As Medical Affairs continues to evolve into a strategic partner within the organization, the role of the Medical Science Liaison (MSL) is broadening to encompass new capabilities for scientific exchange with expanding groups of stakeholders, requiring competencies beyond clinical and scientific expertise. To better understand these changes, the Medical Affairs Professional Society (MAPS) convened a working group of leaders from across the industry to define a 2030 vision for the function (recently published at www.medicalaffairs.org). This article crystallizes how the MSL function will need to change to help achieve the vision.
Major Change Points for MSLs
1: MSLs Will Engage a Broader Range of External Stakeholders
Key audiences will continue to be Healthcare Professionals (HCPs) and Key Opinion Leaders (KOLs), but the definitions of these terms are expanding. Stakeholders will go beyond traditional physicians to include nurses, nurse practitioners, physician assistants, etc., and KOLs may include digital opinion leaders (DOLs) who have significant influence in a disease space despite little or no scientific or medical training. Additionally, MSLs will need to come to own the scientific aspects of patient engagement, participating in scientific exchange with patient associations and advocacy organizations, and even directly with patients themselves (within appropriate compliance guardrails). Likewise, MSLs will continue to engage with academia to set and/or influence treatment guidelines, while working with Health Economics organizations and governments, policymakers, and regulators to provide context for value decisions that affect the implementation of these guidelines. To achieve these strategic objectives, we can expect the further emergence of specialized MSLs focused on decision-makers.
Insights Will Drive Strategic Decisions and Actions
By and large, the industry now appreciates the role of Medical Affairs in general and MSLs specifically in gathering insights, and technological/digital systems are helping teams more successfully capture and analyze unstructured data to identify actionable insights. However, many organizations’ applications of insights remain limited to gap analysis to inform Medical Education activities. In the future, insights will go beyond gap analysis to inform early clinical development and strategic portfolio decisions, while novel, pragmatic insights from patient communities and real-world data will change and improve the practice of medicine. The degree to which Medical Affairs achieves this goal and owns this activity will depend on our ability to envision and describe the value and impact of insights to the organization’s strategic priorities and to the practice of medicine that benefits patients and society.
MSLs Will Require Competencies Beyond Scientific/Clinical Knowledge
While asset value-related activities will continue to be primarily the responsibility of Health Economics & Outcomes Research (HEOR) and Market Access teams, MSLs will need to increase their fluency in the “language of value” to provide scientific context for population-focused decision-makers including payers and policymakers. Additionally, MSLs will need to expand their competency beyond communicating safety and efficacy data to encompass the ability to effectively discuss novel trial designs, such as those utilized in Real World Evidence (RWE) and/or non-human studies. Likewise, MSLs will require competency in incorporating digital solutions into their communications and engagement activities, including the seamless use of on-demand tools. ” Finally (though this list is far from exhaustive), MSLs will increasingly require what have been called “soft skills,” including learning agility, emotional intelligence, and even primary leadership skills for those seeking career advancement.
MSLs Will Drive Patient-Centricity in Drug Development
The industry has struggled to disentangle “patients” and “customers.” Even in Medical Affairs, we have sometimes referred to aspects of engagement and narrative as a “customer journey.” We see this choice in words as more than semantics; it is representative of the core goals of Medical Affairs and the industry as a whole. The commercial is and should remain focused on engaging the “customer.” However, MSLs must remain focused on the needs of “patients.” This will require Medical Affairs organizations to transform patient engagement from a somewhat unidirectional monologue approach in which MSLs inform patient communities of the organization’s actions and progress, to a model in which patients and patient communities work as essential partners with industry throughout the life cycle. For example, MSLs will help the organization understand the natural history of a disease, the burden of the disease, how/when treatment can intervene to create outcomes that are meaningful to patients, and patients’ tolerance for benefit-risk profiles of drugs in different diseases. At the same time, MSLs will ensure that patient insights are gleaned so they can be embedded in all data generation strategies and activities while providing ready access to expert, non-biased information that enables active patient participation in making treatment choices. MSL teams with the passion and vision to conceptualize ways to involve and engage patients throughout the development life cycle will lead their organizations’ success while making a real difference in human lives.
As the traditional model of pharmaceutical sales representatives gives way to a model based on unbiased, balanced scientific exchange, MSLs will have an increasingly important role, with increasingly broad responsibilities which will require new or enhanced team capabilities and individual competencies. MSLs working in Medical Affairs who can adapt to these changing roles, responsibilities, and required competencies have the opportunity to lead their teams into a new era of Medical Affairs.
On behalf of the Medical Affairs Professional Society (MAPS) and contributing members of the MAPS Executive Consortium.
The writing support was provided by Garth Sundem, Director of Communications & Marketing, MAPS, per GPP3 guidelines.
Peter J. Piliero, MD
Peter Piliero is currently the Vice President and Head of Medical Affairs at Melinta Therapeutics. In this role, he is responsible for Medical strategy and leads a team of scientific professionals that are focused on implementing various scientific activities for antimicrobial and acute care therapeutics to ensure patient access to innovative therapies. Pete is also a member of Melinta’s Executive Committee. Dr. Piliero is an Infectious Disease specialist and recognized as a Medical Affairs expert having held significant clinical and leadership positions over the last 28 years at Albany Medical College, Boehringer Ingelheim, Merck, Mallinckrodt, and GSK Consumer Healthcare.
Prior to joining the pharmaceutical industry, Pete was an Associate Professor of Medicine at Albany Medical College and practiced there for 11 years as an Infectious Disease and HIV specialist providing patient care and as medical director of the Clinical Pharmacology Studies Unit.
After transitioning to industry, Pete spent 12 years at Boehringer Ingelheim in Clinical Development & Medical Affairs where he led teams working in various therapeutic areas including Virology, Immunology, CNS, Metabolism, and Women’s Health. At Merck, Pete led Global Medical Information followed by US Medical Affairs (except Oncology). At Mallinckrodt, Pete was responsible for global Scientific Affairs and for the overall strategic planning, governance, and management of the global Field Medical organization. Finally, prior to joining Melinta, Pete led Medical Affairs Americas at GSK Consumer Healthcare.
Since 2017, Pete is a very active member of the Medical Affairs Professional Society and is currently a member of the Board of Directors and the Treasurer of the Executive Committee.
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