Traditionally, the role of Medical Affairs (MA) was to act as a trusted source of information about new drugs and devices. In this model, MA professionals acted as a mouthpiece for the organization. However, it became clear that MA could also act as an earpiece for the organization, not only disseminating information but collecting it. This is the MA function known as Insights – gathering, interpreting and communicating new knowledge from external sources back to the organization. MAPS considers Insights as one of 12 Focus Areas that make up the practice of Medical Affairs. Here we speak with Milana Zivkov, Senior Director, Insights & Training Global Lead, Medical Affairs, Astellas and April Adams, Senior Director, Medical Affairs, BMS, the co-leads of the MAPS Insights Focus Area Working Group (FAWG) about the current state and future directions for Insights in Medical Affairs. For additional context, please see the recently published Insights FAWG white paper, Moving to an Integrated, Holistic Approach to Insights-Related Activities in Medical Affairs.
MAPS: To start, what does “Insights” practice of Medical Affairs mean in the industry?
Milana: What we saw in Insight surveys in April and May of last year, is there is no single vision for the structure and role of Insights practice across organizations. Also, there is significant discrepancy between visions of what Insights mean across the industry. We are far from consensus.
MAPS: Why is that? Why is it so hard to identify and implement a vision for Insights?
April: A few reasons. The first obstacle is that Insights have been traditionally seen as restricted to the Field Medical role – you go out and you bring insights in. That is a simplistic model. What the FAWG is trying to do is establish a more holistic model in which various MA functions are identified as able to generate insights, leading to a kind of overarching Insights function within MA that is in a position to consolidate, analyze, rate and report those insights, and finally to ensure insights are being proactively utilized.
MAPS: As we evolve beyond MSLs as the single source of insights, what other MA functions do you see contributing?
Milana: First let me say that we’ve been seeing many organizations reinforcing insight generation only at the MSL level and investing in currently available software to manage these insights, but that is a very restrictive model that does not use all capabilities within Medical Affairs to enhance our understanding of external environment and stakeholder needs. MSLs operate locally and are typically not directly involved in strategic decision making at a regional or global level, so their contribution may easily be lost. On the other hand, a few innovative organizations are becoming open to a more holistic model in which many MA functions contribute to Insights including colleagues who are part of therapy area or business units, HEOR groups, medical information, external education, publications, etc.
MAPS: That sounds like a lot of data…
Milana: Exactly, and especially in this environment of increased data generation from multiple sources, we need an infrastructure to identify, integrate and curate these insights. As far as I know, a successful structure to integrate insights from multiple MA sources does not exist in any company as of yet.
MAPS: So how do we do it – how do we integrate Insights data?
Milana: April and I are both fortunate to be at the forefront of figuring that out. In my organization, we have an Insight function for MA and I am leading it globally, and one of my major initiatives is to collaborate with global colleagues to agree on an approach to the Insights process that would result in more reliable output. In order to have insights that are reliable you have to think about insights like any data that you generate in clinical trials. You have to have data integrity and the only way to have it is to agree on the process.
April: To follow up on that, in an ideal world, I would say 85 percent of Insights integration should be done through a specifically designated platform that has Artificial Intelligence and Machine Learning capabilities and is able to sift through the narratives that come from global MI systems, advisory boards, independent conversations, possibly even social media and other sources to identify what could be an insight and what is not an insight. Then the remaining 15% falls to human minds. There are no insights without the involvement of the human mind – no technology that can ensure you get information within context.
MAPS: So you see a future in which Insights from many sources are analyzed in a formalized machine/human system. How then do we see the results of these new approaches to Insights generation, analysis and communication?
Milana: This is another case in which Insights and, in fact, Medical Affairs as a whole is working to establish best practices. What is the “impact” of Insights? There is no consensus what that means. There is a consensus that MA contributions should be measured in value and impact, but what are real indicators of that? I don’t think there is a consensus of definitions. I mean, some pieces are easy: We had so many studies, so many presentations, but what is the impact here? How do you measure impact of an insight at the local, regional and global level? Do we really need to quantify impact? In addition, insight is kind of a philosophical category, not something defined only by numbers. How can you quantify the impact of an idea?
MAPS: Do you see a future in which a single organization emerges with answers to these challenges?
April: Organizations tend to be siloed and so each organization may work in isolation to develop an approach that seems best. But I think MAPS is a great platform for people across industry to share ideas and best practices and prevent each organization from having to reinvent the wheel. Reinventing Insights in every organization is a waste. It’s wasteful monetarily and wasteful intellectually. MAPS provides a great opportunity for industry to take a look together at what can be done in a systematic way. The great advantage of this collaborative work is that people with different experiences can come together, think together and put something together to recommend as best practices across organizations.
MAPS: It sounds like the Insights Focus Area Working Group you co-lead has a lot to do.
Milana: So many challenges! Isn’t that wonderful!
April: It is a privilege to be part of the Insights FAWG at such an exciting time for this practice area.
