Biomarker World Congress 2009

• Assay Development
• Molecular Diagnostics
• Clinical Pharmacology
• Translational Medicine
• Clinical Trials
• Safety Assessment
• Personalized Medicine
• Go/No-Go Decision Making
• Oncology Drugs & Diagnostics

Distinguished Faculty

• Executive ThinkTank: Collaborations, Consortia, and Funding Opportunities in Biomarker Development
• Short Course: Fit-for-Purpose Biomarker Assay Development & Validation
• Workshop: Biomarkers for Cancer Drug Development

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Main Conference
Wednesday, May 27

Plenary Keynotes

• Predictive Biomarkers: Using What's Been Learned from Past Regulatory Decisions to Inform Future Development Plans
  Lawrence J. Lesko, Ph.D., F.C.P., Director, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration
  
  
• Genetic and Metabolomic Markers of Disease Risk
  C. Thomas Caskey, M.D., F.A.C.P., Director & Chief Executive Officer, The Brown Foundation Institute of Molecular Medicine and Genetics, The University of Texas, Health Science Center at Houston

Delivering on the Promise of Personalized Medicine

• Biomarkers in Personalized Health Care: Opportunities, Challenges, Approaches
  Klaus Lindpaintner, M.D., M.P.H., Head, Medical Genomics & Vice President, Research, F. Hoffmann-La Roche AG
  
  
• Personalized Medicine: Turning Promise into Reality
  Geert Kolvenbag, M.D., Ph.D., Global Product Vice President, Oncology, AstraZeneca Pharmaceuticals, Inc.
  
  
• Promulgating use of Pharmacogenomics Tests on a National Level: The Medco Experience
  Robert E. Epstein, M.D., M.S., Senior Vice President, Medical & Analytical Affairs; Chief Medical Officer, Medco Health Solutions, Inc.
• A Business Context for Personalized Medicine Research & Development
  Brian B. Spear, Ph.D., Director, Scientific Affairs, Global Pharmaceutical Research and Development, Abbott Labs
• Biostatistics Challenges in Personalized Medicine
  Kwan Lee, Ph.D., Senior Director, Department of Biostatistics and Data Management, GlaxoSmithKline

Biomarker Adoption in Clinical Trials

• Considerations on the Level of Evidence for Biomarker Adoption
  Scott D. Patterson, Ph.D., Executive Director, Medical Sciences, Amgen, Inc.
• Biomarkers in Drug Development Compared to Medical Practice: Overlaps, Gaps, and Flaps
  Linda C. Surh, M.D., Ph.D., FRCPC, Director, CEDD Global Regulatory Affairs, Neurosciences and Pharmacogenetics, GlaxoSmithKline, UK
• Use of a Surrogate Biomarker as an Efficacy Endpoint in Clinical Trials and a Monitoring Tool in Routine Patient Management
  Yaping Shou, M.D., Ph.D., Director, Oncology Biomarkers and Imaging, Novartis Pharmaceuticals

Molecular Diagnostics for Personalized Medicine

• Predictive Biomarkers in Clinical Development
  Darren Hodgson, Ph.D., Biomics Advisor,Oncology Therapy Area, AstraZeneca
• Strategies for Companion Diagnostic Development in a Pharmaceutical Research & Development Setting
  John C. Bloom, V.M.D., Ph.D., Executive Director, Diagnostic & Experimental Medicine, Eli Lilly & Co.
• Regulatory Perspective of the Role of In Vitro Diagnostics in Personalized Medicine
  Alberto Gutierrez, Ph.D., Deputy Director, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD), U.S. Food and Drug Administration
• Therapy Decisions in Breast Cancer Based on Molecular Diagnostics
  Christoph Petry, Ph.D., Head, Molecular Research Germany, Siemens Healthcare Diagnostics Products GmbH

Clinical Pharmacology

• Application of Pharmacodynamic Markers for Proof of Principle
  Hans Winkler, Ph.D., Senior Director & Global Head, Oncology Biomarkers, Pharmaceutical Research & Development, Johnson & Johnson
• Translational Pharmacology: Using PD-Biomarkers and PK/PD Modeling to Bridge Preclinical and Clinical Pharmacology
  Paul J. Fielder, Ph.D., Senior Director & Senior Scientist, Early Development Pharmacokinetics, Pharmacodynamic and Bioanalytical Sciences,Genentech, Inc.
• Developing Biomarkers for Proof-of-Pharmacology
  Mark Fidock, Ph.D., Head, Biochemical and Molecular BioMarkers, Experimental Biological Sciences, Pfizer Limited
• Value of Biomarkers in the Oncology Therapeutic Area in Proof-of-Concept Clinical Evaluations
  Chetan Lathia, Ph.D., Director, Global Clinical Pharmacology, Bayer Corp.

Biomarkers in Translational Medicine

• Translational Medicine in the Pharmaceutical Industry: Addressing Multiple Challenges in the New Environment
  Giora Feuerstein, M.D., Assistant Vice President & Head, Discovery Translational Medicine, Wyeth Research
• Biomarkers in Translational Medicine: Importance of Technological and Operational Innovation
  Ole Vesterqvist, Ph.D., Senior Director, Biomarker Lab & Outsourcing, Clinical Translational Medicine, Wyeth Research

Toxicity Biomarkers

• Predictive Safety Biomarkers in Non-Clinical Development
  Phil Hewitt, Ph.D., Head, Molecular Toxicology, Institute of Toxicology, Merck KGaA
• Identification of Proteasome Gene Regulation in a Rat Model for Hyperlipidemia using Microarray Analysis
  Jeffrey Waring, Ph.D., Associate Research Fellow & Group Leader, Cellular & Molecular Toxicology, Abbott Labs
• Tissue-Specific, Non-Invasive Biomarkers for Pre-Clinical Safety Assessment
  Patrick Y. Mueller, Ph.D., Project Leader, Safety Assessment, Novartis Pharma AG
• Finding Biomarkers that Predict Rare Adverse Events: Assessing the Risk for Acute Idiosyncratic Hepatocellular Injury (AIHI)
  John C. Bloom, V.M.D., Ph.D., Executive Director, Diagnostic & Experimental Medicine, Eli Lilly & Co.

Biomarker Assay Development

• The Next Challenge for Biomarker Assay Development to Monitor Drug Effects
  Francois Legay, Ph.D., Global Head, Marker Localization & Assays, Novartis Pharma AG
• The Critical Role of Characterizing Emerging Technologies Prior to Biomarker Development
  Michael E. Burczynski, Ph.D., Associate Director, Biomarker Lab, Clinical Translational Medicine, Wyeth Pharmaceuticals

Biomarker Qualification: Biological and Analytical Validation

• Biomarker Development and their Clinical Qualification
  Wendy Sanhai, Ph.D., Senior Scientific Advisor, Office of the Commissioner, U.S. Food and Drug Administration
• Critical Path Institute: Collaboration Towards Biomarker Qualification
  Maryellen de Mars, Ph.D., Director, Clinical Biomarkers, The Critical Path Institute
• Biospecimen Research to Enable Molecular Medicine
  Helen M. Moore, Ph.D., Director, Biospecimen Research Network, National Cancer Institute, National Institutes of Health
• RNA Readouts as Clinical Biomarkers
  Stewart Bates, Ph.D., Director, Stevenage Core Technologies Group, Discovery Technology Group, GlaxoSmithKline

Close of Conference

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