CSRC Annual Meeting
December 9th, 2010
White Oak Facility, FDA Headquarters
Silver Spring, Maryland
7:30-8:00 am: Registration & Continental Breakfast
8:00-8:30: Introductory Session
Welcome & Agenda Overview: Norman Stockbridge, MD, PhD
Pediatric Cardiovascular Safety Program Overview: Matthew Killeen, PhD
CSRC: What Is CSRC and How Do We Work: Mitchell Krucoff, MD
CSRC Membership: Who Are We and How Do We Grow?: Theressa Wright, MD
8:30-9:30: PLENARY SESSION: Cardiac Safety in Medical Product Development: Critical Path Collaborations, Public Private Partnerships & Comparative Effectiveness–Where Are We and Where Do We Need to Go? Moderators: Daniel Bloomfield, MD (Industry); Mitchell Krucoff, MD (Academia)
Douglas Throckmorton, MD (Deputy Director, CDER, FDA)
William Maisel, MD (Deputy Director for Science, CDRH, FDA)
Ralph Brindis, MD, MPH (President, American College of Cardiology)
Paul Pomerantz, MD (Worldwide Executive Director, DIA)
9:30-10:50: Reports from the CSRC Scientific Oversight Committee Moderators: Justin Mortara, PhD (Industry); Pierre Maison-Blanche, MD (Academia)
Introduction to the SOC:
Philip Sager, MD (Pharmaceutical Consultant)
Thinktanks & Public Programs Update:
Ignacio Rodriguez, MD (Industry)
CSRC ECG Warehouse Structure, Implications and Future Directions: TQT, Long QT, Arsenic and Beyond
Paul Kligfield, MD
Comparative Evaluation of “Assay Sensitivity”Across QTc Measurement Algorithms: Statistical Standard
Cindy Green, PhD
Panel Discussion: Speakers plus: Joanne Zhang, PhD; Fabio Badilini, PhD; Theressa Wright, MD; Benjamin Eloff, PhD; Jean-Philippe Couderc, PhD
10:50-11:00 Break
11:00-12:00: New Ideas, New Directions in Cardiac Safety: Thinktanks, White papers, Research Projects Moderators: Benjamin Eloff, PhD (FDA) and Philip Sager, MD (Pharmaceutical Consultant)
Panelists: Borje Darpo, MD, PhD (Pharmaceutical Consultant); Tom Todaro, MD (Industry); Marcia Yaross, PhD (Industry); John Finkle, MD (Industry); Ignacio Rodriguez, MD (Industry); Mitchell Krucoff, MD (Academia)
12:00-12:45 Lunch: Face to Face Committee Breakout Meetings
Membership Committee
Scientific Oversight Committee
Public Programs Planning Committee
12:45-14:00: Hot Topics Mini-Symposium I: Diabetes and Cardiac Safety: What Are The Knowledge Gaps & How Can We Work Collaboratively to Address Them? Moderators: Norman Stockbridge, MD, PhD (FDA); Borje Darpo, MD, PhD (Pharmaceutical Consultant)
Academic View: Ralph DeFronzo, MD
Industry View: Anders Svensson, MD, PhD
Industry View: Murray Stewart, MD
Panel Discussion: All speakers
14:00-14:15: Break
14:15-16:15: Hot Topics Mini-Symposium II: Evaluation of Cardiotoxicity in Clinical Drug Development Moderators: Ignacio Rodriguez, MD (Industry); Rick Turner, PhD (Industry)
Part I: Cardiac Monitoring Pros/Cons:
Echo Core Lab Imaging: Bonnie Ky, MD
Nuclear Core Lab Imaging: Diwakar Jain, MD
MRI Core Lab Imaging: Robert Judd, MD
Quality, Logistics, Risk/Benefits of Imaging for Cardiotoxicity: John Finkle, MD
Panel Discussion: All Speakers plus Jennifer Christian, PharmD, MPH
Part II: Biomarker Surveillance & Combining Modalities: Seeking a “Signature” of Early Cardiotoxicity
Conclusions from Troponin: Kristin Newby, MD, MHS
Regulatory View: Karen Hicks, MD
Industry View: Daniel Bloomfield, MD
From Surrogate Markers to “Biosignatures” of Safety: Mitchell Krucoff, MD
Panel Discussion: All Speakers plus: Jennifer Christian, PharmD, PhD
16:15-17:15: CSRC Future Directions: Open Discussion on Procedures, Priorities, Topical Areas of Focus, Strategic Relationships Moderators: Mitchell Krucoff, MD (Academia); Daniel Bloomfield, MD (Industry)
Panelists: Paul Kligfield, MD (Academia); John Finkle, MD (Industry); Benjamin Eloff, PhD (FDA); Philip Sager, MD (Industry); Ignacio Rodriguez, MD (Industry); Theressa Wright, MD (Industry)]
17:15-17:20 Closing Remarks (Norman Stockbridge, MD, PhD: FDA)