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Wednesday, February 22

7:55 am Organizer's Remarks

Kate Skaare, Cambridge Healthtech Institute

8:00 PANEL DISCUSSION: How Have Biomakers Been Applied in Clinical Development?

Moderator: Prakash Purohit, Ph.D., Associate Director, Scientific Affairs, IPSEN Biomeasure, Inc.

Panelists:

Dominic G. Spinella, Ph.D., Head, Translational and Molecular Medicine, Pfizer

James Watters, Ph.D., Head, Applied Genomics, Sanofi Oncology
 

Suso Platero, Ph.D., Director, Oncology Biomarkers, Centocor, Ortho Biotech Oncology Research & Development, a unit of J&J PRD, LLC 

Panelists from informatics, biology, discovery, regulatory to discuss how to much more efficiently turn biomarker assays into diagnostics. What challenges are there? What strategies are best for future use of biomarkers for clinical development? Case examples will be used. 

9:30 From Bench to Clinic:  Quantitatively Assessing Cancer Targets and Biomarkers for Targeted TherapiesCorinne Ramos, Ph.D., Executive Director of Clinical Research, Theranostics HealthTheranostics Health utilizes Laser Capture Microdissection and highly sensitive, quantitative protein microarrays to accurately measure the presence and phosphoactivation status of the target and its downstream signaling pathway elements in tumor or diseased cells at the site of drug action.
 

9:45 Sponsored Presentation (Opportinity Available)

10:00 Transition to Plenary Keynote

 

11:00  Refreshment Break in the Exhibit Hall with Poster Viewing

 

TRANSLATIONAL BIOMARKERS

Chairperson: Suso Platero, Ph.D., Director, Oncology Biomarkers, Centocor, Ortho Biotech Oncology Research & Development, a unit of J&J PRD, LLC

12:00 pm Biomarkers: How to Find them and Apply Them in Clinical Trials

Suso Platero, Ph.D., Director, Oncology Biomarkers, Centocor, Ortho Biotech Oncology Research & Development, a unit of J&J PRD, LLC

12:30  Back to Biomarker Basics for Drug Development

Terry Walker, Ph.D., Director, Translational Immunology, Immunology & Autoimmunity Research Unit, Pfizer

The presentation will provide case study illustrations of simple biomarker challenges:  Right drug target for the disease?  Does the drug hit the target?  Does the drug modify disease activity? 

Sponsored by
 1:00 Luncheon Presentation I
Image Miner for Biomarker Development & Data Quality ControlRajiv Jesudason, Application Scientist, DefiniensThere is a growing need for automated and integrated software solutions that can enable scientists to make more informed decisions on scientific programs.  Definiens offers a comprehensive end to end solution for Biomarker Development and Data Quality Control.  Definiens is the first to market to offer a wholly integrated solution that  combines state of the art Image Analysis software “Tissue Studio” with new innovation “Image Miner” an integrated Imaging miner software package.  Image Miner enables scientists to extract meaningful image base classifiers, correlate them to patient and sample outcome data, and identify which characteristics are best suited for comparing cohorts in a given study.”

Sponsored by  1:30 Luncheon Presentation II 
SOMAmers Enable High Throughput Screening for Protein Biomarkers and DiagnosticsStephen A Williams, M.D., Ph.D., CMO, SomaLogicA synergistic combination of attributes: >1000 proteins measured simultaneously with ELISA-like performance, sample volumes of a few microliters, increasingly high throughput (currently >30,000 samples/yr.), and the same reagents useable for discovery and commercialization. This has enabled an unprecedented productivity breakthrough in mechanistic, diagnostic and prognostic biomarkers.

1:45 Ice Cream Refreshment Break in the Exhibit Hall with Poster Viewing 

 

3:50 Refreshment Break & Poster Awards in the Exhibit Hall

4:25 Chairperson's Remarks

Suso Platero, Ph.D., Director, Oncology Biomarkers, Centocor, Ortho Biotech Oncology Research & Development, a unit of J&J PRD, LLC

4:30 Molecular Profiling of Breast Cancer Trial Sets to Unravel Driving Oncogenic Hubs and Parallel Pathways

Brian Leyland-Jones, M.D., Ph.D., Director, Winship Cancer Institute, Emory University

We are applying complementary molecular profiling methods to tumor bank specimens from several international clinical trials that include all of the major breast cancer subtypes and established a large panel of in vitro cell lines and several xenograft models.

5:00 Biomarker Discovery and Validation: What is Missing

Joerg Heyer, Ph.D., Director, Genetic Models, Translational Research, AVEO Pharmaceuticals

Efforts to establish biomarker discovery in the pre-clinical stage have been limited by insufficient pre-clinical models. Approaches utilizing novel pre-clinical models that enable early pre-clinical biomarker identification and validation.

KEYNOTE PRESENTATIONS

6:00 Close of Day

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