Expert review explores the leadership role of Medical Affairs in evidence generation planning, highlighting strategies to optimize clinical value demonstration and patient access.
An integrated evidence generation plan (IEGP) can transform the effectiveness of how pharmaceutical companies demonstrate the value of new therapies. Medical Affairs professionals are uniquely positioned to lead and shape an IEGP, leveraging their scientific and clinical expertise, while maintaining a focus on patient access needs among competing cross-functional priorities. In this article, we explore key subfunctions within Medical Affairs, describing their contributions to the development of an IEGP and discussing the impact of the evolving healthcare environment on their responsibilities. Finally, we consider how to measure the impact of an IEGP for pharmaceutical companies and describe what success looks like for Medical Affairs in the development of an IEGP. Our companion article in this issue of Pharmaceutical Medicine provides more details of the process of integrated evidence generation planning and considers the impact of evolving regulatory and health technology assessment landscapes.
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Nelissen et al. (2026) studied this question.
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