As of July 16, 2008
MONDAY, SEPTEMBER 22
EDUCATIONAL SESSIONS
12:00 p.m.-2:00 p.m.
SESSION 1A: ASSAY VALIDATION
Chairperson: Andrew Hruszkewycz, National Cancer Institute, Bethesda, MD
- Exploiting the Success and Failure of Cancer Therapies: Investing Now in Accurate Biomarker Data to Improve Outcomes Later
Peter S. Nelson, Fred Hutchinson Cancer Research Center, Seattle, WA
- Biomarker Validation: Pre-analytic and Assay Performance
Herbert A. Fritsche, UT M. D. Anderson Cancer Center, Houston, TX
- Accurate, Reproducible, and Quantitative Measurement of Protein Analyte Concentration(s) in Tissue Slides
David L. Rimm, Yale University School of Medicine, New Haven, CT
- Statistical Issues in Biomarker Assay Development and Evaluation
Viswanath Devanarayan, Abbott Laboratories, Parsippany, NJ
SESSION 1B: NON-CODING RNAS
Chairperson: Carlo M. Croce, Ohio State University, Columbus, OH
- microRNA Reprogramming by Oncogenes and Tumor Suppressors
Joshua Mendell, Johns Hopkins University, Baltimore, MD
- miRNome Integrative Analysis in Ovarian Cancer
George Coukos, University of Pennsylvania Medical Center, Philadelphia, PA
- microRNAs in the Diagnosis and Prognosis of Cancer
Carlo Croce
- microRNAs in Control of Cell Proliferation
Anindya Dutta, University of Virginia, Charlottesville, VA
EDUCATIONAL SESSIONS
2:15 p.m.-4:15 p.m.
SESSION 2A: MOLECULAR MARKERS AND PATIENT DECISIONS
Chairpersons: Jane Perlmutter, Gemini Group, Naperville, IL, and Daniel F. Hayes, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI
- Beyond Comprehension: Challenges in Helping People Use Genetic Information Wisely
Peter A. Ubel, University of Michigan, Ann Arbor, MI
- Title to be announced
Peter M. Ravdin, University of Texas Health Science Center, San Antonio, TX
- Patient Styles of Coping with Risk Feedback
Suzanne M. Miller, Fox Chase Cancer Center, Cheltenham, PA
- Panel Discussion Participants:
Susan Friedman, FORCE, Fort Lauderdale, Florida
Daniel F. Hayes
Jane Perlmutter
Steven Shak, Genomic Health, Inc., Redwood, CA
SESSION 2B: MOLECULAR IMAGING: FROM MOUSE TO HUMAN
Chairperson: Wafik S. El-Deiry, University of Pennsylvania, Philadelphia, PA
- Optimizing Immune Cell Therapies through Imaging
Christopher H. Contag, Stanford University, Stanford, CA
- Optical Imaging of Tumor Progression and Therapeutic Response in Preclinical Models
Wafik S. El-Deiry
- Monitoring of Tumor Response to Therapy by 18F-ML-10, a Novel Small-molecule PET Tracer for Apoptosis: From Pre-clinical to Clinical Studies
Anat Shirvan, NeuroSurvival Technologies, Ltd., Petach-Tikva, Israel
- Imaging Tumor Responses to Treatment with Hyperpolarized Magnetic Resonance Imaging
Kevin M. Brindle, CRUK Cambridge Research Institute, United Kingdom
EDUCATIONAL SESSIONS
4:30 p.m.-6:30 p.m.
SESSION 3A: FROM DISCOVERY TO PRODUCT
Chairperson: Michael K. Samoszuk, Roche Diagnostics Corporation, Indianapolis, IN
- Bringing the Promise of Genomics to Clinical Practice: Lessons from Oncotype DX
Steven Shak, Genomic Health, Inc., Redwood City, CA
- Developing Tissue-based Predictive Biomarkers in Oncology
Paul M. Waring, University of Western Australia, Crawley, Australia
- Fast Translation Strategies for Companion Diagnostics Development
Walter H. Koch, Roche Molecular Systems, Pleasanton, CA
- Implementation of Biomarkers during Oncology Drug Development
Nancy Simonian, Millennium Pharmaceuticals, Cambridge, MA; Representing the Personalized Medicine Coalition, Washington, DC
SESSION 3B: MOLECULAR MARKER DRIVEN TRIAL DESIGN
Chairperson: Donald A. Berry, UT M. D. Anderson Cancer Center, Houston, TX
- Statistical Issues in Identifying, Validating and Using Molecular Markers in Clinical Trials
Marc E. Buyse, International Drug Development Institute, Ottignies, Belgium
- Title to be announced
Steven I. Gutman, Food and Drug Administration, Rockville, MD
- Molecular Marker Driven Trial Design
Donald A. Berry
- Neoadjuvant Trials in Breast Cancer: Integrating Biology, Imaging, and Response to Treatment
Angela M. DeMichele, University of Pennsylvania, Philadelphia, PA
OPENING SESSION
7:30 p.m.-9:00 p.m.
Welcome
Margaret Foti, American Association for Cancer Research, Philadelphia, PA
Introductory Remarks
Gordon B. Mills, UT M. D. Anderson Cancer Center, Houston, TX
KEYNOTE ADDRESS
Personalized Cancer Medicine in the Next Decade
David Sidransky, Johns Hopkins University, Baltimore, MD
KEYNOTE ADDRESS
Models of Molecular Diversity to Facilitate Marker Guided Therapy
Joe W. Gray, Lawrence Berkeley National Laboratory, Berkeley, CA
OPENING RECEPTION
9:00 p.m.-10:00 p.m.
TUESDAY, SEPTEMBER 23
PLENARY SESSION 1: TRANSFORMATIVE TECHNOLOGY
Chairpersons: Edison T. Liu, Genome Institute of Singapore, Singapore, and David A. Tuveson, CRUK Cambridge Research Institute, Cambridge, UK
8:00 a.m.-10:15 a.m.
High Content Imaging in Cancer Drug Discovery
Richard B. Gaynor, Eli Lilly and Company, Indianapolis, IN
New Technologies to Understand and Diagnose Cancer
Stephen Quake, Stanford University, Stanford, CA
PET Technology for Interrogating Genome Functions and Genome Variations in Cancer Cells
Yijun Ruan, Genome Institute of Singapore, Singapore
Short Talk from Proffered Abstracts
Summary
Edison Liu and David Tuveson
PLENARY SESSION 2: PHARMACOGENOMICS
Chairperson: David A. Flockhart, Indiana University Cancer Center, Indianapolis, IN, and Nancy Cox, University of Chicago, Chicago, IL
10:45 a.m.-1:00 p.m.
Germline Pharmacogenomics as a Tool to Individualize Therapy in Breast Cancer
David A. Flockhart
Genome-wide Association Studies in Clinical Trials
Nancy Cox
Personalized Medicine: Advantages and Shortcomings of Genomics versus Metabonomics
Daniel W. Nebert, University of Cincinnati Medical Center, Cincinnati, OH
Short Talk from Proffered Abstracts
Summary
David A. Flockhart
EXHIBITS
1:00 p.m.-4:15 p.m.
POSTER SESSION A
2:15 p.m.-4:15 p.m.
PLENARY SESSION 3: MOLECULAR CLASSIFICATION AND PROGNOSTIC MARKERS
Chairperson: Laura J. van’t Veer, The Netherlands Cancer Institute, Amsterdam, The Netherlands and Margaret R. Spitz, UT M. D. Anderson Cancer Center, Houston, TX
4:30 p.m.-6:45 p.m.
Ovarian Cancer Classification: Lessons from Morphology, Molecules, and Mice
Kathleen R. Cho, University of Michigan, Ann Arbor, MI
Pharmacogenetics of Lung Cancer: An Integrative Epidemiologic Approach
Margaret R. Spitz, UT M. D. Anderson Cancer Center, Houston, TX
Early Detection of Colon Cancer Using Methylated Fecal DNA
Sanford D. Markowitz, Case Western Reserve University, Cleveland, OH
Summary
Laura J. van’t Veer and Margaret R. Spitz
WEDNESDAY, SEPTEMBER 24
PLENARY SESSION 4: MOLECULAR RESPONSE PREDICTION MARKERS
Chairpersons: Barbara L. Weber, GlaxoSmithKline, King of Prussia, PA, and Sanford D. Markowitz, Case Western Reserve University, Cleveland, OH
8:00 a.m.-10:15 a.m.
Molecular Markers Predictive of Response to EGFR Inhibitors
Bruce E. Johnson, Dana-Farber Cancer Institute, Boston, MA
Genomic Strategies towards Personalized Cancer Therapy
Joseph R. Nevins, Duke University, Durham, NC
Targeting the Hedgehog Pathway: From Bench to Clinic
Fred de Sauvage, Genentech, Inc., South San Francisco, CA
Short Talk from Proffered Abstracts
Summary
Barbara Weber and Sanford Markowitz
PLENARY SESSION 5: MOLECULAR MARKERS AND CANCER STEM CELLS
Chairpersons: Thea D. Tlsty, UCSF School of Medicine, San Francisco, CA, and Jenny C. Chang, Baylor College of Medicine, Houston, TX
10:45 a.m.–1:00 p.m.
Intrinsic Therapy Resistance of Breast Cancer Stem Cells
Jenny C. Chang
Characterization and Targeting of Leukemia Stem Cells
Craig T. Jordan, University of Rochester School of Medicine, Rochester, NY
Molecular Targets in Breast Cancer Stem Cells
Max S. Wicha, Comprehensive Cancer Center, University of Michigan, Ann Arbor, MI
Short Talk from Proffered Abstracts
Summary
Thea Tlsty and Jenny C. Chang
PROFESSIONAL ADVANCEMENT SESSION
1:00 p.m.-2:15 p.m.
EXHIBITS
1:00 p.m.-4:15 p.m.
POSTER SESSION B
2:15 p.m.-4:15 p.m.
PLENARY SESSION 6: PHARMACODYNAMICS OF MARKERS
Chairpersons: Gary B. Gordon, Abbott Laboratories, Abbott Park, IL, and Paul M. Waring, University of Western Australia, Crawley, Australia
4:30 p.m.-6:45 p.m.
Practical Application of Pharmcodynamic Markers during Oncology Drug Development
Richard Lesniewski, Abbott Labs, Abbott Park, IL
Title to be announced
Monica M. Bertagnolli, Brigham and Women's Hospital, Boston, MA
Utilizing Pharmacodynamic Studies to Test Biological Hypotheses and Accelerate Anti-cancer Drug Development
Johann Sebastian de Bono, Royal Marsden Hospital, Sutton, United Kingdom
Short Talk from Proffered Abstracts
Summary
Gary B. Gordon and Paul M. Waring
THURSDAY, SEPTEMBER 25
PLENARY SESSION 7: NONINVASIVE MARKERS
Chairpersons: Wafik S. El-Deiry, University of Pennsylvania, Philadelphia, PA, and Samir M. Hanash, Fred Hutchinson Cancer Research Center, Seattle, WA
8:00 a.m.-10:15 a.m.
Inference Engines for Phospho-signaling Networks, Disease Mechanism, and Clinical Outcome at the Single Cell Level
Garry P. Nolan, Stanford School of Medicine, Stanford, CA
Novel Proteomics-based Biomarkers for Early Cancer Detection
Samir M. Hanash
Targeting Cell Signaling in Lung Cancer to Enhance Therapeutic Efficacy
Fadlo R. Khuri, Emory University Winship Cancer Institute, Atlanta, GA
Short Talk from Proffered Abstracts
Summary
Wafik S. El-Deiry and Samir M. Hanash
PLENARY SESSION 8: REGULATORY ISSUES AND SCIENCE POLICY
Chairpersons: Steven I. Gutman, Food and Drug Administration, Rockville, MD, and J. Carl Barrett, Novartis Institute for Biomedical Research, Inc., Cambridge, MA
10:45 a.m.–1:00 p.m.
FDA Perspective on Molecular Diagnostics: Shortening the Critical Path to Market
Steven I. Gutman
Financial Considerations for Development of New Diagnostics
Emily S. Winn-Deen, Cepheid, Sunnyvale, CA
The European Perspective on Molecular Diagnostics: How Regulations Differ across the Pond
Stuart Hogarth, University of Cambridge, Cambridge, UK
Test Method Validation Requirements under CLIA
Penny Keller, Centers for Medicare and Medicaid Services, Baltimore, MD
Short Talk from Proffered Abstracts
Panel Discussion
CLOSING SESSION
1:00 p.m.-1:15 p.m.
DEPARTURE