Bio-medical research is no longer confined to the United States. The higher economic returns, greater patient pools, the lure of the availability of advanced medical facilities, and commensurate high-end clinical research personnel and capabilities in many other countries make it viable and attractive for pharma and device companies to engage in scientific discovery via clinical trials, beyond the geographic borders of the United States. Recent reports confirm the promise of medical affairs outsourcing. The outlook of medical affairs outsourcing outlook was dampened by the pandemic, true of global depressions in virtually every sphere of activity. The pre-pandemic forecasts indicated an estimated $1.41 billion in 2019, and with optimism then, while anticipated growth was $3.28 billion by 2027 (Insight Partners, 2023). The setbacks that the virus thrust upon humanity are now behind us, and if anything, the growth of certain overseas markets, especially India is immense, imminent, and already happening!
In this article, we examine briefly and cite the success of real-world examples in using our personal experiences in Clinical and Legal/Regulatory expertise to develop relationships to facilitate biomedical research overseas. The aspirations of Medical Science and Affairs Laison ultimately are to win successful engagement with clients, culminating in contracts and the successful adoption of the recommended products and services by Thought Leaders and Key Influencers, other leaders, and administrators of medical institutions. We are able to report, that our team of legal experts and strategic MSLs were able to achieve breakthroughs with medical institutions in the form of drawing up and receiving contracts, to be executed by CROs, to undertake biomedical research studies for US and international clients.
Upon analytical reflection, we found that the reassurance and strategic guidance offered based on the clinical, operational, regulatory, and legal experience to key decision makers internationally to this end, was critical in providing medical institutions, with an innate understanding of the risks and rewards associated across ethical, legal, regulatory, clinical, and overall operational dimensions. The multidisciplinary consultative approaches were instrumental in receiving the ‘go ahead’, for the drafting and signing of Memoranda of Understandings and Agreements and therefore to ‘bag’ contracts, which could spell new opportunities in scientific discovery. From the success, it caused us to pause and introspectively assess and possibly propose an expansion of the Medical Science Liaison and Affairs function, to envision one of the multidisciplinary teams to achieve the strategic objectives of revenue generation, while simultaneously contributing to scientific research discovery and innovation.
The classic interpretation of the Medical Science Liaison professional function is one of specific relationship building by certain experts with advanced scientific education and training in the life sciences, in a role within the pharmaceutical, biotechnology, medical device, CRO, and other healthcare industries, as defined in the MSL journal. The scope of the role traditionally, and as defined, implies post-discovery and marketing thereafter. However, in reality, the engagement of clinical, strategic, regulatory, and other personnel often commences much earlier in the drug/device development life-cycle and even during the negotiations by CRO, or in institution/sponsor negotiations to undertake research studies, and more. Therefore, our conclusion is that there is a place for MSLs, albeit with more multidisciplinary skills rather than purely clinical specialists, in collaborative endeavors of engagement with physicians, institutions, researchers, and those involved in the art and science of discovery, through the spectrum of research, including in post-marketing studies, surveillance, and other activities.
In the context of the foray internationally, and the lessons that apply universally, the traditional role needs to be revisited, for the sponsors of trials must contend with regulatory, legal, cultural, linguistic, and other skills that the offshore destination for the trials would make it incumbent upon MSL’s to display in individual and team attributes. The desirable knowledge, skills, and competencies of MSLs are perhaps difficult to narrow down to a few specific skill sets and attributes, such that human research experts are keen to discern the true attributes of the MSL, in the design of performance metrics for their annual and other reviews. Research has led to the creation of evaluation frameworks to measure performance, from human resource optimization perspectives. There are various models of MSL to use fair standards of performance assessment to establish best practices to provide MSL performance assessment frameworks based on products’ lifecycles, as well as a “consensus” model (Navigating Medical Science Liaisons (MSL) Performance Reviews 2023).
Our analysis furthermore uncovered reticence and some wariness of sponsors and institutions to express concerns, however also their tremendous appreciation for the unique legal and regulatory insights we offered, in this emerging leading research destination. The MSL, strategic and legal experiences, and vast global insights helped to acknowledge and offset the concerns of those targeted, with suitable regulatory, ethical, operational, data collection analytical, and other guidance. The plethora of hurdles, regulatory obstacles, protracted efforts in the global harmonization of regulatory standards and studies by the internationalization of agencies, and the judicial rulings from lawsuits, including those involving generic manufacturers, lent credence to the old adage, it’s better to be ‘safe than sorry’. Decision makers and regulatory authorities review information and proposals meticulously in respect of their own capabilities and healthcare standards, therefore a multiplicity of factors must be carefully compiled and artfully presented.
In efforts, our presentations to the institutions and thought leaders have entailed significant efforts in understanding many unique complexities. A breadth of strategic experiences was vital in making pitches to sponsors, institutions, and others, and served as invaluable to that end, with ongoing positive results and indicated the imperatives for success as strategic MSLs. The multidimensions of the business is reflected in the concerns: This is a “critical time where the pharmaceutical and biotechnology industry faces increased scrutiny and demand for transparency due to previous lawsuits and litigations”, as seen in offerings in the design of “user-friendly and comprehensive platform offers healthcare professionals the ability to file a complaint about suspicious pharmaceutical industry activity” to prevent risks associated with ethics, and interactions with healthcare professionals (ACMA, 2023).
Lastly, we found that our credibility in legal circles, as academicians, and excellent international reputation helped in establishing relationships across the board, with government, industry, and institutions in India. For instance, in India, we are also dedicated to continuing to engage in providing outstanding caring initiatives for humanity. We do this in efforts around the world, to make a positive difference in society, as we strive to serve the underprivileged, poor, underserved, needy and those seeking hope and a better future, through initiatives in education, healthcare, biomedical research, and legal services and aid, while engaging in social philanthropy and protection of human and all civil rights! Arguably, an MSL role model should be considered to be one that is dynamic, agile, collaborative, and multidisciplinary, and as an individual and team effort. Of course, broad generalizations are never apt, but the general principles presented by us may contribute to some knowledge pertinent to the acquisition and retention of customers across the continuum of global biomedical discovery, marketing, and business procurement.
Medical Affairs Outsourcing Market Size to Reach $3.28 Billion, Globally, by 2027 at 11.2% CAGR with Medical Science Liaisons Segment Driving Growth During 2020-2027 | Report by The Insight Partners. (2023, July 19). Plus Company Updates
Navigating Medical Science Liaisons (MSL) Performance Reviews 2023: Comprehensive Study Offers Insights and Strategies. (2023, July 24). Plus Company Updates, NA. https://link.gale.com/apps/doc/A758878370/ITBC?u=uphoenix&sid=ebsco&xid=82931389
New Web Platform Launched by the ACMA to Empower Healthcare Providers in Reporting Unethical Practices by Pharma Reps and Medical Science Liaisons. (2023, April 12). Plus Company Updates.
About the author:
Lionel de Souza, LL.B. LL.M. MBA. MACPR. PhD.
Dr. de Souza is the VP of UniversityGoGlobal an organization that creates Worlds of Opportunities in biomedical research, and is engaged in creating new opportunities globally for pharmaceutical/device companies, CROs, and other entities in the biomedical research landscape (www.intellectualaspirations.com), with one goal of expanding the frontiers and boundaries of knowledge and innovation globally! His substantive experience as an MSL is with experience in marketing to hospitals, universities, and medical practitioners in the United States, Canada, and India. He leads global strategic operations spanning international trade, and regulatory affairs, is engaged in the development of biomedical research, regulatory affairs/law, and education worldwide. Dr. de Souza is also the VP of Global Caring for Humanity and the President, of North America of Humansky Association (approved by the Government of India, Corporate Affairs), an organization committed to the protection of Humans and the inalienable rights of Life, Liberty and the pursuit of Happiness. In the course of his distinguished academic and professional career, Dr. de Souza has been at the forefront in upholding human rights and advancing the cause of Diversity, Equity, and Inclusion (DEI). Dr. de Souza has an outstanding record in helping African Americans, Asians, Africans, US citizens, and minorities of all ethnicities and nationalities, academically and professionally. Immersed with passion in global higher education development. He is actively involved in advancing the healthcare and educational needs of deserving populations worldwide.
Dr. S.M. Rajan
Dr. S.M. Rajan is one of the foremost Constitutional law experts in India. A distinguished academician and heading a leading law institution, he is also the President of USWorldLaw & InWorldLaw, which are law firms offering legal services to domestic and international clients, and Global Caring for Humanity. His expertise is valuable in facilitating projects of Scientific and Biomedical/Clinical Research and Discovery from the USA to India, using his vast and unparalleled knowledge of Indian Law, Legal/Regulatory laws, and compliance to Indian pharmaceutical and device regulations, with the understanding of US Food and Drug Administration (USFDA), European, and Global Standards in drug/development, patient rights, industry trends and marketplace dynamics of the healthcare field.