Guest Column | June 3, 2024

Medical Affairs: Unlocking Insights To Drive Innovation, Access, And Value

By Shontelle Dodson, Pharm.D., executive vice president and head of medical affairs, Astellas Pharma

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Progress in healthcare innovation has been transformative in recent years. We’ve seen groundbreaking advances in precision medicine and novel therapeutics, creative new research approaches, and the rapid uptake of digital health. These advances are also ushering in a new era of medical information — with an unprecedented increase in data, medical, and disease-state knowledge, as well as complex science.

This evolving landscape, and the growing demand for value-based solutions, means medical affairs (MA) professionals are playing an increasingly dynamic, strategic role across the innovation life cycle. Our deep understanding of both medical practice and scientific research is informing and refining protocols, enhancing the feasibility of trials, accelerating clinical trial recruitment, and, ultimately, shortening the path from discovery to approval for innovative medicines that address critical patient needs.

Informing And Driving Patient-Centric Evidence Strategies

As the availability and use of information evolve, MA is taking significant steps to improve the “two-way flow” of evidence. As well as informing novel, integrated evidence-generation strategies to elevate and expedite clinical research and real-world evidence (RWE) studies, MA teams continue to evolve and improve the way healthcare professionals and other stakeholders access and navigate this evidence.

In both instances, the starting point is a strong needs assessment addressing the critical question: “How do we get patients and healthcare professionals what they need?”

Through innovative evidence-generation strategies, MA facilitates understanding of disease natural history or burden of disease at global, regional, and local levels. MA teams also play a crucial role in translating patient feedback into actionable insights for R&D teams, bridging from interactions with healthcare professionals to identify unmet needs, understand the patient journey, and incorporate patient experiences and preferences into trial design.

In clinical research, this work is helping to optimize study endpoint and data collection decisions. With their extensive medical insight and multifaceted roles — operating at the intersection of data generation and data dissemination — MA is uniquely positioned to identify endpoints that are meaningful in clinical practice and that matter to patients, while ensuring that data collection methods are accessible and realistic without imposing undue burdens on patients, their caregivers, or the healthcare system.

By elevating patient centricity at all levels of evidence generation MA is ultimately helping to enable access and deliver value-based care.

A Vital Connector Of Knowledge

Medical affairs professionals also help healthcare professionals navigate the comprehensive and complex information that accompanies innovation, so they can improve health research and deliver outcomes for patients.

Likewise, our understanding of how payers and healthcare systems value treatments is crucial. It guides us in generating relevant data to ensure treatments meet their criteria and are accessible to patients.

As RWE becomes increasingly important in ensuring the safety, efficacy, and impact of medicines throughout their life cycle, MA is also taking a more active role in post-approval studies for new treatments, focusing on patient groups not covered in initial trials. A commitment to understanding how medical interventions perform in diverse real-world conditions over the long term will contribute to ongoing improvements in patient care.

With evidence dissemination, MA continues to play a critical role educating about the safe and effective use of therapies, treatment approaches, and related disease state information. The deep knowledge and insight that MA professionals hold are key to understanding and synthesizing the information that will improve healthcare providers’ knowledge to inform treatment decisions.

Delivering On Innovation For Patients

Innovation is only meaningful if patients can access it. The rapid expansion of health information and insight has enormous potential to improve treatment decisions, but it is only useful if it reaches and benefits the intended patients and clinicians. In practice, the current rate at which new information gets adopted into the clinic lags significantly, with critical education gaps. This means many patients, and the broader health ecosystem, may not be seeing the tangible benefits of medical innovation in real time.

By optimizing integrated evidence generation and ensuring subsequent data and related medical information are accessible and useful for diverse stakeholders, MA will play a crucial role in delivering the next generation of innovative medical solutions with the potential to benefit patients worldwide.

About The Author:

From the earliest days of her career as a clinical pharmacist, Shontelle Dodson, Pharm.D., has always been driven to advocate for the patients she serves. Now, as executive vice president and head of medical affairs at Astellas, she leads a team that turns innovative science into value for patients and society for late-stage development and marketed products across all therapeutic and focus areas.

Shontelle was honored to recently contribute alongside 80 other industry leaders to the Medical Affairs Professional Society’s (MAPS) first-of-its-kind medical affairs textbook, Medical Affairs: The Roles, Value and Practice of Medical Affairs in the Biopharmaceutical and Medical Technology Industries — both a primer for aspiring and early-career MA professionals as well as a broad overview of medical affairs for those seeking to power a cross-functional medical affairs career. Order here.