Topic 44 – Amarin Settlement and What It Means for MA

We have been following the developments in the Amarin off-label communication case for awhile and you can find our posts that provide background here, here, and here.

In brief, Amarin has an FDA-approved indication to market its fish oil supplement as a treatment for very high triglycerides. It conducted a study that showed it lowered the triglycerides in moderately high patients but the FDA declined to approve the label extension because Amarin failed to prove a link to prevention of coronary artery disease. Amarin then informed the FDA that it intended to communicate the triglyceride lowering data to the market and the FDA informed them that it would consider any such communication off-label promotion. Amarin then sued the FDA for unfair restraint. Amarin was granted an injunction against the FDA, which appealed the decision.

In the latest development, the FDA has settled with Amarin, closing down the appeal before a ruling could be made to set clear precedence. In the settlement, which can read about here, the FDA agreed that Amarin could inform doctors of the studies supporting the fact that its product lowered triglycerides in a range of patients as long as the data presented was truthful.  It also set up an “optional” provision in which Amarin can meet bi-annually with the FDA to review the material that they wish to present to ensure that the FDA will find that information truthful and any disagreements from these discussions would be sent to a court to make the final decision.

The FDA’s perceived fear of a precedence setting ruling is not going to go unnoticed. Already another pharma company, Pacira, is suing the FDA under similar circumstances, which you can read about here.

If this case is also settled, expect to see the floodgates open.

It is more than past due time for the FDA to provide clear guidance to industry on the use of truthful, non-misleading communication of scientifically valid data that is not supported by the label. When that guidance is finally offered, it will be a game changer for MA. We believe that most organizations will realize that the safest way to communicate such scientific data will be through the use of peer-to-peer communication driven by medical science liaison-type roles and this will lead to a major expansion of many MSL groups.

We will continue to follow this story. We would love to know what you think. Leave a comment.

Topic 43 – Use of Net Promoter Score Measures to Evaluate MSLs

A couple of my clients have discussed the use of the Net Promoter Score lately so I thought I would address it in my blog.

Quick background:

The concept of the Net Promoter Score was introduced in a Harvard Business Review article in 2003 by Fred Reichheld of Bain & Company. The net promoter score is measured by asking a single question: “How likely are you to recommend the company/product/service to a friend or colleague?” and is usually measured on a 0 to 10 basis. Scores of 9 and 10 are called Promoters, scores of 0 to 6 are Detractors and scores of 7 and 8 are called Passives. The Net Promoter Score is calculated by subtracting the percentage of customers that are Detractors from the percentage of customers that are Promoters.

People like the net promoter score because it is a simple measure of loyalty and when it is paired with an open ended question that asks why the particular score was given, it provides insight into what is important to the customer.

So, does the Net Promoter Score (NPS) provide value to MA? My research has not been able to find a single academic or metric-driven study on the use of NPS in MA specifically related to MSL activity. Common sense says this approach should be helpful but for now anyone using this approach is in experimental mode.

In MA the NPS question is often modified to be:

• "How likely are you to recommend engaging with [COMPANY X] Medical Science Liaisons to your colleagues or peers?” OR
• “How likely are you to recommend working with [MSL NAME] from [COMPANY X] to your colleagues?

PRO’s of Using NPS in MA:

• Brief nature of survey makes it suitable for rapid deployment immediately following MSL interaction to avoid the “blending” affect that occurs when HCPs are asked about MSL performance on a standard survey often weeks after their last interaction
• Relatively inexpensive to conduct compared to other market research
• NPS can help gather insights into what an HCP value in an MSL interaction, if open ended questions are employed as well

CONs of Using NPS in MA:

• Message vs Messenger: When an HCP recommends working or engaging with an MSL is that recommendation based on the quality of the content of the interaction or the interpersonal qualities of the MSL herself or himself?
• Not comparative: NPS does not give insight into whether HCPs recommend your MSLs any differently than they recommend competitor MSLs. Perhaps HCPs in a particular therapeutic area simply recommend all MSLs the similarly regardless of company.
• Not clearly actionable: If your NPS drops from one month to the next, what action should be taken? Some insight might be provided by the open ended questions but those responses are often only provided by the most dissatisfied

Given the inherent challenge, it is my opinion that the NPS is still a worthwhile measure, but it needs to be gathered as a part of a broader market research effort to give it the context that can help tease apart the reason for the scores.

The most effective NPS is gathered as soon as possible after the last interaction. In the case of MSLs, a system should be established to seek this guidance directly after a contact has been noted in the company’s contact management system. And, like all market research with HCPs, participation is highly impacted by compensation, so sufficient compensation must be offered to ensure enough participation to make the measure meaningful.

What is your experience with NPS? How do you frame the question? Share your experiences by clicking here.

Topic 42 – The Office-centric MSL

One of my readers asked me an interesting question:

“Are there examples of successful MSL roles that are primarily office-based (minimal travel)?”

Of course I could immediately think of some one-off type of examples like MSLs that focus on supporting other internal teams, like MSLs focused on training, or MSLs focused on providing a clinical development function technical leadership support. But, the simple answer is that I don’t know of any MSL groups that are primarily office-based. If you have experience with this, please leave a comment because my reader would really appreciate it.
Having failed to find a practical example, I nevertheless asked myself if I could imagine such a group existing in the future as a thought experiment. If we take as a given that the role of the MSL is to:

1. Establish relationships with stakeholders (usually thought leaders / key opinion leaders) in order to:

a. Provide the stakeholders with information and education on the disease state
b. Answer unprompted off-label questions about products / pipeline
c. Gather insights from stakeholders to share with the organization

2. Represent their organization in scientific settings like conferences
3. Facilitate efforts to work effectively with the research community
4. Support other scientific needs of the organization externally, like payers

I realize your mileage may vary on this definition, but if we accept it, than is there a future where most of that can be done from a desk?

I think it comes down to how acceptable the use of remote communications like FaceTime or Skype becomes. Today’s reality is that this is rarely done but I believe that this will grow much more common as this type of communication begins to be embedded in our daily interactions. I can imagine a future in 10 years or less where stakeholders express a preference for this type of communication – it is clearly more efficient for a stakeholder to sit at her or his desk and quickly interact with a number of different people than have to do the physical meet and greet with its inevitable open/closing loss of time. However, I think that this change will happen so gradually that we will come to realize that happened only by looking back on the differences.

And even in such a situation, there will still have to be travel for initial introductions which are much more impactful face to face and to conferences/meetings that have not gone virtual.

I just think the MSL job is too fundamentally about human contact to ever be exclusively office-based.

What do you think? Let me know by leaving a comment below.

Topic 31: Changing Relationship between Medical Affairs and Access and Reimbursement

Note: This is a revised and extended version of a post I first published two years ago. This issue continues to evolve and be an area of focus for many MA Leaders.

Introduction

I received a question about what an optimal relationship should be between MA and Access & Reimbursement in the US. Access & Reimbursement (AR) is the function in pharma that is primarily responsible for negotiating the relationship between the company and the major payers and/or providers. In some organizations this group is known as Managed Markets, Market Access, Payer Relationship, or Contracting. Their primary goal is ensuring that the company’s drugs are listed as advantageously as possible on the formulary of the payer.

AR has to make the case for reimbursement of their drug to a payer/providers Pharmacy and Technology Committee (P&T Committee) which is the body that ultimately makes the decision for the payer/provider. In the US, these P&T Committees consider the efficacy and safety of the treatment but they also consider the cost effectiveness of the treatment and its impact on total cost of care for a patient when deciding where to place the treatment on their formularies. The AR function has had to deal with a range of both government and private payers/providers, each with their own formularies.
The AR function in the US has grown in importance as the payers/providers have worked to limit their exposure to treatments they viewed as not cost effective through formulary placements that drive limitations like prior authorizations and co-payments for the patients. Even specialty areas like oncology, which used to have very few restrictions, are now seeing greater control exerted by the payers.

Defining a New Relationship

Just as the pressures on AR are forcing changes in the way they work with payers, those same pressures are changing the relationship between MA and AR. In the past, MA had a limited role to play in AR. For example, MA may have had a responsibility to train AR Account Managers on the scientific underpinnings of a new treatment, not dissimilarly to how MA may train sales staff. And AR might have occasionally asked an MA resource, typically Field Medical, to provide some scientific support for a formulary presentation. But, in general, these situations were ad hoc and limited.

However, now that AR’s success more directly drives the success of the pharma company and thus their importance has grown, the relationship between AR and MA is changing.

For a P&T Committee to control costs, they must be able to differentiate between treatments. This drives two major scientific needs:

1. The formulary committee needs a more robust scientific understanding of the drug’s properties, its known efficacy, its known risks and its place in the overall therapeutic area’s treatment options


2. The formulary committee is demanding more specialized data, specifically health economics and outcomes research (HEOR) data like cost effectiveness and total cost of care, and comparator data to allow them to understand the full impact of the drug’s use

Both of these ramped up requirements have direct impact on MA’s relationship with AR.

More Robust Scientific Understanding

MA’s role in terms of providing scientific support for P&T Committee presentations is growing from a part of the presentation to the core of the presentation. And with that growth comes the need for greater specialization by the presenters.
MA which develops and delivers the scientific elements of those presentations need to have a much more robust understanding of their P&T Committee audiences and how to effectively meet their scientific needs. This is leading to two trends in MA:

1. Much greater degree of training for Field Medical on the role of AR and P&T Committees
   OR


2. The identification and hiring of full time Field Medical-type roles specifically targeted at supporting AR

Given the importance of AR, supporting their needs can no longer be seen by MA as a side responsibility. Instead, it needs to be a core responsibility and an investment in training or personnel is needed to ensure that that Field Medical is prepared to adequately support this need. In addition to training, this will require new measures to be put in place to track Field Medical effectiveness, which I will discuss in a future blog post.

More Specialized Data

In many organizations, MA has taken the lead in developing data post-approval. And while HEOR has always been a part of generating that post-approval data, its importance has grown significantly. The increased demand for HEOR data has a number of implications:

• HEOR data should start being gathered in Phase 3B at least, and thus MA HEOR leaders need to engage with clinical development to ensure endpoints are included to begin the generation of HEOR data sets


• Post-Approval Data Generation Plans, which should be developed by MA to help drive the post-approval study efforts, must give greater consideration to the HEOR needs


• The priority given to Investigator Initiated Studies that cover HEO subjects may need to increase


• The need for specialized MA resources dedicated to developing and managing HEOR may need to increase, with new dedicated positions developed


• Processes for ensuring that the input of AR is gathered in the development of HEOR protocols should be re-examined to ensure that the results will meet the demands of the key formulary committees

In some companies have decided that HEOR is so important to AR that they have shifted the leadership of this research to the AR function itself. Whether the HEOR function reports to AR or is developed within MA, the need to ensure that the changing needs of P&T Committees are addressed has become a major priority for post-approval research.

Closing Thoughts

MA’s role as the owner of scientific education and communication for post-approval drugs is a critical element in today’s formulary-driven environment. MA needs to be an active partner to AR as it works to ensure patient access to the company’s drugs.

In your experience what has been the key to effective MA / AR partnership? Leave your comments below.

If you have a topic you would like me to cover, please email me from the link to the right.

Topic 30: Virtual MA Organizations – Leadership Implications

I have posted about outsourcing in MA in past posts here and here.

Today’s topic is focused on the virtual MA organization – an organization that outsources all or almost all of its key functions.  Given the capabilities of service providers, it is entirely feasible to outsource every sub-function within MA, including medical communications, grants management, medical information, standard and specialty field forces / MSL groups.

My goal today is not to discuss the pros and cons of a decision to form a virtual MA organization but instead to discuss some key aspects to making a virtual MA organization successful.  Although today’s post is looking at a fully virtual MA, the key points would be just as relevant for a mixed virtual and internal MA organization.

Reality of Virtual MA Organizations

Most organizations that decide to use virtual MA are organizations where very little MA infrastructure exists.  Either they are small organizations building their first MA function or they are mid-sized organizations that are going into a new TA.  Regardless of situation, the analysis that leads to a virtual MA organization is usually a buy vs. build decision.  When considering how to make virtual MA successful, we need to start at that point.

Keys to Success

There are three keys to success to managing a virtual MA organization:

• Upfront Expectations


• Sufficient Internal Management Resources


• Structured System for Evaluations

Upfront Expectations
In order for the virtual MA organization to be successful, the vendors that provide the services need to have a clear understanding of what is expected of them and when so that they can develop the correct scope of the work for their pricing.  Defining what is expected of the vendor is easier in some cases, like for Medical Information defining expectations about call wait time and speed of fulfillment.  But, defining expectations is much harder in cases like an MSL group or a specialty education group.  This challenge is heightened by the fact that the reason some organization’s decided to go virtual is that they don’t have a lot of expertise in house.

Nevertheless, it is vital that a clear set of expectations and measures are agreed upon as a part of the vendor selection and contracting process.  There is no point in the process where the company has more control than at the point of contracting.  If clear expectations are set, both sides win because the vendor can appropriately staff and manage the group and the company can achieve their goals.  If not, the vendor may either need to increase the scope during the contract or simply fail to achieve some needed result and the company will face unexpected costs and missed expectations.

In order to set the right expectations a strategy for MA’s work for the next period must be developed in detail.  And this strategy should be developed before the vendor selection process occurs to ensure that the vendors are supporting the strategy not the strategy supporting the vendors.

WARNING: Some vendors in our industry will encourage buyers against doing this work in advance.  The vendors will tell the buyers that the vendor will develop these expectations after the contract is signed and/or after they are active.  Companies that take this approach usually end up spending much more than they expected and achieving less results than they expected.

Sufficient Internal Management Resources

Virtual does not mean management free.  While the vendors will definitely have their own managers, successful virtual MA organizations have learned that they need to closely manage the vendors to achieve expected results.

Given the situation that leads to a virtual MA organization as discussed above, it sometimes comes as a shock to those setting up one that they still need to hire.  And those hires need to be managerial-level staff.

A general rule of thumb is the greater the range of responsibilities and lack of clarity, the greater the need for management.  So, for example, outsourcing a MedInfo group, with clear metrics and expected volumes, might require only a ¼ Associate Director.  But managing an outsourced MSL group during launch, even if there is a clear expectations set up-front, would require a ½ time director to deal with the unexpected and new learnings from the healthcare community.

If the company is unwilling to invest in the resources needed to manage the virtual MA vendors, that is a sign that the value of MA is not really understood within the organization.  Unless that core issue is addressed it is unlikely that the virtual MA group will be successful.

Structured System for Evaluations

In addition to being actively managed, virtual MA vendors need to be on a half yearly or yearly structured evaluation process.  The structured process will force a review of the original goals and scope of the relationship and provide an opportunity to resolve ongoing issues.  Without a structured process for reviews, problems tend to fester and eventually result in a complete breakdown of the relationship.

Many companies entering into a virtual MA environment rely on the vendors to suggest the structures of these types of meeting.  I would recommend that the company own the process and set the agenda.  This will ensure that those issues most important to the company serve as the focus of the process as opposed to an add on.  It also avoids the “make the case for added scope” that many vendor-driven processes tend to become.

Do you have experience setting up or managing a wholly or partially virtual MA organization?  What would you recommend?  Please leave a comment or send me a message.

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 28: Big Data and Medical Affairs

“The era of Big Data is here!”  That may be true but what does that mean for Medical Affairs?  As in all of biopharma, MA is comfortable working with data.  So much of our work revolves around discussing data and the implications of data that many people may think that we were already living in the era of Big Data.

But for most MA organizations, the data sets we have focused on are purpose generated - either our own data or data from similarly-scaled studies conducted by others.  Big Data refers to something different.  I like the differentiation that SAS uses when comparing Big Data to the past data sets.  They break it down to four “V”s and a C:

• Volume: Hugely increased data volume from the past


• Variety: Since the data is produced in many different ways, it has many different formats and structures


• Velocity: Both how fast the data is being produced and how fast it must be processed


• Variability: Inconsistent data flows, with peaks and valleys


• Complexity: Driving value out of these data sets is highly complex and difficult

This is not your grandfather’s data sets.  What are some examples of Big Data as relevant to biopharma and MA:

• Electronic Health Records data from a variety of sources


• Search engine data (see an example of analyzing search data to find safety signals here)


• Sunshine Act Physician Spend Data (when it becomes available)


• Social media data


• Competitors clinical trial data as it is released

Contained within these and many Big Data sources are key tools for MA:

• Valuable therapeutic information


• Unique customer insights


• KOL identification and information


• Visibility of competitors drug development and support efforts


• Important drug safety signals

But, none of these benefits can be achieved unless the question is asked and the data is analyzed.  I would suggest that effective MA organizations of the future will need to have the capacity to ask and answer these types of questions.

In order to do so, MA organizations will either need to build or have access to increased levels of biostatistical and epidemiological resources.  And these resources need to have skills directly related to Big Data.  The characteristics that differentiate Big Data from existing data sets also means that many existing biostats and epi staff do not have the expertise or confidence working with these large, external data sets.  MA organizations need to ensure that people with exactly these skills sets are available within their organizations or from outside vendors and that these resources have the capacity to support MA.

Then, MA needs to improve its overall level of confidence defining Big Data questions, conducting Big Data analysis, and discussing the results with others.  Given the difference in the source of this type of data, the way this data is presented and discussed must be different too.  Everyone in MA, but especially the MSLs, must become more comfortable understanding the nuance of this type of data analysis and discussing both the strengths and weaknesses of working with Big Data.

The era of Big Data is here.  MA has a long history of effectively using data and explaining data in support of its organization.  MA leaders must investigate and embrace Big Data to take advantage of all the tools available today.  The questions unasked are always the questions unanswered.

What is your experience with Big Data?  Please leave a comment.

Topic 27: Disruptive Change in CD and the Opportunity it Presents to MSLs

Disruptive change is a frequent topic on this blog because it represents both a threat and opportunity for MA Leaders.  For example, I have discussed the Caronia ruling at length because it could fundamentally alter the relationship between MA and Commercial.

Clinical Development is facing a disruptive change of its own that not only will alter the way it works but offers an interesting opportunity for some MSL groups.

As most of my readers know, one of the largest expenses in executing a clinical trial is monitoring costs.  The need to send a human being to each site every 4 to 8 weeks during a trial to manually review the paper source records and compare those results to the data entered in the electronic data capture (EDC) system accounts for roughly 30% of a major study’s budget.

However, this is about to change.  With the rise of tablet computers and ubiquitous internet, a range of technology platforms are now available to allow for the elimination of paper-based source records.  For example, the company Clinical Ink, provides a Windows tablet that completely eliminates the need for paper source records by recording not just that data required for the study sponsor (which is what is in the EDC) but also the data needed by the physician administering the study to manage their records.  Once the physicians can eliminate the need to keep separate paper records, the last stumbling block to all electronic source records will have been overcome.

All electronic source records is a highly disruptive change to clinical development.  All electronic source records means that source data verification no longer needs to occur on-site.  The majority of the monitoring visits could be eliminated and the role of the Clinical Research Associate (CRA)  versus role of the Clinical Data Manager (CDM) will change significantly.

Today CRA’s do more than just monitoring visits.  They also conduct site initiation visits, and other high-visibility meetings with the site to ensure that it is on track. However, when you eliminate the need for monitoring visits, it opens an opportunity to ask if the CRA is really the best representative to provide other support to the site.

I would suggest that this disruptive change offers and opportunity for the MSLs to step up and serve as the face of the company for key studies.

Already many MSL groups get involved in this manner along side CRAs for key studies.  In the future MSLs could replace the CRAs for the customer-facing aspects of key studies, just like CDMs will replace CRAs for the electronic source data verification processes.  It would require changes to SOPs and some additional work and training for the MSLs but the benefits for the organization would be significant:

• MSLs already have relationships with many KOLs which serve as PIs and this is an opportunity to strengthen that relationship as well as build new relationships


• MSLs work for the company and therefore understand the importance of building and maintaining long-term positive relationships with the PIs (as opposed to CRAs which are often outsourced and only focused on a single study)


• MSLs have superior scientific training than most CRAs and thus can make a stronger case for the scientific importance and structure of the study, which is cited by PIs as one of the key factor’s driving their willingness to engage in the study


• MSLs can have peer-to-peer discussions with the PIs to ensure that they understand the protocol


• MSLs often glean key scientific insights from PIs when working with them on studies that can be brought back and shared with the organization’s scientific leadership


• MSLs can offer their scientific opinion on aspects of the trial that may be limiting recruitment given their in-depth engagement

These are just a few of the benefits for engaging the MSLs in this new manner.  But, like all disruptive change, this is not going to come about naturally.  For MSLs to engage in this new manner, MA Leadership will need to reach out to their CD counterparts, discuss this disruptive change and push for a new role for MSLs.

What are your thoughts?  Leave a comment or send me an email.

Topic 25: Highlights of Day 2 of the Medical and Scientific Communications 2013 Forum

A great second day for the MSC meeting, with a range of interesting topics.  My take below.

DISCLAIMER:  My focus is on interesting information, I did not try to take verbatim notes and will not try to assign comments to a particular speaker.  Any mistakes are mine alone.

In no particular order, some of things are found interesting included:

-  MSL Value Proposition:

• Questions of value are often linked with a lack of fully understanding what a modern MSL does, vs. MSLs of old


• Many in group have had good success inviting key stakeholders, up to and including CEO, for ride-alongs with MSL
  
  
  
  • Proven track record at overcoming skeptics about MSL skills and value
  
  
  • One key to proving value is remain consistent in priorities to show value over time
    
    
    
    • When priorities are shifting its hard to build up track record
    
    
    • Remember that one of the greatest MSL values, relationships, is the least structured and always make that point clear
    
    
    
    
  
  
  
  

-  Other non-traditional areas where MSLs can show value:

• Training CRAs on underlying science before trials


• Conducting formal evaluations of CME vendors to ensure vendors are providing good value


• Identifying authors for Pub group

-   Measure what matters to the people that matter

• Develop measures that highlight accomplishments that only MSLs can achieve


• Create monthly list of these unique accomplishments to address qualitative questions

-  External Surveys

• Important to get qualitative measures


• But expensive and difficult


• Also, expect lots of push back from people who don’t think they are fair


• Don’t let the complainers win, the data is critical to effectively target efforts

-  A number of MSL organizations use monthly internal newsletters

• Highlight key activities and accomplishments


• Provide some science training


• Implicitly defines values and culture through examples chosen and emphasis

-  Challenge of “boom bust” in MSL team sizing

• Number of speakers referred to the challenge of staffing for launch only to see the team significantly reduced 1 to 2 years after launch


• This is especially challenging outside of the US where country-level resources are very limited


• Need to consider this issue up-front during initial staffing and make the case for the long term from the start

-  Breakout session about MSL management

• Almost everyone in group had turnover of less than 10% and most less than 5%


• Most organizations had two non-managerial  levels of MSL – MSL and Sr. MSL
  
  
  
  • Some organizations had three with an Executive MSL above Sr.
  
  
  • Most organizations had at least two managerial levels but the titles varies
    
    
    
    • Some had three
    
    
    • Expectations about activity level varied but some examples from different companies:
      
      
      
      • 4 visits per week
      
      
      • X number of interactions per week (phone/email/visit)
      
      
      • MSLs will be out in the field 3 to 4 days per week
      
      
      • Key to expectations is flexibility
        
        
        
        • Some MSLs in small geogs some in large, their expectations should be different
        
        
        • Some TAs have large number of meetings, some few, so their expectations should be different
        
        
        
        
      
      
      
      
    
    
    
    
  
  
  
  

-  Mobile technology

• IPADS is the de-facto mobile tech of today


• Currently adjunct devices to laptops, NOT replacements


• Hard to justify on “cost saving” but easy to justify on WOW factor


• Be careful of SOPs that are linked into the old way of doing things, may need to be re-written to accommodate the tablet


• User experience is more important on Ipad than on PCs
  
  
  
  • Users have very low tolerance for clunky Ipad interfaces
  
  
  • Some other interesting ideas:
    
    
    
    • KOLs are likely to grab the Ipad so make sure everything you don’t want them to see is locked down
    
    
    • Ipad syncing is a manual process and may people may avoid, so build in lock outs to programs to force them to update at least monthly
    
    
    • 4 Digit standard Ipad passwords stink – they are breakable in minutes, use a much longer password
    
    
    • Use  cloud-based apps like DropBox or Google Drive only after being approved by compliance
    
    
    • People want to use their Ipads for personal stuff (photos, music, games) and most companies let them use it for that as well
    
    
    • Allow people choice in covers and other accessories since it is very personal
    
    
    • Have an accessories swap program to allow people to turn in accessories they no longer want and others can use
    
    
    
    
  
  
  
  

-  Odds and Ends Ideas

• Conduct “Office Hours” during major meetings when top CD resources are available in booth so MSLs can introduce their KOLs


• Compliance ride alongs – if compliance is unsure of an approach, offer to pilot it with them on a ride along so they can see it in action then make a determination


• Community MSL group focused on non-HCPs, like Advocacy Group

Obviously, this is merely a few key concepts from the day but it should give you some flavor of the type of discussions and the focus of the meeting.

The meeting remains a very positive experience.  One of the key takeaways from today, however, was the desire of the audience to have more time to interact and learn from each other.  A good problem to have!

Topic 24: Highlights of Day 1 of the Medical and Scientific Communications 2013 Forum

As I mentioned earlier, I am attending the DIA MSC meeting in Pheonix, AZ this week.  The MSC has increased value this year because they have added a track specifically focused on MSLs.  Through the hard work of the MSL Track Chair people Rebecca Vermeulen and Ramineh Zoka, as well as the hard work of all the presenters the MSL Track has had a terrific first day.

DISCLAIMER:  My focus is on interesting information, I did not try to take verbatim notes and will not try to assign comments to a particular speaker.  Any mistakes are mine alone.

In no particular order, some of things are found interesting included:

-  A pill is poison unless the right information is wrapped around it.

-  ACA

• Because of the passage of the ACA and the Supreme Court upholding the law, Rx spending is expected to increase 4.7% more than is the law had not passed


• With the ACA’s introduction of roughly 20 million newly insured people in 2014, the US market will become the fastest growing pharmaceutical market in the world

-  Tax Deductibility for Marketing and Sales expenses in Biopharma

• Some talk about eliminating this to increase tax revenue


• Proposed 3 times in the last year but killed each time


• NOT at all clear whether MA would be considered marketing under tax law


• If passed, likely to see major cuts needed to balance budgets in these areas

-  Sunshine Act

• Already happening for 16 companies under CIA’s


• For a taste of the info that will be available, see this link


• New PhRMA/Coalition formed to educate public about wave of new disclosure information coming called National Dialog for Healthcare Innovation

-  Caronia Ruling (you knew I would have to get something in here about this)

• No one knows when it will be law of the land but likely 5 to 10 years


• Old standard of safe – what is on the label


• New standard will be – information that a reasonable consumer would not find misleading


• New standard is current FTC standard for all advertisement


• Data will be king, but not just data submitted to FDA


• For time being, continue like no change

-  History of MSL Role

• First MSLs started 40 years ago


• Up John created role and actually trademarked the name MSL


• Part of the sales teams – scientific sales

-  MSL Facts of Interest

• Most MSLs manage between 25 and 49 KOLs


• 32% of companies surveyed (n~60+) intend to grow MSL team


• Only 11% intend to shrink MSL teams

-  Value of MSLs by Physicians

• Surveys showed physicians do NOT value frequency, they value:
  
  
  
  • Accessibility
  
  
  • Responsiveness
  
  
  • Knowledge
  
  
  • Up to date information
  
  
  • Do NOT want to meet with MSLs if:
    
    
    
    • Only have old or out of date information
    
    
    • Feel they are biased
    
    
    • Have nothing new to tell them
    
    
    
    
  
  
  
  

-  Diagnostic MSLs

• Specific MSL group focused on uptake of diagnostics


• Big challenge – to use a diagnostic, they need the diagnostic platform – often millions of dollars


• Thus broader array of people involved in decision beyond just HCP, including:
  
  
  
  • Bench Tech
  
  
  • Lab Managers
  
  
  • Pathologists
  
  
  • Administration
  
  
  • Opens questions about right regulatory regime for non-HCPs
  
  
  
  

-  CIA Driven Changes

• CIAs require standards and documentation


• Documentation increasingly taking the form of customer relationship management systems specifically for MA


• Most common system by show of hands in the room: Veeva running on Salesforce.com


• To be effective, this type of system needs to:
  
  
  
  • Track interactions
  
  
  • Manage content
  
  
  • Link the two
  
  
  • Key pitfalls
    
    
    
    • Privacy, especially for global systems given EU requirements
    
    
    • Complexity
    
    
    
    
  
  
  
  

Obviously, this is merely a few key concepts from the day but it should give you some flavor of the type of discussions and the focus of the meeting.  Overall I would say the tone was very positive, given the challenges MSLs face in their highly regulated environment.  Everyone at the meeting was confident that MSLs value was high and these challenges could be met.  Look forward to tomorrow.

Off to DIA MSC in AZ

I'm heading out on Monday to the DIA Medical and Scientific Communications 2013 Annual Forum in AZ.  Looks like there will be over 500 people attending which is a great crowd.  I will be presenting on Wednesday at 1:30 as a part of the Hot Topics in Operational Leadership session in the MSL track.  Please come by if you are at the conference.

I will write up summaries of some of the presentations for those of you who cannot attend the meeting.

 

Update: Off Label Free Speech Ruling Left Unchallenged at Appeals Level

As I discussed here, a recent ruling by the Second Circuit Appeals Court provided a new legal foundation for off-label promotion on free-speech grounds.  As the law currently stands in the Second Circuit, as long as the speech is "truthful" it is protected by the First Amendment and thus open to anyone.  Sales reps and MSLs in Ney York, Conn. and Vermont have one less thing to worry about.

Many, myself included, assumed that the FDA would ask for a re-hearing in the Second Circuit, but that date has come and gone without such a request.  You can read about it here.

At this point the FDA can go two ways - they can ignore the ruling and let it stand for the Second Circuit, which may result in a set of haphazard interpretations over time as different Circuit Counts rule differently, or it can appeal the ruling the Supreme Count.  Assuming the Supreme Court would agree to hear the case, appealing it to them could result in a ruling that the Second Circuit ruling should be the law of the land.

So the FDA is left with a choice - take what it has and accept that the off-label promotion rules may gradually crumble or risk those rules completely by appealing to the Supremes.  They have until mid-March (or until mid-May if they wish to extend their timeline) to make that decision.  I will continue to fill you in when I learn more - watch this space!!

Topic20: MSL Organization Structure and Staffing Overview

I have had a number of posts about MSLs, including posts about MSLs driving value, posts about MSL team leadership and posts about MSLs vs. sales.  However, I have not discussed MSL organization structure and staffing.

When thinking about MSL organization, it’s important to start with MSL to management ratios.  Typically, the type of manager to staff ratios that work best in an MSL group is about 8 MSLs to 1 manager.  There are all sorts of reasons why this could be scaled up to 12 to 1, including a fairly static therapeutic areas, MSLs that work extensively with other functions like Clinical or Managed Markets, or a team of all veteran MSLs that need little coaching.  And there are all sorts of reasons you might want to scale back to 6 to 1 or even 5 to 1, if it’s a new therapeutic area for the company or inexperienced MSLs or a challenging KOL environment.  But, those extremes 5 to 1 on one end and 12 to 1 on the other are the practical end limits.  Much more than 12 people and it is not feasible for the manager to have a clear understanding of what their team is doing.  Less than 5 to 1 and there is not enough work to occupy a full time manager and you know I feel that is important (see post here).

Given those ratios, how should the teams be formed?  MSLs are inherently regional and that would lend themselves into regional organization structures, but they are also specialists often focused on a single therapeutic area or set of therapeutic areas.  If the MSL group is large enough, you can do both – separate MSL groups by therapeutic area then by region within those groups.  In reality, however, few organizations are large enough to organize that way.  As a result, most groups mix or combine therapeutic responsibilities and build regional teams.  To the degree that MSLs need therapeutic coaching, it can be provided through cross-team therapeutically aligned training and development.

Determining how many MSLs are needed starts with a clear definition of MSL responsibilities.  MSLs have such a potentially broad remit in today’s environment (they could theoretically be focused on activities in support of Clinical or Market Access activities as well as MA and scientific outreach) that without a clear definition scaling can’t be done.  Sometimes it’s a purely practical matter to determine this question – who is paying for the MSLs?  That often clarifies what types of activities they will perform.  But in many organizations MSLs routinely do work in support of functions other than the budget owner and so it really needs to be well defined.

Once the remit of the MSLs is understood, the next questions that help determine staffing are environmental.  Key factors include:

• New or existing therapeutic area for the company


• Complexity of the therapeutic area


• Degree of competition for access to scientific experts


• Expected changes in the therapeutic area in the next three years

Once the role of the MSL is understood and the environmental factors are clear, a good estimate of the work load can be developed and from there an estimated staffing level.

On another post I will discuss the challenge of starting up an MSL group from scratch and the buy or build decision.

What has been your experience in this area?  What ratios do you follow?

Topic 18 – Site Payments in Phase 4 Clinical Trials

(Full Disclosure – I was introduced to this issue by my client who has a interest in the solution to the problem but regardless I believe this to be a real problem. )

As P4 clinical trials grow larger and more complex, the challenge of site payment computation and accrual grows as an issue.

As more and more sites become sophisticated partners in clinical trials they are demanding customized contracts with payment terms associated with their work and cash flow needs.  It is hard to blame them when pharma and CROs has been so bad about paying, many times paying sites over 90 days after the site incurs the cost and paying inaccurately.

Payments are a source of friction with PIs and thus KOLs.

CenterWatch has identified late payments as the #1 site concern about pharma for the last three years. For a P4 study, Principle Investigators (PIs) are often key opinion leaders (KOLs), since many of KOLs have access to the type of patients needed for the trial.  Developing a strong scientific dialog with KOLs is a fundamental role of MA.  Yet, at the same time we are working so hard to establish a positive working environment to collaborate with KOLs, we are also degrading that relationship due to late or inaccurate study payments.

It is not at all unusual for an MSL to receive complaints about late payments on trials, even though the company has outsourced the trial to a CRO for payments.  The PIs will hold the company responsible despite the CRO’s involvement.

Payments are a source of regulatory risk.

Since payments are generally computed manually even by most CROs, many mistakes are made.  Thus at the end of each study there is a process called “End of Trial Reconciliation” when the actual amounts owed are computed against the final data collected.  Any missing money (and there is often hundreds of thousands in overdue money) is paid at this point.

BUT, the regulatory risk is not in delayed payment.  The regulatory risk is what happens if we find we have paid too much.  This happens often in clinical trials because due patients drop out but due to computational errors the site still receives payments for that patient.  If that occurs we have overpaid the site and the PI (which we discussed are also KOLs).  But this computation error may be from years before.

Now the quandary is – do we demand repayment from the site for our error.  Technically, the site should refund the overpayment.  But, I would ask your operations group if you have ever asked for that money back.  My practical experience is that the overpayments are rarely if ever collected back.  If they are not collected back, we have essentially paid more for the trial than fair market value and thus we have a potential compliance issues.

While this issue has not been one I have seen enforced to date, given the growing scrutiny on all payments to physicians with the Sunshine Act, I think it would be wise to ensure that this risk is avoided.

Payment computation is a hidden cost. 

With these more sophisticated contracts comes the need to administer them and compute payments.  Sites don’t send an invoice.  So, determining the amount to pay is left up completely to the pharma company.  Performing that computation can be complex and time consuming.

Since many pharma companies outsource their P4 trials, what they are doing is paying the CRO to perform this computation for them.  In some larger P4 trials, hundreds of thousands of dollars in fees are spent for the CRO to compute and issue payments.

New solutions are available.

The good news is that a new type of software is being developed to automate the payment process and avoid the need to do any manual calculations.  If you are interested check them out .  My client is www.clinverse.com.  Also their competitor is www.greenphire.com.

What has been your experience with P4 site payments?  Leave your thoughts in the comments.

Topic 17 – New MA Organization – MedComm/SciComm

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.

Topic13: Medical Information Groups

I was talking with a friend the other day who is charged with running the medical information (MI) function for their small pharma company.  Currently they outsource the MI function and she was wondering if it made sense to bring the function in-house of keep the current arrangement.  We discussed how effectively the outsourced MI function works with the current MA group, including the MSL field force, and the answer is that they have some formal links but rarely talk.  We talked some more and reached some conclusions, but I thought this might be a good topic for a post.

MI is both a regulatory mandated function, and a critical component in achieving MA’s educational and public outreach goals.  It is possible to structure and run the MI function merely to meet the regulatory requirements but that would represent a significant waste of an opportunity.

From a regulatory perspective, the MI function needs to be structured to answer calls from both patients and healthcare professionals (HCPs), differentiate between inquires and pharmacovigilance calls and route the calls appropriately, answer questions directly when appropriate, distribute accurate and approved materials to appropriate audiences, and develop outgoing medical communications on important issues (Dear Doctor letters).  It needs to be staffed by people with appropriate qualifications to answer medical and technical questions about the use of company’s products.

But, some organizations gain much more benefit from their investment in MI.  For one thing, MI is often the first sign that a problem is occurring relating to our products or issues are being raised concerning the scientific underpinnings of our products.  Spikes in the type and content of questions help provide a Zeitgeist view of the needs for education in the HCP community.  But, this only works if MA listens.  There must be processes and systems in place to ensure that MI is coding their contacts in a manner that allows for analysis and reporting in place to ensure that the information is summarized on a timely basis.  Finally, clear responsibilities need to be established for who will review and respond to this information.

Other organizations utilize the MI resources to more effectively partner with the MSL field force.  MI and MSL groups tend to talk with related but mutually exclusive audiences.  Given the limitations on MSL time, they need to focus that time on those HCPs that can offer the greatest impact on the medical community, the so-called Key Opinion Leaders (KOLs).  Based on research I have seen in the past, it is very rare for a KOL to call MI.  They tend to expect the answers to come to them through MSLs or research on the internet.  Non-KOL HCPs tend to call MI.  Given that, the opportunities for MSLs and MI to interact is not in terms of serving the same HCPs but instead in terms of “having each other’s backs.”  Often when MSLs are interacting with HCPs, they need to provide those HCPs with additional information and support.  MI is well suited to provide that information and support.  And, when MI is answering questions for HCPs they encounter situations that require more in-depth support, and MSLs are well positioned to provide it.

Establishing a strong partnership between MI and MSL groups brings value to both sides, yet it is not as common as you might expect.  Sometimes it’s due to organization structure – the two groups have unrelated reporting relationships and thus lack incentive to interact.  Other times it’s due to a difference in philosophy, where one of the two groups does not see value in interacting with the other.  Regardless, there is value in establishing this relationship, but it needs to be clearly structured and actively managed to avoid either group “dumping” on the other.

This leads back to the discussion of outsourcing MI.  To really gain value from MI, it needs to tie in easily with the rest of the MA organization.  It may be possible to pull that off with an outsourcer, but its unlikely.  For that reason, I suggest that insourcing MI brings more value to the organization.

My final thought on MI relates to technology.  A call does not have to be a phone call.  Web chats are significantly more efficient to manage and allow for careful scripting of responses.  Providing this service on an after-hours basis may allow more of those KOLs discussed earlier to actually connect.  And, I have yet to see a company develop an MI app, but I think we can’t be too far from having one – just tap the icon and link directly to an MI chat or other dialog.

 

What has been your experience with MI and how it relates to other function in MA?  Please leave your comments below.  And if this is your first time on the blog, please sign up on the right to receive email updates of the latest posts – don’t worry its spam free.

Topic12: Here We Go Again – Oncology Sales Reps and MSLs

Did you see the headlines off this new survey from ZS Associates about sales rep access to oncologists?  The takeaway is that oncologists heavily restrict sales staff access.  Only 39% of oncologists were accessible (by ZS’ definition) to sales staff while the average for other all physicians is closer to 65%.  Take a look at the article here.

For those of us in the oncology space this is not really breaking news but the quantification brings it into focus.   And the article goes on to mention different sales approaches to help overcome this limitation, implying at one point that pharma might re-start the sales arms race and gain access through sheer force of numbers. (I am highly skeptical of this)   We all know when this type of information comes out the next line of reasoning for improving access to oncologists always seems to involve MSLs.

MSLs have access to oncologists, goes the reasoning, and we should use them to “supplement” the limited access of our sales folk.  There was a blog post on this subject in PharmaExec’s blog here that seems to make this case.  In it, the poster cites a study from Industry Standard Research and talks about how MSLs are “…less promotional…” than sales reps and thus more credible.

As MA professionals, we need to nip these arguments in the bud.  While I personally have no issue with taking money that used to go to sales reps and putting it toward MSLs, the justification for doing so cannot be to use MSLs as “scientific sales” or “sales-lite.”  The hard truth is that oncologists are not interested in being marketed to by drug makers.  They are sophisticated physicians with robust knowledge of the scientific state of their therapeutic area, and they don’t need reps to help them make decisions.  What they are interested in is learning and sharing with peers.  And, if we can put MSLs in place that can support that learning and sharing, they will be appreciated and welcome.  But, the minute we try to give MSLs any level of marketing duties, we will simultaneously lose our physician credibility and place the entire MA function in compliance risk.

Instead of seeing the information from ZS as an excuse for pulling MA into marketing, it should be seen as a clarion call for a shift in focus from a customer relationship to an educational and scientific partnership.

MA can have an impact on treatment decisions but not through marketing.  MA’s impact will come from partnering with physicians to ensure they have the scientific facts and support that they need to make informed decisions using their best judgment.

 

What do you think?  Leave your comments below.  And if you are new to the blog, add your email to the list on the right to receive an update when new topics are posted.

Topic11: MSL Team Leadership Challenge

I received a call the other day from an old friend who had taken on a new job.  Her job involved developing the North American MA function for a non-US pharma company.  One of her first tasks was to consolidate and expand the MSL function in the NA. She was very concerned because her budget was fairly limited given the ground she needed to cover with her MSLs.  She wondered whether she could “stretch” her staff by using team leads that have both substantial HCP support and managerial responsibilities.

While practical considerations, especially for very small or very new MSL teams, sometimes dictate the need for MSL Team Leaders to have both substantial HCP support and managerial responsibilities, over time these types of models tend to be unstable.  When Team Leads have substantial HCP responsibilities those responsibilities tend to absorb the time for managing their team.  It is essentially a case of the urgent driving out the important.  In an effort to be responsive, HCP needs tend to trump other requirements, especially requirements that can be put off like team management.  As a result, despite best intents the team suffers from a lack of leadership. And, in cases where the team already has some challenges, like lack of experience or entering a new therapeutic area, this lack of focus can derail the entire MSL effort.

While it is important for the MSL team leads to maintain contact with some very targeted HCPs, it must be a small portion of their workload and their managers need to ensure that they do not lose their focus on their primary responsibility – the leadership of the team.  The important cannot be allowed to be a victim of the urgent.

So what is the magic number where a more-or-less full time team leader is needed?  Putting aside all the caveats that the number varies by TA, product complication, HCP need, etc., I would say the number is between 8 and 12.  Less than 8 it does not make much sense to have a full time-ish team leader.  Over 12 and it too much work for one person.

What has your experience been?  Please leave your thoughts in the comments.  If you are new to the blog, please add your email on the right to receive a notice when new posts occur.