第1回 肝毒性及藥物安全性
5月13日(二) ∼ 14日(三)
Keynote Panel Discussion: Drug Safety: A 2020 Vision
Wendy R. Sanhai, Ph.D., Senior Scientific Advisor, Office of the Commissioner, FDA
Medical Product Development: Addressing Scientific Hurdles Through Strategic Partnerships with Stakeholders
Arthur L. Holden, Chairman and CEO, International Serious Adverse Event Consortium, Ltd.
Formation of an International Effort to Understand the Genetic Basis of Drug Related Serious Adverse Events
Peter J. Pitts, President, Center for Medicine in the Public Interest
The Unintended Consequences of Safety
STRATEGIES FOR PRECLINICAL SCREENING
Chairperson
William B. Mattes, Ph.D., DABT, Director, Toxicology, The Critical Path Institute
Improvements in In Vitro and In Vivo Screening Techniques Using Human Hepatoma (HepG2) Cells
Firouz Darroudi, M.D., Ph.D., Department of Toxicogenetics, Leiden University Medical Centre, The Netherlands
Metabonomics Evaluations of Urine Samples from Multiple Liver Toxicity Studies in Rats
Richard Beger, Ph.D., Branch Chief, Center for Metabolomics, Division of Systems Toxicology, National Center for Toxicological Research
New Preclinical Screens to Detect Drug-Induced Mitochondrial Dysfunction Yield a New Model of Idiosyncratic Organ Toxicity
James Dykens, Ph.D., Senior Principal Scientist, Drug Safety R&D, Pfizer Inc.
PREDICTIVE TOOLS FOR HEPATOTOXICITY SCREENS
Detection of Drug-Induced Liver Toxicity in Early Drug Discovery Process Using Toxicogenomics Approach
Yi Yang, Ph.D., DABT, Associate Research Investigator, Cellular, Molecular and Exploratory Toxicology, Abbott Laboratories
A Protein Chip for Hepatotoxicity
Zhiyuan Hu, Ph.D., Research Scientist, Laboratory of Dr. Leroy Hood, Institute for Systems Biology, Seattle
CLINICAL ASSESSMENT OF DRUG-INDUCED LIVER INJURY
Human Drug Hepatotoxicity: A Contemporary Clinical Perspective
Victor Navarro, M.D., Associate Professor of Medicine, Department of Hepatology at Thomas Jefferson University, Philadelphia
RECOMMENDED SHORT COURSE *Separate Registration Required
(SC1) 心臟的安全性: 改善前臨床預測以獲得到更佳之臨床結果 (5月11日 2:00pm - 5:00pm)
Improving Pre-clinical Predictions to Better Clinical Outcomes Cardiotoxicity is one of the major forms of toxicity seen in drugs and it accounts for most recalls and delays experienced in drug approvals. One of the biggest challenges is how to predict cardiac risk associated with drug candidates very early and accurately in the drug development process. This short course is designed to get researchers and clinicians to question the predictive validity of current cardiac risk assessment strategies and to get them thinking about ways to improve preclinical predictors of cardiac safety. This course will provide an overview of the recent technical and scientific advances in preclinical safety testing such as, improvements in assay design and reagents, availability of new cell lines for in vitro toxicity screening, use of toxicogenomics and other tools for developing safety biomarkers and the success of in silico predictive models for determining cardiac safety. The instructors will also talk about ways to then effectively combine the intelligence gathered from preclinical screens with clinical data and post-marketing pharmacovigilance studies from other drugs, to better assess risk to benefit ratios for new drug candidates.
