Organizing Committee Member

David P.Elder

David P.Elder





Dr. Elder has nearly 40 years of service within the pharmaceutical industry (Sterling, Syntex, and for the last two decades with GSK). He is now an independent CMC consultant and has broad-based experience in excipients, biopharmaceutics, drug products, and analytical method development. Dr. Elder obtained his Ph.D. in crystallography from the University of Edinburgh. Dr. Elder is a visiting professor at King’s College, London. He is a member of the British Pharmacopoeia. He is the immediate past chairman of JPAG (Joint Pharmaceutical Analysis Group). He is a member of the Editorial Advisory Board for the Journal of Pharmaceutical Sciences. He has published 114 and presented 17 webinars and 133 presentations. He has co-edited one book on the Analytical Characterization and Separation of Oligonucleotides and their Impurities (with George Okafor and Mike Webb) and is editing a second book on the ICH Quality Guidelines (with Andy Teasdale, AZ).

Research Area

Dr. Elder has a long-standing interest in impurities and degradation chemistry. He has played a leading role in the identification, analysis and control of mutagenic impurities. He has been part of EfPIA and PhRMA sub-groups on mutagenic impurities and the PQRA group that investigated the formation and control strategies for alkyl sulfonate impurities. He is interested in the role that excipients play in stabilizing/destabilizing molecules and the impact that changes in excipient material attributes can have on processability of drug products. He is interested in biopharmaceutics and its role in devising formulation strategies, as well as the more classical role that biopharmaceutics plays in biowaivers, bioavailability and bioequivalence studies. He is interested in clinically relevant specifications and whether dissolution tests (and related specifications) can ever really be robust enough to be used in a QC environment and sensitive enough to be truly predictive of clinical outcomes.