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Thursday, February 14

7:00 am Breakfast Presentation (Sponsorship Opportunity Available) or Morning Coffee

 8:00 - 9:40 Plenary Keynote Panel: Emerging Technologies & Industry PerspectivesThis session features a series of presentations on emerging and hot technologies in diagnostics, drug discovery & development, informatics, and oncology. Interactive Q&A discussion with the audience will be included. - Read more 

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9:40 Refreshment Break in the Exhibit Hall with Poster Viewing

 

Cancer Clinical Trials in the Era of Personalized Medicine 

10:40 Chairperson’s RemarksJohn A. Todd, Ph.D., Vice President, Research & Development, Singulex, Inc. 

10:45 Case Study of I-SPY2 Trial

Laura Jean Esserman, M.D., MBA, Director, Carol Franc Buck Breast Care Center; Professor of Surgery and Radiology, University of California San Francisco

Screening phase II agents for neoadjuvant breast cancer, matching drugs with patients depending on biomarker subsets, including modeling longitudinal information about individual patients and using adaptive randomization.

11:15 Personalizing NSCLC Therapy: The BATTLE-2 Program

Vassiliki Papadimitrakopoulou, M.D., Professor, Department of Thoracic/Head and Neck Medical Oncology, Medical Oncology, The University of Texas MD Anderson Cancer Center

Comparing the efficacy of experimental therapies within biomarker subsets of non-small-cell lung cancer using adaptive randomization with primary endpoint 8-week disease control.

11:45 Beyond I-SPY 2 and BATTLE

Donald Berry, Ph.D., Professor, Department of Biostatistics, The University of Texas MD Anderson Cancer Center

Extending the I-SPY 2 and BATTLE trial designs beyond breast and non-small-cell cancer, incorporating combinations of experimental agents and adapting therapies within as well as across patients.

 12:15 pm Luncheon Presentation I: Planned Best Practices in Oncology Clinical Development: Driving Gains in Productivity and Efficiency through Molecular Medicine Brad Smith, Ph.D., Vice President, Translational Medicine, QuintilesThis presentation will explore the evolution and planned applications of molecular medicine to drive productivity and efficiencies in oncology clinical development.

12:45 pm Luncheon Presentation II (Sponsorship Opportunity Available)

1:15 Refreshment Break in the Exhibit Hall with Poster Viewing

1:40 Chairperson’s Remarks

1:45 BATTLE-2 and I-SPY 2: The Industry Perspective

Emmett V. Schmidt, M.D., Ph.D., Senior Principal Scientist, Clinical Research, Merck Research Laboratories - Oncology
 

2:15 KEYNOTE PRESENTATION: Novel Strategies for Biomarker-Driven Clinical Trials 

Sandra J. Horning, M.D., Senior Vice President, Global Head, Clinical Development Hematology/Oncology, Genentech 

2:45 Panel Diacussion: Bringing Targeted and Tailored Therapies to PatientModerator: Donald Berry, Ph.D., Professor, Department of Biostatistics, The University of Texas MD Anderson Cancer CenterPanelists:
Laura Jean Esserman, M.D., MBA, Director, Carol Franc Buck Breast Care Center; Professor of Surgery and Radiology, University of California San Francisco
Vassiliki Papadimitrakopoulou, M.D., Professor, Department of Thoracic/Head and Neck Medical Oncology, Medical Oncology, The University of Texas MD Anderson Cancer Center
Emmett V. Schmidt, M.D., Ph.D., Senior Principal Scientist, Clinical Research, Merck Research Laboratories - Oncology
Sandra J. Horning, M.D., Senior Vice President, Global Head, Clinical Development Hematology/Oncology, Genentech
Brad Smith, Ph.D., Vice President, Center of Integrated Drug Development, Quintiles

3:45 Valentine’s Day Celebration and Poster Competition Winner Announced in the Exhibit Hall (Last Chance for Poster Viewing) 

 

Quality of Pre-Clinical Evidence Matters 

4:30 Chairperson’s Remarks

Peter Houghton, Ph.D., Director, Center for Childhood Cancer, Nationwide Children’s Hospital

4:35 Challenges in Translating Pre-Clinical Research into Benefit for Patients: Raising the Bar for Pre-Clinical Cancer Research

C. Glenn Begley, Ph.D., Senior Vice President, TetraLogic

There are multiple challenges translating research findings into drugs that ultimately benefit patients. Some are inherent in the disease and the models we employ, and are extremely difficult to address.Others are inherent to our processes, and may be more readily overcome.

5:05 Building More Predictive in vitro and in vivo Models to Identify Responder Populations Pre-Clinically

Emma Lees, Ph.D., Vice President, Oncology, NIBR Site Head Emeryville, Novartis Institutes for Biomedical Research

5:35 Challenges to Accurately Translating Results from
Pre-Clinical Cancer Models to the Clinic

Peter Houghton, Ph.D., Director, Center for Childhood Cancer, Nationwide Children’s Hospital

Human tumor xenografts have been the predominant models for cancer drug development for about 30 years. However, there are concerns that results from such pre-clinical models do not translate into clinical reality.

6:05 Panel Discussion: Improving Reproducibility and Predictability of Preclinical ResearchModerator: Peter Houghton, Ph.D., Director, Center for Childhood Cancer, Nationwide Children’s Hospital
Panelists:
C. Glenn Begley, Ph.D., Senior Vice President, TetraLogic
Emma Lees, Ph.D., Vice President, Oncology, NIBR Site Head Emeryville, Novartis Institutes for Biomedical Research
Terry A. Van Dyke, Ph.D., Head, Mouse Cancer Genetics Program; Program Director, Cancer Pathways and Mechanisms, National Cancer Institute 

 

 

 

 

6:35 Close of Day

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