Cancer Biomarkers Development and Clinical Use

Monday, June 16, 2008 
at 
The Yale Club of New York City
located at
50 Vanderbilt Avenue directly across the street from Grand Central Station
between East 44th Street and East 45th Street
(one block east of Madison Avenue)
New York, New York, U.S.A. 10017

Presentations:

Joseph F. Dooley, Ph.D., DABCC, FACB CEO, TriMark Publications, LLC

"Welcoming and Introductory Remarks"

Keynote Speaker Martin Fleisher, Ph.D. Chair, Dept. of Clinical Laboratories, Memorial Sloan-Kettering Cancer Center

"Biomarkers As Prognostic Indicators Of Cancer Recurrence"

• What is a biomarker and how is it used?
• Validating biomarkers for clinical use.
• Biomarkers as prognostic indicators of cancer recurrence.
• Biomarkers as surrogate endpoints for monitoring therapy.
  

Maher Albitar, M.D. Director of Hematopathology at Nichols Institute, Quest Diagnostics, Inc.

"Plasma-Based Assays in Hematologic Diseases: New Paradigm in Clinical Testing"

• Why plasma is enriched by tumor-specific DNA, RNA and proteins?
• Why hematologic disease?
• What assays are currently best performed using plasma?
• How plasma is used to determine tumor load?
  

Peter Collins Business Development Director, DxS Ltd.

"A K-RAS Companion Diagnostic for Vectibix"

• Amgen’s Vectibix (panitumumab) is one of several new cancer drugs currently in the market targeting the EGFR pathway. Recent clinical data has established that the 40% of colorectal tumors that carry a mutated K-RAS gene show little or no response to these therapies. 
• DxS has developed and commercialized a companion diagnostic that detects the K-RAS mutations, to support the sale of Vectibix. 
• This presentation will outline the development and approval of the product and also demonstrate a successful model for drug and diagnostic company partnerships.
  

Harry Rittenhouse, Ph.D. Senior Director Cancer Program, Gen-Probe, Inc.

“How Genetics and Molecular Assays Will Change the Diagnosis and Management of Prostate Cancer”

• Most highly over-expressed gene in prostate cancer.
• PCA3 molecular urine test independent mechanism from PSA blood test.
• Early studies show a high potential for PCA3 to complement PSA testing for prostate cancer management. 
• TMPRSS2 is a prostate-specific gene turned on in the presence of androgen.
• ETS family of genes.
• TMPRSS2:ETS gene fusions.
  

W. Jeffrey Allard, Ph.D. Vice President, Clinical Affairs & Business Development, Fujirebio, Inc.

"Evaluation of Multiple Biomarker Assays to Estimate Risk of Ovarian Cancer in Patients Presenting with a Pelvic Mass"

• Pelvic mass and the dilemma of appropriate triage.
• Current practice and guidelines.
• Pilot studies.
• FDI03 pivotal trial.
• Clinical implementation of multi-biomarker algorithm.
  
  

Herbert Fritsche, Ph.D. Professor and Chief, Clinical Chemistry; Chairman, Scientific Advisory Board, MD Anderson Cancer Center

"Bringing New Cancer Assay Technologies into the Lab"

• Many new diagnostic tests for cancer diagnosis and clinical management
  of patients are on the horizon and will soon be ready for implementation
  in routine patient care.
• Clinical acceptance of new cancer diagnostics is based on the level of
  proof for the clinical utility of the new test.
• Laboratory acceptance requires FDA clearance , if the test is
  commercialized in a "kit" format, and "adequate" reimbursement by
  Medicare and third party reimbursers.
• New rules from the FDA will impact on the commercialization of new
  diagnostics currently performed under CLIA regulations.
  

Keith McCormick Director, Sales & Marketing, AviaraDx, Inc.

"New Biomarkers for Breast Cancer Risk Stratification - H/I and MGI"

• H/I (HoxB13:IL17BR Index) and MGI (Molecular Grade Index) independently evaluate distinct biological pathways.
• H/I is a two-gene ratio that stratifies ER-positive breast cancer into low or high risk of recurrence and is predictive of benefit from endocrine therapy.
• MGI is a five-gene index that provides quantitative and objective molecular assessment of tumor grade and proliferation status, stratifies breast cancers in low or high risk of recurrence, and identifies tumors like to be responsive to chemotherapy.
  

Richard Bender, M.D., FACP Vice President and Chief Medical Officer, Agendia, Inc.

"Using Gene Expression Assays to Guide Therapy in Breast Cancer Patients"

• Understanding the methodology used to develop gene signatures for breast cancer prognosis.
• Comparison of the commercially available assays emphasizing their strengths and weaknesses.
• Understanding how these assays are used in clinical practice.
  

Eric Fung, Ph.D. Vice President and CSO, Vermillion, Inc.

"Development of High-Value Diagnostic Assays in Ovarian Cancer and Peripheral Arterial Disease"

• Study design strategies for biomarker discovery. 
• Pitfalls in statistical analysis for genomics and proteomics. 
• Novel biomarkers for ovarian tumor triage and peripheral arterial disease.
• Risk stratification in patient management. 
  

Anthony Shuber, Ph.D. Chief Technical Officer, Predictive Biosciences, Inc.

"Utilizing Urinary Protein Biomarkers for Cancer Management"

• The clinical dilemma facing non-invasive biomarker assays.
• The value of non-invasive biomarkers assays.
• Working within the existing clinical environment. 
• Making “good” biomarkers “great”.
  

Walt Carney, Ph.D. Head, Siemens Medical Solutions Diagnostics, Oncogene Science Biomarker Group

"Monitoring Circulating HER-2/neu Levels In MBC Patients Treated with HER-2/neu Inhibitors"

• Linking circulating biomarkers in treatment of metastatic breast cancer. 
• The rise and fall of serum HER-2/neu levels parallel the clinical course of breast cancer.
• Integrating serum HER-2/neu DX with management of metastatic breast cancer. 
  

Kaiser J. Aziz, Ph.D., FACB, FACS Director, KJ Biomedical Consulting, LLC

"Biomarkers: Discovery, Development and Clinical Applications"

• Development of biomarkers.
• Clinical study design.
• Product review.
• FDA’s quality system requirements.
• Risk management and quality monitoring.