7:30am-8:00am Registration and Continental Breakfast8:00am-8:35am CSRC 2012
- Welcome and Agenda Overview: Philip Sager, MD
- CSRC Mission, How We Work, and Major 2012 Accomplishments: Mitchell Krucoff, MD
- Discussion (20 min)
8:35am-12:15pm Critical Issues in Assessment of Drug-Induced CV SafetyThis session will focus on the need and best practices for CV Safety assessments, including the use of outcome studies in the evaluation of new chemical entities and will highlight new approaches and technologies that may impact the need for outcome trials.
- CV Safety Assessment in Drug Development – The Need of Individual Dedicated Studies vs. Monitoring Throughout Development & Risk Management: Peter Kowey, MD
- The Current Heuristic Approach – Strengths & Weaknesses/CV Assessment in Low Risk Patients when there is no prior signal: Michael Lauer, MD
- CV Outcome Studies in GI Indications to Determine Patient Safety: Joyce Korvick, MD (FDA)
- Sentinel Initiative: Ability of Active Surveillance to Capture Major Cardiac Adverse Events: Monika Houstoun, D. Pharm
- The Use of Existing Large Databases to Better Understand Population and Drug CV Risk: Mary Parks, MD
- 9:55am-10:05am Break
- Innovations in Devices to Facilitate CV Safety Assessment: Rich Fogoros, MD
- Missing Data in Outcome Trials – Implications and Prevention: Jim Neaton, PhD
- CV Safety – What is the Role of CV Adjudication, Key Issues, and When is it Indicated?: Jonathan Seltzer, MD
- How Broad of an Assessment is Necessary When the Data is Sparse for CV Events and Death in Non-Cardiac Studies: Mary Beth Sabol, MD and Commentary: Karen Hicks, MD
- Panel Discussion (80min)
12:20pm Break and Get Working Lunch12:45pm-2:30pm CSRC Future Directions
- Abstract Presentations from CSRC Membership Regarding New Potential CSRC Initiatives
- White Paper on Cardiac Safety in the Development of COPD Drugs: Pierre Maison-Blanche and Antonio Ferrari
- Prospective early clinical QT study of a test set of marketed drugs to evaluate QT interval response without a TQT study: Charles Benson and Nenad Sarapa
- CV Safety Consultations in Pharmaceutical Organizations: Roger Mills and Kathyrn Gargiulo
- How Can the CSRC Be More Involved in Device Issues?: Bram Zuckerman, MD
- Safety Outcome Studies — Key Principles and Case Examples: Robert Temple, MD
- Panel and Open Discussion: What Additional Areas Should the CSRC Focus on in 2013 that are High Impact for Public Health and How Do We Measure Our Impact?
2:30pm-2:45pm Break2:45pm-5:15pm Critical Issues in Assessment of Drug-Induced CV Safety (Continued)
- QT/Arrhythmia Issues: Can the Thorough QT Study Be Replaced?
- Regulatory Perspective: Norman Stockbridge, MD, PhD
- QT/PK Modeling to Replace the TQT — Science, Implications, and Pathways Forward: Borje Darpo, MD, PhD
- Panel Discussion (30min)
- Is More Intensive Evaluation of BP Increases Needed During Drug Development?
- Overview: William White, MD
- State-of-the-art BP Assessments: Eoin O’Brien, MD
- Panel Discussion (45min) All Speakers plus Philip Sager, MD and Eric Michelson, MD