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Vaccines, Blood & Biologics

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Workshop Program - 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