Increasing the global availability of cell and gene therapy products is key to our patients. Understanding the unique clinical, non-clinical and CMC aspects of these products is crucial for harmonization and facilitating regulatory reliance.

Cell and gene therapy (CGT) products have the potential to revolutionize medical treatment and the landscape is rapidly evolving. Understanding the unique considerations for these products are key to advance the field and boost global harmonization of regulatory requirements, which ultimately will enable global access to these products.

The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) has formed the ICH CGT-Discussion group (ICH CGT DG) to address regulatory challenges specific to these products. This group aims to develop recommendations that will provide a common framework for the development and regulations of these therapies. During this session, the status and thinking on the roadmap that will guide global harmonization of technical requirements to support CGT product development will be shared.

Comparability assessments for CGT are crucial to ensuring that any changes made during development, manufacturing or post-approval phases do not negatively impact the products’ safety, efficacy, or quality. The development of these therapies presents unique challenges, and their complexity has the potential for impacting patient outcomes when changes are introduced. During this session, a presentation will be delivered focusing on the comparability requirements for CGTs, with the objective of generating a dialogue about the challenges they pose, and strategies employed.

Unique clinical and non-clinical considerations for CGTs influence the challenges and opportunities for their development. The modality, mechanism of action, route of administration, and therapeutic indication for a CGT product should influence the strategy for clinical and non-clinical development. In addition, this session will feature a presentation on unique clinical and non-clinical considerations for CGT products. The objective is to foster a discussion regarding strategies to overcome challenges and capitalize on the opportunities.

Why Should You Tune In?

• Understand the unique aspects of CGT products that are vital for regulatory alignment
• Explore how the ICH CGT Discussion Group is paving the way for a common regulatory framework
• Learn about comparability assessments to ensure the safety and efficacy of CGT products
• Discover how unique clinical and non-clinical considerations shape development strategies
• Engage in dialogue on the challenges and opportunities in the advancement of CGT products

Don't miss this opportunity to gain valuable insights and contribute to the global advancement of cell and gene therapies.