A Risk-Based Framework for Excipient Development

Ahead of Excipient World 2026, PharmTech spoke with David Schoneker, president, Black Diamond Regulatory Consulting about what goes into the development of a new and/or novel excipient. In part 4 of this series, Schoneker previews a workshop at Excipient World 2026 that will present concepts from a risk-based framework for excipient development, including a draft guideline being created by IPEC-Americas.

“It's an interesting workshop that we're going to have because there are many different types of risks that have to be assessed in bringing forward a new excipient product,” explains Schoneker. “And there's the safety and the quality risks that everybody talks about a lot, but there's also significant cost and market acceptance risk that have to be evaluated to determine whether to bring forward a new excipient. Many times, excipient companies will have a really great and interesting product that could solve a lot of problems, but when they look at the market and acceptance risk, it's just not worth it to them to fund the studies or whatever it might be.”

“Most new excipient products don't have a lot of risk. They don't have a significant need for a whole lot of safety data,” says Schoneker. “In many cases, there is no need for any additional safety information. There's just a matter of maybe pulling it together into a dialogue or a story about why it's safe in this type of application. Because of that confusion, what we have found at IPEC, is every time we ever talk about new excipients, everybody jumps to novel excipients.”

A committee within IPEC-Americas has drafted decision trees for excipients, such as those for higher level of use, new route of administration, new population, pre-mixed, co-processed, and novel products, to determine if they meet certain criteria. The decision trees will be presented at the workshop with the intention of getting feedback from industry, suppliers, and distributors.

“The goal is after Excipient World, after we get this broad feedback from all of industry and regulators and everybody who will be there, we'll then refine the decision trees a little bit, and then our committee will start taking forward and putting text around those decision trees to figure out what are the details about how to do that, those different feasibility analysis pieces, assuming to bring these products forward.”

Watch the interview above to learn more about what goes into the development of a new excipient. Dave will be participating in the workshop, “Risk Based Framework for Development of New Excipient Products”, at Excipient World 2026 being held in Nashville from May 4-6, 2026.1

Reference

1. Raghuram M, Sheehan C, Filler R, Schoneker D, Liu J, Gronewold C. Risk Based Framework for Development of New Excipient Products and USP’s Novel Excipient Emerging Standards Approach to Meet Stakeholder Needs. Presentation at Excipient World Conference & Expo 2026. May 4, 2026. https://s6.goeshow.com/ipec/annual/2026/conference_program_sessions.cfm?session_key=B7748D16-9EBD-188A-D5EE-3FF177ECEAC0&session_date=Monday,%20May%2004,%202026