Project Management for Research and Development

Abstract

Pharmaceutical industry research and development efforts are highly uncertain, expensive, and lengthy projects. These drug development projects require great care from their inception to ensure that unsafe or ineffective projects get canceled as soon as possible, as projects canceled later in the drug development process can incur much greater costs, potentially impacting resources for other projects in medium-sized companies or causing small companies to shutter completely. Proper project management guides executing a project and establishing a communication format for decision-makers in upper management. This work is not a definitive decision-making framework for project progression; however, it crafts a project management system around existing small molecule drug development efforts, aiding the decision-making process. A literature review of existing project management systems when writing yielded no definitive project management methodologies for drug development. Instead, it showed a project management maturity gap in the pharmaceutical industry compared to other industries. Project managers must be adaptive, even in projects with little deviation in expected progression, as those deviations can severely impact the overall project if not handled properly. A project management system that can evolve with an R&D project progression can provide some structure to a very uncertain effort. To identify a project management system for small molecule drug development, main activities, and processes are determined and examined to understand the dynamics of a drug development effort. These general activities and processes are verified by industry personnel, as each company and project may differ. A discussion of existing project management systems also took place to determine if any methodologies exist. Suppose a general drug development process is established, and a project management methodology is developed to best align with the project process. In that case, the project manager can develop the requisite knowledge and skills to lead a complex pharmaceutical R&D project. The model can then be applied to other drug development efforts to ensure proper management and project efforts alignment to meet the unique project or company needs.