A growing pharmaceutical company contacted NovusLife with an acute problem: they required immediate help in preparing the comprehensive Briefing Document required in advance of a pre-IND FDA Type B Meeting. The client 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 deadline for the briefing package to go to ePublishing was just 3 ½ weeks from project start.
NovusLife quickly recognized that successful completion of this type of document required consultant team members with a strong knowledge of the CMC, nonclinical, clinical pharmacokinetics, and clinical safety and efficacy aspects of the drug development process. Thus, a NovusLife medical writer with extensive experience working with a highly motivated interdisciplinary team of Drug Development experts and demonstrated success in writing briefing packages for regulatory submissions in preparation for Type A, B, and C meetings. Further, a NovusLife senior regulatory scientist with 30+ years of experience was engaged to work on the pertinent CMC and nonclinical sections as well as to advise on aspects of the overall strategy and content of the briefing package.
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 company is a strong regulatory position for its forthcoming pre-IND interaction with FDA.Andrew J. Young, Chief Executive Officer