Operationalizing advanced therapy clinical trials using hard-won lessons learned
Cell and gene therapies (CGT) represent a burgeoning area of clinical research. Innovations in CGT are now providing novel cures for once intractable diseases. Such scientific and clinical advances have led to an unprecedented growth in CGT IND applications. In fact, the FDA expects 10-20 CGTs approved annually by 20251. Despite this notable market growth in global CGT, the path to clinical success is laden with operational and regulatory pitfalls. Approved therapies have a well-informed strategy. This strategy needs to start early in the development process to properly account for regulatory and operational tactics. Developing this plan is complicated – in this webinar we will share lessons learned in to gain a competitive advantage in CGT development.
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Key learning objectives
- Operational and regulatory hurdles in developing advanced therapies
- Strategies to accelerate development and reduce timeline delays
- Real-world case studies and lessons learned while conducting cell and gene clinical trials
Medpace experts will dive into case studies explaining the issues that arose with past projects, and how these studies got back on track. The knowledge gained from these experiences accelerate CGT development by avoiding potential pitfalls and getting ahead of regulatory and operational issues. The Medpace team will walk you through the delays associated with these pitfalls and how to avoid them.
There will also be a live Q&A at the conclusion of the presentation.
Can’t make the scheduled time? Register and we will send you the recording of the complete webinar.
Kind regards,
BRW Marketing Team
Business Review Webinars
marketingNS@ns-mediagroup.com
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