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This meeting took place in 2004
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Genomic Biomarkers Impact on Drug Discovery and Clinical Practice (F1)
Organizer(s) Stephen H. Friend and Lawrence J. Lesko
January 26—30, 2004
Hilton Santa Fe Historic Plaza Hotel • Santa Fe, New Mexico USA
Abstract Deadline: Sep 25, 2003
Late Abstract Deadline:
Scholarship Deadline:
Early Registration Deadline: Nov 26, 2003
Sponsored by Merck Research Laboratories
Summary of Meeting:
The past five years has seen a series of advances in the development of various DNA, RNA and protein biomarkers. Many of these biomarkers have evolved past simply being evidence in proof-of concept studies. Starting from variations in DNA, to alterations in the levels of genes expressed and functional proteins, investigators are now shifting attention to the implementation of these emerging technologies in drug development, academic research and clinical practice. This symposium will focus on bringing the developers of these genomic technologies together with the scientists and clinicians expecting to use them in research and in drug development, and the regulatory scientists charged with assessing their appropriate usage in the marketplace. We will focus on two themes. The first theme will be to exemplify how diverse methods to track DNA, RNA, and protein changes have come to rely on sophisticated techniques of pattern recognition bringing up questions of how best to validate these methods and present their results. The second theme is to compare and contrast the strategies needed to develop biomarkers of disease phenotype from intermediate genomic response markers, from other markers such as genome-based predictive markers. We will discuss the similarities and differences between genomic biomarkers and traditional non-genomic biomarkers that are important to clinical research, drug development and regulatory decision-making.
View Scholarships/Awards
The past five years has seen a series of advances in the development of various DNA, RNA and protein biomarkers. Many of these biomarkers have evolved past simply being evidence in proof-of concept studies. Starting from variations in DNA, to alterations in the levels of genes expressed and functional proteins, investigators are now shifting attention to the implementation of these emerging technologies in drug development, academic research and clinical practice. This symposium will focus on bringing the developers of these genomic technologies together with the scientists and clinicians expecting to use them in research and in drug development, and the regulatory scientists charged with assessing their appropriate usage in the marketplace. We will focus on two themes. The first theme will be to exemplify how diverse methods to track DNA, RNA, and protein changes have come to rely on sophisticated techniques of pattern recognition bringing up questions of how best to validate these methods and present their results. The second theme is to compare and contrast the strategies needed to develop biomarkers of disease phenotype from intermediate genomic response markers, from other markers such as genome-based predictive markers. We will discuss the similarities and differences between genomic biomarkers and traditional non-genomic biomarkers that are important to clinical research, drug development and regulatory decision-making.
View Scholarships/Awards
No registration fees are used to fund entertainment or alcohol at this conference
MONDAY, JANUARY 26
TUESDAY, JANUARY 27
WEDNESDAY, JANUARY 28
THURSDAY, JANUARY 29
FRIDAY, JANUARY 30
Conference Program Print | View meeting in 12 hr (am/pm) time
MONDAY, JANUARY 26
19:30—20:30
Keynote Address
Meeting has ended...abstracts no longer viewable online.
Ralph Snyderman,
Duke University, USA
Prospective Medicine: The Next Transformation of Health Care
Prospective Medicine: The Next Transformation of Health Care
08:00—11:15
Sub-Typing Human Diseases
Meeting has ended...abstracts no longer viewable online.
Jeffrey Gulcher,
Nextcode Corporation, USA
Subtyping Common Human Diseases using Disease Genes of Substantial Risk
Subtyping Common Human Diseases using Disease Genes of Substantial Risk
David R. Cox,
Perlegen Sciences, Inc., USA
Human Genetic Variation and Complex Human Traits
Human Genetic Variation and Complex Human Traits
Daniel K. Burns,
GlaxoSmithKline, USA
Our Hands on SNP Experience
Our Hands on SNP Experience
Peter Wagner,
Zyomyx, Inc., USA
Molecular Profiling using Antibody Arrays
Molecular Profiling using Antibody Arrays
*
Grant Williams,
U.S. Food and Drug Administration, USA
Overview of Opportunities and Issues
Overview of Opportunities and Issues
17:00—19:00
Emerging Methods for Genomic Biomarkers (Late Breaking News). Session Sponsored in part by Iconix Pharmaceuticals, Inc.
Meeting has ended...abstracts no longer viewable online.
Benjamin F. Cravatt III,
The Scripps Research Institute, USA
Activity-Based Protein Profiling - Chemical Strategies for Functional Proteomics
Activity-Based Protein Profiling - Chemical Strategies for Functional Proteomics
Michael E. Burczynski,
Wyeth Pharmaceuticals, USA
Short Talk: Pharmacogenomic Identification of Expression Profiles in Pperipheral Blood Mononuclear Cells Associated with Clinical Response in Patients with Advanced Renal Cell Carcinoma
Short Talk: Pharmacogenomic Identification of Expression Profiles in Pperipheral Blood Mononuclear Cells Associated with Clinical Response in Patients with Advanced Renal Cell Carcinoma
*
Benjamin L. Hsu,
GlaxoSmithKline, USA
Short Talk: Transcriptome and Proteomic Analysis of Cyclooxygenase (COX) Inhibition in Human Subjects
Short Talk: Transcriptome and Proteomic Analysis of Cyclooxygenase (COX) Inhibition in Human Subjects
John K. Leighton,
U.S. Food and Drug Administration, USA
Integration of Nonclinical Genomic Data into Safety Assessment
Integration of Nonclinical Genomic Data into Safety Assessment
08:00—09:00
Plenary Address
Meeting has ended...abstracts no longer viewable online.
Robert T. Temple,
U.S. Food and Drug Administration, USA
What is the Same, What is Different with Genome Biomarkers?
What is the Same, What is Different with Genome Biomarkers?
09:00—23:15
Detection of Early Disease
Meeting has ended...abstracts no longer viewable online.
John J. Sninsky,
consultant, USA
Diagnostic Opportunities and Challenges for Biomarker Research
Diagnostic Opportunities and Challenges for Biomarker Research
*
Penelope K. Manasco,
PharmaVigilant,
Protecting Patient Confidentiality in Genetic Studies
Protecting Patient Confidentiality in Genetic Studies
17:00—19:00
Identifying Drug Responders from Non-Responders
Meeting has ended...abstracts no longer viewable online.
Nicholas C. Dracopoli,
Janssen R&D Inc., USA
Pharmacogenomic Applications in Preclinical and Clinical Drug Development
Pharmacogenomic Applications in Preclinical and Clinical Drug Development
Eric Schadt,
Mount Sinai School of Medicine, USA
Integrating Genotypic and Functional Genomic Data to Predict Patient Response to Drug Treatment
Integrating Genotypic and Functional Genomic Data to Predict Patient Response to Drug Treatment
*
Robert J. Meyer,
U.S. Food and Drug Administration, USA
Clinical Trial Design Considerations in Using Genomic Biomarkers of Safety and/or Efficacy
Clinical Trial Design Considerations in Using Genomic Biomarkers of Safety and/or Efficacy
Julie A. Lekstrom-Himes,
Millennium Pharmaceuticals, Inc., USA
Short Talk: Therapeutic Response Biomarkers for Use in Proof of Concept Clinical Trials: Discovery and Validation of Biomarkers Sets using Large Patient Registries
Short Talk: Therapeutic Response Biomarkers for Use in Proof of Concept Clinical Trials: Discovery and Validation of Biomarkers Sets using Large Patient Registries
08:00—11:15
Biomarkers to Monitor the Safety of Compounds
Meeting has ended...abstracts no longer viewable online.
*
William D. Pennie,
Pfizer Inc., USA
Applications of Genomic Biomarkers to Safety Assessment in Drug Discovery and Development: Opportunities and Challenges
Applications of Genomic Biomarkers to Safety Assessment in Drug Discovery and Development: Opportunities and Challenges
Roger G. Ulrich,
RUC Pharmaceutical Development Specialists, USA
Molecular Profiling Approaches for Identifying Toxicological Pathways and Potential Biomarkers of Adverse Drug Effects
Molecular Profiling Approaches for Identifying Toxicological Pathways and Potential Biomarkers of Adverse Drug Effects
Urs A. Meyer,
University of Basel, Switzerland
Diversity of Drug Response: From Genotype to Phenotype
Diversity of Drug Response: From Genotype to Phenotype
James T. MacGregor,
FDA National Center for Toxicological Research, USA
Practical Aspects of Genomic Safety Biomarker Development
Practical Aspects of Genomic Safety Biomarker Development
Sarah C. Stallings,
Massachusetts Institute of Technology, USA
Short Talk: An Economic Framework for Evaluating Personalized Medicine
Short Talk: An Economic Framework for Evaluating Personalized Medicine
Pascale F. Macgregor,
University Health Network, Canada
Short Talk: Identification of the Pathways of Intrinsic Drug Resistance in Epithelial Ovarian Cancer using Molecular Profiling at the RNA and DNA Level
Short Talk: Identification of the Pathways of Intrinsic Drug Resistance in Epithelial Ovarian Cancer using Molecular Profiling at the RNA and DNA Level
15:30—16:30
Case Study
Meeting has ended...abstracts no longer viewable online.
*
Lawrence J. Lesko,
U.S. Food and Drug Administration, USA
Allen D. Roses,
Duke University, Drug Discovery Institute, USA
Pharmacogenetics and Pharmacogenomics: View from a Pharmaceutical Pipeline
Pharmacogenetics and Pharmacogenomics: View from a Pharmaceutical Pipeline
17:00—19:00
Developing a Strategy for Integrating Biomarkers into Clinical Practice
Meeting has ended...abstracts no longer viewable online.
Lawrence J. Lesko,
U.S. Food and Drug Administration, USA
Larry Norton,
Memorial Sloan Kettering Cancer Center, USA
Kathryn A. Phillips,
University of California, San Francisco, USA
Short Talk: Applying Economic Analysis to Genomic Biomarkers: Challenges for Industry
Short Talk: Applying Economic Analysis to Genomic Biomarkers: Challenges for Industry
*Session Chair †Invited, not yet responded.
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