Medical Affairs Focus

Challenges of leading global Medical Affairs

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.

Changing Relationship between Medical Affairs and Access & Reimbursement

Note: This is a revised and extended version of a post I first published two years ago. This issue continues to evolve and be an area of focus for many MA Leaders.

Introduction

I received a question about what an optimal relationship should be between MA and Access & Reimbursement in the US. Access & Reimbursement (AR) is the function in pharma that is primarily responsible for negotiating the relationship between the company and the major payers and/or providers. In some organizations this group is known as Managed Markets, Market Access, Payer Relationship, or Contracting. Their primary goal is ensuring that the company’s drugs are listed as advantageously as possible on the formulary of the payer.

AR has to make the case for reimbursement of their drug to a payer/providers Pharmacy and Technology Committee (P&T Committee) which is the body that ultimately makes the decision for the payer/provider. In the US, these P&T Committees consider the efficacy and safety of the treatment but they also consider the cost effectiveness of the treatment and its impact on total cost of care for a patient when deciding where to place the treatment on their formularies. The AR function has had to deal with a range of both government and private payers/providers, each with their own formularies.
The AR function in the US has grown in importance as the payers/providers have worked to limit their exposure to treatments they viewed as not cost effective through formulary placements that drive limitations like prior authorizations and co-payments for the patients. Even specialty areas like oncology, which used to have very few restrictions, are now seeing greater control exerted by the payers.

Defining a New Relationship

Just as the pressures on AR are forcing changes in the way they work with payers, those same pressures are changing the relationship between MA and AR. In the past, MA had a limited role to play in AR. For example, MA may have had a responsibility to train AR Account Managers on the scientific underpinnings of a new treatment, not dissimilarly to how MA may train sales staff. And AR might have occasionally asked an MA resource, typically Field Medical, to provide some scientific support for a formulary presentation. But, in general, these situations were ad hoc and limited.

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

For a P&T Committee to control costs, they must be able to differentiate between treatments. This drives two major scientific needs:

  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 like cost effectiveness and total cost of care, and comparator data to allow them to understand the full impact of the drug’s use

Both of these ramped up requirements have direct impact on MA’s relationship with AR.

More Robust Scientific Understanding

MA’s role in terms of providing scientific support for P&T Committee presentations is growing from a part of the presentation to the core of the presentation. And with that growth comes the need for greater specialization by the presenters.
MA which develops and delivers the scientific elements of those presentations need to have a much more robust understanding of their P&T Committee audiences and how to effectively meet their scientific needs. This is leading to two trends in MA:

  1. Much greater degree of training for Field Medical on the role of AR and P&T Committees
    OR
  2. The identification and hiring of full time Field Medical-type roles specifically targeted at supporting AR

Given the importance of AR, supporting their needs can no longer be seen by MA as a side responsibility. Instead, it needs to be a core responsibility and an investment in training or personnel is needed to ensure that that Field Medical is prepared to adequately support this need. In addition to training, this will require new measures to be put in place to track Field Medical effectiveness, which I will discuss in a future blog post.

More Specialized Data

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

  • HEOR data should start being gathered in Phase 3B at least, and thus MA HEOR leaders need to engage with clinical development to ensure endpoints are included to begin the generation of HEOR data sets
  • Post-Approval Data Generation Plans, which should be developed by MA to help drive the post-approval study efforts, must give greater consideration to the HEOR needs
  • The priority given to Investigator Initiated Studies that cover HEO subjects may need to increase
  • The need for specialized MA resources dedicated to developing and managing HEOR may need to increase, with new dedicated positions developed
  • Processes for ensuring that the input of AR is gathered in the development of HEOR protocols should be re-examined to ensure that the results will meet the demands of the key formulary committees

In some companies have decided that HEOR is so important to AR that they have shifted the leadership of this research to the AR function itself. Whether the HEOR function reports to AR or is developed within MA, the need to ensure that the changing needs of P&T Committees are addressed has become a major priority for post-approval research.

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

In your experience what has been the key to effective MA / AR partnership? Leave your comments below.

If you have a topic you would like me to cover, please email me from the link to the right.

Apology and Explanation:

I am sorry that I have been away from this blog for so long. As some of you know, I had a family crisis and I needed to focus all my energies on my family. Thankfully family is now well and thriving and I am starting to come out of my cocoon.

Thanks to all of those who have sent notes asking about my disappearance and offering support.

I plan on adding to the posts on MA Focus, and in the next couple of months moving this blog over to my company’s new website.

Topic 30: Virtual MA Organizations – Leadership Implications

I have posted about outsourcing in MA in past posts here and here.

Today’s topic is focused on the virtual MA organization – an organization that outsources all or almost all of its key functions.  Given the capabilities of service providers, it is entirely feasible to outsource every sub-function within MA, including medical communications, grants management, medical information, standard and specialty field forces / MSL groups.

My goal today is not to discuss the pros and cons of a decision to form a virtual MA organization but instead to discuss some key aspects to making a virtual MA organization successful.  Although today’s post is looking at a fully virtual MA, the key points would be just as relevant for a mixed virtual and internal MA organization.

Reality of Virtual MA Organizations

Most organizations that decide to use virtual MA are organizations where very little MA infrastructure exists.  Either they are small organizations building their first MA function or they are mid-sized organizations that are going into a new TA.  Regardless of situation, the analysis that leads to a virtual MA organization is usually a buy vs. build decision.  When considering how to make virtual MA successful, we need to start at that point.

Keys to Success

There are three keys to success to managing a virtual MA organization:

  • Upfront Expectations
  • Sufficient Internal Management Resources
  • Structured System for Evaluations

Upfront Expectations
In order for the virtual MA organization to be successful, the vendors that provide the services need to have a clear understanding of what is expected of them and when so that they can develop the correct scope of the work for their pricing.  Defining what is expected of the vendor is easier in some cases, like for Medical Information defining expectations about call wait time and speed of fulfillment.  But, defining expectations is much harder in cases like an MSL group or a specialty education group.  This challenge is heightened by the fact that the reason some organization’s decided to go virtual is that they don’t have a lot of expertise in house.

Nevertheless, it is vital that a clear set of expectations and measures are agreed upon as a part of the vendor selection and contracting process.  There is no point in the process where the company has more control than at the point of contracting.  If clear expectations are set, both sides win because the vendor can appropriately staff and manage the group and the company can achieve their goals.  If not, the vendor may either need to increase the scope during the contract or simply fail to achieve some needed result and the company will face unexpected costs and missed expectations.

In order to set the right expectations a strategy for MA’s work for the next period must be developed in detail.  And this strategy should be developed before the vendor selection process occurs to ensure that the vendors are supporting the strategy not the strategy supporting the vendors.

WARNING: Some vendors in our industry will encourage buyers against doing this work in advance.  The vendors will tell the buyers that the vendor will develop these expectations after the contract is signed and/or after they are active.  Companies that take this approach usually end up spending much more than they expected and achieving less results than they expected.

Sufficient Internal Management Resources

Virtual does not mean management free.  While the vendors will definitely have their own managers, successful virtual MA organizations have learned that they need to closely manage the vendors to achieve expected results.

Given the situation that leads to a virtual MA organization as discussed above, it sometimes comes as a shock to those setting up one that they still need to hire.  And those hires need to be managerial-level staff.

A general rule of thumb is the greater the range of responsibilities and lack of clarity, the greater the need for management.  So, for example, outsourcing a MedInfo group, with clear metrics and expected volumes, might require only a ¼ Associate Director.  But managing an outsourced MSL group during launch, even if there is a clear expectations set up-front, would require a ½ time director to deal with the unexpected and new learnings from the healthcare community.

If the company is unwilling to invest in the resources needed to manage the virtual MA vendors, that is a sign that the value of MA is not really understood within the organization.  Unless that core issue is addressed it is unlikely that the virtual MA group will be successful.

Structured System for Evaluations

In addition to being actively managed, virtual MA vendors need to be on a half yearly or yearly structured evaluation process.  The structured process will force a review of the original goals and scope of the relationship and provide an opportunity to resolve ongoing issues.  Without a structured process for reviews, problems tend to fester and eventually result in a complete breakdown of the relationship.

Many companies entering into a virtual MA environment rely on the vendors to suggest the structures of these types of meeting.  I would recommend that the company own the process and set the agenda.  This will ensure that those issues most important to the company serve as the focus of the process as opposed to an add on.  It also avoids the “make the case for added scope” that many vendor-driven processes tend to become.

Do you have experience setting up or managing a wholly or partially virtual MA organization?  What would you recommend?  Please leave a comment or send me a message.

Topic 29: “An American in Paris” – Inheriting an EU-based Field Force

A reader (and now friend) recently contacted me with an interesting challenge and agreed to allow me to recap our discussions here (de-identified, of course).

He/she was recently promoted into global responsibilities for managing the MA field force.  For their mid-sized biopharma company, global meant US and EU and this person already had managed the US field force.  He/she wanted to discuss keys to taking on the EU MSLs (although they use a different term).

1.    Time to make your “Grand Rounds” of the EU

Although no one has the time or budget, it is critical to find a way to meet with the EU MSL team members in their individual countries, rather than as a set.  Given the way many EU country organizations are run, the MSL may be significantly more focused on their country-level needs than overall EU level needs.  So you need to go out to the countries and meet them and their key internal stakeholders in the country leadership.  MA’s work with commercial can be more flexible in the EU than in the US, so it is important to explore how the MSLs are supporting their country needs.

This is a critical time to listen and not judge.  The goals and programs of the MSLs tasks can differ quite a bit from the mean country to country.  It is not unusual to find some activities that strike you as being in the grey area (by EU standards) have crept into the MSL remit, especially if the country lead is unclear on the standards and the MSLs don’t hold to the standards clearly.   These activities are usually driven by some high-value, country-specific scientific need so you need to be careful about simply pulling the plug.  Instead you should first explore the compliance aspects (see next point below) and if you decide to terminate them, work with the local stakeholders to find a more compliant alternative.

Regardless, you should come away from the Grand Rounds understanding not just your new MSL team but the environment in which they operate.

2.    Make friends with EU Compliance internal resource or get name for who the organization uses externally to support compliance in the EU

My friend understood that the difference between the EU regulatory environment and the US environment in general, but one of the key points when first managing MSLs in the EU as an American is to break the US-conditioned mind-set that EU countries are the equivalent of US states.  While everyone understands this, it is very common to fall into assumptions about a broad set of rules that apply equally to all of the EU.  There are some of these (privacy laws being one of the biggest differences from the US) but there are also a range of country-specific rules which must be taken into account when considering MSL goals and activity in the EU.

If you are lucky enough to have in-house compliance counsel with EU expertise, my recommendation is that you approach them after each of your country visits, which will allow them to tackle the issues without overloading them.  If you use outside counsel, hold all your questions until the end since them always seem more efficient when you give them a raft of questions vs. one or two at a time.

3.    Determine how much global alignment you want to force

Determining how similarly you want to run the US and EU groups should be carefully considered.  It is possible to force full alignment between the US and the EU, one set of rules, standards and measures for all.  The downside is that you have to go with the strictest regimen between the US and the EU and countries, and this can really stand in the way of effectiveness on both sides of the Atlantic.

Instead, I suggest maintaining two sets of standards.  For example, given the different compliance regimes, to maximize the value in each country a different set of SOPs may be reasonable, despite the cost and inefficiency of having two sets.  Systems may need to vary given EU privacy rules or at least communication about the content of the system.  Even basic metrics and measures of performance will likely need to vary.

What advice do you have for the “American in Paris”?  Leave a comment.

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QuickNote: Sunshine Act – Are Mechanics Crowding Out Relationship Management?

Readers of this blog know that I have strong opinions about MA’s role in the success of the Sunshine Act in their companies.  MA is responsible for long-term scientific engagement with the company’s top external experts, and these are the very people most likely to be negatively impacted by the Sunshine Act compliance if it is handled wrong.  Clinical is focused on the next study, commercial is focused on the next sale, only MA is focused on the overall relationship.

It is for that reason that I have been increasingly concerned when a number of my friends in the industry have told me how little, if at all, many MA organizations have been engaged in the efforts so far.  To be fair, many organizations are focusing on the mechanics right now – gathering the right data, centralizing data from a range of different sources, coding it in the right way and reporting it effectively – most if which is not the responsibility of MA.  Nevertheless, precious time is being wasted on the relationship side of this effort.

So, this is my call to action.  If by June 1, your organization has not begun an overall communications and relationship management plan spearheaded by MA, you are officially behind the curve.  The data will need to be collected as of August 1, and your MSLs should be explaining the why’s and what’s of this process before that data begins to be collected.  They can’t do that without a thorough communication plan.  And, some KOLs are likely to react in a less than positive way to this development – you need a plan to handle this as well.

The platform is burning – time to push ahead and take the lead in this effort!

Topic 28: Big Data and Medical Affairs

“The era of Big Data is here!”  That may be true but what does that mean for Medical Affairs?  As in all of biopharma, MA is comfortable working with data.  So much of our work revolves around discussing data and the implications of data that many people may think that we were already living in the era of Big Data.

But for most MA organizations, the data sets we have focused on are purpose generated – either our own data or data from similarly-scaled studies conducted by others.  Big Data refers to something different.  I like the differentiation that SAS uses when comparing Big Data to the past data sets.  They break it down to four “V”s and a C:

  • Volume: Hugely increased data volume from the past
  • Variety: Since the data is produced in many different ways, it has many different formats and structures
  • Velocity: Both how fast the data is being produced and how fast it must be processed
  • Variability: Inconsistent data flows, with peaks and valleys
  • Complexity: Driving value out of these data sets is highly complex and difficult

This is not your grandfather’s data sets.  What are some examples of Big Data as relevant to biopharma and MA:

  • Electronic Health Records data from a variety of sources
  • Search engine data (see an example of analyzing search data to find safety signals here)
  • Sunshine Act Physician Spend Data (when it becomes available)
  • Social media data
  • Competitors clinical trial data as it is released

Contained within these and many Big Data sources are key tools for MA:

  • Valuable therapeutic information
  • Unique customer insights
  • KOL identification and information
  • Visibility of competitors drug development and support efforts
  • Important drug safety signals

But, none of these benefits can be achieved unless the question is asked and the data is analyzed.  I would suggest that effective MA organizations of the future will need to have the capacity to ask and answer these types of questions.

In order to do so, MA organizations will either need to build or have access to increased levels of biostatistical and epidemiological resources.  And these resources need to have skills directly related to Big Data.  The characteristics that differentiate Big Data from existing data sets also means that many existing biostats and epi staff do not have the expertise or confidence working with these large, external data sets.  MA organizations need to ensure that people with exactly these skills sets are available within their organizations or from outside vendors and that these resources have the capacity to support MA.

Then, MA needs to improve its overall level of confidence defining Big Data questions, conducting Big Data analysis, and discussing the results with others.  Given the difference in the source of this type of data, the way this data is presented and discussed must be different too.  Everyone in MA, but especially the MSLs, must become more comfortable understanding the nuance of this type of data analysis and discussing both the strengths and weaknesses of working with Big Data.

The era of Big Data is here.  MA has a long history of effectively using data and explaining data in support of its organization.  MA leaders must investigate and embrace Big Data to take advantage of all the tools available today.  The questions unasked are always the questions unanswered.

What is your experience with Big Data?  Please leave a comment.

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.

Welcome to MA Focus Blog

Welcome!   I have been getting some 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 (use the “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 proactivityKOL identification, MedComm/SciComm groupsMA at Product LaunchGlobal 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.

Topic 26: Highlights of Day 3 of the Medical and Scientific Communications 2013 Forum

­

The final half day for the MSC meeting had an excellent and well received discussion about MSL metrics.  I also attended an interesting talk on coordinating global publications.  My take on it below

DISCLAIMER:  My focus is on interesting information, I did not try to take verbatim notes and will not try to assign comments to a particular speaker.  Any mistakes are mine alone.

In no particular order, some of things are found interesting included:

–  Metrics

  • Must vary as focus of the organizations varies
    • Plays back to earlier comments about staying focused if you want to see improvement over time
    • Mix of Activity, Value and Compliance measures are needed
    • IIS Metrics
      • Good to track in terms of just a sense of the program
      • NO goals should be put in place
      • Additional metrics discussed
        • Engagement with ACOs or Cancer Networks or other new healthcare entities
        • Congress attendance valued by quality metric of the outputs not the activity
        • Dollars saved by asking MA to assist CD, especially when CD has a bid from a vendor to provide the same service
        • Internal stakeholder feedback
          • Important – best to solicit directly via email/conversation
          • BE CAREFUL – some organizations do not allow feedback from Commercial

–  Reports/Dashboards/Scorecards

  • Need to develop different outputs for different stakeholders
  • What is needed internally at MA is not what you want to focus on with other internal stakeholders
  • Always pair summarized numbers with text explaining value and highlighting accomplishments/learnings

–  MA IT Systems

  • As mentioned earlier, a number of companies seem to be moving toward the Veeva Platform which is built on top of Salesforce.com CRM.
    • Veeva seems to be driven by the commercial side, but it has MA capabilities
    • Some people mentioned that you need to be careful about Veeva training and documentation as it often defaults to commercial language
    • Some organizations use it to track not only KOL interactions but also time spent in the office doing various projects
    • Focus on time tracking seemed to be for internal management not for external publication

–  Global Publication Coordination

  • Increasingly important to have global plan
  • Much easier to manage when Pub Team gets involved earlier in the development cycle
  • MA on Pub Team should work as a facilitator for Pub Team’s interaction with other functions given their central role
  • Press release management globally remains a major challenge
    • General consensus that prior to first presentation at a meeting, press release should be simply binary – met endpoints, did not meet
    • Too much data in press release can tick off journals threatening publication

–  Odds and Ends Ideas

  • Heard from a number of different companies that MSL groups focused on payer support in the US need to be between 6 and 10 in size to cover all the needs – not scientific but an interesting convergence
  • MSLs at clinical study initiation visits:
    • Good idea BUT has GCP implications
    • Need to hammer out how MSLs can fit within CD’s SOPs with ClinOps before engaging
    • May ultimately require update to CD’s SOPs

Obviously, this is merely a few key concepts from the day but it should give you some flavor of the type of discussions and the focus of the meeting.

If you were at the meeting and have other thoughts please leave them in the comments.

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