2013 Archived Content

Clinical Sequencing

Translating NGS from Research to Practice


Day 1Day 2 | Day 3

Friday, February 15

8:00 am Morning Coffee


Companion Diagnostics: Development and Implementation 

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


Molecular Profiling for Patient Selection 

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


Clinical Trial Specimens in Cancer Research 

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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