R Principles

c Strategy - overall direction & operational plan o Goals - strategy, shared learning & generation of support o Product champion (scientist) c Multidisciplinary team c Strategy & plans evolve over time r Pre-Clinical Phase (CDP-1): c Initiated 1 year prior to CTA/IND c Start of phase 1 r Early Development Phase (CDP-2): c Initiated 9-12 months prior to phase 2B o Lead country chosen o Global leader needed r Late Development Phase (CDP-3): c Initiated at phase 2B c Continues through phase 3

Fig. 2.3. Clinical Strategy 3 Phases the most efficient fashion. Study design issues will be shaped based on previous experience in a particular area. Companies with expertise in modeling and simulation may be able to optimize both their development strategy and study design by creating proposals based on their previous experience collected in their centralized databases. During this time period, key thought leaders and people with unique expertise both within and outside the company are identified to help the team. In large companies, a global clinical team leader is identified to begin working with clinical pharmacology to facilitate a smooth transition to the subsequent development phase. Collaboration among the team members will lead to the identification of biological markers and analytical tools designed and refined to assist in the evaluation of the new chemical entity as it moves through the development process. This phase begins prior to the phase I studies and ends 9-12 months before the phase IIB dose-response trial. Each CDP serves multiple purposes. These plans are designed as a strategic document to enhance the understanding regarding the evolving profile (target product profile = TPP) of the new compound; share the learning and the perspective gained; and generate support for the plan (the studies planned, understand the risks, contingency plans, and the investment) and commitment to go forward at the critical decision points. Safety and proof of concept are key targets in this plan. Feedback from outside experts and regulatory review are all incorporated in the evolving strategic plan.

The building of CDP-3 begins with patient enrollment in the phase IIB, dose-response trial. The development costs escalate substantially at this point and really increase as you enter phase IIIA. Strategic issues at this point include consideration on where to conduct the critical phase III safety and efficacy studies. Considerations include where the best clinical expertise resides, availability of patients, past performance of investigators, regulatory environment, costs for doing the studies at particular locations, internal company expertise and monitoring resources, and availability of comparator drugs that will meet the broadest regulatory requirements and management buy-in. This plan will be refined and adjusted as study results become available and feedback from outside experts and regulatory authorities accumulate. Communication with all segments of the organization is critical throughout the development process and becomes more complex as the program progresses and more people get involved in contributing to the process.

The strategic elements in CDP-3 provide the organizational framework for the detailed clinical operational plans. A detailed global clinical operational plan (G-COP) in large companies is generally managed centrally with delegation of responsibilities to individual countries. Ideally, these operational plans should be constructed based on feedback from the individual countries who have the best insight regarding local medical practices and unique elements of their regulatory environment. The global clinical leader (GCL) or a global clinical director may coordinate the CDP-3 (strategy), as well as leading the cross-functional product team. Global clinical operations may work with the GCL to coordinate the operations plan, which includes all the details associated with conducting the individual studies in the various countries. Program management coordinates the interactions with all the departments involved in the overall.

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