Integrated Evidence Generation Planning: Why Medical Affairs is a Critical Partner.

Abstract

In an era of rapidly evolving healthcare systems and escalating demands for value demonstration, pharmaceutical companies face unprecedented pressure to generate robust, relevant evidence for a diverse array of stakeholders. Traditional, siloed approaches to evidence generation are no longer sufficient. The development and use of integrated evidence generation plans (IEGPs) have emerged as strategic imperatives-reshaping how organisations align scientific, regulatory and patient-centred objectives across the product life cycle. The IEGPs bring together evidence-generation activities across functions and geographies, to ensure that robust evidence is delivered throughout the product life cycle. In this article, we present IEGP development as a collaborative and strategic process, which enables pharmaceutical companies to demonstrate the holistic value of a new therapy to a broader range of healthcare decision makers. We argue that Medical Affairs professionals are well positioned to lead this initiative, given their in-depth understanding of the evidence generation needs and priorities of patients and healthcare professionals; however, a close and strategic partnership with other key functions, including Market Access and Clinical Development, regions and countries, is vital to the holistic understanding of all key evidence needs and to establish the strategic differentiation required to bring new medicines to patients. Our companion article in this edition of Pharmaceutical Medicine expands on the role of specific subfunctions of Medical Affairs in the development of an IEGP; it also considers how the impact of Medical Affairs' role can be measured. Please note that in both articles we prefer to use the term 'IEGP', but the reader may also see the similar term 'IEP' (Integrated Evidence Plan) used in the literature-these terms are used interchangeably in the field.