The pharmaceutical industry is witnessing a fundamental shift in how Medical Affairs departments operate, with these teams now positioned at the intersection of scientific innovation and patient care. This transformation reflects the industry's broader evolution toward data-driven, patient-centric approaches to drug development and commercialization.
Strategic Evolution of Medical Affairs
Medical Affairs has undergone a dramatic transformation from its traditional role as a bridge between R&D and commercial operations. Regulatory demands, particularly in the United States, have necessitated greater separation between commercial activities and scientific functions, including grant management, medical education, scientific publications, and investigator-initiated studies.
"It's no longer just about getting the drug approved and on the market," explains Kirk Shepard, Senior Vice President of Global Medical Affairs Oncology at Eisai. "Today we also really want and need insights from patients and healthcare professionals long before and after a product reaches the market."
Real-World Evidence and Stakeholder Engagement
Medical Affairs teams are increasingly leveraging real-world evidence (RWE) to complement traditional clinical trials. This approach provides crucial insights that randomized controlled trials alone cannot capture. The department coordinates cross-functional collaboration to identify and address gaps in disease management understanding.
"You need to bring together all of your experts in the company into one room – your developers, your medical people, clinicians, your health economics people," Shepard emphasizes. "You look at the needs identified externally, and brought in via MSLs, patients, caregivers and physicians."
Medical Science Liaisons: The Field Force Connection
Medical Science Liaisons (MSLs) have emerged as critical players in maintaining scientific dialogue with healthcare providers. These highly qualified professionals serve as the company's scientific representatives, gathering real-world insights while sharing important clinical data.
"MSLs help to create a real-time flow of insights into the company, which we can feed into our drug development strategy," Shepard notes. Their role extends beyond information exchange to include clinical trial site identification and facilitating evidence-based discussions with payers and managed-care organizations.
Advancing Professional Standards Through MAPS
The establishment of the Medical Affairs Professional Society (MAPS) marks a significant milestone in the profession's development. As MAPS President, Shepard leads efforts to standardize best practices and elevate the profession globally. The organization, though only 18 months old, has already garnered significant international interest from Medical Affairs professionals seeking guidance on developing standards within their companies and regions.
Patient-Centric Focus
The evolution of Medical Affairs reflects the industry's broader shift toward patient centricity. Eisai's approach, under Shepard's leadership, involves incorporating patient perspectives earlier in the drug development pipeline, a strategy that has gained support from regulatory authorities including the FDA.
"Our plan at Eisai is to appropriately bring the voice of the patient into the pipeline earlier," Shepard states, highlighting the company's commitment to meaningful patient engagement throughout the drug development process.
