Integration of Knowledge

Projected needs of the pharmaceutical industry are related to the need for broad expertise to deal with increasingly complex projects and the integration of specialist knowledge. Optimization of the drug development process requires technical and scientific expertise in many areas. In some disciplines, such as genetics (human polyphormism), mathematics (modeling, simulation), bioinformatics (prediction), and information technology (including pharmacometrics and information management), there is a lack of well-trained experts. Moreover, due to the multidisciplinary nature of drug development, knowledge covering a range of disciplines is required [9].

An expected central challenge of the pharmaceutical industry in the coming years is the management of complex information. Many shortcomings in drug development can be attributed to insufficient use of available knowledge. The interfaces between the various phases of the R&D process have to be eliminated and a seamless discovery-development process established, ensuring that all knowledge and data are maintained and put to maximum use throughout (Fig. 1). New standards for handling complex data and standardization of the format for knowledge-exchange are required (A.Cohen, personal communication, 2001). This involves, developing IT-supported information data management and decisionmaking process [9]. For example, very promising new standards are to be used in view of the International Harmonization (ICH) initiatives, the Common Technical Document (CTD), and the Electronic Common

Human models Disease models

Pharmacology Toxicology ADME Pharmaceutics

FIGURE 1 Integration of functions. Courtesy of A.Cohen, Center for Human Drug Research, Leiden, The Netherlands, Phase I studies tailored towards proof-of-concept. Personal communication, 2001.

Technical Document (e-CTD). The aim is to provide a harmonized format and content for new product applications to be used with regulatory authorities in different regions of the world.

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