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For the company to be effective, the choice of development candidates should also be based on the corporate mission: the drug must either fit one of the therapeutic areas of the company, round out a product line, or fill a portfolio gap in product introductions. Attractive candidates that do not fit strategically should not be pursued internally but may be good candidates for out-licensing. The decision to continue internal development of such a drug should be done only if it is so attractive that it justifies modifying the corporate strategy: this attractiveness may be based on entry into a new therapeutic area of future strategic importance, or it may enhance the company's image. Unlike discovery, drug development does depend to a large extent on the availability of resources, financial and otherwise. The size of the development budget is determined by the number of products in development and the timetable for project completions. Therefore, it is important to create a development portfolio that ensures that the development budget maximizes the chances for new product introductions. This requires ongoing steering by management throughout development, to keep the project in line with corporate goals. |
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Efficiency is squeezing the most out of what you have. Management must look critically at R & D and make the best use of its resources to maximize achievements with a minimum of cost and time. |
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Time is money. For pharmaceutical development, this is now true more than ever. For a $50 million product, there is an opportunity cost of $2 million for each month's delay in drug development [18]. For a major product, each day the NDA is delayed is a loss of $1 million in sales [19]. Each 400 days of additional effective patent life produces an additional $100 million in sales [5]. These statistics explain why decreasing drug development time is an important priority for pharmaceutical management. Reaching the market sooner provides an earlier return on the investment. Not only does the company's income increase from sales in earlier years, but also there is no extended drain on resources by prolonged development. In addition, the first product introduction in a therapeutic class holds a commanding lead in the marketplace that subsequent products cannot easily displace. Therefore, the financial benefit of a competitive advantage comes not only from providing sales in earlier years but also producing larger product sales than if the product were introduced as the third or fourth product in its class. |
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The financial winners of the future will be those who have as an objective the fastest development and approval for a main indication in all the major world markets [13]. Many approaches are used to decrease development time. One way is to smooth the major transitions between research and development and between development and commercialization [15,20]. Improved planning |
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