Chapter 37: Integrating Diagnostics and Therapeutics for Targeted Therapies – Part 1: Optimizing the Comarketing Plan

Integrating diagnostics and therapeutics for targeted therapies – part 1: Optimizing the comarketing plan The era of paired diagnostics and pharmaceuticals is upon us. Throughout pharmaceutical R&D, diagnostics (in the guise of molecular and genetic testing) and therapeutics are being integrated with considerable productivity benefits. As T. Nagle and colleagues described: “Not only can pharmacogenetic analysis reduce the size and cost of many clinical trials, it also allows researchers to predict which patients will benefit most” (Nagle et al, 2003). The FDA also understands how the industry is evolving. Its officials have noted that: “Major advances in basic research have identified many opportunities for the development of personalized treatments for individuals identified by genomic tests. However, the integration of these tests into routine clinical practice remains a major multidisciplinary challenge” (Lesko and Woodcock, 2004). With a broad range of targeted therapies requiring the use of a diagnostic coming to market, ...

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