Breakthrough Therapy Designation: Evaluation of trends and impact on CMC Strategies

Breakthrough Therapy 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 may lead to accelerated clinical programs, which could be two or more years faster than a “conventional” development program. When the clinical program is accelerated, applicants face challenges to complete quality and manufacturing development and data requirements within the condensed drug development timelines.

Join us as drug product expert Anil Kane and regulatory affairs expert Betty Thompson discuss the problem and dive deep into topics including:

Related Sites

Additional Resources