CPSA Shanghai 2011
Changing Paradigm in Drug Discovery & Development:
East Meets West
April 13 - 16, 2011
Renaissance Shanghai Pudong Hotel
Shanghai, China
Abstract
Thursday PM - Parallel Session I
DMPK Support of Oncology Discovery: Risk Management vs. Pursuit of Drug-Like Propertiest
Hongjian Zhang
PharmaResources (Shanghai) Co., Ltd., Shanghai, China
A balanced ADME property is always sought after for any NME that enters the market place. As such, DMPK scientists have made significant contributions to drug discovery and development, leading to a marked reduction in the attrition rate due to poor PK characteristics. While the pursuit of drug-like properties is the key for success, the diversity in disease targets and/or therapeutic areas would recommend a tailored DMPK strategy during lead optimization and candidate selection. This is particularly true for oncology programs where candidates with some manageable ADME risks are often advanced for unmet medical needs. A case study is presented and data-driven decision making for candidate selection is discussed. Strategies for development and supporting evidence with respect to reaction phenotyping, enzyme kinetics, drug-drug interaction, polymorphic enzymes, metabolite ID and human PK projection are highlighted.
Hongjian is a co-founder and chief operating officer of PharmaResources (泓博智源), a discovery focused services organization located in ZhangJiang High-Tech Park (East).
A chemist by training, Hongjian is an expert in the application of drug metabolism and pharmacokinetic (DMPK) principles to the selection, optimization and characterization of drug candidates. During his tenure at Bristol-Myers Squibb (BMS), he served as a team/project leader in support of various discovery and development programs. Hongjian and his team have selected and characterized more than 15 clinical candidates for multiple therapeutic areas, and several of those compounds have been advanced to Phase I and II clinical trials.
Hongjian enjoys DMPK related sciences and research activities, as evident by more than 40 scientific publications and numerous presentations. He has in-depth expertise in drug-metabolizing enzymes, drug-drug interactions, reaction phenotyping and polymorphism. In addition, Hongjian is highly experienced in the preparation of ADME documents for regulatory filing and clinical trial. He has participated in the discussion with FDA on safety evaluation and Phase I/clinical pharmacology trial design for BMS’s clinical candidates.
Hongjian received a BSc degree in Chemistry from Beijing Normal University and holds a Ph.D. from the University of California-Davis, specializing in the oxidative metabolism of polyunsaturated fatty acids and biosynthesis of various eicosanoids. He completed his postdoctoral training in CNS lipid metabolism and melatonin pharmacology at National Institutes of Health (NIH), Bethesda, Maryland.