James Smith BA

James’ expertise spans various aspects of healthcare translation, including biomanufacturing, regulation, and basic science. James is a Research Associate of the CASMI Translational Stem Cell Consortium, where he is responsible for leading and conducting research into and review of various aspects of regenerative medicine commercialization. Prior to that, he received a research scholarship to Harvard University, where he investigated scale-up costs of a novel biologic, exosomes.

Before moving to the field of healthcare translation, he worked in the R&D department of an integrated supplier of micro-ingredients for animal feeds, AB Vista, where he gained extensive experience applying advanced statistical methods and their operational impact in a commercial setting.

James is a holder of the EU Regulatory Affairs Certification (RAC, EU), the only globally recognised certification for the regulatory profession. He is the lead author of several chapters in books published by the Regulatory Affairs Professionals Society, which is the largest global organization of and for those involved with the regulation of healthcare and related products. James has also contributed to publications in several high impact academic journals, management journals and bioprocessing trade magazines, on a range of topics from cell therapies to detection of falsified medicines.