Background

One of our repeat clients, a West Coast Biotechnology company, needed help with writing and strategic input for their Meeting Request Letter and Briefing Book. This was in preparation for a Type B Meeting with the FDA following a preliminary Breakthrough Therapy Designation Request (BTDR), Preliminary Meeting and Type A Meeting.

Challenge

The preparation for the meeting required the reviewing and consolidation of information from a variety of complex sources. Given the importance of adhering to their strict timelines, it was essential to work with an experienced professional who could collect the relevant data. They also needed us to provide the necessary guidance quickly to ensure they had all of the information needed to successfully prepare for their FDA meeting.

Additionally, they needed someone who could help them develop a strategy and plan for the questions the FDA may ask following their first meeting, in order to progress and get one step closer to bringing their drug to patients.

Solution and Results

Morula Health’s team of highly experienced writers provided an exceptional solution that surpassed the client’s expectations. We assigned a US-based Medical Writer with a wealth of experience in writing Briefing Books and preparing for FDA Meetings. After setting up a Kick-Off Meeting in less than a week, we held a Technical Meeting with our Medical Writer offering valuable input to complete the documents.

As the submission date to the FDA had been set in stone, we worked diligently and relentlessly over the Christmas holidays to ensure we met this. We identified information gaps and provided technical solutions; for example, our Medical Writer took on the task of finalising a Protocol Synopsis for the Briefing Book submission. This ensured the meeting would be efficient and increase the probability of progressing the drug to market. We finalised the two documents, including the Synopsis, and the client was able to submit their meeting request to the FDA and progress to a Type B Meeting.

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