Collaboration between Medical Affairs and Clinical Development – A Business Perspective : Time to Rethink Our Approach ?

Medical Affairs and Clinical Development are considered as important pillars for pharmaceutical companies’ sustainability and growth. Before jumping on how collaboration occurs or can occur between these two pillars, its important to understand collaboration in terms of business perspective.

In recent times, for both Medical Affairs and Clinical Development, the roles and responsibilities have been segregated compared to old school times where a single individual had to perform both functions. In general, Clinical Development is responsible for the research and development of new drugs and medical devices, while Medical Affairs are held responsible for the post-approval medical and scientific support of these products. The common goal for these two essential functions is to ensure the safety and efficacy of drugs or medical devices.

Medical Affairs involve responsibilities of conducting advisory board meetings, international speaker programs (ISP’s), training the field force, product launch, support to business development teams, handling queries on post launch and continued interaction with KOL’s for scientific engagement. On the other side, Clinical Development roles are associated with making a clinical strategy for the products in pipeline, designing clinical studies, analyzing safety & efficacy trends, handle regulatory and ethics committee queries, trainings, and support to pharmacovigilance activities.

The collaboration between Clinical Development and Medical Affairs should start early in the drug development process. 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 well equipped to take a comprehensive approach in understanding of disease states and setting a potential standard for novel drug development programs keeping in mind both clinical and commercial metrics. Understanding disease metrics and running effective signal-finding studies leverage drug development with an objective for strategic pipeline decision-making and further allowing R&D teams to focus efforts on core development competencies.

Also Medical affairs team can provide clinical development team with meaningful insights from healthcare providers, payers, and patients on unmet medical needs, clinical trial design, and endpoints. This information is crucial in developing clinical trial protocols keeping in mind patient centricity and drug/medical device impact on patient reported outcomes. This help address the unmet need of patients and healthcare providers along with satisfaction of regulatory requirements.

As clinical development progresses, medical affairs should continue to provide support by engagement with different stakeholders as listed above also in terms of safety and effectiveness data arising out of Real-World Evidence (RWE) studies or Investigator Initiated studies (IIS), typically the Phase 4 studies.

Once the drug is approved, medical affairs take the lead in providing medical and scientific support to Key Opinion Leaders (KOL’s). Medical Affairs ensures that healthcare providers have access to the latest information about the drug, including clinical trial data and safety information. Medical affairs team also works with payers to ensure that the drug is included in national formularies and patients have access to the drug.

Increasingly, Clinical Development team are looking to the expertise of Medical Affairs professionals to produce the real-world data sets which can be leveraged by different stakeholders to inform product utilization, strategic decision making 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 which covers the competitive market landscape, timeline and budget expectations, and stakeholder perspectives. This produces a data package that augments product launch and enhances commercial uptake curves.

Clinical Development should lean into Medical Affairs as the externally facing branch of R&D to seek paths toward anticipating and generating diversity safety & efficacy data to meet trial, approval, and access requirements. Along those same lines, Medical Affairs can engage closely with the patient advocacy groups 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.

The alignment in these two functions is indeed important to ensure alignment of the clinical development program with the medical and scientific needs of patients and healthcare providers. This results in seamless transition of products from clinical development to medical affairs function, ensuring products are launched effectively with fulfillment of needs of patients and healthcare providers.

In summary, collaboration between clinical development and medical affairs is critical to ensure that drugs and medical devices meet the needs of patients and healthcare providers. This collaboration should start early in the drug development process and to be continued even after the drug is approved. A strong strategic partnership between Medical Affairs and Clinical Development is needed to capitalize on synergistic strengths and drive toward a shared goal to develop, differentiate, and deliver products that impact patients outcomes.

Author:

Dr Sujay Pattil, MD

Clinical Development Professional

(Disclaimer: The views and opinions expressed in this document/session are those of the authors and do not necessarily reflect the official policy or position of the company they work for)