Friday, May 3, 2013

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.

Monday, April 29, 2013

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

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

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

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

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

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

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

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

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

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

3.    Determine how much global alignment you want to force

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

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

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

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Thursday, April 25, 2013

QuickNote: Sunshine Act – Are Mechanics Crowding Out Relationship Management?

Readers of this blog know that I have strong opinions about MA’s role in the success of the Sunshine Act in their companies.  MA is responsible for long-term scientific engagement with the company’s top external experts, and these are the very people most likely to be negatively impacted by the Sunshine Act compliance if it is handled wrong.  Clinical is focused on the next study, commercial is focused on the next sale, only MA is focused on the overall relationship.

It is for that reason that I have been increasingly concerned when a number of my friends in the industry have told me how little, if at all, many MA organizations have been engaged in the efforts so far.  To be fair, many organizations are focusing on the mechanics right now – gathering the right data, centralizing data from a range of different sources, coding it in the right way and reporting it effectively – most if which is not the responsibility of MA.  Nevertheless, precious time is being wasted on the relationship side of this effort.

So, this is my call to action.  If by June 1, your organization has not begun an overall communications and relationship management plan spearheaded by MA, you are officially behind the curve.  The data will need to be collected as of August 1, and your MSLs should be explaining the why’s and what’s of this process before that data begins to be collected.  They can’t do that without a thorough communication plan.  And, some KOLs are likely to react in a less than positive way to this development - you need a plan to handle this as well.

The platform is burning – time to push ahead and take the lead in this effort!

Wednesday, April 17, 2013

Topic 28: Big Data and Medical Affairs

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

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

  • Volume: Hugely increased data volume from the past

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

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

  • Variability: Inconsistent data flows, with peaks and valleys

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

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

  • Electronic Health Records data from a variety of sources

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

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

  • Social media data

  • Competitors clinical trial data as it is released

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

  • Valuable therapeutic information

  • Unique customer insights

  • KOL identification and information

  • Visibility of competitors drug development and support efforts

  • Important drug safety signals

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

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

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

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

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

Tuesday, April 9, 2013

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Friday, March 22, 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


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 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.

Wednesday, March 20, 2013

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!

Tuesday, March 19, 2013

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

  • 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.

Monday, March 18, 2013

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.


Friday, March 15, 2013

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.


Friday, February 15, 2013

Topic 23: Key Implications for MA Leaders in the New Sunshine Act Rules

In previous posts this week I have broken down the key provisions of Sunshine Act rules.  Now I want to provide my thoughts on what this means for MA leaders and their teams.

Owning the Correction Process

Everyone who conveys something of value to a physician within biopharma will need to understand these rules and their part of tracking them.  This is a new administrative burden for many parts of biopharma.

BUT, there is one specific work activity that I want to address before I jump into implementation concerns.  When all this data is compiled and sent to CMS, the physicians will have a yearly chance to review it and offer corrections.  These corrections will need to be reviewed and discussed with the company.

So the big operational question is - Who is going to take point on that correction interaction?  Are we going to expect that the physician try to contact different functional areas within the company directly with their questions?  That may not be reasonable since the reported values will not make it clear who is responsible within the biropharma.

I am going to suggest that someone needs to take clear ownership of this responsibility and in the case of KOLs it should be MA.  MA should be responsible for serving as the point of contact for KOLs with these issues and driving the issues to resolution.  Non-KOL physicians should be handled by an administrative group in finance, but KOLs really need to handled carefully if we do not want to damage our relationships.

Overall Sunshine Implementation

To prepare for the Sunshine Act, MA needs to ensure the following:

  1. Internal systems are being built to properly capture this information

  2. MA personnel and specifically MSLs are receiving proper training to understand how and when to report this information

  3. A physician education program is developed and MA’s role in executing the physician program is clearly defined

I will highlight each of these elements and discuss related key Sunshine Act rules.

1. Internal Systems Developed for Sunshine Reporting

This is one area that MA probably has the least control.  These should already be underway and hopefully MA has already had a fair amount of say.  If MA is part of the stakeholder group that is reviewing these systems, I would ask the following questions based on my reading of the Sunshine Act rules:

  • Will the system cover all payments, even those related to OTC or other non-pharma products?

  • Is the company going to report in a consolidated fashion or separately by subsidiary/JV?

  • Is the organization going to add context statements to payments?  If so, which ones and when?

  • How many products will be associated with each payment?  Rules allow up to 5

  • Are we prepared to track corrections and resubmit within the 15 day window after corrections are due?

2. MA Personnel Training on Sunshine Reporting

There is a fair amount of nuance in the Sunshine Act reporting rules.  It is critical that training is developed that make the following clear to MA staff:

  1. Overall Payments

    • If value is provided to a physician but not at the request of the physician, it still needs to be reported.

    • Waived fees – of a physician suggests it is donated to a charity on their behalf it will still be tracked, unless they truly waive their fee without obligation to the company

    • All payments need to be coded by category – training is needed on the definition and difference (eg. travel vs. meals)

  2. Food

    • If a group meal is provided where the value is greater than $10 per person, each physician that actually partakes of the meal must be tracked

    • Unless the food provided at a large event, in which case it does not have to tracked

  3. Indirect Payments

    • Value provided to a third party but expected to be delivered to a physician must be tracked under the physician’s name

    • Value provided to an institution with the intention that it will go to a physician even if that physician is unnamed must be tracked (eg. providing funding to a teaching hospital for research grants will have to be tracked to the recipient physician)

    • Blinded payments to physicians for market research do not need to be tracked

  4. CME Programs

    • Accredited programs are exempt from reporting only if no names of speakers or even specific criteria for speaker selection is provided and the manufacturer does not pay the speakers directly

    • General subsidies for CME tuition does not have to be tracked

  5. Patient Education

    • Patient education materials and items are excluded from being tracked

3. Educating Physicians and Especially KOLs

It is vital that our KOLs are aware of the rules so that we can avoid confusion and bad feelings.  Some key elements of the rules that I believe every physician/KOL should know:

  1. General Rules of the Road

    • All value provided greater than $10 must now be reported, or multiple smaller transactions that add up to $100 in one year

    • All data is tracked and submitted yearly

    • Physician must register with CMS website to gain access to the data in their name

    • After registration, physician will receive notification when data is posted yearly about them

    • Physician will have 45 days after notifications to review data

    • Physician will go onto CMS website and enter any corrections they think are necessary

    • Manufacturer has 15 days to review the corrections submitted and accept or reject

    • If the manufacturer rejects the correction, the manufacturer and the physician are expected to negotiate and reach consensus

    • If consensus is not reached, the manufacturer value number is used but it is marked as “in dispute”

  2. Nuance of Value Tracking

    • Value tracked will include OTC and other non-pharma products from the company

    • If value is provided to a physician but not at the request of the physician, it still needs to be reported.

    • Value contributed to charity in their name will still be reported – eg. primary research honoraria donated to a cause is still considered value provided and will not be coded as charity contribution but as primary research honoraria

    • Tracking pierces the outsourcing veil – if a manufacturer pays a CRO and the CRO pays the physician, it tracks as the manufacturer paying the physicians

    • Reporting on research payments and value may be delayed for up to 4 years or until FDA approval, so do not be surprised if some clinical trial payments do not show up on the yearly total.  Similarly don’t be surprised to see multiple year’s worth of payments show up in one year after FDA approval, but they will be labeled with the year actually worked.

Wednesday, February 13, 2013

Topic 22: We Read the Sunshine Act Rules So You Don’t Have To - Part 2

This is the second part of my review of the Sunshine Act rules.  You can read all of the exciting  282 pages  here.  The first part of this analysis is here.

There are a lot of these so I will break this into a couple of posts and conclude by highlighting the ones I think are the most challenging to address.

  • Exclusions for Existing Personal Relationships (eg. husband [Pharma employee] give wife [physician] a string of pearls) will remain.  Pg. 111

  • Exclusion for transfers of $10 or below assuming that such transfers do not add up to over $100 during the course of the year remains in effect and the $10 amount will not be raised until 2014. Pg. 112

  • Small incidental items under $10 (eg. notepads, magnets) that are provided at large-scale conferences or events are exempt from tracking including for aggregate purposes. Pg. 114

  • Items intended for patient education will be excluded, even when they hold some potential alternative value for the physician (eg. providing a thumb drive containing patient education material). Pg. 116

  • Education materials that are targeted directly at a physician (eg. reference manual, text book) are not included in the patient education exception and thus their value must be tracked and reported. Pg. 117

  • The exclusion for “in-kind” value provided to a physician supporting the physician’s ability to provide “no charge” services to patients who cannot afford them includes patients that cannot afford the co-pay as well as patients simply unable to pay. Pg. 119

  • The exclusion allowing the short-term loan of a device has been clarified to be for only 90 days or less, even if the device is disposable and not used during the 90 days.  Additionally, the short-term loan is for a total of 90 days during a year, not a series of 90 day loans.  Pg. 122

  • Physicians that receive value as subject in a clinical trial do not have to have that value reported since they receive that value in their role as patient not physician.  Pg. 123

  • Indirect transfers of value or payments do not need to be tracked if the manufacturer is not aware of who the third-party they pay is providing value to.  If they are aware who the third party if providing value than they do need to report that value. Pg. 128

  • Indirect payments do have to be tracked if the manufacturer provides it with instructions that would lead it to be given to a covered physician.  For example, if a manufacturer provides a payment to a teaching hospital specifically to provide grants for research, that manufacturer would need to report who received the grants even if they are not involved in deciding who will receive the money.  If they provided the money to the same teaching hospital but put no restrictions on that money and the hospital decided to use some for grants they would not have to report it.  Pg. 131

  • Indirect payments where the manufacturer is not able to be aware of the payment recipient are excluded from reporting.  For example if a manufacturer hires a market research company to provide double-blind market research, they cannot know who received the value and as such they do not need to track the indirect payments. Pg. 134

  • Indirect payments that result in reporting are to be tracked for two quarters beyond the payment year.  For example if a teach hospital is given money for grants in March of 2013, it must track that money through the end of Q2 2014.  Money dispersed after that point does not have to be tracked.  Pg. 136

  • When industry funds CME, the speaker payments do not need to be tracked if the following is true 1) the CME events meets the ACCME, AMA or other major certification requirement, 2) the manufacturer does not provide suggested speaker names or even a list of suggested names/qualifications, 3) the manufacturer does not pay the speaker directly.  Pg. 140

  • When industry pays to subsidize the accredited CME attendees tuition fees it is exempt from reporting. Pg. 140

  • Payments make in connection with prescriber education beyond materials that is required by REMS must be reported like any other educational value provided. However, the value of “Dear Doctor” and other education materials is excluded.  Pg. 141

  • There is quite a bit about the definitions of stock and option ownership and investment interest that I am not covering in detail because I don’t think it relates extensively to MA.

  • While not required, the rules suggest that prior to report submission the individual physicans are provided with a report of what information is going to be sent in the report to provide them with an opportunity to make corrections.  Pg. 156

  • Reports are due by the end of Q1 of the following year. Pg. 157

  • Reports are to be accompanied by attestations of accuracy by the CEO or similar top company officer.  Pg. 164

  • Physicians and teaching hospitals will be notified that a new report is available and open to be reviewed and corrected generally through web postings at CMS, and directly if they register with the CMS ahead of time. Pg. 171

  • Physicians will be given 45 days after notification and before publication to go online and review the data about to be published and submit corrections. Pg. 172

  • Manufacturers only have 15 days after the 45 day review period to correct their data and resubmit to CMS.  Pg. 173

  • To receive the data for review, physicians will need to register and validate their identify. Pg. 174

  • Physicians who dispute the data provided by a manufacturer in their name must resolve the issue directly with the manufacturer.  The physician will be able to enter their suggested correction in the CMS database and CMS will provide the suggested correction to the manufacturer but will not be engaged in issue resolution. Pg. 180

  • If the physician and the manufacturer cannot come to an agreement within the 15 day correction period, the transaction will be marked as disputed but the manufacturer’s original data will be displayed.  Pg. 184

  • The CMS will update the database at least once after the initial publication to reflect corrected data that arrives after the initial correction period. Pg. 185

  • Reporting on payments made to support development of new drugs, devices, biologics or medical supplies can be delayed until FDA approval or 4 calendar years, whichever comes first. Pg. 194

  • The delayed reporting is only applicable for new drugs, any development of new indications on existing approved drugs is not subject to the delay. However, new generics will be considered new drugs for reporting purposes. Pg. 196

  • Reporting is required even for products that fail in development, after the 4 year time period has expired. Pg 198

  • Delaying the report of value provided for new drug development is optional – the manufacturer still has to report the amount of value provided and then may choose to request that the reporting be delayed.  Pg. 199

  • Information will be maintained on the CMS databases for 5 years after publication date. Pg. 206

  • The new Federal rules will pre-empt state reporting rules after the Federal rules go into effect. Pg. 211

  • Rest of report is Federal administrative analysis, not relevant in terms of rule execution.

I will analyze what this means for MA leaders and their team in a subsequent post.  Please leave your comments below.

Monday, February 11, 2013

Topic 22: We Read the Sunshine Act Rules So You Don’t Have To - Part 1

We have been discussing the Sunshine Act here on the MA Focus blog for awhile.  The much delayed rules of have finally been released – all 282 pages!  And, boy, are they exciting reading!

Biopharma is to begin collecting this data on August 1, 2013 with the first set of reports due to CMS on March 31, 2014.  So, to the degree your teams will need to be educated on what to capture and how to report, there is actually very little time to set up the systems you need.

As a result, even if these rules are not exciting reading, they are important.  I have reviewed them and identified some highlights that I think will be important to everyone in MA.  I summarize the highlights below along with page references if you want to read all the riveting detail.  There are a lot of these so I will break this into a couple of posts and conclude by highlighting the ones I think are the most challenging to address.

  • Unrelated Products – the rule makes clear that you must track all payments (direct and indirect) made to a physician even if those payments are related to a product not covered by the act (eg. a product still in development, an OTC product)  pg. 19

  • If a company is bringing its first covered product to market (meaning its first FDA approved drug or device) then after the approval it has 180 days before it is expected to begin reporting.  Pg.21

  • If a company has subsidiaries or JVs as defined in the statute it has the option to provide its reporting either individually or in a consolidated fashion.  Pg. 27

  • Companies do not need to report on non-physician prescribers, like Nurse Practioners, unless those non-physician prescribers pass the payment or value they receive through to a physician.  Pg. 37

  • The “employee exemption” has been clarified to exclude physicians so an organization cannot claim that a physician is an employee and thus not report on that physician.  Pg. 39

  • Payments to non-healthcare departments of universities affiliated with teaching hospitals are excluded from reporting. Pg. 41

  • All physician information must include name (first, last, middle initial), address, specialty and NPI number.  Additionally, you must report state professional license numbers(s) for at least one state. Pg. 44

  • Value provided that is transferred to another entity at the request of or the benefit of the physician must be reported under the physician’s name.  For example, a payment to a group practice at the request of physician is reported under the requesting physician’s name. Pg.51

  • If value is provided to a physician but not at the request of the physician, it still needs to be reported. Pg. 52

  • Value provided directly to a group of physicians (eg. practice) that are not a covered entity (eg. teaching hospital) will need to be divided among all the physicians in the practice or following some “fair” approach determined by the manufacturer.  Pg.  53

  • Value provided to one covered entity (eg. teaching hospital) but directed by the manufacturer to a physician within the hospital are to be reported against the physician, not covered entity. Pg. 54

  • If a physician or covered entity waives their payment, they need to be clear whether they want it sent to a third party (eg. charity) “on their behalf.”  If so, it will be reported as value received by the physician.  If not, even if the manufacturer donates it, it should not be reported. Pg. 59

  • Manufacturers may provide a brief context statement for each payment but it’s optional.  Pg. 66

  • Manufacturers can report up to 5 products related to a payment or transfer of value using NDC numbers when available.  Pg. 70

  • The nature of each payment needs to be coded into pre-set categories (eg. Consulting , honoraria, gift, education, meals, grant, travel) and when a payment crosses the approved categories it is up to the manufacturer to decided which one is most appropriate. However, if the payments for each category is discrete (eg. meal vs. plane ticket) the payments should be reported separately and coded individually. Pg. 75

  • In the case where a physician requests their payment be made to a charity, the nature of the payment category is not “charitable contribution” but it is the category for the actual value provided (eg. consulting fee, grant) Pg. 82

  • For Food/Beverage, if the manufacturer provided food at a group setting other than a conference, the manufacturer has to track the value of the per person cost (total meal cost divided by total number of people partaking) if it exceeds $10 but only for those physicians that partake in the meal (eg. drink the coffee, eat the sand which). Pg. 85

  • Research payments are those associated with a broad definition of research including preclinical, P1-4 and IIS, and applies when there is a contract for research AND/OR a research protocol. Pg. 101

  • The requirements pierce the outsourcing veil – meaning that a payment made by a manufacturer to a CRO, who pays SMO, who pays the physician – would be tracked as a payment by the manufacturer to the physician for the amount the physician receives. Pg. 101

  • Research payments will be tracked by providing the name of the covered entity (eg. hospital) and the name of the principle investigators (PIs) associated with the research. Pg. 105

End of Part 1 - Only 177 Pages to Go!

Friday, February 1, 2013

Update: Caronia and Off Label Promotion - The Beat Goes On

At a recent CBI compliance conference in DC, Tom Abrams, director of the Office of Prescription Drug Promotion (OPDP) in the Center for Drug Evaluation and Research (CDER) basically said that as far as his agency was concerned nothing was going to change in their enforcement of off-label promotion.  His rationale is, in my non-legal opinion, in the vein of "it depends on what the definition of 'is' is".  I think OPDP has chosen to see what they want to see in the ruling, but regardless they are not changing their approach or tactics.

Take a look at his full statement below:

The government has determined not to seek further review of the Second Circuit’s decision in United States v. Caronia, No. 09-5006-cr (2d Cir.).  FDA does not believe that the Caronia decision will significantly affect the agency’s enforcement of the drug misbranding provisions of the Food, Drug, and Cosmetic Act (FD&C Act).

In 2009, Alfred Caronia was convicted of conspiring to distribute a misbranded drug in violation of the FD&C Act.  A divided panel of the Second Circuit held that the jury instructions erroneously permitted, and that the government’s argument encouraged, the jury to treat speech promoting unapproved (off-label) uses of an FDA-approved drug as a criminal offense in and of itself.  The court of appeals did not address the constitutionality of the theory of liability on which the government had defended the conviction:  namely, that the promotion of a drug for an unapproved use may be relied on as evidence that the unapproved use is an intended one, and a drug that lacks adequate directions for its intended uses is misbranded.

Because the court did not address the constitutionality of a prosecution resting on that theory, and because the court also acknowledged that the First Amendment does not preclude an enforcement action based on speech regarding unapproved uses that is false or misleading, the Second Circuit’s decision does not bar the government from continuing to enforce the misbranding provisions of the FD&C Act, including through criminal prosecution where appropriate, in cases involving off-label promotion.  More generally, the decision does not strike down any provision of the FD&C Act or its implementing regulations, nor does it find a conflict between the Act’s misbranding provisions and the First Amendment or call into question the validity of the Act’s drug approval framework.

Bottom line, they are sticking with the belief that while anyone has the "right" to promote off-label, doing so ultimately leads to misbranding which is in violation of the FD&C act.  How you square this with the Second Circuit's ruling that there is protection for promoting off-label as long as the information provided is true will be an argument that will, no doubt, end up back in court.  I'm not a lawyer but I thought my rights trump your laws.

But for now off-label promotion remains open to OPDP enforcement.

What are your thoughts?

h/t PharmaExec Blog

Friday, January 25, 2013

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

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

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

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

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

Thursday, January 24, 2013

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.

Monday, January 7, 2013

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?