CIPA Update Workshop CSRC-HESI-SPS-FDA Meeting

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

8:05am- 10:40am- Overview

Moderators: Derek Leishman, Krishna Prasad

• The need for a new approach to assessing the proarrhythmic potential of drugs- Philip Sager (15min)
• Mechanisms of ventricular arrhythmogenesis- Craig T. January (15min)
• CIPA overview- key concepts and work streams– Gary Gintant (20min)
• Ion Channel selection for in silico modeling – scientific basis for choices- Derek Leishman (15min)
• The impact of CIPA on drug development: FDA Perspective– Norman Stockbridge (20min)
• The impact of CIPA on drug development: Pharmaceutical Industry Perspective– Hugo Vargas (10min)
• Discussion (60min)

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

Moderators: Thomas Colatsky, David Gutstein

• Introduction– Thomas Colatsky (5min)
• Overview and scientific approach-Natalia Trayanova (20min)
• Development and validation of the model- Sara Dutta and Zhihua Li (20min)
• Proarrhythmia metrics–Gary Mirams (10min)
• Building a community resource–Donna Lochner (10min)
• Discussion (40min)

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

Moderators: Jennifer Pierson, Hugo Vargas

• Test compound selection- Process, methodology, and selected compounds for CiPA efforts– David Gutstein (15min)
• Current state of ion channel testing, testing metrics and specific testing protocols- Bernard Fermini (20min)
• Panel Discussion (45min)
  • To Include James Kramer

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

Moderators: Gary Gintant, Christine Garnett

• Myocyte overview, key concepts, challenges, and metrics– Leslie Tung (15min)
• Myocyte approaches to VSD and MEA testing- core protocols and preliminary data– Jiwen Zhang (15min)
• JiCSA Study Data Review – Yuko Sekino (10min)
• Role of ECG assessment during clinical development under CIPA and experimental findings – David Strauss (20min)
• Panel Discussion (35min)
  • To Include Joseph Wu, Philip Sager

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)
• Japan – Kaori Shinagawa (5min)
• Pharmaceutical developer perspective
  • North America/EU
    • Jean-Pierre Valentin (5min)
  • Japan – Hiroyuki Fukase (5min)
• Academic perspective
  • Peter Kowey (5min)
  • Joseph Wu (5min)
• Panel Discussion (50min)

5:55pm- Summary and next steps