As we dive right into 2023, medical affairs teams are at a turning point.
MSLs are no longer wasting valuable time waiting in line within the halls of ivory towers, trying to get face-time or secure their next appointment with the same few key opinion leaders that everyone else is hoping to tap. Things have changed. Tech-savvy physicians who are out in the field treating patients are using digital channels to spread their influence. With the rapid digitization of the entire industry and a new generation of talent waiting in the wings, Medical affairs teams need access to data and modern technology to engage with this new generation of influencers, improve diversity, and develop stronger go-to-market strategies.
Behavioral Health, Interoperability and eConsent: Meeting the Demands of CMS Final Rule Compliance
In a webinar on April 16 at 1pm ET, Aneesh Chopra will moderate a discussion with executives from DocuSign, Velatura, and behavioral health providers on eConsent, health information exchange and compliance with the CMS Final Rule on interoperability.
There’s no doubt that the future of the industry will be transformed by data, digitization, and diversity. Let’s take a deeper look at how each of these factors will impact and influence Medical Affairs this year.
#1: Data
Roughly one-third of global data generated is within the healthcare industry. Medical affairs professionals are the natural owners of scientific data across the product lifecycle, and it’s clear that this data holds the potential to improve the care everyone receives. Data will touch every aspect of Medical affairs in 2023, from increased hiring of data engineers and analysts, to greater data democratization and the use of real-world data (RWD) to support clinical trials and commercial drug discovery and launch.
- Pharmaceutical companies will lean on data and insights.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Over the past several years, the industry has seen a rapid digital transformation, adopting cloud data lakes and leveraging big data at a break-neck pace. This year, we’ll see a focus on improving the ability to analyze and leverage the data collected and stored by healthcare and pharmaceutical companies to improve decision-making.
- Democratizing and digitizing global healthcare data will be a priority.
Greater access to data yields innovation, brings therapies to market faster, and ultimately improves patient outcomes. A few countries are already prioritizing this: Brazil’s DATASUS provides an integrated and open healthcare database, and Israel captures all patient data digitally from birth to death. Access to this type of information is invaluable and using de-identified data to inform clinical decisions can improve patient outcomes. With recent federal regulations requiring that patients have digital access to their full health records, we will see U.S. healthcare companies prioritize data democratization this year.
- The use of real-world data (RWD) will expand.
Controlled clinical trials often fail to account for the efficacy, safety, benefits, and risks of therapies in the real world. Real-world data (RWD) gathered from sources including electronic health records (EHRs), medical claims, billing and insurance data, patient-generated data, and data gathered from mobile devices and apps will help fill in those gaps. Using RWD has many advantages: It can be more easily accessed, the data is more inclusive of diverse patient populations, and since it’s pooled from a larger patient population than clinical trials, it’s easier to derive patterns and evaluate side effects. RWD can be used to better understand clinical inertia, support better patient outcomes, and improve health equity.
#2: Digitization
The evolving nature of KOLs means that Medical Affairs and MSLs themselves will also have to evolve. In response, pharmaceutical companies will hire professionals more versed in omni-channel strategies and will cultivate these skills in-house. Digital awareness will be a sought-after skill, digital engagement will be a key strategy, and investment in digital tools will increase.
- Digital opinion leaders will gain ground…
Digital influencers, also known as digital opinion leaders (DOLs), have a considerable online presence and are well known in their field. During the pandemic when in-person meetings with traditional KOLs came to a halt, it became critical for MSLs to seek out DOLs. In 2022, the percentage of DOLs that MSLs engaged with was still relatively small compared to the traditional KOLs who dominated the conversation. But, in just a few years, this will drastically change. Research suggests that by 2027, MSLs expect to spend almost as much time identifying DOLs as traditional offline KOLs. MSLs who are prepared now and get an early “in” with these DOLs will be well positioned.
- … and will transform Medical Affairs teams.
Treatment leaders, digital opinion leaders, and yet-undiscovered influencers of tomorrow are the thought leaders that MSLs need to engage with today. With the creation of roles like digital engagement managers, the rise of the GenZ MSL, and a focus on hiring digital-native, tech-savvy employees, the industry will modernize its Medical affairs teams and be better equipped to engage with the next generation of key opinion leaders.
- The pace of digital transformation will continue.
The rapid digital transformation that the pharmaceutical industry experienced during the pandemic isn’t slowing down. Digital transformation is critical for faster drug development, improved patient care, and more transparent, cost-effective clinical trials. We’ll see greater adoption of emerging tools and technologies within pharma. Medical zffairs teams will invest in new AI-based tools for discovering and engaging with DOLs that will help surface, curate, and personalize insights in preparation for meetings. We will also see increased investment in machine learning (ML) and advanced analytics, digital therapeutics, and VR-based training.
#3: Diversity
This year will bring a renewed commitment to diversity across the entire pharmaceutical industry – from diversity in clinical trials to building more diverse in-house teams and tapping a broader diversity of thought.
- Pharma companies will be held accountable for clinical trial diversity.
Governing bodies are finally starting to hold companies accountable for real, substantial changes to their clinical trial processes – the FDA has already made progress with recently issued guidance calling for companies to develop and submit diversity plans. Until companies can conduct truly diverse clinical trials, more drugs will be subject to rejection – not because of efficacy issues, but because diverse patient populations and providers are not being included. These efforts are already making an impact – the FDA recently called on Eli Lilly to conduct new trials of its lung cancer drug and the Centers for Medicare and Medicaid Services recently cited a lack of diversity in the clinical studies for Biogen’s Alzheimer’s drug.
- Medical affairs teams will seek broader diversity of thought.
For too long, pharmaceutical companies have gotten advice from ivory towers … medical professionals who are too detached from the real world. There is a need for increased diversity of thought, and encouraging MSLs to be closer to patients can help achieve this.
Photo: Ridofranz, Getty Images
Stacey Rivkin is Vice President of Client Solutions at H1. She leads a team of subject matter experts who drive client insight generation. Stacey partners with leaders in pharma and biotech to help them build and maintain collaborative, mutually beneficial relationships with key global external experts and other stakeholders through optimized identification, profiling and integrated strategic engagement.
Stacey joined H1 after almost 20 years in the pharmaceutical industry including at Allergan, Boehringer Ingelheim and Merck. She has extensive experience in a broad array of disease areas and has worked globally throughout the pharmaceutical lifecycle from early-development through commercialization. A proud career highlight was working on the Boehringer team that drove the 2016 FDA approval of Jardiance® (empagliflozin) as the first approved diabetes medication to reduce cardiovascular death in adults with type 2 diabetes.
Stacey graduated from Cornell University with a BA in Government. She lives outside New York City with her husband, three children and “pandemic puppy” Otis.
