#445 - What Can Japan Teach Us About Treating Human Milk Fortifier as a Drug? (Part 2)

Send us Fan MailWhat does it take to turn a single struggling baby into a national standard of care? In this episode, Ben sits down with Professor Katsumi Mizuno (Showa Medical University) and Dr. Melinda Elliott (Chief Medical Officer, Prolacta Bioscience) to discuss the landmark Jasmine Trial, the first randomized controlled trial of an exclusive human milk diet (EHMD) in Japan. The results: significantly better weight and length gain, fewer antibiotic days, and improved feeding tolerance in very preterm infants. After an eight-year regulatory journey, Japan's Pharmaceuticals and Medical Devices Agency (PMDA) granted Prolacta's human milk-based fortifier PreemieFort drug-level designation, a global first, ensuring equitable, nationally reimbursed access for every preterm infant in the country. The conversation also looks ahead to the Fuji Trial and what Japan's precedent-setting decision could mean for Europe and the US.The guests joining us today have a direct financial or professional relationship with the topic being discussed in this episode. This may include employment, a consultant role, research funding relationship, or other ties to the company or product being reviewed.Support the showAs always, feel free to send us questions, comments, or suggestions to our email: [email protected]. You can also contact the show through Instagram or Twitter, @nicupodcast. Or contact Ben and Daphna directly via their Twitter profiles: @drnicu and @doctordaphnamd. The papers discussed in today's episode are listed and timestamped on the webpage linked below.Enjoy!