The global outbreak of COVID-19 has had deleterious and substantial effects on the conduct of scientific research over the last few years. The pandemic-induced stalling of drug development efforts worldwide has led companies to make urgent strategic amends to recoup from the delays and economic losses suffered. Meanwhile, the interaction of healthcare professionals globally has taken new dimensions of remote and distance in sustaining the professional relationships expected of them with the current social distancing norms in place. The influencing and communications role in industries in the pharmaceutical, biotechnology, medical device, CRO, and others in the field of healthcare is assigned to specific competencies and professionals. The advanced scientific training and academic qualifications of Medical Science Liaisons (MSLs) make these specialized individuals veritable knowledge repositories in engagement with thought leaders and Key Opinion Leaders (KOL’s) in the healthcare industry. The contention of this writer with years of experience in the field is that MSLs can be strategic by acquiring a breadth of multi-disciplinary industry knowledge.
Evolution: Sales to Specialization
In eons gone by, medical representatives (MRs) of pharmaceutical and medical equipment companies were entrusted to be the bearers of information to medical doctors. A more recent phenomenon from the sixties saw the emergence of the medical science liaison role taking on a more scientific approach, with the recruitment and use of those qualified and clinically adept in compiling and delivering advanced medical and scientific information to health care professionals. The importance of MSLs in dynamic and contemporary settings is such that every avenue of clinical knowledge dissemination must be availed when the opportunity presents itself. The agility and adaptation of the MSL is therefore an imperative, although delivering value in relationships with healthcare professionals and patients is recognized as challenging (Arec et al, 2013).
The Medical Science Liaison is considered a key role, one that is often centered on building and maintaining relationships, perhaps specifically focused on engagement with influential, physicians referred to as Thought Leaders (TL’s) and Key Opinion Leaders. The engagement is usually with healthcare professionals affiliated with major academic institutions and clinics. Universally recognized as being field-based, the MSL portfolio is saddled with increasing importance and responsibilities; perhaps the strategic potential of this function can be further leveraged and developed. The MSL profile is uniquely transformative, as adaptation and resourcefulness are critical, with remote interactions and as a non-sales promotional position (Matesanz-Marín, et al, 2022). MSLs can however contribute strategically when these individuals demonstrate a breadth of knowledge outside of clinical and scientific information, i.e., to include awareness of industry-specific legal/regulatory affairs, strategic marketing, economics, and business dynamics.
A breadth of knowledge in conveying clinical aspects of a drug or device can be complemented if the MSL is able to demonstrate the depth of knowledge in all stages of early drug development, clinical trials, to post activities of market diligence and surveillance. The primary goal of medical science liaison is to engage with medical specialists for a variety of reasons, primarily for scientific content dissemination and clinical relationship-building conversations. Their roles are a little less on commercial, marketing, and other non-clinical aspects of company advancement, and therefore MSLs fundamentally serve as liaisons and influencers. It behooves those in this role to be generalists, as much as specialists, meaning the critical imperative is to be conversationally and scientifically adept in promoting the company’s medical agenda, and can extend to be knowledgeable at a holistic level, i.e. from early drug discovery and development, across the continuum of clinical trials, and post-marketing. Holistic knowledge will likely yield many strategic dividends, notably in being held in high esteem, as compared to others in this role who are merely doing their job, and perhaps with only the knowledge, as that is expected within the MSL role. The responsibilities expected of an MSL are specific in relationship building, which is a given. In some organizations, there is a juxtaposition of MSLs and Sales representatives (SRs) when it comes to scientific exchange versus promotional messaging (Theron et al, 2021), however being scientifically, clinically, and informed holistically, may deliver unique strategic advantages and benefits to organizations.
Strategic Mindset and Commensurate Competencies
The strategic MSL competencies recommended by this writer and researcher include skills and persuasive capability development to foster partnerships and collaborations. The MSL role is primarily intended to provide education about products and facilitate research partnerships between clinicians and industry, as collaborations can yield new products and innovations (Baker, 2010). Innovation can also mean adeptness in forging relationships of strategic benefit and must be ethically upright, which serves to achieve the communication goals of the organization.
Current trends indicate including the nurse practitioner (NP), as pharmaceutical firms have sought to build robust relationships to meet the constantly evolving marketplace changes in health care. Vanderhoef and Johnson (2020) observed the importance of a “scientific peer,” with clinicians with a PhD, DNP, or physician assistant and use the term “clinical practice liaison” (CPL), a role analogous to the MSL, except that the engagement provider type is almost exclusively NPs and PAs. While these researchers contend that the CPL is not a sales representative, but rather a field-based professional, on hand to provide a balanced scientific and clinical exchange. Arguably, these professionals can be strategic contributors to the mission and purpose of the organization. Acquiring a breadth of knowledge in the sphere of biomedical research, notably in marketing, regulatory affairs, and non-clinical areas requires a progressive mindset with some efforts and investments in time.
Similar to MSLs and CPLs, Medical Affairs represents the interface between important medical/scientific activities emanating from a company and the external sphere of the patient, the professional, and the outside world. The scientific and strategic blend of activities entails a combination of providing input to Clinical Development and Drug Regulatory Affairs, drawn judiciously for analysis and intelligence on medical/scientific trends, and also informed by the views of key opinion leaders. Kientop (2010) contended that CPLs contribute to the body of knowledge of a drug from Phase IV activities and other methods of data collection aiming at real-world evidence. Although the focus and emphasis are on developing relationships, as in most organizations, the interests of the MSL are on building strong relationships with individual Key Opinion Leaders, as progressive companies have realized the value that MSLs can also bring to Key Account Management (KAM). The successful integration of Key Accounts into an MSL function is possible, however, requires a certain level of astuteness. To accomplish this degree of strategic thinking warrants understanding the business approach in the KAM identifying the MSL resources on hand with the development of a comprehensive strategic plan and in judiciously careful and adaptable implementation (Kientop, 2010).
Globalization and Localization
Integral to the operations of the MSL position is the independence from marketing and sales in the pharmaceutical or medical equipment functions, something quite prevalent in Europe and the U.S. The MSL separation from commercial function potentially reduces the risk of ethical miss-steps and conflicts of interest. A singular clinical focus of the MSL helps to ensure accurate, timely, and rigorous detail, across the communication continuum of drug discovery and thereafter in their engagement with clinicians.
Looking at the MSL role further worldwide, specifically in Japan, Medical affairs has been plagued with scandals in clinical trials, attributed to improper relationships between medical doctors and the sales departments of pharmaceutical companies, reported, notably from events in 2012 (Hideki, 2021). Expectedly, Hideki (2021) noted, the fallout resulted in the undermining of the integrity and confidence in clinical trials in Japan and consequently made it necessary to separate sales from “the conduct of post-marketing clinical trials and evidence generation”. Medical affairs consequently therefore in Japan are in the process of re-orientation and change, as there is a greater effort in keeping these vital roles, and responsibilities compartmentalized and independent of each other. The lessons are universal, in that ethics should be the bedrock of all healthcare research and development, regardless of geography.
In further evaluation, the role of the regional medical advisor (RMA) is seen as a trend that has emerged since the last decade in the pharmaceutical industry, and the roles and responsibilities of this function of which are still evolving. The RMA in the geographic vicinity provides field-based capabilities to foster collaborative relationships with KOLs that are conducive to a more expeditious exchange of unbiased scientific information between the medical community and the company (Gupta & Naik, 2013). The trend of field-based medical liaison teams is a global one, nevertheless one which is changing with the upheavals in the drug discovery and commercialization discussed herein. The pandemic travel restrictions made the phenomenon of globalization stutter and cause grave apprehension in research and development. The development of vaccines, gene therapy, and the need for larger patient pools inevitably have led drug firms, and many in the sphere of healthcare to turn to global markets to offset some of the setbacks. The pharmaceutical industry’s increased focus on global operations including emerging markets is now quite apparent as the scope and purpose of the MSL will likely continue to evolve as well.
The major objective of the RMA, as the researchers have stated, is to engage with KOLs and in augmenting professional relationships with the healthcare community through peer-to-peer contact. The RMA longitudinal relationships are ideal for investigator-initiated clinical research proposals from approval until completion of the clinical studies initiated within the relevant therapeutic area at the regional/local level (Gupta & Naik, 2013). In such proximity, the breadth of knowledge, as suggested in this discourse, will aid in the overall goals of an ethical relationship.
In summary, it is responsible for those in the field of medical information, communication, and input to facilitate greater strategic inroads into local and global markets. Skilled medical writing and presentation into every aspect of drug performance, and safety, without in any way over or understating, are also adeptness skills unto themselves. The medical input and control of advertising and promotional activities represent “the medical and social conscience of the company” and the Medical Science Liaison holds the keys to disseminating medical/scientific information between the company and the outside world through Medical Science Liaison (Nell, 2018).
A breadth of knowledge in conveying clinical aspects of a drug or device can be complemented when the MSL partnership with Medical Affairs is able to demonstrate a breadth of knowledge that transcends all stages of research and development. The rewards for the sustained pursuit of innovation in any field of human endeavor usually yield a competitive advantage. The innovative demeanor and strategic disposition of the MSL professional to supplement communication and relationship adeptness may similarly also confer unique advantages commensurate with holistic industry knowledge acquisition, requiring ongoing learning and continuous improvement.
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Gupta, S. K., & Nayak, R. P. (2013). An insight into the emerging role of regional medical advisor in the pharmaceutical industry. Perspectives in Clinical Research, 4(3), 186–190. https://doi.org/10.4103/2229-3485.115386
Hideki Maeda. 2021. “Medical Affairs in Pharmaceutical Companies and Related Pharmaceutical Regulations in Japan.” Frontiers in Medicine 8 (August). doi:10.3389/fmed.2021.672095.
Kientop, D. (2010). Integrating Medical Science Liaisons into Key Account Management. Journal of Medical Marketing, 10(1), 45–51. https://doi.org/10.1057/jmm.2009.45
Matesanz-Marín, A., del Castillo, A. G., Sastre, V., & García, C. (2022). The Medical Science Liaison Role in Spain: A Survey Capturing the Opinion of Medical Department Professionals. Therapeutic Innovation & Regulatory Science, 56(5), 805–813. https://doi.org/10.1007/s43441-022-00424-x
Nell, G. K. H. (2018). Chapter 25 – Medical Affairs. Pharmaceutical Medicine and Translational Clinical Research, 393–399. https://doi.org/10.1016/B978-0-12-802103-3.00026-2
Theron, P., Britland, M., Holder, D., Ikeda, Y., Rewers, R. F., & Tiku, A. (2021). Promoting Best Practices for Medical Science Liaisons Position Statement from the APPA, IFAPP, MAPS and MSLS. Therapeutic Innovation & Regulatory Science, 55(6), 1139–1144.
Vanderhoef, D., Roque, A., & Johnson, J. (2020). Science Not Sales: Partnerships and Scientific Exchange With Industry. The Journal for Nurse Practitioners, 16(7), 549–550. https://doi.org/10.1016/j.nurpra.2020.04.021
Lionel de Souza, LL.B., LL.M (IPR Cand) MBA, MACPR, PhD
Dr. de Souza is a well-published and award-winning Professor, Philanthropist, and leads US, International University, and School education initiatives. In the sphere of global higher education development, he is actively involved in advancing the educational needs of aspiring and deserving populations worldwide. Extensive global engagements are in clinical research, management healthcare, and pharmaceutical marketing and he is the CEO of a global law firm. The current projects of Dr. de Souza are in the USA, India, the Middle East, and Africa. Dr. de Souza is currently heading up projects in healthcare, involving Artificial Intelligence and customized IT Solutions to advance and optimize organizational effectiveness. As a professor, he graduates many doctoral graduates and is the recipient of awards and nominations for Excellence in Doctoral and Masters’ advisement in the disciplines of management, business, healthcare, and marketing in leading US/UK institutions. Dr. de Souza is the Executive Director of UniversitiGoGlobal, an organization that creates Worlds of Opportunities for students and Universities, with one goal of expanding the frontiers and boundaries of knowledge and innovation globally!