Managing Partner and Toxicology Consultant
at
D&B ChemTox, LLC
Doug obtained his BS and MS in Biology from St. John’s University, Jamaica, NY in 1977 and 1980, respectively and became board certified in general toxicology (DABT) in 2003. Doug is a full member of the American College of Toxicology (ACT), Society of Toxicology (SOT) and has served as President, VP and Secretary/Treasurer for the Northeast Chapter of SOT (NESOT). Doug was employed as a toxicologist at Sandoz (now Novartis) and Boehringer Ingelheim. Doug has assumed various project and regulatory strategy roles and is currently a Research Fellow in Regulatory Strategy and Compliance at Pfizer. Doug has been the Nonclinical Drug Safety Team Lead for 5 drug product approvals, the most recent being Xeljanz (tofacitinib citrate) for the treatment of rheumatoid arthritis.
A recognized expert in the evaluation and qualification of E&L in drug products. He co-chaired a PQRI L&E work group and co-authored the PQRI Best Practices Recommendations for Evaluation of L&E in Orally Inhaled and Nasal Drug Products (OINDP, 2006). Doug serves as a co-chair for the PQRI work team for L&E evaluation in parenteral and ophthalmic drug products (PODP), the Co-Topic Lead for the International Conference on Harmonisation (ICH) Expert Working Group (EWG) and Implementation. Working Group (IWG) for Elemental Impurities (Q3D), an Expert Panel member for USP <381> Elastomeric Closures for Injection and Biocompatibility <87> and <88>, and is past Chair and current Board member of ELSIE.