FDA/NIST Sponsored Workshop
In Vitro Analyses of Cell/Scaffold Products
WORKSHOP PROGRAM
Thursday, December 6, 2007 (NTSB; Meeting Level)
8:15 a.m.
Welcome
8:20am
Opening Remarks
Jesse Goodman, M.D., M.P.H
Director, FDA/CBER
8:30 a.m.
FDA Perspective/Review of Cell Scaffold Products
Celia Witten, Ph.D., M.D.
FDA/CBER
SESSION 1: In vitro/Bench Top Characterization of Cell/Scaffold Products
9:15 a.m.
Introduction to Session 1: In vitro/Bench Top Characterization of Cell/Scaffold Products
Charles Durfor, Ph.D.
FDA/CDRH
9:30 a.m.
Overview of Cellular Biomarkers
Rocky Tuan, Ph.D.
National Institutes of Health (NIH)
10:00 a.m.
Questions/Discussion
10:15 a.m.
Break
10:30 a.m.
Overview of Biomaterials Characterization
Buddy Ratner, Ph.D.
University of Washington
11:00 a.m.
Questions/Discussion
11:15 a.m.
In vitro Characterization of Hard Tissue Constructs with Structural Role
David Kaplan, Ph.D.
Tufts University
11:45 a.m.
In vitro Characterization of Skin Constructs with a Structural Role
Nancy Parenteau, Ph.D.
Parenteau BioConsultants, LLC
12:15 p.m.
Lunch (on your own)
1:30 p.m.
In vitro Characterization of Cardiovascular Constructs with a Structural Role
Keith Gooch, Ph.D.
Ohio State University
2:00 p.m.
In vitro Characterization of a Bladder Construct
Tim Bertram, D.V.M., Ph.D.
Tengion, Inc.
2:30 p.m.
In vitro Characterization of a Pancreatic Islet Construct
Melissa Carpenter, Ph.D.
NovoCell, Inc.
3:00 p.m.
In vitro Characterization of an Ex Vivo Liver Construct
Scott Nyberg, M.D., Ph.D.
Mayo Clinic
3:30 p.m.
Break
3:45 p.m.
In vitro Characterization of a Fetal Lung Construct
Peter Lelkes, Ph.D.
Drexel University
4:15 p.m.
Characterization of Cell/Scaffold Products
Kimberly Benton, Ph.D.
FDA/CBER
4:45 p.m.
Roundtable Discussion
Moderators: Charles Durfor, Ph.D. (FDA/CDRH)
Deborah Hursh, Ph.D. (FDA/CBER)
5:30 p.m. Adjourn for the Day
Friday, December 7, 2007 (NTSB; Meeting Level)
SESSION 2: Systematic and High Throughput Analyses of Cell/Scaffold Products
8:00 a.m.
MATES IWG and MATES Strategic Plan
Fred Heineken, Ph.D.
National Science Foundation (NSF)
8:25 a.m.
Trends in Tools and Strategies for Quantifying Biological Response
Anne Plant, Ph.D.
National Institute of Standards and Technology (NIST)
8:50 a.m.
Commercial Assay Development and Quantification
Ken Giuliano, Ph.D.
Cellumen, Inc.
9:40 a.m.
Automated Algorithms for High Content Microscopy
Lani Wu, Ph.D.
University of Texas, Southwestern Medical Center
10:20 a.m.
Break
10:30 a.m.
Proteomics of Cell Scaffold Constructs
Dan Martin, Ph.D.
Institute for Systems Biology
11:10 a.m.
Analysis and Manipulation of Cell Adhesion Receptors and Extracellular Matrix Ligands
Andres Garcia, Ph.D.
Georgia Institute of Technology
11:50 a.m.
Novel Methods to Quantify Tissue Structure and Multi-Axial Mechanical Testing
Michael Sacks, Ph.D.
University of Pittsburgh
12:30 p.m.
Lunch (on your own)
1:30 p.m.
Considerations for Quality Control of In Vitro Cell Cultures
John Elliott, Ph.D.
National Institute of Standards and Technology (NIST)
2:10 p.m.
Roundtable Discussion
Moderator: Anne Plant, Ph.D.
National Institute of Standards and Technology (NIST)
2:50 p.m.
Rapporteur Presentation
Robert Nerem, Ph.D.
Georgia Institute of Technology
3:05 p.m.
Concluding Discussion
3:30 p.m.
Meeting Adjourned