Biopharma Medical Affairs: Where We’ve Been and Where We’re Headed

Myrto Lee, PhD

Michael Norton, MD

Sumil Verma, MD

The importance of medical affairs (medical) in biopharma is growing. To better understand medical’s current challenges and what they mean for the future, Myrto Lee, managing director and partner, Boston Consulting Group recently sat down with Michael Norton, former VP, head of US medical affairs, AbbVie, and Sunil Verma, SVP, global head of oncology, medical, AstraZeneca. What follows are edited excerpts from that discussion.

What are your thoughts on the current state of medical affairs in biopharma?

Michael: The current state of medical affairs is quite good. Scientific innovation emerging from industry is rapid and complex. As a result, biopharma companies are building up teams and investing in greater medical affairs capabilities. Patients, providers, and really the overall health system need our medical voice to help improve outcomes. We want to make sure medicines are being utilized for the right patient at the right time and in the right way. We’re living in a time of biologic revolution, of complex medicines and diagnostics, and we need these medical professionals inside industry to help the health system embrace, understand, and properly utilize them.

What are the greatest challenges biopharma is facing in medical affairs?

Sunil: We are on the cusp of a really transformative moment in clinical research. It has evolved from an era where we concentrated primarily on the evidence. Now, we are really focusing on the delivery of care and translating that evidence into the clinical setting. Part of that journey is, how do we better understand the patient voice, and also, how do we better understand the health system challenges and the power of research? So, the challenge for us is how best to integrate this understanding into our medical teams. But I'll also say that is the opportunity.

Michael: Most of our medical departments are driving for additional efficiencies. How do we get better and faster at filling the gaps in data? How do we get faster and better at bringing in insights on the gaps in clinical care, the challenges that patients face?

What does that mean for the future of medical affairs?

Sunil: Traditionally, the aim of medical was to be able to translate evidence into the hands of the clinician, but now we have to understand how medicines reach patients. We also have to consider the health care system aspect and where those gaps exist. That’s critical if we want to have an informed discussion about the additional evidence as well as the gaps that are present, and how we then generate that evidence so we can support the integration of medicines. But then, how do we improve the patient experience with our medicines? I think that’s really the power of medical, moving forward.

What about that excites you the most?

Sunil: What excites me the most is this evolution in care where we have gone from evidence-based medicine to precision medicine, from biomarker X equals treatment Y to personalized medicine with the patient in the center. The full power of medical—from integrated evidence to connected partnership to really redefining what the future of cancer care could look like in partnership, with a personalized medicine focus—is dependent on a patient focus. That is the vision of “science to care” that we are really hoping to bring forward.

I'm assuming you're interacting with health care professionals as part of the multidisciplinary team all the time. So, medical has a big role to play there, right?

Sunil: Medical has a pivotal role. The value of medical affairs is translating health care professional insights, identifying gaps in health systems, understanding clinical care systems, informing them, and bringing that voice to the core of our medicine development and delivery. We as medical professionals are instrumental in making sure that we are driving a better understanding so that more patients can benefit from the therapies and really have their voices heard in the ecosystem.

From your perspective then, what does this mean for biopharma companies right now? What should they do?

Michael: Biopharma companies need to be very thoughtful about the skills that they're adding to their medical departments. The skills of the past are not the skills of the future. We're looking for data scientists. We've got a health care system that is burgeoning with data, but we have not reached the full potential of understanding that data and therefore being able to improve outcomes. And that requires a certain profile, whether it be a statistical profile or data experts who in the past might not have been a core part of our medical team.

Many medical teams are investing heavily in digital, right?

Michael: The reality is, whether we as medical professionals like it or not, most people go to Google or trust what they view on YouTube. So, we (medical departments) need to be really present in the digital space, telling our stories, monitoring what's out there, being comfortable confronting misinformation and aggressively correcting it because otherwise patients are hurt and misled.

The right treatment decisions are not made if you don't have the right information, either as a patient or as part of the multidisciplinary team. Sunil, what is your vision for your team, the AstraZeneca Oncology Business Unit medical team?

Sunil: We aim to bring “science to care.” Our work is in the service of patients and ensuring the right treatment gets to the right patient and that the patient experience is enhanced. So, in the bold vision of science to care, we have three important pillars. First, how do we transform care today? How do we better understand the care gaps but also how do we better understand how to provide the information via the right channels to the clinical community?

The second is, how do we effectively partner? Traditionally, the partnership has been with the clinical team. But I think we recognize that the partnership has to be with a broader health care ecosystem that includes the clinical team, the health system, health technology, data and digital partners, and patient groups. That partnership is critical.

A third pillar is redefining what the cancer care paradigm could look like. The capabilities that we are really looking to build on are in diagnostics, data, and digital. In parallel, we need to make sure that the health system also has the capabilities to be prepared for future trends. These three pillars are critical for us to unleash the full power of what medical can bring to the health system.

What are the three things that you’d say let’s do differently together?

Michael: First, tell better stories. We need scientific storytellers, people who are really comfortable taking complex information and clearly explaining it to other people. And those people could be health care providers, health system leaders, or patients themselves. The volume of data, the volume of innovation that is happening right now is at a pace that most people—even your doctor—can’t keep up with. As medical professionals practicing pharmaceutical medicine, we have the opportunity to hire the best storytellers, who can help the people who manage cancer care, or who are going to be the recipient of care, stay on top of this amazing innovation that’s happening at AstraZeneca and many other places.

Second, we need to get better as leaders in bringing meaning out of the health care data landscape, which has exploded. That’s from the watch I’m wearing to the EMR [Electronic Medical Records] to the insurance data that’s created, because the way we test our products in biopharma companies is generally in a controlled environment. “Is it safe and effective?” isn’t really what the patient or the doctor wants to know. It’s how does the medicine performs in real life and in comparison to other available therapeutic options? What are the combinations of medicines that patients are taking in the real world?And, ultimately, how do you get the best outcome for the individual patient? So, it’s really important to set up that data capability so we can be masters of data, driving meaning from this new data we have in health care.

Sunil: Three things come to mind for me. One, ensuring that the patient’s voice is at the core of everything that we do and in service of everything that we aspire to do. The second really important element is collaboration. That’s critical because health is a team sport, a team ambition. We need to make sure that we continue to collaborate and think more broadly than what we have traditionally done. Just bringing a medicine to the market is no longer sufficient. We need to think about how we best help assimilate, integrate, and ensure data-informed decision making.

The third critical aspect is to focus on understanding the care journey. The care journey has to be learned—it doesn’t just happen at the point where the treatment decision is being made. It begins with the first symptom, then the cancer diagnosis, then the treatment, and afterwards, when patients are surviving and, hopefully, thriving. So, understanding the full care journey is critical for understanding the patient experience. If we start to measure that and bring that understanding to our medicines, I think we'll be better professionals and I think we'll be more valued partners and able to provide more meaning to the medicines for our patients.

The opinions expressed in this article are solely thoseoftheauthor and interviewees,anddonotrepresentthe positions of the organizations of which they are part.