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Thursday, February 23
8:30 am Chairperson's Remarks
Hal Mann, Vice President, Clinical Research Services, ResearchDx, LLC
8:35 The Story of MetMAb Discovery and Development
Stuart Lutzker, M.D., Ph.D., Vice President, BioOncology Exploratory Clinical Development, Genentech
9:05 Translational Genomics in a Phase II Clinical Trial for Patients with Previously Treated Advanced Pancreatic Adenocarcinoma.
Michael Barrett, Ph.D., Associate Professor, Clinical Translational Research Division, Unit Head, Oncogenomics Laboratory, TGEN.
We have developed unbiased methods to molecularly profile tumor genomes in highly admixed and complex clinical biopsies in the setting of a clinical trial. The data for each patient are integrated with prior knowledge of tumor signaling pathways in order to advance improved clinical outcomes.
9:35 Personalized Medicine in a Phase I Clinical Trials Program: The MD Anderson Cancer Center Initiative
Apostolia-Maria Tsimberidou, M.D., Ph.D., Associate Professor, Department of Investigational Cancer Therapeutics, University of Texas, MD Anderson Cancer Center
Tumor molecular profiling for identification of molecular aberrations and use of matched targeted therapy is associated with superior rates of response, time to treatment failure and survival compared to the standard approach in patients with advanced cancer.
10:05 Morning Q&A Session
10:20 Coffee Break
11:00 Testing the Predictive Value of a Genomic Assay
William Barlow, Ph.D., Senior Biostatistician, Cancer Research & Biostatistics Research; Professor, Department of Biostatistics, University of Washington
An individualized approach to clinical trials is needed to improve outcomes in advanced cancer. The speaker will discuss incorporation of state of the art molecular profiling techniques of patients tumor to identify biomarkers and oncogenic mutations which can be matched to targeted agents.
11:30 Clinical Trial Strategies for Deploying Modern Immunotherapies as Monotherapies or in Combinations
Ravi A. Madan, M.D., Assistant Clinical Investigator, Laboratory of Tumor Immunology and Biology & Medical Oncology Branch, National Cancer Institute
Prediction refers to the ability of a marker to choose the best treatment for a patient. We illustrate how to test a continuous marker in a clinical trial and how to design a trial to test a marker's predictive value.
12:00 pm New Approaches to the Treatment of Breast Cancer: The I-SPY TRIAL
Laura Jean Esserman, M.D., MBA, Director, Carol Franc Buck Breast Care Center Professor of Surgery and Radiology, University of California, San Francisco
I-SPY 2 is a precompetitive collaboration that employs an adaptive design, streamlined operational infrastructure, and uses pathologic complete response (pCR) as a "surrogate endpoint" in the neoadjuvant breast cancer setting, to speed the evaluation of new drugs and associated biomarkers.
12:30 Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own
1:45 Chairperson's RemarksHal Mann, Vice President, Clinical Research Services, ResearchDx, LLC
1:50 Key Dimensions and Difficulties when Identifying Predictive Signatures in the Survival Analysis Setting
Jared Lunceford, Ph.D., Associate Director, Merck Research Laboratories
When an oncology trial for an investigational drug (ID) fails to meet its primary efficacy hypothesis or when there is simply a desire to investigate the existence of a more sensitive sub-population after a successful trail, a retrospective exploratory search for a sensitive patient subset may ensue. In the context of microarray gene expression profiling and the modeling of overall survival or progression free survival, this search for a predictive signature is a delicate task and we will review some of the key statistical issues involved when constructing de-novo models for survival endpoints. Included will be a discussion of the critical role of appropriate array processing, the need for cross-validation and an assessment of the statistical significance of putative findings, distinguishing between prognostic (or standard of care) effects and ID-predictive effects, and perspectives on the adequacy of Phase II and Phase III sample sizes to detect ID-predictive effects in the microarray setting.
2:20 Panel Discussion: Biomarkers in Cancer Clinical Trials: a Tool or a Goal?Patricia M. LoRusso, D.O., Director, Center for Experimental Therapeutics, Barbara Ann Karmanos Cancer Institute
3:20 Close of Conference
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