Thoughts on Global Medical Affairs
An MA leader finding themselves responsible for the MA support of launch faces an interesting and challenging situation. Launch is a great time for MA to demonstrate its value to both the healthcare community and the company. But, launch is also a highly commercial endeavor, which can be risky compliance ground.
There are a series of Do’s and Don’ts that I would suggest may make the launch support more effective and satisfying.
DO: Insist representation in the Launch Team
The Launch Team is almost always led by someone from marketing. The Launch Team is responsible for coordinating all the activities associated with launch. Today, in general, MA is invited to be a part of the Launch Team. But, if you are not invited, meet with the Launch Team Leader and push hard for a seat at the table. Not only does everyone on the launch team need to know what MA is doing but MA needs to know what they are doing as well. It is not at all unusual for the MA representative on the Launch Team to discover that a commercial function is planning some type of outreach that is either potentially out of compliance or better done with MA resources
DON’T: Take your seat at the table of the Launch Team for granted
While many of the activities being discussed in the Launch Team are commercial in nature, the MA representative still needs to keep engaged and offer their advice. Ask for and read the market research that the commercial functions have produced. While it is aimed at marketing, some insights into healthcare providers and their needs that are relevant to MA can be gleaned. Understand the issues that the commercial leaders are facing, even if MA is not going to directly be addressing them to remain non-promotional. By understanding those issues, the MA representative on the launch team can bring back valuable insights from both their experience and the insights captured by the MA field force.
DO: Consider outsourcing as a solution for MA operational infrastructure challenges
Just about every activity conducted by MA can be outsourced on a global basis. Many MA organizations fail to consider outsourcing options for Medical Information needs or MA field force hiring and deployment needs. Outsourcing can be a great answer, especially when you don’t think the you can justify full-time positions.
DON’T: Rely too heavily on outsourcing companies’ strategic insight and quality assurance
Many organizations will retain outsourcing companies to do a range of activities like developing publication plans or disease state education materials (as opposed to CME). They are hired because the MA group doesn’t have the resources to do the work itself. While these vendors are hired for their proficiency, the hard truth is that no one will care about the launch as much as the company employees. MA staff from the company need to have the time to engage deeply with these vendors and manage them closely. So, when considering staffing, there must be an assumption of a percentage (1/4 to 1/2) of a full time person’s capacity is assigned to managing the vendor.
DO: Identify key opinion leaders in a data driven manner
Engaging key opinion leaders (KOLs) is critical for educating the healthcare community and other outreach activities associated with launch. Many MA organizations that have worked in the therapeutic area in the past believe that they “just know” who the KOLs are or leave it up to the field force team members to identify the KOLs in their region. Considering how scientifically driven MA is in general, this informal approach is not only out of character, it is also less than effective. KOLs are “opinion leaders” because other healthcare providers look to them for guidance. The best way to know who healthcare providers look to for guidance is simply to ask them. Through targeted research, the actual opinion leaders can be identified. My experience has been that when you compare the list of informally generated KOLs to the list of research generated KOLs from 30 to 40% of KOLs are different. That means without research, a huge number of actual opinion leaders can be missed.
DON’T: Limit the focus of outreach to traditional KOLs
KOLs have typically been research-oriented physicians associated with an academic institution. But, in today’s world both treatment and networks of influence are spread much wider. Depending on the therapeutic area in question, a number of non-traditional KOLs may strongly shape opinion. The MA organization should not limit itself (or its KOL research) to the traditional definition.
What Do’s and Don’ts would you suggest? Leave your thoughts in the comments.