In today’s biopharmaceutical industry, there is a growing disconnect between the level of knowledge handled by a new drug's researchers and that possessed by practitioners, hospital administrators and decision-makers in local regulatory agencies.
To address this gap, sponsors and CROs are now recruiting an MSL or “Medical Science Liaisons”. Even in fields where recruiting an MSL was already common, such as oncology or rare diseases, MSLs are quickly seeing their role expanded.
An MSL is a therapeutic expert who specializes in communicating the complex scientific information involved during the Research and Development process, to other physicians.
Over the years, MSLs have also begun to play a role in strengthening ties with regulatory officials, and in communicating the effectiveness or real-world outcomes of a drug to the general public. MSLs also play a key role in recruiting Key Opinion Leaders (KOLs), who are often looking for as much information as possible before publicly supporting a drug.
In this sense, MSLs are usually tasked with building bridges between the R&D team, the clinicians, and the commercial team.
An MSL needs a rare combination of technical and social skills. Their day-to-day tasks will involve communicating with a variety of stakeholders, many of whom will have different degrees of familiarity with the required subspecialty, or may work in a different one altogether.
The relationships developed by an MSL should go both ways: by liaising with other professionals, or even with patient advocacy groups, they can gather insights that can help future business strategy. For a Marketing team, this information can be invaluable. As a result, the demand for MSLs is steadily growing.\(^1\)
In many ways, an MSL is a customer-facing medical expert. An MSL may be engaged in any of the following areas:
Traditionally, MSLs are often seen as part of the post-clinical trial phase, when they are brought in to help gather scientific advice from regulatory authorities. However, a robust medical strategy can involve an MSL during all stages of the product lifecycle.
Before the clinical trial stage begins, an MSL can approach key opinion leaders (KOLs) and raise their interest about the future product. They can help disseminate the mode of action, or the expected advantages, of the new molecule being studied.
At this point, they can also gage the reaction of clinicians or patients, and gather information for medical strategy plans.
During the pre-launch process, an MSL can continue using these pre-established relationships with KOLs. They can collaborate in order to increase their understanding of the new drug and presenting data at scientific meetings or symposia.
Furthermore, MSLs can help close any information gaps before launch, and start the implementation of the investigator-led study program.
Here, a talented MSL can acquire new prominence. They can share clinical evidence with KOL related to the drug’s indications and dosages. By supporting the medical plan during the launch, the MSL will help push the product’s future commercial success.
At this point, investigator-led study plans are usually implemented. This is a good opportunity for an MSL to provide continued medical education, address prescribers’ questions, and help disseminate related publications.
Often, these tasks often involve generating real-world data, which will point at the possible concerns or needs posed by KOLs. This usually involves establishing possible adverse-reaction registries or more comprehensive observational studies.
The rising demand of talented MSLs, as well as the relatively rare combination of talents required to perform the necessary tasks, means that enlisting one throughout the drug development process can be expensive. Often, sponsors who are struggling to keep their clinical trial within budget may see this as an unnecessary extra expense.
Nonetheless, an MSL can bring the following advantages, which may in turn help save costs and time in the long run.
An MSL can help increase your R&D’s team strategic flexibility by:
For these advantages to be reaped, an MSL must be able to focus on a company’s core portfolio, and prioritize resource allocation. Simultaneously, he or she should be open to any arising ambitious opportunities or strategies.
With regards to marketing strategies, an MSL can also provide a greater degree of tactical adaptability. This can translate in better-allocated resources throughout the product development cycle. By strengthening the overall work of the Medical Affairs team, they can help the organization adapt to changing market dynamics.
If empowered to take rapid and impactful decisions, this will help the drug’s commercial efforts a step ahead from the competitor’s developments.
Finally, the multidisciplinary knowledge possessed by a Medical Science Liaison can help improve adherence to all relevant legislation. In order to take advantage of this, all the different team members will have to understand their roles, and be able to collaborate effectively. Each person’s role should be well-defined, and work harmoniously with the tasks assigned to others.
From its foundation, Dokumeds has made it a priority to recruit and retain the most promising talent in each field. When designing the company’s Medical Services portfolio, Dokumeds paid extra attention to attract experienced MSLs to supervise different teams.
As a result, Dokumeds can now tailor the services each MSL offers to each Sponsor according to the project’s specific needs. This starts from the early development or clinical trial stage, and follows the product through pre-launch, launch and post-launch, bridging the gaps between all development phases.
Dokumeds can assist Sponsors in finding the best model to ensure full MSL support. Depending on the Sponsor’s needs, Dokumeds can simply help select and recruit MSLs in the region of interest, or provide a full scope of services, including additional support services (Pharmacovigilance, Market Access, etc).