MSLs play a critical role in the Pharmaceutical Industry
Medical Science Liaisons (MSLs) are a vital link between the science and art of medicine. They work with healthcare providers (HCPs) to understand the needs of patients and then bring that knowledge back to pharmaceutical companies to help develop and market new drugs that are essential to advance patient care. MSLs are critical in the product life cycle, from early development to post-launch. In fact, they are playing an ever earlier role in guiding drug development during research phases before regulatory review and approval. They are responsible for building and maintaining relationships with HCPs, providing scientific education and support, and gathering insights to bring back to the company. MSLs are trained scientists, and they also deeply understand the real-world challenges that HCPs and patients face. This unique perspective allows them to bridge the gap between science and practice – to help develop new novel therapies drugs that make a real difference in patients’ lives.
| Stage | MSL Responsibilities | Watch-outs |
| Early Development | MSLs work with TAEs to understand unmet medical needs, gather feedback, and build relationships. Play a strategic role in connecting TAEs to clinical development teams, when appropriate. Additionally, Clinical Trial Liaisons (CTLs) play a role in study enrollment, recruitment, and referrals to enhance clinical trial efficiency | MSLs must act in patients’ best interests and provide only scientific evidence-based information. In the pre-approval stage, MSLs should focus on disease state information and avoid making product claims. |
| Clinical Development | MSLs provide scientific support to investigators, ensure trials are conducted according to protocol, communicate with stakeholders, share disease state info, and address data gaps to support regulatory approval and market access. | MSLs are not sales representatives and should not try to influence TAEs to prescribe a particular product. |
| Regulatory Approval | Educate healthcare professionals about the product and how to treat patients safely. Provide support to marketing teams and help develop marketing materials. Communicate effectively with healthcare professionals and understand their needs . | Be cognizant to ensure field medical teams only share data or information approved by the company, as regulators are sensitive to pre-approval promotion. |
| Launch | Gather insights, provide feedback to the product team, and promptly report Adverse Events (AE). Communicate effectively with internal and external stakeholders to understand their needs . | MSLs must adapt to a heavily regulated, evolving industry. They monitor safety events, ensure diagnosis and treatment, and report insights quickly. They gather market intelligence by attending conferences, speaking with TAEs, reviewing data. This helps the company launch products and identify barriers. |
| Post-Launch | Adapt to new technologies and the changing needs of healthcare professionals, patients, TAEs, and other stakeholders. Ensure post-marketing AEs are reported in a timely fashion . Improve data generation and be open to new research. This will help advance care and research. | A strong understanding of the pharmaceutical industry, disease state, and treatment landscape is essential. Information not supported by scientific evidence should not be provided. As the product matures, it is important to keep an open mind about where care trends are going. Research and data generation efforts may be a focus during this time. |
Role of MSLs in Diagnostics
The role of an MSL in diagnostics has several similarities and differences from an MSLs’ role in pharma. In diagnostics, the primary focus of the MSL is to support the science and development of the diagnostic tool and be the primary liaison between the TAEs and the company. The diagnostic MSL may also cross-collaborate with multiple teams, including research, clinical development, marketing, Market Access/HEOR, and commercial, to provide this scientific support and bring insights gathered from the field to the company. Of note, these collaborations will depend on each company’s compliance policies. In diagnostics, the MSL may also serve as the liaison for clinical consults that develop from provider or patient questions directly related to the diagnostic test result. The diagnostic MSL’s role is bridging the gap and is essential for the product life cycle by cross-collaborating to develop a new diagnostic tool to improve patient care.
Digital Therapeutics: A new frontier for Field Medical
Digital therapeutics (DTx) is a more recent category of medicine defined as evidence-based, clinically evaluated software and devices used to treat various diseases and disorders. Because many clinicians and stakeholders have never utilized or worked with DTx, there is a considerable emphasis on educating payers and critical decision-makers on DTx and the clinical value proposition of products.
Medical science liaisons (MSLs) in digital therapeutics still engage with their peers in the scientific community. Still, they must also interact with various stakeholders, including healthcare decision-makers, influencers, and other scientific community members. These stakeholders include managed care organizations, specialty pharmacy providers, pharmacy benefit managers, integrated delivery networks, and non-prescribing clinicians like psychologists and therapists.
Due to the nature of digital therapeutics as software programs and wearables, MSL’s influence and responsibilities during the product life cycle do wade into uncharted territories that are new to the profession. MSLs interface with software engineers and product teams due to the nature of the products. Digital areas of concern that require more exploration include security of systems, patient privacy protection, transfer of value when systems or related materials have a significant monetary value. Additional technical considerations, such as updates to content and visuals in the program and unique outcomes reporting requirements, play a part in digital therapeutics but not prescribed medications.
Integrated Medical Engagement Plans
While there are nuances in the roles and responsibilities of MSLs in Pharma, DTx, and Diagnostics, the activities of successful MSL teams are built on the backbone of an integrated engagement plan. The engagement plan is geared toward ensuring that eligible patients can access the therapies and diagnostics that are appropriate for them. In the peri-launch period, these plans focus on TAE identification, relationship development, assessment of clinician awareness of disease state and products, and support of clinical trials. As the product matures, engagement plans evolve to include tactics related to broader groups of stakeholders and support and dissemination of clinical trials and real-world effectiveness studies. Education of key decision makers within health networks and payers is key to ensuring access, as those external stakeholders determine the effective eligibility of patients for any therapy or diagnostic through their formulary decisions. In all stages of development, field medical teams play a key role in collecting and sharing those observations, or insights, about how and why clinicians make their therapeutic decisions — importantly, these insights may inform new tactics or strategies for improving patient access.
Global alignment and local solutions for maximal MSL effectiveness
Companies must ensure a capability structure exists to support field medical activities worldwide in today’s global economy. This structure includes the processes, tools, and training that ensure MSLs can be successful in their local markets. While medical plans may be developed globally, local markets tailor engagement plans to meet their unique regulatory, payer and health system needs. Within the capabilities structure, systematic documentation of external engagement activities, contribution to the insights generation process, and blinded or unblinded surveys of TAEs may form the backbone for assessing MSL effectiveness.
By ensuring global alignment and local solutions, pharmaceutical companies can maximize the effectiveness of their MSLs and help to ensure that their products are successful in the worldwide marketplace. Another consideration of the globalization of the field medical affairs is cultural differences. Companies must be mindful of appropriate ways of engaging HCPs, considering patient needs, and using communication approaches that engender trust, respect, and integrity.
The MSL role is challenging, yet rewarding
Medical Science Liaisons (MSLs) are at the forefront of cutting-edge science and have the opportunity to make a significant difference in patients’ lives. They do this by working closely with teams across different stages of product development, providing contemporary scientific and medical insights that help ensure a product’s timely launch and safety in the market. Their expertise and knowledge play a significant role in supporting the product’s lifecycle management process and bridging the gap between the science of medicine and the art of how medicine is used from the bench to the bedside.
The value of the field medical role is well-recognized with many companies increasingly investing in medical affairs teams. Additionally, MSLs are more often initiated at earlier stages of novel therapy development to lay a groundwork for healthcare professional engagement, ensure efficient clinical research efforts, and navigate successful launch and commercialization of novel therapies. The evolution of this vital role is expanding, with a strategic focus, to bring new therapies to the patients who are waiting.
Author:
Mitch D’Rozario, Ph.D.
Mitch is a Malignant Hematology MSL at Genentech/Roche. In his MSL career spanning hematology and ophthalmology, Mitch has supported ocular surgical devices, microdosing implants, biologics, antibody-drug conjugates, oral inhibitors, and bispecific antibodies from Phase I-IV. Mitch enjoys advocating for customers and patients, collaborating with internal colleagues, and building strategic tools to make informed business decisions and deliver urgent medical solutions. Mitch earned his Ph.D. from Drexel University and trained as a postdoc at Washington University School of Medicine. In a pre-COVID world, Mitch can be seen keeping pace with his two boys, Francis (2.5 years) and Miles (1 year). In a post-COVID world, he has been busy being a Montessori dad, learning how to bake, and going to OrangeTheory (while maintaining a safe distance) to burn off the said baked goods.
Delilah Huelsing, PhD
Delilah Huelsing is currently a Director of Field Medical Excellence at Amgen. In this role, she partners
with global medical leadership on initiatives that optimize external engagement, continuously improve
the insights generation process, use analytics to help share the value of Field Medical teams. Delilah
draws upon 20 years of experience in various Field Medical roles in the device and pharmaceutical
industries. Prior to that, Delilah was on faculty in the Department of Biomedical Engineering at the
University of Alabama-Birmingham, where her teaching responsibilities and independent research were
focused on cellular cardiac electrophysiology.
Madleine Makori, PharmD
Madleine Makori is a Sr. Medical Science Liaison with Big Health.
Dawn O’Reilly, PhD, PA-C
Dawn O’Reilly is an Oncology Enterprise Research Medical Science Liaison with
AbbVie. She lives in North Carolina with her husband, 3 children, and their spunky golden retriever. She is passionate about healthy living, playing outside with her kids, and she loves to travel.
Jason Carey, PhD
Jason Carey is a Senior MSL with GRAIL.
Cherie Hyder, PharmD, MSL-BC
Cherie Hyder is Syndicated National MSL Director at Syneos Health. In her previous job at Biohaven Pharmaceuticals, she supported a virtual launch of Nurtec ODT for acute migraine. She has been involved in drug development for more than 30 years, working at FDA in CDER and pharmaceutical companies including Pfizer, Lilly, Novartis, Solvay, and Avanir, among others. At the University of Missouri, she received a Doctor of Pharmacy degree with the intention to devote her career to pharmaceutical research. She has multiple adjunct faculty appointments and enjoys teaching opportunities.
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