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during preclinical development will ensure that enough bulk active ingredients are available to initiate key preclinical studies, as well as critical formulation work and the clinical program. Planning also ensures that adequate evaluation is done to understand the drug's metabolic fate in the species used for preclinical testing. These are often the most troublesome areas for delays in preclinical development. |
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In clinical development, steps should be taken to streamline the clinical program by carefully selecting the studies and the countries where studies are performed to ensure that the data are complementary and meet the regulatory requirements in the target countries [13]. The current industry trend is a strategy of coordinated, simultaneous development in all targeted countries [21]. A clinical program that is focused and appropriate in size has a competitive advantage [22]. |
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The registration process is another target for improving efficiency. The chemical, preclinical and clinical requirements should all be addressed early in the planning process, and reassessed frequently during development to ensure that the plan and regulatory requirements stay in synchrony. Both the regulatory requirements and the development program change course many times during development, and reassessment is critical to maintain the shortest path. Efforts to harmonize regulatory requirements in major countries offer hope that future drug applications will be less troublesome. However, a variety of socio-economic concerns are likely to keep the requirements strict and numerous. For the foreseeable future, therefore, the most efficient registration package will likely be one that is constructed to meet the core requirements of key countries, such as the EEC, USA, and Japan, with modular sections that can be added or subtracted to meet country-specific requirements [17]. Such a package requires considerable advance planning, which should take place in conjunction with the development plan and which is actually constructed as each segment of the preclinical and clinical program is completed. Simultaneous, worldwide submissions are already a reality in some companies and, in the future, will be a necessity to stay competitive. |
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Finally, at all stages of the development process, the key to efficient development is a sound overall plan that includes contingency plans, rapid identification of bottlenecks, and vigorous resolution of each bottleneck when it appears [23]. Keeping the project on track is fundamentally a process of meeting target dates and milestones. It is up to management to set the objectives and target dates. This should be done after frank and open discussions with those who are charged with actually doing the work to ensure that the target dates are realistic [13]. Meeting the target dates then becomes a common goal to which both management and the team are committed. Constant diligence and attention to these fundamental activities will be the hallmark of successful companies in the future. |
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