2013 Archived Content
Translating NGS from Research to Practice
Day 1 | Day 2 | Day 3
Friday, February 15
8:00 am Morning Coffee
8:30 Chairperson's Remarks
8:35 Successful Development and Commercialization of Precision Medicines: "It Takes a Village"
Hakan Sakul, Ph.D., Executive Director & Head, Diagnostics, Worldwide R&D, Clinical Research and Precision Medicine, Pfizer
9:05 Emerging Regulatory Trends in Drug-Diagnostic Co-Development
Erling Thor Donnelly, Ph.D., R.A.C., Director, Worldwide Regulatory Strategy, Pfizer, Inc.
9:35 From Biomarker to Companion Diagnostics: The Process Starts Early
Premal Shah, Ph.D., Director, Business Development, Genomic Health, Inc. (tentative)
10:05 Sponsored Presentations (Opportunities Available)
10:35 Coffee Break
11:00 Clonal Analysis and Molecular Profiling for Patient Selection
Michael Barrett, Ph.D., Associate Professor, Clinical Translational Research Division; Unit Head, Oncogenomics Laboratory, TGEN
Cancers frequently arise as a result of an acquired genomic instability and the subsequent evolution of neoplastic cells with variable genomes. Thus the behaviors of distinct clonal populations in each patient's tumor underlie the clinical phenotypes of many cancers.
11:30 Molecular Profiling for Patient Selection: MD Anderson Perspective
Apostolia-Maria Tsimberidou, M.D., Ph.D., Associate Professor, Department of Investigational Cancer Therapeutics, University of Texas MD Anderson Cancer Center
12:00 pm Challenges and Issues in the Clinical Execution of a Biomarker Driven Clinical Trial
Jonathan Cheng, M.D., Director, Oncology Clinical Development, Merck
12:30 Luncheon Presentations (Sponsorship Opportunities Available) or Lunch on Your Own
1:45 Chairperson's Remarks
1:50 Cooperative Oncology Group Banks (CGBS)
Irina A. Lubensky, M.D., Chief, Resources Development Branch, Cancer Diagnosis Program, Division of Cancer Treatment and Diagnosis, NCI, NIH
CGBs collect, store and distribute specimens from patients treated in phase III and large phase II NCI-funded randomized clinical trials.These well-annotated specimen collections are unique because they have associated uniform clinical, treatment, and outcome data.
2:20 The Role of the Biorepository in Cancer Clinical Trials: "From Bed to Bench"
Nilsa C. Ramirez, M.D., Director, Surgical Pathology, Department of Pathology and Laboratory Medicine, Nationwide Children's Hospital; Medical Director, Biopathology Center, Co-I and Lead Pathologist, TCGA BCR, The Research Institute at Nationwide Children's Hospital
Biorepositories directly influence the outcome of translational research in clinical trials.They oversee procurement, banking, testing and distribution of quality clinical trial samples to approved investigators. The role of the biorepository in the cancer cooperative group organization is discussed.
2:50 National Breast Cancer Biobank and Oncology Research
Valerie Speirs, Ph.D., Associate Professor, Leeds Institute of Molecular Medicine, University of Leeds
3:20 The Role of the Tissue Bank in Academic Cancer CentersTeri A. Longacre, M.D., Professor of Pathology, Director, Tissue Procurement Facility, Stanford Cancer Center, Stanford, CaliforniaThe various functions of the tissue bank in academic cancer centers have increased in complexity in the last decade. In this lecture, key problem areas faced by academic cancer centers in the areas of tissue procurement, tissue distribution, quality metrics, accommodation of SPORE and other specific programmatic projects, clinical annotation, and data tracking are discussed. In addition, the concept of a “clinical biobank” as opposed to the traditional “research biobank” is introduced.
3:50 Close of Conference
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