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Fireside Chat with Mary Alice Dwyer and Shaji Kalathil
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
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.
At the conclusion of this session, participants should better understand digital trends seen within Medical Affairs today as well as be aware of why HCP expectations are changing and how to evolve with them to provide better customer experiences.
A Look at Customer Experiences Inside and Outside of the Industry and What It Means for Medical Affairs
Understand the latest technologies—Artificial Intelligence (AI), Machine Learning (ML), Natural Language Processing (NLP), and Natural Language Understanding (NLU). Understand the potential of these technologies to increase efficiencies, enhance effectiveness and potentially reduce compliance risk.
At the conclusion of this session, participants should:
• Better understand contemporary digital trends of Artificial Intelligence (AI), Machine Learning (ML), Natural Language Processing (NLP), and Natural Language Understanding (NLU)
As HCP reliance upon digital and social channels as both a source of educational information and a central meeting place for peer-to-peer interaction continues to increase, it’s critical for Medical Affairs teams to monitor that activity, understand who the Digital Opinion Leaders (DOLs) are and engage them appropriately.
In this session we will provide perspectives on the evolving role of Digital Opinion Leaders in medical education and share approaches for identifying, monitoring and engaging them in a compliant manor with relevant examples.
“The ubiquity of mobile devices now means that we have an opportunity through these digital technologies to improve health outcomes: through basic communication services, but also highly innovative services with regard to tracking and sensor development, measurement of biometrics and delivery of medical services.” He suggests that the vision for digital health is nevertheless relatively straightforward: “It’s not just about providing information, but rather providing integrated services that are proven to improve clinical outcomes.”
Digital therapeutics, Butler adds, are prescribable digital programs or interventions that should be shown to improve outcomes. “They’re called therapeutics because they already have some form of evidence base behind them in a more traditional sense, mostly because they’ve derived out of cognitive behavior therapy and mindfulness where there’s already a lot of evidence for these programs.”
The sheer velocity of the digital revolution means that in in recent years we have seen not only more advanced capability, but increased application in areas of previously unmet need. Metabolic disorders, psychiatric disorders, and cardiovascular health, among others, have seen their management transformed dramatically by digital health solutions, notes Butler.
Health technology companies, academia, HCPs, and patients – as well as pharmaceutical companies – are delivering these digital solutions successfully. Butler highlights a couple of examples, including GlycoLeap’s diabetes system. “This tracks the obvious things like your activity, your nutrition, your glucose levels and your body mass index, but also combines it with a behavioral psychologist and nutritionist that you can access at any time. Basically, you get a personalized diabetes management program through your smartphone app, which would never have been dreamed about 10 years ago.”
There’s also Omron’s smartwatch which measures blood pressure with clinical accuracy at the push of a button. “This can actually take your blood pressure through the watch strap alone and you can link it to AliveCor, an FDA-cleared medical-grade EKG”.
“Essentially, an everyday person can have what would have been not really possible outside of a cardiology department on them all of the time in their own home.” Even if this was available years ago, it would have cost tens of thousands of pounds, he adds.
The key role of Medical Affairs in driving the proliferation of these solutions necessitates a strategic approach. According to Butler, a model of clinical significance, behavioral change and user need must be applied to the development of digital health initiatives.
“Certainly, in the early days of strategically designing any kind of program or initiative, a requirement is that there’s clinical relevance. The days of just ticking a box, or even more than ticking a box, just providing information to patients about the disease through a different channel or on the phone (as opposed to a leaflet) is not really the point of what we’re trying to do with this.”
People tend not to respond to information; rather, the vast majority of decisions in healthcare are emotional decisions and Butler contends that we need contextual support in order to fundamentally change our behavior. Proven clinical outcomes – as well as patient outcomes, which he says are “at least as important” – must therefore be an inherent part of the digital health offering.
Behavioral change is another essential element. Butler explains that in the majority of digital health interventions, particularly in the management of chronic disease, the focus is on trying to help people to slightly modify or change their behavior. “Which, sometimes at least, can drastically improve outcomes. Again, if the program doesn’t have a genuine element of behavioral change in there, or you don’t understand what behaviors you’re trying to modify or support, then it’s probably a red flag that it’s unlikely to be successful.”
User need is the third and final part of this strategic approach, and although it seems obvious, Butler says it can often be omitted completely.
“What’s the actual value for the individual, patient or, more importantly, person that’s using this tool? Even if it’s easy to understand why the pharmaceutical company or even the healthcare professional might want someone to do something, it’s not always obvious why you, as a person, would want to partake in a lot of these things.”
He reels off examples of digital health being superfluous at best, pointless at worst: “data entry systems, diary systems without any obvious value, requirements to complete tasks with degenerative diseases without any kind of user value or interventions that can actually improve your outcome.”
Even with a strategic approach, there are inherent challenges for any pharmaceutical company developing any kind of digital solution. Ultimately, an initiative should be sustainable for that particular organization, and must be given adequate investment of both time and resources, Butler advises. “If you’re not doing something that is sustainable for your organization or meeting your commercial objectives, then it’s unlikely to have any traction over any period of time. Obviously, we know that these things need investment, care and nurturing over years, not just the scope of one motivated person. For example, if you’re working in a disease area where for clinical trial purposes you would like to be able to better track outcomes and you can use digital health tools to do that, then that’s obviously going to be sustainable, especially if you have a long pipeline in the disease area, or it’s incredibly important that you do everything you can to help people stay on the medication, or not to relapse in a condition.”
Butler agrees the future custodians of the vast majority of high-level digital investment will be Medical Affairs and says they must take an active interest in driving the strategy and the implementation of these programs. “At the very least, Medical has to have a key involvement, because this is talking in many ways about doing the same things that you would do for a medicine with regards to bringing that scientific rigor into the design of the program and into the evidential proof that these things have an impact on patients.”
This poses both ethical and compliance challenges, says Nicholas Broughton, an independent consultant in pharmaceutical ethics and compliance. For some in Medical Affairs roles, the word “digital” immediately evokes thoughts of banner adverts, one-too-many email campaigns, or health professional websites seen as commercial tasks that require medical review and approval, he tells Elevate.
“The problem is that this ‘one-bucket’ perspective on digital means that the ‘commercial produce/medical review’ approach is extended into digital activities where it is not appropriate. Provision of digital health solutions is one such area. To me, these are health interventions that solve problems for patients and there is a very clear analogy with the health interventions we call medicines. We have a moral duty to protect patients using such interventions from harm, respect their autonomy and maximize the benefit they can gain.”
Broughton echoes Butler, saying if something is being developed digitally to improve patient care, then it must be understood what the need is, how to prove benefit and how to avoid harm. The ethical implications must be crystal clear. “We can’t afford, as an industry, to provide health interventions that have flaky reasoning, no proven value and which may misinform or mislead and threaten patient safety.”
Yet he is adamant that despite the myriad ethical and compliance obstacles, Medical Affairs are uniquely equipped to lead the development and introduction of digital health solutions in all their guises.
“The skills and knowledge to develop useful interventions and prove they work and are appropriately safe – be they medicines or digital health solutions – lie in the medical and development functions in pharma. By all means, let our marketing colleagues provide ideas and input and promote what we produce, but scientists and health professionals in industry must lead development.”
The amount of data we are currently generating is astronomical. According to one often-quoted article on Forbes.com, some 90 percent of the data in the world was generated over the past two years alone. [1]
Today’s world is defined by data, with 2.5 quintillion bytes of data created everyday – and that pace is only accelerating as the Internet of Things (IoT) expands. No surprise then that Mike Devoy, Chief Medical Officer, Head of Medical Affairs & Pharmacovigilance at Bayer, predicts that the time is right for digital to transform our thinking about healthcare.
“I believe digital is going to become more and more important and, over time, it will transform how healthcare is delivered and also how drugs are researched and discovered. We’ve seen the explosion in data coming from the intensified use of wearable devices, sensors and so on, but now we have the computer power and the technology to start to really understand that information and turn it into relevant action.”
Moreover, Medical Affairs stands at the very epicenter of this digital revolution in healthcare, given the function’s scientific credentials and its potential to define, gather and interpret data to generate the insights that will deliver meaningful outcomes for the entire spectrum of healthcare stakeholders – but especially patients and healthcare professionals.
Sources:1: Bernard Marr, “How Much Data Do We Create Every Day? The Mind-Blowing Stats Everyone Should Read,” Forbes, May 21, 2018, https://www.forbes.com/sites/bernardmarr/2018/05/21/how-much-data-do-we-create-every-day-the-mind-blowing-stats-everyone-should-read/#228be95b60ba.
“In Medical Affairs, we have a unique role because we have a deep understanding of our products and knowledge of diseases. We should be looking to fit the new knowledge and insights that we can collect from Real-World Evidence (RWE) into delivering even better solutions for patients and the healthcare system. And, because we are in daily contact with healthcare professionals, patient associations and other stakeholders, we should be the ones who play a critical role in transforming that into something that actually meets the needs and provides services and solutions for end-users. By connecting what’s coming out of our R&D, the strategy behind the products from a commercial point of view, we could build this into an overall, integrated patient care vision.”
Dr Devoy sees scope for applying digital innovation across a range of areas but suggests that R&D, patient outcomes, and safety are the three to focus on initially. There is significant potential for how we conduct clinical trials: for example, using artificial intelligence (AI) within R&D as part of the drug discovery process, and also helping to better characterize and stratify disease and the according patient populations for study.
“If you look at a disease such as heart failure, we still have a pretty simple way of categorizing patients based on clinical examination, imaging investigation and some clinical tests. But almost certainly there are more different types of heart failure in terms of the underlying pathophysiology. So, if we can apply digital learning and artificial intelligence to better stratify these areas and therefore to personalize treatments, then I think we will overcome a lot of hurdles to improving patient care.”
Cost is already a major issue in healthcare and digital has the potential to help unlock cost-savings for healthcare systems and wider society, as well as for industry.
Digitally integrating electronic medical records (EMR), both to identify patients and then also to follow up and stay connected with them is another considerable area of potential.
“I think there are already examples starting to happen that could dramatically reduce the cost of particularly large outcome studies which you have to do in areas like cardiovascular. There are significant gains that can be achieved by applying technology to make the studies more efficient, more precise, simpler to conduct, and so able to be conducted more quickly and more cheaply.”
Digitally integrating electronic medical records (EMR), both to identify patients and then also to follow up and stay connected with them is another considerable area of potential. “We should be looking at diagnostic technology and EMR to detect and diagnose disease much earlier and enable informed decision-making – that will allow us to intervene with prevention before people become physically sick at the stage they might currently be diagnosed.”
Adherence and product safety are two further areas of great promise for digital.
“For as long as I’ve been in the industry, something we’ve talked about but struggled with is finding ways that we can help patients adhere to the treatment that they’ve been prescribed, so that we actually deliver better outcomes. The use of sensors, wearables and other applications may offer such a solution for enhancing treatment adherence. I also believe that we can help better understand the benefit-risk of our products using AI and big data approaches to identify safety signals and issues with products earlier.”
However, the fact that the technology is so new and accompanied by such a weight of expectation inevitably implies some formidable challenges.
“We read every day about how digital is transforming everything we do – be that personal finance, or interactions with retail – so I think the expectation from society is that healthcare will also transform in that way. But, clearly, healthcare has quite rightly some additional challenges relating to the sensitivity of people’s health data and taking the right care of that. So, we need to work with regulators, governments, patients and physicians to make sure that these solutions are accessible, trusted, compliant and fitted to people’s expectations.
As companies, we need to adapt to working and developing and being successful in a digital environment. So, that will mean hiring and developing new talent with the right skills in areas like data science and data privacy. But, also, we are not just competing with other healthcare companies, now, but numerous other technology companies and other industries for those skill sets. It’s not just hiring new people, but also developing capabilities, making our current employees more savvy about working with digital – how those technologies could be applied, what the potential options are.
One area where Medical Affairs in most companies is usually taking a lead is understanding, communicating and generating real-world evidence. That is going to put increasing demands on Medical Affairs organizations to be able to access and analyze large data sets. To turn this into useful and meaningful evidence that can inform both the decisions of our organizations but also inform other stakeholders such as regulators, physicians and patients.”
At Bayer, digital is already driving new business models and the organization is cultivating a new digital culture across its various businesses. “Digital will change our business models and how we relate to patients and healthcare professionals – it’s a high priority for us and we have created a strategic framework as well as a digital agenda to help us become future-ready. We really want to make digital technologies an integral part of our overall business acumen, value chain, lifecycle management and decision-making, and we’re looking at that as a critical aspect of our overall business. We also recognise that a lot of the innovation and expertise is going to come from outside and from different areas, from different sorts of companies.
“One thing I believe we’ve done very successfully is build up an approach for actively seeking external collaboration. ”Among the initiatives is a global program called Grants4Apps, established in 2013, where Bayer reaches out to companies that are in the early stages of developing in the digital health and care space. Bayer acts as incubator and offers mentoring support and access to Bayer expertise and knowledge to help them develop their business models and solutions. Meanwhile, the Grants4Apps Dealmaker program is a unique opportunity to acquire Bayer as a customer and is tailored for mature teams, startups and companies that have a solution ready to go for identified challenges.
We also partner with research institutions across the world and, where it makes sense, with various technology companies that are also entering the healthcare space. You look at who are the partners that are meaningful to your stakeholders – like patients and healthcare professionals – and how do you do something with that partner that creates more value. We strive to enhance our ecosystem (for example with subsidiaries in San Francisco and Boston) and constantly monitor the external environment trying to link business challenges and evidence needs to potential technological solutions.”
Nevertheless, to harness the potential of RWE – both from EMR and sensors and devices – companies such as Bayer will need to make sure they have the ability to handle large volumes of data, that the data is of the right quality and data privacy is respected, and that they have the right skills and methodological approach to succeed in this space. “I think we need to make sure that we operate to a high standard of scientific integrity and quality because there are certainly risks if you don’t. And you need to bring in different skill sets in areas that will allow you to collect, analyse and interpret that data.” Bayer has been working hard to find people with skills in areas of big data analysis, including data scientists and epidemiologists.
In conclusion, Dr Devoy emphasizes that all of these changes imply a significant mindset shift on the part of MA professionals, who will be moving from their traditional support role to much more of a strategic focus. This will involve the function engaging much earlier in the value chain.
“Medical Affairs will get involved in the early project discussions [helping] research colleagues think about the best approach in terms of patient target groups, disease, models, linking to external expertise and knowledge. He also envisages Medical building a strategy aligned with global and key countries where the function will conceive or build a medical strategy aligned with the overall plan, both in terms of data generation and communication.
“In some key topics, such as real-world evidence, Medical is very much the function that takes the lead role in working with all the internal and external stakeholders to create the strategy and then execute it across the organization. You see it in very tangible things in terms of resource deployment, which has changed very significantly over the last five years.”
Going forward, Dr Devoy sees Medical as being the trusted partner between businesses and key external stakeholders – patient bodies, physicians and regulators – articulating the value companies are providing to healthcare systems and to patients. MA potentially has a unique understanding of how that value can be created and delivered, and a key role in developing the evidence and solutions around that value in collaboration with internal and external partners such as R&D colleagues, digital providers, physician groups and patient advocates.
“As patients become more empowered to make healthcare choices, it’s more important than ever for healthcare companies to create compelling and satisfying experiences. Digital solutions and innovation have never been more at the forefront of healthcare and are an important part of Bayer’s long-term strategy. These solutions can drive down costs or boost efficiency, build connections to patients and dramatically improve patient outcomes.”
Dr Michael Devoy is the Executive Vice President for Medical Affairs and Pharmacovigilance for the Pharmaceuticals Division at Bayer AG. He is also the Chief Medical Officer of Bayer AG. He joined the former Schering AG in 2005 as Senior Vice President of Global Medical Development and was appointed to his current position in 2014.
Dr Devoy studied Medicine and Pharmacology at University College London and graduated with a Bachelor of Medicine/Bachelor of Surgery (MB, BS). He is a member of the Royal College of Physicians in London. He has extensive experience across Clinical Development and International Medical Affairs. His career in the pharmaceutical industry began when he joined Glaxo Group Research in Clinical Pharmacology.
“Probably the most important leadership experience came in my early career, when I became a Medical Director of a country – in that case Australia – where I had to operate with a greater degree of independence, lead quite a large team at the time, and balance all the diverse demands of the different stakeholders that interact with you: patients, physicians, researchers, regulators and internal colleagues in the business. I learned a great deal there about my leadership style: what my values were and what my drivers were, particularly through facing difficult issues and talking, reflecting on what we were trying to achieve; why and how you’re going to do that; and staying true to yourself in managing through those difficult topics.
“In terms of the sums, we had some financial challenges. I had to find a way of making my organization more efficient and responsive, and that was an important – and also, at the time – difficult experience. I then took on more senior global roles and an important step there (which I think applies to a lot of leaders in pharma and Medical Affairs) is managing globally dispersed teams with colleagues in lots of different time zones and countries. This involved balancing people with different cultural expectations, different perspectives on what good leadership looks like and how things should be communicated, how things should be managed, and managing and leading in that set-up.
“I’ve learned something from every leader I’ve had, in terms of how I’ve evolved and grown. In my leadership approach, one important learning I had with a leader was when one day I went to ask if I could do something and they said: ‘You should not be coming to ask my permission.
Come when you need my forgiveness.’ That was at a relatively early stage in my career and I think that gave me a perspective to take more personal responsibility and accountability for addressing situations and finding solutions. Not that it always went to plan, so I think then you accept you also have to take the responsibility for your decisions.
“Also, I had the privilege to work with leaders who modeled the best behaviors in terms of what ultimately is our priority in this industry, which is ensuring that the patients we serve receive the best treatments and optimum care and that we make sure that the trust they put in us as pharmaceutical healthcare companies is fulfilled. I would say that I learned equally from leaders who came from the commercial side of pharma and those who came from a scientific and medical side – all those different individuals have brought aspects to how my style of leadership has evolved.
“You don’t need to be the friend of your leader but, it’s important that you respect and understand their roles and actions and that they understand what you’re doing and how you’re doing it and what your vision is, and how that fits with the overall bigger picture.”
At the conclusion of this eCademy Webinar, participants will be better able to understand:
As healthcare continues to transform, we need to stay connected to our customers in many ways. From Upstream scientific exchange driving research, to clinical trial design establishing evidence, to co-creation workshops establishing value propositions, to education and post-release support to drive adoption, collaboration with customers across the solution lifecycle is key to providing the best solutions to our customers. MSLs are becoming more important and playing key roles across the lifecycle in partnership with many others who play important roles. We will describe the landscape, drivers, and opportunities for engaging with customers across the lifecycle and how we socialize learnings across the organization.
The Scientific Communication Platform (SCP) is the foundation of a strong medical communications strategy for a pharmaceutical product or device, and serves as an important tool to align communications and messaging across functional areas. Even minor discrepancies in cited data and/or the way that data are described can lead to confusion and weaken a product’s overall value proposition. The SCP is based on scientific evidence and requires an in-depth analysis and review of available and anticipated data, the disease and competitive landscape, stakeholder perceptions, and aspirations about the product profile. Since the final SCP output ensures accurate and consistent language and referencing through all communication activities, putting a plan in place to ensure successful cross-functional and regional implementation and utilization of this valuable resource is critical.
After completing this Webinar, participants will be better able to: