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• W213306972 abstract "Bringing new pharmaceutical compounds to market is a challenging process involving many complex decisions. Factors that make the process challenging include long timelines from discovery to product launch, high attrition of molecules throughout the development process, and high development costs. For example, it typically requires more than 12-15 years to develop a compound, while the associated costs can exceed $500 million per compound (1,2). Fewer than 25 percent of the molecules that begin clinical testing actually make it to the marketplace. In addition to discovering and developing compounds internally, most pharmaceutical companies have sought to diversify their development portfolios by relying on external partners to co-develop and market their products. And they are attempting to market products in multiple dosage forms and for multiple disease states. While these diversification strategies create a richer set of opportunities to pursue, they also create demand for scarce R&D resources required to bring products to market. Clearly, those firms that are able to use their R&D resources most productively will be rewarded in the marketplace. Wheelright and Clark proposed a framework for product development that contains the aggregate project plan (APP) as a key construct (3). A primary purpose of the APP is to establish the type and mix of projects that should comprise a firm's development portfolio over time. The APP also allows one to balance the demand for critical development resources that are required to execute the plan with available capacity. Wheelright and Clark consider only specific development projects in their definition of the APP. We relax this definition to include not only specific projects currently in our consideration set, but also projects that might enter it as a result of ongoing R&D or partnerships, for example. The key concept is that the resource planning process requires that one estimate the type and mix of projects that will be pursued over some period of time. The approach suggested by Wheelright and Clark for determining the resource requirements corresponding to a set of proposed projects is project-centric. That is, at any instant in time, one can determine the resource requirements for the set simply by summing the requirements across all projects in the set. This approach simply requires that one know the resources required for the remaining work for each project in the set. We propose a task-centric approach to determining resource requirements for a set of projects under consideration. That is, we consider the R&D process to consist of a set of tasks, each of which consumes resources and whose function is either to filter diverse opportunities or eliminate uncertainty in some feature of the product, such as safety or efficacy in the case of pharmaceuticals. This view of the R&D process is depicted in Figure 1. Note that each stage in this abstraction of the R&D process could consist of any number of more detailed stages. In simple terms, as projects proceed from idea to commercialization, they are either terminated due to some undesirable feature or they progress to the next stage of development. We assume, then, that all projects are either launched as commercial products or are terminated. Determining the resource requirements for projects in this process at any instant in time simply consists of summing the requirements across all stages of R&D. This approach requires knowing the number of projects in each stage over time and the resources required to execute a single project in each stage of the development process. In this article, we present both steady-state and dynamic-capacity models for multiple key resources required for efficient completion of a set of R&D projects. The steady-state model is used to determine nominal resource requirements to achieve a steady output of products to the marketplace from R&D. …" @default.
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• W213306972 modified "2023-09-24" @default.
• W213306972 title "Modeling Resource Requirements for Pharmaceuticals R&D: The Ability to Accurately Estimate and Intelligently Allocate Scarce Development Resources Is Critical to Controlling the Cost of Bringing New Drugs to Market" @default.
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