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cost-constrained environment, where cost effectiveness is a passport of access to patient groups, pharmacoeconomics will be a key strategic driver in formulating development plans. |
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It also requires an understanding of life cycle management. The commercial value of a product will be realized only by ensuring that the product benefits are fully exploited. New medicines will need to earn their keep by justifying price at time of market entry and by sustaining their competitive value during their life cycle. An investment in health economics studies will be needed to underpin this case. Opportunities may exist for developing better dosage forms and dose regimens and may also exist for switching Rx medicines to OTC. Finally it is essential to establish a clear postpatent strategy in good time. |
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In summary many skills are needed to create a strong development strategy. Generally a well-structured project team has these skills. The experienced project manager should have a broad awareness of many of these skill requirements. However, generally, his or her greatest contribution will be in harnessing the skills within the project team to build a robust and farsighted project strategy. |
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II.
Development Strategy from Cradle to Grave |
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A.
Early Development Strategy |
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1.
Improving Input Quality to Development |
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The quality and quantity of preclinical data provided by discovery groups to support the development of a new compound is often suboptimal. It is important to establish appropriate selection criteria for development because much time and resource can be wasted, subsequently, by the development organization in patch and mend strategies which more thought (and training) in discovery could obviate. This is not to advocate a fortress mentality with development playing a prima donna role to discovery. There has to be a reasonable balance with the onus of responsibility on discovery to provide a basic array of technical data to justify development and an onus on development to show maturity and reasonable flexibility. Specific data gaps in a development proposal may exist for good reasons (e.g., obtainable but will incur major delay) and can be addressed in development. Establishing reasonable criteria for development is also valuable to discovery groups though this may not be appreciated at the time! The selection criteria can be used to better discriminate between alternative lead candidates prior to development. Generally, lead candidates are selected on the basis of |
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