Voyager Therapeutics Appoints Industry Veteran Robert G. Pietrusko, Pharm.D., to Senior Vice President of Regulatory Affairs
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Voyager Therapeutics, a gene therapy company developing life-changing treatments for fatal and debilitating diseases of the central nervous system (CNS), today announced that industry veteran Robert G. Pietrusko, Pharm.D., has joined the company’s management team as Senior Vice President of Regulatory Affairs.
“Bob brings unparalleled expertise across the full spectrum of successful drug development and has deep experience in influencing regulatory policy and drug review across multiple divisions of the FDA. He is an important hire for Voyager and will be critical to our commitment of bringing novel gene therapies to patients.”
Dr. Pietrusko brings to Voyager more than three decades of experience in regulatory affairs and pharmaceutical drug development across a range of categories, including CNS disorders, and has been instrumental in the worldwide approval of more than 30 medicines or new indications. As Senior Vice President of Regulatory Affairs, he will oversee all strategy and interactions with regulatory agencies worldwide, including the U.S. Food and Drug Administration (FDA), and foster relationships with patient advocacy groups and the biotech industry.
“Since the launch of Voyager earlier this year, we have made significant progress in assembling an exceptional management team comprised of high-caliber leaders with a proven track record of CNS drug development,” said Mark Levin, Interim Chief Executive Officer of Voyager and Partner at Third Rock Ventures. “Bob brings unparalleled expertise across the full spectrum of successful drug development and has deep experience in influencing regulatory policy and drug review across multiple divisions of the FDA. He is an important hire for Voyager and will be critical to our commitment of bringing novel gene therapies to patients.”
Prior to Voyager, Dr. Pietrusko was Vice President, Global Regulatory Affairs and Quality and Executive Officer at ViroPharma Incorporated, a biopharmaceutical company developing treatments for rare diseases, until the acquisition of the company by Shire plc in January 2014. While at ViroPharma, he oversaw all regulatory activities and quality assurance. Dr. Pietrusko also played a key role in the company’s acquisition of Lev Pharmaceuticals, Inc. and its orphan disease product Cinryze™, a plasma-derived product for the treatment and prevention of hereditary angioedema. Prior to ViroPharma, Dr. Pietrusko was Senior Vice President of Worldwide Regulatory Affairs at Millennium Pharmaceuticals, where he led the company’s regulatory affairs function and strategy. He was instrumental in the approval of Millennium’s products, including the accelerated approval and worldwide regulatory strategy for Velcade®, a product approved in more than 90 countries worldwide. Before Millennium, he spent 19 years at GlaxoSmithKline in positions of increasing responsibility, and served as Vice President and Director, Anti-infective and Antiviral Therapeutic Areas, U.S. Regulatory Affairs. During his tenure at GlaxoSmithKline, he was instrumental in numerous product approvals, including Havrix®, Augmentin® and Infanrix®. In addition, Dr. Pietrusko has directed the submission of more than 30 NDAs, sNDAs and BLAs to the FDA including CNS products, plasma-derived products, antibiotics, anti-virals, vaccines, oncologics, cardiovascular products, pulmonary products and anti-inflammatory compounds. Dr. Pietrusko is the author or co-author of 52 scientific publications. He holds a Bachelor of Science degree in biology and a Bachelor of Pharmacy degree from Rutgers University, and a Doctor of Pharmacy degree from the Philadelphia College of Pharmacy and Science.
“I am driven by my personal passion to help patients suffering from diseases for which there are no cures or truly effective therapies, a challenge and mission that I share with the outstanding team leading the advancement of Voyager’s gene therapy programs,” said Dr. Pietrusko. “Armed with a first-of-its-kind scientific approach based on AAV gene therapy and an accomplished team of founders, scientists and management, Voyager is well-positioned to be the leader in CNS gene therapy. I am enthusiastic about the future of gene therapy as a field, and look forward to collaborating with regulatory authorities to realize the true potential that Voyager’s innovative science holds to make a dramatic difference in the lives of patients suffering from debilitating neurological diseases.”
About Voyager Therapeutics
Voyager Therapeutics is a gene therapy company developing life-changing treatments for fatal and debilitating diseases of the central nervous system (CNS). Voyager is committed to advancing the field of AAV (adeno-associated virus) gene therapy through innovation and investment in vector optimization and engineering, dosing techniques, as well as process development and production. The company’s initial pipeline is focused on CNS diseases in dire need of effective new therapies, including Parkinson’s disease, a monogenic form of amyotrophic lateral sclerosis (ALS), and Friedreich’s ataxia. Founded by scientific and clinical leaders in the fields of AAV gene therapy, expressed RNA interference and neuroscience, Voyager Therapeutics was launched in 2014 with funding from leading life sciences investor Third Rock Ventures and is headquartered in Cambridge, Mass. For more information, please visit www.voyagertherapeutics.com.