Pete Piliero:

Welcome to the Medical Affairs Professional Society’s Medical Strategy and Launch Excellence Focus Area Working Group’s two-part podcast series, Executive Leadership Perspectives on Medical Affairs Strategic Planning. The views expressed in this recording are those of the individuals and do not necessarily reflect the opinions of MAPS or the companies with which they are affiliated. This presentation is for informational purposes only and is not intended as legal or regulatory advice.

In the first podcast, we will discuss two topics: Contributions Medical Affairs makes to assets strategic plans and time horizon, refreshing and resourcing of a Medical Affairs plan. I am Pete Piliero, and I’m currently the VP and Head of Medical Affairs Americas at GSK Consumer Health Care. Also the co-lead along with Monica de Abadal of the MAPS Medical Strategy and Launch Excellence Focus Area Working Group and I am a member of the MAPS board of directors.

The podcast objectives are the following: First to understand cross-functional pharma industry executives’ perspectives on various aspects of Medical Affairs strategic planning. Secondly, recognize what the most important contributions Medical Affairs makes to strategic planning, and finally, appreciate the importance of considering timing and resourcing aspects of Medical Affairs strategic plans.

In March 2020, at the MAPS annual meeting in Miami, a panel of Medical Affairs executives was convened to discuss Medical Affairs strategic planning. Our panelists today are Keith Jones, VP of Global Marketing and Alliance Management at Eli Lilly and Company, Dr. Maria Rivas, the CMO at AMD Serrano, and Ed Gudaitis, President and CEO of a Sarris pharma. So let’s get started. To begin, Keith, what is the most unique or important contribution that Medical Affairs makes to the development of a Medical Affairs asset strategic plan? Thanks.

Keith Jones:

First, I’d like to say that, you know, the way I look at it is there’s a common goal that we all share. And that is the success of the brand in the marketplace, and then our ability to help as many people as possible. So I think when you start from a common purpose or a common goal, then the planning of the strategy in the strategic asset plan becomes more clear with that common goal, but what Medical Affairs, you know, as a commercial leader, where I see Medical Affairs and my Medical partners playing a key role is they bring perspective, it’s obvious, it’s often a unique and varied perspective for my Commercial colleagues. And that I think is critical, though they bring a diverse set of skills and a diverse perspective that is critical to the success of the asset, specifically, where I see Medical Affairs partners playing a huge role is, as you alluded to earlier, which is the early work that Medical Affairs can do to educate shape on market shape and class, reinforce treatment guidelines. Those are all things that I think are critical for Medical Affairs to do. The other thing is they bring a deep Medical expertise, that’s  quite obvious. That’s their, their value proposition. But what that enables us to do is, from a Commercial standpoint, they can have a big impact on our SWOT analysis on our target patient on the helping us to identify the unmet need, aligning and really crystallizing the true insights, intentions, the HCP space, as well as the tensions and frustrations that our consumers face, because they often have seen patients and come with a lot of patient care experience. So I think there’s a ton that our Medical Affairs professionals do to create the overarching grand plan. And then also, you know, really go deep into going after that align goal to develop their, their medical sphere strategies for the overall ring.

Pete Piliero:

Maria, is there anything else that you would like to add?

Maria Rivas:

No, I think he did a fabulous job at articulating the value of Medical Affairs while we bring to our planning and I think it’s to Keith’s point, it starts with, first of all, obviously, for a company, a particular drug needs to be successful in the market. And the way I translate that to our Medical world, is that essentially for that to happen, it needs to be good for patients. And, and if that’s the case, then if we start from what’s in the best interest of patients, then we can really plan in Medical Affairs plan that allows us to properly educate, properly communicate, generate even new data. That will inform how patients should be treated, particularly with this product in throughout the lifecycle not just at launch, but after launch of the product and continuing to work and learn about the real world. And this is these other elements that I think Keith alluded to, which is, I think one of the beauties of medical affairs, in contrast, in terms of value proposition, in contrast to clinical development and other functions is that we’re really anchored in the real world. Most of our companies, either through direct or indirect reports, have a network of medical affairs professionals, wherever that company has a business. And thus, it’s a very unique opportunity for the medical affairs organization to be a learning organism that brings in the insights from what we’re observing in the real world in terms of patient care, the evolution of treatment paradigms, and how perhaps even access and other factors in the patient’s ecosystem are not going to allow for that product or that brand to be used appropriately.

Pete Piliero:

Now, let’s talk about time horizon, refreshing and resourcing of a Medical Affairs plan. We usually talk about doing an annual Medical Affairs strategic plan. Maria is that often enough?

Maria Rivas:

So I divided Medical Affairs planning to two components. One is essentially what our objectives and our objectives should be tied to what we believe are the strategic imperatives or the key, let’s say success factors for a particular brand. And these are usually aligned at a cross functional level, these are usually a core element to all the functions, plans that envelop a commercial plan for a brand. However, there’s a tactical component, a tactical plan for Medical Affairs that should be tied to those overall overarching objectives, which are aligned cross functionally around the brand. But the tactical plan is very unique to Medical, you know, it can only be executed by Medical, the governance ideally should be within Medical so that we can have a peer to peer and also a patient oriented activities, that that would otherwise be difficult in other functions. So with that being said, Now, what is the optimal time to maybe look at both components. For well established brands, in my experience, I would be curious to hear other people’s perspectives, you know, the strategy usually doesn’t vary too much, too much. It should be refreshed every year, but it probably doesn’t mean a whole overhaul to the strategy. However, in newly launched or about to be launched brands, and particularly in specialty areas, like oncology, or other disease areas where the knowledge and science is evolving so fast, it probably needs to be refreshed, because even the strategy needs to at least be looked at very frequently, sometimes even in oncology every other week. That tactical planning needs to be also put in a corollary way looked at more often, but to your point in terms of how we then fund and resource those tactical plans. That’s a third element of my medical plan. I believe that there needs to be resourcing and budgeting that secures that those tactics can be implemented year on year, as you know, we cannot do research one day, and then say next year, we don’t have any more funding for research, that will not be acceptable.

Pete Piliero:

Keith, how do you do it?

Keith Jones:

I think it’s important that you look at the lifecycle of the asset. So the Medical Affairs plan and the overarching global brand plan will probably look different pre-launch than it does at launch and post launch. So that’s just another framework that I think is very valuable. Think about the frequency of refresh strategies across the lifecycle of the brand.

Pete Piliero:

If we think about oncology and rare disease, specifically, is there any difference in the approach that medical marketing and market access should take and doing their strategic planning?

Keith Jones:

I would say and I think it was raised earlier is the timeframe involved in planning in especially in an area like oncology becomes very compressed. I’ve always said oncology changes from conference to conference. And you need to react to the, the n=50 study that was presented that now move something into a different line of therapy. So I think the idea of having this sort of historical large set piece we’re going to plan for five years and then execute each year and do a midstream planning adjustment. You know, that battleship has sailed long time ago. So it has to be a flexible, iterative process because it literally does go from, from ASCO attached as mo and you’ve got to get that feedback, and you’ve got to get – because at the end of the day, you know, health care providers are on the front line, and they’re absorbing this information. And they’re making changes to practice. And they’re and they’re thinking things through. And as industry, we can’t lag behind that process. So I think certainly in an area like oncology, the timeframe is compressed, in a place like rare disease. I mean, the reality is you’re making it up as you go. You’re the first product in the category that never existed before with a treatment. There’s 100 patients globally, you’re making up the plan as you go. And I think, again, to have a very formalistic set process, it’s going to force you into some bad habits to fill in templates and fill in a process when the reality is we’re making this up as we go. You know, we’re going to learn more we’re going to we’re going to come up with ideas and it literally is going to be an iterative process. So I think that’s part of the challenge is to get out of the the template and process mentality yet maintain the discipline and rigor that’s required from planning perspective, which is, you know, understand where you’re going to play, understand how you’re going to win, figure out what has to be true. And then learn from the market, learn what’s happening quickly and come back and readjust everything as you go.

Pete Piliero

I agree. Medical Affairs plans must constantly be assessed throughout the plan year in case adjustments are needed. Thanks to our panelists for an engaging discussion and sharing their perspectives on Medical Affairs strategic planning.

This has been the first podcast in a series on executive leadership perspectives on Medical Affairs strategic planning. The second podcast will discuss the following aspects of Medical Affairs strategic planning, global, regional and local planning, the approach to Medical Affairs strategic planning for rare disease and oncology and compliance considerations. If you are a maps member, thank you for your support of maps. If you’re not yet a MAPS member, and would like access to additional resources in this area, please visit the MAPS website to explore joining today at medicalaffairs.org/membership.