Stem cell-derived medicines have seen somewhat of a renaissance over the last year, following a difficult period in terms of regulatory approval. New stem cell therapies, including many iPSC-based therapies, are now under development for a variety of indications and more traditional regenerative approaches have seen regulatory approval. Despite this, there remain difficult challenges for stem cell-derived products, including product characterization and potency assay development for mechanisms of action that often must be postulated fairly widely.

This session will present case studies by stakeholders that are successfully navigating this field, together with viewpoints from regulators.

Speaker:

Releasing Criteria and Potency Assay Development of an iPSC-Derived Neural Progenitor Cell Product Targeting CNS Diseases

Jing Fan, Hopstem Biotechnology Inc.

Navigating the Regulatory Path: Clinical Translation of iPSCs

Saravanan Karumbayaram, CBER, FDA

Cellular Engineering to Address Manufacturing and Regulatory Concerns

Todd McDevitt, Genentech, a Member of the Roche Group

Panelist:

Andreea Barbu, Swedish Medical Products Agency

Heli Suila

Appearances