Critical Discussion- Future of the Assessment of Drug-Induced Arrhythmias and the Comprehensive in Vitro Proarrhythmia Assay (CiPA)

7:45am-8:00am Breakfast

8:00am- 8:05am Welcome and Introduction- Philip Sager, MD (Stanford University)

8:05am-9:50 Session I: CiPA Overview and Scientific Underpinnings
Moderator: Philip Sager

  • The need for a new approach to assessing the proarrhythmic potential of drugs and Overview of CiPA- Philip Sager, MD (Stanford University)(15min)
  • Talk on TdP mechanisms and theoretical justification for CiPA- Craig January, MD (University of Wisconsin)(15min)
  • The impact of CIPA on drug discovery and development, implications, timelines- Norman Stockbridge, MD, PhD (FDA)(15min)

Discussion (60min)

Panelist: All Speakers and
Peter Kowey, MD (Lankenau Medical Center)

9:50am-11:30am Session II: In Silico Modeling and Ion Channel Approaches.
Moderator: David Strauss, MD, PhD (FDA)

  • Overview, scientific approach, planned outputs, and how data will be used Tom Colatsky, PhD (15min)
  • Overview of ion channel testing strategy (channel and protocol selection), and summary of HT studies Bernard Fermini, PhD (Coyne Scientific)(15min)
  • Summary of manual ion channel results and next steps- Wendy Wu, PhD (FDA)(15min)
  • In silico strategy: development, validation, proarrhythmic metrics, modelling output, key issues, and next steps- Zhihua Li, PhD (FDA)(15min)

Discussion (40min)

Panelist:  All Speakers and
Gary Mirams, PhD (University of Nottingham, UK)
Alfonso Bueno-Orovio PhD (University of Oxford)
Najah Abi-Gerges, PhD (Anabios)

 Lunch 11:30am-12:30pm

12:30pm-1:55pm Session III: Myocyte Efforts
Moderator: Gary Gintant, PhD (AbbVie)

Panelist: All Speakers and
Udo Kraushaar, PhD (Natural and Medical Sciences Institute)
Ksenia Blinova, PhD (FDA)

Discussion (40min)

1:55pm- 3:30pm Session IV: Phase 1 ECG assessment Under CiPA
Moderator: Robert Kleiman, MD (ERT)

David Strauss, MD, PhD (FDA)(15min)
Panelist:  All Speakers and
Corina Dota, MD (Astrazeneca)
Lars Johannesen, PhD (FDA)
Joel Xue, PhD (GE Healthcare)

Discussion (50min)

3:30pm-3:40pm Break

3:40pm-5:00pm Session V: CIPA Regulatory Acceptance and Implementation
Moderators: Norman Stockbridge and Philip Sager

  • CiPA Package, regulatory approaches, and implementation Philip Sager, MD (Stanford University)(15min)

What is the data package required for CIPA regulatory acceptance

Panelist: All Speakers, David Strauss, MD, PhD (FDA), and
Dan Bloomfield, M D  Merck)(5min)
Kaori Shinagawa, MD (PDMA)(5min)
Krishna Prasad, MD (MHRA)(5min)
Colette Strnadova, PhD (Health Canada)(5min)
Derek Leishman, PhD (Eli Lilly)(5min)
Doug Throckmorton, MD (FDA)(5 min)

Discussion (30min)

5:00pm-5:15pm Summary & Next Steps