Thoughts on Global Medical Affairs
Global Medical Affairs (GMA) organizations have, for years, coordinated their investigator sponsored studies (IIS) and publication planning processes, since the publications are generally considered global resources. In the last few years, however, many GMAs are seeking to coordinate a much broader set of activities.
One of the ongoing themes of this blog will be the evolution of the MA function. It might be helpful to start with some history to understand how many organizations got into this position in the first place (bearing in mind this is a fairly gross generalization).
MA has changed a tremendous amount in the past 10 years. For many organizations, MA was born as scientific marketing or scientific support of marketing. Given that the birth of MA was from the commercial side, one consequence was that these nascent MA functions reported to commercial and followed the same structure as their commercial managers.
In the past 10 years, we have seen an evolution in which MA has become essentially an independent function, sometimes reporting to clinical development, sometimes reporting to the CMO or even CEO directly, but very rarely reporting to commercial anymore. The history of this is the subject of a future post. As a result of forming this way, the affiliates were accustomed to thinking of MA as a local function, so when the decision was made to separate MA from the commercial structure, rather than give up that control of MA, the reporting relationship was shifted from commercial to the affiliate general managers (GMs).
In many organizations for years and years, the relationship between Global (or Corporate as it was referred to) MA and the affiliates was more like sister organizations than hierarchical. Each would do similar activities and share results when feasible but they had fairly independent budgets and planning processes. What broke down this type of relationship was the ubiquitous internet. Suddenly, a publication in an Italian journal was easily accessible (and translatable) anywhere. So when a company published an ISS in Italy which resulted in data that happened to contradict the primary scientific messaging of the compound it was immediately seized upon by global competition. Very quickly it became apparent that some type of global coordination was necessary. This was the birth of the Global MA organization.
In the last couple of years we have seen a real growth in the amount of control being exerted by the Global MA organization on the local MA affiliate organizations. We are seeing a evolution from “sister” organizations to a more classic hierarchical organization. In some organizations this change is complete; others are stopping at different points along the way.
Some of the more common activities beyond ISS and publications that organizations are coordinating on a global basis now include:
Medical information (MI) is a logical opportunity for global coordination. Obviously, coordination does not equate always with consolidation. Given the regulatory, language and time zone issues, many organizations retain separate MI organizations but they leverage the materials, systems and best practices on a global basis.
Coordinating and managing field forces on a global basis is much more controversial. Especially if that coordination results in an effort to apply a single compliance standard to the approach taken by the field forces. Given the huge range of different regulatory regimes, as well as the range of interpretations of the US regulatory regime (see Topic1), forcing consistency on a global basis can be a challenge. Even when no effort is made at global coordination of compliance standards, any effort to coordinate the priorities and the activities of the field force on a global basis tends to go into direct conflict with the local general manager’s control.
Clinical Development Support:
Many medical affairs organizations are increasingly taking on the responsibility of supporting the clinical development programs. Given that many P2 and almost all P3 studies are global in nature, and given that most clinical development organizations are corporate-based without staff in the affiliates, MA can serve a vital role as a direct connection with local sites in affiliate counties. Supporting global clin dev studies is not generally on the top of the local GM’s list of priorities so this is another case of conflict between local and global control.
Budgets is one of the last areas to be globalized in many organizations. In many organizations, the MA budget is ultimately controlled by the affiliate GM. Given the nature of the way these organizations are legally set up and managed, shifting the MA portion of the budget from the affiliate to the global can be very difficult and full of controversy.
In future posts on this topic we will discuss the practical challenges of global coordination as well as some challenges and best practices.
What do you think? Is there something I missed in terms of global coordination? Leave a comment below.