Reinforcing a Medical Affairs and Clinical Development Partnership Model

As part of our series covering the future of Medical Affairs, we’ve discussed how the healthcare landscape has shifted in such a way that Medical Affairs is now a critical function in optimizing the trajectory of product launch and traversing market complexities (“Advancing Medical Affairs to be a Value-Based Strategic Partner,”  April 2022). Relatedly, we have seen a change in Clinical Operations in response to those same market pressures that has heralded an expansion in the role of Medical Affairs to include greater and closer involvement in the clinical development process. This evolution necessitates a strong strategic partnership between Medical Affairs and Clinical organizations in order to capitalize on synergistic strengths and drive toward a shared goal to develop, differentiate, and deliver products that improve patients’ lives.

Clinical development programs are increasingly challenged to navigate competing pressures in a complex regulatory environment. Intense competition across the product development and commercialization lifecycle pushes life sciences organizations to accelerate development timelines while also asking them to meet new organizational and approval expectations, including: the requirement for additional requisite evidence beyond traditional clinical data (e.g., real-world utilization); the mandate for diverse patient representation in clinical trials; a renewed focus on patient centricity; the recent shift towards remote trial monitoring; and budget and resourcing constraints. These pressures have encouraged life sciences companies to turn to Medical Affairs to help achieve traditional clinical development goals.

How Can Medical Affairs Augment Traditional Clinical Development?

Today, decision-making stakeholders—such as regulatory bodies, payers, providers, patients, caregivers, and patient advocacy groups—are seeking commercially viable evidence that is outside the remit of traditional regulatory and clinical efficacy data. Not only is it expensive to produce this data (e.g., peri-approval studies, real-world data analysis, health economics and outcomes research, non-registrational trials) through a clinical development program, but the complexities tied to cataloging and benchmarking against additional endpoints and running real-world utilization assessments could risk disrupting clinical operations and negatively impacting trial completion and approval timelines.

Increasingly, Clinical organizations are looking to the expertise of Medical Affairs to produce the critical data sets that are leveraged by payers, patients, and providers to inform product utilization and coverage decisions. It is important that these activities are conducted not only in parallel with, but also in partnership with, ongoing clinical trial programs. Cohesive collaboration early in the product development lifecycle means that Clinical and Medical Affairs teams can work together to develop an Integrated Evidence Generation (IEG) Strategy that considers the competitive market landscape, timeline and budget expectations, and stakeholder perspectives and requirements to produce a data package that augments product launch and enhances commercial uptake curves.

Additionally, Medical Affairs can work in close partnership with Clinical Development teams to streamline the development prioritization process by assuming responsibility for early phase signal-finding studies. Medical Affairs teams are equipped to take a comprehensive approach to understanding disease states and benchmarking potential novel development programs against both clinical and commercial metrics. They can work in partnership with Clinical Development to make the case around pursuing new disease states and running signal-finding studies to feed into strategic pipeline decision-making, which allows R&D teams to focus efforts on core development competencies.

Renewed Focus on Engagement Is Critical to Development Success

In addition to accelerating the path to product approval, Clinical Development programs must find new ways to engage both with external stakeholders and investigators to ensure successful trial execution.

The Food & Drug Administration (FDA) continues to move toward mandates that encourage and advance health equity in the United States through diverse participation in clinical trials. It is often the case that people from different ages, races, and ethnicities display varied response rates and efficacy levels to medical products. While these mandates currently apply to clinical trials, it is likely that decision-making bodies will begin requiring similar diversity and representation related data for product approval and access pathways. As such, life sciences companies are looking for ways to engage at a deeper level with the communities using their products, as well as ways to generate diversity data outside of the traditional trial setting.

A core tenet of the Medical Affairs remit is to engage and build relationships with the stakeholder community, and especially patients, caregivers, and patient advocacy groups (Figure 1). Clinical Development should lean into Medical Affairs as the externally facing branch of R&D to seek paths toward anticipating and generating diversity data to meet trial, approval, and access requirements. Along those same lines, Medical Affairs can engage closely with the patient advocacy community to better understand motivations for trial participation and enrollment. Not only do those relationships help to accelerate enrollment, but they also ensure that the patient voice is represented continuously throughout the product lifecycle, making sure that clinical development is founded on the principles of patient centricity.

Separately, principal investigator engagement levels have dropped precipitously as the role of the Clinical Research Associate (CRA) has shifted away from site management and towards virtual data monitoring in the wake of the COVID-19 pandemic. Field Medical professionals (Medical Science Liaisons/MSLs, Clinical Trial Liaisons/CTLs, etc.) have been able to step in to fill the engagement gap, supporting CRAs to drive patient retention and accelerate trial timelines through investigator and patient relationship management. This collaboration is yet another example of how a strong partnership between Clinical and Medical Affairs teams can enable more effective and efficient clinical trial operations.

In conclusion, a strengthened Clinical-Medical Affairs partnership model can help life sciences partners to face the intense pressure to accelerate product approval timelines and respond to evolving requirements for successful product commercialization. Medical Affairs brings a deliberate approach to evidence continuity throughout both Clinical development and commercialization, the insights of which can drive proactive and strategic decision-making.

Isabella Fernandez, Associate Director, Business Insights, Syneos Health, also contributed to this article.

  • Suma Ramadas, PhD

    Suma Ramadas, PhD is Executive Vice President, Medical Affairs at Syneos Health. Suma leads the creation and delivery of a comprehensive Medical Affairs solution from Syneos Health. She started her 15+ year career in industry, working in Clinical, Marketing, and Medical Affairs before coming to Syneos Health. She is passionate about women and diversity in leadership and was instrumental in creating the employee-driven groups to tackle issues and barriers in the professional landscape.

  • Colin Oliver, PhD, MBA

    Colin Oliver, PhD, MBA is Managing Director at Syneos Health. Colin is a Managing Director in the medical consulting practice at Syneos Health with more than 10 years of pharmaceutical/biotechnological experience at small, medium, and large companies. Colin has a broad range of Medical Affairs experience from working in the field as a Medical Science Liaison (MSL) to building and leading a global Medical Affairs organization.

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