CASE STUDY: A Value Assessment model for Medical Affairs Studies to Support Decision Making and Portfolio Optimization

Marketing authorization is a critical milestone in the lifecycle of a drug. While pre authorization studies focus on securing approval, post-authorization studies aim to deepen the scientific & medical knowledge about a pharmaceutical product or broaden the understanding of its real-world performance. Often, such medical affairs studies are initiated by experienced clinical investigators, who may submit an unsolicited funding request to the product owner to support the study. At Merck we receive >50 of such investigator-sponsored study proposals per year, and prioritization between them is challenging, because classic financial valuation methods don’t capture their main benefits. This case study outlines a project to develop a multi-parametric, non-financial assessment model for medical affairs studies, which helps to objectively evaluate, rank and prioritize a portfolio of medical affairs studies and make informed funding decisions for medical affairs studies to maximize benefits for our patients.