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Biomarker Assay Development - Day 1


Main Conference:


3:00-4:00 Conference Registration

4:00-4:10 Welcoming Remarks from Conference Director
Julia Boguslavsky, Executive Director, Conferences, Cambridge Healthtech Institute

Opening Plenary Session:
Biomarkers in Translational Medicine

(Shared session with Translational Cancer Medicine meeting)

4:10-4:15 Chairperson’s Opening Remarks

4:15-4:45 Use of Biomarkers and Translational Science to Accelerate and Improve Oncology Drug Development: Opportunities and Roadblocks
J. Carl Barrett, Ph.D., Global Head, Oncology Biomarker and Imaging, Novartis Institutes for BioMedical Research, Inc.
The steps in oncology drug development in patients include: optimizing dose-schedule, predicting patients that will respond, detecting tumor responses rapidly for proof-of-concept trials, using surrogate endpoints for disease monitoring, assuring safety of drug therapy, and developing rational-based combination therapies. Biomarkers are pivotal in meeting each of these challenges.  A general strategy for using biomarkers in oncology drug development  will be presented and includes: having a systematic biomarker plan for each new agent that is consistent, science-based and focused using common standards for assays and data; building a biomarker tool kit with analytically and clinically validated biomarker assays; building on clinical experience (positive and negative) and execution excellence involving a team effort (physicians, clinical staff, biomarker experts and data management) and building a strong partnership between Novartis and its clinical investigators.

4:45-5:15 Panel Discusson: Biomarker Translation in Oncology Drug Development
Discussion topics include:

• Biological and analytical validation
• Biomarker translation from animal to human
• Expediting pre-clinical to clinical translation of a drug candidate
• Biggest opportunities and challenges in biomarker implementation
• Role of personalized medicine in oncology drug development

5:15-6:30 Reception with Exhibit and Poster Viewing 
Sponsorship opportunity available. Contact Ilana Schwartz, Manager, Business Development, 781-972-5457 or

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