Not Actually Barcelona — In accordance with best COVID-19-era practices, eyeforpharma Barcelona, the highly anticipated pharmaceutical marketing event, was converted into a string of probing virtual panels. With earbuds dangling, leaders dialed in from all over the globe to share their expertise with one another and listeners on Zoom. One panel, “Conduct Your Evidence Symphony,” convened medical affairs experts from a spread of pharma organizations. Michael Axelson, Head of Clinical Research at Tempus, a precision medicine company based in Chicago, moderated the panel, which explored how different companies were responding to the expectation that medical affairs “move to the left,” or become more integrated into the work of R&D and clinical.
Nico Andre, Head of Medical Affairs at Roche, emphasized that we are not talking about small moves to the left—rather, medical affairs is moving so far left that it’s actually moving beyond the product itself. “If you stay within the product silo, you may end up creating something that doesn’t create value at the point of care or in commercialization,” he explained. “We have to think much more holistically and not just within the conventional lifecycle of one product.” He acknowledged one big challenge: the entire industry has been set up the same way for a long time. But medical affairs, he said, can be a “wonderful catalyst to help the bigger organization come together and join forces.”
Charlotte Kremer, Head of Medical Affairs at Japan’s Astellas Pharma, highlighted the main goal of moving medical to the left: ensuring that data is satisfying to payers, patients, HCPs, and other stakeholders. But, she pointed out, it’s not about one-off evidence generation; rather, organizations should strive to create an evidence “continuum,” through which an organization can obtain the endpoints needed, when they’re needed, without interfering too much with the progress of a study.
This potential for “interference” actually speaks to much of the industry’s hangup about medical’s evolving remit. “There’s a concern at some companies that when MA goes too far to the left, the operating model becomes very complex,” said Michael Seewald, VP of Global Evidence at AstraZeneca. “People may be confused as to who’s doing what. So it’s really interesting to work out what is being brought to the table by each respective team. R&D is conventionally hyper-focused on product, but MA can bring so much in terms of ‘disease context,’ especially in the form of RWE from all over the world, that can greatly inform R&D efforts.”
Integrating medical affairs into clinical development can shine a light on the patient perspective, unmet medical needs, and current gaps in patient treatment. To that end, Ferring Pharmaceuticals recently appointed a Chief Patient Officer. On the panel, Ferring Chief Medical Officer Klaus Dugi explained that this is someone with both a medical affairs and R&D background, enabling them to answer some critical questions, like, “What are the patient-relevant endpoints?” and “What are the patient-reported outcomes that we want to include?” Dugi pointed out that through patient ad boards, Ferring has obtained whole new perspectives on drugs in its pipeline. “[Patients] are already pretty informed through the internet, and that’s only going to grow,” he said. “They can have totally different perspectives than HCPs. I think we need to tailor our development more to the patients and not just to physicians and regulators.”
The moderator posed a timely question: how do you think about patient voice when it comes to approvals for brand-new, paradigm-shifting treatments, like cell and gene therapies?
As a starting point, Dugi highlighted the importance of “tailored communication.” A brand must think about how to demonstrate that its product has value for the payer as well as for the patient—and back up the claim with the right evidence. It’s also important to consider how to convey a product’s unique value proposition to other stakeholders, like a science journalist. “You have to speak the right language to the right audience.”
Seewald made a similar point, saying that, “Value has now reached medical affairs, whereas it typically sat with our access colleagues. You might think that because something is efficacious that it will get through approval breezily”—but we have seen even with some highly efficacious new gene therapies that that is not the case. “You’ve got to be prepared with data to ease payers and other stakeholders through these new challenges,” and this is a way in which medical affairs can partner with market access fruitfully.
Some of these new therapies actually call for novel metrics. Accordingly, Andre said it’s key to “influence the policy areas that drive outcomes definition and perception beyond the conventional outcome metrics,” which are typically limited to morbidity or mortality. “Regulators are really open to understanding how they can introduce the promise of these therapies to patients in a way that is sustainable for society.”
Historically, development programs, siloed away from medical affairs, often fail to meet patient needs and address clinical realities. So, how can a pharma brand avoid falling into this trap? Says Andre: “Bring patients in as standard contributors, co-creators, in areas where usually the scientists and developers…usually want to be left alone.”