One Giant Leap for Medical Affairs
Pharma’s engine of growth lies firmly within Medical Affairs and its ability to partner effectively with other functions.
The star of Medical Affairs (MA) is rising fast, placed under a spotlight by the urgent need of pharmaceutical companies to prove the value of their medicines. Yet, MA has also earned its place at center stage, embracing technology and innovation to enable it to inform strategy and drive influence across the entire organization as well as the healthcare ecosystem.
“I’ve witnessed the progression of Medical Affairs over the last number of years while at Baxalta, Takeda and Shire, and seen it become an equal strategic partner, playing an important part in forming product strategies along with R&D, Commercial, Patient Access and others,” says Kirk Shepard, President of the Medical Affairs Professional Society (MAPS) and previously Senior Vice President and Head of Global Medical Affairs at Shire, ahead of his appearance at eyeforpharma Medical Affairs USA.
“We’ve also become more strategic around data and what’s needed in the development of real-world evidence (RWE), outcomes and health economics data. In addition, we’re leading the development of more powerful scientific communication platforms to distribute that data to our constituents,” he says.
As part of this development, MA’s traditional role of sharing information with stakeholders has become much more complex, he says. “The value of our products needs to be more fully expressed and that value has to be developed through continuous evidence generation, through RWE, observational and outcomes studies. That’s a big area for MA now. Another factor is communicating the value of the product and the data supporting it.”
To succeed in the future, MA must have its finger on the pulse of the medical and scientific world, as well as maintain its independence and authority. “Right now, more MA departments report into R&D, then the next most common set up is MA residing independently. The least common situation is where it reports into Commercial. It’s my feeling that we’ll see more of a trend towards independence, both in structure and budget, rather than reporting into R&D.”
MA is positioned to bring insights and knowledge into the company at decision points; we’ve increased the percentage of our Medical people who have a customer-facing role to 80%, which includes Medical Science Liaisons, managed care people and those interacting with patient advocacy groups.
Yet, extensive internal partnering is essential, he says. “Usually, R&D has so much on its plate that Medical can sometimes get pushed aside in strategy and resource needs. Having experienced all the types of structures, it’s much better when you have Medical reporting directly to CEO level and has its own separate budget. That way, it can function optimally and act as the bridge between R&D, Commercial and Patient Access.”
Source: Kirk Shepard
Focus on the customer
Right across the industry, Medical Affairs colleagues face similar challenges, says Shepard. “The key challenges are to become more customer-facing and patient-centric. MA is positioned to bring insights and knowledge into the company at decision points; we’ve increased the percentage of our Medical people who have a customer-facing role to 80%, which includes Medical Science Liaisons, managed care people and those interacting with patient advocacy groups.”
Yet, evidence generation and insight creation form the foundations of a transformative MA organization. “We’ve been increasing our data generation focus and sophistication. [At Shire], we had a separate group involved with data generation partnered with Clinical Operations and Health Outcomes Research. We also developed processes to capture insight from the customer, both health professionals and patients, and bring those insights into the company in an agile way in order to inform development decisions. Crucially, there’s also much greater emphasis on patient-centric activities and working with Commercial and R&D to bring in the patient voice.”
MA as a function has come a long way already, but the path ahead may diverge for each company depending on its unique structure, organization and maturity. “We need to continue to develop MA competencies, especially in what we have called the five pillars (see Figure 1). We need to look at how early MA is engaged in the development process, to ask whether it is producing the types of data and insights that can inform R&D and demonstrate treatment value. We need to ask, have we the resources in terms of data generation to bring that to a higher level? Also, how do you develop the talent and capabilities required to develop more fully, perhaps by engaging in outreach to engage medical talent earlier in their careers? These are all fundamentals to be mastered.”
If you'd like to learn more from Kirk, he will be opening the proceedings at the eyeforpharma Medical Affairs USA Summit, 20-21 April, Philadelphia. Click here to find out more.
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