Engaging Global Regulators in Discussion on Comparability for Cell-based Medicinal Products: Industry Challenges and a Path Towards Harmonized Solutions

In a rapidly evolving landscape of cell-based medicinal products, ensuring product comparability during manufacturing changes is a critical aspect of maintaining product quality, safety, and efficacy at any stage of product development. To gain insights and perspectives from global regulatory bodies on this topic, a regulatory panel is organized inviting key regulators such as the Food and Drug Administration (FDA), Pharmaceuticals and Medical Devices Agency (PMDA), Health Canada and Swedish Medical Products Agency. The primary objective of this panel is to openly discuss common comparability challenges seen by regulators, engage in a productive dialogue on mitigating these challenges, and explore opportunities for regulatory harmonization.

The panel will focus on key challenges witnessed by global regulatory bodies in assessing comparability studies for cell-based medicinal products, expectations from global regulatory bodies including considerations for establishing comparability, managing manufacturing changes, and ensuring product quality and safety. Regulators will also share their perspectives on the newly issued FDA draft guidance on comparability for cell and gene therapy products, highlighting areas of consensus and divergence with their own regulatory frameworks.

One of the key discussion points would be recognition of the need for greater harmonization and convergence among regulatory agencies to support the development and approval of cell-based medicinal products on a global scale. By aligning their expectations and requirements, regulators can enhance the predictability and consistency of regulatory reviews, reduce duplication of efforts for manufacturers, and ultimately expedite patient access to innovative therapies.

Overall, this panel aims to provide a valuable platform for regulators, industry stakeholders, and experts to come together, exchange insights, and collaborate toward a more harmonized regulatory approach for understanding comparability for cell-based medicinal products. The insights and recommendations generated through this dialogue have the potential to shape future regulatory guidance and facilitate the development and commercialization of advanced therapies for patients worldwide.

Panelists:

Andreea Barbu, Swedish Medical Products Agency

Yoshiaki Maruyama, PMDA

Christopher Storbeck, Health Canada

Andrew Timmons, CBER, FDA

Margarida Menezes Ferreira

Appearances