The International Society for Stem Cell Research (ISSCR) announces today that Bayer is a Founding Member of the ISSCR Consortium on Advanced Stem Cell-Based Models in Drug Discovery and Development, a global cross-sector initiative focused on accelerating the responsible integration of human stem cell-derived models into preclinical drug development.

‍Co-chaired by Daniela Cornacchia, AstraZeneca, USA, and Shuibing Chen, Weill Cornell Medicine, USA, the consortium is leading a coordinated international effort to advance the regulatory qualification and adoption of human stem cell-derived models, including organoids, engineered tissues, and microphysiological systems, as New Approach Methodologies (NAMs) for drug discovery and development.

The International Society for Stem Cell Research (ISSCR) Consortium on Advanced Stem Cell-Based Models in Drug Discovery and Development has submitted comments to the U.S. Food and Drug Administration (FDA) in response to the agency’s draft guidance, General Considerations for the Use of New Approach Methodologies in Drug Development Guidance for Industry.

The consortium, a global collaboration of academic scientists, industry leaders, and regulatory experts convened by the ISSCR, welcomed the FDA’s efforts to advance the integration of new approach methodologies (NAMs) into drug development while emphasizing the importance of maintaining a flexible, fit-for-purpose regulatory framework that can adapt to rapidly evolving technologies. ‍