Last December, an article in this publication listed medical science liaisons (MSLs) among the hot jobs in biotechnology’s transition from R&D-focused activity to commercialization (see Employment Trends in the Biotech Industry, GEN, December 2005). We were delighted to read this, since we have related hot jobs ourselves—we train and develop scientists to serve as MSLs and help biotech, pharmaceutical, and medical-device companies establish and staff MSL departments.
The forecast for MSLs may be sunny, but there’s a hitch—not everyone understands what they do. As the word liaison suggests, the chief responsibility of MSLs is to establish and maintain mutual understanding and collaboration. Externally, MSLs build close relationships with medical thought leaders through the exchange of complex scientific information related to their companies’ areas of research, product development, and commercialization.
Internally, they convey and interpret the information they bring back from the medical community, presenting its scientific and commercial implications. There is no simple way of describing what MSLs do, but understanding how they work and what they contribute makes it clear that they are valuable assets to the maturing biotech industry.
The first MSLs, fielded by large pharmaceutical companies in the 1970s, operated as specialized sales reps. Today, most MSLs are associated with medical affairs departments and have distinctly different responsibilities from anyone else in the biopharmaceutical and medical-device industries.
The shift in MSL roles was initiated by stricter government regulations over the past decade, notably a guidance from the Office of the Inspector General in 2002, which ended the pharmaceutical industry’s more extreme marketing practices and prompted a clear separation between R&D and sales and marketing. In general, the commercial side of the business focuses on direct sales while clinical departments, including MSLs, focus on medical education and the exchange of balanced scientific information.
Guidelines from the pharmaceutical industry and various medical organizations further established the need to separate marketing from scientific education and to field highly trained specialists to direct the scientific exchange. The growth of managed care and the development of increasingly complex products also reinforced the separation and specialization.
MSLs, with the ability to talk as peers with thought leaders and schedule substantial blocks of time for meetings (average 30-plus minutes), became a vital conduit in the necessary, synergistic relationship between investigators and biopharmaceutical companies.
Their ability to discuss all aspects of therapeutic agents, including, when appropriate, responding to off-label topics, also demanded that MSLs become authorities on how to exchange sensitive information in full compliance with legal, as well as regulatory and ethical guidelines. MSLs respect the firewall between marketing and MSL functions and they observe the guidelines established to foster factual, nonpromotional communications. They also understand, however, how their work complements other essential operations within their companies and can contribute to the successful commercialization of new products.