For years, Sara worked in a hospital, making care possible for others. Now, after being diagnosed with breast cancer, she was the one in need of care.
David is a member of the Regulatory Consulting Services (RCS) team within Parexel and advises and consults as a Biologics and Advanced Therapy Quality Subject Matter Expert (SME) on all aspects of CMC drug development and regulatory affairs for the EU market. He guides and advises clients on the preparation of CMC drug development strategies, submission of CTA, MAA and variations as well as on interactions with regulatory authorities.
Prior to joining the RCS team in December 2019, David was a CMC/Quality assessor at the Spanish Medicines Agency (AEMPS) for 4 years. He was involved in the assessment of national CTAs, VHPs, MAA and variations for biological products and advanced therapy products for the European market. David had also a key role in CMC assessment of scientific advices for EMA as well as for the Spanish Medicines Agency. During his work at the Spanish Medicines Agency, David was an active participant as CMC assessor in the CHMP Biologicals Working Party (BWP) at EMA. In addition he was appointed as TSE expert by the EDQM to assess the TSE risk of biological products, as well as CMC expert by the WHO for the Pre-Qualification Pilot Program for biosimilar products.
Prior to joining the Spanish Medicines Agency, David worked at Regeneron Pharmaceuticals as Senior Staff Scientist for over 4 years, leading a virology group involved in the identification and validation of cellular and viral targets susceptible of antibody therapeutic intervention. Prior to Regeneron, he developed an extensive research experience for 8 years in biochemistry, immunology, virology and infectious diseases as a postdoctoral fellow at Rockefeller University (New York), authorizing 18 scientific articles in peer-reviewed international journals.
David earned a degree in Biological Sciences (B.Sc. Biology) from University of Seville (Spain) and a Ph.D. (Molecular Biology) from the Autonomous University of Madrid (Spain).