Stephen F. Amato, PhD

PhD (Molecular and Cellular Biology), Boston College
MBA, Carroll School of Management, Boston College
Regulatory Affairs Certification (RAC), USA and European Union – Regulatory Affairs Professional Society

Stephen Amato

Stephen F. Amato is an Associate Teaching Professor in the Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices program. His research interests include global regulation of biomedical product commercialization, global reimbursement for biomedical products, and drivers of success for biomedical product commercialization. Dr. Amato’s research has been published in the Journal of Immunology and Cancer Research. He co-edited and wrote several chapters for the book, Regulatory Affairs for Biomaterials and Medical Devices, published by Elsevier Publishing in 2015.

Dr. Amato is also a senior lecturer at Boston College and serves on the board of directors for several organizations, including BioSignostix, the Medical Development Group, and the Association of Graduate Regulatory Educators. He holds Regulatory Affairs Certification for both the United States and European Union from the Regulatory Affairs Professional Society. He has presented on regulatory affairs topics in the U.S, European Union, China, and India.

Dr. Amato worked for 20 years in the bioscience industry and regulatory affairs for leading companies. His professional practice has culminated in a boutique consulting practice where he specializes in the development and evaluation of market access strategy, intellectual property valuation, technology transfer, commercialization strategy, and support for global life sciences clients. He is working on a textbook on regulatory affairs and is learning Mandarin.

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