The CSRC has propelled a unique paradigm of transparent, pan-stakeholder collaboration focused on the pre-competitive “landscape” challenges of cardiac safety evaluation of new therapeutics. Using the public-private partnership constituted through the Duke-FDA MOU, a broad range of membership and expertise from the FDA and Health Canada, industry, academics and professional societies have combined to establish the consortium and generate several major areas of novel, public domain cardiac safety evaluation deliverables such as the ECG Warehouse, White Papers, an important Annual Scientific Meeting, and CSRC Thinktank Incubators. Representing a broad array of pharma manufacturers, research organizations, professional societies, and the FDA, we hope you will add your voice and your vision of the future as related to cardiac safety research. Topics are addressed through brief, provocative presentations intended to highly focus on key issues, and to stimulate key, important discussions. Thus the talks are limited to 10 minutes. More than 50% of the total meeting time is intended for open discussion.
8:30am-Registration and continental breakfast
9:00am-9:10am- Introduction (10min) Philip Sager, MD Stanford University
9:10am-9:20am- Background and workshop objectives (10min) Adel Nada, MD Intellia Therapeutics
9:20am-10:35am- Session I: Risk profiling
10:35am-11:50pm- Session II: Dose finding in cell therapies development
11:50pm-12:00pm- Final remarks, and next steps