August 24, 2010 | 11:30 - 1:00 PM EDT
Course Instructor: Stephen T. Sonis, DMD, DMSc, Senior Surgeon Brigham and Women’s Hospital and the Dana-Farber Cancer Institute, Chief Medical Consultant , Clinical Assistance Programs
Course Description: This symposium will frame the challenges faced by drug developers and CROs that are associated with standardizing clinical trial endpoints that are dependent on clinician assessment and judgment. A proven strategy for effectively addressing the issue will be presented along with specific study examples.
Learning Objectives:
- To explain the scope and reasons for endpoint variability.
- To present the rationale and approach for assessor standardization.
- To provide data supporting training specific training strategies.
- To present the concept of endpoint management.
Who Should Attend: Individuals charged with clinical trial design, implementation and management.
Instructor Biography:
Stephen T. Sonis, D.M.D., D.M.Sc. Professor of Oral Medicine, Department of Oral Medicine, Infection and Immunity, Harvard School of Dental Medicine Chief, Divisions of Oral Medicine, Brigham and Women’s Hospital and the Dana-Farber Cancer Institute Senior Surgeon, Brigham and Women’s Hospital
After receiving his DMD from Tufts University, Dr. Sonis entered a combined doctorate and clinical specialty training program at Harvard University. Following completion of his degree and residency, he was awarded a Knox Fellowship to study tumor immunology at Oxford University. He returned to the United States to accept joint positions at the Peter Bent Brigham Hospital, Sidney Farber Cancer Center, and the Harvard School of Dental Medicine. Dr. Sonis’ research converged on studies to define the biology and clinical significance of cancer regimen-related mucosal toxicities. The results of his studies on the molecular and cellular pathogenesis of mucositis have established the basis of a mechanistic paradigm for epithelial injury, and have provided treatment targets for biological and pharmaceutical development. Recognizing that genetics play a role in patient risk for mucositis and other toxicities, Dr. Sonis and his collaborators have identified specific canonical pathways that are critical in toxicity development and have used these to form the basis for SNP-based risk prediction. Furthermore, with the application of network theory to cancer-related toxicities, Dr. Sonis and his colleagues have built on earlier work to define specific toxicity constellations in patients receiving chemotherapy. Dr. Sonis has extensive experience in clinical trials. In collaboration with the University of British Columbia, Dr. Sonis and his Harvard colleagues have enabled a technology built around a Raman spectroscopy platform to assist in the diagnosis, monitor, and treatment response of head and neck cancers. In addition to his academic appointments, Dr. Sonis is a partner in Biomodels, LLC, a principle investigator of TRIAD Burden of Illness Studies, and a Special Government Employee of the FDA. Many of his former students and residents now hold academic and clinical leadership positions. Dr. Sonis has published extensively on the clinical, biological, and health economic aspects of cancer and complications associated with its treatment. He is the author of over 200 original publications, reviews and chapters, 7 books, and 5 patents. He has lectured extensively on the clinical and biological aspects of cancer regimen-related toxicities and cancer diagnostics. Dr. Sonis serves on a number of editorial boards, and is a founding member of the International Society of Oral Oncology and the International Academy of Oral Oncology.