ISSCR Consortium: Stem Cell-Based Models in Drug Discovery

Hosted live on April 8, 2026, learn how the ISSCR Consortium is advancing standards for stem cell-derived NAMs across drug discovery, safety assessment & precision medicine:
Key Topics:
Validation frameworks for hPSC models, organoids & MPS
Addressing quality control & batch reproducibility
Defining CoU for safety sciences
Cross-industry alignment for regulatory acceptance, reducing reliance on animal testing

Advanced stem cell-based models are becoming an increasingly important part of new approach methodologies (NAMs), offering more human-relevant systems (hiPSC models, organoids, and microphysiological systems) for evaluating the safety and efficacy of modern therapeutics. However, broader adoption requires more than scientific innovation; it depends on standardized methods, fit-for-purpose validation, and collaboration across industry, academia, and regulators.

In this webinar, Dr. Daniela Cornacchia introduces the International Society for Stem Cell Research (ISSCR) Consortium on Advanced Stem Cell-Based Models in Drug Discovery & Development. She explains how the ISSCR consortium is helping accelerate the adoption of stem cell-derived NAMs by developing standardized validation frameworks, defining performance metrics, promoting best practices, and facilitating regulatory alignment across research sectors in academia, pharma, TechBio and regulatory agencies. The presentation also explores the scientific and operational challenges that currently limit implementation, including standardization, quality control, reproducibility, and Context of Use.

Key Topics:

Why stem cell-derived models are becoming increasingly important for modern drug discovery
The role of organoids, microphysiological systems, and other advanced in vitro models within NAMs
Current barriers to adoption, including standardization, reproducibility, and technical expertise
The importance of fit-for-purpose validation and defining Context of Use (CoU).
How the ISSCR Consortium is advancing collaboration across academia, industry, and regulatory agencies
Future priorities for regulatory acceptance and implementation of stem cell-based NAMs

Speaker Biography

Daniela Cornacchia, PhD
Director, Advanced Cell Model Innovation, Safety Sciences, Clinical Pharmacology and Safety Sciences, AstraZeneca Sweden
Co-Chair, ISSCR Consortium on Advanced Cell-Based Models in Drug Discovery and Development

Daniela Cornacchia is Director of Advanced Cell Model Innovation in Safety Sciences at AstraZeneca (AZ), where she drives the strategic development and implementation of NAMs for safety assessment and therapeutic index prediction. She obtained her PhD from EMBL and Heidelberg University, completed her postdoctoral training at Memorial Sloan Kettering Cancer Center, and held the position of Visiting Investigator at the New York Stem Cell Foundation. Her expertise spans hPSC-derived advanced cell models, organoids, and microphysiological systems (MPS) for translational applications. She leads AZ's NAMs Hub and serves as founding Co-Chair of the ISSCR Consortium on Advanced Cell-Based Models in Drug Discovery and Development.

Publish Date: June 15, 2026

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Webinar: ISSCR Consortium: Stem Cell-Based Models in Drug Discovery

Hosted live on April 8, 2026, learn how the ISSCR Consortium is advancing standards for stem cell-derived NAMs across drug discovery, safety assessment & precision medicine:

Key Topics:

Validation frameworks for hPSC models, organoids & MPS
Addressing quality control & batch reproducibility
Defining CoU for safety sciences
Cross-industry alignment for regulatory acceptance, reducing reliance on animal testing

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