Program

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 Performancepl
  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.-4:15p.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

  
  Imaging of Immune Cell Trafficking Patterns Refines Development of Cell-based Therapies
  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, Aposense, Ltd., Petach-Tikva, Israel

  Detecting 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

  Multiple Markers-the FDA Perspective
  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.

PLENARY SESSION 1: TRANSFORMATIVE TECHNOLOGY

Chairpersons: Edison T. Liu, Genome Institute of Singapore, Singapore and David A. Tuveson, CRUK Cambridge Research Institute, Cambridge, United Kingdom
8:00 a.m.-10:15 a.m.

High Content Imaging in Cancer Drug Discovery
Richard B. Gaynor, Eli Lilly and Company, Indianapolis, IL

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

High Throughput, Quantitative DNA Methylatioin Screening using a Quantum Dot Based Nanotechnology Assay
Bailey Vasudev, Johns Hopkins School of Medicine, Baltimore, MD

Summary
Edison T. Liu and David A. 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

Plucked Hair is a Noninvasive Surrogate Tissue Useful for Establishing Drug Response and Providing Pharmacodynamic Data in Preclinical Studies
Ged Brady, Epistem PLC, Manchester, United Kingdom

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

Chairpersons: 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

Src Pathway Activation Correlates with Treatment Resistance in Breast Cancer and Identifies Patient Subsets Predicted to Benefit from Src Inhibition
Christina M. Coughlin, Wyeth Research, Collegeville, PA

Summary
Laura J. van 't Veer and Margaret R. Spitz

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

An Intermediate Methylation Signature is Associated with Improved Patient Survival and a Distinct Global mRNA Expression Profile in Glioblastoma: An Interim Analysis of The Cancer Genome Atlas Data
Christopher E. Pelloski, UT M. D. Anderson Cancer Center, Houston, TX

Summary
Barbara L. Weber and Sanford D. 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 Phenotypes of Human Breast Cancer Stem Cells
Thea D. Tlsty

Short Talk from Proffered Abstracts

Summary
Thea D. 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 Pharmacodynamic Studies to Test Biological Hypotheses and Accelerate Anti-cancer Drug Development
Richard Lesniewski, Abbott Laboratories, Abbott Park, IL

Celecoxib for Prevention of Sporadic Colorectal Adenomas: Patient Selection to Optimize Efficacy and Safety
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

Bayesian Adaptive Randomization Designs for Targeted Agent Development
J. Jack Lee, UT M. D. Anderson Cancer Center, Houston, TX

Summary
Gary B. Gordon and Paul M. Waring

NETWORKING RECEPTION AND DINNER

7:00 p.m.-9:00 p.m.

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

Analysis of Circulating Prostate Tumor Cells by Fluorescence in situ Hybridization
Margaret A. Leversha, Memorial Sloan-Kettering Cancer Center, New York, NY

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, United Kingdom

Test Method Validation Requirements under CLIA
Penny Keller, Centers for Medicare and Medicaid Services, Baltimore, MD

Title to be announced
Jeffrey Roche, 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