CSRC Roundtable Discussion: Cardiovascular Safety for Cell Therapies in Development for Cardiovascular Indications
Sheraton College Park North Hotel | Beltsville, Maryland
Friday October 23, 2015 | 9:00am-12:00pm EDT
Meeting Agenda
8:30am-Registration and continental breakfast
9:00am-9:20am- Introduction, background, and workshop objectives
– Philip Sager, MD (10 min) Stanford University
– Setting the stage – Adel Nada, MD (10 min) Intellia Therapeutics
9:20am-10:35am- Session I: Risk profiling
– Safety Considerations in Development of Cell Therapies for Cardiovascular Indications , (10 min) Steve Winitsky, MD ( FDA/CBER)
– Risk as related to source of cells (autologous vs. allogeneic), manipulation, and harvesting procedures (10 min) EMA Representative
– Proposals for approaching risk profiling based on preclinical and clinical data (10 min) Joseph Wu (Stanford University)
– Device-therapeutic combination challenge (10 min) Timothy Henry, MD (Cedars- Sinai)
– Expert panel discussion (35 min)
10:35am-11:50pm- Session II: Dose finding in cell therapies development
– Is demonstration of dose dependency required for establishing safety and bioactivity (10 min) Douglas Losordo, MD (Caladrius)
– Role and unique challenges of potency assays in cardiovascular cell therapy (10 min) Andreas Zeiher, MD (University of Frankfurt)
– Dose scaling based on non-human assays (10min) Thomas Povsic, MD (Duke University)
– Expert panel discussion (45 min)
– To include FDA representation
11:50pm-12:00pm- Final remarks, and next steps
