Monday, June 8

9:00am-12:00pm

Recommended Pre-Conference Short Courses
(SC1) CARDIAC SAFETY:
IMPROVING PRE-CLINICAL PREDICTIONS TO BETTER CLINICAL OUTCOMES

2:00-5:00pm

(SC4) ION CHANNEL ASSAYS FOR SAFETY SCREENING

PRECLINICAL STRATEGIES FOR
EARLY RISK ASSESSMENTS

Introductory Overview of Cardiac Safety Assessments
J. Rick Turner, Ph.D., PGCE, President and Chief Scientific Officer, Turner Medical Communications LLC

Testing Drug-Induced Inhibition of hERG: How Voltage and Inactivation Make a Difference
Harry Witchel, Ph.D., Senior Lecturer, Physiology, Brighton and Sussex Medical School

Challenges of the Integrative Risk Assessment, the “Heart” of Preclinical Cardiac Safety Evaluations
Gary Gintant, Ph.D., Senior Group Leader, Integrative Pharmacology, Abbott Laboratories

Electrophysiological Signatures for TdP
Berengere Dumotier, Ph.D., Preclinical CardioSafety Expert, Safety Pharmacology, Novartis Pharma AG

Developing and Using a Scientific-based Integrated Risk Assessment for Managing Drug Candidates in Early Development
Peter K.S. Siegl, Ph.D., Independent Consultant, Siegl Pharma Consulting LLC

CARDIAC SAFETY IN ONCOLOGY

Cardiotoxicity of Anti-Cancer Drugs: A Matter of Multiple Hits
Giorgio Minotti, M.D., Professor, Pharmacology, CIR and Drug Sciences, University Campus Bio-Medico, G. d’Annunzio Univeristy of Chieti-Pescara, Italy

Cardiac Safety Assessments for Oncology Drugs: A Regulatory Perspective
Colette Strnadova, Ph.D., Senior Scientific Advisor, Therapeutic Products Directorate, Health Canada

NOVEL APPROACHES FOR
BETTER PREDICTION OF TOXICITIES

Keeping Safety as a Focus in Product Development
Wendy Sanhai, Ph.D., Senior Scientific Advisor, Office of the Commissioner, U.S. FDA

Drug Safety Executive Council

The Drug Safety Executive Council (DSEC) is a peer-to-peer membership of drug safety leaders with the common objective of advancing the development of better and safer medicines worldwide. Membership in DSEC is limited to leaders representing companies who develop small and large molecule pharmaceuticals only.