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 26: Highlights of Day 3 of the Medical and Scientific Communications 2013 Forum

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The final half day for the MSC meeting had an excellent and well received discussion about MSL metrics.  I also attended an interesting talk on coordinating global publications.  My take on it 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:

-  Metrics

• Must vary as focus of the organizations varies
  
  
  
  • Plays back to earlier comments about staying focused if you want to see improvement over time
  
  
  • Mix of Activity, Value and Compliance measures are needed
  
  
  • IIS Metrics
    
    
    
    • Good to track in terms of just a sense of the program
    
    
    • NO goals should be put in place
    
    
    • Additional metrics discussed
      
      
      
      • Engagement with ACOs or Cancer Networks or other new healthcare entities
      
      
      • Congress attendance valued by quality metric of the outputs not the activity
      
      
      • Dollars saved by asking MA to assist CD, especially when CD has a bid from a vendor to provide the same service
      
      
      • Internal stakeholder feedback
        
        
        
        • Important – best to solicit directly via email/conversation
        
        
        • BE CAREFUL – some organizations do not allow feedback from Commercial
        
        
        
        
      
      
      
      
    
    
    
    
  
  
  
  

-  Reports/Dashboards/Scorecards

• Need to develop different outputs for different stakeholders


• What is needed internally at MA is not what you want to focus on with other internal stakeholders


• Always pair summarized numbers with text explaining value and highlighting accomplishments/learnings

-  MA IT Systems

• As mentioned earlier, a number of companies seem to be moving toward the Veeva Platform which is built on top of Salesforce.com CRM.
  
  
  
  • Veeva seems to be driven by the commercial side, but it has MA capabilities
  
  
  • Some people mentioned that you need to be careful about Veeva training and documentation as it often defaults to commercial language
  
  
  • Some organizations use it to track not only KOL interactions but also time spent in the office doing various projects
  
  
  • Focus on time tracking seemed to be for internal management not for external publication
  
  
  
  

-  Global Publication Coordination

• Increasingly important to have global plan


• Much easier to manage when Pub Team gets involved earlier in the development cycle


• MA on Pub Team should work as a facilitator for Pub Team’s interaction with other functions given their central role


• Press release management globally remains a major challenge
  
  
  
  • General consensus that prior to first presentation at a meeting, press release should be simply binary – met endpoints, did not meet
  
  
  • Too much data in press release can tick off journals threatening publication
  
  
  
  

-  Odds and Ends Ideas

• Heard from a number of different companies that MSL groups focused on payer support in the US need to be between 6 and 10 in size to cover all the needs – not scientific but an interesting convergence


• MSLs at clinical study initiation visits:
  
  
  
  • Good idea BUT has GCP implications
  
  
  • Need to hammer out how MSLs can fit within CD’s SOPs with ClinOps before engaging
  
  
  • May ultimately require update to CD’s SOPs
  
  
  
  

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.

If you were at the meeting and have other thoughts please leave them in the comments.

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.

Topic 21: ISS and the Web

I was speaking with a long time friend about this subject the other day and thought it would be an interesting blog post.

Investigator Initiated Studies (IIS) supported by biopharma grants is a significant element of MA responsibilities for some companies.  We will not be jumping into the strategic and scientific value of IIS studies with this post.  Instead, I will focus on the operational aspects, and specifically how I would think technology would make the process much more efficient.

Grant Application Process

Technology to manage the grant application process is widely available.  Transparency in this process is critical.  One of the goals of MA is to build positive working relationships with the scientific community and it is that same community of physicians and scientists applying for grants. So it is critical to ensure that the grant application process is just another element of the overall positive relationship.  That’s not to say all grant requests are supported, but the requesting process needs to be clear and efficient.  A good example of this can be seen at Celegene’s grant application webiste which includes an online application process and portal to allow the grant requestor visibility into the grant making process.

Not everyone can afford to build their own portal, but there are plenty of other solutions available over the web that require little in the way of investment and can meet the basic requirements, including here, here and here.

Depending on your interpretation of regulations, you may or may not be able to use these same systems to convey to the grant applicants that the organization’s research priorities are and grant resources are, to ensure that they have reasonable expectations.  See this example on the Genzyme page where they offer a direct link from the grant page to their research focus pages.

Study Execution Process

The use of the technology after the grant has been made varies widely among companies.  In the past, many organizations made the grant decisions, provided the product or funding, and then left the investigator alone.  After a period of time results either would or would not come out but the company had little involvement.  The problem with this approach is the situation where the IIS produced no results.  Without results, it calls into question the ethics of the funding.

So today, most organizations stay engaged in the IIS process but how they stay engaged varies widely.  I would like to suggest that one efficient way to stay engaged is to offer as part of the grant support the use of an electronic data capture (EDC) system.  While small scale studies like IIS don’t have to use systems like EDC since the data is limited, by providing such a service to the IIS it ensure that the study is capturing data in a structure manner, that the data is being managed and that the study will have something to show for the grant.  All these systems work over the web so there is no need for the IIS to manage the software themselves.

What has been your experience using technology to support IIS?  Leave a comment.

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 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.

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.

Topic15: OLIS and Journal Clubs and Journal Articles

I was talking with a friend and client about internal journal clubs in particular and discussing journal articles with HCPs in general. This discussion may be germane to a number of you because it really stems from what I think of as “Overactive Legal Imagination Syndrome.”

OLIS is the reality many of my clients face when their legal group begins to tie itself in knots over the practical implications of the fact that MA must talk about the science involved with its products, and some of that science may ultimately be compelling enough that the HCP decides that our product is something that they should use.  OLIS drives them to wonder “How can we not be promotional if the results of our permissible scientific exchange is that the HCP decides to use our products?”

See our thoughts below:

1)      Can we allow Internal Journal Clubs?

• We already agree that field staff can have permissible scientific exchanges with physicians


• In order to have scientific exchanges they need to know the latest science which is represented by what is being published in peer reviewed journals


• Although our team is good, no one member of the field force has all the knowledge necessary to understand the huge range of potential scientific articles or the time to cover the huge range of journals


• As a group, however, they do posses both the knowledge and the time


• Therefore, they should be allowed to review the new scientific information as a group and share with the members the information they need

2)      What if the conclusions reached in the internal discussions of the articles are biased?

• So what? – we are not going out to the HCPs to present our conclusions but to have a scientific dialog – to listen and answer scientific questions


• Any perspective we have is already perceived to be biased – we work for a major pharmaceutical company and everyone knows it


• The issue is not bias – which is not against the law – the issue is promotion

3)      What if our perspective is deemed to be promotional?

• There is absolutely nothing new about a concern that our scientific dialogs run the risk of being promotional


• BUT, we already have standards and training in place to ensure our staff does not promote during scientific exchange – regardless of whether that exchange is about a new article in a journal or an existing safety issue, etc. etc.

4)      What if the conclusions of the author of the journal article are promotional in and of themselves?

• First, we need to agree that facts, even facts that are favorable to our products, are neither promotional nor non-promotional – facts are facts


• Conclusions drawn from the facts can be promotional


• So if the study finds that patients using our drug have better results than patients using a competitive drug, that fact is NOT promotional UNLESS our field staff says something like:

i.     “I don’t see  how anyone can read this and not put all their patients on our drug”

ii.     “Clearly our drug is the more effective and it wouldn’t be ethical to put your patients on any other treatment”

• If the author of the article draws their own conclusion “…and in the opinion of the authors you would be a fool to treat with anything but X.” then we are back to the points in number 3 above, meaning our team needs to know a promotional statement when it sees it and avoid repeating it


• In this scenario, the internal journal club is actually of value to the company because it allows the group to identify this potentially promotional author conclusions and agree on strategies to engage in this topic without endorsing the author’s conclusions


• Bottom line – these “promotional conclusions” drawn by independent 3^rd parties and published in peer reviewed journals are out in the public sphere and keeping our field team from understanding the article and agreeing on an approach to addressing it without a promotional bias will not stop HCPs from asking them about it and forcing some kind of reply

What has been your experience with OLIS?  What about internal journal clubs?  Leave a comment.

Slightly OffTopic: NEJM Article on BioPharma Research Credibility

Have you seen this special article in the NEJM entitled: A Randomized Study of How Physicians Interpret Research Funding Disclosures.  It is disturbing reading for all of us in the industry, including MA.

In the study, researchers presented 503 board-certified internists with three random studies with a high, medium and low level of methodological rigor.  And then randomly assigned each study one of three funding sources: NIH, Biopharma Industry, Not Disclosed.

The good news is that respondents generally assigned stronger credibility to studies with stronger methodologies.

The difficult news is that the internists believed the results of industry-sponsored were less credible than those that were NIH funded and with no funding disclosed.  And that results remained the same whether the study was of high rigor or low rigor.  Since the funding source was randomly assigned its clear that simply associating industry funding reduced credibility.

And the kicker – over 75% of the respondents accept support from industry in some manner, so these are not a bunch of ivory tower purists throwing stones.  These are exactly the people that MA needs to educate and these are exactly the kinds of studies that we use for that education.  Clearly we have a problem.

In an editorial that accompanies the study entitled Believe the Data, Dr. Jeffery Drazen suggests that physicians need to focus on the data and the rigor of developing that data.  As an industry, we need to echo that exact point.

We know where this skepticism comes from - too many newspaper stories of incomplete study disclosures, too many studies that seemed to lack rigor, too much willingness to spin results.

We cannot ignore this issue.  We need to hit it head on – discussing this now proven bias and why it should not impact the interpretation of results for a given study due to its rigor, etc.

Something that many of us have suspected for awhile, that industry science was being discounted simply because of funding, is now shown to be true.  We must address it openly because like any bias when it is pointed out to people they are less likely to be prey to it.

What do you think we can do to address anti-industry bias?  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!

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.

Topic10: MA Reporting Relationships in Small Companies

A reader wrote in to discuss a situation at a small pharma company.  This company was just starting up its MA group and it was not sure where the MA group should report.  The reader was well aware of the issues with having MA report to a commercial leader that we discussed in this post.

The challenge in this situation was that senior management consisted currently of just a CEO and a COO.  While the CEO is a scientist who handles their development efforts, the COO handles all other responsibilities, including   Commercial, Finance, Legal and HR.  The CEO would be the natural choice for managing MA, but given workloads it was not practically feasible.  Could the COO handle the job of managing MA even though they also have some commercial responsibilities without putting the company at risk?

This is a very common situation for young organizations.  There is often very little senior leadership to go around.  Yet, as we mentioned in this post, it is critical to start MA up early to support a product launch that may be over two years away.  In situations where it is not feasible for MA to report to someone purely on the science side and they need to report to someone with commercial responsibilities, my rule of thumb is that the role they report to should have substantial responsibilities outside of commercial and should be measured on results that go beyond just commercial measures.

In the case above, the COO has commercial responsibilities but they also have non-commercial responsibilities as well.  Having MA report to the COO should not be a problem, as long as the COO understands the role of a compliant MA organization and follows the general rule about MA interactions with commercial that were outlined here.  In the end, the Agency looks for actions not reporting relationships, but the reporting relationship do send a clear signal about the priorities of the MA organization.

What has been your experience about MA reporting relationships?  Please leave a comment below.  And if you are new to the blog please sign up for email updates by clicking on the link to the right.

Topic9: HEOR Studies – Who Should Take the Lead

I was talking with a longtime friend and client the other day and he was describing a situation in his organization.  A tug-of-war of sorts was going on with HEOR studies.  In his business, the amount of funding going into HEOR studies was going up, and although they had typically be run out of the MA shop, there was increasing pressure to move all HEOR studies over to the Access and Reimbursement group.  We had a good discussion on this which I will try to recap here.

Traditionally all post-marketing research has been driven out of MA.  I use the term driven, because in many organizations the actual studies may be managed by a CRO or a clinical development resource.  But the group responsible for identifying the need for the study, budgeting for it, getting approvals to conduct the study and driving the protocol development was almost always MA.  There is a good reason for this, the Medical Director, who typically owns the scientific lifecycle of the compound is in MA and thus should be driving this process.

Now, post-marketing studies is a very large bucket.  It can include additional safety studies, both mandated and not mandated, reformulation studies, label expansion studies, HEOR studies, just to name a few.  And, given the huge range of post-marketing research, it is fairly standard that the Medical Director and MA in general partners with other parts of the organization that have expertise in these areas.

Fast forward to today’s world.  HEOR studies are increasingly critical to the medical and business case that Access and Reimbursement needs to make to payers in order to achieve a beneficial position in their formularies.  Investment in HEOR studies are growing by 0ver 40% in the past few years, as discussed here.  Given their knowledge of the audience, the data that they need and the competitive data that they are likely to have available, no one is in a better position to define the requirements for an HEOR study than the Access and Reimbursement team.

But, does that mean that Access and Reimbursement should be driving the HEOR studies themselves.  My answer remains been no.  Access and Reimbursement should be a defining voice in the development of the protocol, but once that protocol concept has been finalized it becomes an issue of study execution.  This is frankly how it works with most post-marketing studies.  While I can grant that an HEOR study has unique issues, so do many of the targeted post-marketing studies.

Having said all of this, it is also true that I, myself, have set up just such a function for an Access and Reimbursement client.  They had circumstances that made it clear that the MA function was not valuing the need for HEOR research and thus it was not getting done on a timely basis.  This was essentially a political issue but the only way to resolve it in the short-term was the create an dedicated function within Access and Reimbursement.

I am curious to know your experiences in terms of HEOR studies.  Leave me a comment below.  And if you have any question that you would like me to address, please click on the email link to the right.

Topic8: Sunshine Act – Preparing KOLs for 2013

We are little over a year (Sept. 30, 2013) away from the date when Department of Health and Human Services (HHS) has committed to having the first round of Sunshine Act data made available to the public via the web.  Allow me to stipulate that we may have more time since the HHS has managed to miss every other deadline they have had with regards to the Sunshine Act.  And, allow me to stipulate that a fully Republican controlled government may actually repeal Obamacare and the Sunshine Act with it.

But, as we head into the 2013 planning season, I think it would be wise to assume this is actually going to happen and thus budget and plan accordingly.

Up to this point, we have discussed the Sunshine Act purely from an administrative point of view – how to collect this data and meet the immediate 2012 requirements.  But, in 2013 this information is going to be made public and we run the risk of losing the trust and support of the very KOLs that we have all invested so much time in developing.

It is critical that your company take a proactive stance on this situation:

• Reaching out to the KOLs for whom you will be reporting payments


• Educating them on the law and its reporting requirements


• Providing them with the same information provided to HHS and an explanation of that information


• Providing them with some context for this information and how to explain it to others


• Answering any questions they may have

I will discuss some approaches to this in hopes that it aids in your budget and planning efforts.

The first challenge to overcome in addressing this issue is intra-function coordination.  The data provided HHS includes payments from all company elements, including research, development, medical affairs and commercial.  Therefore, in addressing this to KOLs, a single cross-functional approach needs to be created.

I would suggest a meeting with the other relevant functions to address the corporate approach and name members to a task force.  MA is the logical leader for this given its role as straddling the worlds of products in and out of development.

Once this Task Force is formed, I would suggest the following approach:

1. Gather a list of those KOLs impacted by the reporting and prioritize if necessary based on KOLs with the biggest numbers


2. Work with each function reporting to develop standard explanations for the payments made


3. Develop general metrics such as average payments, ranges of payments, number of KOLs in each range, etc.


4. Develop individual KOL reports that contain the same information shared with HHS


5. Develop internal training with information about the Sunshine Act, the general metrics and how the company will explain it to others


6. Develop materials for KOLs that explain the Sunshine Act, the obligation to report, the expected approach by HHS to share the information, an explanation of the company’s payment types, some bullet points on how the information can be conveyed by the KOLs to others, and the general metrics and a FAQ


7. Assign KOLs impacted to specific MSLs with targets for discussions before September 2013


8. Train MSLs


9. Track the results

This should be a straight forward communication project, but it will be easy to put off as more urgent issues begin to crowd it out in 2013 so it will take consistent leadership to get it done.

What are your plans for supporting the rollout of HHS reporting of the Sunshine Act?  Leave your comments or questions (below) or email me directly (link on the right).

Topic7: Coordinating MA and Commercial

A reader asks:  “Given the importance of consistent communication to the healthcare community, my company is seeking to better coordinate commercial and MA messaging.  What is the best approach for doing this?”

Thanks for the question.   The answer is: Very Carefully!  My sense is that your commercial function is driving this requirement.  I infer this from your question because you use the term “messaging” which is generally a marketing term.  Let’s remember that the purpose of marketing is promotional – promoting the sale and safe use of our products.  Since it is promotional, their communications are limited to on-label information.  If their communications go beyond the label, they are promoting off-label.  We all know this is against the law.

MA is allowed to discuss off label topics only under very specific circumstances – when they receive an unsolicited request.  MA is allowed to have some proactive discussions which are educational and non-promotional about related non-label topics depending on the rules of each organization.  See a detailed discussion of this here.

So, marketing is promotional and MA is non-promotional.  What “messaging” can a promotional and non-promotional functions share?  Conservative organizations would argue that any messaging topics that support the promotional needs of commercial is, by definition, not an acceptable topic for non-promotional MA.  But, many organizations would agree that promotional topics can focus on the product and its competitive positioning; while there can be related non-promotional topics such as the underlying disease state.

Most organizations that allow some coordination between promotional and non-promotional topics understand that this is a risk.  To avoid the risk of MA appearing as a promotional entity, most companies expect the coordination will go one way only:  from MA to commercial.  The theory is that MA is going to be educating the market regardless and the commercial function is just becoming aware of what MA is doing.

Going the other way, from commercial to MA, runs the risk of appearing as though MA is part of the promotional machinery.



So, reader, be careful.  Processes and systems must be put in place to ensure that the coordination is going the right way only.  Otherwise, you run the risk of a future whistleblower pulling out a document showing that MA has become a promotional resource.

For example, there need to be clear firewalls between the way MA is measured and the way commercial is measured on the effectiveness of their communication efforts.  We have discussed MA measurements here.  Commercial measures of effectiveness should be much more related to sales and penetration.

Thanks for the question!

If you have a question, please email me or leave it in the comments!

Topic 6: Measuring the Value of Medical Affairs

Introduction

A reader requested a discussion of different approaches for measuring the value of medical affairs.  This is a critical question and one that I touched on briefly when I discussed strategic planning in MA as it relates to launch.  But it is equally important overall for MA.

Like any function in pharma, MA must be able to communicate its value.  Value can be a tricky concept, however, for a non-commercial function like MA.  Value is ultimately a company-specific question.  It stems from the company achieving its strategic goals, which is why defining goals is so important.  Having said this, there are some general categories of value measures that we can discuss as well as some best practices around measuring value.

Value measures in MA typically fall into two types:

1. Objective measures


2. Subjective measures

Objective Measures

In MA, objective measures tend to focus around activity-based measurements.  Since MA cannot be seen as promotional, the other available objective measures like prescriptions written, sales numbers, profitability, etc. are not relevant.

Activity-based measures have both strengths and weaknesses.  On the strength side activity based measures are:

• Easy and cost efficient to gather


• Easy to explain to non-MA colleagues


• Non-controversial

Unfortunately, activity based measures also are:

• Not outcomes focused


• Not usually tied to the direct concerns of the organization


• Potentially misleading

While it may be interesting to know that the MSL group conducted 150 meetings with KOLs in the last quarter, it tends to beg the question – So What?  Activity-based measures tend to focus on the tactics (e.g. reach out to KOLs) rather than the goals (e.g. ensure broad awareness of the latest disease state information).

Activity-based measurement is very appropriate for certain MA functions.  For example, on CME funding, which by definition must be a hands off process, the only important measure is activity-based: Did the organization fund the number of CME programs it had intended to fund?

Or, in the Medical Information function, the key measures relate to answering inquiries and responding.  Activity-based measures (e.g. total number of inquiries managed, average turn-around on inquiries, number of inquiries requiring a second contact) are very appropriate for this type of service.

Finally, activities with multi-year goals like post-approval clinical trials, use activity-based measures to ensure that the overall program is on track.  So activity-based measures like patient recruitment and data collection provides valuable insight.

Activity-based measures are a necessary for MA’s ability to track progress against its goals, but they not sufficient to account for all of MA’s goals.

Subjective Measures

Most MA organizations have goals that require a more subjective type of measure.  Some of these goals relate to the degree of awareness or understanding in the healthcare community.  Measuring understanding or awareness is not as simple as measuring the number of discussions about a certain topic.  Instead, to measure progress on these types of goals, MA needs to gather more subjective data.  Simply put – it needs to ask.

For goals related to subjective measures, the only practical way to measure success is through research.  Unless a company is very lucky and finds that one of its objectives just happens to align with a topic that is already the subject of someone else’s research, this almost always means conduct primary research.

Research-based measures have their own strengths and weaknesses.  The strength of research-based measures include:

• Direct connection to goals related to healthcare community awareness and understanding


• Insight into the knowledge and beliefs of the healthcare community


• May provide insight into other, unmet needs

Research-based measures have some significant drawbacks, including:

• Expensive to conduct, leading to limited number of data points


• Subject to research bias


• May be taxing to the community that the organization is trying to serve

For research-based measures to be understandable, they usually need to be measured against a baseline.  For example, the measure of awareness of new disease-state information in the healthcare community after the efforts of the MA organization is only relevant if the measure of awareness before the efforts were known.  This requires the development of a baseline which both adds to the cost and requires good up-front planning.

But by far the biggest challenge of research-based metrics is the lack of experience and budget to conduct such research.  Many MA organizations do not have experience conducting this type of “market research”.  Without such experience, it can be daunting to initiate the research and structure it in the best manner.  Additionally, many MA organizations do not have money in the budget to conduct this research in a high quality manner.  This is both a product of the lack of experience and the view that this type of research is outside of the mission of medical affairs.

Best Practices

Clearly most MA organizations can benefit from a set of mixed objective and subjective measures.  Developing such a set of measures starts analyzing the strategy and goals outlined in the MA strategic plan.   From there a set of potential measures can be defined and prioritized.  Overall, MA should have between 5 and 10 metrics.  Specific functions within MA may have from 3 to 5 additional detailed metrics.  Once these metrics are defined, the approach for gathering each metric can be identified.  The activity-based metrics are typically gathered from existing tracking systems while the research-based metrics require more active management.

Once the research-based metrics are defined, a draft of a research outline can be developed, specifying the key questions, the research targets, the number of responses expected and the number of research samples to be taken.  This outline can be used as the basis for developing a request for proposal from a research company.

One caution – many organizations are tempted to combine this research with research already being conducted by the commercial market research function.  This may be a problem if the marketing questions are, in themselves, seen as promotional.  Most of my MA clients have been unwilling to risk this crossing of the line but some organizations do follow this practice.  Please work with your compliance function to discuss this approach.  Many organizations are not even comfortable with using research companies that are primarily commercially oriented but, frankly, there is little reason to avoid these companies.

After the approach to both activity- and research-based metrics is in place the next step is to determine how the results will be communicated and to whom.  This should become an ongoing process so it should be automated and standardized as much as possible.

Closing Thoughts

Explaining the value of MA remains one of the primary responsibilities of MA management.  For MA to be perceived as valuable to the organization, its progress against its strategies and goals has to be proven.

What has your experience been with value and measures in MA?  Leave your comments below.

Click on the email link to the right to suggest a topic for future posts.

Topic5: Relationship between MA and Managed Markets

Introduction

I received a question about what an optimal relationship should be between MA and Managed Markets in the US.  Managed Markets (MM) is the function in pharma that is primarily responsible for negotiating the relationship between the company and the major payers.  In some organization this group is known as Reimbursement, Access, Market Access, Payer Relationship, or Pricing.  The primary challenge is ensuring that the company’s drugs are listed as advantageously as possible on the formulary of the payer.  In the US, the MM function has had to deal with a range of both government and private payers, each with their own formularies.

The MM function in the US has grown in importance as the payers have worked to limit their exposure to potentially expensive treatments through formulary placements that drive limitations 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 MM are forcing changes in the way they work with payers, those same pressures are changing the relationship between MM and MA.  In the past, MA had a limited role to play in MM.  For example, MM might occasionally ask an MA resource, typically an MSL, to provide some scientific support for a formulary presentation.  But, in general, these situations were ad hoc and limited.

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

For a formulary committee to control costs, they must be able to differentiate between more and less effective treatments, including the total cost of treatment.  This drives two major 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, 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 MM.

More Robust Scientific Understanding

MA’s role in terms of providing scientific support for formulary 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.

As the importance of the scientific presentations to formularies grows, the developer of those presentations and the presenters need to have a much more robust understanding of their audiences and how to effectively meet their needs.  This is leading to two trends in MA:

• Much greater degree of training for MSLs on the role of MM and formularies  

OR

• The identification and hiring of full time MSL-type roles specifically targeted at supporting MM                                                                 

Given the importance of MM, 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 the field force of MSLs is prepared to adequately support this need.

More Specialized Data

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

• Data Generation Plans, which should be developed by MA to help drive the post-approval data 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 MM 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 MM that they have shifted the leadership of this research to the MM function itself.  Whether the HEOR function reports to MM or is developed within MA, the need to ensure that the needs of MM 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 MM as it works to ensure patient access to the company’s drugs.

In your experience what has been the key to effective MA / MM 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.

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. 

Topic 4: Key Opinion Leaders – Identifying the Right KOLs

The importance of KOLs in achieving medical affair’s goals was discussed in the Introduction.  Left open was the question of how are these KOLs identified.  There are a number of different approaches to identifying KOLs and in this post I will review those approaches and discuss their strengths and weaknesses.  I will also look into the vendors that can support KOL identification.Per

PERSONAL NETWORK

In the past, the standard approach for KOL identification was to hire good Medical Science Liaisons (MSLs) from various regions and rely on their Personal Networks to identify the right KOLs in their region.

This Personal Network approach has some strengths:

• It is very fast, since the MSLs typically already know the KOLs in their personal networks


• Good chance for strong access, since the MSLs typically target KOLs they have a existing relationship, they can often rapidly gain access to those KOLs for educational discussions


• It is inexpensive, since there are no additional costs from outside vendors

The Personal Network has some significant weaknesses:

• MSLs don’t know who they don’t know, some important KOLs may simply not show up on their radar because their personal networks do not cross


• MSLs are biased toward KOLs they have strong relationships who may or may not be the KOLs that are the most effective “hubs” of their formal and informal networks


• MSLs may specifically avoid “difficult” KOLs simply because they do not want to interact with them

The Personal Network approach is most effective in a very small, highly technical specialty medical community setting.  In these types of communities, since there are so few people involved, everyone knows everyone in the community and the risks of the Personal Network approach are mitigated.

SECONDARY RESEARCH

The next most common approach is the use of Secondary Research networks.  Secondary Research networks are developed by gathering information that is publically available about potential KOLs for secondary sources.  Information that is publically available may include:

• Name


• Degrees and institutions


• Specialties


• Institutional affiliation


• Authorship


• Conference presentations


• Principle investigator


• Committee involvement


• Board membership

The list can go on.  This information is collected; each piece is given a weight based on the what is perceived to be likely to contribute to their being a KOL.  The weighting produces a combined value which is then used to identify an individual as a KOL.

The Secondary Research approach has strengths:

• Fact based, eliminating personal bias found in the Personal Network approach


• Broad view, looking at everyone in the therapeutic area, not limited to individuals in a specific institution or with a specific background


• Less expensive than primary research, since the information in question is available in public databases

The Secondary Research approach has some weaknesses:

• Backward looking, since it relies on a preponderance of publically available information, it tends to favor those people who have contributed for the longest period of time


• Academic oriented, since it relies on public databases of information it tends to value those who publish and speak the most and those people tend to be academics


• Subject to weighting bias, if the weighting of the information does not correspond to what is truly makes someone a KOL, the exercise can produce seemingly valid data that misses actual KOLs

The Secondary Research approach works best in therapeutic areas that are fairly static and dominated by academicians.  In these types of environments, there is a strong correlation between age and importance and between academia and practice.

PRIMARY RESEARCH

The third approach to KOL identification is Primary Research.  The Primary Research approach identifies who is a KOL by polling the physicians treating a disease state and directly asking them who influences them.  These responses are then tabulated and the names of those individuals cited the most are given the most weight and are thus considered KOLs.

The Primary Research approach as its strengths:

• Accuracy, this is the only approach that actually asks physicians who influences them and thus is free of any bias or miscalculation


• Broad view, this approach does not limit itself to only KOLs already known by the organization


• Additional insight, at the same time that physicians are polled about influence, there is an opportunity to gain additional insight into their educational needs

The Primary Research approach also has weaknesses:

• Expensive, all direct research is expensive requiring a direct interaction with many physicians and potentially the cost for honoraria


• Sample bias, the sample of physicians polled may be biased, especially if the sample size is kept down by budgetary concerns


• Time consuming, it can take a number of weeks to conduct this type of research

The Primary Research approach is the best approach for less established disease states, less academically driven disease states and for any groups looking for less well established KOLs.

REAL LIFE EXAMPLES

Any of these three approaches may work, and they are often used in combination.

For example, I had a client who was entering a new disease state and thus needed to establish their MSL group from ground up.  During the initial six months, as the MSLs were coming on board and being trained, the company allowed each MSL to use their Personal Network.  Once the group was fully formed, they worked with a vendor to conduct a Secondary Research analysis of the community and create the initial list of KOLs to be targeted.  After the MSLs had been in the field for six more months, they identified a related set of potential KOLs that the Secondary Research had not targeted, and they commissioned a targeted Primary Research effort to identify all the KOLs in this new group.

I have had other clients that used the Primary Research approach to develop their initial list of KOLs then used the Secondary Research approach to continue to track those KOLs and ensure that their staff was fully up to speed on their activities.

VENDORS

Some vendors that support these types of research include:

Secondary Research: Heartbeat Experts, SteepRock, OpenQ, ThoughtLeader Select

Primary Research: AlphaDetail, Encuity Research (full disclosure - I used to be a part of Campbell Alliance, the parent company to Encuity)

In my next post, I will discuss how these KOL interactions should be managed.

As always, I am curious to know your experience with KOL identification.  Please leave comments below.