Agenda

Day One – Monday, June 8, 2026 – Online – Times listed in EDT

Opening Session: Welcome and Workshop Overview
9:00 a.m. – 9:15 a.m. Welcome and Workshop Overview

Oleg Mirochnitchenko, Ph.D.
Nicole Kleinstreuer, Ph.D.
Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI), Office of the Director (OD), National Institutes of Health (NIH)
Keynote Speaker
9:15 a.m. – 10:00 a.m. Complementary Roles for Human Organ Chips, Artificial Intelligence (AI), and Animal Models

Donald E. Ingber, M.D., Ph.D.
Wyss Institute, Boston Children's Hospital, and Harvard Medical School
10:00 a.m. – 10:10 a.m. Q&A
10:10 a.m. – 10:20 a.m. Break
Session 1: The Need for Complex Integration of New Technologies to Study Biological Mechanisms of Human Disease Progression; Complementary Use of Animal Models and New Approach Methodologies (NAMs) for Preclinical Studies and Therapeutic Development
Co-chairs: Rebecca Roof, Ph.D. (National Institute of Neurological Disorders and Stroke, NIH); Jason Shepherd, Ph.D. (The University of Utah)
10:20 a.m. – 10:40 a.m. Tissue-Engineered NAMs for Drug Discovery and Evaluation

Wolfram-Hubertus Zimmermann, Prof. Dr.
Institute of Pharmacology and Toxicology, University Medical Center Göettingen
10:40 a.m. – 11:00 a.m. Organoid NAM-Guided Precision Hepatology

Takanori Takebe, M.D., Ph.D.
Cincinnati Children's Hospital Medical Center
11:00 a.m. – 11:20 a.m. Modeling the Regenerative Endometrium Using 3D Organoids and Assembloids

Diana Monsivais, Ph.D.
Baylor College of Medicine
11:20 a.m. – 11:40 a.m. There and Back Again: A Multi-Platform Journey from Cell Lines to Human Tissue Reveals Direct Interactions Between Helicobacter pylori and Epithelial Stem Cells

Manuel R. Amieva, M.D., Ph.D.
Stanford University
11:40 a.m. – 12:00 p.m. Putting the Pieces Together: Inception of Human Neural Circuits in Assembloids to Study Disease Sergiu P. Paşca, M.D.
Stanford University
12:00 p.m. – 12:35 p.m. Discussion Panelists: Wolfram-Hubertus Zimmermann, Takanori Takebe, Sergiu P. Paşca, Manuel R. Amieva, Diana Monsivais
12:35 p.m. – 1:15 p.m. Lunch
Session 2: Shared Resources to Validate and Promote NAMs; Research Frameworks; Tracking Activities
Co-chairs: Christine Nadeau, Ph.D. (National Cancer Institute, NIH); Thomas Bell, Ph.D. (National Disease Research Interchange)
1:15 p.m. – 1:30 p.m. CuSTOMizing Induced Pluripotent Stem Cells for Modeling Human Disease Michael A. Helmrath, Ph.D.
University of Cincinnati, Cincinnati Children's Hospital Medical Center
1:30 p.m. – 1:45 p.m. NAMs for Interrogating Cancer Scott W. Lowe, Ph.D.
Memorial Sloan Kettering Center
1:45 p.m. – 2:00 p.m. Coordinated Infrastructure for NAMs Benchmarking and Community Access Brenda Ogle, Ph.D.
University of Minnesota
2:00 p.m. – 2:15 p.m. From Standardized Biological Materials to Validated NAMs: The Role of Resource Stewardship, Quality Frameworks, and Scalable Validation Carolina Lucchesi, Ph.D.
American Type Culture Collection
2:15 p.m. – 2:45 p.m. Discussion Panelists: Michael A. Helmrath, Scott W. Lowe, Brenda Ogle, Carolina Lucchesi
2:45 p.m. – 2:55 p.m. Break
Session 3: Building Comparative Databases and Tools to Support Benchmarking and Model Selection; Promoting Predictivity and Reproducibility Through Interoperable Data Standards and Platforms
Co-chairs: Christine Happel, Ph.D. (National Center for Advancing Translational Sciences, NIH); Alice Tarantal, Ph.D. (University of California, Davis)
2:55 p.m. – 3:10 p.m. Bridging the Gap: A Mechanistic Platform to Enhance Translatability of Human-Specific Pharmacology Across Diverse Modalities Murat Cirit, Ph.D.
Javelin Biotech
3:10 p.m. – 3:25 p.m. Standardizing NAM Data for Mechanistic Discovery and Translational Confidence Melissa Haendel, Ph.D.
The University of North Carolina at Chapel Hill
3:25 p.m. – 3:40 p.m. From Atlas to Benchmark: The Infrastructure Required to Compare an Organoid to Human Tissue Jason Spence, Ph.D.
University of Michigan Medical School
3:40 p.m. – 3:55 p.m. Building Confidence Through Curated Data and Open Access Interoperable Computational Tools to Support NAM-Based Chemical Assessment Bridgett Hill, M.S.
General Dynamics Information Technology
3:55 p.m. – 4:25 p.m. Discussion Panelists: Murat Cirit, Melissa Haendel, Jason Spence, Bridgett Hill
4:25 p.m. – 4:35 p.m. Break
Session 4: Multidisciplinary Collaboration, Training, and Future Directions
Co-chairs: Malgorzata Ochocinska, Ph.D. (Office of Strategic Coordination, DPCPSI, OD, NIH); Yongjun Sui, Ph.D. (ORIP, DPCPSI, OD, NIH)
4:35 p.m. – 4:50 p.m. Organs-on-Chips and Organoids: What Can You Ask of Your Microphysiological Systems, How Far Can You Extrapolate Beyond What They Tell You, and What’s Needed? John Wikswo, Ph.D.
Vanderbilt University
4:50 p.m. – 5:05 p.m. Stem Cells, Genomics, and AI for Drug Discovery Joseph Wu, M.D., Ph.D.
Stanford University School of Medicine
5:05 p.m. – 5:20 p.m. Chips for Organoids Ashutosh Agarwal, Ph.D.
University of Miami
5:20 p.m. – 5:35 p.m. Organoids and Mouse Models for Studying and Defeating Human Cancers David Tuveson, M.D., Ph.D.
Cold Spring Harbor Laboratory
5:35 p.m. – 6:05 p.m. Discussion Panelists: John Wikswo, Joseph Wu, Ashutosh Agarwal, David Tuveson
Closing Remarks
6:05 p.m. – 6:10 p.m. Closing Remarks Stephanie Murphy, V.M.D., Ph.D.
ORIP, DPCPSI, OD, NIH

Day Two – Friday, June 12, 2026 – Online – Times listed in EDT

Opening Session: Welcome and Workshop Overview
10:00 a.m. – 10:15 a.m.

Welcome and Workshop Overview

Chair Introduction of the Day

Monika Aggarwal, Ph.D.
ORIP, DPCPSI, OD, NIH
Yong Chen, Ph.D.
ORIP, DPCPSI, OD, NIH
Jeffrey Spector, Ph.D.
ORIP, DPCPSI, OD, NIH
Benjamin Freedman, Ph.D. (Day 2 Workshop Chair)
University of Washington

Session 1: Development and Validation of In Vitro NAMs and Integrated Model Systems
Session Chair: Linda Griffith, Ph.D. (Massachusetts Institute of Technology)
Session Moderators: Linda Griffith, Ph.D. (Massachusetts Institute of Technology); Georgette Jones, Ph.D. (National Cancer Institute, NIH)
10:15 a.m. – 10:45 a.m. Designing and Interpreting NAMs Using System Biology

Douglas Lauffenburger, Ph.D.
Massachusetts Institute of Technology
10:45 a.m. – 11:05 a.m. How Biological Insights Drive Development of Clinically Relevant NAMs Tools

Christopher Hughes, Ph.D.
University of California, Irvine
11:05 a.m. – 11:25 a.m. Parsing Systemic Immunity with NAMs

Martin Trapecar, Ph.D.
Johns Hopkins University
11:25 a.m. – 11:45 a.m. Scaling and Automation to Support NAMs in Routine Screening: A Pharma Perspective

Kimberly Homan, Ph.D.
Anna Bremser, Ph.D.
Genentech Inc.
11:45 a.m. – 12:05 p.m. Scaling, Validating, and Translating NAMs for Detecting Risks to Human Neurodevelopment Randolph Ashton, Ph.D.
University of Wisconsin–Madison
12:05 p.m. – 12:30 p.m. Panel Discussion Panelists: Anna Bremser, Anthony Atala, Linda Griffith, Douglas Lauffenburger, Christopher Hughes, Martin Trapecar, Kimberly Homan, Randolph Ashton, D. Lansing Taylor, Georgette Jones
12:30 p.m. – 12:40 p.m. Break
Session 2: In Chemico NAMs and NAMs Supporting Systems
Session Chair: Robert Damoiseaux, Ph.D. (University of California, Los Angeles)
Session Moderators: Douglas Lauffenburger, Ph.D. (Massachusetts Institute of Technology); Albert Hwa, Ph.D. (National Institute of Diabetes and Digestive and Kidney Diseases, NIH)
12:40 p.m. – 1:10 p.m. High-Throughput Phenotyping in Autism Daniel Geschwind, M.D., Ph.D.
University of California, Los Angeles
1:10 p.m. – 1:30 p.m. Building a Hub for Human-Based and AI-Partnered Drug Discovery Angela Koehler, Ph.D.
Massachusetts Institute of Technology
1:30 p.m. – 1:50 p.m. It Takes a Village (of Robots): Scaling Human Gene-by-Environment Studies in a Dish via AI-Enabled Cell Culture Automation Robert Damoiseaux, Ph.D.
Michael Wells, Ph.D.
University of California, Los Angeles
1:50 p.m. – 2:10 p.m. Models for Fibrotic Disease: A Fibroid Case Study Jennifer Elisseeff, Ph.D.
Johns Hopkins University
2:10 p.m. – 2:30 p.m. DNA-Encoded Chemical Library Screening in Living Tissues Brian Paegel, Ph.D.
University of California, Irvine
2:30 p.m. – 2:55 p.m. Discussion Panelists: Robert Damoiseaux, Douglas Lauffenburger, Daniel Geschwind, Angela Koehler, Michael Wells, Jennifer Elisseeff, Brian Paegel, Albert Hwa
2:55 p.m. – 3:15 p.m. Lunch
Session 3: In Silico NAMs—Leveraging Real-World Data for Model Validation
Session Chair: Reinhard Laubenbacher, Ph.D. (University of Florida)
Session Moderators: Gary An, M.D. (The University of Vermont), Raphael Isokpehi, Ph.D. (Office of Data Science Strategy, DPCPSI, OD, NIH)
3:15 p.m. – 3:45 p.m. The Virtual Human Twin Initiative: From an Engaged Ecosystem to an Incipient Infrastructure Lisbet Geris, Ph.D.
University of Liege, Belgium
3:45 p.m. – 4:05 p.m. A Roadmap to Integrated In Silico Resources: Biology, Data, Model Reinhard Laubenbacher, Ph.D.
University of Florida
4:05 p.m. – 4:25 p.m. Beyond Static Protein Models: In Silico Infrastructure for the Disordered and Flexible Proteome María Rodríguez Martínez, Ph.D.
Yale University
4:25 p.m. – 4:45 p.m. Cheminformatics and Data Infrastructure for In Silico NAMs Alexander Tropsha, Ph.D.
The University of North Carolina at Chapel Hill
4:45 p.m. – 5:05 p.m. Digital Twins for the Win: Infrastructure from Molecules to Medicine Colleen Clancy, Ph.D.
University of California, Davis
5:05 p.m. – 5:30 p.m. Panel Discussion Panelists: Reinhard Laubenbacher, Lisbet Geris, María Rodríguez Martínez, Alexander Tropsha, Colleen Clancy, Gary An, Raphael Isokpehi
Session 4: Future Trends Toward Integration of Model Systems and Clinical Applications
5:30 p.m. – 5:50 p.m. New Approach Methodologies to Accelerate Clinical Trials In-a-Dish Joseph Wu, M.D., Ph.D.
Stanford University
Closing Remarks
5:50 p.m. – 6:00 p.m. Closing Remarks Robin Kawazoe
ORIP, DPCPSI, OD, NIH