The Value and Deliverables of Medical Affairs: Affiliate Perspectives and Future Expectations

A recent survey by Deloitte reported five major impactful areas to ensure future societal improvements, such as curative therapies, customized treatments, digital therapeutics, prevention and early detection, and non-pharmacological interventions [19]. In line with these, and with expectations from Nordic executives [10], we speculate that major competency needs for MA professionals in the future will center around the following:

continued superior knowledge on up-to-date clinical research advancements

data science competencies including analysis and identification of clinical data gaps, study design, data analysis skills, strategic data publication, and dissemination

in-depth health care system understanding

the ability to develop and execute sustainable projects and health care solutions

willingness to partner and collaborate with multiple stakeholders across the evolving health care ecosystem.

We anticipate that future successful MA teams will benefit from widening their collaborations with external stakeholders, including patient groups, health care providers, payers, and politicians, and engaging with these in data-driven discussions to co-lead the transformation of sustainable health care solutions. The value and insights gained from these external collaborations will be fed into the value chain in the company, including R&D, Marketing, and Regulatory Affairs, to ensure that drugs and therapies are developed, tested, and launched effectively and sustainably. Furtner and colleagues recently described the opportunity within MA to take a leadership role in the tactical implementation of environmental, social, and governance (ESG) tactics through the conduct of sustainable and climate-friendly clinical studies, educational symposia, and conduct of meetings, e.g., by utilization of digital platforms and virtual solutions and thus act as a socially responsible entity within the company embracing compliant and sustainable ESG policies [20].

Overall, the future success of MA in pharmaceutical companies will likely be characterized by increased focus on patient-centricity, the use of digital technologies and RWD utilization, extensive creation of RWE, greater collaboration and co-creation with new stakeholders, and increased regulatory scrutiny. Medical Affairs teams will need to adapt to these changes to ensure that they continue to play a critical role. See Table 1 for further details for expected major competency needs and value drivers.

Table 1 The table presents expected major competency needs and value drivers for Medical Affairs professionals in the future

Looking ahead, competency development in the MA teams is first and foremost needed to meet expectations and maximize opportunities within the “outside-in” strategic approach. In previous years, in which most of the industry provided primary care medications, MA employees were generally medical doctors, who held the necessary expert competencies to partake in a dialogue with general practitioners and answer their questions on the optimal use of medicine. Through research and medicinal advancements, which introduced precision medicines, gene therapies, rare disease management, vaccines, and additional advanced technologies, the importance of the hospital setting has advanced significantly [2]. Thus, today, in addition to hiring medical doctors, most companies have broadened the staffing policy within MA to employ competencies within Biomedicine, Molecular Biology, Pharmaceutical sciences, and Biochemistry, amongst others.

Second, continued capability building in MA has received increased attention. This has resulted in advanced capabilities within data generation planning (RWE, pragmatic trials, PROs). Digital competences enable MA engagements with HCPs using more channels, more complex set-ups of educational meetings, for example, hybrid meetings, and social listening projects, where information/activity regarding disease and management of diseases is analyzed in a structural approach.

Third, the strategic focus in the affiliate to optimize diagnostics, treatment initiation and follow-up of patients through co-creation with both HCPs and patients, to collaborate with new stakeholders and between pharmaceutical companies on, e.g., disease awareness and evolutions within, e.g., RWE and digital tools, has proved to be successful. As an example, MAPS, which is a non-profit global MA organization for MA professionals, has developed a platform with access to training and educational material for members, who also are encouraged to contribute and develop new materials [5].

Key competencies are required within evidence generation to bridge data gaps and generate meaningful evidence in support of improved patient outcomes and evidence reflecting real-world clinical setting.

Further, insight gathering and understanding of the value proposition of the KEEs will continue to be of importance to establish collaborations with health care organizations to identify and establish projects and studies in support of a joint value proposition to improve patient outcomes.

Global MA is usually the strategic driver for defining innovative and scientific value propositions for the company’s products, through their understanding of patients, physicians, and global business trends. Global MA defines the medical and value evidence strategies and drives evidence generation with the goal of improving patient health outcomes based on patient, disease, and clinical landscape insights gained through patient and HCP engagements. Furthermore, GMA ensures aligned and compliant communication to patients, HCPs, regulators, and payers. Thus, strong and transparent partnerships between the global and affiliate MA teams are critical for the ultimate success of innovative medicines in the local markets during pre- and post-launch periods. Thus, ”glocalization” potentially plays a critical part in effective MA and strengthening the partnership between global and affiliate MA in critical areas such as insight generation, understanding clinical practices and identifying the most critical points for close GMA and affiliate collaboration will be of future importance. The glocalization model offers further strengthening of the MA strategic contribution and planning, including local insights collection, and analysis to further support evidence generation planning and execution, acknowledging the local insights and experience of innovative treatment.

As the MA role continues to evolve, to address emerging demands and new opportunities, a unified national or regional certification in MA could potentially be valuable. Such certification might support and help address the needs for new competencies and capabilities, and thereby suggest uniform yet personalized and compliant ways to engage with stakeholders and expert networks. Other areas of value considered are how to generate the most relevant clinical evidence and data; rapid tech evolution; increasing adoption and compliance in new communication channels.

The current value of MA from the affiliate perspective and the opportunities that lie ahead of MAs to ensure better health and quality of life for future generations and sustainable societies have been presented. It has been shown that MA is highly fascinating for several reasons, at times even challenging and complex, due to the varying deliverables and accompanying competencies needed.

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