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contribution to team discussion and to escape from their first team meeting without making fools of themselves. Drug development is more comprehensible if the team member has the good fortune to join a project team at its inception rather than, as is often the case, as a replacement team member. It is at the initial team meetings that the core early development strategy is decided. |
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Successful drug development depends on the quality of the development strategy. Ultimately, successful drug development is about translating science into an optimal investment proposal that provides value to a variety of stakeholders and customers. This can be achieved only be establishing a strategy which recognizes who the customers for new medicines are and addresses their needs. This will mean moving increasingly from designing for to designing with the customer. Health care provided in most countries has experienced significant change in recent years. Probably the greatest change to be faced in the future will be the expectation that new medicines will be not only safe and effective but also cost effective in the overall context of disease management. |
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Drug development strategy is concerned with establishing clearly set objectives for the development and life cycle management of an asset, recognizing critical hurdles to success, and structuring plans to achieve the best reward/risk for the investment. It requires a range of skill sets which include strong technical knowledge of drug development and understanding of development risk management. Project attrition rates are high, and it is important to understand why and when these can occur. The overwhelming majority of projects fail. A primary objective in drug development, therefore, is to eliminate from development, at the earliest time, projects that offer poor prospects for commercial return. Termination decisions are rarely made with certain knowledge which is why they are so often painful for teams and companies to take. It requires understanding of the importance of the target product profile (TPP) as a strategic tool and the need for its continuous review throughout development. The TPP definition is critical to the design of clinical development strategy. It is also the basis for establishing clear Go/No Go criteria for the compound through development. |
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It depends on good understanding of planning skills to ensure that alternative development scenarios are recognized and their impacts are fully explored. It also requires business skills to evaluate the investment opportunity integrating the key parameters of risk, time, cost, and return. At the core of all of this is knowledge of the disease area which enables the impact of a new medicine in the total scheme of intervening in the disease state to be assessed. If this analysis is at fault, all else is of little value. In an increasingly |
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