Real World Evidence: The Role of Medical Affairs

How well has RWE integrated into Medical Affairs—and should more be done?

Payers and other stakeholders increasingly expect to see real world evidence (RWE) to support their decision making. Since being added to the medical affairs remit, RWE has taken hold and is actively proving its worth within pharma. Used in R&D, regulatory decision-making, pricing, reimbursement and clinical decision-making—the demands on RWE are growing by the day. But as this complex area becomes ever more sophisticated, how well are medical affairs departments coping with their newest addition? How is RWE evolving? And is your team structured in the best way to get the most from the opportunities resulting from RWE?

We spoke to 7 senior medical affairs and RWE experts at the forefront of this complex discipline. Find out what they said, in their own words, on all the key issues.

Use this report to:

• Assess the current position: What are the key trends in RWE? How are others approaching data generation and analysis? What is the impact of RWE on medical affairs so far?
• Understand how best to move forward: What part should medical affairs play in the design of real world studies? How should RWE be presented? What are the critical success factors?
• Prepare for the challenges ahead: What do stakeholders want to see? Where should investment (in people and in evidence generation) be focused? How should patient privacy be addressed?
• Gain insight into team structures and RWE integration: What key skills are needed from medical affairs and RWE specialists? Is there a training gap to be filled? How and when should medical affairs professionals disseminate RWE to external stakeholders?

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What to expect from this report

The RWE team may have begun as an 'add-on' to medical affairs in response to the big data revolution but its role and importance has grown significantly. Reams of data are now transformed into powerful insight that drives decision-making. And as RWE is now embedded into medical affairs activities, its influence and impact is increasing.

Real World Evidence: The Role of Medical Affairs reveals how this crucial specialist area is evolving and how its natural 'home' within the medical affairs team also needs to move forward.

What did we do?

• We identified 8 current RWE issues from a medical affairs perspective
• We explored these via secondary research plus 22 targeted questions put to 7 US and EU medical affairs experts with up-to-date experience
• We used all of this to identify 48 unique new insights
• Insights are supported by 47 directly quoted comments and 24 source references

Example insight included in Real World Evidence: The Role of Medical Affairs

"Experts emphasise the importance of having a cross-functional team that includes medical affairs to agree the RWE strategy and implementation. Medical affairs can help to design studies that will answer the most appropriate questions. For example, medical affairs may be able to suggest outcomes such as different aspects of utilisation or inclusion of a broader patient population that would not otherwise have been considered. Key insights from medical science liaisons can also be incorporated into study design so that the outcomes can be shared with physicians who had specific questions."

Example quote included in Real World Evidence: The Role of Medical Affairs

"The issue that we have here is that a traditional medical affairs workforce hasn't really worked on or had that kind of an intellectual or technical expertise in real-world evidence. Real-world evidence has evolved within different scientific disciplines: mostly drug epidemiology, observational research, health economics and outcomes research, and patient-centred research. It's a conglomeration of different interrelated scientific disciplines which, from a legacy standpoint, weren't traditionally present in medical affairs. The assumption was that you invest in real-world evidence, you create a separate function, you have it report to medical affairs and the job's done. That's not how it works; real-world evidence has to be fully integrated with the medical strategy."

The expert panel for Real World Evidence: The Role of Medical Affairs

• Usman Iqbal, a medical executive with a portfolio career entailing 15 years of diverse experience spanning R&D, medical affairs and end-to-end evidence and value development, across both large and small cap biopharmaceuticals.
• Charles White, PhD, MD, Senior Medical Scientist and Founder of MedSci Solutions LLC, US. He has served at various levels in medical affairs organisations, from independent consultant, to MSL, to medical director.
• Emma Harvey, Global head of medical affairs at F2G Ltd, a UK biotech, as well as a medical affairs consultant with expertise in rare diseases, specialised medicines and infectious diseases. Formerly Senior Medical Director at Alexion Pharma, UK.
• Lead Medical Director, Top 10 Pharma Company, US
• Senior Medical Director, Global Medical Affairs, biopharmaceutical company, US
• Global Medical Affairs Director, Top 10 Pharma Company, Europe
• Regional Head of Medical Affairs, Top 10 Pharma Company, Europe

Why buy now?

Generating robust, meaningful and scientifically sound RWE is now imperative for every pharma company. Whether to demonstrate to payers that their expectations of new drugs are met, to prove the case for biosimilars, or to increase the market share of existing drugs by highlighting competitive advantage: the benefits of getting RWE right are many. This report shows how RWE capabilities within medical affairs can live up to its promise, but only when both skill sets are working in tandem and are fully integrated.

Find out how to make that happen in your organisation.

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