Achieving breakthrough designation for a novel therapy has long-ranging implications for its commercial success and market acceptance. Breakthrough designation is one of the US’s most successful fast track designations, with nearly half of treatments which receive breakthrough designation ultimately receiving FDA approval.
It can be an uphill battle to secure this special designation, especially for emerging biopharmaceutical companies. Drs. Ira Gupta, VP, Medicine Development Leader, at GlaxoSmithKline PLC, and Shanthi Ganeshan, VP, Global Regulatory Affairs ― Oncology, at Gilead Sciences, discuss obtaining breakthrough designation in a recent episode of The Business of Biotech sponsored by Cytiva.
The pair examines evaluating a therapy’s chances to win it to reapplying in the event an application is rejected. They also discuss the pros and cons of fast tracking, and the biggest challenges to ― and solutions for ― achieving a breakthrough designation.