Track 2: Implementing Personalized Medicine
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FRIDAY, SEPTEMBER 25
7:30-8:15 am Breakfast Presentations (Opportunities Available)
Contact Ilana Quigley, Manager, Business Development, at 781-972-5457 or iquigley@healthtech.com.
8:25-8:30 Chairperson’s Opening Remarks
Bruce Quinn, M.D., Ph.D., Senior Health Policy Specialist, Foley Hoag; Former California Medical Director, NHIC
8:30-9:00 Biomarkers and Diagnostics in Drug Development: Making Medicines Better
Walter H. Koch, Ph.D., Vice President and Head, Global Research, Roche Molecular Systems, Inc.
Disease heterogeneity is one explanation of why some patients treated with a given therapy do not show adequate responses. Biomarkers afford the opportunity to classify subtypes of disease at a molecular level, and in some cases, to specifically predict the likelihood of therapy response. Knowledge of oncogenic pathway dysregulation is also increasingly helping to guide stratification of patient populations to improve patient response in clinical trials, and routine treatment. Recent examples include selection of targeted therapies based on the presence, activation by mutation, or overexpression of a drug target (e.g. ER, EGFR, HER2), as well as knowledge of downstream signaling activation that renders a particular growth factor receptor inhibition strategy less effective (e.g. KRAS ). Examples of clinical trial strategies using mutational status of relevant cancer genes to guide patient selection, and the associated diagnostics development ramifications will be presented.
9:00-9:30 Personalized Diagnostics: The Struggle for Position
Bruce Quinn, M.D., Ph.D., Senior Health Policy Specialist, Foley Hoag; Former California Medical Director, NHIC
Multiplex and other complex diagnostics apply cutting-edge molecular biology techniques to clinical challenges in patient care. As technology advances, the technology becomes reliable enough for clinical use and the per-patient costs of the technology become practical. However, the tests are similar to pharmaceuticals in that the cost of goods sold may be small in proportion to the development risks and the costs of clinical trials to validate the test. Therefore, while the value-based market price may be fully commensurate with the test’s clinical worth, a substantial market price is also required just to recover the development costs. Otherwise, the tests will have a negative total value for the test developer regardless of the size of their clinical value to the public. The problem is, historically, the prices of laboratory tests are very small compared to their clinical value. For example, the troponin test saves lives by diagnosing heart attacks, but the market price of the test is under $20 dollars. This lecture discusses the opportunities and challenges that face multiplex diagnostics in the marketplace.
9:30-10:00 Panel Discussion: Integrating Biomarkers and Diagnostics into Drug Development
10:00-10:30 Networking Coffee Break
(Shared Session with Clinical Biomarkers meeting)
10:30-11:00 Translational Medicine’s Role in Target Validation and Patient Selection in Oncology Drug Development
Giora Feuerstein, M.D., Assistant Vice President and Head, Discovery Translational Medicine, Wyeth Research
The modern era of molecular oncology attempts to deliver anti-cancer drugs that interfere with specific pathways that drive the oncogenic transformation of tumors. Therefore, identifying the specific signaling pathways that underwrite the particular growth and metastasis of each individual tumor in each patient requires meticulous profiling of the tumor tissue for the targeted oncogenic cause. Biomarkers that provide evidence on the presence of mutations and/or activation of such pathways are critical to match the treatment to the particular patient’s tumor. This talk will provide the strategies and case studies on the role of Translational Medicine and biomarkers in modern oncology drug discovery and development.
11:00-11:30 Predictive Markers for Optimizing Selection of Colorectal Cancer Patients for Treatment with ERBITUX® (Cetuximab)
Shirin Khambata-Ford, Ph.D., Director, Oncology Biomarkers, Oncology, Bristol-Myers Squibb Co.
Cetuximab is a chimeric monoclonal antibody directed against the epidermal growth factor receptor (EGFR) with proven clinical efficacy in metastatic colorectal cancer (mCRC) and several other solid tumor types. Several candidate predictive markers of cetuximab efficacy in mCRC have emerged recently from clinical studies, most notably the K-Ras mutation status of the tumor. Retrospective data strongly suggest that the benefit/risk ratio for cetuximab treatment in patients with wild-type K-Ras mCRC tumors is greater than for patients with mutant K-Ras tumors. In addition, a gene expression signature including genes for the EGFR ligands epiregulin and amphiregulin may also identify patients who are likely to benefit from cetuximab. The addition of gene expression information to K-Ras mutation status could further optimize the selection of patients most likely to benefit from cetuximab treatment.
11:30-12:00 12:00-12:30 Oncology Biomarkers and Response to Therapy
Jill M. Kolesar, Pharm.D., Director, Analytical Instrumentation Laboratory for Pharmacokinetics, Pharmacodynamics, and Pharmacogenetics, UWCCC; Associate Professor of Pharmacy, School of Pharmacy, University of Wisconsin
Anticancer therapies are nearly universally expensive and toxic, yet efficacy is limited to a small subset of treated patients. A number of predictive biomarkers are emerging as a method to individualize cancer therapy, treating only those likely to benefit and sparing likely non-responders from the toxicity and expense of unnecessary treatment. Recent advances in Kras and C-met mutational analysis for predicting response to EGFR inhibitors will be discussed.
12:00 Close of Congress