Talk Title:
The NIH Standardized Organoid Modeling (SOM) Initiative: Building Trusted Human-Relevant Platforms for Biomedical Research and Translational Science

Talk Summary:
Organoid and microphysiological system (MPS) technologies have advanced rapidly, enabling increasingly sophisticated models of human tissues and disease. Despite this progress, broader integration into biomedical research, drug development, and translational science remains limited by variability in cell sourcing, culture conditions, analytical endpoints, and performance metrics. While many academic and multi-institutional efforts focus on developing increasingly sophisticated biological models, a critical need remains for cross-platform standardization, benchmarking, and qualification to support defined contexts of use.

The NIH Standardized Organoid Modeling (SOM) Initiative was established to address this challenge by creating a centralized, neutral infrastructure dedicated to standardization, reproducibility, and performance evaluation of human-relevant models. Rather than developing new organoid platforms, NIH SOM focuses on establishing the scientific and technical foundation needed to generate reference-quality organoid models that support benchmarking, method comparison, and downstream translational applications.

During its current foundation-building phase, the initiative is developing standardized operating procedures for organoid generation, culture, maintenance, and multimodal characterization across tissue types. Automation and robotics are being incorporated to improve reproducibility and scalability, while artificial intelligence and machine learning are being integrated to support longitudinal performance assessment, protocol optimization, and definition of acceptable performance ranges. Genetically diverse induced pluripotent stem cell lines are incorporated to better understand biological variability, and experimental data are managed within an integrated data sciences environment to ensure traceability, interoperability, and reuse.

Evaluation of organoid performance requires complementary analytical approaches spanning molecular profiling, functional assays, and quantitative imaging. Together, these modalities provide a comprehensive framework for assessing morphology, cellular organization, functional maturation, biological variability, and responses to perturbation. Within this broader framework, advances in molecular imaging offer important opportunities to enhance non-destructive characterization, longitudinal monitoring, and multimodal data integration that support reproducible evaluation of human-relevant models.

The expected outcomes include standardized organoid reference platforms with defined contexts of use, quantified performance metrics, and improved reproducibility across laboratories. These foundational resources are intended to enable more rigorous comparison of experimental results and increase confidence in human-relevant model systems. As the initiative evolves, NIH SOM is actively engaging academic, industry, and government partners to help establish community-driven standards and ensure broad applicability across biomedical research.

This presentation will discuss the vision and progress of the NIH SOM Initiative and explore how advances in molecular imaging, together with other complementary technologies, can contribute to building trusted, standardized, and interoperable human-relevant platforms that accelerate biomedical discovery, translational research, and ultimately improve patient outcomes.

Presenter Biography:
Srivatsan (Sri) Kidambi, PhD, is Director of the NIH Standardized Organoid Modeling (SOM) Center, where he leads NIH-wide efforts to establish standardized, scalable, and AI-enabled human organoid platforms that advance translational science, regulatory science, and precision medicine. Recruited by the NCI to provide scientific and strategic leadership for its clinical and advanced technology portfolio, he now directs the NIH SOM Center, a cross-NIH effort focused on transforming human-relevant New Approach Methodologies (NAMs) into reproducible, benchmarked, and interoperable research platforms. With more than 20 years of experience spanning academia, industry, and government, Dr. Kidambi has advanced organoids, microphysiological systems, biomaterials, and precision medicine technologies. Prior to joining NIH, he held research positions at Hitachi Chemical Research Center and later served for 14 years as a tenured faculty member in the Department of Chemical and Biomolecular Engineering at the University of Nebraska-Lincoln, where he founded the FOCUS Laboratory. Dr. Kidambi received his PhD in Chemical Engineering and MS in Chemistry from Michigan State University and completed postdoctoral training at Harvard Medical School. He has secured more than $125 million in research funding as PI or Co-PI, authored over 80 peer-reviewed publications, holds six patents, founded Keshava Biosciences, and has mentored more than 55 trainees. He contributes to international standards through leadership in the International Society for Stem Cell Research (ISSCR) and ISO working groups focused on organoids and microphysiological systems. Dr. Kidambi is recognized for building scientific infrastructure that advances trusted, standardized human-relevant models for biomedical research, drug development, and regulatory science.

Author
Srivatsan Kidambi
NIH