Speakers
Richard GAYNOR Eli Lilly and Company, USA Richard B. Gaynor, M.D. joined Eli Lilly and Company as Vice President for Cancer Research and Clinical Investigation in August 2002. Currently, Dr. Gaynor is Vice President, Product Development and Medical Affairs, Oncology Business Unit. Gaynor received a Bachelor of Science degree in biology from Texas Tech University and then received a doctor of medicine degree from the University Of Texas Southwestern Medical School. He served his internship and residency in internal medicine from at Parkland Memorial Hospital in Dallas, Texas. He completed a fellowship in hematology-oncology at the University of California at Los Angeles (UCLA) School of Medicine and then served on the faculty there. He received board certification in internal medicine, hematology and medical oncology. Prior to joining Lilly, Gaynor was a Professor of Medicine and Microbiology at the University of Texas Southwestern Medical Center (UTSW) in Dallas and held several important leadership positions. He was Chief of the Division of Hematology and Oncology at UTSW and Director of the Harold C. Simmons Comprehensive Cancer Center there in addition to his work as the Lisa K. Simmons Distinguished Chair in Comprehensive Oncology. He served on numerous NIH advisory committees and was elected to both the American Society of Clinical Investigation and Association of American Physicians. Gaynor is on the editorial board of several scientific journals and has an extensive publication record totaling more than 140 scientific articles. He serves on the board of the Damon Runyon Cancer Research Foundation and the Walther Cancer Institute and on several committees for the American Association of Cancer Research and other leading cancer organizations. Abstract Title: CHALLENGES IN ONCOLOGY DRUG DEVELOPMENT Oncology therapeutics have been transformed by the development of treatments such as Gleevec and Herceptin that are directed at specific molecular pathways involved in oncogenesis. However, even with these advances, drug development remains a slow and expensive process with less than 10% of molecules being tested in the clinic progressing to registration and commercialization. The cause of such failures have many reasons including insufficient understanding of the mechanism of drug action, lack of predictive pre-clinical models, issues in determining the optimal drug dose and schedule, complexity of tumor biology and inability to appropriately select the appropriate patient populations for treatment. A better understanding of the mechanism of drug action using pharmacodynamic markers coupled with pharmacokinetics and the identification of predictive markers which can serve as surrogates of response should increase clinical success rates. These measures coupled with improved clinical trial methodologies including adaptive designs, utilization of novel-novel combinations and patient enrichment strategies are currently being incorporated into cancer clinical trials. In conclusion, a better understanding of cancer biology coupled with the development of more selective drugs, the identification of appropriate biomarkers to facilitate patient selection criteria and the incorporatation of innovative trial designs should help to increase clinical success rates in order to more rapidly bring needed cancer drugs to patients. |
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