Thoughts on Global Medical Affairs
Data has always been the backbone of medical affairs. Understanding the data that underlies the company’s products and the products of the competition and understanding the prevalence and treatment data available about the disease state has always been a requirement. And, being able to summarize and explain the meaning of the data is one of the greatest values that MA brings to the organization.
But as a generator of data analysis and manager of data, most MA organizations have been passengers not drivers. Most data sets are being generated by clinical development and analyzed by statistical staff within the clinical function. Even after the product is on the market and the data generation turns from a clinical responsibility to a medical responsibility, most MA organizations still rely on these resources or the resources of outsourcers to define, manage and analyze their data.
However, as MA groups grow more sophisticated in their use of data, and as real world data sets available for analysis continue to increase in size and importance, it may become in the best interest of MA to begin developing some data science capability of their own.
Some MA organization already have their own stats staff or stats staff assigned to them but working in clinical, but in my experience this is still the exception not the rule. Instead, most organization rely on stats people internally who are not primarily focused on MA or on outsourced stats resources. There are a number of challenges with this environment. First, for the internally loaned people, most of them are not that familiar with what MA does and they are also usually not familiar with using real world data sets. Leveraging them requires bringing them up the learning curve, sometimes at the expense of time and effectiveness of the analysis.
Relying on to a large degree on outside statistical help is also very problematic. In these outsourcing situations, the cost can be high and the learning curve that you are paying for becomes the property of the outsourcer to resell to your competition. Additionally, when a non-stats person hires and manages a stats outsourcer, it is very difficult for them to understand if they are getting the best thinking out of the outsourcer and suggest other alternate directions if they feel the outsourcer is taking a less than optimal path. It is this very difficulty that led many clinical organizations, even virtual clinical organizations, to realize that they always needed some stats capability in-house, even if it was simply to manage the outsourcers. Finally, working with outsourcers makes it very difficult to answer quick, smaller “what if” questions that always seem to come up after the main analysis is complete.
Given the importance of these analysis for MA and the need to be flexible, I believe that more and more MA organizations will realize that they need their own stats capability on the MA team – focused full time on the data sets and analyses that are most relevant to the post-marketing world.
MA Data Managers
While some MA organizations already have stats, I have yet to see one that has their own data management function. Nevertheless, I am going to suggest that this will be less rare in the future. Data managers are responsible for the “care and feeding” of the databases that the stats team analyzes. A common function on clinical.
As medical affairs becomes more data sophisticated and as cutting edge groups decide to build huge repositories of real world data to perform ongoing analysis, the need for professional MA focused data managers will grow. These data managers will be more focused on the collating and cleaning of external data then their clinical counterparts and that is why I think the need for an MA specialist group will take hold.
What do you think? Does your MA team have its own stats function today? Is data sciences in the plans for the future? If you would like to leave a comment, click here and scroll down.
Have you seen the new FDA guidance about disclosing risk in consumer-directed print advertising that came out in February? (You can see it here) Unless you are a gluten for FDA guidance-reading punishment, my guess is that you skipped this one since it seems to be commercially focused.
BUT, there is actually something that MA should be aware of and perhaps an opportunity to add some value to our commercial brethren. The focus of the guidance is straight forward – under current law print advertising has to also disclose risks, and the safest approach for disclosing that risk is to publish the full package insert (PI) along with the print ad. As we know PIs are a tough read normally, but when shrunk down to fit in a magazine they are almost unreadable and certainly mostly incomprehensible to the very audience they are supposed to be protecting – consumers.
This has not been lost on the FDA and the guidance linked to above was entirely focused on resolving this issue.
In an FDA survey, few respondents reported reading half or more of the brief summary presented in the traditional format. Of those who read at least some of the brief summary, 55 percent described it as hard to read. Over 40 percent of respondents in the survey reported they do not usually read any of the brief summary in direct-to-consumer prescription drug print advertisements.
The FDA realizes that the full PI is aimed at medical professionals and full of details that the vast majority of consumers don’t care about like clinical pharmacology or chemistry. So the FDA is suggesting that manufactures should have the flexibility to replace the PI with something they are now calling “consumer brief summary.”
What is a consumer brief summary? Per the guidance it is an explanation written in consumer-friendly language (ie. drowsiness not somnolence) that includes:
And this is where Medical Affairs comes into play. Now our commercial colleagues and their agencies are going to be needing to develop information that includes medical judgement, like:
These questions are great ones for Medical Affairs to either provide guidance, answer directly or gather information from practitioners during their interactions to answer these questions and others. Given the proper but strong firewalls between MA and commercial, this new guidance provides a value-added opportunity for MA to provide some guidance to commercial.
MA leaders may wish to discuss this topic with their commercial colleagues.
Do you have any thoughts on the new guidance? Leave them in the comments by clicking HERE and scrolling down to the comment box.
As evidence, did you see this article in the NEJM? It’s a research analysis in which they pulled the entire ClinicalTrials.gov database and analyzed it to determine who has been publishing summarized clinical trials results as required by FDAAA from 2007. This analysis was done by cardiologists at Duke, and what got the headlines was that only 38% of completed studies had their data posted as required by the law.
However, dig a little deeper and with more of our focus and you can learn some interesting things about the biopharma industry. Of all the 13,300 (all numbers rough for discussion purposes) completed clinical trials analyzed, 66% were industry sponsored or roughly 8700 trials. Only 5100 of the 13,300 completed clinical trials reported any results, and of 3600 of those 5100 reporting trials, or 71%, were industry trials. So, in a world of terrible compliance, industry was punching above its weight. That still leaves some 5100 industry trials with not results posted despite the law.
BUT, you say, isn’t there some exception for holding back results until after FDA approval/rejection. Yes, a company can file a certificate which allows it to delay posting results in that circumstances. Of the 5100 completed industry trials missing data only 2000 certificates were filed – leaving 3100 or 36% of all industry trials unreported or uncertified per the law.
This is where big data and company reputation risk raises its ugly head. There are big data sources already out there that read all the data from ClinicalTrials.gov. With today’s big data tools it is a straight forward exercise to determine which industry company sponsored which trial and whether it reported/certified per the law. They will also know which products have failed to report/certify if the products are approved. It is not long from now that some reporter will put this together and produce a list of the “best and worst biopharma companies for publishing results” – some uncharitable media outlets (and which ones are charitable to biopharma) may even imply sinister intent at “denying their legal obligation to share this data – what are they hiding.”
Implications for Medical Affairs and Clinical Development
There is a unique opportunity to head this potential distraction off at the pass. We don’t want our MA field team’s spending time justifying why the company is not posting data.
While maintaining ClinicalTrials.gov is generally the responsibility of the CD in most organizations, MA has a strong vested interest to ensuring that the company is bullet proof in this area. MA and CD need to collaborate to make sure that data is posted or the certificates are filed. A process audit to confirm that the processes are in place and are working, as well as verifying that the company does not have any missing posting or filings, is a small bit of work that can save a huge amount of distraction for the entire organization in the future.
What has been your experience in this area? Leave a comment
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.
Note: This is a revised and extended version of a post I first published two years ago. This issue continues to evolve and be an area of focus for many MA Leaders.
I received a question about what an optimal relationship should be between MA and Access & Reimbursement in the US. Access & Reimbursement (AR) is the function in pharma that is primarily responsible for negotiating the relationship between the company and the major payers and/or providers. In some organizations this group is known as Managed Markets, Market Access, Payer Relationship, or Contracting. Their primary goal is ensuring that the company’s drugs are listed as advantageously as possible on the formulary of the payer.
AR has to make the case for reimbursement of their drug to a payer/providers Pharmacy and Technology Committee (P&T Committee) which is the body that ultimately makes the decision for the payer/provider. In the US, these P&T Committees consider the efficacy and safety of the treatment but they also consider the cost effectiveness of the treatment and its impact on total cost of care for a patient when deciding where to place the treatment on their formularies. The AR function has had to deal with a range of both government and private payers/providers, each with their own formularies.
The AR function in the US has grown in importance as the payers/providers have worked to limit their exposure to treatments they viewed as not cost effective through formulary placements that drive limitations like prior authorizations and co-payments for the patients. Even specialty areas like oncology, which used to have very few restrictions, are now seeing greater control exerted by the payers.
Defining a New Relationship
Just as the pressures on AR are forcing changes in the way they work with payers, those same pressures are changing the relationship between MA and AR. In the past, MA had a limited role to play in AR. For example, MA may have had a responsibility to train AR Account Managers on the scientific underpinnings of a new treatment, not dissimilarly to how MA may train sales staff. And AR might have occasionally asked an MA resource, typically Field Medical, to provide some scientific support for a formulary presentation. But, in general, these situations were ad hoc and limited.
However, now that AR’s success more directly drives the success of the pharma company and thus their importance has grown, the relationship between AR and MA is changing.
For a P&T Committee to control costs, they must be able to differentiate between treatments. This drives two major scientific needs:
Both of these ramped up requirements have direct impact on MA’s relationship with AR.
More Robust Scientific Understanding
MA’s role in terms of providing scientific support for P&T Committee presentations is growing from a part of the presentation to the core of the presentation. And with that growth comes the need for greater specialization by the presenters.
MA which develops and delivers the scientific elements of those presentations need to have a much more robust understanding of their P&T Committee audiences and how to effectively meet their scientific needs. This is leading to two trends in MA:
Given the importance of AR, supporting their needs can no longer be seen by MA as a side responsibility. Instead, it needs to be a core responsibility and an investment in training or personnel is needed to ensure that that Field Medical is prepared to adequately support this need. In addition to training, this will require new measures to be put in place to track Field Medical effectiveness, which I will discuss in a future blog post.
More Specialized Data
In many organizations, MA has taken the lead in developing data post-approval. And while HEOR has always been a part of generating that post-approval data, its importance has grown significantly. The increased demand for HEOR data has a number of implications:
In some companies have decided that HEOR is so important to AR that they have shifted the leadership of this research to the AR function itself. Whether the HEOR function reports to AR or is developed within MA, the need to ensure that the changing needs of P&T Committees are addressed has become a major priority for post-approval research.
MA’s role as the owner of scientific education and communication for post-approval drugs is a critical element in today’s formulary-driven environment. MA needs to be an active partner to AR as it works to ensure patient access to the company’s drugs.
In your experience what has been the key to effective MA / AR partnership? Leave your comments below.
If you have a topic you would like me to cover, please email me from the link to the right.
I am sorry that I have been away from this blog for so long. As some of you know, I had a family crisis and I needed to focus all my energies on my family. Thankfully family is now well and thriving and I am starting to come out of my cocoon.
Thanks to all of those who have sent notes asking about my disappearance and offering support.
I plan on adding to the posts on MA Focus, and in the next couple of months moving this blog over to my company’s new website.
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:
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.
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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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!
“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:
This is not your grandfather’s data sets. What are some examples of Big Data as relevant to biopharma and MA:
Contained within these and many Big Data sources are key tools for MA:
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.