Get the Story Straight

Regardless of the project, the challenges are the same. You have to get from your raw data to reports and summaries to Advisory Committee defense to approval!

That may sound intimidating, but the process can be greatly improved by creating the communication strategy for your messaging early, and referring to it throughout the submission process. This will effectively aid the health authority reviewer (simultaneous increasing consistency and credibility with them) as well as help your submission arguments to be understood and believed. There's also an attendant boost in credibility that comes from knowing your issues and articulating them, unafraid.

Your success comes from being able to respond effectively to your issues with appropriate proof for your response. One tool to do so is ECG's MIRS method.

Messaging with MIRS

MIRS is both process and product. It is a way of deciding in advance what the company is doing and what it is going to say about its actions. MIRS is a way of gathering and recording the collective wisdom of people who are concerned as a group with a particular problem. As a process, MIRS provides continuity over time, maintaining consistency or coherence within a group of documents that deal with similar problems in different contexts.

The process is flexible and highly adaptive. It involves a team, whether formed temporarily to create a document or formed to develop a drug, in brainstorming, defining, and organizing main product Messages and associated Issues, then addressing Issues with specific Responses and identifying the Support for the Messages and the Responses. It can be used across disciples and functions--from Marketing to Clinical Development to Labeling to CMC transfer to Due Diligence to presentations and Q&A. Its scope is limited only by the imagination of the people who use it.

Messaging in Action

But how does this all work with a real product preparation? Let's dissect the Benefit:Risk section of the Raxibacumab 2009 Advisory Committee briefing package to identify MIRS elements: Messages, Issues, Responses, and Support.

Download a section of the briefing document to see these examples and support.

As you can see, by filling important gaps identified, thoroughly (yet concisely) supporting safety data, and acknowledging potential risks before submission, the Sponsor/Applicant and reviewers were able to get quickly and efficiently to core issues and, ultimately, be supportive of approval.

Learn to understand the messages, how to use them, and identify associated issues, to create efficiencies, increase credibility, and get your product successfully to market.

Please contact us via email or at +1-201-894-8200 to discuss how we can help you and your team develop a clear, concise, and accurate communication strategy.

Regulatory Communication