At the conclusion of this session, participants should better understand digital trends seen within Medical Affairs today as well as be aware of why HCP expectations are changing and how to evolve with them to provide better customer experiences
Evaluate the commonalities and differences in the use, structure and evolution of scientific communications platforms within and between companies; understand how a HealthScience approach can help to integrate insights, communications and evidence generation plans across multiple functions
Executive Vice President & CMO, UCB, Iris Loew-Friedrich discusses the importance of a purpose-driven culture to employee engagement
Caring for people – patients and colleagues – coupled with the science are the twin elements that form the foundation of Professor Doctor Iris Loew-Friedrich’s approach to her role. And this aligns neatly with the vision of her employer, global biopharma company UCB, and provides a platform for collaboration both within and outside the organization.
A physician by training, Professor Loew-Friedrich started her professional life at the Frankfurt University Medical School and has always tried to combine patient care with high-quality research. Today she is Executive Vice-President Development and Medical Practices and Chief Medical Officer at UCB, where she provides global strategic leadership across a range of areas.
“I still very much consider myself a physician, so patient care is really at the center of what drives me – and more generally it’s care for people: people living with diseases and also people in our company, in my organization and people in our industry are what motivates me very much.” This approach chimes with the way UCB articulates its vision: “Inspired by patients. Driven by science.” Professor Loew-Friedrich is confident that this “really sends out a message about who we want to be.”
She explains: “I think culture is the key driver and so creating a culture that gives colleagues a sense of purpose and the opportunity to make a meaningful impact is important. At UCB, we have one central question that we ask all the time: how will what we do make a difference for patients living with severe diseases? It’s the value-creation topic that is at the center of all of our work.”
And, of course, this vision resonates especially within the Medical Affairs function.
“Our mission in Medical Affairs is to drive the continuous modernization and integration of data from multiple disciplines and sources. Then we need to translate them into actionable insights with scientific integrity, efficiency and transparency so that we optimize the patient and healthcare professional experience. That’s a mission behind which we can all align. We try to ensure that all colleagues in our Medical Affairs practice understand how each of them contributes to this mission and we combine this with forming a culture of high-performing teams.
“Everybody is focused on the same purpose of creating value for patients. On top of this, we try to ensure that we are an organization that cultivates learning, innovating and high performance and all of that integrated with opportunities for personal development, recognition, and rewards. It is the entire package that is required to attract the talent for the future and to maintain and develop that talent in our organization.”
Moreover, continuous learning is key to fostering agility and adaptability, according to Professor Loew-Friedrich. “As the environment keeps changing so quickly, the ability of an organization to be agile and to adapt is very important and so these are important traits that we’re looking for when we are hiring talent – a mindset to innovate, to grow, a mindset of continuous learning.”
How can the organization attract this type of talent? “We aim to create the sense of purpose, the sense of belonging, and key opportunities for personal development and growth. In line with our practice thinking, we are trying to establish communities of colleagues who either have the same role in the organization or who work in the same geography or who are engaged around the same patient population. So, our communities are aligned on common themes and we see that as a major driver of identification with the Medical Affairs organization and a source of inspiration and learning.”
Leadership for Loew-Friedrich has always been about empowering people to have maximum impact in a team environment. “I consider myself very much as someone who creates opportunities and empowers people. I believe you cannot be a leader without being passionate about what you are doing. Of course, we need to be very objective in our decision-making.”
Asked about the key capabilities to be developed within Medical Affairs as we move towards value-based medicine, Professor Loew-Friedrich is clear: “From my perspective the biggest topic is probably around creating and mastering medical insights. The second area of focus is collaborating very broadly for evidence generation.
“In terms of generating and mastering medical insights, I think we have already plenty of data available but how do we then use the data to truly generate insights? For me, this means that it’s not about just generating outputs and results, but really going one step further and distilling meaningful insights, providing context and ultimately driving impact. “On the second topic – collaboration for evidence generation – I think we have plenty of opportunity to join forces with academia or other institutions outside of our industry to invest our joint resources into the acceleration of the advancement of medical science. If a medicine gets to a patient in its first indication, there is a vast opportunity in terms of further knowledge and insights being generated: how can we get to the best ideas and how can we turn them into a true win-win situation that will create value for patients? This is where I believe we can collaborate closely with academic institutes, patient advocacy groups and other stakeholders to really get to the best possible outcome.”
Professor Loew-Friedrich points out that collaboration will be enhanced by advanced technology. “What I am seeing for the future is that we need to launch artificial intelligence capabilities – so that we use the data to simulate scenarios that will very objectively inform the next steps and ultimately enhance patient care. One of the big topics around collaboration for evidence generation is building on the strengths of human intelligence and artificial intelligence and establishing seamless interaction between both.”
How can we measure our performance in this new world? “Performance management is a topic that we continuously need to evolve and that is not as easy as it sounds. We’re trying to move away from very simple, quantitative measures – number of scientific exchanges, number of publications, impact factors – to measuring the quality of our analytical skills and the insight generation. Getting to meaningful qualitative measures is not an easy task. And I understand it’s not only difficult for UCB, it’s a challenge for the entire industry.”
Finally, the new operating model elevates Medical Affairs from a supportive role into a strategic decision-maker and trusted scientific partner: how is this change manifesting itself within the organization? “We are moving towards an integrated model that provides the Medical team the right space to be a trusted scientific and strategic partner ‘eye-to-eye’. What we need to continue to enhance is leadership and business acumen of our medical colleagues. This is not only about scientific leadership and leadership in insight generation, it’s also leadership in the most classical sense of providing direction, engaging and inspiring colleagues – inside Medical Affairs and beyond. That’s a work in progress and a key competency that we continue to strengthen in the organization.”
The digital health revolution implies a clear understanding of strategy, using technology as an enabler to create better outcomes for patients and to power value creation across the healthcare ecosystem. As data specialists, Medical Affairs professionals will be at the forefront of this transformation.
The medical world is changing and changing fast. As multiple new technologies start to transform every aspect of the healthcare ecosystem and the lines between biosciences and data science fade, companies need medical leaders who not only understand the latest medical advances but also the potential and scope of data and digital, along with their implications – not least that this new paradigm requires strategists who are comfortable with organizational transformation and who can lead change. Dr Rajni Aneja is one such strategist: she specializes in the crossover between business and technology across a variety of health sectors.
“My training falls at the intersection of business and technology and I have worked across all different healthcare sectors from payer to a consumer digital company to pharma, as well as being involved in an advisory capacity for innovation and strategy in health for MIT and Harvard Innovation Lab, along with Oliver Wyman, and many other start-up companies.
“From an industry standpoint, I am interested in the role of digital facilitating consumer as well as HCP engagement strategies, or patient journeys through a variety of touch points leading to better clinical outcomes, better clinical interactions, better patient experiences, better healthcare provider experiences, as well as better delivery of healthcare.”
This approach is all about strategically using digital as an enabler driven by data. “When we create a strategy around a digital experience, it’s not about the technology. I see the technology as an enabler: when you apply the right technology at the right point and have the right interventions designed – either for the provider or patients – that is when it actually is impactful or meaningful.”
Longer term, advances in bioscience and digital technology have the potential to add value to the system in multiple ways: for example, by transforming the R&D process to potentially make it shorter, more specific, and take out cost; by ensuring better health outcomes for patients, bringing forward new treatments more quickly, and generally improving the patient experience; and by providing opportunities for physicians through new options to advance patient care and offering new ways to engage and learn.
We are only at the start of this journey today but Dr Aneja points to significant potential that already exists. “As a physician, when you see patients in clinics, you’re only seeing 15 to 20 patients in a day. But if you have technologies like telemedicine, where you are delivering consultations on videos, or you’re delivering care to remote areas, your impact and outreach becomes much wider and much more significant.
“I see telemedicine as one of the technologies to have gained a lot of momentum, not only for its potential in clinical trials but also for prevention and wellness visits, or even acute care visits. But what’s coming next? I think the future is where data is driving or enabling these technologies, and this is where artificial intelligence or machine learning comes into play. However, if the data is not good enough, anything that is going to come out of it is not going to be good enough: garbage in, garbage out. The importance of data as an asset is that you drive intelligent decision-making and that is only done through insights generated by the power of data that is collected from a variety of technology enablers.” As an example, she cites finding the right patient for the right clinical trial at the right time for the right medical condition, while delivering the right care, all of which can be powered and informed by the data.
Today, real-world evidence (RWE) and data – especially continuous real-time data – sits at the heart of where the healthcare ecosystem is headed, not least in the context of value-based health design and care delivery, where (especially in the US) the system is moving from volume to value, and there is more emphasis on better outcomes. This implies that data can be both shared and combined effectively, and also that RWE – including data directly from the consumer, say from wearables – can be integrated with historical data and combined with real-time analytics.
“There’s an evolving trend that we’re seeing: in the last two to three years pharmaceutical companies have started to work very closely with the payers. But the industry is becoming disrupted and I think all these stakeholders can learn from each other to say: ‘How am I going to be a leader in the game instead of a follower?’”
The trend within the healthcare sector is asking for more integration of data and collaboration between organizations – joining the dots – to generate insight from the payers as well as from pharma and from consumers. “This is a collaborative effort around value-based care and an outcome-based approach, which will lead to better patient care and better clinical trials. But there are many challenges remaining before this data utopia becomes reality, including a lack of agreement on definitions of what constitutes value. What is considered good-quality data, data privacy, data governance and data security and many others factors would play a vital role in shaping the thought process as we move along this transformation journey.”
So, what are the hurdles? The regulatory environment is one, but regulators and government are increasingly aware of the need to advance. We have seen the introduction of the 21st Century Cures Act; as well as statement from FDA commissioner, Scott Gottlieb about the importance of digital health and real-world evidence, and there are efforts now around guidance from the governing bodies. Commercial sensitivity is another issue, but industry is increasingly acknowledging the need for collaboration – perhaps through neutral consortium – to harness the power of data and analytics. As an example, Dr Aneja cites the NEWDIGS project, through MIT’s Center of Biomedical Innovation, which brought together various pharmaceutical partners in a neutral, non-biased, cohesive setting. However, she acknowledges that “we’re taking baby steps and are in exploration mode with a desire for more collaborative models, and not yet ready for prime time yet.”
And what about the benefits? There is clearly substantial value in a system that encourages us to learn about the patient – not least, greater customization, personalization, and simplicity for the patient. This encompasses patient-reported outcomes, behavioral profiles, social, and other demographic data leading to consumer segmentation, which in turn can deliver on targeted interventions and interactions.
Dr Aneja elaborates: “I’ll give you an example. Rajni is a 40-year-old female who runs every day and is pretty healthy and motivated and doesn’t take any medicine, but is very interested in her well-being. Because of the combination of data from different sources, we can create a profile of what Rajni wants, what Rajni needs, how we engage her, how we motivate her and do that on a continuous long-term basis; and data can enable targeted, personalized interventions – interactions that are actually applicable to Rajni, not one-size-fits-all. Data can help you get to that level of granularity, but I always say that with a word of caution: we’re not there yet. But that doesn’t mean that we can’t get there; it’s just that we’re on our way to this kind of transformation.”
And this opens up a whole world of further possibilities: Rajni might be part of a cohort that you could segment in the context of preventative health and screening, and so on. So there’s an opportunity to gain a depth of insight into individual patients within a population. “Imagine if you could understand, in your population, who are my well people? Who are my sick people? Who are the people who are very, very motivated? Who are people that actually need a lot of nudging because they’re not motivated? With the years of data, you have the ability to be not only predictive but at some point can be prescriptive, especially for precision medicine.”
Beyond this, digital needs to make life simpler and more convenient for patients. Healthcare is already becoming more consumer-centric. “I think it’s already happening. You already have Uber Health; we have telemedicine solutions; we have remote monitoring; we have wearables and sensors. I think the trend that we see is consumers becoming more involved in taking responsibility for health; they’re becoming more informed. Consumers want to manage their health, want to see their healthcare data, and want to be equally responsible for decision-making.
What needs to happen going forward? “I think it’s an industry shift.” There is recognition that we need to accelerate this process, according to Dr Aneja. In conclusion, she sees a significant role for Medical Affairs within this new environment – as the conduit of the digital transformation. MA can help define the problems we are trying to solve, along with the data sets and technology that will enable a solution. “They are absolutely vital. You would not create an initiative in a silo; technology is an enabler. Ultimately the insights coming from MA about what problems we need to create an effective solution for will lead to better patient outcomes as well as better patient experience.”
Biography
Rajni Aneja is an MIT Connection Science Fellow, healthcare strategist, public speaker, and transformative change agent with expertise in population health management and digital health. She serves as an adviser to a variety of health and wellness organizations. Dr Aneja encompasses various vantage points as a clinician, executive, adviser, entrepreneur, speaker and technology advocate serving in senior leadership roles. These include Chief Medical Officer for WebMD health, EVP of Joslin and a strategic executive and transformation leader at Humana. Most recently she contributed to the building of a digital consumer strategy at Novartis. Dr Aneja received her MD from Research Medical Center in Kansas City and her MBA from the University of Massachusetts.
This MAPS podcast introduces listeners to social listening to gather insights and discusses implementation, value and technologies.
This Webinar provides perspectives on the evolving role of Digital Opinion Leaders in medical education and shares approaches for identifying, monitoring and engaging them in a compliant manor with relevant examples.
“The ubiquity of mobile devices now means that we have an opportunity through these digital technologies to improve health outcomes: through basic communication services, but also highly innovative services with regard to tracking and sensor development, measurement of biometrics and delivery of medical services.” He suggests that the vision for digital health is nevertheless relatively straightforward: “It’s not just about providing information, but rather providing integrated services that are proven to improve clinical outcomes.”
Digital therapeutics, Butler adds, are prescribable digital programs or interventions that should be shown to improve outcomes. “They’re called therapeutics because they already have some form of evidence base behind them in a more traditional sense, mostly because they’ve derived out of cognitive behavior therapy and mindfulness where there’s already a lot of evidence for these programs.”
The sheer velocity of the digital revolution means that in in recent years we have seen not only more advanced capability, but increased application in areas of previously unmet need. Metabolic disorders, psychiatric disorders, and cardiovascular health, among others, have seen their management transformed dramatically by digital health solutions, notes Butler.
Health technology companies, academia, HCPs, and patients – as well as pharmaceutical companies – are delivering these digital solutions successfully. Butler highlights a couple of examples, including GlycoLeap’s diabetes system. “This tracks the obvious things like your activity, your nutrition, your glucose levels and your body mass index, but also combines it with a behavioral psychologist and nutritionist that you can access at any time. Basically, you get a personalized diabetes management program through your smartphone app, which would never have been dreamed about 10 years ago.”
There’s also Omron’s smartwatch which measures blood pressure with clinical accuracy at the push of a button. “This can actually take your blood pressure through the watch strap alone and you can link it to AliveCor, an FDA-cleared medical-grade EKG”.
“Essentially, an everyday person can have what would have been not really possible outside of a cardiology department on them all of the time in their own home.” Even if this was available years ago, it would have cost tens of thousands of pounds, he adds.
The key role of Medical Affairs in driving the proliferation of these solutions necessitates a strategic approach. According to Butler, a model of clinical significance, behavioral change and user need must be applied to the development of digital health initiatives.
“Certainly, in the early days of strategically designing any kind of program or initiative, a requirement is that there’s clinical relevance. The days of just ticking a box, or even more than ticking a box, just providing information to patients about the disease through a different channel or on the phone (as opposed to a leaflet) is not really the point of what we’re trying to do with this.”
People tend not to respond to information; rather, the vast majority of decisions in healthcare are emotional decisions and Butler contends that we need contextual support in order to fundamentally change our behavior. Proven clinical outcomes – as well as patient outcomes, which he says are “at least as important” – must therefore be an inherent part of the digital health offering.
Behavioral change is another essential element. Butler explains that in the majority of digital health interventions, particularly in the management of chronic disease, the focus is on trying to help people to slightly modify or change their behavior. “Which, sometimes at least, can drastically improve outcomes. Again, if the program doesn’t have a genuine element of behavioral change in there, or you don’t understand what behaviors you’re trying to modify or support, then it’s probably a red flag that it’s unlikely to be successful.”
User need is the third and final part of this strategic approach, and although it seems obvious, Butler says it can often be omitted completely.
“What’s the actual value for the individual, patient or, more importantly, person that’s using this tool? Even if it’s easy to understand why the pharmaceutical company or even the healthcare professional might want someone to do something, it’s not always obvious why you, as a person, would want to partake in a lot of these things.”
He reels off examples of digital health being superfluous at best, pointless at worst: “data entry systems, diary systems without any obvious value, requirements to complete tasks with degenerative diseases without any kind of user value or interventions that can actually improve your outcome.”
Even with a strategic approach, there are inherent challenges for any pharmaceutical company developing any kind of digital solution. Ultimately, an initiative should be sustainable for that particular organization, and must be given adequate investment of both time and resources, Butler advises. “If you’re not doing something that is sustainable for your organization or meeting your commercial objectives, then it’s unlikely to have any traction over any period of time. Obviously, we know that these things need investment, care and nurturing over years, not just the scope of one motivated person. For example, if you’re working in a disease area where for clinical trial purposes you would like to be able to better track outcomes and you can use digital health tools to do that, then that’s obviously going to be sustainable, especially if you have a long pipeline in the disease area, or it’s incredibly important that you do everything you can to help people stay on the medication, or not to relapse in a condition.”
Butler agrees the future custodians of the vast majority of high-level digital investment will be Medical Affairs and says they must take an active interest in driving the strategy and the implementation of these programs. “At the very least, Medical has to have a key involvement, because this is talking in many ways about doing the same things that you would do for a medicine with regards to bringing that scientific rigor into the design of the program and into the evidential proof that these things have an impact on patients.”
This poses both ethical and compliance challenges, says Nicholas Broughton, an independent consultant in pharmaceutical ethics and compliance. For some in Medical Affairs roles, the word “digital” immediately evokes thoughts of banner adverts, one-too-many email campaigns, or health professional websites seen as commercial tasks that require medical review and approval, he tells Elevate.
“The problem is that this ‘one-bucket’ perspective on digital means that the ‘commercial produce/medical review’ approach is extended into digital activities where it is not appropriate. Provision of digital health solutions is one such area. To me, these are health interventions that solve problems for patients and there is a very clear analogy with the health interventions we call medicines. We have a moral duty to protect patients using such interventions from harm, respect their autonomy and maximize the benefit they can gain.”
Broughton echoes Butler, saying if something is being developed digitally to improve patient care, then it must be understood what the need is, how to prove benefit and how to avoid harm. The ethical implications must be crystal clear. “We can’t afford, as an industry, to provide health interventions that have flaky reasoning, no proven value and which may misinform or mislead and threaten patient safety.”
Yet he is adamant that despite the myriad ethical and compliance obstacles, Medical Affairs are uniquely equipped to lead the development and introduction of digital health solutions in all their guises.
“The skills and knowledge to develop useful interventions and prove they work and are appropriately safe – be they medicines or digital health solutions – lie in the medical and development functions in pharma. By all means, let our marketing colleagues provide ideas and input and promote what we produce, but scientists and health professionals in industry must lead development.”
Competing on outcomes means designing entirely new systems of health engagement that link and satisfy three perspectives simultaneously: the payer plus the provider plus the consumer (patients and caregivers).
Organizations seeking to create “value” in the new outcomes-based healthcare world require a profound change of mindset. They need to incorporate “big design” thinking to help transform the way they engage with a $7 trillion healthcare market undergoing structural change. This has less to do with the promise of digital and emerging technologies, as it does with understanding that digital – while transformative – is a means to an end, not the end. In healthcare, it’s value innovation first, technology innovation second.
That’s the view of John Singer, Global Head of Health Industry Strategy, Innovation and Technology at Wipro, whose remit is to help clients reframe their market and business strategies to succeed in the new environment.
Navigating this transition space takes a new frame of reference that dissolves boundaries and spans the entire organization – not just a digital bolt-on to the current state – and requires solving for fragmentation and continuous health engagement, at scale. It has many facets encompassing co-creating new models of care with customers, care delivery innovation that weaves in the social determinants of health, as well as technology and digital. “We’re working with one pharma around strategic transformation of their business, helping them understand how you compete on value, not the technical merits of a me-too drug. These are much deeper sorts of conversations than just, say, applying new technology to old business models. One way to understand it is that a dinosaur in a fur coat is not a mammal.”
A significant issue is that product classes with fundamentally new performance profiles – and costs – (such as we see in precision medicine) can’t be dropped into an existing business model and expected to work. The business model – how value is created, captured, and delivered – needs to be reinvented to support the new proposition [1].
“The space of opportunity is for industry to be the catalyst, to lead strategically and be the drivers of change. For instance, if you take a look at what the NHS is asking of pharma, it is to come to the institution with new ideas and ways to co-create new models of care and sustainable systems designed around patient needs.”
As an example of this new approach, Singer points to the recent deal between the NHS and Merck Germany involving the company’s Mavenclad MS drug. (See sidebar 1: NHS outcomes-based pricing deals)
“Merck was trying to get Mavenclad on formulary, but NICE was pushing back, saying they already had enough MS drugs. So Merck went back and reframed their value strategy, essentially positioning themselves as an information service. They asked what if we were to collaborate with you and build out an entirely new infrastructure to capture and analyze real-world evidence across the disease state – not necessarily specific to Merck’s drug, but going ‘above brand’ and co-creating an entirely new capability to enable new insights and better outcomes in multiple sclerosis. Because of that, NHS said okay, and Mavenclad made it on formulary. It’s a great example of value innovation first, technology innovation second.”
[1] Josh Suskewicz and Moni Miyashita,“3 Business Models That Could Bring Million-Dollar Cures to Everyone,” Harvard Business Review, November 12, 2018 https://hbr.org/2018/11/3-business-models-that-could-bring-million-dollar-cures-to-everyone.
NHS England unveiled two bespoke pricing deals with pharma companies at the FT Global Pharma and Biotech conference in London on November 10, 2017. Chief executive Simon Stephens personally announced the two deals and confirmed that such “commercial access agreements” will become a permanent part of the UK pharma market.
NHS England’s motivation was that drug costs were rising faster than general costs and there was a perception that it didn’t always get the best value. An agreement with Merck Germany ensured the availability of its multiple sclerosis drug Mavenclad (cladribine) as part of an outcomes-based pricing agreement. The drug is expensive, with a list price of £2,047.24 per 10mg tablet (albeit that this will be discounted). However, the outcomes-based agreement will mean the NHS will only have to pay for medicines for those patients who respond to the drug.
Going forward, the NHS is looking to pursue more creative and flexible arrangements with pharma. Stephens was quoted as saying: “I think it is a precedent-setting deal, in as much as it includes shared risk in what we hope are going to be very strong outcomes. That is the kind of process we would like to see more of.”
Reference: Andrew McConaghie, “NHS England chief hails ‘precedent setting’ outcomes deal with Merck,” Pharmaphorum, November 10, 2017, https://pharmaphorum.com/news/nhs-england-chief-hails-precedent-setting-outcomes-deal-merck/.
“Those are the kinds of strategic transformations and collaborative innovation models that we see as a new feature to the operating environment, and which are reflective of what pharma customers are looking for – it’s almost more B2B. And then, obviously, the technology stack that goes into that story, including the digital component (both existing as well as emerging) as well as what you can invent, all comes into play in terms of building out that roadmap and that new value proposition.
“But the bigger story is all about leadership: how should the pharma industry step outside of itself and understand how they can co-create a new value strategy in a way the competitors can’t. The story’s going to be less drug-based or less brand-based, versus how can they explore above-brand strategies, collaborating and designing entirely new systems of population health engagement, weaving in the social determinants of health and then managing that system over an extended period of time in terms of generating the evidence, removing the administrative burden.
“We’re working with a pharma company to basically design an entirely new system of health in the State of Missouri, as well as in Korea. And these are very large initiatives – it’s first looking at designing an entirely new infrastructure and then managing that infrastructure in a way that’s going to drive business value. And by infrastructure, I mean how do you connect the payer data, the electronic health record data, and the provider data in a way in which you have those things flowing freely between the pieces – and how do you add value onto that and then how you monetize that?”
Summarizing this approach, Singer says: “I would say, in general, what we’re seeing globally across all of those sectors is a shift from product-based business models to how they can reposition themselves strategically and almost become like an information service in some cases.” Integral to this is for pharma to understand the barriers to full digital adoption and stepping away from the narrow view that the business is simply about how to research, manufacture and sell drugs.
“That’s not the same thing as an outcomes-based model where the drug is a component. And then how do you understand service and experience? And how do you navigate that transition space where the conversation, the dialogue and the business opportunity are becoming much bigger than that, and you’re actually involved in shaping new models of care delivery, which is what the Merck example was. To illustrate this, Singer offers the example of a Netflix-style subscription model for the reimbursement of hepatitis C drugs in the State of Louisiana, developed in conjunction with Gilead, Merck and AbbVie (See sidebar 2: Louisiana subscription-based payment model).
Louisiana has rolled out a potential solution to help it afford the high cost of hepatitis C drugs. This “subscription-based payment model” sees it partnering with pharmacos to pay a fixed annual cost for unlimited access to drugs to treat Medicaid recipients and prisoners. In a request for comments on the proposal, the state notes that the patients are underserved by current payment systems, and that the model could benefit the state and drug-makers alike. Louisiana Department of Health Secretary Rebekah Gee said in a statement that such a model “would create an incentive for us to find and treat as many people as possible.” Gee noted the proposal “would guarantee a fixed purchase price for a contracted period of time, and would allow the drug manufacturer to expand their product reach into populations that otherwise would not have received treatment.”
Reference: Eric Sagonowsky “Louisiana seeking comments on ‘Netflix’ model for hepatitis C drugs,” FiercePharma, Aug 16, 2018, https://www.fiercepharma.com/pharma/louisiana-seeking-comments-netflix-model-for-hep-c-drugs.
He adds: “Again, this touches on the thing that you’re looking for in terms of digital health because you can’t create a Netflix-like subscription model unless you’re really having a digital conversation, a technology conversation, an AI, automation, and data conversation. But all of that has to happen simultaneously and interactively with the business and market conversation.”
So what needs to be done to make this happen? Singer reemphasizes the importance of being able to ‘paint both sides of the fence’ at the same time. This is about thinking new thoughts to create new ideas. “It’s a mind-set shift; it’s a cultural shift. A good example of those two things is that Merck US just hired a new chief digital officer from Nike to bring something like a digital sixth sense to the organization.”
Turning to the specific role of Medical Affairs in this new paradigm, Singer views this as an opportunity to position Medical Affairs not simply as technical product advisers around one drug, but as a source of value to demonstrate to physicians, payers, patient groups and key opinion leaders how to improve outcomes. As the demand for real-world evidence grows, so too will the demand for new scientific understanding of disease.
He sees a transformation from Medical Affairs into “medical value teams”, able to communicate scientific evidence with insight and impact on care delivery, while building long-term relationships with a variety of stakeholders. “You’re almost changing the concept of science so that you’re really evaluating information and ‘specialized cognition’ as an asset to the business, and having conversations and content and new evidence around that.” In the new conversation (which is going to be less about branding a promotion in detail and more around the science or new models of care) this will likely be led by Medical Affairs and the MSLs globally.
In conclusion, Singer argues that “value” in healthcare remains largely unmeasured and misunderstood – and this is an opportunity: whoever does the better job at designing value systemically will be the winners strategically. He stresses the importance of rethinking market strategy and segmentation based around health economics and outcomes modelling. “The faster you can build up that outcomes story and that new economic argument, the more successful you’re going to be selling that in.”
John Singer is Global Head of Health Industry Strategy, Innovation and Technology at Wipro. He brings more than 25 years’ experience in marketing and strategic innovation across all dimensions of the global health sector, including medical device, pharmaceutical, biotechnology, payer and provider clients. He specializes in reconfiguring markets and helping clients navigate the transition space to compete on outcomes.
Singer argues that Medical Affairs is perfectly positioned to drive value-based outcomes, transitioning pharma into new business models and away from an industrial-era view of “market” bounded within the context of discovering, pricing, manufacturing and promoting the technical merits of a physical product (i.e., drug brand), to a model based on embedding “drug” within entirely new systems of health engagement. He is also a guest lecturer on health system innovation and pharmaceutical market strategy at leading organizations and business schools, including Cambridge University, ESCP Europe, the RAND Corporation and McGill University.
Dubbed by New York Times best-selling author and leadership guru Tasha Eurich as the meta-skill of the 21st century, self-awareness is as desirable as it is elusive, given that a staggering 95 per cent of people think they possess self-awareness, but only about 15 per cent of people really do. Self-aware people are more fulfilled, more creative, successful, more confident, build better relationships, and are more respected and effective leaders with more profitable companies. There’s just one problem: most people don’t see themselves quite as clearly as they could, and it’s rare to get candid, objective feedback from colleagues, employees, and even friends and family.
In her new book, Insight, organizational psychologist Eurich tackles this paradox and offers an explanation for this disconnect. “The reason I call it the meta-skill is that it’s underlying or foundational to all of the skills that are required to succeed in the 21st century – things like emotional intelligence, influence, persuasion, sales. If you are not self-aware, if you do not understand who you are, how others see you and the role you play in the world, you are going to come up short. But for most people, it is easier to choose self-delusion over the cold hard truth.”
Eurich argues that the increasingly “me-focused” society makes it easier to fall into this trap. “Recent generations have grown up in a world obsessed with self-esteem, constantly being reminded of their special qualities, and it is fiendishly difficult to examine objectively who we are and how we’re seen.”
Indeed, psychological research indicates that are we are not very good at evaluating ourselves accurately, frequently overestimating our abilities: for example, the Dunning-Kruger effect results in “illusory superiority” – a condition of cognitive bias whereby a person overestimates their own qualities and abilities, in relation to the same qualities and abilities of others. What’s even more alarming is that those with the least ability are most likely to overrate their ability to the greatest extent.
For Anne Welsh, Executive Coach and founder of Synthesis-in-the-City, the first step for a leader is to have a willingness to be self-reflective and, from being self-reflective, to build greater self-awareness over time. “If we think about the old style of leadership, it was very different from now where leaders are asked to be a lot more relational. Personally, I think that it takes courage to build self-awareness, because if you become more self-aware in one area, if you like, you have to actually open to your shadow as well as the positive aspects of self-awareness. So, I think self-awareness is a leadership journey and it demands courage.”
For Welsh, this journey needs to be a conscious choice. “In some ways, this learning could come from feedback from others, from 360-degree feedback from subordinates, colleagues and supervisors, but also I think you can begin to choose to take ownership, even keeping a reflective journal, to begin to recognize what works well in my relationships with others and especially as a leader. Where do I, maybe, get caught where my own beliefs and mindsets are stopping me actually being able to be relational as a leader?”
Watch Tasha Eurich in the video below to learn how to become more self-aware by making three life adjustments: deciding to learn the truth, getting more feedback, and asking what you can do to make a change in every situation.
In her book Insight, Eurich talks about two types of self-awareness: internal and external. “Internal self-awareness has to do with seeing yourself clearly. It’s an inward understanding of your values, passions, aspirations, ideal environment, patterns, reactions, and impact on others. People who are high in internal self-awareness tend to make choices that are consistent with who they really are, allowing them to lead happier and more satisfying lives. Those without it act in ways that are incompatible with their true success and happiness, like staying in an unfulfilling job or relationship because they don’t know what they want.”
External self-awareness according to Insight is about “understanding yourself from the outside in – that is, knowing how other people see you. Because externally self-aware people can accurately see themselves from others’ perspectives, they are able to build stronger and more trusting relationships. Those low in external self-awareness, on the other hand, are so disconnected with how they come across that they’re often blindsided by feedback from others.”
Eurich names “three building blocks” that must be in place for a leader to drive a self-aware team.
“First, if the team doesn’t have a leader who models the way, the process will be seen as insincere or even dangerous. Second, if there isn’t the psychological safety to tell the truth, the chance of candid feedback is almost zero. But even with all this in place, you need an ongoing process— not unlike Ford CEO Mulally’s BPR (Business Plan Review) to ensure that the exchange of feedback is built into the team’s culture.”
For Welsh, it comes down to reviewing your emotional state and having the awareness and capacity to shift that state when needed. “Internally, consider what sort of state am I in: am I in a state that’s available and do I have the capacity to shift my state? And this is where mindfulness can come in or knowing how do we shift our state at any given moment.
The second self-awareness is about awareness of ourselves in relation to others and that takes quite a lot of sensory awareness as well. So, if we think that leaders maybe have to come from a place of ‘head, heart and gut’ (in the old leadership style, it’s much more head-identified) a leader can have greater sensory awareness and the guts to risk finding out ‘how am I coming across to others?’ So I think there’s a piece about awareness involving how we, as a self, are relating to others and how we’re impacting on the environment.”
Welsh advocates that leaders need to be conscious of their impact and how their message affects employees.” I think it’s picking up on body language, even if you think about a leader giving a presentation, do they talk at the people or are they gauging ‘how is this coming across to the people in the room? Are these people who need me to be more relational or do they just want slides?’ Because so often in presentations that leaders are giving, they’re just talking at the audience, they’re not checking out how this is landing, for instance asking “does this have a resonance with you?” which would be a much more relational way of interacting as a leader – so the leader actually asking questions, not just giving information.”
Welsh also advises that leaders be conscious of the dynamics at play within a team setting. “I love Nancy Kline’s work on Time To Think and if we look at self-awareness in teams, we have to be conscious of the psychological dynamics that go on within a team – noticing, what’s the role that I take on in any team; am I always the one that’s the challenger? Am I the icebreaker? Inviting teams to reflect on what are the dynamics that are going on in this team, alongside what is it that we have to do and what do we need to deliver? Because it might be that somebody gets labelled and gets scapegoated in a team and the other members of the team can feel quite comfortable because it’s not them. So, I think that in a team, helping them to think about what is the role that I maybe take on, even from [family] history – because teams are just like families: often you’ll find that the role that people took on in a family is the role that they’ll take on in a team. This can be useful, and especially it can be useful for the ones who are maybe playing a role that they actually don’t want to play anymore.”
The quality of self-awareness requires self-reflection: the act of setting aside time – ideally every day – to quietly and honestly look at yourself, first as a person and then as a leader. Yet according to Eurich’s research, people who introspected were more stressed, more depressed, less satisfied with their jobs and relationships, less in control of their lives. She is in favor of a considered approach when it comes to self-reflection. “Self-analysis can trap us in a mental hell of our own making. Thinking about ourselves is not the same as knowing ourselves.”
Why questions: “why did I behave that way”, should be changed instead to “what”. “Why-questions trap us in that rearview mirror. What-questions move us forward to our future. As human beings, we are blessed with the ability to understand who we are, what we want to contribute, and the kind of life we want to lead. Remember, our self-awareness unicorns had nothing in common except a belief in the importance of self-awareness and a daily commitment to developing it. That means we can all be unicorns. The search for self-awareness never ever stops.”
Blind spots can be the Achilles heel of leadership. Even the most iconic leaders have blind spots and, the more senior the leader, the less likelihood of receiving honest and accurate feedback from employees. Blind spots can help you maintain your confidence in the face of significant obstacles but, when they inhibit you from seeing the truth or make you blind to important issues, they need to be addressed. It’s not always easy to figure out what your own blind spots are and admitting them can seem like admitting weakness. Surround yourself with people who can help you manage your blind spots or weaknesses. If you don’t have strong analytical skills, recruit someone who can help you. If you tend to get defensive when your views are challenged, find a colleague or mentor who can help you deal with those feelings and process the information presented to you. By bolstering your team with people who help you overcome your blind spots, you’ll be better positioned to compensate for them.
Here are three ways to help you identify and fix your blindspots according to Jenn Fenwick, Career Transition and Onboarding Coach, Rebel Road Coaching & Consulting:
1) Get candid feedback: “Feedback can be a rare commodity as a leader; however, it doesn’t have to be and it can truly be a gift to anyone wanting to develop. Ask those around you what is going well and where there are potential areas for growth. Framing feedback as critical insight to support your future self-development helps to break down the barriers people may have in giving feedback around ‘blindspots’. Create an environment where those around you feel comfortable having open and honest conversations around positives and growth areas. This will lead to an empowered learning environment, further building your credibility as a leader.”
2) Coaching: “Coaching is a hugely valuable tool to growing and developing as a leader. Building stronger awareness around strengths, and also identifying areas for growth, develops great breadth and empowers you as a leader. Having a coach is like holding up a mirror, and truly seeing the real you. There are many things we tell ourselves that hinder us; however, if we get clear on what they are, and have an honest look at ourselves, they lose their power. Working with a coach is a safe space to effectively interpret 360-degree feedback, allowing you to ultimately drive forward positive behavioral change. Knowing yourself has huge power, and a coach can help identify what is getting in the way of you achieving your goals and reaching your potential – so you can overcome it.”
3) Regular self-reflection: “There is huge value in building in time each week to self-reflect on what is going well, and what is not going so well. The process of regularly reflecting means we are taking the time to celebrate our progress, which is motivating, and also identifying areas where we are getting stuck. If we can identify patterns, or potential ‘derailers’, we can look to solutions to overcome these. There is no greater learning, than learning from our mistakes – in fact, we always learn more! Reflecting helps you to develop your skills and review their effectiveness, rather than just carrying on doing things as you have always done them. It is about questioning, in a positive way, what you do and why you do it, and then deciding whether there is a better way of doing it in the future. Understanding our own reactions and behaviors helps us relate better with others, make better choices, and overcome the challenges we face. It’s about confronting your limiting beliefs, giving yourself permission to be vulnerable and shaping a new mindset of being comfortable being uncomfortable. Because unless we challenge the status quo, we can’t change and grow.”
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.”
