September 13, 2010
11:30 am – 1:00 pm EDT
Course Description: The antidote to uneconomic “menu driven” drug development, where homogeneous lists of experiments can drive formulaic “stage gate” decisions, this course will enable people involved in translational pharmaceutical science to define cost-effectively what to measure, how to measure it and how good is good enough?
Learning Objectives:
Why fixed menus, criteria and stage gates are often uneconomic
How to decide what to measure and what degree of change is required
How to decide how good is good enough: when to maximize and when to satisfice
How to account for technical, human and economic factors in every decision
How the PhRMA proof of concept process starts pre-clinically and translates into the clinic
Who Should Attend: Discovery scientists, translational medicine scientists, project managers in Exploratory Development, clinical pharmacologists
Instructor: Stephen A. Williams MD, PhD
Steve originally obtained his degrees in physiology, medicine and surgery at Charing Cross and Westminster Medical School, University of London, where he also obtained aPhD in medicine and physiology. This was followed by 3 years training in diagnostic imaging at the University of Newcastle Upon Tyne.
From 1989 to 2007 Steve was at Pfizer Inc.,initially in the Experimental Medicine group, where he was responsible for a variety of Exploratory Development programs across a number of therapeutic areas. In 1997 he created the Clinical Technology group which became a worldwide function on 5 research sites with the objective of validating clinical biomarkers and measurements, and was made VP in 2006. In process initiatives, he led or co-led initiatives in diagnostics, biomarkers, quality of drug candidates and guidelines for development teams to make the decision to start phase III.
External to industry, Steve was on the inaugural National Advisory Council for Biomedical imaging and Bioengineering at the National Institutes of Health from 2003-2007, and chaired the training and development working group. He also co-chaired the PhRMA biomarkers working group He was an instigator in the formation of the FDA-FNIH-PhRMA biomarker consortium and from 2007 to 2009 Steve co-directed Decisionability, a consulting company.
In 2009 he joined SomaLogic Inc. Boulder CO. as Chief Medical Officer. SomaLogic discovers protein biomarkers using a unique aptamer-based multiplex technology platform and develops products for use in diagnostics and personalized medicine.
Steve was the lead author on two recent PhRMA position papers: the first on a process for developing evidentiary standards for biomarkers, surrogate endpoints and diagnostics, the second on best practices for proof of concept. His book “Decisionability: The Skill to Make Your Decisions Productive, Practical and Painless” is available on Amazon.com.