Speaking on behalf of the Product Quality Research Institute (PQRI), Dr. Feinberg's presentation will include an overview of how the PQRI is organized; the results of OINDP hypothesis testing; application to PODP and the PODP hypotheses; chemistry,toxicology and PODP Laboratory Work; and the process for building sound scientific justifications and consensus.
Catalent's Development & Clinical Services support the rapid product development of pharmaceutical and biopharmaceutical products. In addition to an extensive range of analytical services the company offers regulatory consulting, clinical supply services and biologics cell line development. Catalent has made substantial recent investments to extend the capabilities and capacity of the business. Catalent today provides the broadest range of expert development services, which can drive more efficient development timelines, and help customers bring more compounds and better products to market faster.
Dr. Feinberg has over 15 yearspharmaceutical analysis experience and over 25 years experience in mass spectrometry and spectroscopy.
Dr. Feinberg joined Magellan Labs at Research Triangle Park, North Carolina in 1995 and guided the growth of the Structural Chemistry department through both the Cardinal Health acquisition and the launch of Catalent Pharma Solutions.
In 2001, Dr. Feinberg was invited to join the PQRI OINDP Extractables and Leachables working group. He co-authored the recommendation “Safety Thresholds and Best Practices for Leachables and Extractables in Orally Inhaled and Nasal Drug Products (OINDPs)” and two chapters of Wiley's definitive: “Leachables and Extractables Handbook: Safety Evaluation, Qualification, and Best Practices Applied to Inhalation Drug Products”.
Dr. Feinberg has been an active member of the Leachables and Extractables Parenteral Ophthalmic Drug Product (PODP) working group from its inception in 2008. He has written and presented extensively on extractables and leachables issues and advanced analytical chemistry techniques.
The E&L USA Conference starts on Wednesday, May 16th and continues the next day. There is a pre-conference workshop with an “Introduction to Extractables and Leachables Testing” on Tuesday, May 15th. Dr Feinberg's presentation will take place at 11.10 Tremont Plaza Hotel and Grand Historic Venue in Baltimore. For more information on this event, please visit here. To schedule an interview with Dr. Feinberg during or after the conference, please contact Patricia McGee.
To receive a copy of this presentation after the event, please visit us here.