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Makeni Bent

Align Your Launch Message Before It Reaches MLR

Biotech launches rarely stall on the science. They stall when brand, medical, legal, and regulatory read the core claims differently. I find that misalignment early, while it is still cheap to fix.

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Founder led. 15+ years across Johnson & Johnson MedTech, McCann Health, and Publicis Worldwide.

Why Launches Stall

Where Launch Messaging Breaks Down

When brand, medical, legal, and regulatory have not agreed on core claims before submission, the same problems show up:

  • Revision cycles multiply because stakeholders are working from different versions of the claims.
  • MLR returns structural objections, not compliance edits, because the message architecture was never agreed.
  • Field teams enter the first detail visit with different versions of the story.
  • Competitors who aligned earlier reach prescribers first and set the category narrative.

Most of this is visible, and fixable, months before submission.

Makeni Bent’s Launch Messaging Alignment Workshop brings your cross-functional team to consensus in two days.

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See How the Workshop Works
The Workshop

Launch Messaging
Alignment Workshop

A two day working session that brings brand, medical, legal, and regulatory to one set of core claims before submission.

I run the room as a neutral outside facilitator, so the discussion stays on the claims and off internal politics. You leave with decisions, not meeting notes.

A one week launch delay costs far more than this workshop. I will help you size it for your own launch during the first call.

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1
Cross-functional alignment workshop

2
12-point messaging audit identifying misalignment risks

3
Unified messaging framework across all launch materials

4
Stakeholder buy-in from brand, medical, legal, regulatory

5
Clear approval pathway for regulatory submission

2
12-point messaging audit identifying misalignment risks

3
Unified messaging framework across all launch materials

4
Stakeholder buy-in from brand, medical, legal, regulatory

5
Clear approval pathway for regulatory submission
15+ Years in Pharma & MedTech
Deep Cross-Functional Pharma Experience
MLR-Ready Messaging Frameworks
Senior-Level Attention on Every Engagement

Who I Work With

Built for Biotech Teams Approaching Launch

This is designed for pre commercial and early commercial teams who are:

  • Preparing for a first launch with a lean cross functional team
  • Seeing revision cycles grow as more stakeholders review the same claims
  • Building launch materials before core claims are locked
  • Working to reach prescribers before a competitor sets the narrative

Running more than one launch? Ask about portfolio level alignment.

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My Background

Senior Experience on Every Engagement

15+ years across global agencies and in house pharma and MedTech teams, focused on the moment where claims meet stakeholders.

  1. Johnson & Johnson MedTech (2018 to 2020)

    Co led content migration strategy for seven MedTech companies into unified injmedtech.com platform. Managed cross functional coordination across brand, medical affairs, legal, and regulatory.

  2. IPG Health (formerly McCann Health), Publicis Worldwide

    Agency side pharmaceutical marketing across oncology, rare disease, CNS, PAH, immunology, and vaccines, for global pharmaceutical clients. Navigated compliance driven messaging and stakeholder alignment on global brands.

  3. Education

    MBA, Marketing Management, St. John's University (Tobin College of Business). BA, Political Science, University of Notre Dame.

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Frequently Asked Questions

How is this different from our internal alignment meetings?
Internal meetings often stall because no one holds neutral authority over the claims. I facilitate from outside, bring a structured framework and a 12 point audit, and keep the session on decisions that can go to MLR.
What if our launch is 12 months or more away?
That is often the best time. Aligning core claims early costs less than reworking materials later, and it gives every function the same starting point.
Do you work with agencies or directly with biotech and pharma companies?
Both. I work directly with internal launch teams, and I partner with agencies that need launch alignment expertise for their clients.
Do you replace our MLR or regulatory review?
No. I help your teams agree on claims and structure before submission so MLR can focus on compliance. Final approval stays with your medical, legal, and regulatory functions.
Where do the Diagnostic and Audit fit?
They are a lighter first step. They show where your messaging may be drifting and help scope whether a workshop makes sense.

Collaborate with Us!

Tell me where you are in the launch timeline and where messaging feels least aligned. I will reply with next steps.