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Medical Affairs and Innovative Medicinal Product Strategy Development

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Abstract

Innovative medicinal products are required for progress in many therapeutic areas, and in particular, oncology. For these products to succeed, pharmaceutical companies must generate the relevant and robust clinical data required to meet the needs of regulators and healthcare providers. In addition, real-world and health economic evidence is increasingly required to support pricing and reimbursement for innovative medicinal products. To incorporate all of these requirements into the innovative medicinal product strategy early in development, the core principles of how product strategies are developed and applied must be revisited and end-to-end strategic planning implemented. This paper reviews the hurdles faced during development of the integrated strategy for innovative medicinal products, particularly in the oncology field, and examines which functions of a pharmaceutical company should play the greatest role in addressing patient and different stakeholders’ needs. It will then illustrate how Medical Affairs activities are evolving to take on this strategic leadership role.

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Reproduced with permission from IQVIA Digital Solutions, IQVIA Institute [29]

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Reproduced with permission from Medical Affairs Professional Society (MAPS) [30]. FAQs frequently-asked questions, HCP healthcare provider, RWE real-world evidence, SRLs scientific response letters

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Authors and Affiliations

  1. Apogenix AG, Im Neuenheimer Feld 584, 69120, Heidelberg, Germany

    Andriy Krendyukov

  2. Daiichi Sankyo Deutschland GmbH, Munich, Germany

    Dévi Nasy

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  1. Andriy Krendyukov
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  2. Dévi Nasy
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Correspondence to Andriy Krendyukov.

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Andriy Krendyukov is an employee of Apogenix AG, and Dévi Nasy is an employee of Daiichi Sankyo Deutschland GmbH. The opinions and ideas expressed in this article are personal and do not necessarily represent those of the companies. Andriy Krendyukov and Dévi Nasy declare that they have no other potential conflicts of interest that might be relevant to the contents of this article.

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AK conceptualized and designed this work, performed the literature search and data analysis, and created and co-authored the manuscript. DN reviewed the results and co-authored the manuscript. Both authors have read and approve the final submitted manuscript, and agree to be accountable for the work.

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Krendyukov, A., Nasy, D. Medical Affairs and Innovative Medicinal Product Strategy Development. Pharm Med 36, 71–82 (2022). https://doi.org/10.1007/s40290-022-00424-0

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