Thoughts on Global Medical Affairs
Tag Archives: MSL
November 17, 2016Posted by on
On this blog we have discussed the challenges of communicating medical affairs value a number of different times. Specifically, we have addressed the topic here (Topic 6), we have discussed MA value at launch here (Topic 3), and addressed the use of NPS measures in communicating value here (Topic 43).
On subject that we have not addressed is the importance of MA Insights in communicating value to internal stakeholders.
MA has always shared its insights with its internal stakeholders, but in the past the process has been fairly unstructured in the form of MA team members who are working with other functions on specific projects sharing their knowledge. For example, when MA field teams are responsible for helping clinical development identify and initiate sites, they may bring back to the clinical team leadership feedback about the protocol that they learned during their discussions with PIs. Or MA members of cross-functional launch teams may share insights that they gathered doing disease state education that may help commercial colleagues better understand and craft commercial scientific messages.
In the last year or so I have worked with a number of clients that are looking to take these “insight value moments” and make them more frequent by structuring the process for gathering and sharing insights.
Before I share my thoughts on how to best leverage MA insights to drive organizational value, some standard caveats:
- MA is not a market research organization and must never imply that the insights gathered are anything more than valuable but anecdotal information (the plural of anecdote is not data)
- MA is not in the business of “taking orders” from other areas for specific insights, but should at least understand what those areas are interested in (see more on this below)
- MA’s gathering of insights should organically grow from its peer-to-peer scientific interactions, communications and education activities only
Three Elements of Successful Insight Capture and Communication
With that said, I want to share some of the keys to gathering and communicating valuable insights from MA to internal stakeholders. Three elements are required to successfully provide value through insights:
- Awareness of Current Environment and Important Topics
- Method for Capturing Insights
- Approach for Communicating Valuable Insights
I will review each element in more detail below.
Awareness of Current Environment and Important Topics
MA personnel that interact with HCPs and others in the field are constantly learning new information. However, everything that they learn is not worth their time to document nor the time of internal stakeholders to review. As the saying goes, if you do not know what you are looking for, you will never find it.
So how do we make MA personnel that interact with others in the field aware of what are potentially valuable insights for their internal stakeholders? We need to educate them on the internal stakeholders’ situation.
Primary internal stakeholders for MA insights are:
- Clinical Development
- Managed Markets
Each internal stakeholder group has different areas of interest. In order to identify that MA has learned something useful to these groups we need to understand their context – we need to know what is important to them.
Many MA staff already have a good understanding of the priorities and activities of the clinical development function because they have to discuss the organization’s pipeline and development efforts with HCPs.
Types of Insights Sought by Clinical Development:
- Competing studies in the TA where CD has existing or upcoming studies
- Current off-label use of existing marketed products
- Areas of interest about new indications for existing or planned products
- Feedback and challenges with existing studies or protocols
- Enthusiasm for future participation in clinical trials
In order to provide this type of insights, the MA staff needs to understand the context of the current clinical development environment. They need to understand the following:
Elements of Clinical Development Context:
- Detailed pipeline and development strategy for existing products
- Protocols of ongoing and recruiting studies in their TA
- Current status of ongoing trials, including challenges being based
MA organizations have a firewall with commercial for a reason. MA is non-promotional and therefore cannot be seen taking orders from or executing work on behalf of the commercial organization. However, non-promotional does not have to mean commercially uniformed. As long as the communication is one-way, MA sharing insights it learns to commercial, than MA can provide value to commercial without becoming a promotional organization.
Types of Insights Sought by Commercial:
- Feedback on commercial launch activities from HCPs
- New studies from competitors in the organization’s TAs of interest
- Changes in a competitors approach to communicating with the HCPs
- New information about competitor’s pipeline
- Feedback about the scientific messaging in commercial communications
In order to provide this type of insights, the MA staff needs to understand the context of the current commercial environment. They need to understand the following:
Elements of Commercial Context:
- Product positioning in the TA
- Product differentiation in the TA
- Commercial messaging
- Competitive landscape
MA organizations have different relationships with managed market organizations based on the company. Some MA groups are tightly integrated with managed markets, with MA staff specialized to support management markets. Other organizations have limited contacts. Regardless of the structure, MA can provide valuable insights to managed markets.
Types of Insights Sought by Managed Markets:
- Reimbursement concerns expressed by HCPs
- Changes / surprises encountered by HCPs in reimbursement for company’s products
- Communications received by HCPs from payers concerning the company’s products or competitor’s products
- Competitive product reimbursement changes
In order to provide this type of insights, the MA staff needs to understand the context of the current managed market environment. They need to understand the following:
Elements of Managed Market Context:
- Overall payer environment
- Payer relationships within the region
- IDN relationships within the region
Summary of Awareness
With an understanding of the clinical development, commercial and managed markets context, MA personnel can be aware of any insights they may encounter during their dealings with HCPs and be able to highlight those that have the greatest potential for impact on the organization.
As one of my clients put it, we need to shift MA personnel from Medical People to Medical Business People, adding to their knowledge base an awareness of the entire organization’s business.
Method for Capturing Insights
MA insights do not come on a schedule. They can occur whenever MA interacts with an HCP. For that reason, there needs to be an easy, efficient method for capturing insights as they occur. Many organizations leverage their customer relationship management (CRM) systems. Systems like Veeva can be tailored to capture the insights and, with simple drop down lists, at the time of entry they can be coded for internal stakeholder group or groups that may be most interested in the insight.
Leveraging the CRM system has another advantage – visibility. While insights do not come on a set schedule, MA leadership needs to encourage everyone with HCPs interactions to capture insights. The CRM can be used to track who has entered insights in the last period. While I strongly discourage any type of “minimum number of insights” metric, managers should still track who is entering insights and work with any MA team member that interacts with HCPs and fails to capture insights over a significant period of time.
Approach for Communicating Valuable Insights
If MA wants to maximize the impact of its insights, it must communicate them to the internal stakeholders in such a manner that the insights are actionable. Simply providing internal stakeholders with a laundry list of a hundred bullet points of insights, mixing different topics and hoping that they can sort it out to find the needle in the haystack.
Unfortunately this requires the application of judgment, which takes time and attention. However, in return for this effort the MA organization can produce a consistently useful and effective report of competitive intelligence on an ongoing basis. This approach requires the following steps:
- All insights are entered into the system (see previous element above) and coded for internal stakeholder group
- A single reviewer is selected for each stakeholder group reviews all the insights for that group for a given period and:
- Identifies key trends
- Highlights the insights that are potentially most impactful
- Identifies miscoded insights or insights that may impact more than one stakeholder group
- The single reviewer summarizes the results of the for the stakeholder group
Once a summary of the key trends and highlighted insights are developed, the MA reviewer can meet on a periodic basis with a representative of the stakeholder to review the insights and provide context. These insight review sessions can be a very powerful example of how MA drives value into the entire organization.
MA is a significant organization investment. Any opportunity for MA to share its value with its key stakeholders helps it to solidify the important role that MA plays in organization success. Providing actionable insights to the organization is a key way that MA can share its value.
What is your experience with Insight identification, capture and communication? Leave a comment.
March 11, 2016Posted by on
In brief, Amarin has an FDA-approved indication to market its fish oil supplement as a treatment for very high triglycerides. It conducted a study that showed it lowered the triglycerides in moderately high patients but the FDA declined to approve the label extension because Amarin failed to prove a link to prevention of coronary artery disease. Amarin then informed the FDA that it intended to communicate the triglyceride lowering data to the market and the FDA informed them that it would consider any such communication off-label promotion. Amarin then sued the FDA for unfair restraint. Amarin was granted an injunction against the FDA, which appealed the decision.
In the latest development, the FDA has settled with Amarin, closing down the appeal before a ruling could be made to set clear precedence. In the settlement, which can read about here, the FDA agreed that Amarin could inform doctors of the studies supporting the fact that its product lowered triglycerides in a range of patients as long as the data presented was truthful. It also set up an “optional” provision in which Amarin can meet bi-annually with the FDA to review the material that they wish to present to ensure that the FDA will find that information truthful and any disagreements from these discussions would be sent to a court to make the final decision.
The FDA’s perceived fear of a precedence setting ruling is not going to go unnoticed. Already another pharma company, Pacira, is suing the FDA under similar circumstances, which you can read about here.
If this case is also settled, expect to see the floodgates open.
It is more than past due time for the FDA to provide clear guidance to industry on the use of truthful, non-misleading communication of scientifically valid data that is not supported by the label. When that guidance is finally offered, it will be a game changer for MA. We believe that most organizations will realize that the safest way to communicate such scientific data will be through the use of peer-to-peer communication driven by medical science liaison-type roles and this will lead to a major expansion of many MSL groups.
We will continue to follow this story. We would love to know what you think. Leave a comment.
October 13, 2015Posted by on
A couple of my clients have discussed the use of the Net Promoter Score lately so I thought I would address it in my blog.
The concept of the Net Promoter Score was introduced in a Harvard Business Review article in 2003 by Fred Reichheld of Bain & Company. The net promoter score is measured by asking a single question: “How likely are you to recommend the company/product/service to a friend or colleague?” and is usually measured on a 0 to 10 basis. Scores of 9 and 10 are called Promoters, scores of 0 to 6 are Detractors and scores of 7 and 8 are called Passives. The Net Promoter Score is calculated by subtracting the percentage of customers that are Detractors from the percentage of customers that are Promoters.
People like the net promoter score because it is a simple measure of loyalty and when it is paired with an open ended question that asks why the particular score was given, it provides insight into what is important to the customer.
So, does the Net Promoter Score (NPS) provide value to MA? My research has not been able to find a single academic or metric-driven study on the use of NPS in MA specifically related to MSL activity. Common sense says this approach should be helpful but for now anyone using this approach is in experimental mode.
In MA the NPS question is often modified to be:
- “How likely are you to recommend engaging with [COMPANY X] Medical Science Liaisons to your colleagues or peers?” OR
- “How likely are you to recommend working with [MSL NAME] from [COMPANY X] to your colleagues?
PRO’s of Using NPS in MA:
- Brief nature of survey makes it suitable for rapid deployment immediately following MSL interaction to avoid the “blending” affect that occurs when HCPs are asked about MSL performance on a standard survey often weeks after their last interaction
- Relatively inexpensive to conduct compared to other market research
- NPS can help gather insights into what an HCP value in an MSL interaction, if open ended questions are employed as well
CONs of Using NPS in MA:
- Message vs Messenger: When an HCP recommends working or engaging with an MSL is that recommendation based on the quality of the content of the interaction or the interpersonal qualities of the MSL herself or himself?
- Not comparative: NPS does not give insight into whether HCPs recommend your MSLs any differently than they recommend competitor MSLs. Perhaps HCPs in a particular therapeutic area simply recommend all MSLs the similarly regardless of company.
- Not clearly actionable: If your NPS drops from one month to the next, what action should be taken? Some insight might be provided by the open ended questions but those responses are often only provided by the most dissatisfied
Given the inherent challenge, it is my opinion that the NPS is still a worthwhile measure, but it needs to be gathered as a part of a broader market research effort to give it the context that can help tease apart the reason for the scores.
The most effective NPS is gathered as soon as possible after the last interaction. In the case of MSLs, a system should be established to seek this guidance directly after a contact has been noted in the company’s contact management system. And, like all market research with HCPs, participation is highly impacted by compensation, so sufficient compensation must be offered to ensure enough participation to make the measure meaningful.
What is your experience with NPS? How do you frame the question? Share your experiences by clicking here.
September 4, 2015Posted by on
One of my readers asked me an interesting question:
“Are there examples of successful MSL roles that are primarily office-based (minimal travel)?”
Of course I could immediately think of some one-off type of examples like MSLs that focus on supporting other internal teams, like MSLs focused on training, or MSLs focused on providing a clinical development function technical leadership support. But, the simple answer is that I don’t know of any MSL groups that are primarily office-based. If you have experience with this, please leave a comment because my reader would really appreciate it.
Having failed to find a practical example, I nevertheless asked myself if I could imagine such a group existing in the future as a thought experiment. If we take as a given that the role of the MSL is to:
1. Establish relationships with stakeholders (usually thought leaders / key opinion leaders) in order to:
a. Provide the stakeholders with information and education on the disease state
b. Answer unprompted off-label questions about products / pipeline
c. Gather insights from stakeholders to share with the organization
2. Represent their organization in scientific settings like conferences
3. Facilitate efforts to work effectively with the research community
4. Support other scientific needs of the organization externally, like payers
I realize your mileage may vary on this definition, but if we accept it, than is there a future where most of that can be done from a desk?
I think it comes down to how acceptable the use of remote communications like FaceTime or Skype becomes. Today’s reality is that this is rarely done but I believe that this will grow much more common as this type of communication begins to be embedded in our daily interactions. I can imagine a future in 10 years or less where stakeholders express a preference for this type of communication – it is clearly more efficient for a stakeholder to sit at her or his desk and quickly interact with a number of different people than have to do the physical meet and greet with its inevitable open/closing loss of time. However, I think that this change will happen so gradually that we will come to realize that happened only by looking back on the differences.
And even in such a situation, there will still have to be travel for initial introductions which are much more impactful face to face and to conferences/meetings that have not gone virtual.
I just think the MSL job is too fundamentally about human contact to ever be exclusively office-based.
What do you think? Let me know by leaving a comment below.
March 30, 2015Posted by on
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
February 26, 2015Posted by on
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:
- The formulary committee needs a more robust scientific understanding of the drug’s properties, its known efficacy, its known risks and its place in the overall therapeutic area’s treatment options
- The formulary committee is demanding more specialized data, specifically health economics and outcomes research (HEOR) data like cost effectiveness and total cost of care, and comparator data to allow them to understand the full impact of the drug’s use
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:
- Much greater degree of training for Field Medical on the role of AR and P&T Committees
- The identification and hiring of full time Field Medical-type roles specifically targeted at supporting AR
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:
- HEOR data should start being gathered in Phase 3B at least, and thus MA HEOR leaders need to engage with clinical development to ensure endpoints are included to begin the generation of HEOR data sets
- Post-Approval Data Generation Plans, which should be developed by MA to help drive the post-approval study efforts, must give greater consideration to the HEOR needs
- The priority given to Investigator Initiated Studies that cover HEO subjects may need to increase
- The need for specialized MA resources dedicated to developing and managing HEOR may need to increase, with new dedicated positions developed
- Processes for ensuring that the input of AR is gathered in the development of HEOR protocols should be re-examined to ensure that the results will meet the demands of the key formulary committees
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.
May 3, 2013Posted by on
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
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.
April 29, 2013Posted by on
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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April 17, 2013Posted by on
“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.
April 9, 2013Posted by on
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.