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Medical Affairs: Future Custodians of Digital Health?

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Organizations should take a strategic approach to digital health solutions and also treat them with the same level of rigor applied to traditional therapies.

 

We are living in a data-driven digital world, and the pharmaceutical industry has not been immune to the multi-billion dollar promise that digital therapeutics holds. Within the industry, the consensus is that it is a case of when, not if, digital health solutions become the norm.

The phrases digital health, health technology, mHealth and digital therapeutics have taken their place in the pharma vernacular. And as the paradigm shift towards the ubiquity of digital health solutions continues apace, Medical Affairs must once again reflect on its own evolving role and consider how it can drive digital health by innovating and creating.

Improving outcomes

According to Alex Butler, co-founder of Foundry³ the future value of digital is going to be the use of technology to improve clinical outcomes, patient outcomes and to help healthcare professionals improve the provision of care.

The linear approach of a “pill for every ill” has been expanded immeasurably by the application of mobile health, digital health and digital therapeutic solutions, Butler tells Elevate. Addressing key health challenges of the 21st century such as chronic disease, access to care, health inequalities and ageing populations, becomes not only possible but accessible and affordable.

“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.”

 

 

Proliferation of applications

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.

 

 

Three-part strategic approach

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.”

 

Medical uniquely equipped to lead digital development

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.”

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How to Reframe Strategy and Compete on Outcomes

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“The way to understand it is that a dinosaur in a fur coat is not a mammal.”

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.

 

Sidebar 1:
NHS outcomes-based pricing deals

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).

 

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.”

 

Reinventing the role of Medical Affairs

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.”

 

Biography

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.

 

 

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Self-Awareness: How to deepen your insight and see the blind spots that could be holding you back

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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.

 

Decoding self-awareness

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?”

 

 

3 Tips on Self-Awareness

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.

Internal and external self-awareness

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.”

 

Self-analysis trap

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.”

Increase your self-awareness with one simple fix:

 

Finding and fixing blindspots

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.”

Rise.Medical.ELEVATE

The Rise and Rise of Medical

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Can Medical professionals step up to a more strategic role? Dr. Ameet Nathwani discusses the need to define and measure our contribution, and why we must join together as a community to reshape the future of healthcare.

 

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.”

New dynamics in the healthcare ecosystem

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.”

 

Taking control of RWE

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.”

 

Measurement for Impact

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.”

 

Culture

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”.

 

Together is better

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.”

 

3

Digital Health: The Road Ahead for Medical Affairs

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As real-world data and advanced analytics start to transform life sciences, Medical Affairs is transitioning to a new strategic role. However, grasping this opportunity requires a significant mindset shift, and MA professionals will need to acquire a new skillset.

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.

 

Unique role

“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.”

 

 

Top three areas of focus

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.”

 

Challenges

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.”

 

New digital culture

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.”

 

Quality and quantity of data

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.

 

 

 

 

Strategic role

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.”

 

About

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.

 

 

 

Leadership Lessons

“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.”

 

27

Clinical Statistics for Non-Statisticians (Part 2 of 2)

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Objectives:

This series will provide you with tools to critically process and analyze medical scientific literature. You will get a good understanding of basic statistical concepts and theory that enable you to explain, understand and interpret data. These Webinars are practical and based on published articles and the analysis of these. You will work with the theory in practice to increase your understanding of the strengths and weaknesses of the statistics in scientific literature.

Statistical analysis in clinical trials

– Null/alternative hypotheses

– Statistical assumptions (type I error, significance level, type II error, statistical power,)

– Hypothesis testing

– Statistical tests

Statistics used in RCTs

– Type of outcome measures (dichotomous, continuous, time-to-event)

– Statistics used for analysis of dichotomous data (relative risk, odds ratio, risk difference, NNT)

– Analysis of time-to-event variables (plotting and interpretation of Kaplan-Meier curves)

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25

A Global Perspective on Conducting Early Access Programs

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Objectives:

Early Access includes a variety of programs by which pharmaceutical companies make investigational therapies available to patients with life-threatening diseases. These patients have either exhausted available treatments or have no approved options. This presentation will review the processes and procedures to consider in the implementation of an Early Access Program and explore the opportunities and challenges posed therein.

At the end of this webinar the participant will be able to:

  • • List the differences between an early access program and a clinical trial
  • • Compare the different types of early access programs
  • • Describe the components needed to implement an early access program
  • • Understand how local laws and regulations govern the conduct of an early access program
  • • Understand the benefits and drawbacks of conducting an early access program

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28

Patient Engagement in Drug Development: An Opportunity for Medical Affairs

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Objectives:

At the conclusion of this eCademy Webinar, participants will be better able to understand:

  • • The numerous ways in which partnership with patients can impact the development and commercialization of medicines
  • • The current “patient centric” landscape in pharmaceutical drug development, including the patient perspective of clinical trial conduct, recent findings related to the value of patient-centric trial design, and innovative approaches to engaging with patients across the study continuum
  • • Key considerations for patient engagement in clinical trials

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