In biopharma, change is the name of the game, with high-stakes competition, fast-paced scientific discovery, shifting business models, and new molecular entities. Global regulators can expect to overcome challenges when reacting and responding to the numerous ways the industry has evolved over the years.
Scott Cleve, currently Vice President of Regulatory Operations and Compliance at bluebird bio, has witnessed this evolution firsthand throughout more than 20 years in regulatory operations with Accenture, AbbVie, Astellas, and Boehringer Ingelheim. bluebird bio is the maker of a fifth-line multiple myeloma therapy that received FDA approval in March.
Cleve recently sat down with BioProcess Online to talk about today’s regulatory paradigm and what biopharma should remember when engaging with regulators.