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Archived Content

Oncology Clinical Trials 

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Oncology Clinical Trials Promo Video 

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The recent breakthroughs in understanding of the molecular biology of cancer have led to an unprecedented number of new targets in oncology drug development. Many of these are already advancing to the clinical stages, making oncology clinical trials the most prevalent across therapeutic areas.  The success of an oncology trial depends on many factors, the most important being the quality of pre-clinical data that provides a testable hypothesis. Biostatistical, scientific, organizational, regulatory, ethical and economic ingredients are equally important for advancing clinical development of a drug.


Tuesday, February 21

7:00 am Registration


Plenary Keynote SESSION 

8:00 Plenary Keynote Presentations  

Sponsored by
Hologic Molecular Diagnostics - small logo 

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



11:00 Chairperson's Opening Remarks

Steven Piantadosi, M.D., Ph.D., Chair & Director, Phase One Foundation, Samuel Oschin Comprehensive Cancer Institute

11:10 Cancer Clinical Trials in the Era of Personalized Medicine: a Sponsor's Perspective

Hal BarronHal Barron, M.D., Executive Vice President, CMO, Global Product Development, Roche Holding AG

11:40 Cancer Clinical Trials in the Era of Personalized Medicine: an Investigator's Perspective

Margaret TemperoMargaret A. Tempero, M.D., Doris and Donald Fisher Distinguished Professorship, Professor of Medicine, Division of Hematology and Oncology; Director of Research Programs; Deputy Director, UCSF Helen Diller Family Comprehensive Cancer Center

Recent breakthroughs in clinical science suggest there is more diversity in malignant disease than we previously appreciated. Identifying clinically actionable biomarkers demands a paradigm shift in clinical trial design and a focus on small subsets.

12:10 pm Methodologic Issues in Clinical Trials In the Era of Personalized Medicine

Steven PiantadosiSteven Piantadosi, M.D., Ph.D., Chair & Director, Phase One Foundation, Samuel Oschin Comprehensive Cancer Institute

This talk will discuss issues in the design and analysis of trials that test therapies that rely on "personalized" therapy, such as those tailored to specific genetic or other characteristics of the study subjects.


12:40 Enjoy Lunch on Your Own 

1:45 Dessert in the Exhibit Hall with Poster Viewing



2:15 Chairperson's RemarksIonel Mitrica, Ph.D., Director, Clinical Development, Oncology, GlaxoSmithKline 

2:20 SWOG, An International NCI-Funded Cancer Cooperative Group Collaboration on Biomarker Development, Cancer Prevention and Cancer Treatment with Industry

Laurence H. Baker, D.O., Professor of Medicine and Pharmacology, University of Michigan Medical School; Group Chair, Southwest Oncology Group (SWOG)

SWOG, a large multidisciplinary cancer cooperative group in engaged in studies designed to improve our abilities to diagnose, treat and prevent cancer. We have trials in collaboration with industry partners in GI, GU, and breast cancer prevention as well as cancer treatment trials is those areas as well as leukemia, lymphoma, myeloma, melanoma and lung cancer. Our trials are performed in all of the U.S. as well as Canada, Mexico, and Korea. Our clinical trials are performed by 4,000 physicians and caregivers at over 500 sites.    In this presentation we will highlight the methodology of the collaboration as well as describe some obstacles to success.

2:50 Cooperation between Industry and Academic Collaborative Groups in Oncology

Ionel Mitrica, Ph.D., Director, Clinical Development, Oncology, GlaxoSmithKline

This presentation discusses how to effectively approach partnerships between pharma and academic cooperative groups, while meeting both sides' needs as well as regulatory requirements, and ultimately also improving the output of oncology R&D.


3:20 Laboratory and Clinical Endpoints in Cancer Immunotherapy

Michael A. Morse, M.D., MHS, Associate Professor, Division of Medical Oncology, GI Oncology, Duke University Medical Center  

Cancer immunotherapies such as cellular therapies and immune modulators have been recognized to provide clinical benefit, and have received marketing approval in the United States. Nonetheless, well accepted clinical surrogates may not provide effective guidance toward the development of other immunotherapies, or extending the use of the currently approved therapies. The laboratory and clinical endpoints recognized as critical to demonstrating effectiveness will be addressed, along with discussion of their role in informing the development of novel agents.

3:50 CTCs as a Liquid Biopsy

Marielena Mata, Ph.D., Principal Research Scientist, Oncology Biomarkers, Johnson & Johnson

From counting to "seeing" the tumor, CTCs provide access to tumor related information that may significantly impact clinical development decisions. Overview of the use of CTCs in clinical trials as prognostic and predictive markers including practical considerations and logistics.

4:20 Reception in the Exhibit Hall (Sponsorship Available)

5:20 Breakout Discussions in the Exhibit Hall

Concurrent problem solving breakout discussions, open to all attendees, speakers, sponsors, and exhibitors, provide a forum for discussing key issues and meeting potential collaborators. Plan to take part and explore these topics in-depth. Please pick a topic of your choice, find your table and join in.

Forging New Regulatory Pathways for Delivery of Personalized Medicine

Moderator: Linda Burdette, Ph.D., Director, Drug Regulatory Affairs, F. Hoffmann-La Roche, Inc.

-  Brainstorm new regulatory pathways to facilitate co-development of drug/diagnostics

-  Explore areas where additional FDA guidance is needed for co-development of drug/diagnostics

-  Propose incentives for innovation and risk-based approaches to contemporaneous development of drug/diagnostics

To Randomize or Not to Randomize in Oncology Phase 2 Clinical TrialsModerator: Ionel Mitrica, Ph.D., Director, Clinical Development, Oncology, GlaxoSmithKline 

-  Review experience with/bias toward Phase 2 single-arm trials (SATs) vs randomized controlled trials (RCTs) in roundtable participants’ institutions

-  Review some of the pros and cons for SATs vs RCTs, and when one or the other may make more sense

-  Discuss the role of RCTs in early oncology drug development

Genomic Based Approach to Cancer Clinical TrialsModerator: Apostolia-Maria Tsimberidou, M.D., Ph.D., Associate Professor, Department of Investigational Cancer Therapeutics, University of Texas, MD Anderson Cancer Center 

-  Optimization of molecular profiling: challenges

-  Development of novel targeted agents

-  Collaboration and exchange of information regarding molecular profiling and treatment selection

6:20 Close of Day

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