As the pharmaceutical industry continues to stack up scientific breakthroughs, there’s a growing need for experts within pharma organizations who can articulate deep disease knowledge, link clinical results to outcomes, and demonstrate product value. As luck would have it, a small department that’s well suited to the task has steadily been building its capabilities and expanding its reach into new areas. Medical affairs, once a little-known entity, is making its mark on the industry, but if leveraged properly, its impact could be even greater.
Consider the current state of pharma: Data is the new organizational currency. The level of scientific complexity within pharma portfolios is increasing. Pharma reps’ access to their physician customers continues to decrease, and new customer and stakeholder groups are gaining influence over purchase decisions. The list goes on, but suffice it to say that, as dynamics continue to shift within the pharma industry, there’s an opportunity for medical affairs teams to step up and play a data-driven, collaborative role between development and commercial—and beyond.
To gain a better understanding of what medical affairs teams are accomplishing—and what’s holding them back—I reached out to my colleagues Sarah Jarvis and Dean Hakanson, leaders in the medical affairs space at ZS, for their perspectives. Here’s an excerpt from our conversation.
Q: Medical affairs has advanced, at least in the physicians' eyes, in terms of credibility and value, and is maybe even becoming more important than commercial. What has driven this enormous change in the profile, importance and impact of medical affairs?
Sarah Jarvis: It’s the customers—the doctors, in particular—who are driving this trend. The complexity of new products coming to market and the need to have an open and non-promotional dialogue with someone that they can really trust is driving a lot of the growth. Medical science liaisons (MSLs) are the field force in medical. They’re still getting 30 to 45 minutes with their physician customers, and many of these physicians are KOLs and often top investigators. Compare that to commercial roles, which usually just get a handful of minutes with the doctors, maybe.
Dean Hakanson: Another key is that medical affairs can help an organization’s development arm overcome two hurdles to patient access. The first is the regulatory hurdle that everyone thinks of and the second hurdle is reimbursement, which is often poorly addressed due to its complexity. Medical affairs now has a huge role in providing strategic input to early trial design to the development organization, ensuring the creation of a data package for phases I to III that is clinically meaningful and in line with payers’ needs, while simultaneously tackling that first hurdle for approval.
Medical directors must prioritize the insights gathered in the field by MSLs, interactions with global KOLs and competency with published literature in order to drive early- and late-phase data generation strategies. They’re also helping to overcome the reimbursement hurdle by running late-phase trials and evidence-generation activities within medical that address data gaps. This includes phase IIIb to IV clinical trials, investigator-initiated trials and real-world evidence.
Q: From your perspective, is medical affairs frequently being seen as a link between R&D and commercial? Are the people in medical affairs in most pharma companies equipped to take on the challenge, or do you think that it’s going to be a bit of a tough ask?
SJ: Medical affairs should absolutely be viewed this way but often still isn’t. Medical plays a key role in bringing information back to development and coordinating appropriately with commercial in the field with customers. But in many organizations, compliance concerns have created huge firewalls within these groups that make any collaboration, but especially medical-commercial collaboration, difficult at best.
DH: Compliance must be respected but not used as an excuse to silo. Companies are often fearful of regulatory repercussions and eschew collaboration altogether. But unclear silos are riskier than informed collaboration.
There are a couple of companies that are looking at structural ways to overcome that fear factor and cultivate a collaborative spirit across the development, medical and commercial organizations. To encourage appropriate collaboration at all levels, an organization’s leadership needs to drive this change. Companies must continuously assess compliance policies and provide training throughout the organization, not just the management team. It’s too easy to hide behind “compliance walls” when teams and managers don’t understand the policies and guidelines that affect collaboration.
SJ: I completely agree, Dean. On top of that, external pressures are set up against them. We’ve worked with more than 75 different medical affairs clients and see this across the industry. There’s a true fear around the optics of what they do because those in field medical live day in and day out in the gray space of off-label discussion. That, by definition, is their job. People want to do the right thing, and they are doing the right thing in almost all cases, but they’re so worried about what could be seen as doing the wrong thing that, understandably, the easy way out is to say no to almost all collaborations—especially with commercial.
Can the individuals within medical affairs actually be the right people to make this change? That’s a tougher question to answer because I see such variability in leadership within medical affairs. Some have both the clinical and business acumen needed to make it work. Others don’t.
DH: Typically, in small companies, the job becomes easier because everyone is accountable. And it may seem small, but it’s not “someone from commercial.” It’s Joe from across the hall. It becomes easier because it’s more personal and those boundaries are easier to break down. Taking the time to “get to know each other” and understand challenges faced by other people in the company opens staff up to collaboration and reveals opportunities to help each other that were unknown prior to real discussion. When cross-functional teams understand the challenges of their colleagues, we now recognize that these teams have become “bilingual.”
Q: For someone in medical affairs, is business acumen the ability to work with a cross-functional team? Is it the ability to understand what a doctor community needs? What exactly would “business acumen” mean in this context?
DH: Business acumen here means the ability to lead organizations, both internally in a cross-functional, collaborative way and externally to meet customers’ needs. Many medical affairs leaders can lead large organizations, but those who struggle to build a culture of collaboration aren’t “bilingual” and often are too academic in their approach. Developing similar skill sets across various functions of the organization—especially the development and commercial teams— nurtures mutual respect, and helps individuals make decisions that enhance collaboration and productivity. For example, executive-level communication skills and knowing how to have influence when you’re not in a position of authority are important components of advanced business acumen regardless of your role.
For collaborative initiatives to have a lasting foothold, senior leadership must be willing to be involved in the initiatives and make significant changes to the organization. One way to do that would be to create clear, shared objectives for the teams, providing a unifying goal that fosters collaboration. This type of “enterprise” thinking enables siloes to be reduced and engenders a sense of commitment to the broader organization.
Q: A large part of this job is coordination, meaning that medical affairs has to coordinate to some extent with commercial, even though there are risks there, and with development. Thinking about the profile of workers who are typically hired for medical affairs roles, is it time for a change? Does HR need to take a fresh look at who is best suited, and do we need slightly different competencies, not just deep expertise?
SJ: It’s definitely a sensitive topic. The three key elements that you want in field MSLs are the same three key elements that you need internally (though they vary slightly): scientific acumen, communication and business acumen. The first absolutely is scientific acumen. In the field, these folks are going toe to toe with true thought leaders, and they’re getting 30+ minutes with them in each interaction. They have to be able to go deep on the science.
DH: And in the headquarters, leaders are driving evidence generation, which is the content for MSLs to communicate and to meet the regulatory and reimbursement hurdles to achieve patient access. Rigorous scientific acumen is table stakes. In fact, many of the leaders in medical actually come from academia or clinical research as investigators. However, to achieve a competitive advantage, medical directors must go beyond the table stakes of scientific rigor and possess the industry knowledge that’s essential for an “integrated product strategy.”
SJ: Exactly. On top of the strong scientific acumen, those in field roles have to be able to communicate all of that deep science, figure out their customers and tailor their messages appropriately to build meaningful relationships and gather customer insights. They can’t have the same conversation with an integrated delivery network decision maker and a key opinion leader.
DH: In-house medical leadership must also recruit, hire and develop credible, industry-expert physicians who can drive corporate objectives through successful collaboration. They need to be able to communicate with cross-functional colleagues, as well as KOLs, in ways that create value.
The third big piece is business acumen. We talked about it before, but in the field, it’s all about customer centricity. Field medical leadership is placing newfound importance on this skill. Our latest medical affairs outlook report found that nearly a quarter of all training time in 2018 was spent on customer centricity initiatives.
SJ: That’s right! The problem is that if you think about those three areas and core skills, it’s difficult to find someone who’s really good at all of those things. There’s an opportunity for the industry to consider rewriting the medical playbook with more of a partnership mindset.
For pharma companies, the end goal is to find the most effective way to generate, interpret and communicate evidence to their customers and stakeholders. And that begins with understanding the disease as well as the science, data and clinically meaningful aspects of patient care. It’s time that we pull back and look at how different medical affairs roles—headquarters, leadership, medical directors, MSLs or account execs—play along this continuum, and how the right blend of expertise, customer empathy and coordination kind of shifts along the spectrum.
Evidence is the central peg that’s holding the whole thing together, which is why medical affairs teams are well positioned to be powerful collaborators, connecting development and commercial, and out to the customer if the right talent is in place—and if pharma organizations enable that cross-silo collaboration to happen.