2008 Cardiovascular Biomarkers and Surrogate Endpoints Symposium 

BUILDING A FRAMEWORK FOR BIOMARKER APPLICATION

September 10-12, 2008

Program

Introduction

Session 1 – HDL CONTROVERSIES

Session Leaders: Philip Barter, M.D., University of Sydney; H. Bryan Brewer, M.D., MedStar Research Institute; Jay Heinecke, M.D., University of Washington

HDL Overview and Recent Trials - Philip Barter, M.D., University of Sydney

HDL Mimetics - H. Bryan Brewer, M.D., Medstar Research Institute

Anti-inflammatory Properties of HDL - Kerry-Anne Rye, Ph.D., The Heart Research Institute

When Good Cholesterol Goes Bad - Jay Heinecke, M.D., University of Washington

A Mechanistic Understanding of the Anti-Atherogenic Properties of HDL: Occam’s razor revisited

 - Alan Tall, M.D., Columbia University

Panel Discussion:

Christie Ballantyne, M.D., Baylor College of Medicine; Carl Sparrow, Ph.D., Merck Research Laboratories; Alan Tall, M.D., Columbia University; Philip Barter, M.D., University of Sydney; H. Bryan Brewer, M.D., Medstar Research Institute; Jay Heinecke, M.D., University of Washington; Kerry-Anne Rye, M.D., The Heart Research Institute; Jean-Claude Tardif, M.D., Montreal Heart Institute; Peter Libby, M.D., Brigham and Women’s Hospital

Session 2 – PRODUCT DEVELOPMENT AND EVIDENTIARY STANDARDS

Session Leaders: Wolfgang Koenig, M.D, University of Ulm Medical Center; Jean-Jacques Garaud, M.D., F. Hoffmann-La Roche Ltd.; Robert Balaban, M.D., NIH, NHLBI

Systems Biology Approach to ID New Targets and Markers - Robert Balaban, M.D., NIH, NHLBI

Case Studies – Type II Diabetes - Jacques Mizrahi, M.D., F. Hoffmann-La Roche Ltd.

Product Development – Balancing Evidence and Risk in Decision-Making - Jean-Jacques Garaud, M.D., F. Hoffmann-La Roche Ltd.

Biomarkers in Drug Development and Evaluation - David Orloff, M.D., MedPace Inc.

Biomarkers in Device Development and Evaluation - Bram Zuckerman, M.D., US FDA, CDRH

Case Studies  The Critical Gap - Wolfgang Koenig, M.D., University of Ulm Medical Center

Panel Discussion

Elizabeth Mansfield, M.D., US FDA CDRH; Michael Perelman, M.D., Schering-Plough; Benjamin Eloff, Ph.D., US FDA Office of the Commissioner; Jean-Claude Tardif, M.D., Montreal Heart Institute; Peter Libby, M.D., Brigham and Women’s Hospital; Wolfgang Koenig, M.D., University of Ulm Medical Center; Bram Zuckerman, M.D., US FDA CDRH; Jean-Jacques Garaud, M.D., F. Hoffmann-La Roche; Jacques Mizrahi, M.D., F. Hoffmann-La Roche; Robert Balaban, M.D., NIH, NHLBI

Session 3 – SPECIAL IMAGING WORKSHOP

CENTRAL IMAGE ANALYSIS – OPTIMIZING PRACTICES AND PROCEDURES

Session Leaders: Jean-Claude Tardif, M.D., Montreal Heart Institute; Douglas Throckmorton, M.D., US FDA, CDER

Regulatory Considerations in Central Image Analysis - Dwaine Rieves, M.D., US FDA, CDER

Regulatory Considerations in Central Image Analysis - Brandon Gallas, Ph.D., US FDA CDRH

Central Image Analysis in An Academic Core Laboratory Setting - Jean-Claude Tardif, M.D., Montreal Heart Institute.

Central Imaging Issues in the Development of Diagnostic Agents - Jonathan Allis, M.D., GE Healthcare.

The Qualification of Imaging Surrogate Criteria - George Mills, M.D., Perceptive Informatics

The Quality Requirements for Successful Imaging in Clinical Trials: Standardization of Imaging at Clinical Sites & Harmonization of Imaging Across Multicenter Clinical Trials - George Mills, M.D., Perceptive Informatics

Panel Discussion

Joao Lima, M.D., Johns Hopkins University; Zahi Fayad, Ph.D., Mount Sinai; Marcelo Di Carli, M.D., Brigham and Women’s Hospital; Pamela Douglas, M.D., Duke University; Eric Stroes, M.D., Academic Medical Center; Joel Raichlen, M.D., Astra-Zeneca; Norman Stockbridge, M.D., US FDA, CDER; Douglas Throckmorton, M.D., US FDA, CDER; Dwaine Rieves, M.D., US FDA, CDER; Robert Balaban, M.D., NIH, NHLBI; Jean-Claude Tardif, M.D., Montreal Heart Institute; Jonathan Allis, M.D., GE Healthcare; Brandon Gallas, Ph.D., US FDA, CDRH; George Mills, M.D., Perceptive Informatics

Session 4 – SAFETY BIOMARKERS

Session Leaders: Norman Stockbridge, M.D., US FDA, CDER; Eric P. Brass, M.D., Ph.D., Harbor-UCLA Medical Center

Biomarkers of Skeletal Muscle Injury - Eric P. Brass, M.D., Ph.D., Harbor-UCLA Medical Center

Differentiating Biomarkers for Drug-Induced Liver Injury - Roger Ulrich, Ph.D., Calistoga Pharmaceuticals

Markers of Renal Toxicity - Federico Goodsaid, Ph.D., US FDA, CDER.

Biomarkers and Thrombosis - James DeLemos, M.D., University of Texas - Southwestern Medical School

Educating Patients and Physicians About Medical Risk/Benefit Decisions - Jeff Leiden, M.D., Ph.D., Clarus Ventures

Panel Discussion

Philip Sager, M.D., CardioDx, Inc.; Amy Rudolph, Ph.D., Pfizer, Inc.; Norman Stockbridge, M.D., US FDA, CDER; Eric Brass, M.D., Ph.D., Harbor-UCLA Medical Center; Peter Libby, M.D., Brigham and Women’s Hospital; Jean-Claude Tardif, M.D., Montreal Heart Institute; Roger Ulrich, Ph.D., Calistoga Pharmaceuticals; Federico Goodsaid, Ph.D., US FDA, CDER; Jeff Leiden, M.D., Clarus Ventures; Bram Zuckerman, M.D., US FDA, CDRH; James DeLemos, M.D., University of Texas – Southwestern Medical School

Session 5 – SURROGATES FOR REGULATORY APPROVAL

“A 360 Degree Perspective”

Session Leaders: Mary Parks, M.D., US FDA, CDER; David Waters, M.D., University of California, San Francisco; Allen Taylor, M.D., Walter Reed Army Medical Center

Introductory Remarks - David Waters, M.D., University of California, San Francisco

FDA Case Studies (LDL-C, HDL-C, Glucose, Imaging) - Mary Parks, M.D., US FDA, CDER; Case Study - Hylton Joffe, M.D., US FDA, CDER; Case Study - Eric Colman, M.D. US FDA, CDER

Clinicians’ Perspectives – Biomarker Utility and Limitations - Allen Taylor, M.D., Walter Reed Army Medical Center; Clinician's Perspective - Lawrence Leiter, M.D., St. Michael’s Hospital, Toronto; Paul Ridker, M.D., Brigham and Women’s Hospital

How Does Health Canada View the Risk/Rewards of Surrogacy? - Agnes Klein, M.D., Health Canada

FDA Policy on Surrogates for Regulatory Approval - Robert Temple, M.D., US FDA Office of Medical Policy

Panel Discussion

Mary Parks, M.D., US FDA, CDER; David Waters, M.D., University of California, San Francisco; Allen Taylor, M.D., Walter Reed Army Medical Center; Peter Libby, M.D., Brigham and Women’s Hospital; Jean-Claude Tardif, M.D., Montreal Heart Institute; Robert Temple, M.D., US FDA, Office of Medical Policy; Agnes Klein, M.D., Health Canada; Paul Ridker, M.D., Brigham and Women’s Hospital; Lawrence Leiter, M.D., St. Michael’s Hospital, Toronto; Eric Coleman, M.D., US FDA, CDER; Hylton Joffe, M. D., US FDA, CDER

Opening Remarks

Session 6 – PRODUCT DEVELOPMENT AND EVIDENTIARY STANDARDS

Session Leaders: Federico Goodsaid, Ph.D., US FDA, CDER; Christopher Cannon, M.D., Brigham and Women’s Hospital; Christopher O’Donnell, M.D., NIH, NHLBI

Getting Biomarkers from There to Here: Understanding Test Performance - Elizabeth Mansfield, M.D., US FDA, CDRH

Biospecimens Best Practices – What are they and why do we need them? - Carolyn Compton, M.D., Ph.D., NIH, National Cancer Institute

Imaging and Analysis Methods - David Brown, Ph.D., US FDA, CDRH

Statistical Considerations - Gregory Campbell, Ph.D., US FDA, CDRH

Non-Clinical Evidentiary Standards - Patricia Harlow, Ph.D., US FDA, CDER

Clinical Evidentiary Standards for Biomarker Qualification - Melanie Blank, MD, US FDA, CDER

Biomarker Data – From Observational Studies to Clinical Trials - Christopher O’Donnell, M.D., NIH, NHLBI

Impact of the Biomarker Qualification Project on Drug Development - Federico Goodsaid, Ph.D., US FDA, CDER

Panel Discussion

Michael Davidson, M.D., University of Chicago; Chris Cannon, M.D., Brigham and Women’s Hospital; Giora Feuerstein, M.D., Wyeth Research; Federico Goodsaid, Ph.D., US FDA, CDER; Christopher O’Donnell, M.D., NIH, NHLBI; Peter Libby, M.D., Brigham and Women’s Hospital; Jean-Claude Tardif, M.D., Montreal Heart Institute; Elizabeth Mansfield, M.D., US FDA, CDRH; Carolyn Compton, M.D., Ph.D., NIH, NCI; David Brown, Ph.D., US FDA, CDER; Greg Campbell, Ph.D., US FDA, CDER; Paula Trumbo, Ph.D., US FDA, CFSAN; Patricia Harlow, Ph.D., US FDA, CDER

Session 7 – BIOMARKERS IN CLINICAL PRACTICE AND PUBLIC HEALTH

Session Leaders: George Mensah, M.D., Centers for Disease Control and Prevention; James De Lemos, M.D., University of Texas – Southwestern Medical School; Gurvaneet Randhawa, M.D., US Agency for Healthcare Research and Quality

Mapping the Translation Process - Gurvaneet Randhawa, M.D., US AHRQ

Challenges in Translating the Science - George Mensah, M.D., CDC

Biomarkers in Population Screening and Surveillance - James De Lemos, M.D., University of Texas – Southwestern Medical School

Individualized and Personalized Healthcare - Felix Frueh, Ph.D., Medco Health Solutions Inc.

Biomarkers and Evidence Informing Policy Decisions - Mark Grant, M.D., Technology Evaluation Center, Blue Cross Blue Shield Association

Panel Discussion

Colin Berry, M.D., Ph.D., NIH, NHLBI; George Mensah, M.D., CDC; James De Lemos, M.D., University of Texas – Southwestern Medical School; Gurvaneet Randhawa, M.D., AHRQ; Peter Libby, M.D., Brigham and Women’s Hospital; Jean-Claude Tardif, M.D., Montreal Heart Institute; David Waters, M.D., University of California, San Francisco; Mark Grant, M.D., Technology Evaluation Center, Blue Cross and Blue Shield Association; Felix Frueh, Ph.D., Medco Health Solutions; Michele Mercuri, M.D., Novartis

Concluding Remarks – Peter Libby and Jean-Claude Tardif