The regulatory landscape for gene therapy is constantly changing and global harmonization has yet to be aligned. An understanding of the regulations and guidance documents reflecting global regulatory agencies’ current thinking will help to better understand the key challenges. This is an exciting time in the industry with products being developed at an accelerated rate.
This webinar will discuss the current state of regulatory issues around gene therapy product development, key challenges for manufacturing controls and other insights in navigating the path to commercialization.
Gain insights into:
- Regulatory guidelines, with highlights from FDA’s gene therapy guidance documents issued in 2020
- Challenges of following the traditional regulatory framework while trying to keep up with demand for cutting-edge treatments on accelerated timelines
- Regulatory strategies with accelerated clinical plans — a comprehensive CMC plan and why early regulatory agency interactions will ensure long-term success
- Establishing manufacturing controls and developing the appropriate analytical methods
- Keeping up with gene therapy product development while identifying key challenges with high cost of goods, long lead times, manufacturing capacity, scale-up hurdles and increasing demands for plasmids (pDNA)
- Future trends: how the global pandemic is shaping and/or repurposing emerging therapeutics