Medical Affairs Focus

Thoughts on Global Medical Affairs

Monthly Archives: April 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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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!

Topic 28: Big Data and Medical Affairs

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

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

  • Volume: Hugely increased data volume from the past
  • Variety: Since the data is produced in many different ways, it has many different formats and structures
  • Velocity: Both how fast the data is being produced and how fast it must be processed
  • Variability: Inconsistent data flows, with peaks and valleys
  • Complexity: Driving value out of these data sets is highly complex and difficult

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

  • Electronic Health Records data from a variety of sources
  • Search engine data (see an example of analyzing search data to find safety signals here)
  • Sunshine Act Physician Spend Data (when it becomes available)
  • Social media data
  • Competitors clinical trial data as it is released

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

  • Valuable therapeutic information
  • Unique customer insights
  • KOL identification and information
  • Visibility of competitors drug development and support efforts
  • Important drug safety signals

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

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

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

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

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

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

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

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

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

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

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

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

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

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

  • MSLs already have relationships with many KOLs which serve as PIs and this is an opportunity to strengthen that relationship as well as build new relationships
  • MSLs work for the company and therefore understand the importance of building and maintaining long-term positive relationships with the PIs (as opposed to CRAs which are often outsourced and only focused on a single study)
  • MSLs have superior scientific training than most CRAs and thus can make a stronger case for the scientific importance and structure of the study, which is cited by PIs as one of the key factor’s driving their willingness to engage in the study
  • MSLs can have peer-to-peer discussions with the PIs to ensure that they understand the protocol
  • MSLs often glean key scientific insights from PIs when working with them on studies that can be brought back and shared with the organization’s scientific leadership
  • MSLs can offer their scientific opinion on aspects of the trial that may be limiting recruitment given their in-depth engagement

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

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