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Stephen F Amato


Stephen F Amato

Northeastern University, USA

Biography

Stephen F Amato has over 25 years of experience in the pharmaceutical, biotechnology and medical device industries. He is the Program Director of the Biomedical Regulatory Affairs Program in the Professional Advancement Network (PAN) at Northeastern University. Steve has also been the Managing Director of tJun 17 Life Sciences, LLC, an organization that facilitates the global commercialization of early stage medical technologies. Prior to founding and directing operations at Jun17 Life Sciences, Steve was the Executive Director of Marketing at Anika Therapeutics where he served as the Head of Anika's Marketing Department. In this role he
managed all aspects of the company's product portfolio including market segmentation, targeting, and 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 $140 M 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 in Molecular and Cellular Biology from Boston College’s Graduate School of Arts & Sciences, and an MBA from the Carroll School of Graduate Management at Boston College. He has also received the US Regulatory Affairs Certification (RAC) designation and is a Consultant for the Regulatory Affairs Professional Society (RAPS).

Abstract

Abstract : Convergence of regulatory affairs and reimbursement/market Access