The Importance of the Medical Affairs Function in Pharmaceutical Companies

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According to a study published in SpringerLink, the medical affairs (MA) function in pharmaceutical companies creates a unique opportunity to ensure the internal linkage between research & development (R&D) and commercial/marketing functions, in addition to managing external scientific engagements with multiple stakeholders across life-science ecosystems. The authors of the study stated that its purpose is to share a comprehensive set of practical examples of the main deliverables within the MA function in the affiliate, while aligning these with the two distinct phases, pre- and post-launch.¹

The MA function leverages clinical and scientific expertise to engage with healthcare professionals (HCPs) and internal colleagues, ensuring the identification of patient populations benefiting from innovative medicines. Roles such as medical director or medical manager will be required to maintain skills such as partnering for synergies and maintaining patient-centricity. "Inside-Out" principles involve internal value delivery through scientific and clinical research engagements, communication, and ensuring patient access. "Outside-In" principles involve understanding external needs through collaborations, partnerships, and patient-centric approaches.¹

The authors described inside-out as “A customer-centric approach to ensure internal value is delivered to the right customer at the right time.” When it comes to outside-in, they wrote that “The pharmaceutical company aims to understand the needs of the various players within the health care ecosystem in which it operates through active listening and engagement with relevant stakeholders, and thereby develop improved company strategies and action plans that make a difference for patients or society through mutually agreeable goals.”

In an article recently published by McKinsey & Company, five priorities were highlighted for medical affairs by 2030, based on a previous goal laid out in 2018. These include boosting medical affairs leadership to achieve next-level patient impact, integrating end-to-end data analytics, differentiating medical strategies, aligning evidence generation with stakeholder needs, and orchestrating medical engagement.²

“Achieving each of the five priorities outlined in this paper will have a significant impact on patients and on the medical affairs team,” wrote the authors. “Because the priorities are strongly interdependent, the full potential of transformative patient benefits can come from the successful implementation of all five simultaneously. Not all organizations will be prepared to invest now in the full-scale medical affairs transformation laid out here, but this vision should be a cross-industry rallying cry, mobilizing medical affairs to prepare for the future. Progress within an individual company may be uneven, with some regions or assets moving faster than others. Each company will tailor its approach to expand its strengths and address its opportunities for transformation.”

Currently, MA focuses on factors such as clinical research collaboration, clinical insight management, real-world evidence (RWE) generation, health technology assessments, and clinical data analysis. The Springer Link study suggests that the shift from historical "inside-out" strategies to broader "outside-in" strategies involves observing and understanding external needs in the wider healthcare ecosystem, incorporating insights from clinicians, researchers, patients, and payers.¹

Speculating on future competency needs, the authors further ponder the evolving role of MA. Key competencies include knowledge of clinical research advancements, data science skills, understanding of healthcare systems, project development and execution, and collaboration with various stakeholders, focusing on widening collaborations with external stakeholders such as patients and healthcare providers.¹

“The future holds promise of increasing needs for skilled and competent MA colleagues to generate and disseminate clinical, scientific data in support of medicine commercialization,” the authors explain. “It will be crucial for the function to acquire new knowledge and competencies within digital health solutions, artificial intelligence, and machine learning algorithms relevant to clinical practices. The ability to build sustainable external relationships and to collaborate on mutually agreeable goals to co-create practice relevant projects remains crucial to success. Competencies within data science to outline and fill specific evidence gaps in the current treatment traditions will only increase.”

References

1. The Value and Deliverables of Medical Affairs: Affiliate Perspectives and Future Expectations. Springer Link. October 3, 2023. Accessed November 20, 2023. https://link.springer.com/article/10.1007/s40290-023-00501-y

2. A vision for medical affairs 2030: Five priorities for patient impact. McKinsey & Company. October 11, 2023. Accessed November 20, 2023. https://www.mckinsey.com/industries/life-sciences/our-insights/a-vision-for-medical-affairs-2030-five-priorities-for-patient-impact