Hilton Santa Fe Historic Plaza Hotel Floorplan

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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.

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No registration fees are used to fund entertainment or alcohol at this conference

Conference Program    Print  |   View meeting in 12 hr (am/pm) time


MONDAY, JANUARY 26

15:00—19:00
Registration

Promenade
18:15—19:15
Refreshments

Promenade
19:15—19:30
Orientation

Mesa A-B
19:30—20:30
Keynote Address
Meeting has ended...abstracts no longer viewable online.

Mesa A-B
* Stephen H. Friend, Sage Bionetworks, USA

Ralph Snyderman, Duke University, USA
Prospective Medicine: The Next Transformation of Health Care


TUESDAY, JANUARY 27

07:00—08:00
Breakfast

Chamisa
08:00—11:15
Sub-Typing Human Diseases
Meeting has ended...abstracts no longer viewable online.

Mesa A-B
Jeffrey Gulcher, Nextcode Corporation, USA
Subtyping Common Human Diseases using Disease Genes of Substantial Risk

David R. Cox, Perlegen Sciences, Inc., USA
Human Genetic Variation and Complex Human Traits

Daniel K. Burns, GlaxoSmithKline, USA
Our Hands on SNP Experience

Peter Wagner, Zyomyx, Inc., USA
Molecular Profiling using Antibody Arrays

* Grant Williams, U.S. Food and Drug Administration, USA
Overview of Opportunities and Issues

11:15—11:30
Panel Discussion

Mesa A-B
09:20—09:40
Coffee Break

Promenade
16:30—17:00
Coffee & Snacks Available

Promenade
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.

Mesa A-B
Benjamin F. Cravatt III, The Scripps Research Institute, USA
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

* Benjamin L. Hsu, GlaxoSmithKline, USA
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

19:00—20:00
Social Hour

Mesa C

WEDNESDAY, JANUARY 28

07:00—08:00
Breakfast

Chamisa
08:00—09:00
Plenary Address
Meeting has ended...abstracts no longer viewable online.

Mesa A-B
Robert T. Temple, U.S. Food and Drug Administration, USA
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.

Mesa A-B
Sridhar Ramaswamy, TESARO, Inc., USA
Genomic Approaches to Molecular Oncology

John J. Sninsky, consultant, USA
Diagnostic Opportunities and Challenges for Biomarker Research

* Penelope K. Manasco, PharmaVigilant,
Protecting Patient Confidentiality in Genetic Studies

11:15—11:30
Panel Discussion

Mesa A-B
09:20—09:40
Coffee Break

Promenade
11:30—13:00
Poster Setup

Mesa C
13:00—22:00
Poster Viewing

Mesa C
16:30—17:00
Coffee & Snacks Available

Promenade
17:00—19:00
Identifying Drug Responders from Non-Responders
Meeting has ended...abstracts no longer viewable online.

Mesa A-B
Nicholas C. Dracopoli, Janssen R&D Inc., USA
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

* Robert J. Meyer, U.S. Food and Drug Administration, USA
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

19:00—20:00
Social Hour

Mesa C
20:00—22:00
Poster Session

Mesa C

THURSDAY, JANUARY 29

07:00—08:00
Breakfast

Chamisa
08:00—11:15
Biomarkers to Monitor the Safety of Compounds
Meeting has ended...abstracts no longer viewable online.

Mesa A-B
* William D. Pennie, Pfizer Inc., USA
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

Urs A. Meyer, University of Basel, Switzerland
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

Sarah C. Stallings, Massachusetts Institute of Technology, USA
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

11:15—11:30
Panel Discussion

Mesa A-B
09:20—09:40
Coffee Break

Promenade
15:30—16:30
Case Study
Meeting has ended...abstracts no longer viewable online.

Mesa A-B
* 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

16:30—17:00
Coffee & Snacks Available

Promenade
17:00—19:00
Developing a Strategy for Integrating Biomarkers into Clinical Practice
Meeting has ended...abstracts no longer viewable online.

Mesa A-B
* Stephen H. Friend, Sage Bionetworks, USA

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

19:00—20:00
Social Hour

Mesa C
20:00—23:00
Entertainment

Mesa C

FRIDAY, JANUARY 30

 
Departure


*Session Chair †Invited, not yet responded.



We gratefully acknowledge additional support for this conference from:

Iconix Biosciences, Inc. Merck Research Laboratories

We appreciate the organizations that provide Keystone Symposia with additional support, such as marketing and advertising:


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Special thanks to the following for their support of Keystone Symposia initiatives to increase participation at this meeting by scientists from underrepresented backgrounds:


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If your organization is interested in joining these entities in support of Keystone Symposia, please contact: Sarah Lavicka, Director of Development, Email: sarahl@keystonesymposia.org,
Phone:+1 970-262-2690

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Phone:+1 970-262-2676