By Hilary F. Armstrong, PhD, Medical Strategy at Fingerpaint

Pharma is moving from a fee-for-service to a value-based model. As part of this movement, companies are under pressure to show the direct and indirect values of their products. Big data and digital health are supporting this movement with real-world, real-time insights and are bringing patient perspectives to the forefront. Medical affairs has the prominent role of helping healthcare practitioners (HCPs) navigate vast quantities of information and understand how to use new products for the best patient outcomes.


Evidenced by the move to measure and reimburse providers based on the quality, as opposed to the quantity, of care delivered, the healthcare industry is shifting from a fee-for-service to an outcomes or value-based model. Originally employed only by specialty areas such as oncology drugs, the last few years have seen more publicity across the board around this new model. For example, Amgen (Repatha), Gilead (Harvoni), Lilly (Trulicity), and Regeneron (Praluent) have all entered into formal value-based contracts with payers for their various products. The Centers for Medicare & Medicaid Services has also expressed interest in moving to value-based contracts for Medicare Advantage and Part D prescription drug programs.1,2 As part of this shift, pharma companies are under pressure to show the direct and indirect value of their drugs, devices, and services to a diverse group of stakeholders. Communicating safety and efficacy is no longer enough; regulators, policymakers, and in particular, payers are now demanding a more complete picture of the value and distinction of products.

Because of this evolving healthcare landscape, the role of medical affairs is expanding. It now includes new responsibilities, from communicating with stakeholders through different platforms to understanding the consequences of improperly used information. Through medical affairs, companies are uniquely positioned to educate HCPs about the solutions, services, and drugs that are available (and the science behind them). Modern teams help providers, payers, and key opinion leaders understand vast quantities of information and identify the best use for products to improve patient outcomes. The value of medical affairs lies in their scientific and clinical expertise. As a trusted source on complex drugs, in many cases, medical affairs serves as an integral part of improving patient outcomes.  

Traditionally, medical affairs teams have relied on face-to-face interactions or print media to engage with and educate stakeholders. Answering any medical questions that arose with timely data and synthesizing the relevant information or research was part of the job description. Today, HCPs are investing less time meeting in person, signifying the need for the medical affairs team to operate in a digital world. In fact, two-thirds of HCPs prefer to get information on medications through digital channels, compared to in-person meetings through pharmaceutical reps.3 HCPs have become digital consumers, recognizing the convenience digital channels provide with on-demand content. About 72 percent of doctors believe that social media channels improve the quality of patient care, and more than 30 percent use them for professional purposes.4 Moreover, with the increase in the size and complexity of data, medical affairs needs to lead the charge in the information age.

With personalized medicine becoming widespread and scientific advances allowing for the treatment of conditions at a granular level, the amount of data produced is reaching an all-time high. In 2015, more than 40 percent of life-science companies reported that they expected to see their data volumes increase by 50 percent or more in the next year.5 In a time when the pharma salesforce has declined, and digital health is expected to be worth $536 billion by 2025,6 companies at the forefront of the industry are integrating their medical affairs strategies with big data.

Internal approvals and processes can slow the dissemination of information, resulting in medical affairs field personnel experiencing a time lag while HCPs acquire new data directly from online resources. Additionally, HCPs who were dependent on sales reps and medical teams for information five to 10 years ago are now able to obtain it on the internet. The worst-case scenario is when a company can no longer control, or at minimum monitor, the information that is being disseminated to its target audience. It is the role of medical affairs to educate and become the trusted resource for the latest, most reliable, and accurate data for stakeholders. When those stakeholders are able to obtain information on their own from unknown and uncontrolled sources, pharma companies lose their relationship and their communication channel with them.


There’s an app for that

Adding to the sheer amount of data that physicians have access to, the ability to monitor patients (e.g., through wearable devices) provides a detailed and unprecedented amount of patient information. This information can be collected and analyzed in real-time, as well as linked to electronic health records and associated with patient outcomes. Since the Affordable Care Act encourages providers to improve patient outcomes, digital health will become important for helping patients adhere to treatments, and therefore, improve outcomes. It also provides an opportunity to deliver a service beyond the pill for pharma companies in a muddled, competitive environment where differentiation is key to success.

Hilary Armstrong

As part of the 21st Century Cures Act, the FDA is actively working to integrate real-world evidence into regulatory decision-making.7 Digital health (e.g., wearable devices, apps, social media) is now a common presence in many patients’ lives, making real-world evidence accessible and helping industries demonstrate the value of their products. Medical affairs has a prominent role in taking insights gained from digital health and educating HCPs on the ways products can be used to achieve the best patient outcomes. These types of insights are often proprietary information not immediately available online, thus giving medical affairs valuable material to present to stakeholders and solidifying their importance.


Case study: PARADE

In June 2016, GlaxoSmithKline (GSK) partnered with Apple and used their ResearchKit app framework to monitor patient progress in a rheumatoid arthritis trial called PARADE (Patient Rheumatoid Arthritis Data from the Real World). The app gathered data on joint pain and fatigue using a mix of surveys and sensor-enabled tests. GSK used the app to collect real-world data on the day-to-day lives of people with rheumatoid arthritis and how it can build ResearchKit into future clinical trials. Presenting results at Digital Pharma East in October 2017, Michelle Crouthamal, GSK’s platform development leader, showed how a digital study can draw participants’ interest, stream esource data collection, and get quality data at a cost of $500,000 – way below the average $10 million cost of clinical trials. GSK aimed to enroll 300 people within one month. They paid $40,000 for ads on Facebook, targeting five states with high concentrations of rheumatoid arthritis. More than 1,100 people downloaded the app, and 35 percent went on to provide consent and enroll in the trial. For a few months, participants used the app to self-report information on pain and their body, with sensors in their phone recording objective data (e.g., a sensor to detect the wrist’s range of motion). Researchers found an association between joint pain severity and the wrist’s range of motion. “We learned a lot of incredible RA insights; we also developed a potential novel endpoint that we can further validate in the interventional study … Pharma can choose to listen to the voice or not,” Crouthamal added. “I think it would be a missed opportunity if they chose to ignore this.”8


Digital medicine

In Eric Topol’s The Creative Destruction of Medicine, he discusses how social networking, mobile connectivity, digital technologies, increasing computer power, and bandwidth will unite with wireless sensors, genomics, imaging, and health information systems. He refers to this as digital medicine, or the digitization of human beings. Digital medicine (or digital health) will help curb long-term healthcare costs, enable better outcomes, empower both patients and providers with real-time data and connections to each other, and enable the introduction of new contributors to the healthcare ecosystem. Digital health is the future of medicine, and companies that jump onboard now will find themselves ahead of the curve, while those that wait will get left behind.

Digital health does not come easily to everyone, however. HCPs can be reluctant to engage with technology, partly due to the scale, speed, and proliferation of development. The deficiency of education and training for deploying in a clinical setting leaves staff with a lack of confidence to use the technology effectively. Medical affairs teams can have a large impact by training HCPs to use the technology properly and showing them how it results in the best patient outcomes.


Following the digital footprint

The role of medical affairs in leading the digital health revolution is not limited to interactions with HCPs; patients also represent an important opportunity to connect and tailor insights. Patients discuss a wealth of information online through social media, online communities, and patient portals. In fact, more than a quarter of patients comment or post status updates on health-related experiences.10 Investing in digital monitoring solutions provides insights into online discussions where patients talk about their disease and drug experiences, concerns, and questions. Companies are able to stay ahead of the curve by analyzing patient behavior and assessing questions that patients may be embarrassed to ask their HCPs. By having medical affairs analyze and digest this information for HCPs, they will be better able to treat and ask the right questions of their patients. 

Beyond gathering information online, identifying digital opinion influencers (DOI) is a key strategic step, as they can effectively communicate and advocate for pharmaceutical solutions as well as, or better than, key opinion leaders (KOLs) do in more traditional channels (publications, conferences, etc.). DOIs are not necessarily medical professionals; they can be industry analysts, reporters, patients, caregivers, or external experts who have become invested in a particular treatment or disease area. Since they use digital channels, the reach and activity of DOIs can be measured and tracked, while ensuring that the company’s relationships with them go through proper channels so any and all compliance requirements are met.

Many DOIs are personally motivated to participate and can lend a credible voice from a different perspective than other KOLs, one that helps the brand and stakeholders alike. DOIs offer an intriguing opportunity to diversify the thought leader roster and outreach potential, increasing a company’s online presence and influence from a non-market-driven angle.

It is critical for medical affairs to form relationships with DOIs and their unique information path and access to health communities. For example, Boehringer Ingelheim has leveraged its DOI relationships to host a live Twitter chat during a respiratory congress. They were rewarded by being the most mentioned Tweeter – more than 380 times – far exceeding any other Twitter user at the congress.


Case study: PatientsLikeMe

PatientsLikeMe is an online patient community and real-time research platform that’s unique in both the depth of data collected and how much it shares with its members. Users report data about the nature of their disease to help themselves and other members of the community. This information also helps researchers, pharma companies, regulators, providers, and nonprofit organizations develop more effective products, services, and care. The majority of patients choose to share their data only with other members of the community, but many make their information public to anyone searching. PatientsLikeMe also helps patients find clinical trials that are right for them, and companies find patients that are right for their trials. In 2017, PatientsLikeMe stated having 600,000-plus members11 who report their experiences on 2,800 conditions. The forum has generated more than 43 million data points about disease and has created one of the largest repositories of patient-reported, cross-condition data available today. Example: A poll of 2,559 patients indicates that those living with fibromyalgia, post-traumatic stress disorder (PTSD), and major depressive disorder (MDD) are the least satisfied with their provider or care, while those with ALS, multiple sclerosis (MS), and Parkinson’s disease are among the most satisfied.


Engaging digitally 

Using new technology expands a company’s reach and allows for more interactive engagement. With competing demands for time, availability, and ease of use, 85 percent of HCPs are willing to try new technologies such as “virtual services” to access sales reps, which allows them to contact a rep online and request information or support services. This gives them the option to connect at-will instead of having a defined meeting scheduled during their workday. Life-science companies are adopting digital technology, as well as new channels such as online meetings, virtual events, and web-based training that are coupled with a centralized library or approved medical content. They are moving beyond PowerPoint to engaging and dynamic content that drives knowledge retention. Compared to static, interactive content is more effective in increasing knowledge retention. While learners only retain 10 percent of what they hear, they can recall up to 75 percent of material they have an opportunity to actively engage with.12


Investing in the future 

While some companies are collecting data and developing insights, the information channels are constantly changing. This leads to a disconnect in effectively communicating information to the growing number of stakeholders that influence purchase decisions. Capitalizing on digital technologies that generate and analyze large volumes of data can give medical affairs teams the edge in developing evidence-based communication strategies for stakeholders and ensuring that the right KOLs are engaged. Incorporating digital health is integral to staying alive in an increasingly competitive environment. Companies at the forefront of their industries have already ingrained this opportunity into the core of their processes.



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