(478f) FDA’s Emerging Technology Program: Innovation and Collaboration to Advance Product Quality

Over the past decade, there has been substantial progress towards modernizing pharmaceutical manufacturing. However, at the same time, pharmaceutical manufacturing continues to confront a number of challenges, which result in unacceptably high occurrence of product quality issues. Working with industry to encourage the modernization of pharmaceutical manufacturing technology is a mutually beneficial approach to increase manufacturing efficiency, improve overall drug quality, avoid shortages, and prepare for future regulatory challenges.

To encourage the adoption of innovative approaches in pharmaceutical manufacturing and to prepare for reviews and inspections involving technology for which there is little experience, the Agency established the Emerging Technology Program. This program features a cross-functional Emerging Technology Team (ETT) which works directly with industry to identify and resolve potential scientific and policy issues that may impact technologies new to the pharmaceutical industry. In a relatively short period of time, the Emerging Technology Program has facilitated the approvals of the first 3D-printed drug product, the first drug product made via continuous manufacturing, and the first switch to a continuous manufacturing process for an approved drug product.

The other key components of the Emerging Technology program are stakeholder engagement and advancing regulatory science. The program components aim to complement each other. Early stakeholder engagement and communication can be used to identify innovative technologies that have significant potential to advance product quality. Collaborating with public-private partnerships or other pre-competitive groups can potentially accelerate the implementation of emerging technologies by fostering multi-disciplinary collaborations among researchers, manufacturers, and government organizations to enable the type of feedback interactions critical to the innovation process. As part of the partnership or through other avenues FDA can support regulatory science activities to address any knowledge gaps that could impact the commercial implementation and assessment of the novel technology. Then as industry begins to develop the technology for commercial use, ETT provides a mechanism for early one-on-one engagement to promote shared learning and address specific product and process issues.

This talk will describe the current state and the continuing maturation of the Emerging Technology program towards a scalable, forward looking, and globally influencing program.