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Activity Number: 377
Type: Topic Contributed
Date/Time: Tuesday, August 5, 2014 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract #313019 View Presentation
Title: Designing Phase III Trials to Optimize the Value of a Portfolio
Author(s): Nitin Patel*+ and Suresh Ankolekar
Companies: Cytel and Maastricht School of Management
Keywords: Clinical Trials ; Optimization ; Portfolio ; Budget allocation ; Adaptive design ; Net Present Value
Abstract:

We develop a value-driven approach to optimizing pharmaceutical portfolios that integrates inputs from clinical research, clinical operations and commercial functions. Our approach highlights the importance of clinical trial parameters such as sample size and interim looks in adaptive designs. We will describe a Stochastic Integer Programming (SIP) implementation of a Bayesian decision analysis that optimally allocates a drug development budget in a Phase 3 portfolio. The SIP uses Expected Net Present Value (ENPV) as the optimizing criterion and includes out-sourcing, in-sourcing, and partnering opportunities. We show how this model can be used to control risk and investigate the impact of adaptive designs. We show how adaptive designs can attract investment by financial firms by reducing and quantifying risk.


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