Stephen F. Amato, PhD, MBA, RAC (US/EU)
Dr. Amato has more than 25 years of professional experience in the fields of global regulatory affairs, reimbursement coverage, coding and payment, and quality assurance in the specialty pharmaceutical, biotechnology, clinical diagnostics and medical device industries. A Senior Faculty Member and Faculty Director at Northeastern University, he has worked directly for and with a diverse array of life science product manufacturers and CRO’s including Siemens Healthcare, Smith & Nephew, Myriad Genetics, Boehringer Ingelheim, Takeda, Cardinal Health, IQVIA, Parexel & McKesson. During his tenure as Managing Director of tJun17 Life Sciences, LLC, Dr. Amato has also served as a Managing Director with Cardinal Health Regulatory Sciences, and a Senior Consultant with GfK Global, a global market access and reimbursement consultancy. Prior to tJun17 Life Sciences, Dr. Amato was an Executive Director at Anika Therapeutics where he managed all commercialization aspects of the product portfolio including clinical development, global regulation, marketing, reimbursement/market access and quality assurance. From 2000 to 2007 he was the Global Group Director of Knee Repair at Smith & Nephew Endoscopy where he managed $175M orthopedic, $15M women’s health and $10M general surgery/vascular diagnostic and surgical product portfolios. Earlier in his career, he worked in Toronto, Canada for Visible Genetics/Siemens Healthcare, where he developed and commercialized DNA sequencing and clinical genotyping testing kits for infectious disease and oncology applications, including HPV subtyping and HIV retroviral drug resistance testing. Dr. Amato has also worked with Critical Therapeutics on the development and commercialization of treatments for critical care medicine, including infectious diseases and gram negative sepsis.
Dr. Amato holds an AB in Biochemical Sciences from Harvard College, a Ph.D. in Molecular and Cellular Biology from Boston College’s Graduate School of Arts & Sciences, and an MBA in Marketing from the Carroll School of Graduate Management at Boston College. He has also received the US and European Union Regulatory Affairs Certification (RAC) designations, and is a Consultant for the Regulatory Affairs Professional Society (RAPS). For additional information on Dr. Amato’s professional experience or for a copy of his curriculum vitae he can be reached at email@example.com.