Drug companies under regulatory pressure to separate R&D and commercial operations use medical affairs teams to bridge the gap between the two disciplines.
Typical responsibilities of the role are difficult to define as there is considerable company-to-company variation; however, in general medical affairs staff support late-stage development and post market support for drugs and devices.
This breadth and complexity of the role has meant that traditionally pharmaceutical companies have kept medical affairs in-house. But this is now changing according to industry expert Neal McCarthy from Fairmount Partners.
He told this publication that: “Medical affairs and medical monitoring have been discussion topics at a couple recent industry meetings” adding that his general impression is that pharmaceutical companies are starting to outsource this type of work.
McCarthy added that while medical affairs are important to drugmakers’ efforts to ensure their products are safe that they comply with regulations, it is “not something that would make lots more money.”
Phase III medical affairs
Other aspects of medical affairs are already routinely outsourced according to Andrew Schafer, President of ISR, who cited the planning and monitoring aspects of Phase III trials as an example.
“Once a compound reaches phase III, the stakes increase dramatically. The trial size gets larger and the need for more investigative sites and patients drives up the cost and complexity of these trials substantially.
“From our vantage point, these trials are typically outsourced, at a fairly high rate, to the larger, full-service CROs as they are seen by pharma to have the geographic reach and a resource bench that is deep enough to make these trials successful.”
CRO market dynamics
A further indication of the pharmaceutical industry’s growing interest to outsource medical affairs can be seen by recent investments that have been made by contract research organizations (CROs).
In June, for example, PPD partnered with Anthem subsidiary HealthCore to bolster its post approval offering. A month earlier LabCorp CEO, Dave King, said he wanted the recently expanded contractor to be the drug industry’s partner of choice for real-world research. Similarly, when Parexel bought Quantum Solutions India in March it underlined its growing interest in post-market research.
Quintiles is also eyeing the later stages of the drug development process as an opportunity. Last month Zia Haque, senior director of data management at Quintiles, told us “This part of the clinical research cycle has definitively expanded in the past 10-15 years.”
“An approved medication’s extrapolation to the broader population is only possible by studying the drug as it is prescribed outside of strictly controlled clinical trials. This has led to a stage where regulatory authorities insist on more Post Approval Safety Studies (PASS) as a condition for approving a NDA,” he said.
More evidence for this can be seen in provisions to streamline post-market research in the 21st Century Cures Act and the US Food and Drug Administration’s (FDA) recent partnership with PatientsLikeMe.