第2回 心臟毒性及藥物安全性
5月12日(一)∼13日(二)
Keynote Panel Discussion: Drug Safety: A 2020 Vision
Medical Product Development: Addressing Scientific Hurdles Through Strategic Partnerships with Stakeholders
Wendy R. Sanhai, Ph.D., Senior Scientific Advisor, Office of the Commissioner, FDA
Formation of an International Effort to Understand the Genetic Basis of Drug Related Serious Adverse Events
Arthur L. Holden, Chairman and CEO, International Serious Adverse Event Consortium, Ltd.
Peter J. Pitts, President, Center for Medicine in the Public Interest
The Unintended Consequences of Safety
STRATEGIES FOR PRECLINICAL RISK ASSESSMENT
Chairperson
Peter Siegl, Ph.D., Portfolio Management, Cardiovascular Franchise, Merck & Co., Inc.
Leveraging Early Liability and Drug Safety Assessment by Integration of Innovative Screening Automation and Novel Bioassay Technology
Mary Ellen Cvijic, Ph.D., Senior Research Investigator, Lead Evaluation-Applied Biotechnology, Bristol-Myers Squibb Co.
Developing and Using an Integrated Risk Assessment for Managing Drug Candidates in Early Development
Peter Siegl, Ph.D., Portfolio Management, Cardiovascular Franchise, Merck & Co., Inc.
Title to Be Announced
Gary Gintant, Ph.D., Senior Group Leader, Integrative Pharmacology, Abbott Laboratories
QT ASSESSMENT FOR CARDIAC LIABILITY
Regulatory, Procedural, and Statistical Considerations in the Thorough QT Study: The Complexity of the Design of a Thorough QT Study
Charles M. Beasley, Jr., M.D. FFPM, Chief Scientific Officer, Global Product Safety, Eli Lilly & Co.
The Impact of Autonomic Tone on QT Prolongation Assessment-Translation of Preclinical Data to Clinical Outcomes
Anthony Fossa, Ph.D., Research Fellow, Translational and Molecular Medicine, Pfizer Global Research & Development
Debatable Issues around QTc Assessment in Clinical Trials
Nenad Sarapa M.D., M.Sc., Senior Director, Experimental Medicine, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Proarrhythmic Cardiac Safety: Assessment Methodologies and Benefit-Risk Assessments
J. Rick Turner, Ph.D., PGCE, Chairman, Clinical Research and Director, Center for the Study of Cardiac Safety, Campbell University School of Pharmacy, North Carolina
NEW APPROACHES FOR CARDIAC SAFETY ASSESSMENT
Cardiomyocytes Derived from Human Embryonic Stem Cells – Novel Opportunities for Drug Safety Assessment
Peter Sartipy, Ph.D., Senior Scientist and Project Manager, Cellartis AB
Understanding Cardiotoxicity of Tyrosine Kinase Inhibitors
Thomas Force, M.D., Professor of Medicine and Clinical Director of the Center for Translational Medicine at Thomas Jefferson University, Philadelphia
Re-Engineering of Imatinib to Decrease Cardiac Risk: Translational Ideas in Drug Discovery
Ariel Fernandez, Ph. D., Chair in Engineering and Professor of Bioengineering, Rice University, Texas
Translating Pharmacogenomics to Personalized Medicine: Optimizing Drug Safety in Clinical Studies to Prevent Cardiotoxicity
Amalia M. Issa, Ph.D., MPH, Associate Professor, University of Houston and Director, Program in Personalized Medicine and Targeted Therapeutics
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)
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.
