Teresa Pepper

BioMarin U.K. Ltd.

Dr. Teresa Pepper is currently Head of EMEA CMC Regulatory Affairs at BioMarin (UK) Ltd based in London. She previously held the same roles at MSD Ltd (Merck Inc) and Amgen UK Ltd. Prior to working at Amgen, she was a senior biotechnology assessor at the MHRA and represented UK on the Biotechnology Working Party and Vaccine Expert Group and Joint Committee on Vaccines and Immunisation (JCVI). She originally trained as a pharmacist at UCL London and has a PhD in Vaccine Development (defense vaccines) from Aston University funded by the UK Ministry of Defense/DEFRA and an MBA from Aston Business School.

Dr. Pepper specialized in the development of nanosphere co-encapsulated Yersinia pestis sub-unit vaccines and analysis of local and systemic immunological responses after oral, intra-nasal and intra-muscular administration. Since leaving academia, she has worked as a regulatory professional predominantly supporting the registration and assessment of new global marketing authorization applications for monoclonal antibodies, bispecific antibodies, recombinant protein products, vaccines and gene therapy medicinal products. Her current interests include exploring strategies to take CMC out of the critical path for development of innovative products licensed through accelerated pathways and the implementation of ICH Q12 Life Cycle Management