Drug Metabolism Related Safety Considerations in Drug Development Webinar

Presenter: Larry Wienkers, Ph.D., XenoTech Consultant

With the close of our 2019 Drug Metabolism Updates Seminar Series, Dr. Wienkers presented his primary keynote topic as a webinar for all of those who could not attend one of our seminar events.

Synopsis:
Approximately 30 years ago, sub-optimal DMPK properties were recognized as the primary contributor to the failure (~40%) of potential new therapies in early clinical trials. This observation precipitated a renaissance period across the discipline which served to align DMPK efforts within discovery to assist in selecting optimal drug candidates to advance to clinical testing. As a consequence, the failure rate for NCEs due to poor DMPK attributes is currently below 5%. While the success of DMPK groups to resolve issues is impressive, there is still a critical need to understand the activity and safety implications of key drug metabolites as part of the overall evaluation of the NCE.

This overview touches upon strategies for building phase appropriate packages for metabolites to account for pharmacological activity, potential drug interaction and associated metabolism-dependent drug safety concerns.

Download a copy of the slides: https://www.xenotech.com/access-adme-...
Questions, comments and requests: https://www.xenotech.com/contact-us
More information on our research services and test systems: https://www.xenotech.com
Other previously aired webinars: https://www.xenotech.com/scientific-r...
Upcoming webinar notifications: https://www.xenotech.com/newsletter-s...
Request a webinar topic: https://www.xenotech.com/scientific-r...

About the presenter: Larry C. Wienkers received his BS in Chemistry and Biology in 1986 and his MS in Chemistry in 1988 from Western Washington University. He then earned his PhD in Medicinal Chemistry from the University of Washington in 1993 under the direction of Dr William F. Trager. He performed postdoctoral work in the department of Drug Metabolism at the Upjohn Company and subsequently joined the company as a Research Scientist in 1995. In 1998, Dr. Wienkers became Director of Drug Metabolism Enabling Technologies at Pharmacia & Upjohn and in 2002 became Executive Director of Pharmacokinetics, Dynamics and Metabolism at Pfizer. In 2004 Dr. Wienkers moved to Amgen and recently retired as Vice President and Global Head of the Department of Pharmacokinetics and Drug Metabolism. He is an American Association of Pharmaceutical Scientists (AAPS) Fellow with over 80 peer reviewed manuscripts and book chapters. One of Dr. Wienkers’ long standing research interests is focused on exploring bioactivation pathways associated with small molecule drug metabolism with particular focus on the prospective application of this information to predict drug-drug interactions in the clinic. To this end, he and collaborators apply a multidisciplinary approach using organic chemistry, biochemistry and biophysical techniques to study cytochrome P450 mechanism-based inactivation and the characterization of biotransformation pathways of novel therapeutics.