Agenda

December 10, 2026 – Open session

Part 1 — From Innovation to Decision-Grade Human-Relevant Models – Building the Scientific Infrastructure for the Future of Biomedical Research

NIH leadership and NIH SOM leads present an overview of why NIH SOM is needed now, and the infrastructure it provides to move organoid models from scientific innovation to reproducible, benchmarked, decision-grade tools for human biology. It introduces NIH SOM's vision and mission, with governance and community engagement opportunities covered as supporting detail.

8:30–9:15 AM — Opening Keynote — NicoleKleinstreuer

Introduces the NIH‑wide NAM strategy and frames how the SOM Initiative fits into NIH‑level national priorities

9:15–9:35 AM — Session I: One NIH, One Mission — JamesCherry & KristinKomschlies

Outlines cross‑NIH governance for SOM, including the roles of DPCPSI, NIAID, and NCI in coordinated oversight of the Initiative

9:35–10:15 AM — Session II: NIH SOM Center Overview — SrivatsanKidambi

Describes the SOM Center’s scientific and operational framework, including standards for reproducibility, benchmarking, and data stewardship.

10:15–10:45 AM — Questions

10:45–11:00 AM — Break

Part 2 — Charting the Future – Building the NIH SOM Ecosystem through Partnerships, Standards, and Community

Interactive sessions involving various stakeholders from a variety of viewpoints will discuss needs within the field; from the research community, industry and regulators. Discussions will capture the field’s biggest challenges in standards, qualification, access, partnerships, automation, data infrastructure, and regulatory alignment, building the shared foundation needed for confidence and trust in organoid models.

By the end of the symposium, the NIH SOM Team will have direct stakeholder input on needs and priorities, and participants will have shaped the roadmap that guides the Initiative's next phase

11:00 AM–12:00 PM — The Standards Perspective

This panel convenes standards bodies to describe the current gaps in metadata, qualification, and reference frameworks needed to ensure reproducibility and trust in human‑relevant models.

12:00–1:00 PM — Lunch

1:00–2:15 PM — Enabling Real‑World Impact: Linking Translational Science to Clinical End Users

This panel brings together clinicians and translational researchers to identify the challenges and needs in using human‑relevant models for precision medicine and patient‑connected applications.

2:15–3:30 PM — Innovation at the Frontlines: Technology Developers Shaping the Future of Human‑Relevant Models

This panel features biotech developers discussing barriers to reproducibility, scalability, interoperability, and adoption, and how standardized models and data infrastructures could address those obstacles.

3:30–3:45 PM — Break

3:45–5:00 PM — From Discovery to Decision Making: How Human‑Relevant Models Are Transforming Drug Development and Regulatory Approval

This panel brings together pharma and regulatory experts to explore how organoid and NAM data are used in development pipelines and regulatory submissions, and what evidence gaps still hinder adoption.

5:00–5:15 PM — Meeting wrap up, summarizing panel recommendations

 

December 11, 2026 – Closed session to discuss recommendations from the prior day.