IMGC HYBRID Symposium 2025
Hosted by INSC
On September 16, 2025, INSC members presented a poster titled “Mind the Gap — Identifying Language Barriers Between Translational Science and Regulators.”
Abstract
Human milk, the gold standard for infant nutrition, is a complex system and a limitless source of innovation. Advances in discovery science have expanded knowledge of how nutrition impacts infant development, while breakthrough technologies in food manufacturing have produced isolated or biosimilar milk ingredients with potential to bring the composition of infant formula closer to human milk. However, questions about the safe inclusion of these ingredients remain. This poster explores the gap between translational science and regulatory frameworks using two case studies: recombinant human lactoferrin (rhLf) and isolated bovine osteopontin (bOPN). While these bioactive milk proteins hold promise for improving infant nutrition, their safety evaluation processes highlight critical language barriers between scientific discovery and regulatory interpretation. Material from the US FDA Freedom of Information Act (FOIA) reading room including GRAS Notifications, notifier communications, internal memorandums, and referenced publications were reviewed for (a) expert scientific opinion and (b) questions from regulatory officials.
A key challenge lies in the differing lexicons of researchers and regulators. Scientific literature often emphasizes mechanisms of action, biomolecular interactions, and translational potential, whereas regulatory agencies prioritize risk assessment and establishment of standards. For rhLf, concerns over structural equivalency, allergenicity, and manufacturing consistency complicated regulatory acceptance, while isolated bOPN encountered scrutiny regarding its compositional comparison to human milk OPN and potential immunogenic effects. These case studies underscore the necessity of clearer communication strategies to facilitate regulatory approval. Misalignment in terminology, data expectations, and frameworks often results in prolonged review periods and scientific misunderstandings. Opportunities to align regulatory, industry, and academic scientists are needed to ultimately advance infant nutrition.
About the International Milk Genomics Consortium (IMGC) Symposium
The Annual IMGC Symposium is the IMGC’s flagship conference, hosted in the fall every year in a different location worldwide. The symposium features the latest, cutting-edge scientific research and discoveries in milk science and their applications for human health. The Symposium is instrumental in building a collaborative, multi-disciplinary, pre-competitive platform for scientific discoveries of the structures, functions, actions, and benefits of milk and to facilitate the application of that knowledge into practice for health.
