Abstract

Typically, at the beginning of a project, the scope is defined along with the timelines and budget. As project team leaders negotiate with functional managers to recruit key team members, including outsourced resources, the ad hoc approach to team recruitment often results in critical gaps in required skills or resources. This can result in missing or inadequate information at major decision-making milestones. Model-based drug development (MBDD) provides an basis for continually performing gap analyses during the lifecycle of development, including team recruitment. Models defining the determinants of drug outcomes can be used to integrate the specialized and varied scientific resources around a central concept based on understanding the determinants of drug efficacy and safety. In adopting MBDD, the integrated project team (IPT) must ensure that all team members contribute to the gap analyses and the design of experiments required to address these gaps. Thus ensuring team-wide knowledge sharing and facilitating the incorporation of scientific and medical expertise.

The IPT decision-making functions around a core set of modeling and simulation processes that continually generates and refines the signals emerging from early development studies and identifies the knowledge gaps that must be addressed in future studies. At a minimum, the core processes supporting the IPT can be used to define the inputs and outputs that must be supplied by the various R&D functions that best meet the needs of upstream and downstream stakeholders.

As the R&D functions acquire data that add value to the models enabling them to be more predictive of future outcomes, the models can be used to project the future value of a product and provide a basis for defining project priorities within a portfolio and determining how resources are to be allocated across the IPT. The models also provide a feedback loop to the team in terms of objective criteria for decision-making at critical stage gates and assistance in designing optimal future trials. These feedback loops and the subsequent specification of required knowledge to close gaps serve as an important organizing basis for team planning and resource allocation. A strong integrated function, such as MBDD, within an organization can change the way resourcing of projects is thought about and allocated.

Project Management Institute (PMI) Pharmaceutical Special Interest Group (PharmaSIG), Philadelphia, Pennsylvania, March 2010

By Cynthia A. Walawander, Thaddeus H. Grasela, B Ruhland, P Vecchione