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CSRC Roundtable Discussion: Cardiovascular Safety for Cell Therapies in Development for Cardiovascular Indications

October 23, 2015

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.

Registration Now Open!

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

  • Safety Considerations in Development of Cell Therapies for Cardiovascular Indications , (10min) Steve Winitsky, MD ( FDA/CBER)
  • Risk as related to source of cells (autologous vs. allogeneic), manipulation, and harvesting procedures (10min) EMA Representative
  • Proposals for approaching risk profiling based on preclinical and clinical data (10 min) Joseph Wu (Stanford University)
  • Device-therapeutic combination challenge (10min) Timothy Henry, MD (Cedars- Sinai)
  • Expert panel discussion (35min)

10:35am-11:50pm- Session II: Dose finding in cell therapies development

  • Is demonstration of dose dependency required for establishing safety and bioactivity (10min) DouglasLosordo,MD(Caladrius)
  • Role and unique challenges of potency assays in cardiovascular cell therapy (10min) Andreas Zeiher, MD (University of Frankfurt)
  • Dose scaling based on non-human assays (10min) Thomas Povsic, MD (Duke University)
  • Expert panel discussion (45min)
  • To include FDA representation

11:50pm-12:00pm- Final remarks, and next steps