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

Friday, October 23, 2015

Final agenda and links to presentation

8:30am-9:00am- Registration and continental breakfast

9:00am-9:10amIntroduction -Philip Sager, MD (Stanford University) (10min)

9:10am-10:35amSession I: Risk Profiling

Safety Considerations in Development of Cell Therapies for Cardiovascular Indications. Steve Winitsky, MD (FDA/CBER) (10min)
Risk as related to source of cells (autologous vs. allogeneic), manipulation, and harvesting procedures. Marc Penn, MD, PhD (Summa Cardiovascular Institute) (10min)
Proposals for approaching risk profiling based on preclinical and clinical data. Joseph Wu, MD, PhD (Stanford University) (10 min)
Device-therapeutic combination challenge. Amit Patel, MD (University of Utah) (10min)

Expert panel discussion (45min)

10:35am-11:50pmSession II: Dose Finding in Cell Therapies Development
Is demonstration of dose dependency required for establishing safety and bioactivity? Douglas Losordo, MD (Caladrius) (10min)
Role and unique challenges of potency assays in cardiovascular cell therapy. Andreas Zeiher, MD (University of Frankfurt) (10min)
Dose scaling based on non-human assays. Thomas Povsic, MD (Duke University) (10min)

Expert panel discussion (to include FDA representation) (45min)

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