Operationalizing advanced therapy clinical trials using hard-won lessons learned

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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.

While many clients think they have a grasp on the requirements for a cell and gene therapy clinical trial, in practice the clinical development process may be delayed or terminated due to operational and regulatory hurdles. Medpace experts have experience in conducting over 70 trials in advanced therapies and navigated common pitfalls in developing these complex therapies. For example, the FDA and EMA require cell tracking for cell therapies – a step that Medpace has developed a specific process for managing. This process provides a map for regulatory compliance and transparency for the Sponsor.

Our 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. Our team will walk you through the delays associated with these pitfalls and how to avoid them.

Register now to reserve your seat and learn the following key topics:

· 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