For years, medical affairs was considered the function most likely to say no, whether to sharing data on off-label uses or to promoting products within scientific discussions. Fairly or not, it was tagged with the reputation as the in-house group that slowed things down by acting out of a supreme abundance of caution.
But as decision-making in healthcare has become far more evidence-driven. HCPs have made it clear that they want deeper scientific engagement around data, treatment patterns and outcomes. And that has made medical affairs, which has long played a pivotal role in forging connections between clinical evidence and the way medicine is practiced in the real world, an even more essential part of the commercial and strategic mix.
Med affairs teams spend considerable time engaging with clinicians, making them uniquely qualified to accumulate and interpret insights about emerging trends in patient care, unmet needs and more. “That perspective is especially important in therapeutic areas where treatment paradigms are evolving quickly,” says Eckhard Leifke, M.D., chief medical officer at Phathom Pharmaceuticals.
The evolution didn’t happen overnight. Over the past decade, Leifke notes, the function has shifted from “primarily supporting commercialization to helping shape the broader scientific and evidence strategy for a therapy or disease area.” Among other tasks, medical affairs teams have been charged with identifying gaps in clinical understanding and guiding evidence generation – essentially “ensuring that engagement with the medical community remains grounded in credible science,” as Leifke puts it.
That’s a role and a responsibility that medical affairs leaders embrace. Christine Clemson, SVP, global head of medical affairs at Entrada Therapeutics, first started working as a medical science liaison in 2010 and has since held medical affairs and medical director roles at Albireo Pharma and Sage Therapeutics, among other firms. She recalls that the first product upon which she worked had 50 indications on its label.
“It set up medical affairs to be super-central to the strategy of the company,” she says.
While Clemson recognizes the distinctness of that particular situation, she has long believed that medical affairs should be involved in top-flight strategy decisions – and is encouraged that many organizations seem to be moving in that direction. “Some of the things that seemed revolutionary 15 years ago are common now,” she says. “The companies looking beyond tactical execution and engaging medical affairs early are seeing results.”
But even as medical affairs groups have largely been shielded from recent staff cuts at pharma companies, there remains a sense that the function remains misunderstood, especially at larger organizations with more moving parts (and the internal maneuvering for influence that comes with them). “I don’t think everybody is there yet,” Clemson says plainly. “There’s a compliance piece that, at large companies, can restrain the role of medical affairs. The innovation is at smaller biotech companies.”
Key to the function’s surge is a shift in day-to-day responsibilities. A decade ago, the job was largely reactive in nature (for instance, responding to unsolicited requests); now, it very much calls for a proactive mindset (generating and shaping evidence early in the commercialization process). The changes have been driven by numerous factors: increasing pressure on HCPs and health systems, a rise in the volume of HCP touchpoints, evolving access considerations and AI making it possible to operationalize field insights quickly and broadly.
As Samantha Gothelf, PharmD, VP and head of U.S. medical affairs at Genmab, explains, the medical affairs function has shifted from executing against strategy to shaping it. “It acts as a strategic connector, bringing scientific insights and real-world perspectives into decisions before strategies are put in place,” she says.
At companies where medical affairs is prioritized, it influences how data are interpreted and how priorities are set organization-wide. That influence is felt early and often: It begins in early clinical development and extends through the product lifecycle.
“Because medical affairs engages closely with all our external and internal stakeholders, it’s uniquely positioned to bring those perspectives back to the organization in a meaningful way,” Gothelf adds.
It’s not hard to understand how these changes have given rise to medical affairs’ increasing prominence. With the healthcare landscape continuing to increase in complexity and the pace of scientific innovation quickening, companies need to connect scientific expertise with on-the-ground happenings in clinical practice and health systems faster and more efficiently. Forging those connections, it goes without saying, is very much in the function’s wheelhouse.
“Medical affairs brings that perspective, influencing decisions from discovery through launch and lifecycle development,” Gothelf says.
Not everyone believes that medical affairs has bolstered its clout, however. Asked whether the function has truly grown in influence or whether its supporters have just become more vocal, Subbu Viswanathan, executive director, global medical affairs technology at Gilead Sciences, responds that both can be true at the same time. “The influence is real where medical affairs has gotten close to the patient journey and evidence generation. It’s mostly noise where orgs gave medical affairs a seat at the table but didn’t change the decision rights.”
Meanwhile, misperceptions still abound. Among the more glaring ones: That medical affairs is predominantly a support function.
“Medical affairs ensures that new therapies are not only developed, but appropriately understood,” Gothelf notes. “By identifying gaps and translating insights from physicians and health systems into action, medical affairs helps organizations drive forward the work that matters most for patients.”
Leifke agrees. “One of the biggest misconceptions is that medical affairs is a reactionary or service-oriented function. When it operates at its best, it is deeply strategic.”
By way of example, he points to a handful of therapeutic categories. “In areas like gastroenterology, where many patients remain symptomatic despite standard therapies, understanding how disease is managed in the real world is critical,” he continues. “Medical affairs helps surface those insights and translate scientific data into information that can ultimately help inform patient care.”
Viswanathan disputes the notion that medical affairs “is a compliance firewall,” noting that “the real misperception is that ‘scientific rigor’ and ‘commercial relevance’ are in tension.” He believes the most effective medical affairs teams are the ones “who have figured out that they’re actually the same thing – that credibility is the commercial asset.” Along those lines, Clemson takes issue with the notion that the function “exists to serve commercial, that our role is reduced to just that.”
This particularly rankles longtime medical affairs staffers. Some healthy tension between medical affairs, marketing and commercial teams is natural, given the distinct nature of their responsibilities. But Viswanathan believes companies that strive to minimize the inherent tension are missing the point.
“Smart orgs stop trying to eliminate the tension and instead institutionalize the handoff – which means shared insight repositories, co-designed content frameworks and clear rules of engagement,” he explains. “The tension becomes productive when both sides trust the data layer underneath.”
Minimizing whatever friction may or may not exist requires addressing both current tensions as well as ones staffers still carry with them from their past professional lives. “Medical affairs people come into their jobs with all sorts of histories about what their other companies allowed and didn’t allow – ‘I couldn’t talk to my salesperson,’ ‘MSLs are only brought in reactively,’ things like that,” Clemson explains. “So the first thing a company should do is be specific about its rules and policies.”
Gothelf says that such explanatory efforts are likely to smooth over any bumps. “We’ve seen an increased appreciation that strong science equals good business,” she explains. “Medical, commercial and marketing teams naturally bring in different perspectives… The key to success is creating the right governance and ways of working so these teams can collaborate closely while maintaining scientific integrity and compliance.”
Leifke, for his part, envisions a scenario in which medical affairs leads scientific engagement with the medical community and generates insights from clinicians, while commercial teams use those insights to inform market access and communication strategies. “Ideally the relationship would be built around a shared understanding of the disease and the patient journey,” he says. “When both groups stay aligned around advancing patient care while respecting clear compliance boundaries, cross-functional collaboration becomes far more effective.”
Given an opportunity to reimagine the medical affairs/commercial relationship from scratch, medical affairs lifers have no shortage of ideas. Viswanathan anticipates a future in which there’s a shared intelligence layer but two distinct execution lanes: “Commercial owns the persuasion; medical affairs owns the evidence and the scientific narrative. But they share the same real-time field signal feed. There’s no more ‘medical affairs generates insights and commercial ignores them six months later.’ The loop closes in weeks, not quarters.”
Clemson, on the other hand, believes the best way to address tension or frustration is by over-communicating. “The two things you hear are, one, that nobody really knows what we do; and two, that nobody understands that what we do is really important,” she explains. “Well, if we don’t explain what we do and we don’t show the value of it, that’s on us.”
She notes that a handful of organizations, among them Agenus and Vor Bio, have recently added a chief medical affairs officer to their C-suites. “That speaks to the respect that many people and companies have for medical affairs.”
So yeah, nobody’s slapping medical affairs with the naysayer label anymore. Its teams are more than ready to meet the moment.
“Medical affairs will have a more explicit leadership role in shaping company strategy,” Gothelf predicts. “Rather than being brought in primarily as a source of scientific input, medical affairs will be expected to help guide decisions across a product’s lifecycle.”
How has the medical affairs function at your organization evolved over the last several years? Drop us a note at hello@kinara.co, join the conversation on X (@KinaraBio) and subscribe on the website to receive Kinara content.
