Thoughts on Global Medical Affairs
Topic3: MA at Launch – Importance of MA Launch Strategy
June 22, 2012Posted by on
The good news for many MA leaders today is that launch leaders (most of whom are typically commercial leaders) rarely need to be convinced that MA needs a role in launch. In today’s world, most launch leaders understand that MA should have a role.
Instead, the challenge for MA leaders today is ensuring that the role and activities of MA are driven by their understanding of both MA’s proper role and their deep understanding of the scientific underpinnings of the drug being launched. Like it or not, commercial people still often view MA as another “messaging” platform and may put MA in the position of serving as a promotional resource without understanding the risks in doing so.
Therefore, it is critical that MA leaders approach launch leader with a well thought out MA strategy to support the launch. This strategy should not be developed in isolation – MA’s commercial colleagues should contribute to and review the MA launch strategy. BUT, is should be MA leadership that is driving the MA launch strategy.
An MA launch strategy should have the following characteristics:
- Thorough review of the scientific basis for the drug, including mechanism of action
- Analysis of current treatment standards and the likely position of the new drug on those treatment standards
- The role MA will need to play in the launch, considering the degree of scientific education required on:
- The disease state
- The current treatment options
- The mechanism of action
- The administration of the drug and management of side effects
- Any related diagnostics
- A gap analysis of current MA operational infrastructure’s capability to support this launch including:
- Experience and scientific reputation of MA in this particular therapeutic area (TA) and disease state (Especially does the company currently of a medical director (MD) with a strong reputation in this TA)
- Degree MA currently has field resources (MSLs) capable of supporting the launch:
- Presence of the MSLs with key opinion leaders (KOLs) in TA
- Capacity of MSLs to take on support of a launch
- Expertise of current MSLs on the disease state and capabilities of current MSLs to support drug
- Ability of the organization to support likely call volume within existing medical information (MI) function
- Capability of current clinical study management infrastructure to support expected volume driven by launch
- Plan for the likely changes in infrastructure based on the gap analysis
- High-level (1 page) starter plans for key elements of the MA launch which may include:
- Publication plan
- Congress Plan
- KOL Plan
- Medical Information Plan
- Advocacy Plan
- Health Economics Outcomes Research (HEOR) Plan
- Investigator Initiated Study (IIS) Plan
- Phase 4 Plan
- REMS Plan
- Internal Training Plan
- Access and Reimbursement Support Plan
- Overall MA launch budget and implementation plan
Only after MA has developed its own launch strategy can it successfully negotiate with the launch leader the degree that the launch program can support its needs. Without an MA launch strategy, MA is placed constantly in a reactionary mode.
In my next post I will discuss the timing of all of these types of activities, but one important note is that the MA launch strategy is a living document. It is likely to be revised a number of times as new data and new realities become clear. This is to be expected and everyone involved should have this understanding from the start.
Finally, as mentioned above, MA is only a part of the bigger launch effort and therefore must coordinate its activities with the launch leader and ensure that its work supports the overall launch plan.
What has been your experience in developing MA strategies for launch? Leave a comment below.