Regulatory Science

Funded Research

Stem/Progenitor Cell-Derived Human Micro-organs and -tissues (U18) RFA-RM-12-001

PI Name Institution Name Title

CHRISTIANO, ANGELA M

COLUMBIA UNIVERSITY HEALTH SCIENCES

Modeling complex diseases using iPSC-derived skin constructs

DONOWITZ, MARK 

JOHNS HOPKINS UNIVERSITY

Human Intestinal Organoids: Pre-Clinical Models of Non-Inflammatory Diarrhea

HARTUNG, THOMAS 

JOHNS HOPKINS UNIVERSITY

A 3D Model of Human Brain Development for Studying Gene/Environment Interactions

LYNCH, JOHN P

UNIVERSITY OF PENNSYLVANIA

Modeling oxidative stress and DNA damage using GI organotypic culture systems

NICHOLS, JOAN E

UNIVERSITY OF TEXAS MEDICAL BR GALVESTON

3D human lung model to study lung disease and formation of fibrosis

TUAN, ROCKY S

UNIVERSITY OF PITTSBURGH

3-D Osteochondral Micro-tissue to Model Pathogenesis of Osteoarthritis

WELLS, JAMES M

CINCINNATI CHILDRENS HOSPITAL MED CTR

Generating Human Intestinal Organoids with an ENS



Integrated Microphysiological Systems for Drug Efficacy and Toxicity Testing in Human Health and Disease (UH2/UH3) RFA-RM-11-022

PI Name Institution Name Title

GEORGE, STEVEN CARL

UNIVERSITY OF CALIFORNIA IRVINE

An integrated in vitro model of perfused tumor and cardiac tissue

GRIFFITH, LINDA G

MASSACHUSETTS INST OF TECH

All-Human Microphysical Model of Metastasis Therapy

HEALY, KEVIN EDWARD (contact)
LEE, LUKE P.

UNIVERSITY OF CALIFORNIA BERKELEY

Disease-Specific Integrated Microphysiological Human Tissue Models

HIMMELFARB, JONATHAN 

UNIVERSITY OF WASHINGTON

A Tissue Engineered Human Kidney Microphysiological System

PARKER, KEVIN KIT

HARVARD UNIVERSITY

Human Cardio-Pulmonary System on a Chip

SHULER, MICHAEL L (contact)
HICKMAN, JAMES J

CORNELL UNIVERSITY

Microphysiologial systems and low cost microfluidic platform with analytics

TAYLOR, D. LANSING LANSING (contact)
YARMUSH, MARTIN L

MASSACHUSETTS GENERAL HOSPITAL

A 3D biomimetic liver sinusoid construct for predicting physiology and toxicity

THOMSON, JAMES ALEXANDER

MORGRIDGE INSTITUTE FOR RESEARCH

Human iPS/ES Cell-Based Models for Predictive Neural Toxicity and Teratogenicity

TRUSKEY, GEORGE A

DUKE UNIVERSITY

Circulatory system and integrated muscle tissue for drug and tissue toxicity

WIKSWO, JOHN PETER (contact)
NISWENDER, KEVIN D
WEBB, DONNA J

VANDERBILT UNIVERSITY

Neurovascular Unit on a Chip: Chemical Communication, Drug and Toxin Responses



Advancing Regulatory Science through Novel Research and Science-Based Technologies (U01)
RFA-RM-10-006
PI Name Institution Name Title
BARSAN, WILLIAM G (contact)
BERRY, DONALD A
LEWIS, ROGER J
UNIVERSITY OF MICHIGAN AT ANN ARBOR Accelerating Drug and Device Evaluation through Innovative Clinical Trial Design
CERVEN, DANIEL R (contact)
DEGEORGE, GEORGE L.
MB RESEARCH LABORATORIES, INC. Replacement Ocular Battery (ROBatt)
HOURCADE, DENNIS E. WASHINGTON UNIVERSITY Characterization/Bioinformatics-modeling of Nanoparticle: Complement Interactions
INGBER, DONALD E HARVARD UNIVERSITY (MEDICAL SCHOOL) Heart-Lung Micromachine for Safety and Efficacy Testing





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Division of Program Coordination, Planning, and Strategic Initiatives  •  National Institutes of Health  •  Bethesda, Maryland 20892