This case study-based webinar discusses how to connect the dots between internal training and improve patient outcomes, specifically focusing on Medical Affairs teams.
The Series Podcast Objectives are:
Podcast objectives include understanding how the medical affairs strategic planning process can drive decision making throughout the year
This webinar describes the NeuroLeadership Institute’s SCARF model (Status, Certainty, Autonomy, Relatedness, Fairness) and its application to the practice of Medical Affairs
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 Now Murali compares this might-as-well approach to the biopharmaceutical industry’s traditional (and increasingly outdated) model of brand planning.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.
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.
This collaborative webinar discusses available postgraduate courses and insights from alumni into how their qualification helped advance their understanding of pharmaceutical medicine and their career.
As technology advances inexorably transforming the healthcare landscape, Medical is poised for a more strategic role within pharma – that’s the view of former Chief Medical Officer of Sanofi, Ameet Nathwani. However, nobody with whom he works closely would be surprised to learn that he is not a fan of the term “Medical Affairs”.
“This harks back to an understanding of the way that Medical functions used to work about 15 or 20 years ago, which was much more around supporting the scientific base of the commercial organization. I prefer to just refer to the Medical function as it has evolved and expanded enormously; it’s a much more strategic function now and where it sits in Sanofi, reporting directly to CEO level speaks loudly to the progress made in this regard.”
Underpinning this evolution are a series of distinct trends (see Figure 1) including the digital health revolution, the empowerment of the patient, and a requirement for continuous evidence generation. He explains: “It takes seven to eight years to develop a drug and, in that time, the healthcare system, the digital technologies, the innovation available, the way physicians practice, what the expectations of patients are, may have all fundamentally changed. So the question is: is the biologically innovative drug still relevant to patients and the healthcare system at the end of a long development process? And how do we ensure that digital health technology – the superconvergence of mobile, social, biometrics, genomics and AI – is being capitalized in everything we do? We see integrating digital health as a fundamental role of the Medical organization; from building a drugs-plus type of approach, through to real-world evidence is something the Medical function has to master.”
Another driver of Medical’s current transformation is the requirement for continuous evidence generation. This is the melding of Real World Evidence (RWE), digital health, post-approval evidence and patient insight. “At Sanofi, Medical is in charge of the Real-World Evidence platform. We’ve built it and we, in turn, provide a service to R&D, Medical teams and Market and Patient Access. We should be able to move earlier into development, by leveraging the RWE platform for adaptive registration approaches to new products. With a really effective Real-World Evidence platform, good analytics and a transparent network, you could set up a very comprehensive, continuous observational program that continually helps to refine the benefits and risks of our products in real life as well as uncover new indications.”
Nathwani thinks how we maximize RWE will define the Medical function’s strategic value in the future. “We can’t be regarded as a strategic function if we’re not looking at how we can play a relevant role in the rapidly changing healthcare system. So, as a Medical function, we need to understand and define what the future of Medical should be in anticipation of these changes. How do we re-define ourselves? Where do we get our inspiration from – which other parts of the business or which other businesses do we send our medical teams to for inspiration? For example, are some of our Medical teams spending time at the Consumer Electronics Show, where you can pick up signals on future trends and behaviors of consumers in general – how a view of how these trends could be applied to the health sector? At Sanofi, we spend a lot of time engaging with tech companies to try and get a sense of where they are going and brainstorming on how to apply these to health. The main message is that Medical needs to look at what’s happening broadly in the world of technology, analytics, as well as in the traditional areas of medicine and healthcare, and zealously bring some of those ideas back internally to assess if we can integrate them to help us improve outcomes for patients.”
One of the key challenges for Medical involves clarifying its new remit within the organization. Sanofi has selected nine strategic priorities for the function (see Figure 2), which serve as a roadmap for the transformation within the context of the evolving healthcare landscape. For Nathwani, the clarity this provides is a fundamental first step to making the function more value-driven, from early development right through to the end of the product lifecycle.
“There’s been a reluctance to measure the impact of Medical in the past as there wasn’t a clear definition of what it can achieve. We don’t measure return on investment, as commercial metrics don’t apply. We’ve been through this whole exercise of what we could do and what success looks like and how we measure the value that we bring: have we really made an impact on patients and physicians, have we fundamentally changed healthcare systems, have we introduced a drugs-plus solution that has truly improved outcomes? Do physicians regard the information provided by the Medical organization as credible, is the quality of the dialogue good, has it changed behavior? While complex and not easy to measure, these are the performance measures that we are trying to formulate in each pillar of our activities.”
Much of the work around redefining Medical’s role within the organization goes beyond just structural issues, and there are considerable challenges around culture and changing roles and expectations. “It’s probably the hardest thing to do right now. A first step is having top-down support. Following that, at the grassroots level, is there a clear roadmap or vision, is the platform that we’re trying to build and the vision for Medical truly understood by all stakeholders at all levels, including within the Medical function? There are many individuals in Medical today who have very different experiences and mindsets, some from a time where Medical occupied a more traditional support function role and maybe some of the teams are not fully convinced that we can truly make a difference to the strategic direction of the organization. It’s vital to get the whole organization on board and that comes from having a strong conviction, and a clearly defined roadmap of how to make this happen.”
A key component of a successful transformation will be an expansion of Medical’s capabilities – to allow a company to understand the patient experience, access, and influence a broad array of external healthcare stakeholders, and to act as a liaison between the medical community and the internal research organization.
“We described the required capabilities of the future Medical organization and we are creating the training platforms to accompany that. And we help them to understand the processes by which you transform. It’s not easy at the country level, where the ‘rubber hits the road’, because the pressure of the business and the resources and experience to lead change is much more difficult to obtain. We have taken the long view, so when we hire today, we try to hire for the future. We try to bring in people who have a better understanding of biotechnology, drug development, are strong on analytics and with a solid grounding in medicine, and where possible, a strong interest in the digital side. It’s tough. We also look for people with a very strong patient-centric focus as the energy and passion these individuals bring to our organization is tremendous, and keeps us grounded in our purpose”.
With today’s life science industry now under extreme pressure to deliver superior medical outcomes while simultaneously cutting the cost of drug development, the time is right for Medical organizations to earn their place at the leadership table by creating opportunities to deliver new value for both patients and the healthcare ecosystem. Different companies are at different stages of maturity in terms of their progression towards being a fully-fledged strategic partner. However, the lack of a unified voice is hampering progress, Nathwani suggests.
“Our weakness is the heterogeneity of the role that Medical plays across organizations. We have extremes, from Medical as a well-accepted key strategic partner, right through to other organizations where Medical is probably more in the mainly customer support role. That heterogeneity means that it’s very hard to get alignment. If you look at the R&D organizations across industry, there is more clarity around their value and role. The main R&D leaders regularly meet together in a pre-competitive forum to look at the future direction of R&D and discuss macro trends. We don’t systematically do that across the Medical leaders in industry. There are a few useful platforms, but given the heterogeneity of our roles, the discussions are not consistent and our collective influence and voice is not at the level it could be.”
Nathwani is a strong advocate for Medical Affairs coming together as a community to decide on the future direction of MA. “We need to align on what are the key priorities that we believe Medical should be working towards across industry. For example, can we agree what would be a reasonable way to present the value of Medical internally and externally? Can we agree on what are the areas that Medical should try to drive within organizations – be that digital or drugs-plus or lifecycle management, and so on. Can we agree on the optimal methodologies for collecting and using RWE or utilizing advanced analytics for post-registration studies? What’s our approach on the many industry topics around bioethics?
“For example, in our organization, Medical runs the Sanofi Bioethics Committee, which helps to form company-wide positions on fundamental issues such as data transparency, the way we conduct trials, our approach to patient groups, positions on nanotechnologies or genetic therapies. Medical could be much more instrumental on matters like these if we had a platform across industry which could integrate positions from other companies and gain alignment on them. There’s a lot of areas I think that an organization like MAPS could focus on, to really elevate the Medical organization and its voice in our industry.”
Medical has a window of opportunity to become a strategic function. It needs to make itself relevant to the changing healthcare ecosystem and is well-positioned to do so but it could easily “miss the bus” on this if it carries on as is.
The future of the function is very much in our hands, Nathwani believes. “It depends on what we do next. In fact, I think we’re at a tipping point right now. We either prove our innovative value by adapting to and addressing the external changes happening in healthcare and our industry, or we will continue to remain a mainly support function. There’s a lot to do. If we can, for example, use Real World Evidence platforms to fundamentally change the way we carry out drug development, understand patients and diseases, and leverage these to bring through our biologic innovations faster, more safely and at a reduced cost, that to me will be a remarkable achievement.”
The amount of data we are currently generating is astronomical. According to one often-quoted article on Forbes.com, some 90 percent of the data in the world was generated over the past two years alone. [1]
Today’s world is defined by data, with 2.5 quintillion bytes of data created everyday – and that pace is only accelerating as the Internet of Things (IoT) expands. No surprise then that Mike Devoy, Chief Medical Officer, Head of Medical Affairs & Pharmacovigilance at Bayer, predicts that the time is right for digital to transform our thinking about healthcare.
“I believe digital is going to become more and more important and, over time, it will transform how healthcare is delivered and also how drugs are researched and discovered. We’ve seen the explosion in data coming from the intensified use of wearable devices, sensors and so on, but now we have the computer power and the technology to start to really understand that information and turn it into relevant action.”
Moreover, Medical Affairs stands at the very epicenter of this digital revolution in healthcare, given the function’s scientific credentials and its potential to define, gather and interpret data to generate the insights that will deliver meaningful outcomes for the entire spectrum of healthcare stakeholders – but especially patients and healthcare professionals.
Sources:1: Bernard Marr, “How Much Data Do We Create Every Day? The Mind-Blowing Stats Everyone Should Read,” Forbes, May 21, 2018, https://www.forbes.com/sites/bernardmarr/2018/05/21/how-much-data-do-we-create-every-day-the-mind-blowing-stats-everyone-should-read/#228be95b60ba.
“In Medical Affairs, we have a unique role because we have a deep understanding of our products and knowledge of diseases. We should be looking to fit the new knowledge and insights that we can collect from Real-World Evidence (RWE) into delivering even better solutions for patients and the healthcare system. And, because we are in daily contact with healthcare professionals, patient associations and other stakeholders, we should be the ones who play a critical role in transforming that into something that actually meets the needs and provides services and solutions for end-users. By connecting what’s coming out of our R&D, the strategy behind the products from a commercial point of view, we could build this into an overall, integrated patient care vision.”
Dr Devoy sees scope for applying digital innovation across a range of areas but suggests that R&D, patient outcomes, and safety are the three to focus on initially. There is significant potential for how we conduct clinical trials: for example, using artificial intelligence (AI) within R&D as part of the drug discovery process, and also helping to better characterize and stratify disease and the according patient populations for study.
“If you look at a disease such as heart failure, we still have a pretty simple way of categorizing patients based on clinical examination, imaging investigation and some clinical tests. But almost certainly there are more different types of heart failure in terms of the underlying pathophysiology. So, if we can apply digital learning and artificial intelligence to better stratify these areas and therefore to personalize treatments, then I think we will overcome a lot of hurdles to improving patient care.”
Cost is already a major issue in healthcare and digital has the potential to help unlock cost-savings for healthcare systems and wider society, as well as for industry.
Digitally integrating electronic medical records (EMR), both to identify patients and then also to follow up and stay connected with them is another considerable area of potential.
“I think there are already examples starting to happen that could dramatically reduce the cost of particularly large outcome studies which you have to do in areas like cardiovascular. There are significant gains that can be achieved by applying technology to make the studies more efficient, more precise, simpler to conduct, and so able to be conducted more quickly and more cheaply.”
Digitally integrating electronic medical records (EMR), both to identify patients and then also to follow up and stay connected with them is another considerable area of potential. “We should be looking at diagnostic technology and EMR to detect and diagnose disease much earlier and enable informed decision-making – that will allow us to intervene with prevention before people become physically sick at the stage they might currently be diagnosed.”
Adherence and product safety are two further areas of great promise for digital.
“For as long as I’ve been in the industry, something we’ve talked about but struggled with is finding ways that we can help patients adhere to the treatment that they’ve been prescribed, so that we actually deliver better outcomes. The use of sensors, wearables and other applications may offer such a solution for enhancing treatment adherence. I also believe that we can help better understand the benefit-risk of our products using AI and big data approaches to identify safety signals and issues with products earlier.”
However, the fact that the technology is so new and accompanied by such a weight of expectation inevitably implies some formidable challenges.
“We read every day about how digital is transforming everything we do – be that personal finance, or interactions with retail – so I think the expectation from society is that healthcare will also transform in that way. But, clearly, healthcare has quite rightly some additional challenges relating to the sensitivity of people’s health data and taking the right care of that. So, we need to work with regulators, governments, patients and physicians to make sure that these solutions are accessible, trusted, compliant and fitted to people’s expectations.
As companies, we need to adapt to working and developing and being successful in a digital environment. So, that will mean hiring and developing new talent with the right skills in areas like data science and data privacy. But, also, we are not just competing with other healthcare companies, now, but numerous other technology companies and other industries for those skill sets. It’s not just hiring new people, but also developing capabilities, making our current employees more savvy about working with digital – how those technologies could be applied, what the potential options are.
One area where Medical Affairs in most companies is usually taking a lead is understanding, communicating and generating real-world evidence. That is going to put increasing demands on Medical Affairs organizations to be able to access and analyze large data sets. To turn this into useful and meaningful evidence that can inform both the decisions of our organizations but also inform other stakeholders such as regulators, physicians and patients.”
At Bayer, digital is already driving new business models and the organization is cultivating a new digital culture across its various businesses. “Digital will change our business models and how we relate to patients and healthcare professionals – it’s a high priority for us and we have created a strategic framework as well as a digital agenda to help us become future-ready. We really want to make digital technologies an integral part of our overall business acumen, value chain, lifecycle management and decision-making, and we’re looking at that as a critical aspect of our overall business. We also recognise that a lot of the innovation and expertise is going to come from outside and from different areas, from different sorts of companies.
“One thing I believe we’ve done very successfully is build up an approach for actively seeking external collaboration. ”Among the initiatives is a global program called Grants4Apps, established in 2013, where Bayer reaches out to companies that are in the early stages of developing in the digital health and care space. Bayer acts as incubator and offers mentoring support and access to Bayer expertise and knowledge to help them develop their business models and solutions. Meanwhile, the Grants4Apps Dealmaker program is a unique opportunity to acquire Bayer as a customer and is tailored for mature teams, startups and companies that have a solution ready to go for identified challenges.
We also partner with research institutions across the world and, where it makes sense, with various technology companies that are also entering the healthcare space. You look at who are the partners that are meaningful to your stakeholders – like patients and healthcare professionals – and how do you do something with that partner that creates more value. We strive to enhance our ecosystem (for example with subsidiaries in San Francisco and Boston) and constantly monitor the external environment trying to link business challenges and evidence needs to potential technological solutions.”
Nevertheless, to harness the potential of RWE – both from EMR and sensors and devices – companies such as Bayer will need to make sure they have the ability to handle large volumes of data, that the data is of the right quality and data privacy is respected, and that they have the right skills and methodological approach to succeed in this space. “I think we need to make sure that we operate to a high standard of scientific integrity and quality because there are certainly risks if you don’t. And you need to bring in different skill sets in areas that will allow you to collect, analyse and interpret that data.” Bayer has been working hard to find people with skills in areas of big data analysis, including data scientists and epidemiologists.
In conclusion, Dr Devoy emphasizes that all of these changes imply a significant mindset shift on the part of MA professionals, who will be moving from their traditional support role to much more of a strategic focus. This will involve the function engaging much earlier in the value chain.
“Medical Affairs will get involved in the early project discussions [helping] research colleagues think about the best approach in terms of patient target groups, disease, models, linking to external expertise and knowledge. He also envisages Medical building a strategy aligned with global and key countries where the function will conceive or build a medical strategy aligned with the overall plan, both in terms of data generation and communication.
“In some key topics, such as real-world evidence, Medical is very much the function that takes the lead role in working with all the internal and external stakeholders to create the strategy and then execute it across the organization. You see it in very tangible things in terms of resource deployment, which has changed very significantly over the last five years.”
Going forward, Dr Devoy sees Medical as being the trusted partner between businesses and key external stakeholders – patient bodies, physicians and regulators – articulating the value companies are providing to healthcare systems and to patients. MA potentially has a unique understanding of how that value can be created and delivered, and a key role in developing the evidence and solutions around that value in collaboration with internal and external partners such as R&D colleagues, digital providers, physician groups and patient advocates.
“As patients become more empowered to make healthcare choices, it’s more important than ever for healthcare companies to create compelling and satisfying experiences. Digital solutions and innovation have never been more at the forefront of healthcare and are an important part of Bayer’s long-term strategy. These solutions can drive down costs or boost efficiency, build connections to patients and dramatically improve patient outcomes.”
Dr Michael Devoy is the Executive Vice President for Medical Affairs and Pharmacovigilance for the Pharmaceuticals Division at Bayer AG. He is also the Chief Medical Officer of Bayer AG. He joined the former Schering AG in 2005 as Senior Vice President of Global Medical Development and was appointed to his current position in 2014.
Dr Devoy studied Medicine and Pharmacology at University College London and graduated with a Bachelor of Medicine/Bachelor of Surgery (MB, BS). He is a member of the Royal College of Physicians in London. He has extensive experience across Clinical Development and International Medical Affairs. His career in the pharmaceutical industry began when he joined Glaxo Group Research in Clinical Pharmacology.
“Probably the most important leadership experience came in my early career, when I became a Medical Director of a country – in that case Australia – where I had to operate with a greater degree of independence, lead quite a large team at the time, and balance all the diverse demands of the different stakeholders that interact with you: patients, physicians, researchers, regulators and internal colleagues in the business. I learned a great deal there about my leadership style: what my values were and what my drivers were, particularly through facing difficult issues and talking, reflecting on what we were trying to achieve; why and how you’re going to do that; and staying true to yourself in managing through those difficult topics.
“In terms of the sums, we had some financial challenges. I had to find a way of making my organization more efficient and responsive, and that was an important – and also, at the time – difficult experience. I then took on more senior global roles and an important step there (which I think applies to a lot of leaders in pharma and Medical Affairs) is managing globally dispersed teams with colleagues in lots of different time zones and countries. This involved balancing people with different cultural expectations, different perspectives on what good leadership looks like and how things should be communicated, how things should be managed, and managing and leading in that set-up.
“I’ve learned something from every leader I’ve had, in terms of how I’ve evolved and grown. In my leadership approach, one important learning I had with a leader was when one day I went to ask if I could do something and they said: ‘You should not be coming to ask my permission.
Come when you need my forgiveness.’ That was at a relatively early stage in my career and I think that gave me a perspective to take more personal responsibility and accountability for addressing situations and finding solutions. Not that it always went to plan, so I think then you accept you also have to take the responsibility for your decisions.
“Also, I had the privilege to work with leaders who modeled the best behaviors in terms of what ultimately is our priority in this industry, which is ensuring that the patients we serve receive the best treatments and optimum care and that we make sure that the trust they put in us as pharmaceutical healthcare companies is fulfilled. I would say that I learned equally from leaders who came from the commercial side of pharma and those who came from a scientific and medical side – all those different individuals have brought aspects to how my style of leadership has evolved.
“You don’t need to be the friend of your leader but, it’s important that you respect and understand their roles and actions and that they understand what you’re doing and how you’re doing it and what your vision is, and how that fits with the overall bigger picture.”