Pink Sheet reporter and editors discuss a new pilot project allowing collaborative reviews of gene therapies by multiple regulators (:42), predictions for the upcoming year by current and former US FDA leaders (11:12), and the FDA commissioner’s take on artificial intelligence (21:23).

More On These Topics From The Pink Sheet

Don’t Call It Project Orbis: CoGenT Global Will Pilot Collaborative Review Of Gene Therapies: https://pink.citeline.com/PS149607/Dont-Call-It-Project-Orbis-CoGenT-Global-Will-Pilot-Collaborative-Review-Of-Gene-Therapies

EMA To Become Observer Of FDA’s Project Orbis Early This Year: https://pink.citeline.com/PS149579/EMA-To-Become-Observer-Of-FDAs-Project-Orbis-Early-This-Year

New Year’s Predictions From FDA Leadership Past And Present: GLP-1s, Mental Health, Big Data: https://pink.citeline.com/PS149583/New-Years-Predictions-From-FDA-Leadership-Past-And-Present-GLP1s-Mental-Health-Big-Data

US FDA’s Role In Artificial Intelligence/Machine Learning Development Is ‘Convener,’ Califf Says: https://pink.citeline.com/PS149608/US-FDAs-Role-In-Artificial-IntelligenceMachine-Learning-Development-Is-Convener-Califf-Says