The Product Development Pathway: Charting the Right Course

  • Craig D. Shimasaki


Development of a product is the key focus of all biotechnology companies. Detailed and accurate planning of the development pathway is vital for success. In this chapter, we review a prototypical product development pathway and identify some examples of things that must be accomplished during each stage. Product development is so diverse that it is unrealistic to characterize all pathways as similar; however, this may serve as a helpful example. All product development stages of a company need to be accurately characterized according to their particular product. If these stages are not well-defined, it is impossible to correctly estimate the amount of capital required to support product development through to each successive stage. If the company fails to reach the next product development stage, it generates unfulfilled expectations, making it more difficult to raise the next round of capital. Companies are rewarded for meeting goals, not for running out of money. By reviewing some general aspects of product development for therapeutics and diagnostics, the reader should be better able to outline their product development plan, and then estimate the amount of capital required to complete each stage.


Product Development Core Competency Biotechnology Company Contract Research Organization Biotechnology Product 
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Copyright information

© American Association of Pharmaceutical Scientists 2009

Authors and Affiliations

  • Craig D. Shimasaki
    • 1
  1. 1.BioSource ConsultingInterGenetics IncorporatedEdmondUSA

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