Topic 39: House Clears 21st Century Cures Act – What could it mean for MA and CD?

As we have alluded to before, the House and Senate have been considering another tweaking of regulations related to pharma as part of the broad 21^st Century Cures Act (Act).  The House has taken a big step forward by approving on a bi-partisan basis the Act.  Most of the headlines are focused on the increase in NIH funding, but for pharma people there is a lot of interesting suggested changes in the regulatory environment.  NOTE: this is just the House version, the Senate will not take up the bill to later this year so we don’t know if any of these changes will come to pass – so far at least the White House is not threatening a veto.

You can find the whole bill here.

Medical Affairs: All about off label communication

Act Requirement:

Subsection 2102 explicitly requires the regulatory clarification about acceptable dissemination of off-label information:

Not later than 18 months after the date of enactment of this Act, the Secretary of Health and Human Services shall issue draft guidance on facilitating the responsible dissemination of truthful and non-misleading scientific and medical information not included in the approved labeling of drugs and devices.

Implication for MA:

While conceivably once this guidance is issued anyone (commercial and medical) from the company can share off-label information, if the guidelines are anything like the guidance provided by the FDA in their response to the Amarin lawsuit which we discussed here that guidance will explicitly require that the information be discussed by someone from the company with “…  the appropriate background or training to accurately communicate scientific information.” 

So, conservatively interpreting that definition, if this act passes MA should finally have clear guidelines on how to proactively discuss off-label information.  A BIG win for MA.

Clinical Development and Medical Affairs: Support for innovation in clinical trials

Act Requirements:

There are a number of requirements that could be clarified by the Act.  I will highlight a few I think are most impactful.

The first is section 2021 which discusses the use of biomarkers.  It establishes a process whereby biomedical research consortia can identify and agree upon biomarkers, then submit those biomarkers to the FDA for their review and approval, and once approved can be used by industry as surrogate endpoint.  Draft guidance on this process is due no later than 24 months after enactment.

The second is subsection 2061, focused on broader use of adaptive trial design and Bayesian statistics. The Act requires the FDA to update and finalize the guidance on adaptive trial design within 18 months and issue draft guidance on the use of Bayesian statistical models within 48 months.  So not exactly pushing the envelope on the Bayesian timeline for draft guidance.

The next is subsection 2062 deals with the use of “real world” observational / registry / safety data in the application for additional indications or to meet post-approval requirements.  It requires that a program for the use of this type of data in these ways be established within 24 months including delineating when this type of data will be acceptable to the FDA, the standards and methods needed to be followed when collecting this data.  One year after the program is up and running draft guidance is due and then a year after that final guidance is due.

Implications for CD MA

The implications of the acceptance of biomarkers as acceptable surrogate endpoints should have huge implications.  Currently these endpoints are gathered but are not relied upon for fear that they will not be acceptable.  Knowing in advance that they will be acceptable to the FDA will allow for much more streamlined data collection efforts.

Further clarity on adaptive trial design will be helpful but not earth-shattering.  Adaptive trial design draft guidance already exists so all the act is really doing to pushing to get it out of the draft phase and finalized which should reduce risk and make adaptive trial designs more acceptable to less risk-tolerant organizations.  This will hopefully push into becoming a standard in P2 trials, reducing the need for multiple trials.  I’m not really qualified to discuss how the Bayesian statistical model impact development – if you understand this better than me please leave a note in the comments.

The “real world” data requirement, assuming it produces clear definitions from the FDA about the qualities that the data has to have to be acceptable, could be a dual edged sword.  On the one hand, if they have very high expectations about the quality and cleanliness of this data in some cases, especially registries, it could raise the costs.  On the other hand, clear definition of what data will be acceptable for additional indication applications will allow for the use of this data more broadly and thus more of these studies to be conducted, which is great overall for pharma.

I am curious to know what you think.  Please leave a comment here.

Topic 29: “An American in Paris” – Inheriting an EU-based Field Force

A reader (and now friend) recently contacted me with an interesting challenge and agreed to allow me to recap our discussions here (de-identified, of course).

He/she was recently promoted into global responsibilities for managing the MA field force.  For their mid-sized biopharma company, global meant US and EU and this person already had managed the US field force.  He/she wanted to discuss keys to taking on the EU MSLs (although they use a different term).

1.    Time to make your “Grand Rounds” of the EU

Although no one has the time or budget, it is critical to find a way to meet with the EU MSL team members in their individual countries, rather than as a set.  Given the way many EU country organizations are run, the MSL may be significantly more focused on their country-level needs than overall EU level needs.  So you need to go out to the countries and meet them and their key internal stakeholders in the country leadership.  MA’s work with commercial can be more flexible in the EU than in the US, so it is important to explore how the MSLs are supporting their country needs.

This is a critical time to listen and not judge.  The goals and programs of the MSLs tasks can differ quite a bit from the mean country to country.  It is not unusual to find some activities that strike you as being in the grey area (by EU standards) have crept into the MSL remit, especially if the country lead is unclear on the standards and the MSLs don’t hold to the standards clearly.   These activities are usually driven by some high-value, country-specific scientific need so you need to be careful about simply pulling the plug.  Instead you should first explore the compliance aspects (see next point below) and if you decide to terminate them, work with the local stakeholders to find a more compliant alternative.

Regardless, you should come away from the Grand Rounds understanding not just your new MSL team but the environment in which they operate.

2.    Make friends with EU Compliance internal resource or get name for who the organization uses externally to support compliance in the EU

My friend understood that the difference between the EU regulatory environment and the US environment in general, but one of the key points when first managing MSLs in the EU as an American is to break the US-conditioned mind-set that EU countries are the equivalent of US states.  While everyone understands this, it is very common to fall into assumptions about a broad set of rules that apply equally to all of the EU.  There are some of these (privacy laws being one of the biggest differences from the US) but there are also a range of country-specific rules which must be taken into account when considering MSL goals and activity in the EU.

If you are lucky enough to have in-house compliance counsel with EU expertise, my recommendation is that you approach them after each of your country visits, which will allow them to tackle the issues without overloading them.  If you use outside counsel, hold all your questions until the end since them always seem more efficient when you give them a raft of questions vs. one or two at a time.

3.    Determine how much global alignment you want to force

Determining how similarly you want to run the US and EU groups should be carefully considered.  It is possible to force full alignment between the US and the EU, one set of rules, standards and measures for all.  The downside is that you have to go with the strictest regimen between the US and the EU and countries, and this can really stand in the way of effectiveness on both sides of the Atlantic.

Instead, I suggest maintaining two sets of standards.  For example, given the different compliance regimes, to maximize the value in each country a different set of SOPs may be reasonable, despite the cost and inefficiency of having two sets.  Systems may need to vary given EU privacy rules or at least communication about the content of the system.  Even basic metrics and measures of performance will likely need to vary.

What advice do you have for the “American in Paris”?  Leave a comment.

And if you are new to the blog, don’t forget to enter your email and get new blog posts sent directly to your in-box.

Topic 19 – EU Considering Major Change in P4 Trials

A new position paper has been floated by the European Commission Health and Consumer Directorate-General that may have HUGE impacts on the way P4 trails are conducted in the EU (and the rest of the world).  My take on it is below:

Stemming from the new EU regulations around pharmacovigilance, the EU is also considering the role of post-marketing efficacy studies (PAES).  In a position paper seeking feedback, found here, the EU lays out its perspective that the new PV legislation also refers to the possibility of requiring the market authorization holder to develop PAES to complement the efficacy data used to grant marketing authority.  That power is granted where “concerns relating to some aspects of the efficacy of the medicinal product are identified and can be resolved only after the medicinal product has been marketed.”

Regulatory Purpose

The position paper goes on to lay out the regulatory purpose of PAES and suggest that after the results of a required PAES were provided to the regulatory agencies, they would be free revisit the authorization decision and determine if “…the marketing authorization should be maintained as granted, varied or even withdrawn on the basis of the new data resulting from the study.”

While regulatory agencies have always been free to revisit their decisions, this approach seems to imply that they are obligated to reconsider their decision after the required PAES.  This makes thoroughly changes the role of the non-PV focused P4 trial from today’s approach to a much more high-stake trial.  Under this approach, these types of P4 trials would have much higher risk and would likely need to be treated much more like we treat P3 studies.  This means a likely significant increase in cost for these trials.

Efficacy vs. Effectiveness

The next section of the position paper focuses on the question of efficacy vs. effectiveness.  The paper comes down clearly on the side of efficacy.  Again, this could be a major change for P4 trials, many of which are focused on developing real-world effectiveness data to provide support for reimbursement decision makers.  This change may also force a significant revisiting of the P4 approach followed today.  Additional P4 trials may be needed if the mandated trials focus on efficacy and cannot be tasked with also considering effectiveness.  This will have a significant impact on time and budget as well.

Situations Where PAES May Be Required

The paper then proposes a set of 7 situations where PAES may be required.  They are:

Situation Where PAES May Be Required	Comment
1.   Studies aimed at determining clinical outcome following initial assessment based on surrogate endpoints	This type seems very logical.  If surrogate end points were used to get authorization, then a study may be required investigating the underlying endpoint sought.  But, this may significantly add to the cost of using surrogate endpoints for approval, since surrogates are sometimes used because of the time (and cost) of gathering data on the underlying endpoints.
2.   Studies on combinations with other medicinal products	Acknowledging that testing for authorization can only cover a limited range of combinations, P4 trials may be required to test additional combinations.
3.   Studies in sub-populations	Given the limitations on the number of sub-populations, additional sub-populations may be required to be tested.
4.   Studies in the context of the European standard of care	If the trial uses subjects primarily from outside of the EU, the EU may request additional information from patients treated within the EU.  This would negate any cost savings a company might hope to garner by working in other markets.
5.   Studies linked to a change in the understanding of the standard of care for the disease and/or the pharmacology of the medicinal product	This is a scary one.  It proposes that if the standard of care for a disease had changed, the authorization holder may be required to develop new efficacy data addressing the new standard of care.  This could result in a never-ending need for new efficacy trials – a major change in way we think of authorized products.
6.   Studies aimed at determining the long-term efficacy of a medicinal product	This is one of the “traditional” reasons for P4 is long-term analysis.  Difference is focus on efficacy instead of effectiveness.
7.   Studies in everyday medical practice	The proposals suggests that these would be required when “…there is clear evidence that the benefits of the medicinal product underdiscussion as shown by randomised controlled clinical trials might be significantly affected by the real-life conditions of use.”  This seems to open the door for any misgivings or concerns by the regulatory authorities to result in the requirements for a trial – and when they get results they will be obliged to revisit the approval.

Final Thoughts

While this is still in proposal stage, the direction is clear.  PAES is going to become a new tool for regulators who have efficacy concerns about both new approved and legacy products to address their concerns.  It is likely to have a significant impact on the cost, risk and structure of Medical Affairs if it comes into effect.

I urge you if you have comments to follow the process found in the document to express them.  I will be doing so.

What are your thoughts?  Am I overreacting? Please leave a comment.

h/t PharmExecBlog

Topic16: Greater Clinical Trial Transparency and Medical Affairs Rapid Response

GSK announced this week that it would open up its clinical trial data sets to researches who receive approval from a GSK review board.  Next year, the EMA intends to open up access to all new clinical data files that are part of a product registration filing.

I believe this is a trend that will not stop – the increasing openness of biopharma with its clinical trial data.  What does this mean for medical affairs?  I have some initial thoughts below but I would be curious to hear your perspective.

As this data becomes more open, other scientists, some perhaps not fully qualified to understand the data set, are going to review it and draw conclusions.  Since our culture has incentives for publicity in academia, expect that at least some of the scientists are going to spin the data into the scariest sounding headline they can.

The result is, I predict, a sharp rise in news stories highlighting safety risks of products, often blown out of proportion.  Nevertheless, it will ultimately fall to MA to deal with this misinformation on the scientific side.   While this can happen today, it is still fairly rare.  I believe it is going to be common place.

In order to be ahead of this, MA leaders are going to need to set up a Rapid Scientific Response capability (if they don’t already have one):

• Identify Potential Areas Requiring Responses  –  First step is determining what potential areas require rapid scientific responses.  Start with a brainstorming exercise and prioritize to get to the top 5 to 10 topics.


• Determine Leader of Response – For each topic area, identify who from the MA or other functions team should take the lead on coordinating the rapid scientific response


• Identify Internal Experts and Voices – Search through the organization and determine who else has the scientific expertise and other skill sets needed to support the rapid scientific response – PR and Legal should be a part of each team


• Develop Rapid Response Plan – Create a plan for assessing the situation, determining the outline of the response, assigning elements to team members, pulling it together, getting it reviewed and getting the message out  

The entire goal of develop the Rapid Scientific Response capability is to be able to move quickly when the event occurs and produce an accurate and complete response in as little time as possible.  Without this advanced planning, when issues hit no one is clear who should be taking the lead and how.

Do you have a plan for Rapid Scientific Response?  What other impacts do you think the increasing openness of clinical trial data will bring to MA?  Leave your thoughts in the comments section.

Topic14: SOPs in MA

Now for a topic no one wants to talk about but everyone should become more familiar with – Standard Operating Procedures.  The hard truth of today’s world is that SOPs are no longer optional for MA.  In fact, SOPs are critical for success in today’s global MA.  In this post, I will discuss SOPs in general as well as share some do’s and don’ts for developing effective MA SOPs.

Our brethren in Clinical Development have been living in a world of SOPs for much longer than MA because their work was more explicitly regulated.  When you are regularly audited by agencies looking for an excuse to delay the marketing of your next blockbuster, you are highly motivated to have whatever documentation they are looking for.  And, in CD, that means SOPs that clearly demonstrate that all clinical trials are conducted following GCP and other related standards.

In MA we used to be less concerned about regulation enforcement, but those days are over.  So, what is the state of MA’s SOPs?  If your environment is like those in my experience, the answer is a mixed bag.  Many organizations have some good SOPs but few organizations would claim their SOPs are simultaneously:

1. Complete


2. Accurate


3. Trained and understood by the relevant staff


4. Consistently updated

Most MA leaders will tell you it’s important and on the organizational To Do list but it rarely seems to rise up to the top of that list and almost nothing below number 3 on that list can get addressed in any given year.

Yet SOPs represent one of the very best defenses any organization has to arguments that it is operating contra to regulations.  By having clearly defined processes that are compliant, a training program to show that people learned and understood those processes and a program to ensure that those SOPs remain updated, the organization has a very strong argument in its favor, even if a single actor is caught performing incorrectly, the argument can be made that it is a single bad actor not an institutional problem.

But SOPs are not just defensive in nature.  When well done, SOPs represent an opportunity to capture best practice and apply that best practice on a global level.  Every country, every region does not need to re-invent the wheel.  What we do in MA is standard enough that we should be able to build a single optimized approach that we can apply on a global basis.

When building SOPs there are some definite Do’s and Don’ts.

DO’S

• Leverage major disruptive changes to implement or enhance SOPs
  
  
  
  • SOPs are a major effort and often difficult to justify on their own (see To Do comment above)
  
  
  • Instead, leverage a new system implementation, new regulatory regime or other major change that seems to hit every year or two as the vehicle for investing in SOPs
  
  
  
  


• Be inclusive
  
  
  
  • Ensure to involve every function and every region that is affected by the SOPs, even those that are outside MA
  
  
  • Make sure the SOPs remain valuable throughout the globe if possible
  
  
  
  


• Develop MA-specific SOP templates and development processes
  
  
  
  • Trying to take the CD SOP development templates and processes can result in over engineered MA SOPs
  
  
  • MA SOPs don’t need to be as detailed or structured as CD SOPs because the goals are different in terms of regulatory support – CD SOPs need to comply with GCP at a minimum which drives a certain level of depth that is not necessarily required in MA
  
  
  
  


• Remember the Training
  
  
  
  • Training is the link between SOP development and real world value, yet many organizations fall down on this important step
  
  
  • SOP development efforts seem to lose steam after the creation effort and often result in training programs that fail to ensure that everyone who should learn does learn
  
  
  
  

DON’T

• Pave the Cow Path
  
  
  
  • Don’t just document the current process (cow path), instead take the opportunity of SOP development to do some process improvement work capturing best practices and defining new approaches
  
  
  • This may take a bit longer but the results are significantly more valuable
  
  
  
  


• Get Overly Complex
  
  
  
  • SOPs are guidelines not computer programs – the more detail the LESS valuable the SOPs can become as more and more real world situations don’t fit into the very specific processes
  
  
  
  


• Forget Certification
  
  
  
  • Its great to train, but in the future someone will question whether the training was effective – without some type of certification to prove understanding on the part of the trainees this is very difficult to prove
  
  
  • Certification does not, and should not, be onerous – just enough to prove that the key points are understood
  
  
  
  

SOPs in MA – not a topic anyone gets excited about tackling.  Yet, SOPs are going to grow increasingly important as the regulatory burden on MA grows.

What is your experience with MA SOPs?  Leave a comment and let me know!

Topic4: Key Opinion Leaders – Managing KOL Interactions Efficiently

Identifying the right KOLs to focus on with the limited resources available is the critical first step and in the last post we discussed some alternate approaches.  Once those KOLs are identified, the next key to success is ensuring that the interactions with the KOLs produce the greatest value for both the KOLs and the pharmaceutical company.

Many organizations that invest in identifying KOLs, often fail to ensure that those KOLs are actually being well served by MA’s outreach efforts.  They provide their field force of MSLs with the names of the KOLs but very little direct direction.  The theory for this hands off approach is that the MSLs are expected to have a peer to peer interaction with the KOL and thus they want that interaction to guide the discussions.  While this is certainly the only way to discuss topics that are not suitable for proactive engagements (see this for further discussion on proactivity), for those topics that are suitable for proactive discussion it places an undue burden on the KOL to know what questions to ask.  In other words, KOLs don’t know what they don’t know and thus, when appropriate, benefit from the direct, proactive engagement of the MSL.

The only way to know how to provide the greatest value from direct engagement is to start by identifying the goals.  What need does the pharma company hope to support through its informational and educational outreach efforts?  The needs of the KOLs may be self-evident to the MA scientific interactions with the KOLs, but if it is not they will need to conduct some research to find out, which may be formal or informal.  Regardless of the approach, however, the needs should be defined by the KOLs and not by MA’s commercial colleagues in order to avoid any promotional bias.  The needs can then be expressed in terms of goals for MA’s outreach efforts.

With the goals in hand, a structured approach can be developed for these proactive outreach effort.  Plans can be developed on the type of outreach to be done, and materials developed to support that outreach.  And, once the plan is in place, progress against that plan can be tracked, measured and reported.

It is truly amazing to me how many MSLs lack a clear plan for their KOL engagement.  Operating without a plan denies the MSL the ability to measure their progress against a standard.  Operating without a plan denies their managers metrics they need to evaluate their performance.  And operating without plan makes justifying the investment in MSLs more difficult for MA leadership.

Building a detailed plan for each MSL that not only defines their KOLs but also details on a time-boxed basis the expected activities is a critical part of effective KOL engagement.  These plans can be in almost any form as long as they can be translated into direct measurement.

These measures should be as results oriented as possible.  Activity driven metrics may be easier but they rarely align directly with goals.  If the results sought relate to growth in understanding of a disease state, for example, then the measure may require some primary research.

Finally, those measurements need to be analyzed and fed back to the MSLs as well as their managers so that everyone can learn from the results of the outreach efforts.

Some of the vendors I mentioned in this post also support MSL plan management and tracking.  More about that in future posts.

Please share your experiences in the comments.

Legal Note:  All information and interpretations presented are only the opinion of the author(s) who are not lawyers. And, even if we were lawyers, given the wide range of interpretations of the current regulations you would still need to get the input from your own compliance organization. 

Topic2: Global Coordination – Challenges and Best Practices

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):

1. Senior Leadership Alignment


2. Engagement and Ownership


3. 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.

Consistent Support

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.

Topic2: Global Coordination – Methodologies

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:

1. Bottom Up Coordination


2. Top Down Coordination


3. 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.

 

Hybrid Coordination

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.

 

Topic2: Global Coordination – Areas for Coordination

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


• Budgets

Medical Information:

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.

Field Force:

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:

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.

Topic2: Introduction - Global Coordination In MA

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.