This Medical Affairs Professional Society (MAPS) podcast features medical affairs thought leaders offering insights into the Medical Affairs strategic planning process
Murali Gopal, MD, Vice President | Global Medical Department at Mallinckrodt
Murali Gopal, MD, remembers being a young clinician in the bygone era of giveaways during conference meetings when he would walk by pharma booths and pick up a water bottle or a tie or whatever they may be giving away. Would he ever wear the tie or use the water bottle? Probably not. But it cost him nothing and so why not? Now Murali compares this might-as-well approach to the biopharmaceutical industry’s traditional (and increasingly outdated) model of brand planning. As Vice President of the Global Medical Department at Mallinckrodt Pharmaceuticals, he is helping his organization evolve into a future that includes the contributions of science and business to attain the goal of innovation. Here the Medical Affairs Professional Society (MAPS) talks with Murali about the strategy he uses to guide this change – Integrated Brand Planning – which he not only credits with bridging the gap between science and business in biopharmaceutical organizations, but sees as a philosophy that has led to his personal development as a leader and decision-maker.
MAPS: Okay, you have to start by telling us how brand planning is like stocking up on conference giveaways.
Murali: Think about what happens when Medical Affairs comes over and says we can generate X, Y and Z data for an asset – if you’re a Commercial person and you’re trying to maximize the opportunity of the molecule, and have no financial downside or obligation…why wouldn’t you take all options? It’s the same mentality as conference swag: If you can get something for nothing, you do it. That may have worked well without today’s challenges. But now companies that still use this model place themselves at a disadvantage.
MAPS: You’re saying this model of saying yes to all possibilities for a new drug leads to inefficiencies?
Murali: Yes, I am saying that, and that it also leads to increased costs and the need for increased resources. At a previous position, we ended up with 7,000 different promotional materials for one molecule in one year. Some were used once and some just sat in warehouses. A handful of them would be the key materials that were used over and over. It was as if we were creating things for the sake of creating things and not focusing on what the external stakeholder may have felt was most compelling or intriguing. Another example can be that perhaps the organization may determine they need some data without fully understanding that it may take five years to conclude a particular study, or may cost, say, $3 million dollars.
MAPS: And how is Integrated Brand Planning different?
Murali: With Integrated Brand Planning, or what some organizations call the General Manager model, the GM becomes responsible for the profit and loss of a molecule. What this means is that everything becomes visible. Commercial, safety, R&D all becomes visible, because they’re all centered around some level of cost. It forces the organization to align on their priorities and to create targeted strategies.
MAPS: It sounds like you’re talking about a more integrated flow of information between science and business during brand planning?
Murali: Traditionally the separation between science and business was intentional. Many scientists felt, and some may still feel, that science and business need to be separated and if Medical Affairs or Commercial has input to science, it takes away some of the scientific credibility. I like business but I’m a scientist at heart – I want to be measured against the science we engage in, and fortunately the GM model allows us to do both so that I can continue to grow my business acumen as well.
MAPS: What do you mean?
Murali: Let’s say our end goal is innovation – we live longer today because innovation helped us learn to deal with illnesses that would have killed us in our 30s and 40s. And look at the effect of the cholesterol medicine race in the cardiovascular space, heart transplants, etc. or the vaccine industry in general. The biopharmaceutical industry has always struggled to articulate the impact of innovation on society. But combining the business impact and scientific development aspects together, we can now measure and even predict how a therapy is going to provide value, as well as, to understand its economic impact so that we can make better decisions.
MAPS: You’re saying business has a role in innovation?
Murali: Certainly. At a previous position, we hired a top scientist in their field to work with a new molecule. He had great relationships, knew the unmet need, knew what the molecule could do, but he didn’t take into account what other companies were doing, or the needs of payor organizations, or the high level of focus on pricing at that time. When we got ready to introduce the molecule, the potential price and utilization scared the payors – they said it was going to break the healthcare system and that we would need to somehow restrict who is eligible for the therapy, and if we couldn’t do that, possibly no one would get it. Our internal leader couldn’t accept these business realities and the drug was by many measures unsuccessfully launched. For me, that was a very poignant experience. The fact is, you need relationships with scientific leaders, but to run a therapeutic area, you need just as much acumen on the landscape and business side to marry with the scientific aspects to be successful.
MAPS: This sounds like a cautionary tale of science overbalancing business, but of course we have cautionary tales in which business overbalances science as well.
Murali: I believe there are companies out there increasing profitability and cost because they can, but there are also companies trying to do the right thing, and it all gets lumped together. Integrated Brand Planning creates checks and balances.
MAPS: Oh, interesting! And how is that?
Murali: It’s about collaboration at the stage of annual planning. Instead of Commercial proposing studies to R&D, or R&D proposing studies to Commercial, with Integrated Brand Planning, it’s a collaborative, open discussion from the start. Scientists don’t need to also be MBAs and Commercial doesn’t need to hold PhDs, but the dialogue helps scientists elevate their business acumen, and Commercial elevate their scientific acumen. You need the perspective of external stakeholders as well. Most companies will put the patient or a disease at the center of what they do, then you have your organization or company’s resources sitting in the next circle around this center, but there’s an external circle as well that includes: advocacy groups for that therapeutic area, politicians, KOLs in academia, clinicians, etc. This brings the awareness and impact of patient journey and access journey into the planning process.
MAPS: It sounds challenging to help organizations transition from the traditional, siloed way of doing things into this new model of collaboration. What do you do to help generate this?
Murali: Three things. First, I’m trying to educate the scientific organization this can work and not to be afraid, but rather to embrace it. Second, I’m trying to explain what good actually looks like by walking through my own process of evolution from previous experiences at other companies – maybe by seeing how it’s worked elsewhere, we can skip some of the painful learnings. Third, I try to lead by example by sitting in wherever I can as a leader for the Medical organization.
MAPS: With collaboration comes complexity…
Murali: These actions have helped me develop not just as a better leader, but as a better individual. Balancing business and science in this collaborative process of brand planning helps me to not look at things as only black and white. It affects how I approach complex challenges. Sometimes in a discussion, you find out how complex something is and it surprises you through all of the aspects that may need to be considered and planned for. That’s fun for me. How we work together to solve complex problems is fundamentally interesting to me. And when you’re constantly looking at all these variables to make decisions, you get better at it, not just with regard to business decisions, but life decisions as well. When there are things that are hard to pick between, you can use the same mentality to make a well-rounded decision. It might sound strange, but after engaging and leading in this process for so many years, I feel like I ruminate on decisions a lot less, and that I am more secure in my decision-making ability. Don’t get me wrong, it takes effort. You can go through the motions and not get anything out of it. But I dug into it. I really wanted to unpack how far we could take commercial and scientific collaboration and I think it’s facilitated my growth as a leader and attaining this level in my career and in my life.
It’s no secret that major forces have pushed the pharmaceutical industry to think differently about how it operates and how it can deliver greater value to society. The good news is that we’re seeing more connected, more agile and more outcomes-focused organizations arise from the disruption.
R&D teams have increasingly broken free from traditional scientific silos through increased internal collaboration and external partnerships with biotech and academia. They have embraced transformative science and technological advances and we are starting to see a new generation of medicines forged by our enhanced ability to capture, interpret and apply data.
Our engagement models have also adapted to changing stakeholder needs. More specialty products with more complex data mean that our clinical and access stakeholders are demanding deeper scientific exchanges to understand the patient impact and value to society.
Like many pharma companies, the role of Medical Affairs at Astellas has transformed in recent years, from a support function to a strategic organization to internal and external stakeholders.
Today, Medical Affairs is comprised of the most important and valued capabilities in the business, playing the role of key connector between internal pharma and external stakeholders.
We are driving scientific exchange and evidence generation with an ever-expanding external stakeholder community of healthcare professionals, scientific experts, health authority bodies, payers and patients.
Our role is not just limited to knowing what these stakeholders want and need. We’re fulfilling information needs through data-generation (clinical trials and real-world data analyses), data sharing through publications, medical information and scientific exchange, pinpointing the investments and activities that will drive the biggest impact for each of these groups. The result, ensuring the safety, efficacy, value and real-world utilization of our therapies are fully understood.
As Medical Affairs integrates its wealth of external insights into a consolidated and aligned strategy to guide its own global activities, it also needs to align with Commercial and R&D colleagues. Through governance and operational excellence, Medical Affairs ensures information needs and data are shared across organizations, as and when needed, to enhance the effectiveness and impact of all respective groups.
As our operating environment has changed, Medical Affairs has become a more business-savvy, scientifically influential, connected and agile function. While we’re making great progress, companies like Astellas know that the disruption won’t stop.
New challenges lie ahead, such as our ability to address wider societal issues and to create value for a variety of stakeholders that is wider than ever before. Another key challenge for us will be the use of artificial intelligence to generate data from combined big data sources, such as clinical health records, real-world data and the variety of ‘omics’ data sets. This information will need to be delivered in an increasingly digitally-savvy way, for example via interactive medical information websites and other digital channels.
We also know that downward pricing pressures are unlikely to go away. We will need to demonstrate how innovations create value to a wider variety of stakeholders than ever before. So, every commercial decision will have greater consequences.
With this mind, I believe that Medical Affairs professionals must continue to build on the range of capabilities that enable them to act as orchestrators of company strategy with R&D and Commercial functions. Central to this is effective leadership. Medical Affairs leaders need to be ready to interact with the C-Suite and inform corporate strategies because it is helping companies to make smarter decisions and focus performance measures on patient-centric outcomes. And that’s value creation that makes a real difference.
8/18/16 10:06:55 AM — Astellas portrait session. Charlotte Kremer © Todd Rosenberg Photography 2016
Charlotte Kremer, M.D.
EVP, Head of Medical Affairs,
Astellas Pharma Inc.
In this second of two podcast episodes, Pete Piliero moderates a discussion on contributions Medical Affairs makes to Asset Strategic Plans and Resourcing of a Medical Affairs Plan.
Pete Piliero, MD, moderates a discussion on contributions Medical Affairs makes to Asset Strategic Plans.
Medical Affairs’ role in securing a bright future for pharma is undeniable, yet many before have struggled to bring forth concise and consistent descriptions that communicate the full range of benefits and expertise that Medical Affairs (MA) brings to the table. As a result, the wider understanding of MA’s role is not where it should be. To that end, this white paper explores the role and value of MA, backed up with commentary from industry leaders, as we define clear pillars of MA that communicate its true value. What’s more, we propose a short elevator pitch that MA professionals can use to quickly yet succinctly describe the importance of MA for every successful pharma venture in the future.
By: Simon Kyaga1; Keith Morris2; Kiely Flanigan3
1Global Medical Lead, Psychiatry, Servier; 2Executive Managing Director, Scientific and Medical Affairs, Syneos Health; 3Director, Medical Affairs Syneos Health
This article aims to position learning agility as an emergent capability that supports the future-proofing of Medical Affairs strategic planning processes and outputs. In essence, learning agility is a set of skills, competencies, and mindsets that support our capability of “knowing what to do when we don’t know what to do.”1 Our position is that learning agility is a capability that should be developed internally and applied to the development and operationalization of strategic plans. Through the enablement of learning agile behaviors, the approach to strategic plans can be made with an eye toward ongoing reflection and updates. We define four descriptive behaviors (contextual curiosity, vision-driven adaptability, educated risk taking, and accountable learning) that match up to MAPS best practices in strategic plans and then discuss how to apply those learning agility behaviors. We conclude with future recommendations for the development and application of learning agility.
Learning agility, strategic plan, strategic thinking, medical strategy, capabilities enhancement
The COVID-19 pandemic has accelerated the need to develop Medical Affairs capabilities in learning agility. Not unlike various industry shifts over the years that have impacted the role of Medical Affairs, we’ve experienced a shift in the way Medical Affairs organizations are responding to changes affecting the execution of strategic plans. Field Medical is learning to engage stakeholders virtually and support HCPs in new ways as they engage with their patients through new technologies. Clinical trials adopted new protocols to protect patients and sustain recruitment. Conferences and congresses were postponed. Organizations are seeking flexible resourcing models to manage downturns in business and leveraging downtime to upskill team members. All of these changes have required an openness to change and the development of new skills to learn new ways of achieving our work objectives. We are now not only shifting how we do our Medical Affairs work, but also planning for a “new normal” as we navigate doing business virtually.
Yet, however uniquely disruptive COVID-19 has been, it is still only one more example of the bucket of business disruptions that have affected the skills, knowledge, and capability needs within Medical Affairs work. At the heart of the changes asked of us and our teams is learning agility. As a core capability associated with managing ambiguity and “knowing what to do when you don’t know what to do,” learning agility is particularly relevant and useful in developing adaptive and dynamic Medical Affairs strategic plans that stand the test of change and disruption.1
Learning agility in strategic planning is important because by incorporating learning agility behaviors and mindsets into the development and implementation of Medical strategic plans, teams are better able to pivot and innovate, as needed, to changing internal and external dynamics, while remaining in alignment to the overall medical vision and business objectives.
This article aims to position learning agility as an emergent capability that supports the future-proofing of Medical Affairs strategic planning processes and outputs. Our position is that learning agility is a capability that should be developed internally and applied to the development and operationalization of strategic plans. We then define four descriptive behaviors that map to aspects of Medical Affairs strategic plans and discuss how to apply those learning agility characteristics.
Medical Affairs strategic plans include both intellectual components, such as situational analyses and medical strategies, as well as tactical components, including tactical and operational plans, and assessment and measurement metrics.2 Medical plans are important because they guide decision making across the organization and support the communication and assessment of Medical Affairs’ efforts and impact.
Medical Strategic Planning is an integral part of setting strategic direction and articulating the tactics for driving Medical Affairs value and impact for patient and organizational outcomes. But, how do you create a realistic and viable strategic plan given a VUCA (volatile, uncertain, complex, and ambiguous) Medical Affairs ecosystem? What brings Medical strategic plans to life beyond and ensures it gets referenced more than once a year in the annual planning process? How do we make the strategic plan content memorable and keep it top of mind with our key audiences? We suggest that the secret to effective Medical Affairs strategic plans is learning agility.
In a Medical Affairs context, learning agility brings key behaviors and mindsets into the Medical planning, development, and execution processes that ensure the content contains relevancy and resonance for the organization. Although variations exist between companies in terms of influences affecting the strategic planning process (e.g., preferred timing of Medical support of launches, products, therapeutic area considerations, and operational competencies versus strategic positioning priorities), the Medical Affairs strategic planning process reflects multiple stakeholder insights, business objectives alignment, and tangible data for strategic decision making. The strategic plan is not intended as a fixed manual that is reviewed once a year.
There are several descriptive behaviors team members can use in approaching the development, communication, and operationalization of strategic plans to support success:
Each of these behaviors is based on the capabilities needed to design, communicate, and execute on a strategic plan. The descriptiveness of the terms reflects a desire to position these learning agility behaviors as both foundational and aspirational. Learning agile behaviors are both critical for the here and now in performing work, but also for guiding toward the future and inspiring learning and development.
Learning agility is relatively new to the Medical Affairs scene, but it is starting to see more traction as our industry seeks to build capabilities in individuals and teams to navigate and harness the rapidly changing nature of Medical Affairs. Originally used to develop the managerial capabilities of high-potential, high- performing talent, learning agility can be applied not only at the individual level, but also at the team and organizational levels, and is associated with higher levels of organizational performance.3,4 For purposes of this article, we’ll focus on developing learning agility at the individual level and use the following definition:
Learning agility requires both adaptive readiness to change and proactive innovation in times of ambiguity.5 In essence, learning agility activates the value and impact of Medical Affairs strategic planning components (i.e., situational analysis, medical strategy, tactical and operational plans, and assessment and measurement metrics) despite change and shifting expectations internally and externally.
When it comes to Medical Affairs strategic plans, it is no longer sufficient to rely on the intellectual and tactical domains of competence. Successful Medical Affairs strategic plans reflect a collective organizational capability—an integrated representation of knowledge, skill, and mindset—that brings to life within the plan the flexibility to adapt, learn, and pivot toward changing needs. Learning agility is the “how” behind the “what” of Medical Affairs strategic plans.
The integration of learning agility and Medical strategic planning is important to how both strategic and day- to-day operational decisions are made. This is even more important today as Medical Affairs is being asked to communicate and demonstrate its impact and value within competing priorities from more diverse and increasingly challenging internal and external stakeholder needs. In addition, due to COVID-19 disruptions, including closed conferences, Medical Affairs is forced to reconsider how to communicate and how to balance between strategy and tactics in an uncertain environment.
Using the strategic planning framework developed by MAPS, the section below looks at the fundamentals of Medical strategic planning and suggests related learning agility behaviors and mindsets that are instrumental to both intellectual and tactical outcomes. The learning agility behaviors form a kind of permeable flexibility and protection that ensures the strategic plan is created and maintained with maximum adaptiveness (as seen in the above diagram). Learning agility brings strategic plans to life and articulates specific behaviors that support the strategic plan having bigger impact through greater relevancy. A strategic plan must be relevant to have impact and the learning agility behaviors associated with MAPS’ four elements of strategic plans makes them applicable for the teams using them.
In this article, we have identified learning agility as an emergent capability that brings to life and ensures the relevancy of Medical Affairs strategic plans. Specific applications were discussed for each learning agility behavior in context to its associated strategic planning element. The importance of developing the skills and mindsets to navigate change, uncertainty, and disruption are evident, now more than ever with COVID-19, and important to developing the capabilities to harness the future, whatever may come within Medical Affairs.
1. Hallenbeck, G., & Santana, L. (2019). Great leaders are great learners: How to develop learning-agile high potentials. Center for Creative Leadership white paper, 1-16.
2. MAPS Annual Conference (2020). The importance of Medical strategic planning. Conference presentation: Miami, 1-23. Access in the Community Portal.
3. De Meuse, K.P. (2017) Learning agility: Its evolution as a psychological construct and its empirical relationship to leader success. Consulting Psychology Journal: Practice and Research, 69(4), 267–295.
4. McCann, J., Selsky, J., & Lee, J. (2009). Building agility, resilience and performance in turbulent environments. People & Strategy, 32(3).
5. Doeze Jager-van Vliet, SB, Born, MPh, & van der Molen, HT (2019). Using a portfolio-based process to develop agility among employees. Human Resource Development Quarterly, (30), 39–60.
6. Bourgoin, A. & Harvey, J-F. (2018). Professional image under threat: Dealing with learning–credibility tension. Human Relations, 71(12), 1611–1639.
Joseph Eid, MD, SVP, Head of Global Medical Affairs at Bristol Myers Squibb, describes how Medical Affairs can ensure representation of the patient voice in product development, and the positive shift and elevated prominence Medical Affairs is achieving within companies.
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Download the Presentation
Members may also download a PDF copy of Dr. Eid’s panel discussion on The Value of Medical Affairs from the MAPS 2020 Global Annual Meeting as well as a recording of the session in the Community Portal.
View the White Paper
You may also view our latest white paper on the Communicating the Value of Medical Affairs, by clicking here.
