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U.S. Department of Health and Human Services

Science & Research

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May 10, 2013 FDA Workshop: Developing Microphysiological Systems for Use as Regulatory Tools


FDA Targets Drug Side Effects - (JPG)Cosponsored by FDA, the National Institutes of Health (NIH), National Institute for Environmental Health Sciences (NIEHS), and the National Center for Advancing Translational Science (NCATS), Environmental Protection Agency (EPA), the Johns Hopkins School of Public Health Center for Alternatives to Animal Testing, and the International Consortium for Innovation and Quality in Pharmaceutical Development, the workshop's objectives were to:

  •  discuss crucial elements needed to create microphysiological systems as regulatory tools
  • explore pathways to qualification as regulatory tools


 Workshop Agenda

Web Cast 8:45 a.m. -- 10:00 a.m. 

8:45 a.m. –- 9:00 a.m.

Welcome and Introductory Remarks (15 min)
Jesse L. Goodman, M.D., M.P.H.
Chief Scientist, Food and Drug Administration

9:00 a.m. -- 10:00 a.m.        
Session IOverview of Microphysiological Systems: Promise or ‘Pie in the Sky’?
Chair:  Yvonne Dragan, Ph.D

1.  Microphysiological Systems: An Academic Perspective   (20 min)
Donald E. Ingber, M.D, Ph.D.
Director, Wyss Institute for Biologically Inspired Engineering, Harvard University
Judah Folkman Professor of Vascular Biology, Harvard Medical School and Vascular Biology Program, Boston Children’s Hospital
Professor of Bioengineering, Harvard School of Engineering and Applies Sciences

2.  Microphysiological Systems: An Industry Perspective (20 min)
James L. Stevens, Ph.D.
Distinguished Research Fellow, Lilly Research Laboratories
3.  Microphysiological Systems: A Regulatory Perspective (20 min)
Douglas C. Throckmorton, M.D.
Deputy Director for Regulatory Programs, CDRH, FDA


Web Cast 10:15 a.m. -- 12:15 p.m.


10:15 a.m. --11:15 a.m.
Session II:  Inventing Microphysiological Systems: Cells Types, Tissues, and How to Apply Them
Chair: Thomas Hartung, M.D., Ph.D.
Johns Hopkins University Center for Alternatives to Animal Testing
1. Good Cell Cultures-and Quality Control (30 minutes)
    Thomas Hartung, M.D., Ph.D., Johns Hopkins University Center for Alternatives to Animal Testing
2. Importance of Stem Cells (30 minutes)
    Kyle Kolaja,Ph.D., Cellular Dynamics
11:15 a.m. -- 12:15 p.m.   
Session III: Panel Discussion - Speakers from Session I and II (60 minutes)
Moderator: Suzanne Fitzpatrick, Ph.D.
Senior Advisor for Toxicology, CFSAN, FDA

Web Cast 1:15 p.m. -- 3:30 p.m.
1:15 p.m. -- 3:30 p.m.           
Session IV:  Building A Representative Microphysiological Organ System (135 minutes)
Chair:  Dan Tagle, Ph.D.
Associate Director for Special Initiatives
National Center for Advancing Translational Sciences, National Institutes of Health  

1. Liver (45 minutes)
D. Lansing Taylor, Ph.D
Director, Drug Discovery Institute, University of Pittsburgh
2. Gastrointestinal Including Microbiome (45 minutes)
Don Ingber, M.D, Ph.D.
Director, Wyss Institute for Biologically Inspired Engineering, Harvard University 

Renal (45 minutes)
Jonathan Himmelfarb, M.D.
Director, Kidney Research Institute, Professor of Medicine, University of Washington
Joseph W. Eschbach Endowed Chair in Kidney Research

Web Cast 3:45--5:00 p.m.

3:45 p.m. -- 5:00 p.m.
Session V: Integration of Microphysiological Organ Systems: What’s Essential, What’s Nice and What’s Not (75 minutes)
Bob Kavlock, Ph.D.
Deputy Assistant Administrator for Science, EPA
Melvin E.  Andersen, C.I.H., Ph.D., D.A.B.T., F.A.T.S.
Charles E. Hamner, Jr. Distinguished Fellow, The Hamner Institues for Health Sciences