October 2008

CSRC/HESI Annual Meeting

Marriott Pooks Hill

5151 Pooks Hill Road, Bethesda, Maryland 20814

Presentations, agendas, and other material pertinent to the recently concluded 2008 CSRC/HESI Annual Meeting are provided below.

(All files are in Adobe Acrobat PDF format. Download the free Acrobat Reader program by clicking here.)

(Agenda Slides)

Day 1

Monday, October 6, 2008

07:00-08:00 Registration & Continental Buffet

08:00-09:35 Opening Session

  • Introduction of Attendees: Mitchell Krucoff, Duke University
  • Brief Welcomes: 

CSRC: Daniel Bloomfield, Merck
HESI: Brian Berridge, GlaxoSmithKline
FDA: Norman Stockbridge, FDA

  • Organizational Updates:

HESI: Update on Cardiac Safety Initiatives: Syril Petit, HESI
CSRC: Annual Meeting Update: Overview of CSRC 2008, Mitchell Krucoff, Duke University; Scientific Oversight Committee Report, Philip Sager, CardioDx; Medical Strategies Committee Report,John Finkle, GlaxoSmithKline

  • Special Reports from CSRC:

Challenges and Solutions to Data Sharing Process: An FDA Perspective: Benjamin Eloff, FDA; Data From the CSRC ECG Warehouse: First Proof-of-Concept Report: Paul Kligfield, Cornell University

  • Plenary Presentation I: “Collaboration, Critical Path and Cardiac Safety: The FDA View” Douglas Throckmorton, FDA
  • Anatomy of a Think Tank: Mitchell Krucoff, Duke University

09:35-11:00 Cardiotoxicity and Troponin: Where Do They Fit in Drug Development?

10:45-11:00 Break

11:00-12:30 Preclinical and Clinical Testing for QT Proarrhythmia: How Do they Relate to one Another and to Risk of Life-threatening Arrhythmic Events?

12:30-13:45 Working Lunch: Insights Into Regulatory Policy (talks at 1pm)

  • Plenary Presentation II: How Can Collaborations in Cardiac Safety Efforts Best Impact the Regulatory Landscape? Robert Temple, FDA
  • Open Session Q&A: Leveraging Opportunities for Collaborations in Cardiac Safety
  • Moderator: Mitchell Krucoff 
  • Panel: Robert Temple, Paul Kligfield, Brian Berridge, John Finkle, Daniel Bloomfield, Wendy Sanhai, Benjamin Eloff, Norman Stockbridge

13:45-15:15 Preclinical and Clinical Evaluation of Non-QT Proarrhythmia

  • Preclinical Academic View: Gan Yan, Main Line Health Heart Center
  • Preclinical Industry View: Pete Siegl, Siegl Pharma Consulting
  • Preclinical FDA View: John Koerner, FDA
  • Clinical Academic View: Ed Pritchett, Duke University
  • Clinical Industry View: Corina Dota, AstraZeneca
  • Clinical FDA View: Chirstine Garnett, FDA
  • Translational View: Borje Darpo, Pharmaceutical Consultant
  • Lead Discussant: Lawrence Satin, Cardiocorel; Peter Kowey, Main Line Health Heart Center
  • Discussion

15:15-15:30 Break

15:30-17:00 Biologics and Large Molecules: How Do We Evaluate Proarrhythmia and Myotoxicity when Thorough QT Cannot be Performed?

  • Preclinical Academic View: Allan Jaffe, Mayo Clinic
  • Preclinical Industry View: Hugo Vargas, Amgen
  • Preclinical Regulatory View: Thomas Papoian, FDA
  • Clinical Industry View: Philip Sager, CardioDx
  • Clinical FDA View: Suchitra Balakrishnan, FDA
  • Translational View: Andrew Erdman, Genentech
  • Lead Discussant: Ignacio Rodriguez, Roche
  • Discussion

17:00-17:30 Summarizing Day 1

  • FDA CDER Perspective: Norman Stockbridge, FDA
  • CSRC Perspective: Daniel Bloomfield, Merck
  • Academic Perspective: Mitchell Krucoff, Duke University
  • FDA Critical Path Perspective: Wendy Sanhai, FDA
  • HESI Perspective: Brian Berridge, GlaxoSmithKline
  • Adjournment of Day

Day 2

Tuesday, October 7, 2008

07:30-08:00 Continental Breakfast

08:00-09:30 Risks & Benefits Developing Drugs with Safety Signals – What are the Challenges?

  • Preclinical Academic View: Robert Christenson, University of Maryland
  • Preclinical Industry View: Rob Wallis, Pfizer
  • Clinical Academic View: Marek Malik, University of London
  • Clinical Industry View: Daniel Bloomfield, Merck
  • Clinical FDA View: Bob Temple, FDA
  • Translational View: Pete Siegl, Siegl Pharma Consulting
  • Lead Discussant: Ed Pritchett, Duke University
  • Discussion

09:30-11:00 New Horizons of Cardiac Safety Programs: Do We Need “Thorough” Blood Pressure, Heart Rate, Platelet, and Lipid Studies?

  • Preclinical Academic View: Fred Apple, University of Minnesota
  • Preclinical Industry View: Dusty Sarazan, Covance
  • Preclinical FDA View: Patricia Harlow, FDA
  • Clinical Academic View: Robert Christenson, University of Maryland
  • Research Industry View: Jeff Heilbraun, Medifacts
  • Clinical FDA View: Robert Fiorentino, FDA
  • Translational View: Norman Stockbridge, FDA
  • Lead Discussants: John Finkle, GlaxoSmithKline; David Whellan, Jefferson University/Duke University
  • Discussion

11:00-12:30 Wrap Up: Where Do We Go From Here – Priorities & Next Steps

  • Preclinical View: Jean-Pierre Valentin, AstraZeneca
  • Clinical View: Paul Kligfield, Cornell University
  • FDA CDER View: Norman Stockbridge, FDA
  • Industry View: John Finkle, GlaxoSmithKline
  • Clinical Research View: Marek Malik, University of London
  • FDA View Office of Commissioner: Wendy Sanhai
  • CSRC View: Mitchell Krucoff, Duke University
  • HESI View: Brian Berridge, GlaxoSmithKline
  • Discussion
  • Next Steps
  • Adjournment
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