Medical Affairs Focus

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Tag Archives: Launch

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.

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Topic3: MA at Launch – MA Launch Generic Timeline

Introduction

As we discussed in a previous post, MA must have its own launch strategy to ensure that it is capable of proactively addressing the scientific needs of the healthcare community in a manner that is both effective and compliant.

In addition to having a clear strategy, another key success factor is the timing of MA launch activities.  In this post, I will share a generic MA launch timeline.  However, all launches are unique, with their own set of requirements, so in order to put together even a generic timeline I will need establish a scenario as the basis:

  1. The drug being launched is a relatively recent in-license from a smaller company with no MA group.
  2. The drug is in P3 testing, with results expected in 10 to 12 months and an NDA filing expected soon after.
  3. The company managing the MA support of launch has an existing MA function but no experience in the drug’s  therapeutic area
  4. As a result, the current field force (MSLs) are not sufficient to support the new drug

When we consider launch, the work breaks down into four broad categories:

  • Operational Infrastructure:  This includes people, processes and technology needed to support the MA launch (and post-launch) activities
  • Scientific Outreach:  All activities required to educate the healthcare community about the therapeutic area, disease state and drug.
  • Research:  All activities with the goal of data generation.
  • Internal Support:  All activities in which MA assists other functions within the company.

For simplicity sake, I will consider each of these categories in four different time periods:

  • -24 to -18 Months before Launch
  • -18 to -12 Months before Launch
  • -12 to -6 Months before Launch
  • -6 Months to Launch

During each time period, I will attempt to highlight some of the key deliverables in all the categories that are relevant.  Not all categories are relevant in all time periods.

 

-24 to -18 Months before Launch

During this period, the primary goal is to develop and gain approval for the MA Launch Strategy.  Since our example demands a fair amount of operational infrastructure development, the budget and timing for the needed resources must be agreed upon in this period.  In some companies the Launch Team has not yet been formed, and in those cases MA will need to work with commercial leadership to ensure that its’ initial plans are in alignment with the current best thinking of the launch.

Category Key Activities and Deliverables in this Period Comments
Operational Infrastructure
  • Agree on hiring plan for all MA resources, but especially for a Medical Director and MSLs
  • Develop position descriptions for new positions
  • Recruit new Medical Director (MDir)
  • Develop any new processes needed to support the infrastructure
  • Identify and begin selection of any new information systems needed
  • The Medical Director, with strong TA credibility, is key to the overall launch success and hiring such a person is a high priority t this state.
Scientific Outreach
  • After the MDir comes on board, they can begin to informally reach out to their peers in the TA
Research
  • The MDir should engage with the existing P3 research team and begin working on Data Generation Plan for P3B and post-approval studies
Internal Support
  • The MDir should become a valuable advisor to the entire Launch Team

-18 to -12 Months before Launch

This is a critical period for planning and infrastructure development.  We are assuming in our example the need to hire a new MSL team, and the bulk of this activity takes place this period as well.

Category Key Activities and Deliverables in this Period Comments
Operational Infrastructure
  • Hire MSLs – this typically can take 3 to 6 months
  • Train MSLs – this can typically take 1 month
  • Implement new processes
  • Implement new information systems
  • MSL recruitment can be a slow process and should be begun as early as possible
Scientific Outreach
  • Identify national and regional Key Opinion Leaders (KOLs) for educational and research engagement
  • Develop the Publication Plan, if it has not already been developed
  • Publish according to the Publication Plan
  • Develop Disease State Education Plan
  • Develop disease state education materials
  • Develop the Congress and Meeting Plan
  • Attend initial congresses with MDir and available MSLs
  • Develop Ad Board Plan
  • Conduct Ad Boards
  • A huge amount of planning work needs to go on during this period – it is likely that the entire MA function will need to support this effort
  • The Publication Plan will likely be revised every 6 months or so during this period.
  • For compliance reasons, Ad Boards should be coordinated by MA although the purpose of the Ad Board may be commercial.
Research
  • Develop the Data Generation Plan, if not already completed
  • Develop Investigator Initiated Study Plan (IIS Plan)
  • Work with Development to start executing P3B, 4 and HEOR studies
  • Research is likely to be done in partnership with Development if not owned by them completely.
Internal Support
  • Develop REMS Plan
  • Develop Scientific Training Plan
  • Develop Access and Reimbursement Support Plan
  • REMS may be driven by another function but MA should engage to ensure that it links in with the other MA plans.
  • Scientific training plans may support a number of commercial groups including marketing and sales personnel

-12 to -6 Months before Launch

This is the period when the work of supporting the launch begins in earnest for MA.

Category Key Activities and Deliverables in this Period Comments
Operational Infrastructure
  • Train MSLs, if not already complete
  • Hire or retain capacity for Medical Information
  • Train Medical Information resources
  • Medical Information should be available no later than 3 months prior to launch but 6 months is safer to handle expected inquiries
Scientific Outreach
  • Outreach to national KOLs and begin outreach to regional KOLs
  • Revise the Publication Plan, if necessary
  • Publish according to the Publication Plan
  • Conduct disease state education efforts
  • Attend congresses and meetings
  • Conduct Ad Boards
  • Develop Medical Information Plan
  • Disease state education is a critical goal for this period.  MA can establish a strong understanding of the current disease state among their targeted KOLs.
Research
  • Begin IIS outreach to alert the medical research community to the potential availability of grant funding and the grant application process
  • Continue to execute P3B, 4 and HEOR studies
  • IIS outreach must focus on the facts of the program and process not specific research goals in order to remain compliant.
  • P3B protocols should already be completed by this point, with study initiation beginning in this period.
Internal Support
  • Support REMS Plan
  • Conduct scientific training
  • Support Access and Reimbursement scientific needs

-6 Months to Launch

Like the last period, this period is focused on the execution of the plans developed earlier.  One critical role that MA should be playing during this period is providing feedback that they are hearing to the rest of the organization.  MA is not a market research function, but the questions they receive is valuable information that the commercial organization may wish to know.

Category Key Activities and Deliverables in this Period Comments
Operational Infrastructure
  • Train Medical Information resources, if not completed
Scientific Outreach
  • Outreach to national KOLs and outreach to regional KOLs
  • Revise the Publication Plan, if necessary
  • Publish according to the Publication Plan
  • Conduct disease state education efforts
  • Attend congresses and meetings
  • Conduct Ad Boards
  • Develop medical information deliverables
Research
  • Begin IIS grant review process
  • Continue to execute P3B, 4 and HEOR studies
Internal Support
  • Support REMS Plan
  • Conduct scientific training as needed
  • Support Access and Reimbursement scientific needs

Closing Thoughts

Different therapies can drive very different timetables.  If the drug in question is a new formulation of an existing, well established product, very little specific work may need to be done and the whole process can begin and end in the 6 months prior to launch.  If it is a novel new oncology treatment with a companion diagnostic, you may wish to move up the timelines on certain activities like IIS which may even start before approval.

I would like to hear about your experience at launch.  Please leave a comment below.

Topic3: MA at Launch – Importance of MA Launch Strategy

The good news for many MA leaders today is that launch leaders (most of whom are typically commercial leaders) rarely need to be convinced that MA needs a role in launch.  In today’s world, most launch leaders understand that MA should have a role.

Instead, the challenge for MA leaders today is ensuring that the role and activities of MA are driven by their understanding of both MA’s proper role and their deep understanding of the scientific underpinnings of the drug being launched.  Like it or not, commercial people still often view MA as another “messaging” platform and may put MA in the position of serving as a promotional resource without understanding the risks in doing so.

Therefore, it is critical that MA leaders approach launch leader with a well thought out MA strategy to support the launch.  This strategy should not be developed in isolation – MA’s commercial colleagues should contribute to and review the MA launch strategy.  BUT, is should be MA leadership that is driving the MA launch strategy.

An MA launch strategy should have the following characteristics:

  • Thorough review of the scientific basis for the drug, including mechanism of action
  • Analysis of current treatment standards and the likely position of the new drug on those treatment standards
  • The role MA will need to play in the launch, considering the degree of scientific education required on:
    • The disease state
    • The current treatment options
    • The mechanism of action
    • The administration of the drug and management of side effects
    • Any related diagnostics
  • A gap analysis of current MA operational infrastructure’s capability to support this launch including:
    • Experience and scientific reputation of MA in this particular therapeutic area (TA) and disease state (Especially does the company currently of a medical director (MD) with a strong reputation in this TA)
    • Degree MA currently has field resources (MSLs) capable of supporting the launch:
      • Presence of the MSLs with key opinion leaders (KOLs) in TA
      • Capacity of MSLs to take on support of a launch
      • Expertise of current MSLs on the disease state and capabilities of current MSLs to support drug
    • Ability of the organization to support likely call volume within existing medical information (MI) function
    • Capability of current clinical study management infrastructure to support expected volume driven by launch
  • Plan for the likely changes in infrastructure based on the gap analysis
  • High-level (1 page) starter plans for key elements of the MA launch which may include:
    • Publication plan
    • Congress Plan
    • KOL Plan
    • Medical Information Plan
    • Advocacy Plan
    • Health Economics Outcomes Research (HEOR) Plan
    • Investigator Initiated Study (IIS) Plan
    • Phase 4 Plan
    • REMS Plan
    • Internal Training Plan
    • Access and Reimbursement Support Plan
  • Overall MA launch budget and implementation plan

Only after MA has developed its own launch strategy can it successfully negotiate with the launch leader the degree that the launch program can support its needs.  Without an MA launch strategy, MA is placed constantly in a reactionary mode.

In my next post I will discuss the timing of all of these types of activities, but one important note is that the MA launch strategy is a living document.  It is likely to be revised a number of times as new data and new realities become clear.  This is to be expected and everyone involved should have this understanding from the start.

Finally, as mentioned above, MA is only a part of the bigger launch effort and therefore must coordinate its activities with the launch leader and ensure that its work supports the overall launch plan.

What has been your experience in developing MA strategies for launch?  Leave a comment below.

Topic3: Medical Affairs at Launch

One of the great challenges for Medical Affairs is determining how to most effectively support a drug at launch.  As you may know, drug launch is absolutely critical to the success of a drug.  And since in our business that means the penetration of treatment to patients who needs them, MA must view launch as a unique opportunity to educate the healthcare community.  In discussing this topic, I will address the following topics:

As usual, I am curious to hear about your experiences at launch.  Please share them in the comments.