TUESDAY, JANUARY 27
7:30-8:15 Sponsored Presentation (Opportunity Available) or Morning Coffee
TOP 10 OPPORTUNITIES IN TRANSLATIONAL CANCER MEDICINE
1. COMBINATION THERAPIES
8:30-9:00 Combination Approaches for the Treatment of Solid Tumors: Opportunities and Obstacles in the Era of Targeted Therapy
Jon M. Wigginton, Ph.D., Director, Clinical Oncology, Merck & Co., Inc.
Abstract unavailable at the time of printing. Please visit www.TranslationalCancerMedicine.com for updated info.
2. NEW TARGETS
9:00-9:30 To be Announced
9:30-10:00 Sponsored Presentations (Opportunities Available)
10:00-11:00 Coffee Break with Exhibit and Poster Viewing
3. MOLECULAR DIAGNOSTICS
11:00-11:30 To be Announced
4. COMPANION DIAGNOSTICS
11:30-12:00 The Potential Impact of Recently Approved and Emerging Molecular Diagnostics in Drug-Diagnostics Co-Development
Francis Kalush, Ph.D., Network Leader, Diagnostics, Office of the Center Director, Center for Devices and Radiological Health, Food and Drug Administration
The FDA under its Critical Path Initiative is leading several efforts to streamline regulatory pathways in Personalized Medicine. An overview of the strategies and impact of recently and emerging molecular diagnostic biomarkers in companion drug-diagnostics will be discussed.
5. BETTER in vitro MODELS
12:00-12:30 Employing Brain Tumor Stem-Like Cells for Drug Testing and Drug Development
Gregory J. Riggins, M.D., Ph.D., Irving J. Sherman M.D. Professor of Neurosurgery Research, Professor of Neurosurgery & Oncology, Department of Neurosurgery, Johns Hopkins University
Traditional cell lines do not always maintain the same genomic or in vivo characteristics when compared to the primary tumor. We have developed oncosphere cultures grown in stem cell media that maintain better the original genomic profile. These cells produce intracranial tumors that grow invasively, similar to the primary tumor. Small molecule screens and drug testing based on these oncospheres cultures have been developed. Evidence suggests that cultures and tumors grown from stem-like cells produce a model more faithful to tumor biology and drug response.
12:30-2:00 Lunch on your own
6. BETTER in vivo MODELS
2:00-2:30 Mouse Cancer Models in Translation: Past, Present and Future
Glenn Merlino, Ph.D., Chief, Laboratory of Cancer Biology and Genetics; Head, Cancer Modeling Section, National Cancer Institute
Standard preclinical approaches currently employed to evaluate potential anti-cancer agents (e.g., xenograft mouse models) have been mostly ineffective in predicting future clinical benefits. The advent of genetically engineered mouse models that more faithfully recapitulate the development of human cancers with respect to histopathology, molecular genetics and biology have provided novel insights into cancer mechanisms, and a fresh approach to preclinical modeling. It is anticipated that these new mouse models will facilitate target validation, biomarker discovery and tumor response assessment, and significantly improve cancer drug development.
7. BIOMARKERS TO PREDICT DRUG RESPONSE
2:30-3:00 Matching Oncology Drugs with Patient Benefit: Preclinical and Clinical Discovery of Predictive Markers of Therapeutic Response
Garret Hampton, Senior Director, Biochemistry & Biomarker Development, Celgene Research
The incremental benefit of oncologic therapeutic intervention over the past 30 years, and the high attrition rate of new oncology therapeutics during development, have focused the industry on how to better evaluate new compounds in the context of disease. This presentation will focus on both prospective and retrospective approaches used to predict likely patient response, in essence matching drugs with causal tumor biology. The output these efforts at Celgene, and in the industry as a whole, is expected to be a significant increase in patient benefit, definable and justifiable cost / benefit propositions and a shift in cancer care from acute, life-threatening illnesses to manageable chronic diseases.
3:00-3:30 Sponsored Presentations (Opportunities Available)
3:30-4:30 Refreshment Break with Exhibit and Poster Viewing
8. CANCER BIOLOGICS
4:30-5:00 Title to be Announced
Bahija Jallal, Ph.D., Vice President, Translational Science; Head, Oncology, MedImmune
Abstract unavailable at the time of printing.
9. PHASE 0 CLINICAL TRIALS
5:00-5:30 Risk-Based Compliance for Production of Agents for Phase 0 Studies
John A. Gilly, Ph.D., Deputy Director, Biopharmaceutical Development Program, SAIC-Frederick/NCI-Frederick
Exploratory IND studies (Phase 0) describe studies in patients in very early Phase I. ExpIND studies provide for an understanding between the relationship of the drug candidate and the mechanism of the disease. It also provides options to explore the biodistribution of the NME in micro-dosing studies. Many companies and academic laboratories are considering Phase 0 studies as part of their program. Important risk-based compliance decisions must be made in the development of these agents. Examples of drugs under development at the NCI will be discussed.
10. TRANSLATIONAL IMAGING
5:30-6:00 Translational Molecular Imaging: Oncology
Syed Mahmood, M.D., Associate Medical Director, Clinical Imaging Physician, Oncology Clinical Imaging, Novartis Pharmaceuticals Corporation
This talk is intended to provide an approach to Translational Molecular Imaging in oncology – from an introduction perspective to clinical translation. Specifically, we will address the major areas in which molecular imaging strategies to target the “cancer cell biology” have started to make some progress. We will cover what molecular imaging is, and how it is different from the imaging that is routinely performed in radiology departments. We will briefly discuss how the most commonly employed molecular imaging modalities work and how they can be utilized in current and emerging applications of molecular imaging.
6:00 Close of Day
