This blog discusses how decision analysis approaches can help drug developers to better decisions under multiple criteria and uncertainty.Read More
Author: Rajesh Krishna and Bill Poland
About Rajesh Krishna: Raj’s areas of interest includes the application of novel approaches to new drug development by leveraging decisionable biomarkers and quantitative methods to maximize the probability of development success. During his career, he has been credited with numerous scientific and strategic accomplishments, most notable of which as the principal architect of quantitative clinical pharmacology at Merck, a concept that gained widespread industry adoption. Raj received his Ph.D. in pharmaceutical sciences from the University of British Columbia, Canada and a mid-career MBA from Warwick Business School, UK. He is an elected fellow of the American Association of Pharmaceutical Scientists and American College of Clinical Pharmacology. Raj sits on the editorial board of the Journal of Clinical Pharmacology and BMC Medicine and has published over 80 peer-reviewed publications in leading journals such as The Lancet, Cancer Research, and Clinical Pharmacology and Therapeutics. In addition, he has edited or co-edited 4 books on new drug development as it relates to translational medicine, dose selection, biopharmaceutics and pharmacokinetics. Raj is an adjunct assistant professor of pharmacology and therapeutics at Thomas Jefferson University and takes an active interest in education initiatives. About William Poland: Dr. Poland has provided pharmaceutical companies guidance in drug development decisions through scientific and decision-analytic modeling and simulation since he joined Certara in 1998. In over 40 projects for top pharmaceutical companies, he has advised on trial and program design for HCV, HIV, and other therapeutic areas, using integrated treatment adherence, pharmacokinetic, pharmacodynamic, and trial models. Recommendations included go/no-go, doses and regimens, arm sizes, and target populations. In central nervous system diseases, he has used simulations to develop flexible strategies for optimal Phase 2-3 development of multiple drugs with overlapping indications, incorporating market models to value outcomes. In oncology, he has performed and reported population exposure-efficacy and exposure-tolerability analyses for regulatory submissions. Poland’s research interests include practical viral dynamics modeling, portfolio optimization, and Bayesian adaptive program design trading off efficacy and side effects, for which he is co-author of a patent submission. Before joining Certara, he performed decision analyses for pharmaceutical and other industries at Strategic Decisions Group. He received his Ph.D. in Engineering-Economic Systems from Stanford University in 1994. He has an M.S. from the same department, an M.S. in Operations Research from the University of California at Berkeley, and a B.S. in Engineering and Applied Sciences from Harvard University.