2013 Archived Content
Third Annual

Oncology Clinical Trials

Bringing Effective and Safe Cancer Therapy to Patient


Day 1Day 2 | Day 3

Friday, February 15

8:00 am Morning Coffee


Companion Diagnostics: Development and Implementation 

8:30 Chairperson’s RemarksPremal Shah, Ph.D., Director, Business Development, Genomic Health, Inc. 

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 Clinical Development of an Oncology Drug with a Companion Diagnostic: It’s Not Just About the Drug!Kenneth Emancipator, M.D., Director, Companion Diagnostics, Merck 

9:35 Use of NGS as a Biomarker Tool for Oncology Drug Development: A Diagnostic Company’s Perspective

Premal Shah, Ph.D., Director, Business Development, Genomic Health, Inc. 
The ability to effectively use Next Generation Sequencing techniques for biomarker discovery provides therapeutic manufacturers an important tool to develop effective and safe drugs. But unlike the past where pharma companies spent money and invested in nascent technologies themselves, there is a capable and robust infrastructure, led by diagnostics companies, that will enable low-cost and powerful biomarker discovery for every drug development program. In oncology, where low number of NMEs, high development time and costs are pervasive, biomarker discovery using NGS is not just a nice-to-have, but a must have. NGS techniques such as whole transcriptome profiling, or DNA-seq can help identify simple to complex signatures (e.g., multi-gene panel that includes gene fusions). And while the industry has historically focused on single gene markers since they are easier to deploy in "kit" form, the reality is that the biomarkers of the future will have to be complex. And complex biomarkers, by definition, will have to be delivered by emerging companies such as Genomic Health, Foundation Medicine, and Myriad. The future is here and the tools are there.

10:05 Coffee Break


Molecular Profiling for Patient Selection 

10:30 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.

11:00 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

11:30 pm Challenges and Issues in the Clinical Execution of a Biomarker Driven Clinical Trial

Alexandra Gunchenko, Associate Director, Clinical Research, Merck

12:00 Luncheon Presentations (Sponsorship Opportunities Available) or Lunch on Your Own


Clinical Trial Specimens in Cancer Research 

1:15 Chairperson’s RemarksIrina A. Lubensky, M.D., Chief, Resources Development Branch, Cancer Diagnosis Program, Division of Cancer Treatment and Diagnosis, NCI, NIH 

1:20 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.

1:50 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.

2:20 National Breast Cancer Biobank and Oncology Research

Valerie Speirs, Ph.D., Associate Professor, Leeds Institute of Molecular Medicine, University of Leeds

2:50 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. 

3:20 Close of Conference

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Premier Sponsors

Beckman Coulter Life Sciences 

Boston Healthcare



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Cofactor Genonics


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