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Optimization of Pharmaceutical R&D Programs and Portfolios pp 155–180Cite as

Portfolio Optimization of Therapies and Their Predictive Biomarkers

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Abstract

The future of oncology drug development depends on the identification of predictive biomarkers that can identify subsets of patients who will benefit from the therapy. When predictive biomarkers work, they increase the value of therapies, and decrease the risk and potentially the cost of therapeutic development. However, predictive biomarkers do not always work, and when they do not, they add cost, time, and complexity to development. This chapter describes methods to adaptively integrate predictive biomarkers into oncology clinical development in a data-driven manner that invests in a predictive biomarker in proportion to its proven ability to predict therapeutic efficacy. This not only increases the value of associated therapeutics but also optimizes the investment in predictive biomarkers by managing the uncertainty in their predictive ability. At the end of the chapter, we discuss a global view of portfolios as a group of putative therapies and putative predictive biomarkers competing for limited resources. In modern drug development, portfolio optimization should ultimately be performed across both of these asset categories as an integrated whole.

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Acknowledgements

The authors wish to thank Jason Clark for contributing the decision analysis guided Phase 2-Phase 3 predictive biomarker transition, and Donald Bergstrom, Daniel Freeman, Robert Phillips, Richard M. Simon, and Linda Sun for helpful discussions.

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Authors and Affiliations

  1. Center for Evolution and Cancer, Helen Diller Family Cancer Center, University of California at San Francisco, San Francisco, CA, USA

    Robert A. Beckman M.D.

  2. Oncology Clinical Research, Daiichi Sankyo Pharmaceutical Development, Edison, NJ, USA

    Robert A. Beckman M.D.

  3. 1045 Hereford Drive, Blue Bell, PA, 19422, USA

    Robert A. Beckman M.D.

  4. Biostatistics and Decision Research Sciences, Merck Research Laboratories, Upper Gwynedd, PA, USA

    Cong Chen Ph.D.

Authors
  1. Robert A. Beckman M.D.
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  2. Cong Chen Ph.D.
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Correspondence to Robert A. Beckman M.D. .

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Editors and Affiliations

  1. Cytel Inc., Cambridge, Massachusetts, USA

    Zoran Antonijevic

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Beckman, R.A., Chen, C. (2015). Portfolio Optimization of Therapies and Their Predictive Biomarkers. In: Antonijevic, Z. (eds) Optimization of Pharmaceutical R&D Programs and Portfolios. Springer, Cham. https://doi.org/10.1007/978-3-319-09075-7_10

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