Portfolio and project planning and management in the drug discovery, evaluation, development, and regulatory review process

Drug discovery, evaluation, development, and regulatory reviews are complex, lengthy, and costly processes that involve in excess of 10,000 interdependent activities. In order to be successful in biopharmaceutical new product development, one needs a set of general principles that provide guidance in (1) the construction of a Research and Development (R&D) Portfolio, (2) the construction of individual Product Development Plans, and (3) the subsequent tracking and controls required to keep the portfolio and product development plans current as learning occurs. The following five Principles of Optimal Product Development form the basis for defining a decision-based operational model, identifying and quantifying the critical information required at each major decision point, projecting the probabilities of various outcomes, and informing key stakeholders (management, board, investors, etc.) with clear and concise status information that is needed for effective product development governance. This chapter covers the five principles of optimal product development: Market advantage Product readiness Value-driven program execution Learning and confirming Regulatory collaboration These principles are applicable to all medical product development programs regardless of technology, therapeutic area, or indication, and can be applied to the development of devices and diagnostics as well. However, not all of these principles are fully applicable to all product development programs, nor are they applied in precisely the same manner and to the same extent from program to program. Consequently, their use must be guided by adequate experience and judgment so that these principles can be adapted to the specific needs of each program based on informed interpretation of study results and midcourse corrections can be made on the basis of accumulating knowledge. Each organization will need to develop corollaries for these principles that provide more specific guidance and help keep the product development effort focused on the critical success factors and key data and knowledge needed to support major decisions. To operationalize these five principles and to manage and optimize the returns of this complex, lengthy, and costly product development process, the biopharmaceutical enterprise has embraced the concept of portfolio and project management.