This week's Fierce Pharma is brought to you by Thermo Fisher Scientific.

Tuesday, June 21, 2022 | 11am ET / 8am PT

Designation (BTD) was introduced by the US FDA to help shorten the development and review time of novel drugs intended to treat serious or life-threatening diseases.  To qualify, preliminary evidence must show the drug may demonstrate substantial clinical improvement over available treatments. Assignment of BTD could lead to accelerated clinical programs, which could be two or more years less than a “conventional” development program.

This webinar discusses the trends in breakthrough status in recent years and strategies to address the impact on the Chemistry, Manufacturing and Control (CMC) part of a development project when a project is assigned BTD status.