Improving Drug Development Success Rates With Evidence Based Descision Analysis
— evidence-based approach, undesirable and costly choices, unwarranted assumptions and approximations
Speaker: Leonard Wesley
Meeting Date: Thursday, June 6, 2013
Time: 6:00 PM: Registration & Informal Networking, 6:30 PM: Management Forum / Guided Networking, 7:00 PM: Dinner, 7:30 PM: After Dinner Presentation, 9:00 PM: Adjourn
Location: RAMADA Silicon Valley – 1217 Wildwood Ave Sunnyvale, CA 94089
Summary:
Management Forum / Guided Networking: Bring Your Management Challenge; Arrive by 6:30 PM to join this exciting Management Forum. Following informal networking is a guided discussion typically related to the topic of the evening’s after dinner talk, or of general Technology Management interest.
Light Dinner: This month we’re continuing with our light dinner format — typically sandwiches, salad, drinks, and cookie or similar light dinner.
Presentation: Improving Drug Development Success Rates With Evidence Based Decision Analysis
Current literature reports that developing one successful drug compound takes ten to fifteen years and approximately one billion dollars. Less than five percent of all candidate drug compounds make it to market. Improving the drug success rate, even marginally, translates into saving between $200M to $300M per compound and saving hundreds of lives. To help improve the current success rate, we present an evidential-based approach to drug development decision making. The approach treats decision-related data as evidence for or against pursuing competing development alternatives as opposed to treating all data as probabilistic in nature. A benefit of the evidential approach is that decision makers are not forced to make unwarranted assumptions and approximations when complete statistical data are lacking. As a consequence, an evidential approach is able to give better insight into the impact of assumptions, approximations, and uncertainty on multi-million dollar drug development decisions. The insight provided by an evidential approach can help decision makers avoid making undesirable and costly choices. We will present a summary of results from using an evidential approach, in a blind retrospective study, that identified false positive drug compounds that were approved by the FDA and when released to market resulted in over hundred human deaths.
Bio:
Dr. Wesley has a Ph.D. in Computer Science from the University of Massachusetts, Amherst. He is currently an Associate Professor and the director of the Master of Science Bioinformatics emphasis within the General Engineering Department at San Jose State University. Under his leadership, the bioinformatics curriculum was recently updated with guidance from a bioinformatics industry board consisting of senior management and technical staff from Roche-Genentech, Bristol-Myers Squibb, Genomic Health, and Merck. Since implementing the revised curriculum in 2012, the emphasis has grown over 25% in the last year.
Dr. Wesley came to SJSU from the Artificial Intelligence Center at SRI International in Menlo Park, CA, where he was a Senior Scientist. He has over twenty years experience and over 50 publications related to basic and applied R&D in the areas of computational decision analytics and evidential reasoning. During the previous seven years, his interests has focused primarily on bioinformatics and helping the pharmaceutical industry improve drug success rates.