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nology streams [2]. It is about organizing the companies' work and delivering value. Part of core competence is a commitment to working across organizational boundaries. |
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A small pharmaceutical company might have only one core competence: the technology or biology that brought forth their product. For a contract research organization the core competence might be data-flow automation or excellence in the conduct of in-house Phase I studies. Other services might be added to the companies as they grow, but if integral core competencies are not grown in parallel, the quality of these additional services may not be as great as the original. |
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Large pharmaceutical companies may not have defined well their core competencies in the past. However with the less favorable economic climate, companies are being forced to determine what core competencies should be retained. This decision must be based upon which of these competencies is central to future success. It is then easier to devise a strategy for managing and assignment of internal versus external resources. |
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Clinical pharmacology is considered a core competency in many pharmaceutical companies. In order to assist in selecting the drug candidate with discovery scientists, to set the Phase I plan, to agree to the preclinical plan prior to taking the chemical into humans, and to collaborate with clinicians down-stream on dose recommendations, there are three scientific areas of mastery: |
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clinical pharmacokinetic/dynamic theory and application, |
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disease biology-pharmacology-clinical medical axis, and |
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clinical trial design, conduct, and information access. |
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To meet the challenge, people with these skills who are working to the same mission need to be organized so that they can form focused early-development teams. Traditional pharmaceutical industry structure has people with these skills working in different departments and, at times, competing on the same project rather than developing a close partnership. There may be a competitive advantage for companies that bring together and grow these skills for the focused mission of drug discovery and development. The challenge is in how to do it. |
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V. Applications of Science to Drug Development |
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A series of clinical case studies follow to demonstrate the value of applying biopharmaceutic and integrated pharmacokinetic/dynamic principles to solve drug development problems. The cases are meant to demonstrate the value of applying science as opposed to empiricism in approaching common issues. It |
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