He also led the submission and approval strategies for more than 30 new drug applications (NDAs), supplemental NDAs, biologics license applications, and marketing authorization applications in multiple therapeutic areas. As an early team member at Voyager Therapeutics, Bob pioneered regulatory strategies to translate gene therapies from research into the clinic. Prior to Voyager, Bob 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 U.S. and in more than 90 countries worldwide. Earlier in his career, he was Vice President of Regulatory Affairs at SmithKline Beecham (now GlaxoSmithKline).
Bob has played a key role in shaping U.S. 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). Bob 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.