Thoughts on Global Medical Affairs
Monthly Archives: June 2012
June 25, 2012Posted by on
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.
June 22, 2012Posted by on
As we discussed in a previous post, MA must have its own launch strategy to ensure that it is capable of proactively addressing the scientific needs of the healthcare community in a manner that is both effective and compliant.
In addition to having a clear strategy, another key success factor is the timing of MA launch activities. In this post, I will share a generic MA launch timeline. However, all launches are unique, with their own set of requirements, so in order to put together even a generic timeline I will need establish a scenario as the basis:
- The drug being launched is a relatively recent in-license from a smaller company with no MA group.
- The drug is in P3 testing, with results expected in 10 to 12 months and an NDA filing expected soon after.
- The company managing the MA support of launch has an existing MA function but no experience in the drug’s therapeutic area
- As a result, the current field force (MSLs) are not sufficient to support the new drug
When we consider launch, the work breaks down into four broad categories:
- Operational Infrastructure: This includes people, processes and technology needed to support the MA launch (and post-launch) activities
- Scientific Outreach: All activities required to educate the healthcare community about the therapeutic area, disease state and drug.
- Research: All activities with the goal of data generation.
- Internal Support: All activities in which MA assists other functions within the company.
For simplicity sake, I will consider each of these categories in four different time periods:
- -24 to -18 Months before Launch
- -18 to -12 Months before Launch
- -12 to -6 Months before Launch
- -6 Months to Launch
During each time period, I will attempt to highlight some of the key deliverables in all the categories that are relevant. Not all categories are relevant in all time periods.
-24 to -18 Months before Launch
During this period, the primary goal is to develop and gain approval for the MA Launch Strategy. Since our example demands a fair amount of operational infrastructure development, the budget and timing for the needed resources must be agreed upon in this period. In some companies the Launch Team has not yet been formed, and in those cases MA will need to work with commercial leadership to ensure that its’ initial plans are in alignment with the current best thinking of the launch.
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-18 to -12 Months before Launch
This is a critical period for planning and infrastructure development. We are assuming in our example the need to hire a new MSL team, and the bulk of this activity takes place this period as well.
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-12 to -6 Months before Launch
This is the period when the work of supporting the launch begins in earnest for MA.
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-6 Months to Launch
Like the last period, this period is focused on the execution of the plans developed earlier. One critical role that MA should be playing during this period is providing feedback that they are hearing to the rest of the organization. MA is not a market research function, but the questions they receive is valuable information that the commercial organization may wish to know.
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Different therapies can drive very different timetables. If the drug in question is a new formulation of an existing, well established product, very little specific work may need to be done and the whole process can begin and end in the 6 months prior to launch. If it is a novel new oncology treatment with a companion diagnostic, you may wish to move up the timelines on certain activities like IIS which may even start before approval.
I would like to hear about your experience at launch. Please leave a comment below.
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.
June 22, 2012Posted by on
One of the great challenges for Medical Affairs is determining how to most effectively support a drug at launch. As you may know, drug launch is absolutely critical to the success of a drug. And since in our business that means the penetration of treatment to patients who needs them, MA must view launch as a unique opportunity to educate the healthcare community. In discussing this topic, I will address the following topics:
As usual, I am curious to hear about your experiences at launch. Please share them in the comments.
June 6, 2012Posted by on
Creating an integrated, global MA organization is difficult work. Local affiliates or regions that have had a fair amount of autonomy are unlikely to want to give that up. Many efforts to build global coordination fail, resulting in local affiliates and regions going through the motions of coordination but actually investing most of their efforts in activities that either skirt the global coordination or ignore it altogether. Making matters worse, they may be encouraged to take such action by the local or regional GM who may see it as the only way to get their affiliate or region the support they need. In the end, the company as a whole would have been better off without these efforts since so much time is wasted on internal activities without any corporate benefit.
However, when global coordination works well everyone benefits. The corporation benefits by having its resources focused most efficiently on a global basis, the global MA organization can achieve its goals, and the local affiliates or regions benefit from shared resources and a broader, global perspective.
In my experience, successfully implementing a globally coordinated MA function requires the following three factors to be put in place (each of which I will discuss in more detail below):
- Senior Leadership Alignment
- Engagement and Ownership
- Consistent Support
Senior Leadership Alignment
Global coordination efforts risk failure if the local affiliate or regional GMs are not supportive of the effort. Therefore it is critical to start any global coordination effort by reaching out to the local affiliates or regional GMs, sharing the plans for global coordination and the rationale behind the need for coordination. There discussions have to be as much about listening as telling – the concerns and objections of the GMs need to be understood and directly addressed. Many of those objections will likely revolve around the need to address specific, local conditions. Carve-outs of the global process should be defined to specifically address the most pressing of these local concerns. Defining these carve-outs before any effort is made to create a global coordination process will ensure that they are seen as part of the plan rather than push-back against the plan.
Once these discussions have taken place and the needs of the GMs have been addressed, they will be expected to be supportive of the process. Providing them with clear guidance about how and when they can offer their support will ensure that the right messaging is being conveyed to their organizations.
Engagement and Ownership
Once senior leadership is supportive, the next step is to develop the coordination process. Regardless of what methodology you follow, a formal process for executing the methodology needs to be put in place. Developing this process should be done collectively by representatives of all the local affiliates or regions affected along with members of global MA. The temptation that many organizations succumb to is having global MA create the process and simply send it out to the local affiliates or regions.
People support what they create. By engaging with the local affiliate or regional staff in the development of the new global processes, there is a much higher likelihood that they will support the final results. There are often detailed nuance, including the timing of local holidays, that must be considered for the global processes to be successful.
Once the local affiliate or regional staff have worked collectively with the global MA team to develop the new global processes, they can take the lead in rolling it out to their affiliate or region.
After the new processes have been defined and rolled out, the next key to success if consistent follow up. The new processes will require people to think and act differently. While they may understand this theoretically during training, it’s only during the actual execution of the processes that people make those changes. Ensuring that people have the support they need during the actual execution of the process is critical to achieving success. And its not enough to only support the process for one year. , The processes need to be supported for a number of iterations and since many of these global coordination processes are periodic in nature it may take two or more years to get past the first four iterations when help is needed most. Many organizations lose interest in supporting a new process after the first iteration and the subsequent iterations begin to deviate significantly from the optimal path.
What has your experience implementing global coordination processes been like? What other best practices would you include? Leave your comments below.
June 5, 2012Posted by on
As discussed in the previous post, MA organizations take different approaches to what they choose to coordinate on a global basis. Similarly, organizations follow different methodologies in terms of how to coordinate globally.
In today’s blog post, we will be discussing three different methods for global coordination, when theyt may be appropriate, and their associated strengths and weaknesses. We will be looking at:
- Bottom Up Coordination
- Top Down Coordination
- Hybrid Coordination
It is important to note that a single MA organization may employ multiple methods. For example, it may do Top Down Coordination for it publication planning but Bottom Up Coordination for its budgeting. And, of course, none of these methodologies are ever implemented without some exceptions or refinements.
Bottom Up Coordination
Description: Bottom Up Coordination places the initial emphasis on the various affiliates or regional MA organizations to propose their approach to a topic and then the global MA organizations collates the inputs, finds commonality and negotiates the differences between the MA organizations’ plans.
Example: Budgets are often developed following the Bottom Up Coordination. The individual affiliate or region proposes what its budgetary needs are for the upcoming period, then the global organization gathers the collective needs, compares it to the global priorities and available resources, and proposes an alternative budget which is finally negotiated into agreement.
When Appropriate: Many organizations that are transitioning from local control to a global coordination start with a Bottom Up Coordination method, because the local groups are accustomed to setting their own priorities and have the processes in place to do so.
Strengths: This method does a great job feeding the voice of the people “on the ground” into the discussions at a global level. By starting with this approach, the needs of the local affiliates or regions are more likely to be me. And, as noted above, it is an easier transition to the start of global coordination.
Weaknesses: This method is highly inefficient. Many times the priorities of one or many regions does not match global priorities, so the work they do to develop and explain those priorities is “lost” when they are rejected as not matching global priorities. It also places the global organization in a position of always “denying” the local affiliate or regional organizations some of their priorities, which can easily turn into an Us vs. Them mentality over time. Finally, the negotiation required for this model is highly inefficient requiring significant time commitments from all involved.
Top Down Coordination
Description: Top Down Coordination typically consists of the global MA organization determining a range of priorities and then communicating those priorities to the local affiliates and regions so that they can develop detailed local plans to execute.
Example: Publication plans are often developed in a Top Down manner. The decisions about what will be published, where and when are often made centrally, then communicated to the local affiliates or regions for related preparations.
When Appropriate: This is most appropriate when a global MA organization is just starting out and developing local affiliate or regional MA organizations. In these circumstances, having strong central control ensures that the new organizations are aligned strongly.
Strengths: This is the most efficient method since the least people make the most decisions. It ensures global consistency and the ability to seamlessly share processes and systems between global MA organizations.
Weaknesses: This method allows for very little local control and, thus, can put the company at a severe disadvantage is unique requirements of a particular country or region are not being addressed. This is also a generally dis-empowering approach, leading to less feeling of ownership by the local affiliates or regions.
Description: As the name implies, this is a mix of top down and bottom up coordination. Typically, the top works the representatives of the local affiliates or regions to agree on a series of global priorities and the process for establishing priorities for the year. Then the local affiliates or regions develop their own suggested approach within that framework. Finally, the recommendations are collated by global MA and any tweaks needed are made.
When Appropriate: This is most appropriate in mature organizations that want to evolve past a bottom up approach but don’t need the command and control nature of top down. For this methodology to be successful there must be trust between the global and local affiliate or regional organizations and a culture of shared responsibility must be developed.
Strengths: This approach overcomes the limitations of both the top down and bottom up approaches. It is highly empowering while also allowing consistency on a global basis. And it encourages strong cooperation between global and the local affiliates or regions.
Weaknesses: This method takes good planning and time. The group need to meet to establish global priorities and that must be done in advance of all other planning, so planning itself needs to start sooner. Also, it takes time and resources to follow this approach that some organizations simply do not have.
There are an almost infinite number of permutations of these three approaches, but these represent simple examples. What has your experience been in this area. Leave a comment below.
June 4, 2012Posted by on
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
- Medical field force (Medical Science Liaisons, etc.) management and compliance standards
- Clinical development and Phase 4 support
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.
June 4, 2012Posted by on
One topic that a number of MA leaders are facing right now is the decision about how much coordinate on a global level. Most MA organizations that have staff in affiliate countries coordinate at some level but the type and degree of coordination is growing as organizations are seeking to benefit from their global footprint.
In considering this topic, I will discuss the following:
- Areas for potential global coordination
- Different methodologies for global coordination
- Challenges and best practices in global coordination
I am interested in learning about your experiences in this area. Leave a comment with your thoughts.