CIPA Update Workshop CSRC-HESI-SPS-FDA Meeting

8:00am-Introduction Philip Sager (5min)

8:05am- 10:40am- Overview

Moderators: Derek Leishman, Krishna Prasad

10:55am-12:35pm- In Silico Reconstruction

Moderators: Thomas Colatsky, David Gutstein

1:05pm-2:25pm- Test compound selection and Ion Channel testing approach

Moderators: Jennifer Pierson, Hugo Vargas

2:25pm- 4:00pm- Myocyte Efforts and Early Stage Development ECG assessment

Moderators: Gary Gintant, Christine Garnett

4:20pm-5:55pm- What is necessary for CIPA acceptance? Moderators: Philip Sager, Norman Stockbridge

Panel Discussion (each participant first gives a viewpoint for ~3 min without slides on what they think is required for CIPA acceptance).

  • EU- Krishna Prasad (5min)
  • JapanKaori Shinagawa (5min)
  • Pharmaceutical developer perspective
    • North America/EU
      • Jean-Pierre Valentin (5min)
    • JapanHiroyuki Fukase (5min)
  • Academic perspective
    • Peter Kowey (5min)
    • Joseph Wu (5min)
  • Panel Discussion (50min)

5:55pm- Summary and next steps