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MSL Corporate Strategy and Growth (Part One)

The Medical Science Role: To become an effective Medical Science leader it is critical to understand the role of the Medical Science Liaison and to understand the legal philosophy that guides the Medical Science strategy. To provide light on these areas we will proceed through a few of the important factors and steps that lead to best practices within this endeavor.
The Medical Science Role: To become an effective Medical Science leader it is critical to understand the role of the Medical Science Liaison and to understand the legal philosophy that guides the Medical Science strategy. To provide light on these areas we will proceed through a few of the important factors and steps that lead to best practices within this endeavor. 

In many organizations, MSLs educate clinical peers about the latest scientific developments and treatment guidelines affecting a specific therapeutic area. In addition, MSLs are sometimes called on to provide summaries of recent scientific congresses, make formulary presentations, or address unsolicited efficacy or safety questions. MSLs may also facilitate educational or research grants submissions or be asked to organize regional advisory boards. The services provided by MSLs are quite varied and are continually evolving. 

There are several bodies of law that regulate the MSL environment in the United States and one is the Drug and Cosmetic Act, which places a restriction on off-label marketing and advertising. The MSL role has evolved significantly in response to this act and other heightened legal, regulatory, and compliance mandates. 

In today’s corporate environment there is a two-fold element of risk that affects a corporation as it relates to medical science and more directly to the Medical Science Liaison (MSL). This risk is comprised on one hand by the improper actions of an MSL brought about from improper or incomplete MSL knowledge. On the other hand, risk is comprised of the improper actions of an MSL brought about by the lack of legal knowledge. These elements of risk though similar are different in their specific areas of knowledge and threaten a coherent contact and communications strategy. To counter these elements of risk and others a comprehensive training and evaluation program is required within an organization’s MSL program and course of study. 

The basis and beginnings of an MSL program should normally be to evaluate the therapeutic market. This can be accomplished by completing a GAP analysis of current business stance in the market as compared to others and to current and foreseen goals. 

Additional, an inventory of a Key Opinion Leader (KOL) and their professional profiles should be identified and mapped. There are major companies that can assist an organization with KOL mapping for a contracted fee. The importance when mapping KOLs is that this report should be unbiased, be completed in a timely manner, and provide the key leaders in the therapeutic environment.

The key emphasis for the KOL mapping process and its output should be that it is used to optimize your organizational performance and that it be a guide for the selection of future speakers at grand rounds and conferences. To prevent promotional bias, the strategy should be completed independently and not collaborated with the commercial side of the organization.  This should also be a task that is completed and redefined at least yearly. 

MSLs are organizational leaders, organizational representatives, and scientific professionals. As such, they are required to align and establish relationships with selected KOLs. The process of relationships building should be conducted and documented in a manner that is both beneficial and transparent with a focussed aim. Direct inquiries by MSLs into KOL needs can support the transparent communication that is key to a sustainable peer relationship and in direct support of the organization and its goals.

The Author of this work is Jennifer Williams and titled: MSL Corporate Strategy and growth, Part 1, 2015 © is protected by the Copyright Laws of the United States (Public Law 94-553, revised in the 1976). Consistent with fair use as defined in the Copyright Laws, brief quotations from this material are allowed with proper acknowledgement. Use of the material for financial gain without the author‘s expressed written permission is not allowed.  

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  MSL Corporate Strategy and Growth (Part One)
MS Word Document: 169.0 KB

8th January 2016

Downloads

  MSL Corporate Strategy and Growth (Part One)
MS Word Document: 169.0 KB

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