Regulatory Science - Funded Research

The Regulatory Science Program has transitioned from Common Fund support. For more information please visit https://commonfund.nih.gov/regulatoryscience.

Please note that since the Regulatory Science program is no longer being supported by the Common Fund, the program website is being maintained as an archive and will not be updated on a regular basis.

**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
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
VUNJAK-NOVAKOVIC, GORDANA	COLUMBIA UNIV NEW YORK MORNINGSIDE	Integrated heart-liver-vascular systems for drug testing in human health and dise
WIKSWO, JOHN PETER (contact) NISWENDER, KEVIN D WEBB, DONNA J	VANDERBILT UNIVERSITY	Neurovascular Unit on a Chip: Chemical Communication, Drug and Toxin Responses
WOODRUFF, TERESA K	NORTHWESTERN UNIVERSITY AT CHICAGO	Ex Vivo Female Reproductive Tract Integration In a 3D Microphysiologic System

**Limited Competition for NIH-Industry Pilot Program: Discovering New Therapeutic Uses for Existing Molecules (UH2/UH3) RFA-TR-12-004**
PI Name	Institution Name	Title
AKHLAGHI, FATEMEH (contact) LEGGIO, LORENZO	UNIVERSITY OF RHODE ISLAND	A Novel Compound for Alcoholism Treatment: a Translational Strategy
BREIER, ALAN	INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS	The Efficacy and Safety of a Selective Estrogen Receptor Beta agonist (LY500307)
BRUNZELL, DARLENE H (contact) PERKINS, KENNETH ALAN	VIRGINIA COMMONWEALTH UNIVERSITY	Medication development of a novel therapeutic for smoking cessation
EISSA, TONY	BAYLOR COLLEGE OF MEDICINE	Therapeutic Strategy for LAM (Lymphangioleiomyomatosis)
KRYSTAL, JOHN H	YALE UNIVERSITY	Translational Neuroscience Optimization of GlyT1 Inhibitor
MILLER, JORDAN D (contact) ENRIQUEZ-SARANO, MAURICE SCHAFF, HARTZELL V.	MAYO CLINIC ROCHESTER	Therapeutic Strategy to slow progression of calcific aortic valve stenosis
STRITTMATTER, STEPHEN M (contact) NYGAARD, HAAKON BERGE VAN DYCK, CHRISTOPHER H	YALE UNIVERSITY	Fyn Inhibition by AZD0530 for Alzheimers Disease
WAGNER, KATHRYN R (contact) FROEHNER, STANLEY C	HUGO W. MOSER RES INST KENNEDY KRIEGER	Partnering to treat an Orphan Disease Duchenne Muscular Dystrophy

**Limited Competition for NIH-Industry Pilot Program: Discovering New Therapeutic Uses for Existing Molecules (UH3) RFA-TR-12-005**
PI Name	Institution Name	Title
ANNEX, BRIAN H	UNIVERSITY OF VIRGINIA	Reuse of ZD4054 for patients with symptomatic PAD

**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
VUNJAK-NOVAKOVIC, GORDANA	COLUMBIA UNIV NEW YORK MORNINGSIDE	Integrated heart-liver-vascular systems for drug testing in human health and dise
WIKSWO, JOHN PETER (contact) NISWENDER, KEVIN D WEBB, DONNA J	VANDERBILT UNIVERSITY	Neurovascular Unit on a Chip: Chemical Communication, Drug and Toxin Responses
WOODRUFF, TERESA K	NORTHWESTERN UNIVERSITY AT CHICAGO	Ex Vivo Female Reproductive Tract Integration In a 3D Microphysiologic System

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