Web Desc
Genomic Biomarkers Impact on Drug Discovery and Clinical Practice
Organizer(s): Stephen H. Friend and Lawrence J. Lesko
Date: January 26 - 30, 2004
Location: Hilton Santa Fe Historic Plaza Hotel, Santa Fe, NM, USA
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.
Discounted Abstract Deadline: September 25 2003
Discounted Registration Deadline: November 26 2003
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:

Click here to view more of these organizations
Special thanks to the following for their support of Keystone Symposia initiatives to increase participation at this meeting by scientists from underrepresented backgrounds:

Click here to view more of these organizations

Program

Monday, January 26 | 3:00PM - 7:00PM
Registration
Room: Promenade


Monday, January 26 | 6:15PM - 7:15PM
Refreshments
Room: Promenade


Monday, January 26 | 7:15PM - 7:30PM
Orientation
Room: Mesa A-B


Monday, January 26 | 7:30PM - 8:30PM
Keynote Address
Room: Mesa A-B

Speaker 1 of 2
* Stephen H. Friend, Sage Bionetworks, USA

Monday, January 26 | 7:30PM - 8:30PM
Keynote Address
Room: Mesa A-B

Speaker 2 of 2
Ralph Snyderman, Duke University, USA
Prospective Medicine: The Next Transformation of Health Care

Tuesday, January 27 | 7:00AM - 8:00AM
Breakfast
Room: Chamisa


Tuesday, January 27 | 8:00AM - 11:15AM
Sub-Typing Human Diseases
Room: Mesa A-B

Speaker 1 of 5
Jeffrey Gulcher, Nextcode Corporation, USA
Subtyping Common Human Diseases using Disease Genes of Substantial Risk

Tuesday, January 27 | 8:00AM - 11:15AM
Sub-Typing Human Diseases
Room: Mesa A-B

Speaker 2 of 5
David R. Cox, Perlegen Sciences, Inc., USA
Human Genetic Variation and Complex Human Traits

Tuesday, January 27 | 8:00AM - 11:15AM
Sub-Typing Human Diseases
Room: Mesa A-B

Speaker 3 of 5
Daniel K. Burns, GlaxoSmithKline, USA
Our Hands on SNP Experience

Tuesday, January 27 | 8:00AM - 11:15AM
Sub-Typing Human Diseases
Room: Mesa A-B

Speaker 4 of 5
Peter Wagner, Zyomyx, Inc., USA
Molecular Profiling using Antibody Arrays

Tuesday, January 27 | 8:00AM - 11:15AM
Sub-Typing Human Diseases
Room: Mesa A-B

Speaker 5 of 5
* Grant Williams, U.S. Food and Drug Administration, USA
Overview of Opportunities and Issues

Tuesday, January 27 | 9:20AM - 9:40AM
Coffee Break
Room: Promenade


Tuesday, January 27 | 11:15AM - 11:30AM
Panel Discussion
Room: Mesa A-B


Tuesday, January 27 | 4:30PM - 5:00PM
Coffee & Snacks Available
Room: Promenade


Tuesday, January 27 | 5:00PM - 7:00PM
Emerging Methods for Genomic Biomarkers (Late Breaking News)
. Session Sponsored in part by Iconix Pharmaceuticals, Inc.

Room: Mesa A-B

Speaker 1 of 4
Benjamin F. Cravatt III, The Scripps Research Institute, USA
Activity-Based Protein Profiling - Chemical Strategies for Functional Proteomics

Tuesday, January 27 | 5:00PM - 7:00PM
Emerging Methods for Genomic Biomarkers (Late Breaking News)
. Session Sponsored in part by Iconix Pharmaceuticals, Inc.

Room: Mesa A-B

Speaker 2 of 4
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

Tuesday, January 27 | 5:00PM - 7:00PM
Emerging Methods for Genomic Biomarkers (Late Breaking News)
. Session Sponsored in part by Iconix Pharmaceuticals, Inc.

Room: Mesa A-B

Speaker 3 of 4
* Benjamin L. Hsu, GlaxoSmithKline, USA
Short Talk: Transcriptome and Proteomic Analysis of Cyclooxygenase (COX) Inhibition in Human Subjects

Tuesday, January 27 | 5:00PM - 7:00PM
Emerging Methods for Genomic Biomarkers (Late Breaking News)
. Session Sponsored in part by Iconix Pharmaceuticals, Inc.

Room: Mesa A-B

Speaker 4 of 4
John K. Leighton, U.S. Food and Drug Administration, USA
Integration of Nonclinical Genomic Data into Safety Assessment

Tuesday, January 27 | 7:00PM - 8:00PM
Social Hour
Room: Mesa C


Wednesday, January 28 | 7:00AM - 8:00AM
Breakfast
Room: Chamisa


Wednesday, January 28 | 8:00AM - 9:00AM
Plenary Address
Room: Mesa A-B

Speaker 1 of 1
Robert T. Temple, U.S. Food and Drug Administration, USA
What is the Same, What is Different with Genome Biomarkers?

Wednesday, January 28 | 9:00AM - 11:15PM
Detection of Early Disease
Room: Mesa A-B

Speaker 1 of 3
Sridhar Ramaswamy, Google Ventures, USA
Genomic Approaches to Molecular Oncology

Wednesday, January 28 | 9:00AM - 11:15PM
Detection of Early Disease
Room: Mesa A-B

Speaker 2 of 3
John J. Sninsky, Translational Sciences, USA
Diagnostic Opportunities and Challenges for Biomarker Research

Wednesday, January 28 | 9:00AM - 11:15PM
Detection of Early Disease
Room: Mesa A-B

Speaker 3 of 3
* Penelope K. Manasco, PharmaVigilant, USA
Protecting Patient Confidentiality in Genetic Studies

Wednesday, January 28 | 9:20AM - 9:40AM
Coffee Break
Room: Promenade


Wednesday, January 28 | 11:15AM - 11:30AM
Panel Discussion
Room: Mesa A-B


Wednesday, January 28 | 11:30AM - 1:00PM
Poster Setup
Room: Mesa C


Wednesday, January 28 | 1:00PM - 10:00PM
Poster Viewing
Room: Mesa C


Wednesday, January 28 | 4:30PM - 5:00PM
Coffee & Snacks Available
Room: Promenade


Wednesday, January 28 | 5:00PM - 7:00PM
Identifying Drug Responders from Non-Responders
Room: Mesa A-B

Speaker 1 of 4
Nicholas C. Dracopoli, Janssen R&D Inc., USA
Pharmacogenomic Applications in Preclinical and Clinical Drug Development

Wednesday, January 28 | 5:00PM - 7:00PM
Identifying Drug Responders from Non-Responders
Room: Mesa A-B

Speaker 2 of 4
Eric Schadt, Mount Sinai School of Medicine, USA
Integrating Genotypic and Functional Genomic Data to Predict Patient Response to Drug Treatment

Wednesday, January 28 | 5:00PM - 7:00PM
Identifying Drug Responders from Non-Responders
Room: Mesa A-B

Speaker 3 of 4
* Robert J. Meyer, U.S. Food and Drug Administration, USA
Clinical Trial Design Considerations in Using Genomic Biomarkers of Safety and/or Efficacy

Wednesday, January 28 | 5:00PM - 7:00PM
Identifying Drug Responders from Non-Responders
Room: Mesa A-B

Speaker 4 of 4
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

Wednesday, January 28 | 7:00PM - 8:00PM
Social Hour
Room: Mesa C


Wednesday, January 28 | 8:00PM - 10:00PM
Poster Session
Room: Mesa C


Thursday, January 29 | 7:00AM - 8:00AM
Breakfast
Room: Chamisa


Thursday, January 29 | 8:00AM - 11:15AM
Biomarkers to Monitor the Safety of Compounds
Room: Mesa A-B

Speaker 1 of 6
* William D. Pennie, Pfizer Inc., USA
Applications of Genomic Biomarkers to Safety Assessment in Drug Discovery and Development: Opportunities and Challenges

Thursday, January 29 | 8:00AM - 11:15AM
Biomarkers to Monitor the Safety of Compounds
Room: Mesa A-B

Speaker 2 of 6
Roger G. Ulrich, RUC Pharmaceutical Development Specialists, USA
Molecular Profiling Approaches for Identifying Toxicological Pathways and Potential Biomarkers of Adverse Drug Effects

Thursday, January 29 | 8:00AM - 11:15AM
Biomarkers to Monitor the Safety of Compounds
Room: Mesa A-B

Speaker 3 of 6
Urs A. Meyer, University of Basel, Switzerland
Diversity of Drug Response: From Genotype to Phenotype

Thursday, January 29 | 8:00AM - 11:15AM
Biomarkers to Monitor the Safety of Compounds
Room: Mesa A-B

Speaker 4 of 6
James T. MacGregor, FDA National Center for Toxicological Research, USA
Practical Aspects of Genomic Safety Biomarker Development

Thursday, January 29 | 8:00AM - 11:15AM
Biomarkers to Monitor the Safety of Compounds
Room: Mesa A-B

Speaker 5 of 6
Sarah C. Stallings, Massachusetts Institute of Technology, USA
Short Talk: An Economic Framework for Evaluating Personalized Medicine

Thursday, January 29 | 8:00AM - 11:15AM
Biomarkers to Monitor the Safety of Compounds
Room: Mesa A-B

Speaker 6 of 6
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

Thursday, January 29 | 9:20AM - 9:40AM
Coffee Break
Room: Promenade


Thursday, January 29 | 11:15AM - 11:30AM
Panel Discussion
Room: Mesa A-B


Thursday, January 29 | 3:30PM - 4:30PM
Case Study
Room: Mesa A-B

Speaker 1 of 2
* Lawrence J. Lesko, U.S. Food and Drug Administration, USA

Thursday, January 29 | 3:30PM - 4:30PM
Case Study
Room: Mesa A-B

Speaker 2 of 2
Allen D. Roses, Duke University, Drug Discovery Institute, USA
Pharmacogenetics and Pharmacogenomics: View from a Pharmaceutical Pipeline

Thursday, January 29 | 4:30PM - 5:00PM
Coffee & Snacks Available
Room: Promenade


Thursday, January 29 | 5:00PM - 7:00PM
Developing a Strategy for Integrating Biomarkers into Clinic
al Practice

Room: Mesa A-B

Speaker 1 of 4
* Stephen H. Friend, Sage Bionetworks, USA

Thursday, January 29 | 5:00PM - 7:00PM
Developing a Strategy for Integrating Biomarkers into Clinic
al Practice

Room: Mesa A-B

Speaker 2 of 4
Lawrence J. Lesko, U.S. Food and Drug Administration, USA

Thursday, January 29 | 5:00PM - 7:00PM
Developing a Strategy for Integrating Biomarkers into Clinic
al Practice

Room: Mesa A-B

Speaker 3 of 4
Larry Norton, Memorial Sloan Kettering Cancer Center, USA

Thursday, January 29 | 5:00PM - 7:00PM
Developing a Strategy for Integrating Biomarkers into Clinic
al Practice

Room: Mesa A-B

Speaker 4 of 4
Kathryn A. Phillips, University of California, San Francisco, USA
Short Talk: Applying Economic Analysis to Genomic Biomarkers: Challenges for Industry

Thursday, January 29 | 7:00PM - 8:00PM
Social Hour
Room: Mesa C


Thursday, January 29 | 8:00PM - 11:00PM
Entertainment
Room: Mesa C


Thursday, January 29 | 8:00PM - 11:00PM
Cash Bar
Room: Mesa C


Friday, January 30 | 10:26AM - 10:26AM
Departure


*Session Chair.