About Us

Stephen F. Amato, PhD, MBA, RAC is the Principal Advisor and Chief Strategist of tJûn17 Life Sciences Advisors, providing senior-level regulatory, product development, commercialization, and litigation support to companies, investors, attorneys, and other stakeholders across the life sciences industry.

Dr. Amato brings more than 25 years of experience in the pharmaceutical, biotechnology, medical device, and diagnostics industries. His expertise spans FDA regulatory strategy, product development and commercialization, clinical and regulatory pathways, reimbursement and market access, product positioning, and postmarket regulatory requirements.

He also provides FDA regulatory expert witness and litigation consulting services involving medical devices, pharmaceuticals, diagnostics, product liability, labeling and warnings, adverse-event reporting, clinical investigations, regulatory compliance, and other matters involving FDA-regulated products. His litigation work has included case assessment, regulatory analysis, expert reports, depositions, and trial testimony.

Prior to founding tJûn17 Life Sciences Advisors, Dr. Amato held senior industry leadership positions with Anika Therapeutics and Smith & Nephew, where his responsibilities included regulatory strategy, reimbursement, market segmentation, product positioning, pricing, and commercialization. Earlier in his career, he worked in molecular diagnostics and pharmaceutical development with Visible Genetics and Critical Therapeutics.

Dr. Amato formerly held academic leadership and teaching positions in graduate-level regulatory affairs education at multiple institutions, including Northeastern University, where his work included regulatory affairs, quality assurance, market access, product development, and the education and mentorship of regulatory professionals.

He holds an AB in Biochemical Sciences from Harvard University, a PhD in Molecular and Cellular Biology from Boston College, and an MBA from Boston College’s Carroll School of Management. He has earned Regulatory Affairs Certification (RAC) credentials in both the United States and European Union.

Through tJûn17 Life Sciences Advisors, Dr. Amato works directly with clients to provide practical, experienced guidance on complex regulatory and business challenges throughout the healthcare product lifecycle.