New To The MA Focus Blog?

Welcome!  My stats say that I have been getting a bunch of new readers and I wanted to welcome you to the MA Focus blog.  My goal with the blog is to discuss issues that are relevant to MA leaders.  I encourage you to add your email to the distribution list (follow this blog link on the right) so you will be notified when there is a new post.  Promise, no spam!

Please take the time to look over some of our archives.  We have discussed a range of topics including MSL proactivity, KOL identification, MedComm/SciComm groups, MA at Product Launch, Global MA and MA's Relationship with Commercial, just to name a few.

Finally, I really enjoy feedback so please feel free to leave comments or email directly with questions (link on right).

Thanks for your interest.

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.

Topic19: MA Impact of the Caronia Ruling

As most of you know, the Caronia Ruling by the Second Circuit Court of Appeals found that a pharma rep was within his 1^st Amendment rights to discuss off label use of his company’s drugs, assuming that those discussions were truthful.  This went off like a rifle shot within the pharma world with all sorts of discussions, you can read some of them here, here and here.

It is very likely that this ruling will be appealed to the full Second Circuit, and/or directly to the Supreme Court.  But there are reasons to believe that the Supremes may be open this interpretation given their past rulings on similar subjects.  Regardless, until this is settled it only applies to the Second Circuit so unless you are a pharma company only doing business in the Second Circuit in and around New York, you can’t make much change.

BUT, what if this becomes the new law of the land?  What does it mean for Medical Affairs?  That’s what I want to explore in this blog post.

The most obvious impact it has is on all the current focus we place on “proactivity”.  I have discussed this topic in detail here, here, and here.  I bemoaned the unclear state of the current regs here. Now we are imagining a world where the issue of proactivity has to be seen in a completely different light.  MA avoided proactively discussing off-label data on our products because proactivity implied promotion and it is (or in our scenario was) illegal to promote off label.  Under this scenario that thinking would be wrong.  Replaced, potentially, with a focus on “truthfulness”.

Now, for MA at least, this is an expectation we are more than willing to meet.  In the past MA has typically thought of any peer reviewed study as truthful but some of the commentators are suggesting that the definition might become the same one that they use for the FTC.  The FTC definition id focused on “…competent, reliable scientific evidence supporting the claims you are making…” so it may not require a peer reviewed journal publication.  The one caveat, however, is that if you conduct a test and find that the content being shared is misleading to 20% or more of the targeted consumers, than it is not considered truthful.  In general, then, although peer reviewed journals would not be a requirement, it would represent a fairly safe harbor to avoid the risk of sounding misleading.

So, in the future world we are imagining, our field force of MSLs would be free to go out to HCPs armed with peer reviewed journal articles, and introduce the HCP to that article and then proceed to have a scientific exchange about the results, assuming they stick to findings documented in that or other peer reviewed articles.

Scientifically speaking, this frees MSLs to have very wide ranging discussions with HCPs at their initiation and allows for much greater control over the type of discussions that we have with the HCPs.  It will allow MSLs to show much greater value to the organization by allowing the targeting of discussions that are the most meaningful to our products.  And if you think is hard to hire MSLs today, watch out.  With that increase in value will come greater investment in both MSLs and in Investigator Initiated Studies and P4 studies that will now be seen as more valuable as well.

What do you think?  Do you think it we will see the end of proactivity restrictions in the next three years?  Leave your comments above.

QuickNote: Off Label Promotion Ruled OK by US District Court

In a ruling with huge potential impact on MA as well as commercial functions, the Court of Appeals for the Second Circuit in Manhattan has overturned a conviction of a salesperson who was promoting the off-label use of a product! This 2-1 ruling goes against years of court rulings stating that pharma does not have the right to promote off-label.  In fact,  in the past month GSK has been fined $3 billion for off-label promotion and J&J fined $181 million for off label promotion.

Clearly, new legal ground is being broken here.  BUT, if urge caution.  This is one ruling that contradicts years of previous rulings.  It may serve as grounds for kicking this up to the Supreme Court, but until clear legal direction is given I would not be changing any policies.

Take a look at the article here and the actual ruling here.

Topic 19 – EU Considering Major Change in P4 Trials

A new position paper has been floated by the European Commission Health and Consumer Directorate-General that may have HUGE impacts on the way P4 trails are conducted in the EU (and the rest of the world).  My take on it is below:

Stemming from the new EU regulations around pharmacovigilance, the EU is also considering the role of post-marketing efficacy studies (PAES).  In a position paper seeking feedback, found here, the EU lays out its perspective that the new PV legislation also refers to the possibility of requiring the market authorization holder to develop PAES to complement the efficacy data used to grant marketing authority.  That power is granted where “concerns relating to some aspects of the efficacy of the medicinal product are identified and can be resolved only after the medicinal product has been marketed.”

Regulatory Purpose

The position paper goes on to lay out the regulatory purpose of PAES and suggest that after the results of a required PAES were provided to the regulatory agencies, they would be free revisit the authorization decision and determine if “…the marketing authorization should be maintained as granted, varied or even withdrawn on the basis of the new data resulting from the study.”

While regulatory agencies have always been free to revisit their decisions, this approach seems to imply that they are obligated to reconsider their decision after the required PAES.  This makes thoroughly changes the role of the non-PV focused P4 trial from today’s approach to a much more high-stake trial.  Under this approach, these types of P4 trials would have much higher risk and would likely need to be treated much more like we treat P3 studies.  This means a likely significant increase in cost for these trials.

Efficacy vs. Effectiveness

The next section of the position paper focuses on the question of efficacy vs. effectiveness.  The paper comes down clearly on the side of efficacy.  Again, this could be a major change for P4 trials, many of which are focused on developing real-world effectiveness data to provide support for reimbursement decision makers.  This change may also force a significant revisiting of the P4 approach followed today.  Additional P4 trials may be needed if the mandated trials focus on efficacy and cannot be tasked with also considering effectiveness.  This will have a significant impact on time and budget as well.

Situations Where PAES May Be Required

The paper then proposes a set of 7 situations where PAES may be required.  They are:

Situation Where PAES May Be Required	Comment
1.   Studies aimed at determining clinical outcome following initial assessment based on surrogate endpoints	This type seems very logical.  If surrogate end points were used to get authorization, then a study may be required investigating the underlying endpoint sought.  But, this may significantly add to the cost of using surrogate endpoints for approval, since surrogates are sometimes used because of the time (and cost) of gathering data on the underlying endpoints.
2.   Studies on combinations with other medicinal products	Acknowledging that testing for authorization can only cover a limited range of combinations, P4 trials may be required to test additional combinations.
3.   Studies in sub-populations	Given the limitations on the number of sub-populations, additional sub-populations may be required to be tested.
4.   Studies in the context of the European standard of care	If the trial uses subjects primarily from outside of the EU, the EU may request additional information from patients treated within the EU.  This would negate any cost savings a company might hope to garner by working in other markets.
5.   Studies linked to a change in the understanding of the standard of care for the disease and/or the pharmacology of the medicinal product	This is a scary one.  It proposes that if the standard of care for a disease had changed, the authorization holder may be required to develop new efficacy data addressing the new standard of care.  This could result in a never-ending need for new efficacy trials – a major change in way we think of authorized products.
6.   Studies aimed at determining the long-term efficacy of a medicinal product	This is one of the “traditional” reasons for P4 is long-term analysis.  Difference is focus on efficacy instead of effectiveness.
7.   Studies in everyday medical practice	The proposals suggests that these would be required when “…there is clear evidence that the benefits of the medicinal product underdiscussion as shown by randomised controlled clinical trials might be significantly affected by the real-life conditions of use.”  This seems to open the door for any misgivings or concerns by the regulatory authorities to result in the requirements for a trial – and when they get results they will be obliged to revisit the approval.

Final Thoughts

While this is still in proposal stage, the direction is clear.  PAES is going to become a new tool for regulators who have efficacy concerns about both new approved and legacy products to address their concerns.  It is likely to have a significant impact on the cost, risk and structure of Medical Affairs if it comes into effect.

I urge you if you have comments to follow the process found in the document to express them.  I will be doing so.

What are your thoughts?  Am I overreacting? Please leave a comment.

h/t PharmExecBlog

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.

QuickNote: The Sunshine Act is Here to Stay!

Given the results of the presidential election, the remaining hopes I have heard expressed that the Sunshine Act would not be implemented should have evaporated.

We have already discussed here some immediate work MA needs to do to start prepping the ground for the data.  While it is looking likely that implementation may be delayed, MA leaders should be planning for this in their 2013 budgets.

Any other impacts of the election that MA leaders should consider?  Leave your thoughts in the comments.

Topic 17 – New MA Organization – MedComm/SciComm

A reader and I discussed her dilemma the other day.  She was being tapped to create a new MA function for a small biotech that was bringing its first product to market.  She had fairly broad latitude but was not sure where to begin.  Some of the points of our discussion are captured below.

We have already discussed preparing an MA team for launch here, the effective way to manage MSL groups here  and the best way to develop a MedInfo function here, I thought I would focus on the Medical Communications or Scientific Communication group with this post.  A note about function names.  I very much prefer the term Scientific Communication because it more correctly reflects the role of the function which is to provide scientific data to the market place some of which is purely medical but some of which may be of a health economic nature that are not purely medical.

SciComm is a critical function for MA but developing one from scratch is as much a challenge in internal politics as a challenge in terms of operations.  At a small company, before there is a SciComm group the company is already publishing.  So, developing a group can be sensitive and many toes can be treaded upon if one is not careful.  The best approach is to co-opt the staff that have been driving the publication efforts in designing (and maybe leading) the new SciComm function.  But, it is critical that everyone involved realize that publications take on a broader role in SciComm than they did in CD.

In CD the role of publication was primarily focused on the results of clinical trials.  That continues to be a responsibility of SciComm but its role of sharing scientific data expands to identifying the scientific questions that the marketplace needs answered, some of which will be answered through literature analysis or through non-clinical studies.

Given that CD is typically handling the publications in advance of the SciComm function, the temptation may be to put developing the group on the back burner until other MA functions have been more fully developed.  This would be a mistake.  SciComm needs to be analyzing the scientific needs of the HCP community and ensuring that the required scientific information is available concurrently with launch.  Any delays can result in a vacuum of information and who knows what will fill that vacuum (or which competitors will try to fill that vacuum).  So, at least 18 months prior to the launch the SciComm group should be launched, right along side the MSL function.

What has been your experience with SciComm groups at launch?  Leave a comment.

Topic16: Greater Clinical Trial Transparency and Medical Affairs Rapid Response

GSK announced this week that it would open up its clinical trial data sets to researches who receive approval from a GSK review board.  Next year, the EMA intends to open up access to all new clinical data files that are part of a product registration filing.

I believe this is a trend that will not stop – the increasing openness of biopharma with its clinical trial data.  What does this mean for medical affairs?  I have some initial thoughts below but I would be curious to hear your perspective.

As this data becomes more open, other scientists, some perhaps not fully qualified to understand the data set, are going to review it and draw conclusions.  Since our culture has incentives for publicity in academia, expect that at least some of the scientists are going to spin the data into the scariest sounding headline they can.

The result is, I predict, a sharp rise in news stories highlighting safety risks of products, often blown out of proportion.  Nevertheless, it will ultimately fall to MA to deal with this misinformation on the scientific side.   While this can happen today, it is still fairly rare.  I believe it is going to be common place.

In order to be ahead of this, MA leaders are going to need to set up a Rapid Scientific Response capability (if they don’t already have one):

• Identify Potential Areas Requiring Responses  –  First step is determining what potential areas require rapid scientific responses.  Start with a brainstorming exercise and prioritize to get to the top 5 to 10 topics.


• Determine Leader of Response – For each topic area, identify who from the MA or other functions team should take the lead on coordinating the rapid scientific response


• Identify Internal Experts and Voices – Search through the organization and determine who else has the scientific expertise and other skill sets needed to support the rapid scientific response – PR and Legal should be a part of each team


• Develop Rapid Response Plan – Create a plan for assessing the situation, determining the outline of the response, assigning elements to team members, pulling it together, getting it reviewed and getting the message out  

The entire goal of develop the Rapid Scientific Response capability is to be able to move quickly when the event occurs and produce an accurate and complete response in as little time as possible.  Without this advanced planning, when issues hit no one is clear who should be taking the lead and how.

Do you have a plan for Rapid Scientific Response?  What other impacts do you think the increasing openness of clinical trial data will bring to MA?  Leave your thoughts in the comments section.

Topic15: OLIS and Journal Clubs and Journal Articles

I was talking with a friend and client about internal journal clubs in particular and discussing journal articles with HCPs in general. This discussion may be germane to a number of you because it really stems from what I think of as “Overactive Legal Imagination Syndrome.”

OLIS is the reality many of my clients face when their legal group begins to tie itself in knots over the practical implications of the fact that MA must talk about the science involved with its products, and some of that science may ultimately be compelling enough that the HCP decides that our product is something that they should use.  OLIS drives them to wonder “How can we not be promotional if the results of our permissible scientific exchange is that the HCP decides to use our products?”

See our thoughts below:

1)      Can we allow Internal Journal Clubs?

• We already agree that field staff can have permissible scientific exchanges with physicians


• In order to have scientific exchanges they need to know the latest science which is represented by what is being published in peer reviewed journals


• Although our team is good, no one member of the field force has all the knowledge necessary to understand the huge range of potential scientific articles or the time to cover the huge range of journals


• As a group, however, they do posses both the knowledge and the time


• Therefore, they should be allowed to review the new scientific information as a group and share with the members the information they need

2)      What if the conclusions reached in the internal discussions of the articles are biased?

• So what? – we are not going out to the HCPs to present our conclusions but to have a scientific dialog – to listen and answer scientific questions


• Any perspective we have is already perceived to be biased – we work for a major pharmaceutical company and everyone knows it


• The issue is not bias – which is not against the law – the issue is promotion

3)      What if our perspective is deemed to be promotional?

• There is absolutely nothing new about a concern that our scientific dialogs run the risk of being promotional


• BUT, we already have standards and training in place to ensure our staff does not promote during scientific exchange – regardless of whether that exchange is about a new article in a journal or an existing safety issue, etc. etc.

4)      What if the conclusions of the author of the journal article are promotional in and of themselves?

• First, we need to agree that facts, even facts that are favorable to our products, are neither promotional nor non-promotional – facts are facts


• Conclusions drawn from the facts can be promotional


• So if the study finds that patients using our drug have better results than patients using a competitive drug, that fact is NOT promotional UNLESS our field staff says something like:

i.     “I don’t see  how anyone can read this and not put all their patients on our drug”

ii.     “Clearly our drug is the more effective and it wouldn’t be ethical to put your patients on any other treatment”

• If the author of the article draws their own conclusion “…and in the opinion of the authors you would be a fool to treat with anything but X.” then we are back to the points in number 3 above, meaning our team needs to know a promotional statement when it sees it and avoid repeating it


• In this scenario, the internal journal club is actually of value to the company because it allows the group to identify this potentially promotional author conclusions and agree on strategies to engage in this topic without endorsing the author’s conclusions


• Bottom line – these “promotional conclusions” drawn by independent 3^rd parties and published in peer reviewed journals are out in the public sphere and keeping our field team from understanding the article and agreeing on an approach to addressing it without a promotional bias will not stop HCPs from asking them about it and forcing some kind of reply

What has been your experience with OLIS?  What about internal journal clubs?  Leave a comment.

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.

Topic14: SOPs in MA

Now for a topic no one wants to talk about but everyone should become more familiar with – Standard Operating Procedures.  The hard truth of today’s world is that SOPs are no longer optional for MA.  In fact, SOPs are critical for success in today’s global MA.  In this post, I will discuss SOPs in general as well as share some do’s and don’ts for developing effective MA SOPs.

Our brethren in Clinical Development have been living in a world of SOPs for much longer than MA because their work was more explicitly regulated.  When you are regularly audited by agencies looking for an excuse to delay the marketing of your next blockbuster, you are highly motivated to have whatever documentation they are looking for.  And, in CD, that means SOPs that clearly demonstrate that all clinical trials are conducted following GCP and other related standards.

In MA we used to be less concerned about regulation enforcement, but those days are over.  So, what is the state of MA’s SOPs?  If your environment is like those in my experience, the answer is a mixed bag.  Many organizations have some good SOPs but few organizations would claim their SOPs are simultaneously:

1. Complete


2. Accurate


3. Trained and understood by the relevant staff


4. Consistently updated

Most MA leaders will tell you it’s important and on the organizational To Do list but it rarely seems to rise up to the top of that list and almost nothing below number 3 on that list can get addressed in any given year.

Yet SOPs represent one of the very best defenses any organization has to arguments that it is operating contra to regulations.  By having clearly defined processes that are compliant, a training program to show that people learned and understood those processes and a program to ensure that those SOPs remain updated, the organization has a very strong argument in its favor, even if a single actor is caught performing incorrectly, the argument can be made that it is a single bad actor not an institutional problem.

But SOPs are not just defensive in nature.  When well done, SOPs represent an opportunity to capture best practice and apply that best practice on a global level.  Every country, every region does not need to re-invent the wheel.  What we do in MA is standard enough that we should be able to build a single optimized approach that we can apply on a global basis.

When building SOPs there are some definite Do’s and Don’ts.

DO’S

• Leverage major disruptive changes to implement or enhance SOPs
  
  
  
  • SOPs are a major effort and often difficult to justify on their own (see To Do comment above)
  
  
  • Instead, leverage a new system implementation, new regulatory regime or other major change that seems to hit every year or two as the vehicle for investing in SOPs
  
  
  
  


• Be inclusive
  
  
  
  • Ensure to involve every function and every region that is affected by the SOPs, even those that are outside MA
  
  
  • Make sure the SOPs remain valuable throughout the globe if possible
  
  
  
  


• Develop MA-specific SOP templates and development processes
  
  
  
  • Trying to take the CD SOP development templates and processes can result in over engineered MA SOPs
  
  
  • MA SOPs don’t need to be as detailed or structured as CD SOPs because the goals are different in terms of regulatory support – CD SOPs need to comply with GCP at a minimum which drives a certain level of depth that is not necessarily required in MA
  
  
  
  


• Remember the Training
  
  
  
  • Training is the link between SOP development and real world value, yet many organizations fall down on this important step
  
  
  • SOP development efforts seem to lose steam after the creation effort and often result in training programs that fail to ensure that everyone who should learn does learn
  
  
  
  

DON’T

• Pave the Cow Path
  
  
  
  • Don’t just document the current process (cow path), instead take the opportunity of SOP development to do some process improvement work capturing best practices and defining new approaches
  
  
  • This may take a bit longer but the results are significantly more valuable
  
  
  
  


• Get Overly Complex
  
  
  
  • SOPs are guidelines not computer programs – the more detail the LESS valuable the SOPs can become as more and more real world situations don’t fit into the very specific processes
  
  
  
  


• Forget Certification
  
  
  
  • Its great to train, but in the future someone will question whether the training was effective – without some type of certification to prove understanding on the part of the trainees this is very difficult to prove
  
  
  • Certification does not, and should not, be onerous – just enough to prove that the key points are understood
  
  
  
  

SOPs in MA – not a topic anyone gets excited about tackling.  Yet, SOPs are going to grow increasingly important as the regulatory burden on MA grows.

What is your experience with MA SOPs?  Leave a comment and let me know!

OffTopic: JAMA Article on Accelerated Review

I was reading about the JAMA article on accelerated review and it really bugged me.  Just as I was about to write a post about why, Derek Lowe over at In the Pipeline read my mind and wrote the perfect post on this subject.  Take a look.  I could not agree more.

What are your thoughts on the topic?  Have we both drunk the industry kool-aid?

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.

Topic12: Here We Go Again – Oncology Sales Reps and MSLs

Did you see the headlines off this new survey from ZS Associates about sales rep access to oncologists?  The takeaway is that oncologists heavily restrict sales staff access.  Only 39% of oncologists were accessible (by ZS’ definition) to sales staff while the average for other all physicians is closer to 65%.  Take a look at the article here.

For those of us in the oncology space this is not really breaking news but the quantification brings it into focus.   And the article goes on to mention different sales approaches to help overcome this limitation, implying at one point that pharma might re-start the sales arms race and gain access through sheer force of numbers. (I am highly skeptical of this)   We all know when this type of information comes out the next line of reasoning for improving access to oncologists always seems to involve MSLs.

MSLs have access to oncologists, goes the reasoning, and we should use them to “supplement” the limited access of our sales folk.  There was a blog post on this subject in PharmaExec’s blog here that seems to make this case.  In it, the poster cites a study from Industry Standard Research and talks about how MSLs are “…less promotional…” than sales reps and thus more credible.

As MA professionals, we need to nip these arguments in the bud.  While I personally have no issue with taking money that used to go to sales reps and putting it toward MSLs, the justification for doing so cannot be to use MSLs as “scientific sales” or “sales-lite.”  The hard truth is that oncologists are not interested in being marketed to by drug makers.  They are sophisticated physicians with robust knowledge of the scientific state of their therapeutic area, and they don’t need reps to help them make decisions.  What they are interested in is learning and sharing with peers.  And, if we can put MSLs in place that can support that learning and sharing, they will be appreciated and welcome.  But, the minute we try to give MSLs any level of marketing duties, we will simultaneously lose our physician credibility and place the entire MA function in compliance risk.

Instead of seeing the information from ZS as an excuse for pulling MA into marketing, it should be seen as a clarion call for a shift in focus from a customer relationship to an educational and scientific partnership.

MA can have an impact on treatment decisions but not through marketing.  MA’s impact will come from partnering with physicians to ensure they have the scientific facts and support that they need to make informed decisions using their best judgment.

 

What do you think?  Leave your comments below.  And if you are new to the blog, add your email to the list on the right to receive an update when new topics are posted.

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.

Topic10: MA Reporting Relationships in Small Companies

A reader wrote in to discuss a situation at a small pharma company.  This company was just starting up its MA group and it was not sure where the MA group should report.  The reader was well aware of the issues with having MA report to a commercial leader that we discussed in this post.

The challenge in this situation was that senior management consisted currently of just a CEO and a COO.  While the CEO is a scientist who handles their development efforts, the COO handles all other responsibilities, including   Commercial, Finance, Legal and HR.  The CEO would be the natural choice for managing MA, but given workloads it was not practically feasible.  Could the COO handle the job of managing MA even though they also have some commercial responsibilities without putting the company at risk?

This is a very common situation for young organizations.  There is often very little senior leadership to go around.  Yet, as we mentioned in this post, it is critical to start MA up early to support a product launch that may be over two years away.  In situations where it is not feasible for MA to report to someone purely on the science side and they need to report to someone with commercial responsibilities, my rule of thumb is that the role they report to should have substantial responsibilities outside of commercial and should be measured on results that go beyond just commercial measures.

In the case above, the COO has commercial responsibilities but they also have non-commercial responsibilities as well.  Having MA report to the COO should not be a problem, as long as the COO understands the role of a compliant MA organization and follows the general rule about MA interactions with commercial that were outlined here.  In the end, the Agency looks for actions not reporting relationships, but the reporting relationship do send a clear signal about the priorities of the MA organization.

What has been your experience about MA reporting relationships?  Please leave a comment below.  And if you are new to the blog please sign up for email updates by clicking on the link to the right.

Topic9: HEOR Studies – Who Should Take the Lead

I was talking with a longtime friend and client the other day and he was describing a situation in his organization.  A tug-of-war of sorts was going on with HEOR studies.  In his business, the amount of funding going into HEOR studies was going up, and although they had typically be run out of the MA shop, there was increasing pressure to move all HEOR studies over to the Access and Reimbursement group.  We had a good discussion on this which I will try to recap here.

Traditionally all post-marketing research has been driven out of MA.  I use the term driven, because in many organizations the actual studies may be managed by a CRO or a clinical development resource.  But the group responsible for identifying the need for the study, budgeting for it, getting approvals to conduct the study and driving the protocol development was almost always MA.  There is a good reason for this, the Medical Director, who typically owns the scientific lifecycle of the compound is in MA and thus should be driving this process.

Now, post-marketing studies is a very large bucket.  It can include additional safety studies, both mandated and not mandated, reformulation studies, label expansion studies, HEOR studies, just to name a few.  And, given the huge range of post-marketing research, it is fairly standard that the Medical Director and MA in general partners with other parts of the organization that have expertise in these areas.

Fast forward to today’s world.  HEOR studies are increasingly critical to the medical and business case that Access and Reimbursement needs to make to payers in order to achieve a beneficial position in their formularies.  Investment in HEOR studies are growing by 0ver 40% in the past few years, as discussed here.  Given their knowledge of the audience, the data that they need and the competitive data that they are likely to have available, no one is in a better position to define the requirements for an HEOR study than the Access and Reimbursement team.

But, does that mean that Access and Reimbursement should be driving the HEOR studies themselves.  My answer remains been no.  Access and Reimbursement should be a defining voice in the development of the protocol, but once that protocol concept has been finalized it becomes an issue of study execution.  This is frankly how it works with most post-marketing studies.  While I can grant that an HEOR study has unique issues, so do many of the targeted post-marketing studies.

Having said all of this, it is also true that I, myself, have set up just such a function for an Access and Reimbursement client.  They had circumstances that made it clear that the MA function was not valuing the need for HEOR research and thus it was not getting done on a timely basis.  This was essentially a political issue but the only way to resolve it in the short-term was the create an dedicated function within Access and Reimbursement.

I am curious to know your experiences in terms of HEOR studies.  Leave me a comment below.  And if you have any question that you would like me to address, please click on the email link to the right.

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).

Topic7: Coordinating MA and Commercial

A reader asks:  “Given the importance of consistent communication to the healthcare community, my company is seeking to better coordinate commercial and MA messaging.  What is the best approach for doing this?”

Thanks for the question.   The answer is: Very Carefully!  My sense is that your commercial function is driving this requirement.  I infer this from your question because you use the term “messaging” which is generally a marketing term.  Let’s remember that the purpose of marketing is promotional – promoting the sale and safe use of our products.  Since it is promotional, their communications are limited to on-label information.  If their communications go beyond the label, they are promoting off-label.  We all know this is against the law.

MA is allowed to discuss off label topics only under very specific circumstances – when they receive an unsolicited request.  MA is allowed to have some proactive discussions which are educational and non-promotional about related non-label topics depending on the rules of each organization.  See a detailed discussion of this here.

So, marketing is promotional and MA is non-promotional.  What “messaging” can a promotional and non-promotional functions share?  Conservative organizations would argue that any messaging topics that support the promotional needs of commercial is, by definition, not an acceptable topic for non-promotional MA.  But, many organizations would agree that promotional topics can focus on the product and its competitive positioning; while there can be related non-promotional topics such as the underlying disease state.

Most organizations that allow some coordination between promotional and non-promotional topics understand that this is a risk.  To avoid the risk of MA appearing as a promotional entity, most companies expect the coordination will go one way only:  from MA to commercial.  The theory is that MA is going to be educating the market regardless and the commercial function is just becoming aware of what MA is doing.

Going the other way, from commercial to MA, runs the risk of appearing as though MA is part of the promotional machinery.



So, reader, be careful.  Processes and systems must be put in place to ensure that the coordination is going the right way only.  Otherwise, you run the risk of a future whistleblower pulling out a document showing that MA has become a promotional resource.

For example, there need to be clear firewalls between the way MA is measured and the way commercial is measured on the effectiveness of their communication efforts.  We have discussed MA measurements here.  Commercial measures of effectiveness should be much more related to sales and penetration.

Thanks for the question!

If you have a question, please email me or leave it in the comments!

OffTopic: The FDA Monitoring and Whistleblowing Scandal

Have you been following this issue?  It gets more and more fascinating the further you dive into it.  A excellent and definitive analysis can be found here, but for those of you too busy to read six small print pages, allow me to summarize:

The Setting:

Late in the 2^nd Bush Admin, at the Center for Devices and Radiological Health (CDRH)

The Baseline Concern:

Some first-line reviewers felt that computer-aided cancer screening diagnostics should not have been approved for use based on their interpretation of the risks associated with by-product radiation and their lack of confidence in the data within the application

The Baseline Grievance:

 The first-line reviews saw their recommendations overturned by their senior management, who granted approval.

The Work to Resolve the Grievance:

 The first-line reviews complained to Office of Special Counsel (OSC), OIG,  members of Congress and eventually to the New York Times about the situation.

OK, already a nightmare but at least fairly clear.  Government employees are permitted under the law to ignore certain confidentiality requirements if the safety of the public is at risk.  They are not, however, allowed to disclose non-safety related confidential information publically.  This is where the first line may have been crossed.

The NY Times Gets Involved:

The NY Times publishes an article describing the situation and including certain confidential information contained in the application and that may not have been directly related to safety concerns.

The Companies React:

The companies whose confidential information is now plastered over the front page of the NY Times demands that this stop.

 FDA Senior Management Reacts:

FDA senior management arranges to have the FDA-issued computers of a number of potential leakers secretly monitored – every website visit, every key stroke, every file downloaded.

Quick aside: to be fair to the FDA, every time an employee logs onto their FDA computer they are forced to read the following “You have no reasonable expectation of privacy regarding any communications or data transiting or stored on this information system….”  Seems to me its hard to argue that they did not have fair warning.

FDA Senior Management Finds the Leakers/Whistleblowers:

Some of those first-line responders are clearly found to be communicating with the NY Times and other media outlets.  They also find correspondence with Congress, OSC and OIG.

FDA Senior Management Terminates the Leakers/Whistleblowers:

Over the next couple of years the contracts of the leakers were not renewed.

Leakers/Whistleblowers Sue FDA for Wrongful Termination:

A lawsuit is, of course, already pending on this.

So far this is a really sad situation, but at least understandable.  Now, however, its all about to blow up.

FDA Contractor Screws Up Big Time:

An FDA document management vendor makes a world-class screw up – posting thousand of pages of information that was secretly captured from the computer monitoring on an unsecured website.  A terminated leaker/whistleblower discovers this accidentally while Googling her own name.

Everyone Blows a Gasket:

With the documents revealed, all sorts of groups blow a gasket.  The leakers/whistleblowers claim their rights were infringed.  Congress is furious because some of the communication that was monitored included communication to Congress.  The OSC and the OIG are very upset because some of the communication was to them.  Neither Congress nor OSC/OIG communications are supposed to be monitored.

And this is where we are today.

Frankly, this whole situation is a major fiasco.  It makes the FDA look like the most dysfunctional organization in the government, and that is saying something.  Clearly CDRH needs to be stripped down to the floorboards and rebuilt with a functional culture.

Why am I taking a “blame everyone” perspective instead of supporting the leakers/whistleblowers.  Normally that would be where my heart was at, but it was just released that those same leakers/whistleblowers had filed a secret lawsuit in court against the manufacturers whose products they felt were unsafe.  And this lawsuit was filed while those leakers/whistleblowers were still employed by the FDA reviewing exactly these products.  And those same leakers/whistleblowers demanded at least 15% of what would be a multi-billion dollar settlement.  Not what you would consider an impartial set of reviewers.

So, this is a pox on both houses situation.  We deserve and should expect better from the FDA.

What do you think?  Anything I missed?  Leave your comments below.

Topic 6: Measuring the Value of Medical Affairs

Introduction

A reader requested a discussion of different approaches for measuring the value of medical affairs.  This is a critical question and one that I touched on briefly when I discussed strategic planning in MA as it relates to launch.  But it is equally important overall for MA.

Like any function in pharma, MA must be able to communicate its value.  Value can be a tricky concept, however, for a non-commercial function like MA.  Value is ultimately a company-specific question.  It stems from the company achieving its strategic goals, which is why defining goals is so important.  Having said this, there are some general categories of value measures that we can discuss as well as some best practices around measuring value.

Value measures in MA typically fall into two types:

1. Objective measures


2. Subjective measures

Objective Measures

In MA, objective measures tend to focus around activity-based measurements.  Since MA cannot be seen as promotional, the other available objective measures like prescriptions written, sales numbers, profitability, etc. are not relevant.

Activity-based measures have both strengths and weaknesses.  On the strength side activity based measures are:

• Easy and cost efficient to gather


• Easy to explain to non-MA colleagues


• Non-controversial

Unfortunately, activity based measures also are:

• Not outcomes focused


• Not usually tied to the direct concerns of the organization


• Potentially misleading

While it may be interesting to know that the MSL group conducted 150 meetings with KOLs in the last quarter, it tends to beg the question – So What?  Activity-based measures tend to focus on the tactics (e.g. reach out to KOLs) rather than the goals (e.g. ensure broad awareness of the latest disease state information).

Activity-based measurement is very appropriate for certain MA functions.  For example, on CME funding, which by definition must be a hands off process, the only important measure is activity-based: Did the organization fund the number of CME programs it had intended to fund?

Or, in the Medical Information function, the key measures relate to answering inquiries and responding.  Activity-based measures (e.g. total number of inquiries managed, average turn-around on inquiries, number of inquiries requiring a second contact) are very appropriate for this type of service.

Finally, activities with multi-year goals like post-approval clinical trials, use activity-based measures to ensure that the overall program is on track.  So activity-based measures like patient recruitment and data collection provides valuable insight.

Activity-based measures are a necessary for MA’s ability to track progress against its goals, but they not sufficient to account for all of MA’s goals.

Subjective Measures

Most MA organizations have goals that require a more subjective type of measure.  Some of these goals relate to the degree of awareness or understanding in the healthcare community.  Measuring understanding or awareness is not as simple as measuring the number of discussions about a certain topic.  Instead, to measure progress on these types of goals, MA needs to gather more subjective data.  Simply put – it needs to ask.

For goals related to subjective measures, the only practical way to measure success is through research.  Unless a company is very lucky and finds that one of its objectives just happens to align with a topic that is already the subject of someone else’s research, this almost always means conduct primary research.

Research-based measures have their own strengths and weaknesses.  The strength of research-based measures include:

• Direct connection to goals related to healthcare community awareness and understanding


• Insight into the knowledge and beliefs of the healthcare community


• May provide insight into other, unmet needs

Research-based measures have some significant drawbacks, including:

• Expensive to conduct, leading to limited number of data points


• Subject to research bias


• May be taxing to the community that the organization is trying to serve

For research-based measures to be understandable, they usually need to be measured against a baseline.  For example, the measure of awareness of new disease-state information in the healthcare community after the efforts of the MA organization is only relevant if the measure of awareness before the efforts were known.  This requires the development of a baseline which both adds to the cost and requires good up-front planning.

But by far the biggest challenge of research-based metrics is the lack of experience and budget to conduct such research.  Many MA organizations do not have experience conducting this type of “market research”.  Without such experience, it can be daunting to initiate the research and structure it in the best manner.  Additionally, many MA organizations do not have money in the budget to conduct this research in a high quality manner.  This is both a product of the lack of experience and the view that this type of research is outside of the mission of medical affairs.

Best Practices

Clearly most MA organizations can benefit from a set of mixed objective and subjective measures.  Developing such a set of measures starts analyzing the strategy and goals outlined in the MA strategic plan.   From there a set of potential measures can be defined and prioritized.  Overall, MA should have between 5 and 10 metrics.  Specific functions within MA may have from 3 to 5 additional detailed metrics.  Once these metrics are defined, the approach for gathering each metric can be identified.  The activity-based metrics are typically gathered from existing tracking systems while the research-based metrics require more active management.

Once the research-based metrics are defined, a draft of a research outline can be developed, specifying the key questions, the research targets, the number of responses expected and the number of research samples to be taken.  This outline can be used as the basis for developing a request for proposal from a research company.

One caution – many organizations are tempted to combine this research with research already being conducted by the commercial market research function.  This may be a problem if the marketing questions are, in themselves, seen as promotional.  Most of my MA clients have been unwilling to risk this crossing of the line but some organizations do follow this practice.  Please work with your compliance function to discuss this approach.  Many organizations are not even comfortable with using research companies that are primarily commercially oriented but, frankly, there is little reason to avoid these companies.

After the approach to both activity- and research-based metrics is in place the next step is to determine how the results will be communicated and to whom.  This should become an ongoing process so it should be automated and standardized as much as possible.

Closing Thoughts

Explaining the value of MA remains one of the primary responsibilities of MA management.  For MA to be perceived as valuable to the organization, its progress against its strategies and goals has to be proven.

What has your experience been with value and measures in MA?  Leave your comments below.

Click on the email link to the right to suggest a topic for future posts.

Topic5: Relationship between MA and Managed Markets

Introduction

I received a question about what an optimal relationship should be between MA and Managed Markets in the US.  Managed Markets (MM) is the function in pharma that is primarily responsible for negotiating the relationship between the company and the major payers.  In some organization this group is known as Reimbursement, Access, Market Access, Payer Relationship, or Pricing.  The primary challenge is ensuring that the company’s drugs are listed as advantageously as possible on the formulary of the payer.  In the US, the MM function has had to deal with a range of both government and private payers, each with their own formularies.

The MM function in the US has grown in importance as the payers have worked to limit their exposure to potentially expensive treatments through formulary placements that drive limitations 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 MM are forcing changes in the way they work with payers, those same pressures are changing the relationship between MM and MA.  In the past, MA had a limited role to play in MM.  For example, MM might occasionally ask an MA resource, typically an MSL, to provide some scientific support for a formulary presentation.  But, in general, these situations were ad hoc and limited.

However, now that MM’s success more directly drives the success of the pharma company and thus their importance has grown, the relationship between MM and MA is changing.

For a formulary committee to control costs, they must be able to differentiate between more and less effective treatments, including the total cost of treatment.  This drives two major needs:

1. 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


2. The formulary committee is demanding more specialized data, specifically health economics and outcomes research (HEOR) 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 MM.

More Robust Scientific Understanding

MA’s role in terms of providing scientific support for formulary 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.

As the importance of the scientific presentations to formularies grows, the developer of those presentations and the presenters need to have a much more robust understanding of their audiences and how to effectively meet their needs.  This is leading to two trends in MA:

• Much greater degree of training for MSLs on the role of MM and formularies  

OR

• The identification and hiring of full time MSL-type roles specifically targeted at supporting MM                                                                 

Given the importance of MM, 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 the field force of MSLs is prepared to adequately support this need.

More Specialized Data

MA has typically taken the lead in developing data post-approval.  And while HEOR has always been an part of generating that post-approval data, its importance has grown significantly.  The increased demand for HEOR data has a number of implications:

• Data Generation Plans, which should be developed by MA to help drive the post-approval data 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 MM 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 MM that they have shifted the leadership of this research to the MM function itself.  Whether the HEOR function reports to MM or is developed within MA, the need to ensure that the needs of MM are addressed has become a major priority for post-approval research.

Closing Thoughts

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 MM as it works to ensure patient access to the company’s drugs.

In your experience what has been the key to effective MA / MM 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.

Authors Note:

Since I started this blog I have been focusing on major topics and posting three or more posts on those topics for your consideration.  I have received a couple of emails asking me to address more specific topics and as a result I will be adding new posts that address a single topic.

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.