Time：2015-4-10 9:20-9:50 am
Location：The Report Meeting Room, The biotech building
Lecturer: Dr. & Prof. Donglu Zhang
Genentech – South San Francisco, USA
Abstract：
The clinical success of a drug candidate depends on an overall balance of optimal efficacy, safety and pharmacokinetics (PK). Although potency is an important requirement of a drug candidate, the PK profile dictates its clinical effectiveness and safe therapeutic use. The PK profile is determined by Absorption, Distribution, Metabolism, and Excretion (ADME). A series of ADME studies must be performed in discovery and development to support toxicity and efficacy studies. In general, the IND (investigational new drug) package submitted to regulatory agents should include early ADME properties in addition to general safety pharmacology and toxicology in pre-clinical animal species, the manufacturing information and clinical protocols and investigator information. A typical IND-enabling ADME package contain information ranging from a number of in vitro and in vivo ADME studies suggesting minimal PK and drug-drug interaction (DDI) liability, the in vitro metabolism, permeability, and in vivo PO and IV single dose and multiple dose PK in rodent and non-rodent species and toxicokinetic analysis in relevant animal species. At late stage, more definitive ADME studies are conducted to support NDA filing and post-marketing monitoring. These studies include radiolabel mass balance in animals and humans, metabolic pathways, reaction phenotyping, drug transporter characterization, tissue distribution by quantitative whole-body autoradiography (QWBA), mechanistic investigation and special studies to support clinical trials. This presentation will focus on applications of model systems to study drug ADME properties in support of drug discovery and development.
Resume of Lecturer：
Dr. Donglu Zhang is a senior scientist at Genentech. He has previously worked at ARIAD Pharmaceuticals and Bristol-Myers Squibb. Dr. Zhang’s research interests include discovery of antibody-drug conjugates (ADC), identification of metabolites and metabolism enzymes, extrahepatic metabolism, LC/MS methodologies, and their applications to drug discovery and development. Dr. Zhang has contributed to several NDA filings including apixaban, dasatinib, ixabepilone, and atazanavir. He has taught short courses on drug metabolism at ACS and EAS, is a co-editor of the two books ‘Drug metabolism in drug design and development' (which was also translated into Chinese) and 'ADME-enabling technologies in drug design and development', and has published >80 peer-reviewed articles. He is a co-inventor of mass defect filtering (MDF) technology.
Contact：1806 group Guang-Bo Ge (Dr. & Asso. Prof.) （Tel: 84379317-601）