12/09/2010: CSRC Annual Meeting

12/09/2010: CSRC Annual Meeting

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:

John Finkle, MD (Industry)

White Papers Update:

Ignacio Rodriguez, MD (Industry)

 Research Projects Update:

Benjamin Eloff, PhD (FDA)

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

Evaluation of a Novel Automated QTc Measurement Algorithm Using the CSRC ECG Warehouse: NewCardio Experience

Sam George

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)