FDA Officials Offer Insights on Emerging Technology Programs

FDA’s Joel Welch, Pfizer’s Connie Langer and Lisa Skeens

The U.S. Food and Drug Administration (FDA) accepts a variety of applications into its Emerging Technologies Program (ETP), not just focusing on serially manufactured products, said Joel Welch, associate director of science and biosimilar strategy in the agency’s Office of Biotechnology.

“I think sometimes there is a misconception that advanced manufacturing is just continuous manufacturing,” said Welch, who provided an update on ETP at the recent PharmaLink conference hosted by the Regulatory Affairs Professional Society (RAPS) and Food and Drug Officers (AFDO). He added, “Actually, advanced manufacturing certainly includes continuous manufacturing, but it’s much more than that.”

Advanced manufacturing can include new manufacturing methods that improve process robustness, new dosage forms, new modeling tools for analytical testing, and new container closure systems.

Since the program’s launch in 2014, the ETP has accepted 110 advanced manufacturing proposals.

FDA data shows that the ETP program accepts a wide range of technologies, although continuous manufacturing remains the most common type of technology accepted by the program; 46 have been accepted. Novel analytical techniques represented the next most common technology with 12 applications, followed by new aseptic techniques such as continuous aseptic spray drying systems with 11 applications. Other applications accepted for the program include novel dosage forms, 3D printing and novel container closures, and applications involving modular or portable point-of-care manufacturing.

While continuous manufacturing applications remain the most common type of submission, an increasing number of applications are for novel aseptic technologies.

After experiencing steady growth, the number of ETP acceptances has declined steadily in recent years. Twenty-four proposals were submitted in 2019, 17 in 2020, 13 in 2021 and six in 2022. Welch attributed the decline to a shift in priorities caused by the pandemic.

Welch also answered frequently asked questions, such as whether sponsors must wait until molecular development is complete before requesting participation in the ETP program. Even if a company is considering five or six molecules for a new test, they can participate, he said. “We were happy to get involved and provide feedback at that time. We learned that early engagement is the hallmark of success.”

Sponsors do not have to wait until they have submitted an Investigational New Drug Application (IND) to participate in the program. “As long as you can make a case for an emerging technology, we can meet in this situation,” Welch said.

The FDA has encouraged the adoption of advanced manufacturing technologies for at least a decade. The agency claims that advanced manufacturing methods can help companies reduce costs and quality defects, and can improve the global competitiveness of U.S. manufacturing. (related: FDA officials tout advances and achievements in advanced manufacturing, Regulatory focus October 15, 2021)

AFDO/RAPS meeting