Thoughts on Global Medical Affairs
A couple of years ago I wrote a post (check it out here) on the emergence of big data for Medical Affairs. Given the rapid evolution of big data, two years is a long time ago so it’s worth revisiting this topic.
Let’s recap what we mean by “big data.” It is a broad concept, but for our discussion today we will be using big data to refer to the new capability to pull together huge quantities of data that were not directly generated for the purpose they are now being applied. Biopharma has excelled at generating proprietary data sets for a specific purpose, but big data take advantage of non-proprietary data that was generated for a different purpose by applying it in a new way.
These external data sources range in structure, format and value. The real trick to big data is pulling the data from disparate sources, efficiently cleaning it and standardizing it to allow it to be cross-referenced, then finding novel ways to use it.
Example of Big Data in MA
In the last couple of years we have seen examples of companies set up to provide big data services to MA. I will single out one here as an example, but this is not intended as an endorsement. I have no relationship with this company or practical experience with their products.
The company, Med’meme, is a case study of big data in MA. Based on their website, Med’meme takes large, public data sets – in this case lists of scientific presentations from medical meetings and peer-reviewed journals and clinical trial information at least – and in their backroom they apparently standardize it to make all those data cross referenceable. How well they do this, how complete and how accurate the data is, I can’t say. But, when you think about that data source as an MA professional I am sure you are jumping to a bunch of potential uses – like the ability to rank KOLs, to identify new KOLs, to track TA trends in publishing, to identify potential investigators, to be alerted to new publication identification, etc.
And that is the beauty of big data – there does not appear to be anything in their data set that has not been available (with some costs) to biopharma for years. Their service is finding a way to scrape it all together, standardize it and allow it to be searched effectively.
Buy v Build in Big Data
When I first published the article about big data I had a number of “buy vs. build” questions. The reality of big data in its current form is about re-using publically available data in novel ways, so building it internally is unlikely to produce proprietary value. However, combining these data sets with proprietary data, or asking interesting and unique questions of the data is something that can remain proprietary – so some hybrid solutions may be valuable.
If big data is not a part of the MA information technology planning it should be. This capability represents an opportunity for strategic advantage in the short-term until it is widely adopted.
Big data is a new reality. A huge new data set, the Sunshine Act database, has just come on-line, and other data sources are increasingly making their data available for these types of analysis. Expect to see major development in this area in the coming couple of years.
What has been your experience with big data in MA? Leave a comment.
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!
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.
– Tax Deductibility for Marketing and Sales expenses in Biopharma
– Sunshine Act
– Caronia Ruling (you knew I would have to get something in here about this)
– History of MSL Role
– MSL Facts of Interest
– Value of MSLs by Physicians
– Diagnostic MSLs
– CIA Driven Changes
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.
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:
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:
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:
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:
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.
I will analyze what this means for MA leaders and their team in a subsequent post. Please leave your comments below.
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.
End of Part 1 – Only 177 Pages to Go!