Elevate Magazine | Medical Affairs Professional Society

Digital Health: The Road Ahead for Medical Affairs

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.”

April 20, 2019/by Medical Affairs Professional Society

Elevate Magazine, Open Access, Leadership & Management Skills

The Rise and Rise of Medical

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.”

April 30, 2019/by Medical Affairs Professional Society

Elevate Magazine, Open Access, Leadership & Management Skills

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

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.”

May 20, 2019/by Medical Affairs Professional Society

Elevate Magazine, Open Access

How to Reframe Strategy and Compete on Outcomes

“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.

July 31, 2019/by Medical Affairs Professional Society

Elevate Magazine, Open Access, Digital

Medical Affairs: Future Custodians of Digital Health?

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.”

August 10, 2019/by Medical Affairs Professional Society

Elevate Magazine, Open Access

Seeing the Big Picture: How Business Acumen Can Help Medical Affairs Deliver Value

Medical Affairs leaders want to be more effective and valuable. They want to secure their seat at the table and influence decisions, impact company performance, and deliver better patient outcomes. To do this, they need to understand the “big picture” of the business and grasp how their decisions and actions contribute to long-term profitability and growth. Or in other words, MA leaders need strong business acumen.

Many MA leaders, though functionally brilliant, may not count business acumen as a core skill. But they are not alone. Harvard Business Review confirms that 95% of employees do not fully understand their company’s strategy. “This is not an indictment of Medical Affairs leaders, by the way,” says Ben Cook, President of Acumen Learning, a training organization that specializes in business acumen training and counts 23 of the Fortune 50 among its client list. “Pretty much every function is represented in that data point. But the net effect across the board is the same. I like to compare it to a commercial I recently saw – there’s a guy in a suit diligently clearing and scraping snow from his car but then he discovers that it’s not actually his car. MA can likewise focus too much on their function and technical expertise, only to find themselves expending energy in ways that are not aligned with the company’s objectives.”

According to Cook, MA speaks the language of Medical Affairs fluently, but they lack the business acumen needed to speak the language of business. This inability to speak the same language as the C-suite is hampering MA’s influence. “If you are making a recommendation but you’re not speaking the language of the executive team, it’s not fitting with where they’re trying to go, so the ability to gain access to resources in order to fulfill that vision is certainly not going to be there in most cases. So, we have to align our priorities and focus on areas that the executive team, who sign off on these decisions, are most attentive to. Our credibility, our access to resources, and our ability to partner is best enabled when we understand where the company is going. We need to start asking, ‘Are we scraping the right windows?’”

Untapped value

Another driver for MA to build its business acumen muscle is the growing requirement for MA professionals to interact with C-suite executives from health systems and health plans as well as other decision-makers who are responsible for market access and formulary decisions. Effectively playing these roles will likely require different skills and competencies that have not traditionally been central to the MA function. “The circle of medicine development, licensing, reimbursement and commercialization requires the creation of value for all stakeholders and being focused on sustainable value generation is thus a must for Medical Affairs professionals who play a pivotal role in all aspects of this circle,” says Michael Zaiac, Head of Medical Affairs Oncology, Region Europe, Novartis.

Armed with business acumen, MA can operate a number of levers both internally and externally to drive value. “Internally, MA can deliver integrated insights efficiently and inform development programs accurately, allowing for optimized development plans yielding reimbursable medicines. People with business acumen are more aware of operational efficiencies, as they understand the way different contributions affect the different elements. Any imbalances here are inefficient. Externally, MA can support the development of novel business cases or beyond-the-pill services that greatly enhance the value of a medicine to all stakeholders, which often makes the difference to patients having or not having access to critical medicines. Business acumen is key to identifying the most sustainable and successful ways for value generation for patients through identifying the right stakeholders and addressing their needs,” says Zaiac.

For Cook, the time has come to re-examine the role and level of influence of Medical Affairs in a world focused on communicating the economic and health system value of a product, rather than “selling”. “Medical Affairs is often thought of as a cost center but there are a number of ways MA can really drive value. Communicating treatment value using scientific and medical information in a manner that supports the incentives and needs of the various stakeholder groups is one way, but it requires an appreciation of hospital and IDN (Integrated Delivery Network) incentives and the long-term strategic imperatives at play. The ability to link arm in arm to find mutual incentives that drive health outcomes can actually have a huge impact on a global basis.”

Option B: Streamlining costs

Operational efficiency isn’t a sexy concept, but it is the key to fully maximizing profit and boosting the bottom line. Senior leaders can’t afford to work in silos and behave as independent functional experts. In today’s dynamic environment, both cross-disciplinary collaboration and deep functional expertise are required skills. Medical Affairs must look at how it can cultivate the ability to anticipate needs among a much broader range of stakeholders to deliver value for both patients and the healthcare ecosystem through the delivery of superior medical outcomes, while simultaneously reining in costs and reducing excessive spending.

“There’s an old adage that says a dollar saved is a dollar earned, but that’s not the complete story. Imagine you’re able to save $100 (Option B), that $100 will drop straight to your bottom line less any additional expenses like taxes. If taxes are 20%, that would leave you with $80 in additional profit. Now let’s say that you’re able to increase revenues by $100 through selling additional products (Option A), a lot of that additional revenue will be eaten by the cost of creating and selling those products. If those costs are $80, that would leave you with $20 in additional profit. If you can be a little more attentive to Option B, you have four times the impact on the bottom line. This is a simple concept, but it’s one that most people don’t think about.”

For Cook, there’s a real opportunity to build credibility and free up resources to spend in other areas. “If Medical Affairs can understand these levers and appreciate both sides, they’re seeing the big picture. If you can develop your Option B mindset and use the language of Option B in your business cases, you’ll start to elevate your credibility especially with those who already have this mindset, like finance. That’s not to say that I’m favoring one lever over the other; we all know that if you push too hard on driving efficiencies, you can hamper growth, or negatively impact people. You have to be considerate of the five drivers of business: cash, profit, assets, growth, and people. When you’re able to balance these drivers, you’re helping the business run better, which enables the company to create more lifesaving products.”

More right-hand turns

Today’s industry also faces considerable headwinds. The outlook for pricing and volume expansion is becoming less attractive across all regions, given the sustained pressure on drug pricing in Europe, the growing size and bargaining power of payors in the United States, the looming biologics patent cliff, and the mounting competitive pressure in emerging markets. Meanwhile, advances in technology and analytics are opening up opportunities for powerful tech entrants to engage with patients and consumers in radically new ways, offering innovative healthcare solutions in conjunction with payors and providers. These entrants threaten to disintermediate pharma companies as the primary owners of patient data and take control of their value story. Should that happen, it would have drastic repercussions for pharma’s R&D and commercial models.1

Why UPS trucks (almost) never turn left

In a challenging business environment, operational efficiency and cost control become increasingly important. Cook illustrated this point with a story from UPS: “By keeping left-hand turns to a minimum, UPS saves millions of dollars in fuel and reduces CO2 emissions by more than 100,000 metric tonnes a year. This seemingly simple idea has a $100 million impact to the bottom line each quarter. Now that’s impact! We need to start asking, ‘What right turns can we make in Medical Affairs to demonstrate our value?’”

Historically, companies have narrowly defined the role of Medical Affairs, but if you want to be more visible and valued, you need to demonstrate your business acumen and how MA fits into the big picture of the overall business. “As we think about growing our market share, we need also to think about the most efficient ways to get there and how to marshal the resources we already have to optimize our impact. Remember, you can be functionally brilliant, but unless you see that big picture and develop your business acumen, you’ll have very little influence with senior leader decision-makers. In other words, your ideas and proposals will have less of an impact.”

Sources:

1: Rethinking Pharma Productivity https://www.mckinsey.com/industries/pharmaceuticals-and-medical-products/our-insights/rethinking-pharma-productivity

Business Acumen Defined:

Business acumen is keen, fundamental, street-smart insight into how your business operates and how it makes money and sustains profitable growth, now and in the future. Understanding the “business of the business” is critical to know which opportunities to pursue and which to ignore.

Benefits for Medical Affairs:

Armed with business acumen, Medical Affairs leaders can influence top-line revenue and bottom-line profitability, and prioritize day-to-day actions in alignment with organizational strategy. The result? More resourcing, more credibility, better partnership.

Five Business Drivers:

Cash – Cash is the fuel that drives a business; it’s more important than your mother as the founder of Seagate Technology once said. Without cash, a business can’t pay its bills, can’t pay its employees, can’t buy the goods it needs to produce the products or services it sells. If you evaluate the three key components of cash – cash position, cash flow, and liquidity – you will have a better understanding of how you generate cash and how to use it wisely and spur growth. Pharmaceutical and Medical Device companies actually need significantly more cash than the average company due to the risk and time required for developing products, getting those products to market, making acquisitions/buying licenses/trademarks/patents, and supporting the development of future products.

Profit – Profit is simply the difference between how much you make by selling goods and services and how much it costs to produce and sell them. By looking at the differences between profit and cash flow, and explore the concept of profit margin, you can reveal how efficiently a company is turning revenue into profit. Pharmaceutical and medical device companies typically have higher profit margins than the average company to compensate for the higher risk in developing products that need to pass regulatory approvals and gain market access, and the extended time the companies spent on product development, the regulatory processes, the market-access process, and support in getting products to market.

Assets – Assets include everything a company uses to produce revenue, whether these are tangible, such as buildings and equipment, or intangible, such as patents. Balancing asset strength with asset utilization is a dilemma all businesses face; having more resources to buffer the company from uncertainty is beneficial but making sure any asset the company has is most optimally deployed is also a vital priority for successful companies. Exploring how a company meets its obligations, takes advantage of opportunities and survives tough economic times – with asset utilization – is vital to produce revenue and sustainable growth. Many drug and medical companies could benefit from enhanced scrutiny on its processes and systems to ensure they are most efficient and are eliminating waste and non-value-added activities.

Growth – Constant change is a reality in today’s business environment, and growth is one of the few ways to handle it. Growth can be measured in terms of both revenue and profit. Understanding how growth strategies impact business performance and the bottom line will provide a smoother roadmap to success. Making sure the company is able to grow its top-line faster than the market through innovation, differentiation, market development, and speed is vital. But companies also need to ensure their bottom line is also growing as they operate as efficiently as possible to ensure sales translate into profits.

People – People lie at the center of the five key drivers. Kevin Cope, founder of Acumen Learning says: “People make the decisions, supply the financial resources, buy the products, and provide the labor and services. They drive cash, profit, assets, and growth. Meeting, exceeding, and even anticipating the wants, needs, and expectations of your employees, customers, and other important stakeholders is essential to your financial success.” And with Medical Affairs sitting at the vital nexus of R&D, Commercial, and customers, it is extremely vital for MA to understand what each part needs and wants and how to best deliver those in the best way possible.

Source: Acumen Learning

Five ways MA can drive the cost-efficiency agenda

1. MSL deployment – marshal resources at the right time to optimize resources and minimize cost.

2. Digital transformation – streamline costbase to improve internal or external customer experience.

3. Process engineering – look at every process that is less efficient than it needs to be and drive improvements in those processes.

4. Tight collaboration – while working with the other functions, collaborate tightly to ensure limited duplication of activities, limit rework due to miscommunication, and find clear agreement early on to the goals/outcomes for initiatives to accomplish well-defined roadmaps.

5. Organizational knowledge transfer – not only collaboration across functions and geographies, but also capture and make accessible key learnings at all levels with initiatives to ensure mistakes don’t proliferate and key learnings are institutionalized.

How do we best balance people and profits as we work?

Be process efficient and system minded.
Be attentive to budget.
Align recommendations to organizational strategies.
Optimize your Return on Time (ROA).
Enhance capability for speed & agility.
Be ahead of the market and customer trends.
Expand your knowledge on company direction and financial language.

September 9, 2019/by Medical Affairs Professional Society

Elevate Magazine, Open Access, Digital

RWE & The Transformational Role of Digital Health

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.”

Technology as an enabler

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.

Start of the journey

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.

Data requirement implies collaboration

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.”

HURDLES…

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 BENEFITS

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.

THE FUTURE

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.”

“It actually allows you to apply the right interventions to the right patient at the right time, which is critical.”

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.

September 10, 2019/by Medical Affairs Professional Society

Elevate Magazine, Open Access

Purpose-driven culture: How to make an impact in a value-driven world

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.”

Culture is a key driver

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

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.”

Prof. Dr. Iris Loew- Friedrich: Career Path

October 11, 2019/by Medical Affairs Professional Society

Elevate Magazine, Open Access, Digital

Driving the Next Wave of Digital Innovation in Healthcare for Medical Affairs

Fireside Chat with Mary Alice Dwyer and Shaji Kalathil

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Healthcare has the potential to be radically transformed by digital technology and we believe that the most competitive pharmaceutical companies in the coming decade will leverage data and digital technologies to drive differentiating services and will be in the forefront of pushing the boundaries of digital innovation in healthcare. These leaders will generate and analyze vast volumes of research and real-world data to discover transformational medicines and will excel at communicating scientific evidence to stakeholders. They will help physicians navigate in a far more sophisticated and complex healthcare ecosystem and help them make difficult decisions that are the right decisions for patients. Medical Affairs teams can become a strategic force for pharmaceutical companies in this journey with their deep scientific knowledge, disease understanding, and the healthcare technology advancements that aid in the betterment of the entire medical industry.

Mary Alice Dwyer, MAPS Executive Leadership Committee member and Lead of the Digital Focus Area Working Group, Principal Consultant, Medical Innovation and Insights and former Vice President, Global Medical Excellence and Patient Centricity, Global Medical Affairs, AstraZeneca and Shaji Kalathil, Executive Director, Global Head of IT for Medical Affairs, Bristol-Myers Squibb discuss how advancements in transformative technologies are driving a new wave of digital innovation opportunities for healthcare.

“There is a tremendous opportunity for Medical Affairs to be leaders in advancing digital innovation and truly change how they engage Health Care Providers and patients. Through the strategic implementation of digital innovation, Medical Affairs can embrace technology that will transform not only what we deliver, but how we engage with HCPs and patients. Exploring technologies like AI and ML and other innovative tools will further define the impact Medical Affairs can have.” –Mary Alice Dwyer

“These are exciting times in the pharmaceutical industry with fast- paced digital innovation and the potential to transform the Medical Affairs customer engagement model and data generation capabilities with disruptive technologies, artificial intelligence and advanced analytics. I also envision significant advancements in “beyond the product” digital solutions and services for complex therapies in the future that will improve patient outcomes and Medical Affairs becoming the custodian of these services.” –Shaji Kalathil

How do you foresee the evolution of the Medical Affairs customer engagement model in the future and the impact of digital innovation in healthcare?

Mary Alice:
Medical Affairs leaders continue to expand their role in “customer” engagement, whether the customer is the health care provider (HCP) or the patient. While Medical Affairs has always been responsible for Thought Leader or KOL engagement, it is often viewed from the perspective of what information Medical Affairs could provide to the HCP. As teams begin to explore digital solutions and new ways of engaging, it opens the opportunity to think from the “customer” point of view. This new perspective enables Medical Affairs to approach information exchange from a “customer experience perspective”. Digital Innovation in healthcare enables Medical to engage in scientific exchange in new and unique ways and deliver what the “customer” wants, when and how they’d like to receive it. Ultimately, Medical Affairs needs to anticipate what the HCP or patient needs, so their experience is optimized. We need to plan for a truly personalized approach to our scientific engagement.

The expectation to deliver information in new and innovative ways has been set by the customer and is a high bar for Medical Affairs to achieve. Our customers (HCPs and patients) experience seamless information access in their daily lives and expect that same experience in their professional and healthcare interactions. People expect to search for answers when it is convenient for them, they like multiple sources of information, and they want answers quickly. A key challenge for Medical Affairs is to be easily accessible and be the trusted source of information.

Shaji:
I am really thrilled about the possibilities for transforming the Medical Affairs customer engagement model with digital technologies. We now have an influx of innovations in the pharma industry, especially in Oncology, making incredible strides toward better and safer treatments for patients. Science is delivering a large amount of knowledge that will help us understand diseases that have until now been beyond our reach. Today, technology is giving us tools to capture vast amounts of patient data and genetic information, which will fuel an unprecedented expansion of biomedical research. This will continue to shift pharmaceutical innovation into higher gear especially with the foray into new scientific innovations such as cell therapy. Medical Affairs is in a prime position to advance the understanding of these highly complex therapies for the healthcare community and support patient centric outcomes. The power of digital technologies, big data and artificial intelligence can be strong drivers to achieve this goal and we need to seize this opportunity.

There are three key areas with great opportunities to apply healthcare technology advancements and transform the Medical Affairs customer engagement model.

1.Delivering exceptional customer experience focused on science through a deeper understanding of medical insights, physician journey, preferences and needs from all digital touchpoints, AI-powered engine to predict best engagement plans & actions, real time digital interaction tools and beyond the product digital services & solutions.

2.Seamless connection of our digital medical information assets with external digital channels for healthcare professionals (EMR solutions, Patient Care Management Solutions, Physician Digital Networks etc.) to communicate highly scientific medical information at the point of care in real time.

3.Use of artificial intelligence models and machine learning technologies to enrich and expand the utility of real world evidence, and generate faster, more precise insights.

There seems to be great interest on the topic of customer insights generation by Medical Affairs to shape strategy and impactful customer engagement. Can you share your perspectives?

Mary Alice:
Medical Affairs has a tremendous opportunity to impact how our organizations understand the healthcare landscape as well as the HCP and the patient’s perspective. We are in a unique position to engage decision makers, understand the clinical healthcare environment and patient experience. Digital innovation in healthcare would further our ability to not only capture these insights, but to also analyze and identify trends. The insights that Medical Affairs team gathers can improve the understanding of how the medicine is being used and the potential need for further data. These insights can improve clinical programs and launches. Technologies such as machine learning and artificial intelligence, will enable us to gather, analyze and interpret these insights. The growing importance of Medical Affair’s role with Real World Data further cements the need for digital tools to manage this amount of data. For Medical Affairs to shape strategy and impact customer engagement we must capture, analyze and incorporate robust insights. Digital tools will be critical to enable this capability.

How do you think digital innovation can advance the medical insights capabilities?

Shaji:
Digital innovation in healthcare can play an impactful role in transforming the medical insights capability in two areas – the way our customer facing teams in Medical Affairs collect medical insights as well as the approach to analyze the unstructured insights to understand emerging trends on unmet medical needs, and clinical practice. The first part is pure technology automation with the opportunity to create an exceptional digital user experience for the medical insights collection and collaboration processes. The second part of analyzing medical insights for uncovering trends is a classic use case to leverage artificial intelligence capabilities – We can use Natural Language Processing (NLP) to synthesize these insights and understand emerging trends that will speed up the analysis and help drive timely, proactive actions, and impact strategy. The fast paced innovation in the NLP space will help us position this approach to add more business value in the future.

Together these solutions can create a powerful “digital medical insights engine” that will influence Medical Affairs customer engagement strategy and strategic decisions in Commercial and Clinical Development.

If you look towards the future (5-10 years) what areas of Medical Affairs would you see as completely transformed by the digital innovation of healthcare and how will you describe the business impact of this transformation?

Mary Alice:
I believe all parts of Medical Affairs have the opportunity to transform, both by improving operational efficiency and through delivering a more tailored “customer-focused” engagement. I believe these innovations will improve our communications and engagements. One of the most immediate opportunities is in Medical Information and exploring a move to on-demand information provision. Also, the area of promotional material review is an area that is ready for utilization of artificial intelligence and machine learning.

If I look 5 to 10 years into the future, Medical Affairs will have made great progress, including getting the right infrastructure in place. Important areas such as having a customer master, the ability to tag data and information and having an external web presence will be customary. We’ll be exploring virtual reality and augmented reality in education and training. We’ll be perfecting opportunities in areas like digital publications. We will be increasing the automation of routine functions that enable the highly trained Medical Affairs staff to focus on scientific opportunity. Medical Affairs will be utilizing digital to create websites that create unique opportunities to engage HCPs and patients. Medical Affairs will be a trusted source of information, providing education and optimizing knowledge transfer.

What are the most promising innovations you are seeing in the technology landscape that can transform Medical Affairs?

Shaji:
There is no better time than now to embrace disruptive digital technologies in the pharma industry. I am most excited about three technology trends with the potential to transform Medical Affairs digital capabilities and help improve patient outcomes.

1. Advanced digital customer engagement technologies that can deliver personalized experiences and innovative services for the healthcare professionals based on their needs and preferences in real time will have a profound impact on accelerating their understanding of safe and appropriate use of our medicines and the underlying science.

2. The pace of advancements in AI and specifically natural language processing/understanding (NLP/NLU) will dramatically increase. We are going to see some major breakthrough innovations in the NLP/NLU space in the coming years that will surprise everyone and mimic the advancements in image recognition/deep learning, powering the driverless car revolution. This will also have positive implications on how we use the voice technologies to enhance personalized services for customers. We will transition to an “AI-fueled” customer engagement model in Medical Affairs with more matured customer intelligence datasets that will leverage next generation digital tools. This will help the Medical Affairs colleagues in engaging with their customers more effectively by better understanding their needs and by providing access to the most relevant scientific data at the right time.

3. Patient data analytics will become key to clinical decision support, quality measure performance, improved patient care and demonstrating value. We will need to position scientific exchange with the ability to combine, analyze, and interpret disparate data sets to support the interactions with stakeholders and ultimately to improve patient outcomes. This will involve use of real-world evidence, electronic medical records, curated sets of aggregated data on various disease types and novel sources of data, such as genomics in combination with innovative ways of mining and interpreting that data.

There is a lot of buzz about the possibilities with artificial intelligence in pharma. How do you envision the digital innovation of healthcare impacting Medical Affairs with advancements in artificial intelligence?

Mary Alice:
Medical Affairs is consistently being expected to work with growing amounts of data, whether this data comes from insights, Real World Data, or working with the “data lake”. Artificial Intelligence is critical for analyzing large data sets and it will be important for Medical Affairs to have the capability to utilize these tools. I believe these technologies will transform how we understand the clinical environment and decision making, how we deliver information, and engage HCPs, Payers and Patients. These technologies will enable us to improve our ability to deliver a more tailored approach to everyone we interact with because we are basing those interactions on evidence.

Shaji:
Artificial Intelligence has great potential to drive up productivity and enhance several core aspects of the pharma business from disease diagnosis and drug discovery to more effective scientific exchange with healthcare professionals. Specifically there are opportunities in Medical Affairs to leverage natural language processing and machine learning AI capabilities for analyzing trends from medical insights, generating insights for precision treatment & improved patient outcomes with real world evidence, engaging with the healthcare professionals using voice technologies, and helping the customer facing medical teams to present the most value-added scientific information based on customer needs and preferences. Advancements in machine learning and high quality customer data for Medical Affairs can lead us to “Scientific Engagement Advisor” digital solutions akin to the ”Next Best Action” concept in Financial Services and “Recommendation Engines” concept in Retail/Streaming Media. This will help predict effective customer engagement strategies to empower the MSLs (medical scientific liaisons) based on previous engagement experiences, medical insights and all customer data points. The importance of having good quality data to drive your AI solutions should not be underestimated, especially given the fact that the customer data for Medical Affairs is largely in unstructured format. I am very optimistic about these uses cases for Medical Affairs that should redefine positive customer experience and ultimately help the patients.

We should be mindful about the tendency to blindly chase after shiny technology objects without really connecting them to real business problems. Often times this is highly visible in the artificial intelligence space with exuberant claims on possibilities and the result is a major gap between visionary/lofty discussions on on the digital innovation of healthcare and actual delivery of digital solutions for customers and patients on the frontlines. We need to be very cautious about falling into this “innovation bubble trap” and rather should focus on driving impactful ideas to reality with a fail fast approach.

We are seeing an increasing number of technology innovators focusing on healthcare. How do you foresee this external innovation fueling Medical Affairs in driving transformative digital capabilities?

Shaji:
There are considerable opportunities to build more effective partnerships with pure play technology companies that will address complex problems in healthcare. We need to think in terms of bringing each other’s strengths to the table and co-creating digital solutions. Pharma has a unique understanding of the challenges physicians and patients are facing and can help guide these partners. At the same time these digital technology partners can offer new technology capabilities that will help us reimagine the type of solutions we can deliver to our customers and patients. Digital therapeutics is an area where we are seeing success, and there are advancements in improving diagnoses, adherence, disease awareness, and self-management of conditions. Creating strong, co-development partnerships with core technology companies and healthcare technology startups does not happen in a flash. It is important to define a common value proposition with these type of partnerships and we need to look through the lens of co-developing solutions, not just funding startups. These mutually beneficial partnerships can drive a culture of innovation in larger pharma organizations as well.

We also need to closely watch and adapt digital innovations from other industries with similar business capabilities such as

Retail industry for online & in-store digital customer experience
Hospitality industry for enhanced service automation tailored on individual preferences
Financial services for personalized wealth management & virtual customer interactions
Aerospace industry for operational excellence in predictive maintenance & fuel monitoring through big data analytics

What are the most important factors leaders like you should take into consideration for success in driving digital innovation of healthcare for Medical affairs?

Mary Alice:
To ensure success in driving the digital innovation of healthcare, many factors need to be in place. Leaders need to be ready to build the right capabilities and this might involve changes in structure. These new capabilities can be built by bringing in external resources, working with internal resources or training current staff. One critical question for the future will be how Medical Affairs will build the expertise to incorporate digital innovation in how we do our daily jobs. I don’t think we can go this alone. We’ll need to partner across the enterprise to leverage unique expertise (eg IT, data analytics, etc). Many Medical Affairs teams are bringing in non-traditional Medical Affairs capabilities by hiring employees with background in areas such as data science. Roles with this expertise bring a unique skill and by embedding these roles in the Med Affairs team and encouraging partnerships an innovative environment is created. Many Medical Affairs teams are also partnering with their internal data and analytics team. This partnership is uncovering new opportunities, especially as companies establish huge sources of data across the enterprise.

A critical area that is often overlooked is the need to free up time for the Medical Affairs leaders and their teams to explore how this new innovation will change how they deliver their accountabilities. Digital innovation in healthcare is a transformational change and how it impacts the team and their work needs to be considered. Another area that requires the investment of time is considering how the team will engage senior leaders to get traction and funding on their projects. These are important aspects that must be considered if Medical Affairs is to be successful in driving digital innovation.

Shaji:
The most important focus with any digital innovation journey should be on driving differentiation and competitive advantage. We need to think beyond the “easy to chase digital innovation concepts” and elevate the innovation thinking process to truly transformative ideas that will address our biggest business problems and significantly improve customer experience. Essentially, we should dial up the emphasis on transformational innovation. In order to accomplish this, the leaders should create an entrepreneurial environment for ideation and development of these ideas. This will require a deeper dive into the core business value drivers for Medical Affairs with the right talent to understand the innovative technologies and an “artistic approach” to imagining the possibilities, often connecting the dots between multiple business value drivers and the disruptive potential of the latest technologies. A deep-rooted culture based incentive system (leaders encouraging to take big leaps forward and providing sponsorship for experimentation with cover for expected failures) is also necessary to drive this shift.

Driving digital transformation in Medical Affairs also requires a broader enterprise mindset compared to other functions. Since Medical Affairs is very closely connected to R&D and Commercial, it is important to visualize the concepts of digital innovation in healthcare through an enterprise lens and have an “outside in” perspective (such as customer experience alignment with touchpoints beyond Medical Affairs) for solutions targeted for customers and patients.

Finally, we will need to educate the executive leadership team on how technology is impacting their business, engage them in imagining the possibilities, and make them strong digital advocates by bringing them along the innovation journey.

December 10, 2019/by Medical Affairs Professional Society

Elevate Magazine, Open Access, Med Tech

Medical Devices are from Mars, Pharmaceuticals are from Venus. What can we learn from each other?

Medical devices and pharma: two sides of the same coin; significantly different but part of the same larger ecosystem. Dr. John Pracyk discusses the implications for Medical Affairs professionals.

So why have we called this piece Medical Devices are from Mars; Pharmaceuticals are from Venus? According to Dr. John Pracyk, it is a useful metaphor based on the classic relationship guide by Dr. John Gray: Men Are from Mars, Women are from Venus. Expanding on the analogy, he explains that the majority of Medical Affairs professionals in the medical device sphere are surgeons, whereas pharma is dominated by physicians. Beyond this, of course, there are other significant differences that stem from a close alignment between medical devices and therapeutic expertise.

Dr. Pracyk, who is Worldwide Integrated Leader, Medical Affairs, Pre-Clinical & Clinical Research, for DePuy Synthes – Spine (part of the Johnson & Johnson stable), says: “It’s important because Medical Affairs is now aligning towards the fact that you’re most likely going to be working in an operating company in line with your sub-specialty training and board certification, along with operative proficiency and clinical practice experience, which will be at least a decade or more. After that you begin to have the skill set that industry is looking for. That’s decidedly different than Medical Affairs in pharmaceuticals, where there is a much more diverse range of clinical experience and educational backgrounds.

“In other words, to deliver the most value to the device industry we can only make the transition once we are board certified and bring a wealth of clinical practice experience to the table.”

Meanwhile, in pharmaceuticals, the classical model is an internal medicine residency with sub-specialty fellowship, or research training, followed by a highly variable period of time in clinical practice. Some physicians forgo residency and clinical practice entirely and make the transition to industry immediately following medical school or, alternatively, a post-doctoral research fellowship, while others have had meaningful careers in healthcare consulting.

The differences between devices and pharmaceuticals is especially significant from the perspective of the new European Medical Device Regulation that was passed on May 26, 2017 and comes into full effect on May 26, 2020, after a three-year phase-in period.

“Medical device companies need medical directors that have specific subject-matter surgical expertise that reads directly to the product portfolio. Why? Because the MDR credentials section has become more stringent, as have the state-of-the-art requirements – these require medical affairs surgeons to have deep clinical insights into a specific therapeutic area, as they are medically responsible as signatories for the Clinical Evaluation Report, (CER) which is the formal application for the CE mark in the European Union. For example, as a spine fellowship-trained neurological surgeon, it is quite appropriate that I lead medical and clinical affairs for our spine platform. Similarly, orthopedic surgeons lead trauma and joint reconstruction, whereas an otolaryngologist leads our ENT platform.”

Beyond this, there are further differences between devices and pharmaceuticals in terms of Medical Affairs’ scope of responsibility. “Typically, Medical Affairs in pharmaceuticals is primarily involved once the drug has launched. Clinical Affairs is responsible for all the pre-launch activities such as R&D and drug development. In devices, Medical Affairs spans that entire spectrum from initial ideation and front-end conceptualization through the stage-gate, development process, bringing that product to market and then launching it. It doesn’t stop there, as once it is in the field, maintaining it through its lifecycle and then removing from the market is also our responsibility. Medical Affairs in devices is subdivided into two major divisions, 1) Franchise, which is responsible for product development through the R&D pipeline all the way up to launch, and 2) Lifecycle, which picks up the product at launch and manages it through its entire lifespan on the market. We typically refer to it as ‘pipeline and portfolio ’: pipeline being franchise, portfolio being lifecycle.

“In pharmaceuticals, Medical Affairs is predominantly involved in the post-launch affairs, getting the product to market, medical communications, scientific engagements with KOLs, for purposes of studies, clinical trials, publications, podium presentations, and supervising all of the field medical professionals, such as medical science liaisons (MSLs).

“In devices, we are both internally and externally facing. For example, we work closely with Health Economics & Market Access (HEMA), to establish evidence of differentiated value to position products to successfully navigate value analysis committees (VACs). Similarly, we often oversee clinical investigational studies and investigator-initiated studies that support our products for purposes of safety and performance for our regulatory authorities. Internally, we work with R&D, Quality, Regulatory, Global and Regional Marketing in helping our colleagues understand what it’s like on the hospital and surgeon side of the equation.

“When I was practicing, I was the surgeon champion on the VAC for my health system. Now, I use that prior clinical and hospital administrative experience to help guide our interactions as a device manufacturer with the VACs of our customer hospitals and integrated delivery systems. Simply put, it is different ends of one vary large supply chain. Not surprisingly, I have also been involved in engaging our own contract manufacturers through speaking engagements and moderating panels at the Orthopedic Manufacturers Technology Exposition and Conference (OMTEC), as I now need to learn about how supply chains in industry work, while reciprocally informing our contract manufacturers on the global transition taking place clinically from volume to value that ultimately impacts their businesses as well.

Medical Affairs informs strategic decision-making

Medical Affairs is increasingly becoming a strategic partner for both commercial and R&D teams. “One way to look at this is through a go-to-market strategy that is refracted through the lens of three evidentiary audiences. The first is regulatory, where we must place the product ‘in country’. Next is hospitals/integrated delivery networks, where were we need to work with the VACs to get the product ‘on contract ’. Thirdly, we must secure reimbursement from the payers, whether they be private, commercial insurers, or government entities. As you can see, Medical Affairs is involved in a very broad range of medical and scientific engagement activities.

Diverse skillsets

Medical Affairs professionals in devices are fewer in number and require a very diverse skillset, whereas Medical Affairs in pharmaceuticals are far larger in number and, historically have been around much longer. “When you consider the sheer numbers of Medial Affairs in pharmaceuticals, both internally and with the MSLs in the field, it is literally an army. Conversely, on the devices side, we’re more of a ‘special forces’ model, where you just have a few people who are very specialized, but cross-functionally trained in diverse areas, which is a force multiplier.

So how hard is it to obtain the specialist knowledge and overcome the significant shortage of talent? Surgeons coming into Medical Affairs often have skillsets that are much in demand, beyond their specialist clinical expertise. For example, time spent learning how to develop a practice and building business acumen are highly prized in industry.

“Many physicians and surgeons are now going to business school to get their MBAs, while others have been involved in hospital leadership committees or have commercialized devices as an entrepreneur. These transferrable skills are valuable when you consider the range of activities that Medical Affairs delivers against: namely, understanding business operations, manufacturing, finance, accounting, communications, strategic development, and pre-clinical and clinical research – and being able to navigate the spectrum from bench top, to small animal, large animal, and ultimately first in human. Not surprisingly, surgeons who possess these essential business, research and clinical skills will meet with great success in devices.”

Leaving clinical practice

In pharma it is not uncommon for clinicians to maintain some form of clinical practice, which can take a variety of forms from an occasional clinic, to volunteering, or mission work. However, due to both legal and healthcare compliance issues, surgeons working in devices must stop operating and close their clinical practice upon entering industry. For a surgeon, who has spent years acquiring a unique set of skills this is a huge deal. Fortunately, maintenance of operative skills is accomplished through a variety of cadaver settings: wet labs, validation labs, and prototype testing.

Yet, there is one remarkable upside, according to Dr. Pracyk. “Believe it or not, we can secure visiting professor privileges anywhere in the world that permits us to scrub into surgery with key opinion leader surgeons – not to clinically perform the operation (in fact, we are specifically prohibited from touching the patient), but more importantly to observe, learn, and distill out the critical insights that help identify and address true unmet needs. The simple fact that this worldwide peer-to-peer surgeon exchange occurs from within the operative field is absolutely amazing.”

Lessons on both sides

“I think what pharmaceuticals can learn from the device side is that we are very good at these cross-functional skills.” Flipping it around the other way, what can devices learn from pharma? “I think pharmaceuticals has a much more thorough and deep understanding of ‘patient centricity’.

“In devices, the surgeon is the proxy for the patient. However, with the concept of surgeon employment and the advent of spine and brain institutes in neurological surgery or musculoskeletal institutes in orthopedic surgery, the multidisciplinary model of care is taking hold. Ultimately, the patient will be at the center of what we do and a more comprehensive approach to care redesign will certainly elevate patient centricity globally as the medical devices sector continues to learn, share and advance care more holistically like our pharmaceutical colleagues.

January 25, 2020/by Garth Sundem

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.

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