Dr. Thomas Felix is a Medical Director, R&D Policy in Amgen’s Global Regulatory Affairs and Safety organization. He has interests in advancing patient-focused policy in the areas of patient preference inclusion in drug development, risk management and drug traceability.
He has been at Amgen since 2006 and 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, multidisciplinary team committed to advancing science, policy and manufacturer accountability for a successful, patient-focused biosimilar 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 2016, he will serve as the Vice-Chair to AMIA’s Industry Advisory Council (IAC). He will also serve as Amgen’s representative on the Academy of Managed Care Pharmacy’s Biologics & Biosimilars Collective Intelligence Consortium (AMCP BBCIC) Planning Committee. He has numerous publications in the field of pharmacovigilance. Most notable is a comprehensive review of PV considerations for biosimilars in the United States, published in Biodrugs.