Regulatory Affairs Considerations for Nano & Biomedical Commercialization

Dr. Stephen F. Amato has over 25 years of experience in the pharmaceutical, biotechnology and medical device industries. Prior to his position as Faculty Director of Graduate Regulatory Affairs and Life Sciences at Northeastern University, Steve was the Founder and Managing Director of tJun17 Life Sciences Advisors, LLC, and also a Managing Director for Cardinal Health Regulatory Sciences. Additionally, as an Executive with GfK Health, Dr. Amato managed and worked on client global regulatory affairs and reimbursement projects in the areas of market access, pricing, and payer coverage, coding and payment strategy. Prior to GfK Health, as an Executive Director at Anika Therapeutics, Steve managed all aspects of the company’s product portfolio including regulatory, reimbursement, market segmentation, targeting, positioning, pricing and promotional strategies. From 2000 to 2007, he was the Group Director of Knee Repair at Smith & Nephew Endoscopy where he managed a $140M orthopedic product portfolio. Earlier in his career, Steve worked for Visible Genetics, where he was responsible for developing and launching genomic molecular diagnostics products used for subtyping Human Papilloma Virus (HPV) and other infectious disease agents. \He has also worked with Critical Therapeutics on the development and commercialization of treatments for gram-negative sepsis.

Steve holds an AB in Biochemical Sciences from Harvard University, a Ph.D. in Molecular and Cellular Biology from Boston College’s Graduate School of Arts and Sciences, and an MBA from the Carroll School of Graduate Management at Boston College. He has also received the U.S. and EU Regulatory Affairs Certification designations and is a Consultant for the Regulatory Affairs Professional Society.