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This open-access webinar available to MAPS members and non-members features Todd Neuville, Worldwide Leader – Life Sciences, Amazon Web Services presenting a case study of Amazon’s approach of “working backwards,” in discussion with our expert panel.
• Understand why medical affairs is strategically positioned to drive positive customer experience
• Explain the core criteria for delivering good customer experience and interactions in medical affairs
• Describe the critical imperatives for success
• Identify the key challenges when embedding a customer-centric mindset
Through this course you will recognize terms such as artificial intelligence (AI), machine learning (ML), deep learning, and neural networks to arrive at best decisions and insights needed for success.
Topics Discussed in the Town Hall Include:
-Managing Individual Performance Remotely
-Virtual Leadership Mindset & Skills
-Effective Team Engagement in the Virtual Space
-Engagement of KOLs Virtually
SPEAKERS:
Cezary Statuch
VP, Medical, Intercontinental Region
Biogen
Greta James-Chatgilaou
Field Medical Strategy and Execution Director
Biogen
Alan McDougall
VP, Head of Medical Affairs, International Markets and Greater China
Astellas
Qasim Ahmad
Corporate Officer/VP, Head of Japan Medical Affairs, OBU
Novartis
WATCH IT HERE:
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Bill Strickland, AVP, US Field Medical at Allergan, speaks on “demystifying artificial intelligence” at the MAPS 2020 Global Annual Meeting in Miami, and how AI can enhance daily life in this new frontier for Medical Affairs professionals. Dr. Strickland also touches on patient centricity and his leadership philosophy.
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Download the Presentation
Members may also download a PDF copy of the slides as well as a recording of the session in the Community Portal. Not a member and wish to access the slides? Membership is only $250 USD per year ($425 for a 2-year subscription) and includes access to all new live Webinars, all on-demand Webinars (over 50 Webinars and growing each month), discussion forums to share best practices and questions with over 4,000 Medical Affairs professionals from across the globe, copies of past meeting presentations, white papers, standards & guidance tools and templates, and much, much more. Click here for membership details or to sign up: https://medicalaffairs.org/membership/
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.
The digital health revolution implies a clear understanding of strategy, using technology as an enabler to create better outcomes for patients and to power value creation across the healthcare ecosystem. As data specialists, Medical Affairs professionals will be at the forefront of this transformation.
The medical world is changing and changing fast. As multiple new technologies start to transform every aspect of the healthcare ecosystem and the lines between biosciences and data science fade, companies need medical leaders who not only understand the latest medical advances but also the potential and scope of data and digital, along with their implications – not least that this new paradigm requires strategists who are comfortable with organizational transformation and who can lead change. Dr Rajni Aneja is one such strategist: she specializes in the crossover between business and technology across a variety of health sectors.
“My training falls at the intersection of business and technology and I have worked across all different healthcare sectors from payer to a consumer digital company to pharma, as well as being involved in an advisory capacity for innovation and strategy in health for MIT and Harvard Innovation Lab, along with Oliver Wyman, and many other start-up companies.
“From an industry standpoint, I am interested in the role of digital facilitating consumer as well as HCP engagement strategies, or patient journeys through a variety of touch points leading to better clinical outcomes, better clinical interactions, better patient experiences, better healthcare provider experiences, as well as better delivery of healthcare.”
This approach is all about strategically using digital as an enabler driven by data. “When we create a strategy around a digital experience, it’s not about the technology. I see the technology as an enabler: when you apply the right technology at the right point and have the right interventions designed – either for the provider or patients – that is when it actually is impactful or meaningful.”
Longer term, advances in bioscience and digital technology have the potential to add value to the system in multiple ways: for example, by transforming the R&D process to potentially make it shorter, more specific, and take out cost; by ensuring better health outcomes for patients, bringing forward new treatments more quickly, and generally improving the patient experience; and by providing opportunities for physicians through new options to advance patient care and offering new ways to engage and learn.
We are only at the start of this journey today but Dr Aneja points to significant potential that already exists. “As a physician, when you see patients in clinics, you’re only seeing 15 to 20 patients in a day. But if you have technologies like telemedicine, where you are delivering consultations on videos, or you’re delivering care to remote areas, your impact and outreach becomes much wider and much more significant.
“I see telemedicine as one of the technologies to have gained a lot of momentum, not only for its potential in clinical trials but also for prevention and wellness visits, or even acute care visits. But what’s coming next? I think the future is where data is driving or enabling these technologies, and this is where artificial intelligence or machine learning comes into play. However, if the data is not good enough, anything that is going to come out of it is not going to be good enough: garbage in, garbage out. The importance of data as an asset is that you drive intelligent decision-making and that is only done through insights generated by the power of data that is collected from a variety of technology enablers.” As an example, she cites finding the right patient for the right clinical trial at the right time for the right medical condition, while delivering the right care, all of which can be powered and informed by the data.
Today, real-world evidence (RWE) and data – especially continuous real-time data – sits at the heart of where the healthcare ecosystem is headed, not least in the context of value-based health design and care delivery, where (especially in the US) the system is moving from volume to value, and there is more emphasis on better outcomes. This implies that data can be both shared and combined effectively, and also that RWE – including data directly from the consumer, say from wearables – can be integrated with historical data and combined with real-time analytics.
“There’s an evolving trend that we’re seeing: in the last two to three years pharmaceutical companies have started to work very closely with the payers. But the industry is becoming disrupted and I think all these stakeholders can learn from each other to say: ‘How am I going to be a leader in the game instead of a follower?’”
The trend within the healthcare sector is asking for more integration of data and collaboration between organizations – joining the dots – to generate insight from the payers as well as from pharma and from consumers. “This is a collaborative effort around value-based care and an outcome-based approach, which will lead to better patient care and better clinical trials. But there are many challenges remaining before this data utopia becomes reality, including a lack of agreement on definitions of what constitutes value. What is considered good-quality data, data privacy, data governance and data security and many others factors would play a vital role in shaping the thought process as we move along this transformation journey.”
So, what are the hurdles? The regulatory environment is one, but regulators and government are increasingly aware of the need to advance. We have seen the introduction of the 21st Century Cures Act; as well as statement from FDA commissioner, Scott Gottlieb about the importance of digital health and real-world evidence, and there are efforts now around guidance from the governing bodies. Commercial sensitivity is another issue, but industry is increasingly acknowledging the need for collaboration – perhaps through neutral consortium – to harness the power of data and analytics. As an example, Dr Aneja cites the NEWDIGS project, through MIT’s Center of Biomedical Innovation, which brought together various pharmaceutical partners in a neutral, non-biased, cohesive setting. However, she acknowledges that “we’re taking baby steps and are in exploration mode with a desire for more collaborative models, and not yet ready for prime time yet.”
And what about the benefits? There is clearly substantial value in a system that encourages us to learn about the patient – not least, greater customization, personalization, and simplicity for the patient. This encompasses patient-reported outcomes, behavioral profiles, social, and other demographic data leading to consumer segmentation, which in turn can deliver on targeted interventions and interactions.
Dr Aneja elaborates: “I’ll give you an example. Rajni is a 40-year-old female who runs every day and is pretty healthy and motivated and doesn’t take any medicine, but is very interested in her well-being. Because of the combination of data from different sources, we can create a profile of what Rajni wants, what Rajni needs, how we engage her, how we motivate her and do that on a continuous long-term basis; and data can enable targeted, personalized interventions – interactions that are actually applicable to Rajni, not one-size-fits-all. Data can help you get to that level of granularity, but I always say that with a word of caution: we’re not there yet. But that doesn’t mean that we can’t get there; it’s just that we’re on our way to this kind of transformation.”
And this opens up a whole world of further possibilities: Rajni might be part of a cohort that you could segment in the context of preventative health and screening, and so on. So there’s an opportunity to gain a depth of insight into individual patients within a population. “Imagine if you could understand, in your population, who are my well people? Who are my sick people? Who are the people who are very, very motivated? Who are people that actually need a lot of nudging because they’re not motivated? With the years of data, you have the ability to be not only predictive but at some point can be prescriptive, especially for precision medicine.”
Beyond this, digital needs to make life simpler and more convenient for patients. Healthcare is already becoming more consumer-centric. “I think it’s already happening. You already have Uber Health; we have telemedicine solutions; we have remote monitoring; we have wearables and sensors. I think the trend that we see is consumers becoming more involved in taking responsibility for health; they’re becoming more informed. Consumers want to manage their health, want to see their healthcare data, and want to be equally responsible for decision-making.
What needs to happen going forward? “I think it’s an industry shift.” There is recognition that we need to accelerate this process, according to Dr Aneja. In conclusion, she sees a significant role for Medical Affairs within this new environment – as the conduit of the digital transformation. MA can help define the problems we are trying to solve, along with the data sets and technology that will enable a solution. “They are absolutely vital. You would not create an initiative in a silo; technology is an enabler. Ultimately the insights coming from MA about what problems we need to create an effective solution for will lead to better patient outcomes as well as better patient experience.”
Biography
Rajni Aneja is an MIT Connection Science Fellow, healthcare strategist, public speaker, and transformative change agent with expertise in population health management and digital health. She serves as an adviser to a variety of health and wellness organizations. Dr Aneja encompasses various vantage points as a clinician, executive, adviser, entrepreneur, speaker and technology advocate serving in senior leadership roles. These include Chief Medical Officer for WebMD health, EVP of Joslin and a strategic executive and transformation leader at Humana. Most recently she contributed to the building of a digital consumer strategy at Novartis. Dr Aneja received her MD from Research Medical Center in Kansas City and her MBA from the University of Massachusetts.
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.
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.
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.”
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.”
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