Medical affairs teams are growing in prominence in the pharma and clinical research communities. As more data is available to patients, payers and physicians, MA teams fulfill a vital role of being a reliable conduit of information.
Indeed, the proliferation of data, the potential of big data and the advancement of AI all present opportunities for the MA function to thrive. But medical affairs professionals will need to adapt to the changing demands.
We explore what the data surge means for medical affairs teams and how the MA role is evolving because of it.
Nearly 20 years ago, there weren’t any databases (other than big pharma) holding clinical data from rheumatologists and their patients regarding the safety and efficacy of emerging therapies. So the Consortium of Rheumatology Researchers of North America (Corrona) set about doing so, writes Leslie R. Harrold, chief scientific officer at Corrona.
Corrona has used post-approval safety study data of multiple pharma companies to form a collaborative database. It has also merged additional databases — RA, Psoriasis Register and NPS — including information on safety analysis to time-to-event analysis, along with comparative research and other analyses.
One of Corrona’s goals is to understand why patients change or stop taking medications. It believes the findings will help inform research on biosimilars to treat RA, psoriasis, PsA, SpA and IBD. The project has pushed the MA team to new places. For instance, MA professionals staff the biostats team, which conducts comparative analyses on biosimilars.
Following closely behind big data is the power of artificial intelligence. But, neither can be suitably employed by pharma companies and their MA teams if the industry does not clean up its data, argues Vas Narasimhan, chief executive officer of Novartis.
“In our own shop, we’ve been working on a few big projects, and we’ve had to spend most of the time just cleaning the data sets before you can even run the algorithm. That’s taken us years just to clean the datasets. I think people underestimate how little clean data there is out there, and how hard it is to clean and link the data,” he explains.
Once the data quality is improved, the AI algorithms can become more effective. What this means for MA teams and medical science liaisons (MSLs) is a complete shift in the quality of their insights, writes David Bennett, chief commercial officer at label management platform Kallik. Keener insights improves their ability to communicate with physicians and other key opinion leaders (KOLs) and make better decisions.
With AI-powered clinical data reviews, MA teams can determine whether therapies meet patients’ needs and explore, using real-world evidence, the safety of the drugs and how these therapies are influenced by patients’ characteristics such as age, gender, race and co-morbidities.
But Bennett warns that amid the AI transformation, MSLs will need to be led by human factors to deliver meaningful engagement with healthcare practitioners. AI will be a valuable tool to help them to do more with fewer resources and also upskill them into more digital-savvy professionals.
Digital transformation has made clinical information more accessible. Perhaps the function most likely to benefit from this surge in data is the MA or regulatory affairs teams. Those responsible must ensure that the collected and analyzed data adheres strictly to any compliance requirements, Erick Gaussens, chief scientific officer at Product Life Group, explains.
Life sciences firms and regulating bodies have improved the way they process and share product-related data to smooth the journey to market. These include standards-based document templates and electronic application submissions. But the quality and verifiability of data demands remain paramount, says Gaussens.
It’s essential, then, that both medical affairs and regulatory affairs teams seize these new digitization capabilities — XML formats and live databases — to eliminate human error. Their role becomes one of ensuring compliance of all product-related data to share with key opinion leaders and physicians.
Data capabilities will continue to improve for pharma organizations and, in response, the companies will have to build internal data governance capabilities. Indeed, MM&M senior editor Larry Dobrow says it will need to become an internal discipline.
In his article, Dobrow cites multiple players in the healthcare space regarding this issue:
Kevin Troyanos, head of analytics at Publicis Health, says organizations need to formulate a better understanding of what data governance entails. Data has grown but governance has trailed behind.
Asaf Evenhaim, CEO of pharma data/analytics supplier Crossix, says data privacy needs to be improved and this process needs to be continuous. The problem is an MA team or pharma marketing department might not be technically equipped to deal with data privacy requirements.
Rather than expecting them to make these important data security decisions, they should collaborate with other technical colleagues in the company to ensure governance is maintained.
Carlos Rodarte, founder and managing director of digital health consultancy Volar Health, says the data proliferation is forcing a shift in multiple roles, including global medical affairs, development, marketing and sales. And it’s hard to find a proper governance procedure because of the different ways and reasons why they wish to use the data.
Medical governance differs from compliance. The former is more forward-thinking and strategic, proactive rather than reactive. MA teams are having to adapt to this shift, says Shurjeel Choudhri, SVP and head of medical and scientific affairs at Bayer HealthCare. The MA role now requires professionals to be skilled at digital health, remote monitoring technologies and patient support programs.
Choudhri notes that MA teams must develop skills to manage these large amounts of data but their organizations need to help them by building the necessary infrastructure.
Science and data are pharma’s core tools to deliver outcomes for patients, payers and customers. That’s why the MA function is growing ever more strategic. Indeed, Matthias Evers, Arnie Ghatak, Brindan Suresh, and Ann Westra at McKinsey & Company call medical affairs the third strategic pillar of a pharma organization, with R&D and commercial being the other two.
Pharma companies that thrive in the big data landscape are those able to understand various data sets and integrate them into their science, the authors say. The MA teams will need to use real world evidence, EHRs and new data sources to form coherent, useful and cutting-edge insights.
For MA teams to become more strategic, changes to the function need to happen. The authors note that medical affairs will need to embrace data and analytics, and prioritize digital engagement. But, they will also need to become medical leaders within their organizations.
That means MA teams should position themselves as key members in the C-suite. There, they can influence the reputation of the industry, and ensure that delivering patient outcomes is the driving force of all pharma decisions. Transforming medical affairs into a C-suite function requires hiring strategic medical talent, prioritizing strategic planning and using resources to improve performance management.
The belief in MA’s future strategic performance is gaining traction. Alex Butler, cofounder of strategic consultancy Foundry3, says MA teams will be the custodians of digital investment. They will need to apply to digital health the same scientific rigor they use to provide proof of products for patient’s health.
But MA teams can access digital tools to help improve their strategic clout. AI presents a unique opportunity, writes Antonio Pesqueira, international commercial operations country and cluster lead at Alexion Pharmaceuticals.
Ways to become more strategic include connecting in meaningful ways with KOLs and influencers with links to external data sources and systems. Pesqueira lists PubMed, ClinicalTrials.Gov, ResearchGate and LinkedIn as examples. Of course, MA teams will also need to use AI capabilities to source KOL-related information from their research and commentary, and mine data to help make better decisions.
The pharma salesforce has declined while digital health is booming. This puts MA teams at the core of delivering key health information to relevant parties. Hilary Armstrong at Pharmalive says MA teams will be key to helping HCPs deal with the large quantities of data.
Fast dissemination of information is essential to keep HCPs in the loop but MA teams are often subject to slow internal processes. The result is HCPs seek their information elsewhere. MA teams have to ensure they are the trusted conduits of information.
As more real world evidence becomes available through wearables and electronic health records, MA teams are tasked with translating the resultant insights into concise and informative messaging for HCP so they will know which and how products can be used to deliver the best treatment to patients. Medical affairs teams can also use these insights to boost ROI on products and help companies hone their competitive edge, explain Loic Plantevin, Christoph Schlegel and Maria Gordian, partners at Bain & Company.
Big data is shifting the way MA teams work, but is also providing them with a unique opportunity to demonstrate their strategic value. By collating and packaging data for KOLs, HCPs and patients, they can lead the digital health revolution and enhance their reputation as a scientifically rigorous function.
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