By its very nature, biopharmaceutical research and development (R&D) is fraught with uncertainties. Often, decisions whether to initiate the development of a novel product or to complete certain aspects of the development program in parallel or sequentially must be made in the absence of all relevant information. As a result, a company may have to commit major investments to a development program at risk before much is known about the likelihood of success, or the lack thereof, of the program. Regulators also make critical decisions regarding the type, timing, quantity, and quality of data that a Sponsor must provide to support the level of evidence required for the approval of a novel product. This session will discuss different types of uncertainty and examine strategies for implementing R&D projects to increase confidence and reduce uncertainty using different case studies. The session will be an interactive discussion led by seasoned industry and regulatory agency representatives who are familiar with pragmatic approaches that have been applied to product development and regulatory decision making, and will discuss a variety of topics, including sources of uncertainty, strategies to increase confidence in or reduce uncertainty, use of innovative clinical trial designs to accelerate product development, and use of real world evidence (RWE) in regulatory decision making.
Learning Objectives:
Upon completion of this session, participants should be able to understand and describe at least two sources of uncertainty in R&D:
Upon completion of this session, participants should be able to apply different strategies to increase confidence and reduce uncertainty in R&D
Upon completion of this session, participants should be able to understand different innovative clinical trial designs and use of RWE in regulatory decision-making