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Topic 45: Medical Affairs Insights – A Key Value Proposition

Overview

On this blog we have discussed the challenges of communicating medical affairs value a number of different times. Specifically, we have addressed the topic here (Topic 6), we have discussed MA value at launch here (Topic 3), and addressed the use of NPS measures in communicating value here (Topic 43).

On subject that we have not addressed is the importance of MA Insights in communicating value to internal stakeholders.

MA has always shared its insights with its internal stakeholders, but in the past the process has been fairly unstructured in the form of MA team members who are working with other functions on specific projects sharing their knowledge. For example, when MA field teams are responsible for helping clinical development identify and initiate sites, they may bring back to the clinical team leadership feedback about the protocol that they learned during their discussions with PIs. Or MA members of cross-functional launch teams may share insights that they gathered doing disease state education that may help commercial colleagues better understand and craft commercial scientific messages.

In the last year or so I have worked with a number of clients that are looking to take these “insight value moments” and make them more frequent by structuring the process for gathering and sharing insights.

Before I share my thoughts on how to best leverage MA insights to drive organizational value, some standard caveats:

  • MA is not a market research organization and must never imply that the insights gathered are anything more than valuable but anecdotal information (the plural of anecdote is not data)
  • MA is not in the business of “taking orders” from other areas for specific insights, but should at least understand what those areas are interested in (see more on this below)
  • MA’s gathering of insights should organically grow from its peer-to-peer scientific interactions, communications and education activities only

Three Elements of Successful Insight Capture and Communication

With that said, I want to share some of the keys to gathering and communicating valuable insights from MA to internal stakeholders.  Three elements are required to successfully provide value through insights:

  1. Awareness of Current Environment and Important Topics
  2. Method for Capturing Insights
  3. Approach for Communicating Valuable Insights

I will review each element in more detail below.

Awareness of Current Environment and Important Topics

MA personnel that interact with HCPs and others in the field are constantly learning new information. However, everything that they learn is not worth their time to document nor the time of internal stakeholders to review. As the saying  goes, if you do not know what you are looking for, you will never find it.

So how do we make MA personnel that interact with others in the field aware of what are potentially valuable insights for their internal stakeholders? We need to educate them on the internal stakeholders’ situation.

Primary internal stakeholders for MA insights are:

  • Clinical Development
  • Commercial
  • Managed Markets

Each internal stakeholder group has different areas of interest. In order to identify that MA has learned something useful to these groups we need to understand their context – we need to know what is important to them.

Clinical Development

Many MA staff already have a good understanding of the priorities and activities of the clinical development function because they have to discuss the organization’s pipeline and development efforts with HCPs.

Types of Insights Sought by Clinical Development:

  • Competing studies in the TA where CD has existing or upcoming studies
  • Current off-label use of existing marketed products
  • Areas of interest about new indications for existing or planned products
  • Feedback and challenges with existing studies or protocols
  • Enthusiasm for future participation in clinical trials

In order to provide this type of insights, the MA staff needs to understand the context of the current clinical development environment. They need to understand the following:

Elements of Clinical Development Context:

  • Detailed pipeline and development strategy for existing products
  • Protocols of ongoing and recruiting studies in their TA
  • Current status of ongoing trials, including challenges being based

Commercial

MA organizations have a firewall with commercial for a reason. MA is non-promotional and therefore cannot be seen taking orders from or executing work on behalf of the commercial organization. However, non-promotional does not have to mean commercially uniformed. As long as the communication is one-way, MA sharing insights it learns to commercial, than MA can provide value to commercial without becoming a promotional organization.

Types of Insights Sought by Commercial:

  • Feedback on commercial launch activities from HCPs
  • New studies from competitors in the organization’s TAs of interest
  • Changes in a competitors approach to communicating with the HCPs
  • New information about competitor’s pipeline
  • Feedback about the scientific messaging in commercial communications

In order to provide this type of insights, the MA staff needs to understand the context of the current commercial environment. They need to understand the following:

Elements of Commercial Context:

  • Product positioning in the TA
  • Product differentiation in the TA
  • Commercial messaging
  • Competitive landscape

Managed Markets

MA organizations have different relationships with managed market organizations based on the company. Some MA groups are tightly integrated with managed markets, with MA staff specialized to support management markets. Other organizations have limited contacts. Regardless of the structure, MA can provide valuable insights to managed markets.

Types of Insights Sought by Managed Markets:

  • Reimbursement concerns expressed by HCPs
  • Changes / surprises encountered by HCPs in reimbursement for company’s products
  • Communications received by HCPs from payers concerning the company’s products or competitor’s products
  • Competitive product reimbursement changes

In order to provide this type of insights, the MA staff needs to understand the context of the current managed market environment. They need to understand the following:

Elements of Managed Market Context:

  • Overall payer environment
  • Payer relationships within the region
  • IDN relationships within the region

Summary of Awareness

With an understanding of the clinical development, commercial and managed markets context, MA personnel can be aware of any insights they may encounter during their dealings with HCPs and be able to highlight those that have the greatest potential for impact on the organization.

As one of my clients put it, we need to shift MA personnel from Medical People to Medical Business People, adding to their knowledge base an awareness of the entire organization’s business.

Method for Capturing Insights

MA insights do not come on a schedule. They can occur whenever MA interacts with an HCP. For that reason, there needs to be an easy, efficient method for capturing insights as they occur. Many organizations leverage their customer relationship management (CRM) systems. Systems like Veeva can be tailored to capture the insights and, with simple drop down lists, at the time of entry they can be coded for internal stakeholder group or groups that may be most interested in the insight.

Leveraging the CRM system has another advantage – visibility. While insights do not come on a set schedule, MA leadership needs to encourage everyone with HCPs interactions to capture insights. The CRM can be used to track who has entered insights in the last period. While I strongly discourage any type of “minimum number of insights” metric, managers should still track who is entering insights and work with any MA team member that interacts with HCPs and fails to capture insights over a significant period of time.

Approach for Communicating Valuable Insights

If MA wants to maximize the impact of its insights, it must communicate them to the internal stakeholders in such a manner that the insights are actionable. Simply providing internal stakeholders with a laundry list of a hundred bullet points of insights, mixing different topics and hoping that they can sort it out to find the needle in the haystack.

Unfortunately this requires the application of judgment, which takes time and attention. However, in return for this effort the MA organization can produce a consistently useful and effective report of competitive intelligence on an ongoing basis. This approach requires the following steps:

  1. All insights are entered into the system (see previous element above) and coded for internal stakeholder group
  2. A single reviewer is selected for each stakeholder group reviews all the insights for that group for a given period and:
    • Identifies key trends
    • Highlights the insights that are potentially most impactful
    • Identifies miscoded insights or insights that may impact more than one stakeholder group
  3. The single reviewer summarizes the results of the for the stakeholder group

Once a summary of the key trends and highlighted insights are developed, the MA reviewer can meet on a periodic basis with a representative of the stakeholder to review the insights and provide context. These insight review sessions can be a very powerful example of how MA drives value into the entire organization.

 

Conclusion

MA is a significant organization investment. Any opportunity for MA to share its value with its key stakeholders helps it to solidify the important role that MA plays in organization success. Providing actionable insights to the organization is a key way that MA can share its value.

 

What is your experience with Insight identification, capture and communication? Leave a comment.

 

 

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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 3rd 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.