Need for Optimal Design of Pharmaceutical Programs and Portfolios in Modern Medical Product Development

Zoran Antonijevic ()
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Zoran Antonijevic: Cytel Inc.

Chapter Chapter 1 in Optimization of Pharmaceutical R&D Programs and Portfolios, 2015, pp 3-16 from Springer

Abstract: Abstract In drug development decisions regarding various development options should be defined such that that the expected value of a product or a portfolio is maximized. This needs to be done through the process of quantitative optimization of development decisions. This process involves development of multiple scenarios that are best compared by using simulations. While this optimization could focus on individual development programs, it is preferable that these decisions are made at the portfolio level, as individual programs are interdependent. The value of a product depends on quality of product itself, and quality of development program. The value of a portfolio depends on the value of individual products and the strategy for portfolio optimization. Key concepts that are addressed here are: 1. Drug development decisions should be made at the portfolio level. Budgets are limited and are determined at the portfolio level; therefore decisions within individual programs should be interrelated. 2. Study design and development strategy have a major impact on the success of drug development at: Trial level by application of adaptive design. Program level. More effective dose-finding leads to higher success rates in Phase 3 and an improved efficacy/safety profile Portfolio level. Improved allocation of a fixed budget into individual trials leads to an improved value of the portfolio. 3. An integrated, R&D and commercial approach is necessary for optimizing pharmaceutical portfolios.

Keywords: Value of R&D programs and portfolios; Value of design; Decision making; Development scenarios; Simulations; Optimization; Uncertainty (search for similar items in EconPapers)
Date: 2015
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DOI: 10.1007/978-3-319-09075-7_1

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