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Health and Human Services
Town Hall Meeting:
Hot Topics 2006
8:00 AM - 5:30
PM
Room 207AB
Moderators: Aaron V. Kaplan, Mitchell
W. Krucoff, Roxana Mehran, Stephen C.
Mockrin, Steve Phurrough, Gregg W. Stone,
Bram Zuckerman
What's New in 2006/2007
8:00 AM
Introduction
Gregg W. Stone
8:05 AM
FDA/CDRH
8:05 AM
FDA/CDRH
Daniel G. Schultz
8:35 AM
Q&A
8:50 AM
NIH/NHLBI
Susan B. Shurin
9:20 AM
Q&A
9:35 AM
CMS
Steve Phurrough
10:05 AM
Q&A
Hot Topics 2006/2007:
Improving and Accelerating the Device
Approval Process
Standardization
of DES Definitions, Issues of Data Poolability
and
Information Technology and Transfer
10:20 AM
Introductory Comments
Ashley B. Boam
10:28 AM
Introductory Comments
Charles P. Friedman
10:36 AM
Moderated Discussion
Panel Moderator: Mitchell W.
Krucoff
Discussants: Ashley B. Boam; Donald
Cutlip; David L. DeMets; Stan Fink;
Charles P. Friedman; Roxana Mehran;
Stuart J. Pocock; Takahiro Uchida;
Gerrit-Anne van Es
Accelerating
DES Clinical Trials: Surrogate Endpoints,
Composite Endpoints and
Adaptive Trial Designs
11:01 AM
Introductory Comments
Gregory Campbell
11:09 AM
Introductory Comments
Stuart J. Pocock
11:17 AM
Moderated Discussion
Panel Moderator: Mitchell W. Krucoff
Discussants: Heather Agler; Gregory Campbell;
David L. DeMets; Dennis Donohoe; Robert
P. Fiorentino; Laura Mauri; Stuart J.
Pocock; Susan B. Shurin; Lilly Yue
Specific
DES Issues - Preclinical Evaluation,
Device Iteration, Non-Inferiority
Trials,
Label Expansion, Next Generation Devices,
Speed to Market vs. Safety, etc.
11:42 AM
Introductory Comments
Andrew Farb
11:54 AM
Moderated Discussion
Panel Moderator: Martin B. Leon
Discussants: David L. DeMets; Michael
Domanski; Andrew Farb; Joerg Koglin; LeRoy
LeNarz; William H. Maisel; Hina M. Pinto;
Stuart J. Pocock; John Somberg; Judah
Z. Weinberger; Alan C. Yeung
12:24 PM
Break
Evolving Roles
of Safety Reporting and the DSMC in the
Clinical Trial Process
2:00 PM
Introductory Comments
Bram Zuckerman
2:08 PM
Moderated Discussion
Panel Moderator: Roxana Mehran
Discussants: David L. DeMets; Bernard
J. Gersh; David J. Gordon; Mitchell
W. Krucoff; Stuart J. Pocock; Mary
E. Russell; Wolf Sapirstein; Susan
B. Shurin; Bram Zuckerman
Off-Label
Device Usage and Adoption of Evidence-Based
Medicine
2:23 PM
Introductory Comments
Daniel G. Schultz
2:31 PM
Introductory Comments
Steve Phurrough
2:39 PM
Moderated Discussion
Panel Moderator: Aaron V. Kaplan
Discussants: Ashley B. Boam; Nicolas
A. F. Chronos; Michael Domanski;
Dennis Donohoe; Andrew Farb; Steve
Phurrough; Mary E. Russell; Richard
Schatz; Daniel G. Schultz
Introduction
of Novel Devices: The Example of Aortic
and Mitral Percutaneous Valves
2:59 PM
Introductory Comments - FDA Perspectives
Julie A. Swain
3:07 PM
Introductory Comments - Industry
Perspectives
Stanton J. Rowe
3:15 PM
Moderated Discussion
Panel Moderator: Blasé A. Carabello
Discussants: Ted Feldman; A. Marc Gillinov;
Martin B. Leon; William H. Maisel; Steve
Phurrough; Campbell D.K. Rogers; Stanton
J. Rowe; Wolf Sapirstein; John Somberg;
Julie A. Swain; Carolyn D. Vaughan
Post Market
Surveillance: Mechanisms and Consequences
3:35 PM
Introductory Comments - FDA Perspectives
Thomas Gross
3:43 PM
Introductory Comments - Lessons
from the Dynamic Registry, and Ongoing
NIH Initiatives
Patrice Desvigne-Nickens
3:51 PM
Moderated Discussion
Panel Moderator: Roxana Mehran
Discussants: David S. Buckles; Eric A.
Chen; Patrice Desvigne-Nickens; William
A. Gray; Thomas Gross; James Kirklin;
David J. Malenka; Steve Phurrough; Wolf
Sapirstein
Conflict of
Interest: Industry, HHS, Physician Inventors/Investigators,
Physician Run Hospitals and Labs, and
Other Considerations
4:11 PM
Introductory Comments
Aaron V. Kaplan
4:19 PM
Introductory Comments
William H. Maisel
4:27 PM
Introductory Comments
Donna R. Lochner
4:35 PM
Moderated Discussion
Panel Moderator: Aaron V. Kaplan
Discussants: Donald S. Baim; Paul Buckman.;
Thomas J. Fogarty; David J. Gordon; Shunichi
Homma; Donna R. Lochner; John J. Smith;
Barry F. Uretsky; Scott R. Ward
Reimbursement
as a Regulatory Tool and Driver of Physician
Behavior
4:56 PM
Introductory Comments
Steve Phurrough
5:06 PM
Moderated Discussion
Panel Moderator: William W. O'Neill
Discussants:
David J. Cohen; Brian G. Firth; William
A. Gray; Gary C. Johnson; Paul A. LaViolette;
Steve Phurrough; Janet Trunzo; Barbara
Zimmerman
5:30
PM
Adjourn
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