PODCAST | Regulation
How cancer regulation is — and isn’t — changing at FDA: a BioCentury podcast
Plus: Insights from ICON’s Liz O’Brien on how biotechs can navigate FDA, EMA regulatory paths
July 8, 2025 11:32 PM UTC
Oncology regulation has been less affected by recent changes in FDA leadership than other parts of the agency. On a sponsored edition of the BioCentury This Week podcast, BioCentury’s analysts assess what has and hasn’t changed at FDA when it come to regulating cancer therapeutics.
Guest Liz O’Brien joins BioCentury’s analysts to discuss how biotechs can navigate FDA’s Project Optimus and EMA’s Joint Clinical Assessment as well as the differences between the two agencies. O’Brien is a former EMA regulator who is now therapeutic expert, oncology and women’s health, drug development solutions at BioCentury This Week sponsor ICON Biotech.