Medical Affairs Focus

Thoughts on Global Medical Affairs

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.

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One response to “Topic3: MA at Launch – MA Launch Generic Timeline

  1. Pingback: Topic3: Medical Affairs at Launch « Medical Affairs Focus

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