By Members of the MAPS Board of Directors
This publication represents the consensus opinion of members of the MAPS Board of Directors but does not represent formal endorsement by the authors’ organizations.
What Is Medical Affairs?
Medical Affairs is a function within the biopharmaceutical, consumer healthcare, and MedTech industries that sits alongside other functions including Research & Development (R&D) and Commercial as one of the strategic pillars of the industry. R&D develops new drugs, devices and diagnostics; Commercial markets and sells these products; and Medical Affairs generates and communicates data that help healthcare professionals (HCPs), payors, policy makers and others make informed decisions that ensure the best use of treatments to benefit patients. In this way, Medical Affairs plays a vital role in providing scientific evidence and understanding to appropriately change clinical practice.
Just as there are many roles within R&D and Commercial, individuals working within Medical Affairs are responsible for many activities, especially including the following:
- Communicating unbiased, evidence-based expert scientific and medical information to HCPs, scientific leaders, patient advocacy groups, payors, policy makers and others within the healthcare ecosystem
Bringing insights from external sources including healthcare professionals, opinion leaders, advisory boards, patient advocacy groups and more back to the organization to better inform decision making in areas such as education, research, development, compassionate use, publications, strategy, etc. - Generating new data about marketed and emerging treatments, often through the use of Real-World Evidence (RWE), Health Economics and Outcomes Research (HEOR), Investigator- Sponsored Studies or pre- and post-approval studies that may support product registration or can be non-registrational in nature
- Collaborating with industry leaders from other functions including R&D, Commercial and Business Development to drive the strategic direction for the organization to benefit patients
Who Works in Medical Affairs?
Medical Affairs is composed of medical and scientific professionals, many of whom have advanced, Doctoral- level degrees, usually in the life sciences. Supporting these scientific experts are a range of roles including data analysts, communications specialists, experts in adult education, technologists, business leaders, administrative associates and many more. Some Medical Affairs professionals enter the function immediately upon completion of their training; others come to the function having worked elsewhere in healthcare, industry, business or academia. Some Medical Affairs roles are external-facing and tend to attract individuals who are naturally drawn toward relationship building and scientific exchange with peers in the healthcare community. Other roles are involved in evidence generation and knowledge creation through studies, research projects or analyses and often appeal to those with technical and scientific backgrounds. Still other roles are involved in strategic leadership, offering opportunities for individuals to lead goal-directed teams. Thus, the skills and training required for a successful career in Medical Affairs are varied and depend on the specific role within the function, but often include a mix of scientific, technical, business, leadership and emotional intelligence expertise.
The History and Current Practice of Medical Affairs
The concept of a Medical Science Liaison (MSL) started at the Upjohn Company in 1967 as a primarily executional role within the industry’s Commercial/Marketing function. At Upjohn and then elsewhere, experienced and scientifically oriented sales reps were designated as MSLs to answer more in-depth scientific questions about the appropriate use of drugs and devices; later, these early MSLs whose expertise grew from sales experience were replaced by MSLs with scientific and medical degrees. With increased regulation, scrutiny and complexity of the pharmaceutical industry, the MSL function moved out of Commercial and into the new function called Medical Affairs, which now takes the lead in providing HCPs and others within the healthcare ecosystem with non-promotional, accurate and fair-balanced scientific information. This direct interaction with HCPs with the intent to improve clinical outcomes for patients was the genesis and remains at the heart of the Medical Affairs function.
However, in the early 2000s, it became clear that the unbiased, scientific expertise of Medical Affairs had value beyond just these direct interactions with HCPs, and Medical Affairs teams started to grow even more into the external-facing voice for the organization’s scientific communication and exchange. When HCPs reached out to the organization to ask questions about the real-world use of drugs, devices and clinical research, it was Medical Information teams working within Medical Affairs that provided (and still provide) the answers; when there were identified data gaps in our understanding, Evidence Generation groups within Medical Affairs built the capability to design and conduct post-approval studies to generate and disseminate new knowledge; and as it became clear that HCPs were only one of many audiences in need of expert, data-driven context describing the real-world use of emerging treatments, Medical Affairs developed greater capabilities in Scientific Communications, Publications, External Education and more.
Today, the scientific complexity of treatments has increased, with new drugs and devices targeting specific patient populations. For some time we’ve known that the safety and efficacy data from registration trials, performed with a narrow and carefully selected patient population, may not perfectly generalize to a real-world patient population that includes individuals with diverse geographic, racial, ethnic, age, compliance, comorbidity and treatment journey characteristics. At the same time, audiences desiring medical and scientific information have further expanded to include, for example, patients and patient advocacy groups, and all audiences expect near real-time, accurate information presented across a range of channels.
Medical Affairs is the function within the broader biopharmaceutical industry best positioned to help external stakeholders make sense of treatment complexity; it is the function best positioned to answer questions of real-world safety and effectiveness; and it is the function best positioned to not only disseminate scientific knowledge but to also listen and respond to external stakeholders’ need for information.
These changes in the fabric of healthcare and society have elevated Medical Affairs to the point of no longer being simply a support group providing responsive, ad hoc information and education. With the expertise to better understand the challenges faced by patients, HCPs, and other stakeholders, the ability to address any gaps in understanding of data, and the means to contextualize these matters for clear communication by the company, Medical Affairs is now clearly one of the strategic pillars of the healthcare industry.
MAPS thanks the following members of the MAPS Board of Directors for their contributions to this paper:
