FAST Congress
2013 Archived Content

Fifth Annual

Clinical and
Translational Biomarkers

November 5-6, 2013 | Boston Marriott Cambridge | Cambridge, MA

The promise of personalized medicine has been driven by the need to accurately predict patient response to therapy while ensuring drug efficacy and safety. Reducing costs and the time required for drug development is also a driving force in the use of biomarkers. Cambridge Healthtech Institute’s Fifth Annual Clinical and Translational Biomarkers meeting will cover the timeline in developing companion diagnostics, clinical and analytical biomarker validation, and the role of biomarkers in clinical decision making.

Day 1 | Day 2 | Download Brochure 

Tuesday, November 5

12:00 pm Main Conference Registration

Implementing Personalized Medicine: Biomarkers for Patient Stratification 

1:30-1:35 Chairperson’s Opening Remarks

1:35-2:00 Patient Selection Biomarker for Notch Inhibitors in Cancer

Theresa Zhang, Ph.D., Associate Director, Exploratory and Translational Sciences, Merck

Notch can play both oncogenic and tumor suppressive roles in human cancer. Therefore, it is critical to identify biomarkers that can predict response to Notch inhibition (e.g., GSI [gamma-secretase inhibitors]) and develop clinical assays that can select appropriate patients into clinical trials. This talk will focus on efforts to discover and validate predictive biomarkers for GSI and to develop potential clinical assays for the resulting biomarkers.

2:00-2:25 Broad-Based Cancer Genotyping in Routine Clinical Practice

Darrell R. Borger, Ph.D., Co-Director, Translational Research Laboratory; Director, Biomarker Laboratory, Massachusetts General Hospital Cancer Center

Multiplexed tumor genotyping has been offered as a physician-ordered clinical test at a major US cancer center, with over 5,000 patients tested across cancer disease types. Advantages of a broad-based profiling approach will be highlighted, indicating how this has revealed new molecular signatures and has been used to foster a genotype-directed approach to clinical trial design. This has provided the foundation for expanding into next-generation sequencing approaches.

RemedyMD2:25-2:40 The Use of Ontology Driven Registries to Advance Personalized Medicine

Michael Cummens, M.D., CMO, Remedy Informatics, Inc.

2:40-3:05 Talk Title to be Announced

Kimberly Walter, Ph.D., Senior Research Assistant, Genentech

3:05-4:15 Refreshment Break in the Exhibit Hall with Poster Viewing

4:15-4:40 Stratifying Patients to Molecular Clinical Trials in the Era of Precision Medicine

David A. Fenstermacher, Ph.D., Chief Research Information Officer, Virginia Commonwealth University

A prospective longitudinal study, Total Cancer Care, currently underway at the Moffitt Cancer Center, has been used to create a comprehensive data warehouse that is able to integrate clinical and molecular data that is being used for in silico clinical trial design in solid tumor malignancies to match patients with novel therapeutics. The studies presented will provide insights to the challenges to use point-of-care clinical data and research-grade molecular data to aid in the design of biomarker-based clinical trials.

4:40-5:05 Implementation of Personalized Cancer Therapy

Apostolia-Maria Tsimberidou, M.D., Ph.D., Associate Professor, Investigational Cancer Therapeutics, University of Texas MD Anderson Cancer Center

Implementation of personalized medicine requires the consistent and successful identification of genetic alterations in patients’ tumors and effective inhibition of the function of the altered genes. Use of molecular profiling and targeted therapy in our Phase I program has been associated with improved rates of response, time to treatment failure and survival compared to the standard approach in patients with advanced cancer. Standardization of molecular profiling, novel drug discovery, carefully designed prospective clinical trials and development of “N of 1” shared databases will expedite the implementation of personalized medicine.

6:00-9:00 Dinner Course*

SC3: Next-Generation Sequencing as a Clinical Test 

6:00-9:00 Dinner Course*

SC4: Preclinical Tumor Models 

*Separate registration required

Day 1 | Day 2 | Download Brochure