Dr. Thomas Felix is a Medical Director, R&D Policy in Amgen’s Global Regulatory Affairs and Safety organization. He has been at Amgen since 2006 and is currently based in Washington, DC, USA.
Dr. Felix serves in a technical policy role in the United States and in Amgen’s Intercontinental region that includes Canada, Latin America, Turkey, Middle East and Africa. He has experience working in medical affairs on both small molecule and biologic therapeutics. The scientific differences between these medicines serve as the underpinning for the establishment of separate standards and regulatory approval pathways. Dr. Felix contributes to a cross-functional, global multidisciplinary team committed to advancing science, policy and manufacturer accountability for a successful, patient-focused biosimilar implementation. Dr. Felix has met with regulatory authorities around the world to share scientific considerations for biologic and biosimilar application review and post-approval implementation. Dr. Felix also works to advance pharmacovigilance (PV) systems to more accurately identify adverse events and associated manufacturers in a timely manner. He partners with pharmacovigilance experts and electronic health information stakeholders to evolve adverse event traceability capabilities for multisource biologics in various treatment settings and regions. Dr. Felix also serves as a subject matter expert, informing U.S. state governments on necessary legislative provisions to allow for science-based substitution of biosimilars in the retail pharmacy setting. He represents Amgen as a corporate member to the following organizations: American Medical Informatics Association (AMIA), National Patient Safety Foundation (NPSF), and the Pharmacy HIT Collaborative. In 2017, he will serve a second year as the Vice-Chair to AMIA’s Industry Advisory Council (IAC) and as a member of AMIA’s Public Policy Committee. He also serves as Amgen’s representative on the Academy of Managed Care Pharmacy’s Biologics & Biosimilars Collective Intelligence Consortium (AMCP BBCIC) Planning Committee. He also has interests in advancing patient-focused policy in the areas of patient preference inclusion in drug development, risk management and drug traceability.
Dr. Felix earned his medical degree at the PSG Institute of Medical Sciences and Research (India). Prior to Amgen, Dr. Felix was Vice President of Medical Affairs at an NBC Universal health media company (Healthology, Inc., New York, NY, USA), an organization dedicated to the development of physician-led educational programs on disease management across therapeutic areas.