Although he initially thought he would go to medical school to become a cardiovascular surgeon, James became interested in the pharmaceutical industry while working on a master’s degree in healthcare law and policy. “I was very interested in product development, clinical research, and the usability of products for patients. Part of the program focused on challenges and opportunities within the healthcare industry from developing products to ensuring treatments are available to the patients in need.”
Now as the Head of Global Regulatory Affairs for Combination Products, Devices, and Emerging Technologies at AbbVie, James oversees a department that has grown from five people to 25 people in six years. That department is working to bring products from development into commercialization and then sustain those products in the commercial space for years to come. “Years ago, you had stand-alone devices and stand-alone medicinal products, but now with the growth of precision medicine and the next generation of medicine, the industry has to become more focused on advanced technologies for medicinal delivery which are user-centric.”
“The biopharmaceutical industry continues to increase its focus on precision medicine; to match the right medicine to the right patient at the right time. In addition, there will be a focus on developing products that are more user-centric to deliver medicines to address areas of unmet medical needs. One of the challenges we need to focus on is development of a range of user-centric delivery systems to ensure we address the user requirements from the pediatric population to the adult population.”
James is also an Adjunct Assistant Professor at University of Southern California School of Pharmacy –Regulatory and Quality Sciences, an international speaker, chair for various symposia, council member of the Drug Information Association (DIA)’s Americas Regional Advisory Council (RAC), a moderator for various global regulatory panel discussions, and an active member of ISPE.
“I am honored to be the Chair for the Combination Products Community of Practice (CoP). We are currently working on providing feedback pertaining to the US Food and Drug Administration draft guidance for essential drug delivery outputs (EDDO) pertaining to devices, platform technologies, and use-related risk analysis (URRA) for drug- and biologic-led combination products. New draft guidance has come out in the past few months, and we are working within the industry cross-functionally to identify areas for clarification.”
“ISPE leadership understands the global regulatory landscape within the industry and has given our CoP the ability to collaborate with other CoPs such as the ATMP [advanced therapy medicinal product] CoP to present on a cross-functional panel at the ISPE Annual Meeting & Expo where we explored innovative medical device concepts and products to address unmet medical needs.”
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