Moderated by:
Mandy Xu – Vice President, DMPK at Pharmaron
Speakers:
Dr. James E. Polli – Professor of Pharmaceutical Sciences at University of Maryland
Dr. James E. Polli is Professor of Pharmaceutical Sciences and Ralph F. Shangraw/Noxell Endowed Professor in Industrial Pharmacy and Pharmaceutics at University of Maryland. His two main research interests are maximizing oral bioavailability through formulation and chemical approaches and developing public quality standards for oral dosage forms. Currently, he is co-Director of the University of Maryland Center of Excellence in Regulatory Science and Innovation (CERSI) and the Center for Research on Complex Generics, each an FDA-funded collaborative agreement with the Agency. Dr. Polli is also the Director of the online MS in Regulatory Science program, a fellow of the American Association for Pharmaceutical Scientists and a member of the University of Maryland General Clinical Research Center Advisory Committee and the University of Maryland institutional review board (IRB).
Chris Bode, Ph.D. – VP Scientific and Corporate Communications at Absorption Systems, a Pharmaron company
As VP of Scientific and Corporate Communications, one of Dr. Bode’s responsibilities is to capture and disseminate the mission and messages of Absorption Systems to the world. He has had multiple roles since joining the company in 2006. Over the past ten years, he has been Study Director for most of the Biopharmaceutics Classification System (BCS) conducted by Absorption Systems in support of numerous BCS-based biowaivers. He has also directed several transporter studies, serves as Scientific Reviewer for many types of studies, and either directs or provides scientific input into various research projects, grants, and contracts. Prior to Absorption Systems, Dr. Bode spent seventeen years in the pharmaceutical industry, working on both pharmacokinetics and pharmacodynamics. His Ph.D. in pharmacology is from the University of Colorado, and postdoctoral research was conducted at UC San Diego.
Danxi Li, Ph.D. – Director, in vitro ADME at Pharmaron
Dr. Li is working as one of the main study directors of in vitro ADME department in Pharmaron and leading an experienced team to support various sponsors from early screening to regulatory submission. As ADME project coordinator, she helps sponsors to establish many specific assay platforms in Pharmaron, provides scientific input to optimize assay systems and ensures high quality data submission in a time efficient way. Before joining Pharmaron in early 2011, Dr. Li has worked at University of Medicine and Dentistry in New Jersey, USA, for 2 years as a visiting researcher. Her research work there focused on functionality investigation of CYP polymorphism using transfected cell models, which was continued work from her Ph.D. thesis work at Zhejiang University in China.
