The concept of patient-centric drug development has been a frequent topic of discussion in recent years. Increasingly, companies have moved to adopt practices that create more active, networked relationships and interactions between physicians, patients, advocates and drug developers. The aim of such practices is to better respond to patient and physician needs and concerns, while gathering real-world data and feedback from those “customers” that can inform and improve the drug development process, pipeline decision-making, and commercial activities, including better communication of value to payers and “real-world” experience to regulators. As we wrote last year in our In Vivo publication, “Orphans Should Live Alone,” much of this movement has been — at least initially — driven by the increased emphasis on drug development for orphan and rare diseases, where a company’s ability to connect, create relationships, and respond effectively to patient communities and physician thought leaders is essential to its success.
But as orphan and rare disease drug developers — and their counterparts at larger firms — have shown the way, increasingly we’re seeing the start of a more general trend towards building strong, networked communications bridges between stakeholders, to the benefit of all concerned. The critical center of this communications hub is held by a group that until now played a different support function within pharma: the Medical Affairs team.
The role of Medical Affairs originally emerged in reaction to pressure from regulators to separate the medical and commercial functions. The group’s job was to provide the scientific and clinical expertise to support commercial products post-approval, answering requests for information from physicians, serving as internal consultants to others in the company, and directing medical education in support of products.
With the move towards greater patient-centricity in drug development, as well as the need for more and better data to prove “value” to regulators and payers, the Medical Affairs Group has moved into a more central role that serves as a bridge between key external and internal audiences.
As scientific and clinical experts, the Medical Affairs Groups are able to effectively build strong partnerships and facilitate communications with all of a pharmaceutical company’s external audiences: opinion leaders, physicians, patients and patient advocates, regulators, payers, and policy makers. They are able to generate and present high quality scientific knowledge to the market and educate external stakeholders about new products.
Through their interactions with these varied external audiences, they are also able to elicit valuable feedback on patient needs and the market potential of new drugs that can add value to drug development throughout the company — whether at the earliest stages of work on a potential new product or in preparation for a market launch. Similarly, they are ideally positioned to help their company develop and make sense of important data on real-world evidence of the “value” of a new treatment that supports the company not only in sales and marketing, but with reimbursement strategies and related issues. Such input provides a critical advantage to drug developers throughout the life cycle of a product, from early identification of a promising candidate to post-launch market strategies and next generation product improvements.
It is evident that the evolving role of Medical Affairs holds the prospects of benefiting patients by clearly demonstrating the value of new treatments to both healthcare practitioners and payers and becoming a trusted source of unbiased medical information. Medical Affairs professionals are likewise in an excellent position to give their companies a strong competitive advantage, by helping them to effectively implement patient-centricity throughout the drug development process and better communicate value to each of the company’s audiences: patients, physicians, and payers. By embracing this new role for the Medical Affairs team, companies have the opportunity to improve treatment access and outcomes while building public trust.