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CLICK HERE to subscribe to the Elevate Podcast Channel on Apple iTunes.
Medical devices and pharma: two sides of the same coin; significantly different but part of the same larger ecosystem. Dr. John Pracyk discusses the implications for Medical Affairs professionals.
So why have we called this piece Medical Devices are from Mars; Pharmaceuticals are from Venus? According to Dr. John Pracyk, it is a useful metaphor based on the classic relationship guide by Dr. John Gray: Men Are from Mars, Women are from Venus. Expanding on the analogy, he explains that the majority of Medical Affairs professionals in the medical device sphere are surgeons, whereas pharma is dominated by physicians. Beyond this, of course, there are other significant differences that stem from a close alignment between medical devices and therapeutic expertise.
Dr. Pracyk, who is Worldwide Integrated Leader, Medical Affairs, Pre-Clinical & Clinical Research, for DePuy Synthes – Spine (part of the Johnson & Johnson stable), says: “It’s important because Medical Affairs is now aligning towards the fact that you’re most likely going to be working in an operating company in line with your sub-specialty training and board certification, along with operative proficiency and clinical practice experience, which will be at least a decade or more. After that you begin to have the skill set that industry is looking for. That’s decidedly different than Medical Affairs in pharmaceuticals, where there is a much more diverse range of clinical experience and educational backgrounds.
“In other words, to deliver the most value to the device industry we can only make the transition once we are board certified and bring a wealth of clinical practice experience to the table.”
Meanwhile, in pharmaceuticals, the classical model is an internal medicine residency with sub-specialty fellowship, or research training, followed by a highly variable period of time in clinical practice. Some physicians forgo residency and clinical practice entirely and make the transition to industry immediately following medical school or, alternatively, a post-doctoral research fellowship, while others have had meaningful careers in healthcare consulting.
The differences between devices and pharmaceuticals is especially significant from the perspective of the new European Medical Device Regulation that was passed on May 26, 2017 and comes into full effect on May 26, 2020, after a three-year phase-in period.
“Medical device companies need medical directors that have specific subject-matter surgical expertise that reads directly to the product portfolio. Why? Because the MDR credentials section has become more stringent, as have the state-of-the-art requirements – these require medical affairs surgeons to have deep clinical insights into a specific therapeutic area, as they are medically responsible as signatories for the Clinical Evaluation Report, (CER) which is the formal application for the CE mark in the European Union. For example, as a spine fellowship-trained neurological surgeon, it is quite appropriate that I lead medical and clinical affairs for our spine platform. Similarly, orthopedic surgeons lead trauma and joint reconstruction, whereas an otolaryngologist leads our ENT platform.”
Beyond this, there are further differences between devices and pharmaceuticals in terms of Medical Affairs’ scope of responsibility. “Typically, Medical Affairs in pharmaceuticals is primarily involved once the drug has launched. Clinical Affairs is responsible for all the pre-launch activities such as R&D and drug development. In devices, Medical Affairs spans that entire spectrum from initial ideation and front-end conceptualization through the stage-gate, development process, bringing that product to market and then launching it. It doesn’t stop there, as once it is in the field, maintaining it through its lifecycle and then removing from the market is also our responsibility. Medical Affairs in devices is subdivided into two major divisions, 1) Franchise, which is responsible for product development through the R&D pipeline all the way up to launch, and 2) Lifecycle, which picks up the product at launch and manages it through its entire lifespan on the market. We typically refer to it as ‘pipeline and portfolio ’: pipeline being franchise, portfolio being lifecycle.
“In pharmaceuticals, Medical Affairs is predominantly involved in the post-launch affairs, getting the product to market, medical communications, scientific engagements with KOLs, for purposes of studies, clinical trials, publications, podium presentations, and supervising all of the field medical professionals, such as medical science liaisons (MSLs).
“In devices, we are both internally and externally facing. For example, we work closely with Health Economics & Market Access (HEMA), to establish evidence of differentiated value to position products to successfully navigate value analysis committees (VACs). Similarly, we often oversee clinical investigational studies and investigator-initiated studies that support our products for purposes of safety and performance for our regulatory authorities. Internally, we work with R&D, Quality, Regulatory, Global and Regional Marketing in helping our colleagues understand what it’s like on the hospital and surgeon side of the equation.
“When I was practicing, I was the surgeon champion on the VAC for my health system. Now, I use that prior clinical and hospital administrative experience to help guide our interactions as a device manufacturer with the VACs of our customer hospitals and integrated delivery systems. Simply put, it is different ends of one vary large supply chain. Not surprisingly, I have also been involved in engaging our own contract manufacturers through speaking engagements and moderating panels at the Orthopedic Manufacturers Technology Exposition and Conference (OMTEC), as I now need to learn about how supply chains in industry work, while reciprocally informing our contract manufacturers on the global transition taking place clinically from volume to value that ultimately impacts their businesses as well.
Medical Affairs informs strategic decision-making
Medical Affairs is increasingly becoming a strategic partner for both commercial and R&D teams. “One way to look at this is through a go-to-market strategy that is refracted through the lens of three evidentiary audiences. The first is regulatory, where we must place the product ‘in country’. Next is hospitals/integrated delivery networks, where were we need to work with the VACs to get the product ‘on contract ’. Thirdly, we must secure reimbursement from the payers, whether they be private, commercial insurers, or government entities. As you can see, Medical Affairs is involved in a very broad range of medical and scientific engagement activities.
Diverse skillsets
Medical Affairs professionals in devices are fewer in number and require a very diverse skillset, whereas Medical Affairs in pharmaceuticals are far larger in number and, historically have been around much longer. “When you consider the sheer numbers of Medial Affairs in pharmaceuticals, both internally and with the MSLs in the field, it is literally an army. Conversely, on the devices side, we’re more of a ‘special forces’ model, where you just have a few people who are very specialized, but cross-functionally trained in diverse areas, which is a force multiplier.
So how hard is it to obtain the specialist knowledge and overcome the significant shortage of talent? Surgeons coming into Medical Affairs often have skillsets that are much in demand, beyond their specialist clinical expertise. For example, time spent learning how to develop a practice and building business acumen are highly prized in industry.
“Many physicians and surgeons are now going to business school to get their MBAs, while others have been involved in hospital leadership committees or have commercialized devices as an entrepreneur. These transferrable skills are valuable when you consider the range of activities that Medical Affairs delivers against: namely, understanding business operations, manufacturing, finance, accounting, communications, strategic development, and pre-clinical and clinical research – and being able to navigate the spectrum from bench top, to small animal, large animal, and ultimately first in human. Not surprisingly, surgeons who possess these essential business, research and clinical skills will meet with great success in devices.”
Leaving clinical practice
In pharma it is not uncommon for clinicians to maintain some form of clinical practice, which can take a variety of forms from an occasional clinic, to volunteering, or mission work. However, due to both legal and healthcare compliance issues, surgeons working in devices must stop operating and close their clinical practice upon entering industry. For a surgeon, who has spent years acquiring a unique set of skills this is a huge deal. Fortunately, maintenance of operative skills is accomplished through a variety of cadaver settings: wet labs, validation labs, and prototype testing.
Yet, there is one remarkable upside, according to Dr. Pracyk. “Believe it or not, we can secure visiting professor privileges anywhere in the world that permits us to scrub into surgery with key opinion leader surgeons – not to clinically perform the operation (in fact, we are specifically prohibited from touching the patient), but more importantly to observe, learn, and distill out the critical insights that help identify and address true unmet needs. The simple fact that this worldwide peer-to-peer surgeon exchange occurs from within the operative field is absolutely amazing.”
Lessons on both sides
“I think what pharmaceuticals can learn from the device side is that we are very good at these cross-functional skills.” Flipping it around the other way, what can devices learn from pharma? “I think pharmaceuticals has a much more thorough and deep understanding of ‘patient centricity’.
“In devices, the surgeon is the proxy for the patient. However, with the concept of surgeon employment and the advent of spine and brain institutes in neurological surgery or musculoskeletal institutes in orthopedic surgery, the multidisciplinary model of care is taking hold. Ultimately, the patient will be at the center of what we do and a more comprehensive approach to care redesign will certainly elevate patient centricity globally as the medical devices sector continues to learn, share and advance care more holistically like our pharmaceutical colleagues.
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
The Medical Affairs teams demonstrate leadership and value each year through the annual strategic planning process that aligns all multifunctional MA competencies on common objectives needed to support the product and organization. A focused and cohesive medical strategy must be developed to navigate the complex therapeutic environment for each product – overcoming challenges, taking advantage of opportunities and filling any scientific or clinical gaps. A comprehensive and supportive tactical plan aligned to the medical strategy should define the activities that will provide the most impact and benefit to stakeholders in therapeutic space while taking the MA team one-step closer to achieving annual goals.
The MAPS Medical Affairs Strategic Planning Guide and Template has been developed to provide guidance and recommendations to selected components that comprise the strategic medical affairs planning for a product – including the situational analysis, medical strategy, tactical/operational planning, and medical plan summary.
Executive Vice President & CMO, UCB, Iris Loew-Friedrich discusses the importance of a purpose-driven culture to employee engagement
Caring for people – patients and colleagues – coupled with the science are the twin elements that form the foundation of Professor Doctor Iris Loew-Friedrich’s approach to her role. And this aligns neatly with the vision of her employer, global biopharma company UCB, and provides a platform for collaboration both within and outside the organization.
A physician by training, Professor Loew-Friedrich started her professional life at the Frankfurt University Medical School and has always tried to combine patient care with high-quality research. Today she is Executive Vice-President Development and Medical Practices and Chief Medical Officer at UCB, where she provides global strategic leadership across a range of areas.
“I still very much consider myself a physician, so patient care is really at the center of what drives me – and more generally it’s care for people: people living with diseases and also people in our company, in my organization and people in our industry are what motivates me very much.” This approach chimes with the way UCB articulates its vision: “Inspired by patients. Driven by science.” Professor Loew-Friedrich is confident that this “really sends out a message about who we want to be.”
She explains: “I think culture is the key driver and so creating a culture that gives colleagues a sense of purpose and the opportunity to make a meaningful impact is important. At UCB, we have one central question that we ask all the time: how will what we do make a difference for patients living with severe diseases? It’s the value-creation topic that is at the center of all of our work.”
And, of course, this vision resonates especially within the Medical Affairs function.
“Our mission in Medical Affairs is to drive the continuous modernization and integration of data from multiple disciplines and sources. Then we need to translate them into actionable insights with scientific integrity, efficiency and transparency so that we optimize the patient and healthcare professional experience. That’s a mission behind which we can all align. We try to ensure that all colleagues in our Medical Affairs practice understand how each of them contributes to this mission and we combine this with forming a culture of high-performing teams.
“Everybody is focused on the same purpose of creating value for patients. On top of this, we try to ensure that we are an organization that cultivates learning, innovating and high performance and all of that integrated with opportunities for personal development, recognition, and rewards. It is the entire package that is required to attract the talent for the future and to maintain and develop that talent in our organization.”
Moreover, continuous learning is key to fostering agility and adaptability, according to Professor Loew-Friedrich. “As the environment keeps changing so quickly, the ability of an organization to be agile and to adapt is very important and so these are important traits that we’re looking for when we are hiring talent – a mindset to innovate, to grow, a mindset of continuous learning.”
How can the organization attract this type of talent? “We aim to create the sense of purpose, the sense of belonging, and key opportunities for personal development and growth. In line with our practice thinking, we are trying to establish communities of colleagues who either have the same role in the organization or who work in the same geography or who are engaged around the same patient population. So, our communities are aligned on common themes and we see that as a major driver of identification with the Medical Affairs organization and a source of inspiration and learning.”
Leadership for Loew-Friedrich has always been about empowering people to have maximum impact in a team environment. “I consider myself very much as someone who creates opportunities and empowers people. I believe you cannot be a leader without being passionate about what you are doing. Of course, we need to be very objective in our decision-making.”
Asked about the key capabilities to be developed within Medical Affairs as we move towards value-based medicine, Professor Loew-Friedrich is clear: “From my perspective the biggest topic is probably around creating and mastering medical insights. The second area of focus is collaborating very broadly for evidence generation.
“In terms of generating and mastering medical insights, I think we have already plenty of data available but how do we then use the data to truly generate insights? For me, this means that it’s not about just generating outputs and results, but really going one step further and distilling meaningful insights, providing context and ultimately driving impact. “On the second topic – collaboration for evidence generation – I think we have plenty of opportunity to join forces with academia or other institutions outside of our industry to invest our joint resources into the acceleration of the advancement of medical science. If a medicine gets to a patient in its first indication, there is a vast opportunity in terms of further knowledge and insights being generated: how can we get to the best ideas and how can we turn them into a true win-win situation that will create value for patients? This is where I believe we can collaborate closely with academic institutes, patient advocacy groups and other stakeholders to really get to the best possible outcome.”
Professor Loew-Friedrich points out that collaboration will be enhanced by advanced technology. “What I am seeing for the future is that we need to launch artificial intelligence capabilities – so that we use the data to simulate scenarios that will very objectively inform the next steps and ultimately enhance patient care. One of the big topics around collaboration for evidence generation is building on the strengths of human intelligence and artificial intelligence and establishing seamless interaction between both.”
How can we measure our performance in this new world? “Performance management is a topic that we continuously need to evolve and that is not as easy as it sounds. We’re trying to move away from very simple, quantitative measures – number of scientific exchanges, number of publications, impact factors – to measuring the quality of our analytical skills and the insight generation. Getting to meaningful qualitative measures is not an easy task. And I understand it’s not only difficult for UCB, it’s a challenge for the entire industry.”
Finally, the new operating model elevates Medical Affairs from a supportive role into a strategic decision-maker and trusted scientific partner: how is this change manifesting itself within the organization? “We are moving towards an integrated model that provides the Medical team the right space to be a trusted scientific and strategic partner ‘eye-to-eye’. What we need to continue to enhance is leadership and business acumen of our medical colleagues. This is not only about scientific leadership and leadership in insight generation, it’s also leadership in the most classical sense of providing direction, engaging and inspiring colleagues – inside Medical Affairs and beyond. That’s a work in progress and a key competency that we continue to strengthen in the organization.”
The digital health revolution implies a clear understanding of strategy, using technology as an enabler to create better outcomes for patients and to power value creation across the healthcare ecosystem. As data specialists, Medical Affairs professionals will be at the forefront of this transformation.
The medical world is changing and changing fast. As multiple new technologies start to transform every aspect of the healthcare ecosystem and the lines between biosciences and data science fade, companies need medical leaders who not only understand the latest medical advances but also the potential and scope of data and digital, along with their implications – not least that this new paradigm requires strategists who are comfortable with organizational transformation and who can lead change. Dr Rajni Aneja is one such strategist: she specializes in the crossover between business and technology across a variety of health sectors.
“My training falls at the intersection of business and technology and I have worked across all different healthcare sectors from payer to a consumer digital company to pharma, as well as being involved in an advisory capacity for innovation and strategy in health for MIT and Harvard Innovation Lab, along with Oliver Wyman, and many other start-up companies.
“From an industry standpoint, I am interested in the role of digital facilitating consumer as well as HCP engagement strategies, or patient journeys through a variety of touch points leading to better clinical outcomes, better clinical interactions, better patient experiences, better healthcare provider experiences, as well as better delivery of healthcare.”
This approach is all about strategically using digital as an enabler driven by data. “When we create a strategy around a digital experience, it’s not about the technology. I see the technology as an enabler: when you apply the right technology at the right point and have the right interventions designed – either for the provider or patients – that is when it actually is impactful or meaningful.”
Longer term, advances in bioscience and digital technology have the potential to add value to the system in multiple ways: for example, by transforming the R&D process to potentially make it shorter, more specific, and take out cost; by ensuring better health outcomes for patients, bringing forward new treatments more quickly, and generally improving the patient experience; and by providing opportunities for physicians through new options to advance patient care and offering new ways to engage and learn.
We are only at the start of this journey today but Dr Aneja points to significant potential that already exists. “As a physician, when you see patients in clinics, you’re only seeing 15 to 20 patients in a day. But if you have technologies like telemedicine, where you are delivering consultations on videos, or you’re delivering care to remote areas, your impact and outreach becomes much wider and much more significant.
“I see telemedicine as one of the technologies to have gained a lot of momentum, not only for its potential in clinical trials but also for prevention and wellness visits, or even acute care visits. But what’s coming next? I think the future is where data is driving or enabling these technologies, and this is where artificial intelligence or machine learning comes into play. However, if the data is not good enough, anything that is going to come out of it is not going to be good enough: garbage in, garbage out. The importance of data as an asset is that you drive intelligent decision-making and that is only done through insights generated by the power of data that is collected from a variety of technology enablers.” As an example, she cites finding the right patient for the right clinical trial at the right time for the right medical condition, while delivering the right care, all of which can be powered and informed by the data.
Today, real-world evidence (RWE) and data – especially continuous real-time data – sits at the heart of where the healthcare ecosystem is headed, not least in the context of value-based health design and care delivery, where (especially in the US) the system is moving from volume to value, and there is more emphasis on better outcomes. This implies that data can be both shared and combined effectively, and also that RWE – including data directly from the consumer, say from wearables – can be integrated with historical data and combined with real-time analytics.
“There’s an evolving trend that we’re seeing: in the last two to three years pharmaceutical companies have started to work very closely with the payers. But the industry is becoming disrupted and I think all these stakeholders can learn from each other to say: ‘How am I going to be a leader in the game instead of a follower?’”
The trend within the healthcare sector is asking for more integration of data and collaboration between organizations – joining the dots – to generate insight from the payers as well as from pharma and from consumers. “This is a collaborative effort around value-based care and an outcome-based approach, which will lead to better patient care and better clinical trials. But there are many challenges remaining before this data utopia becomes reality, including a lack of agreement on definitions of what constitutes value. What is considered good-quality data, data privacy, data governance and data security and many others factors would play a vital role in shaping the thought process as we move along this transformation journey.”
So, what are the hurdles? The regulatory environment is one, but regulators and government are increasingly aware of the need to advance. We have seen the introduction of the 21st Century Cures Act; as well as statement from FDA commissioner, Scott Gottlieb about the importance of digital health and real-world evidence, and there are efforts now around guidance from the governing bodies. Commercial sensitivity is another issue, but industry is increasingly acknowledging the need for collaboration – perhaps through neutral consortium – to harness the power of data and analytics. As an example, Dr Aneja cites the NEWDIGS project, through MIT’s Center of Biomedical Innovation, which brought together various pharmaceutical partners in a neutral, non-biased, cohesive setting. However, she acknowledges that “we’re taking baby steps and are in exploration mode with a desire for more collaborative models, and not yet ready for prime time yet.”
And what about the benefits? There is clearly substantial value in a system that encourages us to learn about the patient – not least, greater customization, personalization, and simplicity for the patient. This encompasses patient-reported outcomes, behavioral profiles, social, and other demographic data leading to consumer segmentation, which in turn can deliver on targeted interventions and interactions.
Dr Aneja elaborates: “I’ll give you an example. Rajni is a 40-year-old female who runs every day and is pretty healthy and motivated and doesn’t take any medicine, but is very interested in her well-being. Because of the combination of data from different sources, we can create a profile of what Rajni wants, what Rajni needs, how we engage her, how we motivate her and do that on a continuous long-term basis; and data can enable targeted, personalized interventions – interactions that are actually applicable to Rajni, not one-size-fits-all. Data can help you get to that level of granularity, but I always say that with a word of caution: we’re not there yet. But that doesn’t mean that we can’t get there; it’s just that we’re on our way to this kind of transformation.”
And this opens up a whole world of further possibilities: Rajni might be part of a cohort that you could segment in the context of preventative health and screening, and so on. So there’s an opportunity to gain a depth of insight into individual patients within a population. “Imagine if you could understand, in your population, who are my well people? Who are my sick people? Who are the people who are very, very motivated? Who are people that actually need a lot of nudging because they’re not motivated? With the years of data, you have the ability to be not only predictive but at some point can be prescriptive, especially for precision medicine.”
Beyond this, digital needs to make life simpler and more convenient for patients. Healthcare is already becoming more consumer-centric. “I think it’s already happening. You already have Uber Health; we have telemedicine solutions; we have remote monitoring; we have wearables and sensors. I think the trend that we see is consumers becoming more involved in taking responsibility for health; they’re becoming more informed. Consumers want to manage their health, want to see their healthcare data, and want to be equally responsible for decision-making.
What needs to happen going forward? “I think it’s an industry shift.” There is recognition that we need to accelerate this process, according to Dr Aneja. In conclusion, she sees a significant role for Medical Affairs within this new environment – as the conduit of the digital transformation. MA can help define the problems we are trying to solve, along with the data sets and technology that will enable a solution. “They are absolutely vital. You would not create an initiative in a silo; technology is an enabler. Ultimately the insights coming from MA about what problems we need to create an effective solution for will lead to better patient outcomes as well as better patient experience.”
Biography
Rajni Aneja is an MIT Connection Science Fellow, healthcare strategist, public speaker, and transformative change agent with expertise in population health management and digital health. She serves as an adviser to a variety of health and wellness organizations. Dr Aneja encompasses various vantage points as a clinician, executive, adviser, entrepreneur, speaker and technology advocate serving in senior leadership roles. These include Chief Medical Officer for WebMD health, EVP of Joslin and a strategic executive and transformation leader at Humana. Most recently she contributed to the building of a digital consumer strategy at Novartis. Dr Aneja received her MD from Research Medical Center in Kansas City and her MBA from the University of Massachusetts.
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.