Only 26% of biopharmaceutical companies have chief medical officers in place to oversee their medical affairs departments, according to a study.

An autonomous medical affairs function is more likely to have a chief medical officer in charge of the department. But autonomy does not necessarily require the company to hire a chief medical officer. Slightly more than one-third of surveyed companies report having an autonomous medical affairs department in place.

Today, many drug manufacturers have organized their medical affairs teams under larger R&D departments. A study published by Cutting Edge Information, "Medical Affairs: Resource Allocation for the Global Marketplace," revealed that medical affairs and R&D have synergies that warrant the two groups sitting closely under the same umbrella. Although as companies grow and the demands placed on medical affairs teams increase, many companies opt to remove medical affairs from under the R&D organization. Before doing so, however, companies should establish criteria or thresholds to justify such a move.

In the case of one medical affairs executive interviewed, his medical affairs team currently reports up through the research and development group. For the time being, the reporting relationships function well and the company has no plan to create an autonomous medical affairs team. In addition, the company's portfolio is relatively small and senior management cannot justify two separate groups. Therefore before making the change happen of having stand-alone medical affairs groups, senior managers would like to see the company reach specific milestones.

Additionally, the study found that portfolio size is not the only criterion to consider when determining whether to create an autonomous medical affairs organization, however. Sometimes regulatory and safety issues warrant a structure more closely tied to research and development.

"Medical Affairs: Resource Allocation for the Global Marketplace" (http://www.cuttingedgeinfo.com/research/medical-affairs/global-resource-allocation/) includes detailed data on optimal medical affairs structures and best practices for cross-functional communication with clinical and marketing teams. It also includes four years of budget data for the medical affairs function. Use this report to:

  • Strengthen medical affairs staffing, structure and organizational support within pharmaceutical or medical device companies.
  • Empower medical affairs teams via adequate budget and staffing resources prior to product launch.
  • Position health economics teams under the medical affairs umbrella.

For more information about medical affairs operations, contact Cassie Demeter at 919-403-6583.

Cutting Edge Information
Cassie Demeter, 919-403-6583