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)
- Myocyte overview, role in CiPA, and metrics- Gary Gintant, PhD (AbbVie)(15min)
- Myocyte approaches to VSD and MEA testing- research studies and preliminary results
- VSD talk- Godfrey Smith, PhD (University of Glasgow)(10min)
- MEA talk- Daniel Millard, PhD (Axion Biosystems)(10min)
- Japanese Stem Cell Efforts- Yuko Sekino, PhD(JiCSA)(10min)
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)
- New ECG biomarkers and their role under CiPA Jose Vicente, PhD (FDA)(15min)
- Practical implications, workflow, and open source code Robert Kleiman, MD (ERT)(15min)
- Interpretations based on Phase 1 ECG assessments David Strauss, MD, PhD (FDA)(15min)
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