Topic 32: Big Data in MA – Revisited

Overview

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.

Conclusion

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.

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.

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

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

Owning the Correction Process

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

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

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

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

Overall Sunshine Implementation

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

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


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


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

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

1. Internal Systems Developed for Sunshine Reporting

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

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


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


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


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


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

2. MA Personnel Training on Sunshine Reporting

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

1. Overall Payments
   
   
   
   • If value is provided to a physician but not at the request of the physician, it still needs to be reported.
   
   
   • Waived fees – of a physician suggests it is donated to a charity on their behalf it will still be tracked, unless they truly waive their fee without obligation to the company
   
   
   • All payments need to be coded by category – training is needed on the definition and difference (eg. travel vs. meals)
   
   
   
   


2. Food
   
   
   
   • If a group meal is provided where the value is greater than $10 per person, each physician that actually partakes of the meal must be tracked
   
   
   • Unless the food provided at a large event, in which case it does not have to tracked
   
   
   
   


3. Indirect Payments
   
   
   
   • Value provided to a third party but expected to be delivered to a physician must be tracked under the physician’s name
   
   
   • Value provided to an institution with the intention that it will go to a physician even if that physician is unnamed must be tracked (eg. providing funding to a teaching hospital for research grants will have to be tracked to the recipient physician)
   
   
   • Blinded payments to physicians for market research do not need to be tracked
   
   
   
   


4. CME Programs
   
   
   
   • Accredited programs are exempt from reporting only if no names of speakers or even specific criteria for speaker selection is provided and the manufacturer does not pay the speakers directly
   
   
   • General subsidies for CME tuition does not have to be tracked
   
   
   
   


5. Patient Education
   
   
   
   • Patient education materials and items are excluded from being tracked
   
   
   
   

3. Educating Physicians and Especially KOLs

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

1. General Rules of the Road
   
   
   
   • All value provided greater than $10 must now be reported, or multiple smaller transactions that add up to $100 in one year
   
   
   • All data is tracked and submitted yearly
   
   
   • Physician must register with CMS website to gain access to the data in their name
   
   
   • After registration, physician will receive notification when data is posted yearly about them
   
   
   • Physician will have 45 days after notifications to review data
   
   
   • Physician will go onto CMS website and enter any corrections they think are necessary
   
   
   • Manufacturer has 15 days to review the corrections submitted and accept or reject
   
   
   • If the manufacturer rejects the correction, the manufacturer and the physician are expected to negotiate and reach consensus
   
   
   • If consensus is not reached, the manufacturer value number is used but it is marked as “in dispute”
   
   
   
   


2. Nuance of Value Tracking
   
   
   
   • Value tracked will include OTC and other non-pharma products from the company
   
   
   • If value is provided to a physician but not at the request of the physician, it still needs to be reported.
   
   
   • Value contributed to charity in their name will still be reported – eg. primary research honoraria donated to a cause is still considered value provided and will not be coded as charity contribution but as primary research honoraria
   
   
   • Tracking pierces the outsourcing veil – if a manufacturer pays a CRO and the CRO pays the physician, it tracks as the manufacturer paying the physicians
   
   
   • Reporting on research payments and value may be delayed for up to 4 years or until FDA approval, so do not be surprised if some clinical trial payments do not show up on the yearly total.  Similarly don’t be surprised to see multiple year’s worth of payments show up in one year after FDA approval, but they will be labeled with the year actually worked.
   
   
   
   

Rant: Treatment Guidelines and Biopharma

Have you seen the recent analysis by the Milwaukee Journal Sentinel about biopharma’s influence on treatment guidelines?  If not, you should take a look at it here.

In summary, it reveals the startling fact that physicians who are on treatment writing committees are also often consultants to Biopharma and states that because of this there is a conflict of interest for the physicians.  I find these arguments incredibly frustrating and I think we as a community must push back against them strongly.

On the surface, the conflict of interest argument makes sense but when you scratch the surface a bit it falls apart.  By definition, treatment guidelines not only serve to support patient treatment but they are also used to define standard of care for reimbursement purposes - reimbursement not just for drugs but for all the aspects of treatment.  In general a practicing physician, even one that gets some income from Biopharma consulting, earns most of their income by being reimbursed for treatment they perform.   Some physicians have major financial stakes in treatment reimbursement but no one is (or should) suggesting that a doctor would push for an unnecessary or less effective treatment option just because it would likely be more lucrative to the doctor.  No one is claiming that the largest sources of most of these physicians’ incomes drive a conflict of interest.

But, when it comes to drug treatment, the newspaper story argues that this same ethic goes right out the window and the physicians become pawns to the big bad Biopharma companies.  This is ridiculous.  Physicians who consult to Biopharma generally do so because they are subject matter experts and want the drugs that are developed to most effectively treat their patients.  To imply that by providing that support to Biopharma they suddenly lose their ability to correctly judge what should or should not be in a treatment guideline is insulting to the professionalism of physicians.

As someone who has dedicated a big chunk of my career to helping Biopharma work better with physicians, I know that those physicians are professionals and will do what is best, not lackeys that will do as they are told.

What do you think?  Please leave a comment.

Topic 18 – Site Payments in Phase 4 Clinical Trials

(Full Disclosure – I was introduced to this issue by my client who has a interest in the solution to the problem but regardless I believe this to be a real problem. )

As P4 clinical trials grow larger and more complex, the challenge of site payment computation and accrual grows as an issue.

As more and more sites become sophisticated partners in clinical trials they are demanding customized contracts with payment terms associated with their work and cash flow needs.  It is hard to blame them when pharma and CROs has been so bad about paying, many times paying sites over 90 days after the site incurs the cost and paying inaccurately.

Payments are a source of friction with PIs and thus KOLs.

CenterWatch has identified late payments as the #1 site concern about pharma for the last three years. For a P4 study, Principle Investigators (PIs) are often key opinion leaders (KOLs), since many of KOLs have access to the type of patients needed for the trial.  Developing a strong scientific dialog with KOLs is a fundamental role of MA.  Yet, at the same time we are working so hard to establish a positive working environment to collaborate with KOLs, we are also degrading that relationship due to late or inaccurate study payments.

It is not at all unusual for an MSL to receive complaints about late payments on trials, even though the company has outsourced the trial to a CRO for payments.  The PIs will hold the company responsible despite the CRO’s involvement.

Payments are a source of regulatory risk.

Since payments are generally computed manually even by most CROs, many mistakes are made.  Thus at the end of each study there is a process called “End of Trial Reconciliation” when the actual amounts owed are computed against the final data collected.  Any missing money (and there is often hundreds of thousands in overdue money) is paid at this point.

BUT, the regulatory risk is not in delayed payment.  The regulatory risk is what happens if we find we have paid too much.  This happens often in clinical trials because due patients drop out but due to computational errors the site still receives payments for that patient.  If that occurs we have overpaid the site and the PI (which we discussed are also KOLs).  But this computation error may be from years before.

Now the quandary is – do we demand repayment from the site for our error.  Technically, the site should refund the overpayment.  But, I would ask your operations group if you have ever asked for that money back.  My practical experience is that the overpayments are rarely if ever collected back.  If they are not collected back, we have essentially paid more for the trial than fair market value and thus we have a potential compliance issues.

While this issue has not been one I have seen enforced to date, given the growing scrutiny on all payments to physicians with the Sunshine Act, I think it would be wise to ensure that this risk is avoided.

Payment computation is a hidden cost. 

With these more sophisticated contracts comes the need to administer them and compute payments.  Sites don’t send an invoice.  So, determining the amount to pay is left up completely to the pharma company.  Performing that computation can be complex and time consuming.

Since many pharma companies outsource their P4 trials, what they are doing is paying the CRO to perform this computation for them.  In some larger P4 trials, hundreds of thousands of dollars in fees are spent for the CRO to compute and issue payments.

New solutions are available.

The good news is that a new type of software is being developed to automate the payment process and avoid the need to do any manual calculations.  If you are interested check them out .  My client is www.clinverse.com.  Also their competitor is www.greenphire.com.

What has been your experience with P4 site payments?  Leave your thoughts in the comments.

Slightly OffTopic: NEJM Article on BioPharma Research Credibility

Have you seen this special article in the NEJM entitled: A Randomized Study of How Physicians Interpret Research Funding Disclosures.  It is disturbing reading for all of us in the industry, including MA.

In the study, researchers presented 503 board-certified internists with three random studies with a high, medium and low level of methodological rigor.  And then randomly assigned each study one of three funding sources: NIH, Biopharma Industry, Not Disclosed.

The good news is that respondents generally assigned stronger credibility to studies with stronger methodologies.

The difficult news is that the internists believed the results of industry-sponsored were less credible than those that were NIH funded and with no funding disclosed.  And that results remained the same whether the study was of high rigor or low rigor.  Since the funding source was randomly assigned its clear that simply associating industry funding reduced credibility.

And the kicker – over 75% of the respondents accept support from industry in some manner, so these are not a bunch of ivory tower purists throwing stones.  These are exactly the people that MA needs to educate and these are exactly the kinds of studies that we use for that education.  Clearly we have a problem.

In an editorial that accompanies the study entitled Believe the Data, Dr. Jeffery Drazen suggests that physicians need to focus on the data and the rigor of developing that data.  As an industry, we need to echo that exact point.

We know where this skepticism comes from - too many newspaper stories of incomplete study disclosures, too many studies that seemed to lack rigor, too much willingness to spin results.

We cannot ignore this issue.  We need to hit it head on – discussing this now proven bias and why it should not impact the interpretation of results for a given study due to its rigor, etc.

Something that many of us have suspected for awhile, that industry science was being discounted simply because of funding, is now shown to be true.  We must address it openly because like any bias when it is pointed out to people they are less likely to be prey to it.

What do you think we can do to address anti-industry bias?  Leave your thoughts in the comments section.

Topic13: Medical Information Groups

I was talking with a friend the other day who is charged with running the medical information (MI) function for their small pharma company.  Currently they outsource the MI function and she was wondering if it made sense to bring the function in-house of keep the current arrangement.  We discussed how effectively the outsourced MI function works with the current MA group, including the MSL field force, and the answer is that they have some formal links but rarely talk.  We talked some more and reached some conclusions, but I thought this might be a good topic for a post.

MI is both a regulatory mandated function, and a critical component in achieving MA’s educational and public outreach goals.  It is possible to structure and run the MI function merely to meet the regulatory requirements but that would represent a significant waste of an opportunity.

From a regulatory perspective, the MI function needs to be structured to answer calls from both patients and healthcare professionals (HCPs), differentiate between inquires and pharmacovigilance calls and route the calls appropriately, answer questions directly when appropriate, distribute accurate and approved materials to appropriate audiences, and develop outgoing medical communications on important issues (Dear Doctor letters).  It needs to be staffed by people with appropriate qualifications to answer medical and technical questions about the use of company’s products.

But, some organizations gain much more benefit from their investment in MI.  For one thing, MI is often the first sign that a problem is occurring relating to our products or issues are being raised concerning the scientific underpinnings of our products.  Spikes in the type and content of questions help provide a Zeitgeist view of the needs for education in the HCP community.  But, this only works if MA listens.  There must be processes and systems in place to ensure that MI is coding their contacts in a manner that allows for analysis and reporting in place to ensure that the information is summarized on a timely basis.  Finally, clear responsibilities need to be established for who will review and respond to this information.

Other organizations utilize the MI resources to more effectively partner with the MSL field force.  MI and MSL groups tend to talk with related but mutually exclusive audiences.  Given the limitations on MSL time, they need to focus that time on those HCPs that can offer the greatest impact on the medical community, the so-called Key Opinion Leaders (KOLs).  Based on research I have seen in the past, it is very rare for a KOL to call MI.  They tend to expect the answers to come to them through MSLs or research on the internet.  Non-KOL HCPs tend to call MI.  Given that, the opportunities for MSLs and MI to interact is not in terms of serving the same HCPs but instead in terms of “having each other’s backs.”  Often when MSLs are interacting with HCPs, they need to provide those HCPs with additional information and support.  MI is well suited to provide that information and support.  And, when MI is answering questions for HCPs they encounter situations that require more in-depth support, and MSLs are well positioned to provide it.

Establishing a strong partnership between MI and MSL groups brings value to both sides, yet it is not as common as you might expect.  Sometimes it’s due to organization structure – the two groups have unrelated reporting relationships and thus lack incentive to interact.  Other times it’s due to a difference in philosophy, where one of the two groups does not see value in interacting with the other.  Regardless, there is value in establishing this relationship, but it needs to be clearly structured and actively managed to avoid either group “dumping” on the other.

This leads back to the discussion of outsourcing MI.  To really gain value from MI, it needs to tie in easily with the rest of the MA organization.  It may be possible to pull that off with an outsourcer, but its unlikely.  For that reason, I suggest that insourcing MI brings more value to the organization.

My final thought on MI relates to technology.  A call does not have to be a phone call.  Web chats are significantly more efficient to manage and allow for careful scripting of responses.  Providing this service on an after-hours basis may allow more of those KOLs discussed earlier to actually connect.  And, I have yet to see a company develop an MI app, but I think we can’t be too far from having one – just tap the icon and link directly to an MI chat or other dialog.

 

What has been your experience with MI and how it relates to other function in MA?  Please leave your comments below.  And if this is your first time on the blog, please sign up on the right to receive email updates of the latest posts – don’t worry its spam free.

Topic11: MSL Team Leadership Challenge

I received a call the other day from an old friend who had taken on a new job.  Her job involved developing the North American MA function for a non-US pharma company.  One of her first tasks was to consolidate and expand the MSL function in the NA. She was very concerned because her budget was fairly limited given the ground she needed to cover with her MSLs.  She wondered whether she could “stretch” her staff by using team leads that have both substantial HCP support and managerial responsibilities.

While practical considerations, especially for very small or very new MSL teams, sometimes dictate the need for MSL Team Leaders to have both substantial HCP support and managerial responsibilities, over time these types of models tend to be unstable.  When Team Leads have substantial HCP responsibilities those responsibilities tend to absorb the time for managing their team.  It is essentially a case of the urgent driving out the important.  In an effort to be responsive, HCP needs tend to trump other requirements, especially requirements that can be put off like team management.  As a result, despite best intents the team suffers from a lack of leadership. And, in cases where the team already has some challenges, like lack of experience or entering a new therapeutic area, this lack of focus can derail the entire MSL effort.

While it is important for the MSL team leads to maintain contact with some very targeted HCPs, it must be a small portion of their workload and their managers need to ensure that they do not lose their focus on their primary responsibility – the leadership of the team.  The important cannot be allowed to be a victim of the urgent.

So what is the magic number where a more-or-less full time team leader is needed?  Putting aside all the caveats that the number varies by TA, product complication, HCP need, etc., I would say the number is between 8 and 12.  Less than 8 it does not make much sense to have a full time-ish team leader.  Over 12 and it too much work for one person.

What has your experience been?  Please leave your thoughts in the comments.  If you are new to the blog, please add your email on the right to receive a notice when new posts occur.

Topic8: Sunshine Act – Preparing KOLs for 2013

We are little over a year (Sept. 30, 2013) away from the date when Department of Health and Human Services (HHS) has committed to having the first round of Sunshine Act data made available to the public via the web.  Allow me to stipulate that we may have more time since the HHS has managed to miss every other deadline they have had with regards to the Sunshine Act.  And, allow me to stipulate that a fully Republican controlled government may actually repeal Obamacare and the Sunshine Act with it.

But, as we head into the 2013 planning season, I think it would be wise to assume this is actually going to happen and thus budget and plan accordingly.

Up to this point, we have discussed the Sunshine Act purely from an administrative point of view – how to collect this data and meet the immediate 2012 requirements.  But, in 2013 this information is going to be made public and we run the risk of losing the trust and support of the very KOLs that we have all invested so much time in developing.

It is critical that your company take a proactive stance on this situation:

• Reaching out to the KOLs for whom you will be reporting payments


• Educating them on the law and its reporting requirements


• Providing them with the same information provided to HHS and an explanation of that information


• Providing them with some context for this information and how to explain it to others


• Answering any questions they may have

I will discuss some approaches to this in hopes that it aids in your budget and planning efforts.

The first challenge to overcome in addressing this issue is intra-function coordination.  The data provided HHS includes payments from all company elements, including research, development, medical affairs and commercial.  Therefore, in addressing this to KOLs, a single cross-functional approach needs to be created.

I would suggest a meeting with the other relevant functions to address the corporate approach and name members to a task force.  MA is the logical leader for this given its role as straddling the worlds of products in and out of development.

Once this Task Force is formed, I would suggest the following approach:

1. Gather a list of those KOLs impacted by the reporting and prioritize if necessary based on KOLs with the biggest numbers


2. Work with each function reporting to develop standard explanations for the payments made


3. Develop general metrics such as average payments, ranges of payments, number of KOLs in each range, etc.


4. Develop individual KOL reports that contain the same information shared with HHS


5. Develop internal training with information about the Sunshine Act, the general metrics and how the company will explain it to others


6. Develop materials for KOLs that explain the Sunshine Act, the obligation to report, the expected approach by HHS to share the information, an explanation of the company’s payment types, some bullet points on how the information can be conveyed by the KOLs to others, and the general metrics and a FAQ


7. Assign KOLs impacted to specific MSLs with targets for discussions before September 2013


8. Train MSLs


9. Track the results

This should be a straight forward communication project, but it will be easy to put off as more urgent issues begin to crowd it out in 2013 so it will take consistent leadership to get it done.

What are your plans for supporting the rollout of HHS reporting of the Sunshine Act?  Leave your comments or questions (below) or email me directly (link on the right).

Topic4: Key Opinion Leaders – Managing KOL Interactions Efficiently

Identifying the right KOLs to focus on with the limited resources available is the critical first step and in the last post we discussed some alternate approaches.  Once those KOLs are identified, the next key to success is ensuring that the interactions with the KOLs produce the greatest value for both the KOLs and the pharmaceutical company.

Many organizations that invest in identifying KOLs, often fail to ensure that those KOLs are actually being well served by MA’s outreach efforts.  They provide their field force of MSLs with the names of the KOLs but very little direct direction.  The theory for this hands off approach is that the MSLs are expected to have a peer to peer interaction with the KOL and thus they want that interaction to guide the discussions.  While this is certainly the only way to discuss topics that are not suitable for proactive engagements (see this for further discussion on proactivity), for those topics that are suitable for proactive discussion it places an undue burden on the KOL to know what questions to ask.  In other words, KOLs don’t know what they don’t know and thus, when appropriate, benefit from the direct, proactive engagement of the MSL.

The only way to know how to provide the greatest value from direct engagement is to start by identifying the goals.  What need does the pharma company hope to support through its informational and educational outreach efforts?  The needs of the KOLs may be self-evident to the MA scientific interactions with the KOLs, but if it is not they will need to conduct some research to find out, which may be formal or informal.  Regardless of the approach, however, the needs should be defined by the KOLs and not by MA’s commercial colleagues in order to avoid any promotional bias.  The needs can then be expressed in terms of goals for MA’s outreach efforts.

With the goals in hand, a structured approach can be developed for these proactive outreach effort.  Plans can be developed on the type of outreach to be done, and materials developed to support that outreach.  And, once the plan is in place, progress against that plan can be tracked, measured and reported.

It is truly amazing to me how many MSLs lack a clear plan for their KOL engagement.  Operating without a plan denies the MSL the ability to measure their progress against a standard.  Operating without a plan denies their managers metrics they need to evaluate their performance.  And operating without plan makes justifying the investment in MSLs more difficult for MA leadership.

Building a detailed plan for each MSL that not only defines their KOLs but also details on a time-boxed basis the expected activities is a critical part of effective KOL engagement.  These plans can be in almost any form as long as they can be translated into direct measurement.

These measures should be as results oriented as possible.  Activity driven metrics may be easier but they rarely align directly with goals.  If the results sought relate to growth in understanding of a disease state, for example, then the measure may require some primary research.

Finally, those measurements need to be analyzed and fed back to the MSLs as well as their managers so that everyone can learn from the results of the outreach efforts.

Some of the vendors I mentioned in this post also support MSL plan management and tracking.  More about that in future posts.

Please share your experiences in the comments.

Legal Note:  All information and interpretations presented are only the opinion of the author(s) who are not lawyers. And, even if we were lawyers, given the wide range of interpretations of the current regulations you would still need to get the input from your own compliance organization. 

Topic 4: Key Opinion Leaders – Identifying the Right KOLs

The importance of KOLs in achieving medical affair’s goals was discussed in the Introduction.  Left open was the question of how are these KOLs identified.  There are a number of different approaches to identifying KOLs and in this post I will review those approaches and discuss their strengths and weaknesses.  I will also look into the vendors that can support KOL identification.Per

PERSONAL NETWORK

In the past, the standard approach for KOL identification was to hire good Medical Science Liaisons (MSLs) from various regions and rely on their Personal Networks to identify the right KOLs in their region.

This Personal Network approach has some strengths:

• It is very fast, since the MSLs typically already know the KOLs in their personal networks


• Good chance for strong access, since the MSLs typically target KOLs they have a existing relationship, they can often rapidly gain access to those KOLs for educational discussions


• It is inexpensive, since there are no additional costs from outside vendors

The Personal Network has some significant weaknesses:

• MSLs don’t know who they don’t know, some important KOLs may simply not show up on their radar because their personal networks do not cross


• MSLs are biased toward KOLs they have strong relationships who may or may not be the KOLs that are the most effective “hubs” of their formal and informal networks


• MSLs may specifically avoid “difficult” KOLs simply because they do not want to interact with them

The Personal Network approach is most effective in a very small, highly technical specialty medical community setting.  In these types of communities, since there are so few people involved, everyone knows everyone in the community and the risks of the Personal Network approach are mitigated.

SECONDARY RESEARCH

The next most common approach is the use of Secondary Research networks.  Secondary Research networks are developed by gathering information that is publically available about potential KOLs for secondary sources.  Information that is publically available may include:

• Name


• Degrees and institutions


• Specialties


• Institutional affiliation


• Authorship


• Conference presentations


• Principle investigator


• Committee involvement


• Board membership

The list can go on.  This information is collected; each piece is given a weight based on the what is perceived to be likely to contribute to their being a KOL.  The weighting produces a combined value which is then used to identify an individual as a KOL.

The Secondary Research approach has strengths:

• Fact based, eliminating personal bias found in the Personal Network approach


• Broad view, looking at everyone in the therapeutic area, not limited to individuals in a specific institution or with a specific background


• Less expensive than primary research, since the information in question is available in public databases

The Secondary Research approach has some weaknesses:

• Backward looking, since it relies on a preponderance of publically available information, it tends to favor those people who have contributed for the longest period of time


• Academic oriented, since it relies on public databases of information it tends to value those who publish and speak the most and those people tend to be academics


• Subject to weighting bias, if the weighting of the information does not correspond to what is truly makes someone a KOL, the exercise can produce seemingly valid data that misses actual KOLs

The Secondary Research approach works best in therapeutic areas that are fairly static and dominated by academicians.  In these types of environments, there is a strong correlation between age and importance and between academia and practice.

PRIMARY RESEARCH

The third approach to KOL identification is Primary Research.  The Primary Research approach identifies who is a KOL by polling the physicians treating a disease state and directly asking them who influences them.  These responses are then tabulated and the names of those individuals cited the most are given the most weight and are thus considered KOLs.

The Primary Research approach as its strengths:

• Accuracy, this is the only approach that actually asks physicians who influences them and thus is free of any bias or miscalculation


• Broad view, this approach does not limit itself to only KOLs already known by the organization


• Additional insight, at the same time that physicians are polled about influence, there is an opportunity to gain additional insight into their educational needs

The Primary Research approach also has weaknesses:

• Expensive, all direct research is expensive requiring a direct interaction with many physicians and potentially the cost for honoraria


• Sample bias, the sample of physicians polled may be biased, especially if the sample size is kept down by budgetary concerns


• Time consuming, it can take a number of weeks to conduct this type of research

The Primary Research approach is the best approach for less established disease states, less academically driven disease states and for any groups looking for less well established KOLs.

REAL LIFE EXAMPLES

Any of these three approaches may work, and they are often used in combination.

For example, I had a client who was entering a new disease state and thus needed to establish their MSL group from ground up.  During the initial six months, as the MSLs were coming on board and being trained, the company allowed each MSL to use their Personal Network.  Once the group was fully formed, they worked with a vendor to conduct a Secondary Research analysis of the community and create the initial list of KOLs to be targeted.  After the MSLs had been in the field for six more months, they identified a related set of potential KOLs that the Secondary Research had not targeted, and they commissioned a targeted Primary Research effort to identify all the KOLs in this new group.

I have had other clients that used the Primary Research approach to develop their initial list of KOLs then used the Secondary Research approach to continue to track those KOLs and ensure that their staff was fully up to speed on their activities.

VENDORS

Some vendors that support these types of research include:

Secondary Research: Heartbeat Experts, SteepRock, OpenQ, ThoughtLeader Select

Primary Research: AlphaDetail, Encuity Research (full disclosure - I used to be a part of Campbell Alliance, the parent company to Encuity)

In my next post, I will discuss how these KOL interactions should be managed.

As always, I am curious to know your experience with KOL identification.  Please leave comments below.

Topic4: Key Opinion Leaders – Introduction

Educating the healthcare community on new information is both an obligation of and an important benefit for a pharmaceutical company.  Impacting the knowledge of the healthcare community may be the single most valuable service that a medical affairs organization offers.

As much as a medical affairs organization may wish to educate all healthcare providers, the reality is that resources are always limited.  Given limited resources, most organizations look to educate people who will go on to share that education with others.

The fact is that healthcare providers, like almost all specialized professions, have strong formal and informal networks.  These networks may be directly associated with their institution, like a hospital, or indirectly formed by friends and mentors developed over many years.  These formal and informal networks exist because they are valuable to the members of the network.  That value takes many forms – from help with personal job searches, to patient referrals across geographies.  One value that these networks provide is supporting the group’s knowledge on their specific specialty.  If one member of the network discovers something of value concerning their specialty, they will very often share it with others within the network.   These formal and informal networks provide a multiplier effect for education – educating the right person in a network can result in multiple members of the network benefiting from the same information.

Medical affairs organizations tap into this network capability to multiply the impact of their limited resources.  Medical affairs organization look for individuals who serve as information “hubs” in their formal and informal network and apply their education efforts to those individuals, expecting that the information will then be conveyed out to the “spokes”.  As a short hand, many organizations use the term Key Opinion Leaders (KOLs) for those individuals who serve as information “hubs” of their formal and informal networks.  The term stems from the fact that others in their network value the KOLs opinion that a piece of new information is worth knowing.  Other terms for these individuals include Thought Leaders, Subject Matter Experts, Scientific Community Leaders, etc.  For simplicity sake, I will use the term KOLs.

Like everything in medical affairs, educating KOLs is rife with compliance concerns.  These concerns primarily hinge on the difference between education and promotion.  The way I like to describe it is:

Education (or scientific communication) is focused on presenting valuable information to healthcare providers to ensure that they are aware of the latest scientific information.

Promotion is encouraging a healthcare provider to use a given treatment.

Most organizations would cite disease state education as a clear example of the difference.  Disease state education is focused on the disease state in general and not on any particular treatment.  Therefore it is education focused not promotional focused.

Where things start getting “trickier” is around product-specific education.  Some organizations allow it and some do not.  For more in depth discussion on this topic, see this post.

Regardless of where your organization lands on the education question, there are a number of best practices that any organization that educates KOLs should be using.  I will discuss them further in the following posts:

• Identifying the Right KOLs


• Managing KOL Interactions Effectively

As always, I am curious to know your opinion.  How would you describe pharma’s efforts to educate KOLs?  Leave your comments below.

Legal Note:  All information and interpretations presented are only the opinion of the author(s) who are not lawyers. And, even if we were lawyers, given the wide range of interpretations of the current regulations you would still need to get the input from your own compliance organization.  Simply put – your mileage may vary.