Clinical Development Strategy

Drug development is a team sport. Corporate management determines which disciplines will provide the organizational leadership in the drug development process. Companies may drive the development process through their program management organization, their clinical organization, or their regulatory organization. Regardless of the source of development team leadership, as in any sport, team chemistry and good communication are the critical underpinnings required to be successful. The players and leadership involved in these global development teams tend to change as programs progress from the preclinical phase to the market place. Good processes alone doe not guarantee success. While this chapter will focus on the overall portfolio management process and global program management, a brief discussion of clinical strategy and clinical operation provides a view of the drug development process from the vantage point of one of the critical segments. The clinical strategy discussed below is a central component in portfolio and program management for an individual compound. This strategy may be focused on a particular claim or a variety of indications.

Clinical development requires both a strategic and an operational plan. The strategic plan includes the overall direction and the operational outline for how the compound will be developed. This information is compiled in the clinical development plan (CDP). The CDP evolves over time, generally in three stages (Fig. 2.3): preclinical phase; the early development phase; and the late development phase. Each plan will build on the former plan. A multidisciplinary team with specific expertise in those aspects of development adds their unique perspective to this evolving plan. The leadership, as well as the membership of these clinical teams that writes the CDP, also may change as the project evolves from the preclinical phase to the development phase.

The initial CDP (CDP-1) may be driven by a product champion originating in one of the preclinical disciplines. Generally, the product champion is someone who was instrumental in the compound's discovery and has an understanding of the clinical environment. In leading development companies, this person and process is considered a best practice. This individual introduces the organization to the unique features associated with the new chemical entity and helps others understand how this new compound will address an unmet medical need. The original product champion will lead the team in producing the first CDP (CDP-1) and stimulating and exploring the organization's interest in pursuing subsequent investment. The preclinical development team will prepare a development plan for R&D management to consider and approve. It will consist of a discussion of the product opportunity; any early preclinical data that supports the proposal, toxicology needs, pharmacokinetic and pharmacody-namic profile, patent potential, the studies needed to bring the product to the next stage (go-no go decision point), compound available, and the potential investment costs. During this phase, someone with expertise in clinical pharmacology will work with the preclinical scientists to determine what information (studies) is needed to advance the project to the subsequent phase. This individual may subsequently lead the next development phase. Early collaboration facilitates a smooth transition between phases. Preliminary discussions will be held with marketing to garner their interest and support. This work will be initiated approximately 1 year prior to the preparation of the Clinical Trial Application (CTA)/Investigational New Drug (IND) application. The information collected during this phase of development will be shared with the regulatory authorities to determine whether the proposal is suitable to study in man.

The early development plan (CDP-2) builds on the information collected in the preclinical phase and includes both the strategy of where and how the new compound will be first investigated in man. Strategic issues include global considerations, such as which countries have both the regulatory expertise and clinical expertise to enable study initiation in

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