vnewjay

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 include:


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

"Current Recommendations for Cancer Assays"

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.


--------------------------------------------------------------------------------


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.



--------------------------------------------------------------------------------


Antonius Schuh, Ph.D.
Chief Executive Officer, 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.