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2008 Symposium Topics and Agenda


BUILDING A FRAMEWORK FOR BIOMARKER APPLICATION
September 10—12, 2008 Bethesda, MD		 Print Agenda

Agenda:

September 10, 2008  
Dinner 6:00-6:30 INTRODUCTION – Jean-Claude Tardif/Peter Libby
6:00pm – 10:00pm 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
  Speakers:

Phil Barter (30 min) “HDL Overview and Recent Trials”
H. Bryan Brewer (30 min) “HDL Mimetics”
Kerry-Anne Rye (30 min) “Anti-inflammatory properties of HDL”
Jay Heinecke (30 min) “When Good Cholesterol Goes Bad”
Alan Tall (30 min) “A Mechanistic Understanding of the Anti-atherogenic Properties of HDL: Occam’s razor revisited”
  Panel Discussion: (30 minutes)

  Panelists:

Jean-Claude Tardif
Peter Libby
David Orloff
Christie Ballantyne
Alan Tall
Phil Barter
H. Bryan Brewer
Jay Heinecke
Kerry-Anne Rye
   
September 11, 2008  INTRODUCTION – Jean-Claude Tardif/Peter Libby 
8:00am – 11:30am 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, MD, NIH, NHLBI
  Speakers:

Discovery

Robert Balaban (30 min)“Systems Biology Approaches to ID New Targets and Markers”
Jacques Mizrahi “Case Study (30 min)– Type II Diabetes”

Product Development

Jean-Jacques Garaud  (30 min)“Markers in Drug Development – Balancing Evidence and Risk in Decision-Making” 

BREAK (20 min)

Bram Zuckerman  (15 min) “Biomarkers in Device Development and Evaluations”
David Orloff (15 min) “Biomarkers in Drug Development”
Wolfgang Koenig (20 min) Case Studies
Jean-Claude Tardif  (20 min) Case Studies
  Panel Discussion: (30 min)
  Panelists:

Wolfgang Koenig
Bram Zuckerman
Jean-Jacques Garaud
Jacques Mizrahi
Robert Balaban
Jean-Claude Tardif
Peter Libby
Elizabeth Mansfield
Michael Perelman
Joel Raichlen
Ben Eloff
12:00pm – 3:00pm 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
  Speakers:

Regulatory Considerations in Central Image Analysis
     Dwaine Rieves, M.D. (30 min)
     Brandon Gallas, M.D. (30 min)
     
Central Image Analysis for Research and Product Development
     George Mills, M.D. (12 min) “The Qualification of Imaging Surrogate Criteria”
     Jean-Claude Tardif, M.D. (15 min)
     Jonathan Allis, M.D. (15 min)
     George Mills, M.D. (20 min) “The Quality Requirements for Successful Imaging in Clinical Trials: Standardization of Imaging at Clinical Sites & Harmonization of Imaging Across Multicenter Clinical Trials”
  Roundtable Discussions: (60 min)
  Panelists:

Douglas Throckmorton
Dwaine Rieves
Norman Stockbridge
Robert Balaban
Jean-Claude Tardif
Joao Lima
Don Black
Brandon Gallas
David Brown
Joel Raichlen
George Mills
3:00pm – 6:30pm SAFETY BIOMARKERS
  Session Leaders: Norman Stockbridge, M.D., US Food and Drug Administration
Eric P. Brass, M.D., Ph.D., Harbor-UCLA Medical Center
Jean Rouleau, M.D., University of Montreal

  Speakers:

Eric Brass (30 min)“Proteomics/RNA expression profiling for skeletal muscle”
Roger Ulrich (30 min) “Differentiating Biomarkers for Drug-Induced Liver Injury”
Federico Goodsaid (30 min) “markers of renal toxicity”

BREAK (30 min)

James DeLemos (30 min) “Biomarkers and Thrombosis”

Jeff Leiden (30 min)“Educating People About the Risk/Benefit Decisions”
  Panel Discussion: (30 min)

  Panelists:

Jean Rouleau
Norman Stockbridge
Eric Brass
Peter Libby
Jean-Claude Tardif
Roger Ulrich
Federico Goodsaid
Jeff Leiden
Amy Rudolph
Bram Zuckerman
James DeLemos
Philip Sager
6:30pm – 7:00pm   Dinner
7:00pm – 10:00pm SURROGATES FOR REGULATORY APROVAL – A 360 degree Perspective
  Session Leaders: Mary Parks, M.D., US Food and Drug Administration
David Waters, M.D., University of California, San Francisco
Allen Taylor, M.D., Walter Reed Army Medical Center
  Speakers:

David Waters, M.D. (10 min) Introduction

FDA Case Studies:
     LDL - Mary Parks, M.D. (20 min)
     Glucose - Hylton Joffe, M.D. (20 min)
     HDL/Imaging - Eric Colman, M.D. (20 min)

Clinician’s Perspective
     Clinician #1  Allen Taylor, M.D. (15 min)
     Clinician #2  Lawrence Leiter, M.D. (15 min)
     Clinician #3  Paul Ridker, M.D. (15 min)
  Panel Discussion:

Regulatory Perspective
    US FDA -  Robert Temple, M.D. (20 min)
    Health Canada - Agnes Klein, M.D. (20 min)
  Panelists:

Surrogates versus Outcome Studies? (30 min)

Mary Parks
David Waters
Allen Taylor
Peter Libby
Jean-Claude Tardif
Robert Temple
Agnes Klein
Paul Ridker
Lawrence Leiter
Eric Coleman
Hylton Jaffe
Michele Mercuri
Russell Basser
   
September 12, 2008  
8:00am – 11:30am EVIDENTIARY STANDARDS FOR BIOMARKER QUALIFICATION
  Session Leaders: 

Federico Goodsaid, M.D., US Food and Drug Administration
Christopher Cannon, M.D., Brigham and Women’s Hospital
Christopher O’Donnell, M.D., NHLBI, National Institutes of Health

Technical, Validation and Standardization Issues

Elizabeth Mansfield, M.D, (20 min)– Getting Biomarkers There from Here: Understanding Test Performance"
Carolyn Compton M.D., Ph.D. (20 min) – Biospecimens Best Practices – What are they and why do we need them?
David Brown, Ph.D. (20 min) Imaging and Analysis methods
Gregory Campbell, Ph.D. (20 min) - Statistical Considerations

BREAK (20 min)

Non-Clinical Evidentiary Standards (20 min) Patricia Harlow
Biomarkers in Global Risk Assessment (20 min) Christopher O’Donnell
Biomarker Qualification Project (20 min) Federico Goodsaid
  Panel Discussion (30 min)
  Panelists:

Chris Cannon
Federico Goodsaid
Christopher O’Donnell                             
Peter Libby
Jean-Claude Tardif
Elizabeth Mansfield
Carolyn Compton
David Brown
Greg Campbell
Paula Trumbo
Patricia Harlow
Michael Davidson
11:30am – 12:00pm Lunch
12:00pm – 3:30pm  BIOMARKERS IN CLINICAL PRACTICE AND PUBLIC HEALTH
  Session Leaders:   George Mensah, M.D., Center for Disease Control and Prevention
James De Lemos, M.D., University of Texas-Southwestern Medical School
Gurvaneet Randhawa, M.D., US Agency for Healthcare Res. and Quality
  Speakers:

“Mapping the Translation Process” (20 min) – Gurvaneet Randhawa
“Challenges in Translating the Science” (20 min) – George Mensah
“Biomarkers in Population Screening and Surveillance” (20 min) – James DeLemos
  Panel Discussion: (20 min)
  Panelists:

George Mensah
James De Lemos
Gurvaneet Randhawa
Peter Libby
Jean-Claude Tardif
Christie Ballantyne
David Waters
Michael Perelman
Colin Berry

Break (20 min)

Individualized and Personalized Healthcare (20 min) – Felix Frueh
Role of Government and Professional Societies in Clinical Guideline Development” (20 min) – TBD
“Economic/Reimbursement Considerations” (20 min) – TBD
  Panel Discussion: (20 min)

  Panel:

Jean Rouleau
George Mensah
James De Lemos
Gurvaneet Randhawa
Mark Grant
Peter Libby
Jean-Claude Tardif
Wolfgang Koenig
Felix Frueh

List of Topics:

Evaluating Biomarkers in Light of New Clinical Trial Data
Recent data on HbA1c, LDL-C, HDL-C, CRP, and BNP
Translating Science into Clinical Applications
Population Screening and Risk Stratification
Biomarker Guided Therapeutic Targets
Established and Emerging In-vitro Biomarkers and Diagnostics
Established and Emerging Imaging Technologies       
Proteomics and Genomics       
Lipoproteins, Inflammation, and Other Related Risk Factors
Biomarker Economics
Evidentiary Standards and Validation
Maximizing Biomarker Utility
Drug/Diagnostic Development Strategies
Biomarkers in Risk and Therapeutic Assessment
Biomarkers as Safety Surrogates
Atherothrombosis, Hypertension and Heart Failure
Use of Biomarkers and Surrogates for Regulatory Decision-Making
Cardiovascular Markers in Food Safety and Nutrition
Biomarkers in Model-Based Drug Development           
NIH/NHLBI Biomarker Initiatives
Statistical Considerations in Biomarker Evaluation     
Application of Systems Biology to Biomarkers
Diabetes, Obesity and Metabolic Syndrome
Molecular Imaging
Biomarker Qualification in Regulatory Science
Application of CV Markers to Clinical Practice and Public Health
Regulatory Considerations for Soluble and Imaging Biomarker Applications
Pathogenesis of Atherothrombotic Disease and Biomarker Identification


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