Case Study/Regulatory

Pre-IND Briefing Book

Challenge:

A growing biopharmaceutical company contracted NovusLife to solve an acute problem: they required immediate help in preparing a comprehensive Briefing Document required in advance of a pre-IND FDA Type B Meeting. The Sponsor had a good breadth of internal staff to draft many of the briefing document sections, but they lacked a medical writer teamed with a regulatory expert to insure they’d meet the FDA’s timeline. The ePublishing deadline for the briefing package was just 3 ½ weeks from project start.

Solution:

NovusLife quickly recognized that the successful completion of this type of document required a team with a strong knowledge of the CMC, nonclinical, clinical pharmacokinetics, and clinical safety and efficacy aspects of the drug development process. Thus, NovusLife put their chief medical writer, with extensive experience working with a highly motivated interdisciplinary team of Drug Development experts and a demonstrated success in writing briefing packages for regulatory submissions in preparation for Type A, B, and C meetings, on the team right away. Further, we rearranged the schedule of one of our senior regulatory scientists, with 30+ years of experience working on pertinent CMC and nonclinical sections, to be able to advise on all aspects of the overall strategy and content of the briefing package.

Result:

This highly functional team stepped into the project and had an immediate impact, aiding with the document’s development in an aggressive yet effective manner. An understanding of the Sponsor’s desired process and a detailed timeline for the development of the briefing document were quickly established. The briefing document template was rapidly developed, assignments were made with respect to ‘who was writing what’, and over the subsequent 2 weeks, several drafts of the briefing document were written and reviewed by both project team and executive team contributors; the final document was successfully completed on-time and delivered to ePublishing within the 3 ½ week timeframe. This put the Sponsor in a strong regulatory position for its forthcoming pre-IND interaction with FDA.

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