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Making Better Go/No-Go Decisions: Improving Success Rates and Reducing Costs
Session Chair(s)
Joseph A DiMasi, PHD
Director of Economic Analysis and Research Associate Professor , Tufts Center for the Study of Drug Development, United States
This session will examine trends in success rates and recently developed methods which establish a set of factors that can be scored and combined to improve the predictability of approval for compounds that have undergone mid-stage clinical testing.
Learning Objective : Analyze the historical record concerning technical risks in clinical development of new drugs and biologics; Assess how clinical, compound, operational, and economic characteristics can be used to make better go/no-go development decisions.
Speaker(s)
Wayne Rackoff, MD, MA
Vice President, Clinical Oncology, Janssen Research & Development, LLC, United States
APGAR Begets ANDI: What Drug Developers Can Learn from Orchestra Auditions and Crying Newborns
Joseph A DiMasi, PHD
Director of Economic Analysis and Research Associate Professor , Tufts Center for the Study of Drug Development, United States
Improving Phase 2 Go/No-Go Decision-Making with a Simple Scoring Algorithm
Rick Sax, DrMed, FACP
Managing Director, Pharma Design Solutions, Ltd., United Kingdom
Looking at Cost/Time/Risk/Value Scenarios to Improve Clinical Program Decision-Making
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