en.Wedoany.com Reported - The International Society for Stem Cell Research (ISSCR) announced that Bayer has become a founding member of the "ISSCR Consortium on Advanced Stem Cell-Based Models in Drug Discovery and Development." This consortium is a global cross-sector initiative aimed at accelerating the responsible integration of human stem cell-derived models into preclinical drug development processes.
The consortium is co-chaired by Daniela Cornacchia of AstraZeneca (USA) and Shuibing Chen of Weill Cornell Medicine (USA). It leads a coordinated international effort to advance human stem cell-derived models, including organoids, engineered tissues, and microphysiological systems, toward regulatory acceptance and industry adoption as New Approach Methodologies (NAMs) for drug discovery and development.
The consortium's goal is to establish standardized evaluation frameworks, performance criteria, and regulatory guidelines to support the 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 repository for stem cell-based NAM data. These efforts aim to help build regulatory confidence and validation, integrating stem cell-based models into future drug discovery and safety assessments. Additionally, the consortium's activities align with recent regulatory and policy shifts toward NAMs and a greater emphasis on human-based research.
Keith Alm, CEO of ISSCR, stated that the consortium builds on decades of rigorous stem cell science, and Bayer's commitment helps translate this scientific foundation into the standards, tools, and infrastructure needed to responsibly integrate models into drug development, thereby driving more predictive preclinical research and ultimately better outcomes for patients.
Bayer joins the consortium as a founding member alongside the Burroughs Wellcome Fund, with contributing members including Xellar Biosystems. The consortium also plans to host a special session at the ISSCR 2026 Annual Meeting in Montreal, Canada, titled "ISSCR Consortium: Stem Cell Models for Drug Development," offering attendees the opportunity to learn about and discuss the consortium's goals, priorities, and implementation timeline. The International Society for Stem Cell Research (@ISSCR), spanning over 80 countries, is the leading global interdisciplinary scientific organization dedicated to advancing stem cell research and its translation into medicine.
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