Globalization of field-based medical science liaison programs: the scientific basis for global success: the deployment of field-based medical science liaisons (MSLs) has become common practice in the United States. However, transplanting this same model into foreign markets is not an easy task. When using MSL programs in overseas markets, they must conform to local regulatory guidelines, employment policies, and market subtleties.

The global pharmaceutical market is dominated by the United States. However, markets outside of the United States (ex-U.S. markets) account for 54% of total worldwide pharmaceutical sales and represent a significant future growth opportunity for the industry. Over the past decade, medical science liaison (MSL) programs have significantly proliferated in the U.S. marketplace, whereas such programs in ex-U.S. markets is growing at a much slower pace. As companies and their brand teams continue to become more globalized, MSL teams must extend their relationships and borders beyond domestic contacts. Establishing relationships with global physician experts and providing them with resources including clinical data, educational platforms, slide sets, continuing medical education and speaking opportunities, and clinical trial participation opportunities will ultimately contribute to the success and uptake of a company's products in the global arena.

Since a successful MSL model has been developed and implemented in the United States, one might consider it a simple task to apply the same model to the overseas market. However, this is not always the case, as overseas markets may not be receptive or may even be distracted by MSL programs if they are not implemented in a simple, clear fashion. This article will offer key essentials for rolling out a successful international local market MSL program.

An Effective Model for Global Field-Based MSL Programs

Global field-based MSL programs provide a key mechanism to achieve corporate goals within local markets. Success depends on consistent application of initiatives across different settings, while allowing for inherent market differences and avoiding the implementation of overly complex and impractical systems. It is important to remember that few countries have the same regulations for field-based programs.

Three widely adopted models for development of global MSL programs include: (1) corporate funding with corporate direction, (2) corporate funding with local direction, and (3) local funding with local direction (Figure). The first model is characterized by central appointments of MSLs. Although this model facilitates control and consistency among markets, it is often limited in that it garners affiliate objections, risks not meeting local market needs, and incurs delays because of a lack of local cooperation.

[FIGURE OMITTED]

The second model is most effective for establishing global field-based MSL programs. It provides central funding for local programs and reflects corporate confidence in affiliate companies by allowing them to take responsibility for their respective markets. The corporate entity sets the global view: a plan of clearly identified strategic goals, with local companies deploying MSLs to achieve tactical goals such as localization to comply with regulatory and promotional guidelines; customization of materials for market subtleties, administration to employment policies; and integration with clinical, medical, and marketing functions.

The third model allows individual companies complete autonomy over both the budget and direction of MSL programs. It is the most commonly adopted MSL model, but it is also largely responsible for why ex-U.S. markets lag behind the United States in terms of MSL development. Local markets are often unwilling to invest their limited budgets in prelaunch initiatives when more pressing concerns exist.

The Key to Success: Alignment

Choosing a valid model for MSL program development is the first step to ensure program success. Implementing a corporate program and making it succeed at a local level requires the proper recognition and cooperation of both corporate and local stakeholders. Key representatives include global and regional medical directors, who are likely to be responsible for managing the direction of the MSL program, and global and regional marketing leaders, who may administer the financial direction of the program. It is also essential to gain the support of, and communicate with, the research and development, medical affairs, marketing, clinical research, and medical communications departments, as well as the departments responsible for human resources and information technology (IT). Human resources and IT support are critical, since many employment factors must be considered when rolling out a global MSL program. Unlike the United States, where many employment laws are similar across the states, each country--and possibly province--overseas has its own set of rules and regulations. These laws, public policies, and trends pertaining to the employment process must be carefully studied, as they affect such issues as recruiting, leave time, compensation, discipline, termination, and employment contracts. Differences in health and welfare benefits and how they are sponsored may also vary widely; as such, they must also be reviewed to ensure compliance with local standards.

Defining the Role of the MSL

The role of the MSL is often confused with that of a medical advisor, particularly in the ex-U.S. markets. However, these roles are almost polar opposites in terms of their approach to the communication of data in support of product introductions. The MSL role is almost always external, with programs being deployed during the prelaunch and perilaunch periods of the drug. It is of considerable importance that MSLs are perceived by key opinion leaders (KOLs) as credible scientific contacts; therefore, their role should be data based and nonpromotional. Generally, MSLs have a medical or scientific background and are excellent communicators.

Specific tasks of global MSLs include KOL development activities, scientific support at medical meetings and congresses, competitive intelligence, speaker identification and recruitment, publication and abstract management, reimbursement and formulary decision support, development of clinical practice guidelines, education, and training. Appropriate performance metrics should be developed and implemented to measure the success of all MSL-related activities, including approved coverage and frequency of KOL contacts, speaker development, appropriate dissemination of information, and feedback.

Prelaunch Opportunities for Global Initiatives

It is during the critical prelaunch period that MSLs develop important networks with KOLs and decision makers to ensure the product lifecycle begins in the most positive manner. One objective is to raise company awareness, given that many top U.S. pharmaceutical and biotechnology companies may not be as well known in other markets. In addition, it is important to increase disease state awareness among KOLs to ensure they understand the targeted disease pathways. Medical science liaisons also play a role in clinical trial programs, particularly at the phase 3 level. Although phase 3 trials may be administered centrally, local support from MSLs can aid patient recruitment and retention as well as data analysis. Local MSL programs can focus on the development of publications based on local study subpopulations. Other prelaunch opportunities include facilitation of advisory boards and KOL education and development programs.

Overseeing the Global Program

A split between corporate and local market responsibilities is ideal when overseeing a global MSL program. For example, the global agenda of the program should be centrally developed to ensure a consistent direction across markets; local countries can then deploy MSLs to achieve these goals. This structure facilitates appropriate compliance with country-specific regulatory and promotional guidelines; customization of materials for market subtleties; administration to meet employment policies; and integration with clinical, medical, and marketing at a country level.

Global Deployment

Global MSL deployment involves contracted MSLs, internal MSLs, or a mix of both. Outsourcing, as a means of allowing companies to focus on their core competencies is becoming increasingly common across all business organizations, and the pharmaceutical industry is no exception. In particular, many companies choose to outsource at least part of their MSL programs to minimize risks and limit investment in recruiting, training, and infrastructure, while utilizing the services of experts in this field.

Internationally, MSLs typically support leading national academic centers and health care institutions to interface with KOLs in specific therapeutic areas. Furthermore, relationships are often developed between MSLs and representatives in key government agencies, such as the United Kingdom National Institute for Clinical Excellence or the Canadian Office for Health Technology Assessment, which have a major effect on drug utilization in their respective countries.

In the United States, MSL programs are generally initiated 12 to 18 months before the launch of a product; in Europe, this may be as early as three years in advance of a drug launch.

The Importance of Applying Best Practice