Building a consortium to accelerate stem cell models for drug discovery
Original story from the International Society for Stem Cell Research (ISSCR).
The ISSCR announced on Monday 15 June 2026 that Bayer (Leverkusen, Germany) 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 (DE, USA) and Shuibing Chen, Weill Cornell Medicine (NY, 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 consortium aims to establish standardized evaluation frameworks, performance criteria and regulatory guidance to support fit-for-purpose use of these human-relevant models in preclinical decision-making. By bringing together academia, industry and regulatory agencies, the initiative will aggregate and harmonize multi-site datasets, benchmark model performance against clinical outcomes, and develop interoperable data infrastructure, including an open-access repository of stem cell-based NAMs data. These efforts are intended to help enable regulatory confidence, validation and integration of stem cell-based NAMs into future drug discovery and safety assessment. Additionally, the consortium’s activities align with recent regulatory and policy shifts toward new approach methodologies and greater emphasis on human-based research.
“We are grateful to Bayer for its support as a founding member of the ISSCR Consortium on Advanced Stem Cell-Based Models in Drug Discovery and Development,” said Keith Alm, ISSCR CEO. “These models are built on decades of rigorous stem cell science, and Bayer’s commitment helps turn that foundation into the standards, tools, and infrastructure needed to integrate them responsibly into drug development — advancing more predictive preclinical research and, ultimately, better outcomes for patients.”
Bayer joins the Burroughs Wellcome Fund (NC, USA) as a founding member as well as contributing member, Xellar Biosystems (MA, USA).
Additionally, the consortium will host a featured session at the ISSCR 2026 Annual Meeting in Montréal, Canada, titled “ISSCR Consortium: Stem Cell Models for Drug Development.” The session will provide attendees with an opportunity to learn about and discuss the consortium’s goals, priorities, and implementation timeline.
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