Thoughts on Global Medical Affairs
A reader and I discussed her dilemma the other day. She was being tapped to create a new MA function for a small biotech that was bringing its first product to market. She had fairly broad latitude but was not sure where to begin. Some of the points of our discussion are captured below.
We have already discussed preparing an MA team for launch here, the effective way to manage MSL groups here and the best way to develop a MedInfo function here, I thought I would focus on the Medical Communications or Scientific Communication group with this post. A note about function names. I very much prefer the term Scientific Communication because it more correctly reflects the role of the function which is to provide scientific data to the market place some of which is purely medical but some of which may be of a health economic nature that are not purely medical.
SciComm is a critical function for MA but developing one from scratch is as much a challenge in internal politics as a challenge in terms of operations. At a small company, before there is a SciComm group the company is already publishing. So, developing a group can be sensitive and many toes can be treaded upon if one is not careful. The best approach is to co-opt the staff that have been driving the publication efforts in designing (and maybe leading) the new SciComm function. But, it is critical that everyone involved realize that publications take on a broader role in SciComm than they did in CD.
In CD the role of publication was primarily focused on the results of clinical trials. That continues to be a responsibility of SciComm but its role of sharing scientific data expands to identifying the scientific questions that the marketplace needs answered, some of which will be answered through literature analysis or through non-clinical studies.
Given that CD is typically handling the publications in advance of the SciComm function, the temptation may be to put developing the group on the back burner until other MA functions have been more fully developed. This would be a mistake. SciComm needs to be analyzing the scientific needs of the HCP community and ensuring that the required scientific information is available concurrently with launch. Any delays can result in a vacuum of information and who knows what will fill that vacuum (or which competitors will try to fill that vacuum). So, at least 18 months prior to the launch the SciComm group should be launched, right along side the MSL function.
What has been your experience with SciComm groups at launch? Leave a comment.