Review of Portfolio, Program, and Project Management in the Pharmaceutical and Biotechnology Industries
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Review of Portfolio, Program, and Project Management in the Pharmaceutical and Biotechnology Industries Harpum P, ed. Portfolio, Program, and Project Management in the Pharmaceutical and Biotechnology Industries. Hoboken, NJ: Wiley; 2010, 331 pp. Reviewed by: Edward Tabor, MD Quintiles, Rockville, Maryland, USA
This book is about the concept of ‘‘P3M,’’ an acronym that stands for Portfolio, Program, and Project Management. This hierarchical approach to running project management for new pharmaceutical product development or other organizational initiatives may not be familiar to many regulatory affairs experts, although it has been applied in some sectors of the pharmaceutical industry for several decades. (Other authors have sometimes called this ‘‘P3M,’’ and the order of its components is sometimes reversed, as in ‘‘Project, Program, and Portfolio Management.’’) The book opens with a 3-chapter section on the ‘‘Life Science Industry Context’’ for good project management. I particularly enjoyed the chapter on ‘‘The Impact of Organizational Size on Drug Project Management.’’ Although certain key ingredients in good project management are common to companies of all sizes (‘‘success . . . is . . . defined by how well products are actually delivered’’), the size of the company does affect the process. Small companies need to have a whatever-it-takes attitude in order to be successful, and the project manager at a small company always has the ability to go straight to the CEO about important questions. Large companies may lack some of these features, but on balance they have more resources and of course a greater number of
Drug Information Journal 46(4) 493 ª The Author(s) 2012 Reprints and permission: sagepub.com/journalsPermissions.nav DOI: 10.1177/0092861512450569 http://dij.sagepub.com
products under development, with many clinical trials going on simultaneously, which balances the risks of some projects by the likelihood of success in others. Project management is truly the key to success in drug development. In addition, as pointed out in the chapter on ‘‘P3M Best Practices,’’ ‘‘the most efficient and reliable way to ensure corporate strategy is delivered is through project management.’’ Integrating good project management into good program management and good portfolio management is particularly important. A project may be the development of one new drug for one indication; it may be part of a program consisting of related projects on overlapping timelines, such as the development of that same drug for other indications, the development of pediatric indications for the same drug, and development of an alternative formulation. A well-selected and well-managed portfolio of both high- and low-risk products can balance the risks and expenses. Some other chapters include ‘‘Project Control,’’ ‘‘Managing Uncertainty in Drug Projects,’’ ‘‘Managing Drug Safety Risk,’’ ‘‘Developing Program Strategy,’’ and ‘‘Developing Products with Added Value.’’ The book ends with a 4-chapter section on integrating the processes of pro
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