Developing a Sustainable Medical Affairs Department in Regenerative Medicine

The MSL Society’s recent issue, March 2021, was focused on diversity and inclusion (D&I). For my sustainability and corporate social responsibility course in Spring 2020, I pondered on some of these sustainability, diversity, and inclusion issues within the medical science liaison and medical affairs career. The course was taught by Dr. Reynold Byers, a supply chain management professor at the WP Carey School of Business at Arizona State University, where I recently completed my MBA degree. Professor Byers taught me that sustainability is about the triple bottom line: people, planet, and profit (PPP). He stressed the dynamism and uncertainty that comes with the discourse of sustainability. His syllabus mentions the opportunity to innovate in this space, develop or use new technologies, leverage new markets, and build new markets and new business processes for the better. The focus of the course was on profitability, increasing a firm’s sustainability, and social responsibility. We addressed several topics, had case discussions, guest speakers, and developed both group and individual reports during the course. For my projects, I wrote about sustainability issues for medical science liaisons and medical affairs within the context of my six years of experience in medical affairs and medical science liaison within the regenerative medicine and orthobiologics space.

Medical Affairs (MA) departments are responsible for generating and interpreting real-world clinical data to meet the needs of internal and external stakeholders. These departments are composed of scientifically, and medically trained professionals, including medical doctors, pharmacists, and Ph.D. trained scientists. Ultimately, the goal of medical affairs is to positively impact patient outcomes by ensuring the safe and efficacious use of products based on evidence-based medicine. Internally, the MA departments partner with other internal scientific and commercial colleagues across the product life-cycle to inform scientific and clinical studies, product development, marketing, and, ultimately, corporate strategy. Externally, MA interfaces with multiple stakeholders through peer-to-peer professional interactions with health care providers, payers, and other decision-makers in the health care ecosystem. These interactions include medical information and education, congress, advisory boards, publications, collaborations, investigator-initiated research, therapeutic insights, and other modalities which generate, communicate, and disseminate information. These activities are conducted throughout the life cycle of products. Traditionally MA departments function as cost centers.

Consequently, MA does not generate a profit or income for the company but is considered more of an overhead. They provide service to the company internally and as well as to external stakeholders. For compliance reasons, medical affairs activities, and performance of their field medical personnel, the Medical Science Liaisons (MSLs) cannot be tied to sales metrics. The financial priorities of MA are to track and contain costs but are not typically concerned with revenue generation. The advantages of cost centers include management efficiency, loss prevention, cost containment, and keeping to the budget. However, being a cost center makes it more challenging to demonstrate value to the organization. The need for MA is increasing amidst an evolving healthcare landscape, rising complexity of data, competition, globalization, and a call for more value-based and clinical outcome-based reimbursement models in health care. Furthermore, regulatory and compliance challenges are becoming stricter. There is also a need for more transparency, more governance, treatment protocols, and guidelines.1 Leaders in MA and MA societies are continuously producing tools to address the ever-changing landscape. In summary, these are the challenges and opportunities for Medical Affairs departments:

MA is traditionally a cost center and struggles to show value.
There is an increasingly complex healthcare landscape, and MA needs to increase its capabilities to meet evolving demands.
The world is changing, and there is an opportunity for MA to step up to join the challenge of actively contributing to a sustainable world.
MA departments are composed of highly qualified scientists and medical professionals capable of increasing service offerings to internal and external stakeholders for service excellence.
There are unique challenges for Regenerative Medicine.

Proposed Solution

It is proposed that for more sustainable MA departments, the traditional business model as a cost center can be converted into a profit center. This can be achieved by fostering more external collaborations, leading to cost-sharing, and generating revenue through grants and contracts. Also, integrating artificial intelligence into operations and data analysis may increase efficiencies and lead to product creation. Four solutions for sustainability are listed below and further described.

Develop sustainable Medical Affairs departments by:

The transition from a cost center to a profit center through more strategic external collaborations and funding mechanisms.
Integrate artificial intelligence into medical affairs operations and activities.
Develop new reimbursement models for regenerative medicine as a curative therapy,
Pursue opportunities for unmet medical needs in health disparities and global health as part of corporate social responsibility and reduce financial impact through synchronicities and cost-sharing with priority agenda.

Fostering Sustainable Medial Affairs Departments

This figure illustrates how all these solutions may fit together as activities and synergies in a MA department.

(a) Medical affairs transition from a cost center to a profit center through more strategic external collaborations and funding mechanisms

Cost centers are considered overhead departments that cost organizations money to operate but do not contribute directly to the company’s profitability. One activity of MA is Investigator-Initiated Studies (IIS). In this activity, funds or products are awarded through a grant process to external health care providers or scientists to conduct research that is of strategic interest to the awarding company to generate data. The company may assist the external investigators with the administrative aspects of the IIS grant application process but have no input on the study design or research itself. The data and analysis are the property of the external investigator. This activity is a component of the medical affairs budget and is a cost. An alternative approach is to conduct research and fill data gaps in knowledge through collaborations. In collaboration, the clinical and scientific goals are achieved with external stakeholders towards a joint objective without the company funding the investigator. Research collaborations are seen more commonly in other departments, such as in research and development centers.

Furthermore, MA departments could jointly pursue external funding mechanisms through a private foundation, government grants, and contracts with academic institutions. These types of activities are already part of MA departments. However, developing more of these activities may be beneficial, especially within the context of the emerging importance of real-world evidence generation.

(b) Integrate artificial intelligence into medical affairs operations and activities

The artificial intelligence (AI) market size is expected to reach 390 billion by 2025. Artificial intelligence is currently used for multiple applications, including patient engagement, adherence, diagnosis, and treatment recommendations. The role of MA centers on data generation and dissemination. They are positioned to become an avid user in its traditional role in the services to internal and external stakeholders and produce new products that can be leveraged towards MA transition from a cost to a profit center. There are also several tools already available in the market for Medical affairs. For example, MarkBio, Inc. is a leading AI solution provider for global medical affairs. Their leadership, Mike Abbadessa, PharmD, and Jason Smith, published an article entitled “Improving Digital Technology Implementation in Medical Affairs” in the March 2021 issue of the MSL society journal. The report highlights the need for data analytics, AI, and machine learning in external healthcare spaces like hospitals and MA departments. Digital health solutions such as electronic health records serve to improve patient care by providing more access and reducing data errors and omissions. In medical affairs, AI and data analytics can generate more meaningful insights and relationships from primary text-based information such as journal articles and conference abstracts. In the same issue of the MSL society journal, Sabita Sankar, Ph.D., and Lana Feng, Ph.D., reported a survey about leveraging data by MSLs for personalized engagements. The report mentioned that even though MSLs are open to adopting new AI and data analytics solutions, the challenges for adoption identified by MSL leadership are budget constraints.

The goal of RM is to address the root cause of the disease or disorder. Regenerative medicine has the potential to reverse and cure chronic conditions such as sickle cell disease, diabetes, heart failure, Parkinson’s, spinal cord injury, osteoarthritis, and many others. Some of these therapies in development are expected to offer single administration, which will be curative. As a result, these therapies may have substantial economic, quality of life, and productivity gains for the patients and the health care systems that take care of them. It is projected that the RM market will reach 38.7 billion by 2024 at a CAGR of 23.8%. According to the most recent report by the Alliance for Regenerative Medicine (ARM), there are over 900 RM companies worldwide, 1066 ongoing clinical trials. Furthermore, to date, 52 therapies have obtained the Regenerative Medicine Advanced Therapy (RMAT) designation. The growth in RM is attributable to the introduction of the 21st Century Cures Act by the FDA, the development of CAR-T cell therapies, and increasing demand in several fields, including orthopedics and chronic wounds.

Reimbursement is a challenge, especially for those classified as RMAT. There are various reasons for these challenges, including; (1) RMATs can offer onetime durable curative treatment that is extremely costly to manufacture. For example, when administering Kymriah (Novartis), a curative treatment for non-Hodgkin Lymphoma can exceed $1.5 million, including the cost of the drug ($475,000) administration and other costs of care. (2) The durability of these treatments has not yet been fully delineated by long-term outcomes studies. (3) These therapies do not fit into existing coding and payment systems. (4) The current health economics approaches, including cost-effectiveness, budget impact analysis, health insurance actuarial modeling, etc., use precise estimates of the cost and benefits of treatments that currently do not exist for regenerative therapies. A study reported that only 10% of US health plans had updated their policies to prepare for emerging regenerative therapies.2 On the other hand, 85% of US health plans have taken no steps, nor have they thought about how reimbursement for regenerative and advanced therapies will be addressed.2 For RMAT to gain extensive use and adoption, product value demonstration, new payment models, and reimbursements mechanisms are imperative. The size and duration of the effect of the RMAT need to be demonstrated by pivotal clinical trials. It is expected that post-marketing studies will also impact reimbursement as with precision medicine, which can predict patient response and tailor therapies specific to their genotypes and phenotypes. Furthermore, enrolling patients in registries may be increasingly important to monitor the magnitude and duration of therapeutic effect and safety and adverse events over long periods. The requirements are eminent for access and sustainability, and it will need to be a joint effort between corporations, governments, payors, and advocacy groups.3 In Europe, several models have been suggested for reimbursement, including standard upfront payment, standard upfront payment with 10% discount, pay for performance, and easing arrangement where payment is made month to month if the patient survives. 2

(d) Pursue opportunities for unmet medical needs in health disparities and global health as part of corporate social responsibility and reduce financial impact through synchronicity cost-sharing with priority agendas

Global health is the study of health issues that transcend national borders to reduce disparities, protecting against global threats, and achieve health equity for all people worldwide.4 The current COVID-19 pandemic, associated loss of life, and economic shutdown show that society is not optimally prepared for this level of a natural disaster. Ethnic and racial health disparities are defined as the differences in the burden of disease, injury, death, and disability based on ethnicity and race.6,7 Minority populations, including African Americans in the US, share a disproportionate disease burden and health outcomes in the leading causes of cardiovascular disease, stroke, cancer, and diabetes. The recent COVID-19 pandemic also highlights health disparities. Black people are dying at nearly two times higher than their population share. The data indicate that although blacks account for 13% of the population, the death rate is 24%, where race is known https://COVID-tracking.com/race.

While an avid area of research in public health, addressing health disparities is not typically included in the strategic plans of biotechnology and pharmaceutical companies. I do not know why not, but it may be because of limited market size or a lack of awareness that these disparities in outcomes exist. However, MA is uniquely positioned to contribute to this arena because of existing relationships with external stakeholders in academic institutions. The MSL society journal March 2021 issue on diversity and inclusion had several articles about initiatives in health disparities and global health led by MSLs and medical affairs teams. For example, Carney et al. reported on the health equity initiative led by field medical science liaisons at Taiho Oncology. Their paper highlighted the disparity in the oncology workforce, with only 2% of the oncology physician workforce who are black or African American and 3% Hispanic or Latino. Taiho Oncology Inc. launched its Taiho Cares- Diversity Breeds Innovation Initiative in 2020. This initiative responded to the need to address diversity and health equity set forth by the American Society of Clinical Oncology® (ASCO) Strategic Plan for Increasing Racial and Ethnic Diversity in the Oncology Workforce. Their initiative partners with academia, focusing on historically black colleges and universities to increase the exposure of diverse students to oncology careers. Some examples of their programs include complimentary conference registration projects to increase students’ exposure to oncology by the opportunity to attend a medical conference. In addition, they provided opportunities for networking and education around industry careers, including providing opportunities for resume review and interview skills. This article encourages MSLs to, regardless of whether they are in small teams, take initiatives for health equity.

Conclusion

Overall, this article highlights some opportunities for sustainability, diversity, and inclusion from medical affairs departments of regenerative medicine companies. My recommendations were to increase collaborations and potentially shift medical affairs to a profit center as a result of revenue generation from academic collaborations. Second, integrate AI into medical affairs departments. Thirdly, develop new reimbursement models for regenerative medicine to facilitate access. Lastly, pursue opportunities for unmet medical needs in health disparities and global health as part of corporate social responsibility and to reduce financial impact through synchronicities and cost-sharing with priority agenda. These recommendations are provided from a perspective of an MBA student who has five years of experience as a field medical science liaison and a year of experience as an internal medical affairs associate. Many of these recommendations are in sync with efforts and strategies already underway in practice. Leaders in the field documented several of these initiatives in the March 2021 issues of the MSL society journal. The MSL Society is launching a new diversity and inclusion initiative for collaboration on strategies to optimize and enhance diversity and inclusion. Hence more opportunities and dialogue will emerge for MSLs to develop and participate in these initiatives within their careers and the companies they work for.

References

Abbadessa, M. & Smith, J., Title: Improving Digital Technology Implementation in Medical Affairs (2021). https://themsljournal.com/article/title-improving-digital-technology-implementation-in-medical-affairs/
Spinner, D. S., Ringo, M. & Faulkner, E. Reimbursement and Payment Models for Therapies With Transformative and Curative Intent. Second Generation Cell and Gene-based Therapies (2020). doi:10.1016/b978-0-12-812034-7.00027-3.
Cook, F., Slocomb, T. & Werner, M. Regenerative Medicine Is Here: New Payment Models Key To Patient Access. In Vivo (Brooklyn). (2018).
Hinchman, A. et al. Global health is local health: A multidisciplinary perspective of COVID-19. Ochsner J. 20, 123–133 (2020).
Golchin, A., Seyedjafari, E. & Ardeshirylajimi, A. Mesenchymal Stem Cell Therapy for COVID-19: Present or Future. Stem Cell Rev. Reports 16, 427–433 (2020).
CDC. Coronavirus Disease 2019 (COVID-19). Racial and Ethnic Minority Groups. Coronavirus Dis. 2019 2019, 5 (2020).
Cook, S., Answers, F., El-shamaa, M. & Answers, M. P. H. F. Reducing Health and Health Care Disparities : Implementation Lessons and Best Practices for Health Care Organizations. 1–17 (2015).

Author:

Eyitayo S. Fakunle, PhD, MPH, MBA

I have six years of experience in medical affairs and medical science liaison. I have been living in Arizona since 2015. My Therapeutic areas of experience are; cell therapy and regenerative medicine, stem cells, orthopedics, and cartilage repair. My dynamism is enabled by an undergraduate degree in chemical engineering, an interdisciplinary doctoral degree in cell and molecular biology, a master’s in public health, and postdoctoral training in bioengineering & regenerative medicine. Overall, in the last 15 years after obtaining my Ph.D. in 2006 from the University of Arkansas, I have gained experience in regenerative medicine spanning scientific research, public health, medical affairs & medical science liaison. I have a proven history of building relationships with thought leaders, clinical investigators, health care professionals, and academic centers through the provision of scientific information and disease state education. I graduated on May 3rd, 2021 with my Masters of Business Administration Degree from the WP Carey School of Business, Arizona State University, Professional Flex MBA Program, and completed the Executive MBA Health Care Electives available to cross-platform MBA students. I am a Senior Medical Science Liaison at COVIS. In the spirit of diversity and inclusion, I am spending my free time developing a sustainable social venture, “I am Pluripotent” providing after-school STEM programs to foster curiosity and learning and to prepare girls and diverse youth for future careers in STEM.