Biopharmaceuticals (includes Biologics)
This session will provide an overview of the current policy environment on the use of patient preference information in medical product decision-making. Results from seminal and notable public-private partnerships, regulatory initiatives, and forthcoming FDA guidances on patient preference information will be discussed. Examples of preference studies used by regulators to support regulatory decisions will be shared. The ongoing IMI (Innovative Medicine's Initiative) PREFER public-private partnership is among the notable projects in this space and will provide the focus of this session. PREFER is a research collaboration involving pharmaceutical companies, patient groups, FDA, EMA, HTA bodies and academic experts with a goal of developing recommendations for how patient preference information can be used in industry and within regulatory and HTA applications. Results from PREFER will be presented, including the design and methodological expectations that can be applied today on how and when patient preference studies may be informative and supportive to decisions. The session will guide regulatory professionals on strategies for working with clinical teams planning to include patient preference studies in development programs and for interacting with regulatory agencies on submissions that include patient preference studies.