2013 Archived Content
November 5-6, 2013 | Boston Marriott Cambridge | Cambridge, MA
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Wednesday, November 6
7:30 am Breakfast Presentation (Sponsorship Opportunity Available) or Morning Coffee
8:25-8:30 Chairperson’s Opening Remarks
Rakesh Dixit, Ph.D., DABT, Vice President, R&D and Global Head, Biologics Safety Assessment, MedImmune
8:30-8:55 Big Data and Small Clinical Trials: Translating Biological Data into Useful Biomarkers
Nicholas C. Dracopoli, Ph.D., Vice President, Janssen R&D, Johnson & Johnson
Developing useful clinical biomarkers has proved difficult. Thousands of biomarkers have been identified, but few have sufficient clinical utility to justify widespread implementation. This presentation will describe the minimal criteria needed to develop predictive markers including discussion of samples, variables, endpoints and algorithms. The development of two different predictive markers will be described to demonstrate the different steps and potential errors in developing robust predictive markers. A comparison will be made between developing single analyte markers and complex molecular profiles. Finally, a summary of the role of biomarkers in oncology drug development will be made showing the recent history of companion diagnostic development in this field.
8:55-9:20 Impact of Protein Biomarkers in a Clinical Study
Yoshiya Oda, Ph.D., President, Biomarkers and Personalized Medicine Core Function Unit, Eisai
Appropriate biomarkers play important roles in drug development to confirm target engagement, to determine right dosage, to select right patients and to monitor drug efficacy. One of the bottlenecks in biomarker research is to obtain a sufficient quantity and quality of clinical samples. Access to tumor tissues is not always straightforward. Biofluid would be ideal as clinical samples and protein biomarkers are probably major molecules in biofluid samples. Examples using clinical samples will be shown.
9:20-9:50 Circulating Tumor Cells: From Enumeration to Comprehensive Characterization
Mark Connelly, Ph.D., Scientific Director, Janssen R&D
9:50-10:05 Identifying the Enemy: Decoding the Malignant Message
Kalle Ojala, Ph.D., Chief Product Officer, MediSapiens, Ltd.
Using NGS and oncogenomics Big Data to identify clinically relevant oncogenic biomarkers.
10:05-11:20 Coffee Break in the Exhibit Hall with Poster Viewing
11:20-11:45 RNA Sequencing to Help Decision Making in Drug Development: An Example in Hepatocellular Carcinoma
Oscar Puig, Ph.D., Biomarker Experimental Medicine Leader, Roche
Hepatocellular carcinoma (HCC) is a devastating disease with 5-year survival rates of about 12%. Sorafenib is the only approved systemic treatment for advanced HCC; thus, new therapies are a critical medical need. Biomarkers that can select patients benefiting from specific therapies is an active field of research. We will share our experience using RNAseq to profile liver tumor biopsies in search of predictive markets of response and efficacy.
11:45-12:10 pm Stromics: A Renewed Focus on Host Biomarkers
Richard Levenson, M.D., Professor and Vice Chair for Strategic Technologies, Department of Pathology & Laboratory Medicine, University of California, Davis Medical Center
12:10-12:35 Using Clinical Trial Data as a Tool in Evaluating New Safety Biomarkers
Stephen T. Furlong, Ph.D., Safety Science Lead, AstraZeneca
The qualification process for new safety biomarkers is a fundamentally new approach, and an important aspect of qualifying new biomarkers is an understanding of how they compare to the assays they will replace. In this talk we will describe our process for using retrospective data across large sets of clinical trials to review laboratory safety data in healthy volunteers and patient populations. This analysis provides the basis for a comparison of classical safety assays and new safety biomarkers, and helps provide an understanding of how to use these new biomarkers.
12:35-1:00 Pharmacodynamics and Safety Biomarkers of Mavrilimumab Activity in a Phase 2a study in RA Patients
Dominic Sinibaldi, Ph.D., Scientific Manager, R&D IS Clinical Informatics, MedImmune
GM-CSF plays a central role in the pathogenesis of rheumatoid arthritis (RA) through effects on macrophages and neutrophils. Mavrilimumab (CAM-3001) is a human monoclonal antibody targeting the alpha subunit of GM-CSF receptor. Mavrilimumab was recently evaluated in RA subjects in a phase 2a study (EARTH). Biomarker (BM) assessments were performed to elucidate mechanistic and safety aspects of mavrilimumab. Results suggest that suppressing macrophage activity by targeting GM-CSF receptor alpha may be a novel approach for the treatment of RA.
1:00 Close of Clinical and Translational Biomarkers Meeting
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