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In years past, the role of the medical-affairs department was narrowly defined. Medical science liaisons (MSLs) served as a bridge of communication between R&D and sales and marketing teams, almost always during the crucial period spanning clinical trials and market launch. But since high-science drugs have captured the industry’s attention — and relegated mass-market ones to the backburner — MSLs have become increasingly crucial cogs in the commercialization machine.
With more high-science drugs, the need for individuals fluent in the science to carry on deeper clinical conversations with HCPs and payers increases. Factor in continuing technological advances and a boom in the volume of real-world health data and you’ve established the perfect storm of circumstances for MSLs to rise in prominence.
“Their traditional role was reactive,” notes Dr. Thérèse McCall, a member of the Medical Affairs Professional Society (MAPS) executive leadership committee. “Historically, MSLs were not valued as partners by clinical development and may have been considered not to have the relevant expertise. Increasingly though, there is a greater awareness on the value and perspective MSLs bring. As a result, there is a stronger voice for the patient, the disease state, and the potential place of the asset in therapy. This results in better trials and launches with more targeted stakeholder data.”
MSLs will continue to work with other arms of pharma organizations on their traditional tasks: ensuring regulatory compliance, responding to customer questions that fall outside the label, and collaborating with investigators on presentations, among others. However, a case study from Cutting Edge Information found that more than half of MSLs — 60% — have become active at the registration or launch of a drug.
“MSLs are the superheroes of the pharma industry,” says Natalie DeMasi, research team leader at Cutting Edge Information. “You don’t need many MSLs to have a profound impact. You just need good ones.” Yet DeMasi still believes that MSLs may be underutilized. “Most won’t start before phase II [of a trial], mainly because of resources, whether it’s money or a lack of time. MSLs still have to prove their value,” she adds.
A TRUE CHANGE?
Kara Zubey, senior director, promotion management at GlaxoSmithKline, doesn’t see the MSL role changing. Rather, she believes that other company units — notably marketing and sales — interact with medical-affairs people in a different manner now.
“Some companies may be more integrated and others more risk-averse, thus leading to separate plans that support the launch, but aren’t intentionally integrated in any way,” she says. “The latter could be described as silo work and the former as more informed and integrated, but both follow the regulatory guidelines. They’re just different.”
That makes sense, given how doctors and patients consume and circulate information differently. Patients now share their drug experiences online; doctors ingest data in shorter, more customized snippets. These trends generate greater responsibilities and opportunities for MSLs. “They understand a drug and how customers are going to use it,” notes Lee Fraser, SVP, group director of science and medicine at Digitas Health. “They triangulate where the product is going to land when it goes to market and tell its story in the best way possible.”
Patrick Reilly, CEO of PhactMI, agrees, adding, “Medical liaisons play a key role, especially now that traditional sales reps are not enough. Products are more sophisticated and the science is different. MSLs are highly trained and scientifically based.”
A key MSL responsibility is to target KOLs and the provider community, notes Robert Groebel, VP of global medical strategies for Veeva Systems. He believes that duty will evolve to “playing a role in identification of potential trial sites.” Groebel sees the biotech world eventually “forgoing a sales organization to focus on MSLs pre- and post-launch.”
The changes are coming quickly. Discovery Worldwide chief scientific officer Wolf Gallwitz describes recent clinical-trial work on behalf of a client with a pipeline molecule. Advisory boards found that physicians were concerned about efficacy and safety, while nurses were interested in patient-reported outcomes. He notes that it has become the job of MSLs to package such information into usable, readily digestible materials for patients, regulators, doctors, and insurers.
“People expect a high level of scientific integrity,” says Shontelle Dodson, SVP and head of medical affairs, Americas, at Astellas. “The role of medical affairs is ensuring accuracy and validity of data.” Adds Mike Townsend, a research analyst at IDC Health, “They are turning data into science.”
A CONTINUOUS CLINICAL TRIAL
As for how the role of medical affairs will evolve in the months and years ahead, McCall points to an “acceleration of knowledge transfer” via the internet and social media. That means MSLs will likely find themselves involved even earlier in the commercialization process than they are now. “Knowledge moves across borders and is no longer siloed,” she notes. “By 2025, medical affairs will be the patient-access advocate, honing conversations and data.”
According to Reilly, blockbuster launches of the past were focused on share of voice; essentially, marketers bombarded their target. Now, he notes, more attention is paid to smaller, more thoughtful dialogues. “The communication and touch points are simplified. There’s one point of contact to get all the information you need,” Reilly says.
“Blockbusters are now personalized treatments,” McCall adds. “The world is a continuous clinical trial with a real-world audience. Does the drug still perform the same way? Increased transparency gives others the ability to interrogate your data.”
Gallwitz points to the continued decline in the number of sales reps as a sure sign that nonpersonal tactics will continue to surge in importance — which may leave MSLs as the dominant voice of authority. “With face-to-face contact happening further apart, the knowledge will come from medical affairs,” he predicts.
As for how companies should prepare themselves for the imminent change, experts suggest they allocate enough budget to bring MSLs into the mix as early as possible. Right now, many organizations have other plans. “Small and large companies get the value of MSLs from an early stage. Midsize companies don’t always see it,” DeMasi says. Gallwitz recommends that medical affairs should have a say “as early as phase II.”
Given the corresponding shift in the stakeholder base — more millennial patients and HCPs — the move to prioritize medical affairs can’t be put off much longer. “Pharma has to move more rapidly than normal,” says Groebel. “Medical affairs is responsible for the scientific need of a stakeholder and for delivering on that need.”