Medical Affairs Focus

Thoughts on Global Medical Affairs

Monthly Archives: March 2013

Welcome to MA Focus Blog

Welcome!   I have been getting some new readers and I wanted to welcome you to the MA Focus blog.  My goal with the blog is to discuss issues that are relevant to MA leaders.  I encourage you to add your email to the distribution list (use the “Follow this blog”  link on the right) so you will be notified when there is a new post.  Promise, no spam!

Please take the time to look over some of our archives.  We have discussed a range of topics including MSL proactivityKOL identification, MedComm/SciComm groupsMA at Product LaunchGlobal MA and MA’s Relationship with Commercial, just to name a few.

Finally, I really enjoy feedback so please feel free to leave comments or email directly with questions (link on right).

Thanks for your interest.

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.

Caronia Legal Discussion

For those of you who can’t get enough discussion about the Caronia case and its impact on off label promotion, Law Journal TV has done a panel discussion about it.  Worth a watch but mostly confirms what we have been discussing here.

Off to DIA MSC in AZ

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

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