(264c) Quality By Design and Expedited Development Programs

There is significant pressure on the CMC team to complete the product development process in ever shorter timeframes. Several new molecules have had rapid clinical development programs that have shortened Phase 3 or have had no Phase 3 in the case of oncology therapeutics. Gone are the days when a multiyear Phase 3 clinical program allowed for the CMC team to complete the drug development cycle in a standard timeframe. CMC activities are being pushed forward in the development cycle. The CMC team is more reliant on company platform technology and Quality by Design (QbD) principles that can allow the CMC team to complete development faster and create a robust control strategy.

The regulatory dossier must capture elements of the development process, it must show how our clinical drug product links to the commercial drug product and it must outline our control strategies for commercial manufacturing. This presentation will highlight the successes and challenges of rapid drug development and how our global regulatory dossier has evolved to deal with these complexities.

Kevin Fitzpatrick is an employee of AbbVie and may own AbbVie stock. AbbVie sponsored and funded the study; contributed to the design; participated in the collection, analysis, and interpretation of data, and in writing, reviewing, and approval of the final publication.