Dr. Norwood is a Distinguished Research Fellow in Analytical Development for Boehringer Ingelheim Pharmaceuticals, Inc., and has held senior industry positions at Magellan Laboratories and the Glaxo Research Institute. He chaired the PQRI working group on Leachables and Extractables in Orally Inhaled and Nasal Drug Products, and is currently a member of the PQRI working group for Parenteral and Ophthalmic Drug Products.

Bill received his B.S. in Biology from Mount Saint Mary’s University, and his Ph.D. in Toxicology from the University of Maryland. After completing post-doctoral work at the University of Connecticut Toxicology Program, he joined Pfizer’s Drug Safety Research and Development department in Groton, Connecticut. Bill is a Diplomate of the American Board of Toxicology. In his 24 years of experience in the pharmaceutical industry, Bill has been involved in a wide range of toxicology issues associated with impurities in drugs, including the development of strategies to risk assess extractables and leachables.

Dr. Dennis Jenke is a Baxter Distinguished Scientist in the Technology Resources Division of the Baxter Healthcare Corporation. In this role, he works with a team of analytical chemistry professionals whose primary responsibility includes the development, validation and application of diverse analytical strategies and methods for the discovery, identification and quantification of trace constituents in pharmaceutically relevant solutions and samples.

Ms. Paskiet has over twenty years of experience in polymer analysis relating to product failures, deformualtion and migration studies. She has served as a project advisor in support of qualification studies associated with container closure systems for IND and NDA filings. Her current responsibilities include coordination of studies for technical support and innovations as well as providing a forum for education of those technologies. She is serving a five year term on the USP Packaging, Storage and Distribution Expert Committee and Chair of the PQRI PODP Leachables and Extractables Working Group. She has authored national and international papers on the subject of leachables and extractables and is a faculty member of the PDA Training Institute as well as a frequent speaker and organizer of conferences.

Doug has been at Pfizer since 2000 as a Research Fellow in Drug Safety Evaluation and serves as both Drug Safety and Regulatory Strategy Leads for candidates in early and late stages of drug development. He is a recognised expert in the evaluation of leachables and extractables (L&E) in drug products and co-chaired a Product Quality Research Institute (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 (2006) He currently serves as a co-chair for the PQRI work team for L&E evaluation in parenteral and ophthalmic drug products and is chairman of the Extractables and Leachables Safety Information Exchange (ELSIE).