A Risk Assessment Framework for Decisionmaking in Drug Product Development

• Activity Number: 414
• Type: Contributed
• Date/Time: Tuesday, August 2, 2011 : 2:00 PM to 3:50 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Amit Phansalkar*+
• Companies: Straight Line Performance Solutions
• Keywords: Risk Assessment ; Bayesian modeling ; scenario analysis tool ; quantitative decision making

Abstract

The issues surrounding low productivity and escalating costs of drug product development have been well documented in the past. The overriding concern with making product portfolio decisions is lack of information. The ability to quantify risks and identify the influence of behavioral bias towards project decisions is crucial to the successful launch of a drug product. We present a Bayesian framework (tool) for modeling uncertainty and quantitative decision making for drug product development. The quantitative risk evaluation method is implemented as a scenario analysis tool estimating the probability of success of a decision at various stages of drug development. It also helps ferret out possible biases and assumptions in the critical factors and compare alternatives. The tool identifies factors that are likely predictive in the selection of most viable alternative in making the decision. Based on the set of initial assumptions regarding the influence of these factors, the tool estimates the percentage risk associated with each decision. A case study is presented to illustrate the modeling procedure and the effectiveness of the tool in making project selection decision.