7:30-8:00am- Registration and Continental Breakfast
8:00-9:20am- Session 1: The context and the concept of ‘Early ECG assessment’
Session chair and moderator: Borje Darpo
- Background and objectives of the IQ-CSRC project–Borje Darpo, iCardiac (20min)
- Regulatory background (e.g. From the thorough QT study to newer ways of confidently assess ECG effects of new drugs)- Doug Throckmorton, FDA(20min)
- Exposure response analysis as an evolving tool for regulatory decision making for the assessment of ECG effects of new drugs- Kevin Krudys, FDA(20min)
- Study design and choice of drugs– Nenad Sarapa, Bayer HealthCare Pharmaceuticals (20min)
9:45-12:15pm- Session 2: Results and interpretations of the study
Session chair: Nenad Sarapa
- Results of the study:
- Part 1: Statistical considerations and methods- Georg Ferber, Statistik Georg Ferber GmbH (15min)
- Part 2: Results- Steve Riley, Pfizer (30min)
- FDA’s analysis and interpretation of the data – Jiang Liu, FDA (30min)
- Panel discussion on results with speakers and invited panelists (75min)
Moderator: Steve Riley- Corina Dota, AstraZeneca
- Catherine Ortemann-Renon, Sanofi
- Venkat Jarugula, Novartis
- Christine Garnett (ex-E14), Certara
- Qianyu Dang, Biostatistics, FDA
- Yaning Wang, FDA
- Jiang Liu, FDA,
- Lars Johannesen, FDA
1:30-3:30pm- Session 3: Clinical and regulatory implications of the study
Session chair and moderator: Christine Garnett
- The sponsor’s perspective: How can these data help us design phase 1 SAD/MAD studies to generate ECG data to replace the TQT study?- James Keirns, Astellas (15mins)
- FDA perspective- Norman Stockbridge (15min)
- Cardiologist’s perspective- Peter Kowey, Lankenau Heart Group (15min)
Panel discussion on clinical and regulatory implications of study results with presenters and invited panelists.
Moderator: Borje Darpo
- James Keirns, Astellas
- Dan Bloomfield, Merck
- Philip Sager, Stanford University/Sager Consulting Experts
- Charles Benson, Eli Lilly
- Corina Dota, AstraZeneca
- Kaori Shinagawa, PMDA,
- Colette Strnadova, Health Canada,
- Norman Stockbridge, FDA
- Bob Temple, FDA
- Doug Throckmorton, FDA
- Krishna Prasad, MHRA
- Christine Garnett (ex-E14), Certara
4:00-5:00pm- Session 4: Next steps
Session chair and moderator: James Keirns
- How do the results from the IQ-CSRC study impact the ICH E14 clinical guidance?- Norman Stockbridge, FDA (15min)
- Open-access research: The CSRC ECG warehouse for continuous waveforms- Cindy Green, CSRC and DCRI (15min)
- How does the CiPA initiative relate to the IQ-CSRC project?- Philip Sager, Stanford University/Sager Consulting Experts (15min)
- Concluding remarks – The path forward- Christine Garnett, Pharsight Consulting Services, Certara (15min)