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OCR for page 27
Proceedings from the Workshop on Science-Based Assessment: Accelerating Product Development of Combination Medical Devices
APPENDIXES
OCR for page 28
Proceedings from the Workshop on Science-Based Assessment: Accelerating Product Development of Combination Medical Devices
APPENDIX A
WORKSHOP AGENDA
Tuesday, April 22, 2003
7:45 AM
Continental Breakfast
8:30 AM
Welcome and Introduction
Robert Nerem, BEMA Chair
8:35 AM
Setting the Context: Scientist/Engineer
John Watson, NIH
8:55 AM
Setting the Context: Clinician
Renu Virmani, Armed Forces Institute of Pathology
9:15 AM
Setting the Context: Risk/Benefit Ratio
Paul Citron, Medtronic, Inc.
9:35 AM
Discussion
All
10:00 AM
Break
10:30 AM
Science-Based Testing for Devices
Aric Kaiser, FDA
10:45 AM
Science-Based Testing for Biologics
Darin Weber, FDA
11:00 AM
Experimental Design Technologies
Jim Rutledge, DataVision
11:30 AM
Discussion
All
12 NOON
Lunch
1:00 PM
Scientific and Process Design
Steve LaRiviere, Boeing
1:30 PM
Discussion
All
1:45 PM
BMP-Orthopedic Repair
Session Chair: Joshua Jacobs, Rush Medical College
1:45 PM
Overview of Science and Test Methods
Barbara Boyan, Georgia Institute of Technology
OCR for page 29
Proceedings from the Workshop on Science-Based Assessment: Accelerating Product Development of Combination Medical Devices
2:05 PM
Industry Presentation
Amy LaForte, Stryker Biotech
2:25 PM
Industry Presentation
Bill McKay, Medtronic Sofamor Danek
2:45 PM
Discussion
All
3:15 PM
Break
3:45 PM
Drug-Eluting Stents
Session Chair: Terry Woods, FDA
3:45 PM
Clinician Presentation
Robert Schwartz, Minneapolis Heart Institute
4:05 PM
Industry Presentation
Semih Oktay, CardioMed
4:25 PM
Industry Presentation
Ronald Sahatjian, Boston Scientific Corporation
4:45 PM
Discussion
All
5:15 PM
Break
5:30 PM
Biofilms and Medical Devices
William Costerton, Montana State University
6:15 PM
Reception
Great Hall, NAS Building
7:15 PM
Adjourn
Wednesday, April 23, 2003
7:45 AM
Continental Breakfast
All
8:30 AM
Ethics Presentation
Leonard Weber, University of Detroit
9:00 AM
Cell-Matrix Cartilage Implants
Session Chair: Crystal Cunanan, Edwards Lifesciences
OCR for page 30
Proceedings from the Workshop on Science-Based Assessment: Accelerating Product Development of Combination Medical Devices
9:00 AM
Clinician Presentation
Richard Coutts, University of California at San Diego
9:20 AM
Industry Presentation
Jim Burns, Genzyme
9:40 AM
Industry Presentation
Anthony Ratcliffe, Synthasome, Inc.
10:00 AM
Discussion
All
10:30 AM
Break
11:00 AM
General Discussion
All
12 NOON
Adjourn
Representative terms from entire chapter:
technologies continental