Catriona Roscoe-Cutting is a regulatory leader with over 20 years of global regulatory experience defining regulatory strategies for drug development from pre-IND through to marketing authorisation and line extensions for NCE, biologics and ATMPs with a particular interest around orphan indications.
A review of paediatric development challenges, FDA collaboration and future trends
Susan McCune M.D., is a paediatrician and neonatologist, with 18 years’ academic clinical and research experience. This was followed by 18 years at the US FDA where, from 2017 to 2021, she was the director of the Office of Pediatric Therapeutics in the Office of the Commissioner. She was responsible ...