April 1, 2006 (Vol. 26, No. 7)

MSLs Have Role in Developing & Refining Business Strategy & Commercializing Products

Last December, an article in this publication listed medical science liaisons (MSLs) among the hot jobs in biotechnology&#8217s 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&#8212we 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&#8217s a hitch&#8212not 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&#8217 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&#8217s 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.

MSL Architecture

Most MSLs have science-related doctorates or medical degrees plus prior careers in science or medicine. Many also have MBAs and other practical business experience. This background gives them a professional maturity vital for successful field work, as well as the rare ability to understand and balance clinical objectives with business priorities. Their training and experience also enable them to communicate effectively with external thought leaders, as well as with internal decision makers.

As biotech companies tend to be smaller and leaner than traditional pharmaceutical companies, MSLs in biotech typically have exposure to most key operational areas of their companies and work cross-functionally with several departments.

MSLs are important educators. Because of their science backgrounds, they are equipped to communicate a deep understanding of disease-state issues, examine the limitations of current treatment options, readily grasp the key points of new research data, and address all aspects of a new compound. This facility is especially valuable to biotech companies, whose stock in trade is novel compounds with novel mechanisms of action.

MSLs devote considerable attention to educating healthcare providers about the science of such new compounds. This helps establish a firm foundation of clinical knowledge about the products. It also helps dispel any misperceptions about the risks of commercializing innovative new biotech products.

If a biotech company is not yet well known, the MSL is sometimes charged with building an understanding of the company, the work it is doing, and the therapeutic compounds it hopes to bring to market. Many biotech companies were started by scientists rather than established business leaders, and as a result the challenges of commercialization can sometimes seem far greater than those of product R&D. MSLs are able to help address this challenge.

Through the clinical data and disease-state information they take to thought leaders, MSLs help provide credibility and support for their companies&#8217 products. Through the information they bring back to their companies from some of the country&#8217s best medical minds, MSLs help uncover prevailing thoughts and attitudes, track treatment patterns, identify unmet patient needs, learn competitive information, detect emerging trends, and develop new therapeutic ideas.

Operating at the nexus between science and business makes MSLs extremely helpful in developing and refining business strategy and creating effective programs for commercializing new products. Following are six key ways of leveraging the opportunities presented by MSLs.

Leveraging MSL Opportunities

First, biotech companies can use MSLs to learn how investigators respond to current studies, what research they would like to see initiated, and where they think a new drug will fit within existing therapies. This helps predict where specific markets are going and facilitates awareness of company products.

Second, biotech companies can use MSLs to identify what product information key opinion leaders want and how they want it presented. Answers to questions, such as &#8220How would you discuss this product with other physicians?&#8220, &#8220What would influence you to use this as first-line therapy?&#8220, and &#8220What would you say to patients about this drug?&#8220, yield valuable information for marketing managers.

Third, biotech companies can use MSLs to involve medical thought leaders in advisory boards and speakers bureaus. MSLs frequently invite opinion leaders to discuss their experiences and opinions of specific compounds with company managers, as well as with other healthcare providers.

Fourth, biotech companies can call on MSLs when unexpected challenges or opportunities arise. Both the medical community and the media look to thought leaders for guidance on how to understand and apply new developments in science and medicine.

Having ready access to key opinion leaders&#8212access made possible by long-term relationships cultivated by MSLs&#8212provides companies with the insights and often the spokespeople to develop and deliver appropriate responses in unexpected situations.

Fifth, biotech companies should involve MSLs in the clinical training of sales and marketing staff. Besides ensuring that everyone who conveys product information has a solid understanding of the science surrounding each product, MSL involvement also ensures that thought-leader perspectives are factored into training materials and that everyone fully understands the regulatory requirements involved in discussing product features.

And sixth, biotech companies can call upon MSLs to recommend candidates for investigator-initiated pilot trials and Phase IV studies.

Medical thought leaders will continue to play a vital role in conducting research, defining product challenges, responding to new data, and influencing prescribing practices and treatment guidelines. MSLs will continue to be the specialists who establish long-term peer relationships with these thought leaders. Such relationships help lay the groundwork for product introductions, shorten the length of time required for products to reach their peak potential, expand market share, and support new indications.

The roles of MSLs will continue to change and may always defy easy categorization, but biotech, traditional pharma, and device companies that fully leverage the knowledge, skills, and relationships of their MSLs will find them to be one of the hottest resources in the industry.

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