Strategic Medical Affairs: Building the Capabilities to Deliver Value

May 18, 2018
By Pharmaceutical Executive Editors

At this year’s Annual Meeting in Miami, The Medical Affairs Professional Society (MAPS) convened a roundtable consisting of global Medical Affairs leaders to discuss the potential of Medical Affairs as a key value driver and the role MAPS will play in bringing that potential to fruition.

MAPS former President, Kirk Shepard, Senior Vice President, Head of Global Medical Affairs Oncology at Eisai; MAPS President, Charlotte Kremer, EVP and Head of Medical Affairs at Astellas; and MAPS EMEA President, Ornah Levine-Dolberg, VP & Global Head of Medical Affairs, Research & Development at Glenmark participated in the Q&A panel which was moderated by Thérèse McCall, VP Medical Affairs Depomed.

Thérèse McCall: Why was MAPS formed?

Kirk Shepard: Many of us in medical affairs started discussing what is needed for the function to take it to the next level. We realized there wasn’t one common place that people could come together to discuss issues, talk about cross-industry standards, or how to move medical affairs to those next levels of excellence rather than each of us individually trying to achieve that.

MAPS’ goal is to be the voice of Medical Affairs. At the same time, we wanted the members to form that voice. We had a wonderful Executive Leadership Committee that asked professionals, “What do you need as far as medical affairs is concerned?  What can we do? What are the strongest things of value?”

Ornah Levine-Dolberg: I think that Medical Affairs issues are the same, whether you’re in a small company, a large company, a biotech, or a pharmaceutical company. Wherever you sit in the world, you face the same type of challenges; the products might be different and the regulatory environment in which you’re aiming to launch could be significantly different, but, for example, the framework that governs your interactions with healthcare professionals and thought leaders is the same.

There is a way that you interact with them and that is guided by the fact that you come from the medical profession and the interactions will always be scientific, medical, clinical, and relevant to patient care. And that is not unique to any region. That comes from the profession and that really typifies what we do as medical professionals inside a company.

In speaking to meeting attendees, they said they felt understood. They felt that all those problems and issues they’d been struggling with on their own in their companies were the same for everyone.

Shepard: Soon after the formation of MAPS, we realized two very important aspects of medical affairs: one is partnership, and bringing ourselves up to that level of excellence so that we are strong partners with commercial and R&D. And the second is the patient. In everything we do, no matter what part of the world, we’re centered on the patient.

Levine-Dolberg: I often tell my team that Medical Affairs is best positioned to represent the voice of the patient inside the company. There is no other function who really can. Several functions have an understanding and can gain insight, but the only true representative of the patient’s voice inside of a company is Medical Affairs.

Charlotte Kremer: Also, the changes in the external environment are happening so rapidly. There is such an opportunity for medical affairs to capture those changes and be a leader at the forefront. But are we equipped with the information, the resources, the capabilities to tackle these external changes that are happening? Medical Affairs has a unique opportunity.

Levine-Dolberg: I want to have the global MAPS ELC engaged in content on the regional level, because I think that will not only show the support that global has for the regions, but also give people who attend global meetings exposure to the global team. And our profession is a profession where we learn by modelling.

I would like to see this for the regions. That we aspire to be what the global MAPS is, in terms of the diversity, in terms of the richness of the offering, in terms of the inclusiveness.

McCall: Our external stakeholders are constantly evolving and placing new demands on how we work. How do you connect with these externally changing stakeholders? Lets start with the patient.

Shepard: In the last two or three years, I’ve been at two companies. In the first one, we concentrated a lot on patient-centricity as far as the input from the patient is concerned, especially now with more patient input in the pipeline and R&D. Now at Eisai, it’s called human health care. They’ve been doing this for 30 years, putting the patient at the center and having them drive and actually bring business solutions. And that’s overwhelming because of two aspects. Firstly, how do we get in touch with the patient? Because now it really isn’t just patient-centric, it’s patient-driven. Secondly, the data that goes with that, how do we pick the right data to develop drugs that are right for the patient and caregivers? We’re just beginning to look at these elements of patient-driven development of drugs.

Kremer: As Medical Affairs, we know the patients, so if we don’t take the voice of the patient into account, we’re not doing a good job.

And I think there’s a role for Medical Affairs in working with the development organization to identify what are the appropriate patient reported outcomes and ensure these are included in the development phase so that results are available at time of launch. I think the other thing is the disclosure of information.  We went through the 1990s and the disclosure of clinical trial data.  I think we’re now really going a step further in sharing data with patients.  We have patients participating in all our clinical trials but what do they need?   Do we report out to them on what the data is in lay terms?  There are a lot of these little steps that Medical Affairs can really drive.

Levine-Dolberg: I think that’s one of the first points where we need to engage more with patients and really demonstrate patient centricity in clinical trials. Because what is relevant for the authorities to register a drug very often means absolutely nothing to the patient who is taking the medication.

We must ask patients, “What would be a meaningful outcome for you and how can we demonstrate that?” Obviously, it’s easier said than done, but it’s something we all need to consider. It should be a standard today in clinical development programs. This is a hot topic, how to do this and to do it in an ethical way that’s respectful for patients.

McCall: How far along are we in the continuum of becoming a key strategic partner?  What goes into becoming that strategic partner within an organization?

Shepard: I think we’ve come a long way. The last 10 years or so, we were considered a supportive function, and doing it very well, I might add. But now when they [Commercial & R&D] see the value of what we can bring to the strategic table, it’s happening more and more. Even with companies where we weren’t there yet, they realized the value after Medical Affairs worked with them for a while.

And it makes sense. All of us have science as our background, clinical attachment to the patient, which is probably the most important thing, and a real-time connection to the patient.  So where other people have maybe had indirect experience working with patients and HCPs, we are out there, the MSL being one example, “boots on the ground” in many countries, bringing insights into the company. Someone once told me at the strategic table, “Bringing us insights from the HCPs, patients, and KOLs, to me, is the most valuable thing you bring to the table.”

Kremer: The knowledge is something that binds us all and is our strength. And that was very comfortable in a support role where people were asking us and then we delivered that knowledge. But with the changing expectations of being the leader and not waiting to be asked, but being that equal and proactive strategic partner, we have to ensure that we have the capabilities to be successful in that area.

MAPS did a survey among its membership and two things really came out.  The major one was really learning what is medical strategy. So being a business partner, knowing what strategy is, what tactics are, be it accountability to execution.  Showing the value of Medical Affairs will be very important in that changing paradigm from support to an equal partner.

Levine-Dolberg: When I started in the industry, Medical Affairs sat under ‘Strategic Marketing’.  So, we’ve come a long way. You can also see that reporting lines have changed from the Head of Commercial to much more commonly these days, R&D, CMO, or directly to the CEO.

MSLs and sales reps bring insights from outside the organization but there’s a difference in the type of information they bring and the value of the information. I think that’s one of our unique contributions, that we can interpret and understand the data and the insights that are brought in from the field in a way that sales reps or Commercial can’t because of the understanding of the stakeholders and their relative importance, their relative influence and this changing stakeholder map.

I think it hasn’t fully happened yet because it’s a work in progress, but I think all the signs indicate that Medical Affairs will be sitting directly next to the CEO.

McCall: How do we ensure that Medical Affairs has an automatic seat at the table for strategic discussion within our organizations?

Shepard: One way I think MAPS can help is to share how each of us has got to that strategic table. Everybody’s saying, “Nobody’s letting me. I can’t get there.” We can help by giving examples from people who have been through it. One of the ways we did it was by forming our own strategic process within Medical Affairs and saying, “No matter what kind of process you have, we’re developing a process and we link right in and align.” They soon realized there’s good stuff coming out of here from our situational analysis to what our objectives and strategy should be and so they elevate you to a partner.

Levine-Dolberg: We had the same struggle in one of the companies I work with. How do we gain that seat? One of our drivers was learning to speak the language of the business, in a medical way and an ethical way, but speak it in a way that resonates with Commercial so that they can understand us better.  I think that was a game changer for us. This idea that Medical Affairs cannot stand alone in this ‘silo of purity’. 

Kremer: You mentioned strategy. Don’t think in siloes. We all work together, and we have to take it as an integrated approach. Then, every other function, including Medical Affairs, has their expertise to develop the tools, to develop the activities, to govern ourselves. But it’s all in an overarching umbrella strategy where we will have to work together internally, but also with our external stakeholders.

Shepard: One of the most frequent questions I’ve been asked in the past year is, “How do we form a strategy? What are we really talking about in Medical Affairs? How do we do that?” This is where the collective wisdom of MAPS comes is. A lot of people have come together and said, “This is a basic standard or template and instructions on how to do that strategy.”

And then you take these tools and they’ll change from company to company. You will adapt them even maybe for geography, but at least you’ll have the essentials and a place to start.

McCall: Increasingly Medical Affairs is driving a lot of data ownership in our respective organizations.  How do we better prepare to be able to inform plans on the data needed? This may be a discussion with our clinical development partners as they plan trials or our own accountability for data generation with real world evidence being a very core discussion for us right now.

Shepard: You mentioned two processes that can bring down the walls between Medical and the other disciplines in the company. One is scientific communication platform, and the other one is data gap analysis. In both, Medical has driven those processes. When you go into the scientific communication platform process at or before phase two and say, “We’re going to access all the data we have right now, and this should be the communication platform of what we say in our strategies,” and you include Commercial, R&D, Patient Access with you, right away you’re demonstrating your seat at the table.

It’s the same with data gap analysis. We have a process where we come together—everyone, Commercial, R&D, Patient Access, & Medical.  We first want to hear, “Where are the gaps?” simply put.  And then we’ll figure out how to do it as far as the methodology. So, there’s two ways that bring the walls down between you and Commercial, R&D, and other partners, that demonstrates leadership, and you’re also having a process that brings everyone together.

Kremer: Everybody is looking at how to capture some of the analytics of what’s happening externally.  And I think we are just starting that in the Medical Affairs community. Here, I think, Medical Affairs has to step up.  What is our insights process? I know a lot of companies are thinking about it, how to synthesize the insight and make an analysis.  And also, then make the next step.  What are we going to do with the insight?  That, I think, will help Medical Affairs professionals a lot, if we standardize that a bit more.  And I think MAPS, again, can be a great resource for that in sharing best practices and developing a cross-industry standard for that.

Kremer: I would like to ask Ornah’s perspective on globalization and insights. Where are treatment patterns and treatment guidelines becoming standardized and where do we still have to take the opportunity and appreciate the differences at a country level? What is your view on how much we should globalize that and how can we ensure that the insights from deep within our organizations are being heard at a local level?

Levine-Dolberg: At the end of the day, Medical Affairs is an activity that is done on a country level.  It’s that meeting, the MSL meeting with the opinion leader, the pharmacist, or the physician, whoever it is, and having that discussion about practices and guidelines as they are performed on that country level with that specific patient journey. That is very, very country-specific. And sometimes even less than country, even regional-specific. You really must not only respect that, but that’s the road to success, understanding and being aware of that. Global, in that sense, is a governance process. It tells you what the directions are, what the key drivers are, how we operate, our philosophy and our values, and what is important to us. But global, at the end of the day, I think, might not be a good thing if it tells the countries how to practice and how to do things really on that interactive level.

So, it’s hard to prescribe how to gain insight from a country level to drive global decisions and vice versa.  How to devise this global strategy that will be effective in almost every country; that’s almost impossible, I think. What I’ve seen is that companies that haven’t taken into account how things are practiced on a country level are not successful eventually.  So, you really must be very, very open.

You talked about being inclusive.  What we’ve done, when I worked on global missions, was to have representation from the country level in not just R&D and Commercial, but also country medical directors, who were able to tell us, “This is not going to work,” or “This is exactly what we need, you should do more of this.”  So, I think that’s one way to look at it.

And also, to be aware that strategy needs to leave room for the individual countries, for the regions to tailor it and adapt it to what is relevant or executable in their region or country.

Do you remember there was a webinar on the changing healthcare landscape in the US? I thought this was not going to be relevant for the EMEA organization. That’s not true. People were very, very interested in that, because obviously it’s the most mature market, it’s the most developed market, it’s the biggest market. People were saying there were learnings from this change that we can even bring into our companies and say, “Look, this is what’s happening in the US.  Maybe we should prepare for that, because eventually it very well may come to EMEA and Latin America and other regions of the world.”

Kremer: It’s interesting, Ornah, that you say that, because I also think it’s vice versa.  I think the HDA environment in Europe and the requirements and the needs and how Medical Affairs can address that, I think that’s where other countries can learn from the European countries and be ready for that more systematic approach to reimbursement.  So, I think that is the uniqueness of MAPS, now that we are a global community and sharing these best practices.

 Shepard: I hope that MAPS never loses sight of the patient. I love it so far. It’s part of our vision, everybody talks about it, whether it’s patient-centricity, whatever word you want to use, that the patient is driving all five of those medical pillars of competencies and action to make their lives and their caregivers’ lives better. I would like MAPS to keep us focused on the patient.

The second part is around the fact that we are partners. That, to me, represents a big role for MAPS facilitating partnership. It’s all about bringing down the walls and inviting everyone to be a part of data gap analysis, scientific communication platform, launch excellence or whatever.  And then, lastly, elevating the excellence. How do you get there? Whether you are a large company or small, and with the changing environment, we can’t do it alone. All companies have to work together on this.

 

MAPS will be hosting its first Annual EMEA meeting in Berlin, October 21-23, 2018. For more information, see www.medicalaffairs.org

 

 

View clips of the Q&A panel discussion below:

 

https://vimeo.com/channels/1366979/267725554

https://vimeo.com/channels/1366979/267724899

https://vimeo.com/channels/1366979/267690577

https://vimeo.com/channels/1366979/267689294

https://vimeo.com/channels/1366979/267688067

 

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