| 7:55 AM | Welcome & Introduction | Mitchell W. Krucoff, MD (Speaker)
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| 8:00 AM | Hot Topics Session 1: Novel Devices Focus—The Path Forward for DEB and New DES and Bioabsorbable Stents | Mitchell W. Krucoff, MD (Moderator) Bram D. Zuckerman, MD (Moderator)
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| 8:00 AM | Novel Devices Focus—The Path Forward for DEB and New DES and Bioabsorbable Stents: Academic View | Bruno Scheller, Other (Speaker)
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| 8:10 AM | Novel Devices Focus—The Path Forward for DEB and New DES and Bioabsorbable Stents: DEB Industry View | Dennis W. Wahr, MD (Speaker)
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| 8:20 AM | Novel Devices Focus—The Path Forward for DEB and New DES and Bioabsorbable Stents: BDS Industry View | Campbell D. K. Rogers, MD (Speaker)
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| 8:30 AM | Novel Devices Focus—The Path Forward for DEB and New DES and Bioabsorbable Stents BDS Industry View | Richard J Rapoza, PhD (Speaker)
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| 8:40 AM | Novel Devices Focus—The Path Forward for DEB and New DES and Bioabsorbable Stents: FDA View | Hina M. Pinto, Other (Speaker)
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| 8:50 AM | Novel Devices Focus—The Path Forward for DEB and New DES and Bioabsorbable Stents: Panel Discussion & Questions from the Audience | Sidney A. Cohen, Other (Panelist) Aaron V. Kaplan, MD (Panelist) Semih Oktay, PhD (Panelist) Hina M. Pinto, Other (Panelist) Richard J Rapoza, PhD (Panelist) Campbell D. K. Rogers, MD (Panelist) Bruno Scheller, Other (Panelist) Erica Takai, PhD (Panelist) Dennis W. Wahr, MD (Panelist) Ron Waksman, MD (Panelist)
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| 9:30 AM | Hot Topics Session 2: Novel Trial Design Focus: Left Main and “All Comers” DES Studies | Mitchell W. Krucoff, MD (Moderator) Bram D. Zuckerman, MD (Moderator)
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| 9:31 AM | Novel Trial Design Focus - Left Main and “All Comers” DES Studies: Left Main Interventional View | Gregg W. Stone, MD (Speaker)
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| 9:35 AM | Novel Trial Design Focus - Left Main and “All Comers” DES Studies: Left Main Interventional View | Michael J. Domanski, MD (Speaker)
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| 9:40 AM | Novel Trial Design Focus - Left Main and “All Comers” DES Studies: Left Main FDA View |
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| 9:45 AM | Novel Trial Design Focus - Left Main and “All Comers” DES Studies: Left Main Industry View | Charles A. Simonton, MD (Speaker)
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| 9:50 AM | Novel Trial Design Focus - Left Main and “All Comers” DES Studies: All-Comers Studies Interventional View | Jeffrey J. Popma, MD (Speaker)
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| 9:55 AM | Novel Trial Design Focus - Left Main and “All Comers” DES Studies: All-Comers Studies FDA View | Ashley B. Boam, Other (Speaker)
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| 10:00 AM | Novel Trial Design Focus - Left Main and “All Comers” DES Studies:All-Comers Studies Industry View | Richard E Kuntz, MD (Speaker)
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| 10:05 AM | Novel Trial Design Focus - Left Main and “All Comers” DES Studies: All-Comers Studies Statistical View | Victor Hasselblad, PhD (Speaker)
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| 10:10 AM | Novel Trial Design Focus - Left Main and “All Comers” DES Studies: Panel Discussion & Questions from the Audience | Ashley B. Boam, Other (Panelist) Michael J. Domanski, MD (Panelist) Stephen G. Ellis, MD (Panelist) Yonghong Gao, PhD (Panelist) Victor Hasselblad, PhD (Panelist) Spencer B. King, MD (Panelist) Richard E Kuntz, MD (Panelist) Jeffrey J. Popma, MD (Panelist) Charles A. Simonton, MD (Panelist) Gregg W. Stone, MD (Panelist) Krishna Sudhir, Other (Panelist)
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| 11:00 AM | Back to the Future: The Moving Landscape of Device Evaluation in the USA | Mitchell W. Krucoff, MD (Moderator) Bram D. Zuckerman, MD (Moderator)
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| 11:00 AM | Back to the Future - The Moving Landscape of Device Evaluation in the USA: FDA View | Jeff Shuren, MD (Speaker)
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| 11:10 AM | Back to the Future - The Moving Landscape of Device Evaluation in the USA: U.S. Congressional View | Becca Stein, (Speaker)
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| 11:20 AM | Back to the Future - The Moving Landscape of Device Evaluation in the USA: CMS View | Marcel E Salive, MD (Speaker)
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| 11:30 AM | Back to the Future - The Moving Landscape of Device Evaluation in the USA: Industry View | Rosean M. White, (Speaker)
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| 11:40 AM | Back to the Future - The Moving Landscape of Device Evaluation in the USA: Academic View | Jeff A. Brinker, MD (Speaker)
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| 11:50 AM | Back to the Future - The Moving Landscape of Device Evaluation in the USA: Panel Discussion & Questions from the Audience | Jeff A. Brinker, MD (Panelist) Marcel E Salive, MD (Panelist) Jeff Shuren, MD (Speaker) Rosean M. White, (Panelist)
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| 12:30 PM | Lunch Symposium: How will the New Health Care Reform Impact on Innovation, Device Development and FDA Approval (See Emerging Technologies Agenda for Details) |
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| 2:00 PM | Hot Topics Session 3: Novel Critical Path Focus on Obligatory Drug-Device Interactions | Mitchell W. Krucoff, MD (Moderator) Bram D. Zuckerman, MD (Moderator)
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| 2:00 PM | Novel Critical Path Focus on Obligatory Drug-Device Interactions: Academic View: Why the Critical Path? | Mitchell W. Krucoff, MD (Speaker)
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| 2:05 PM | Novel Critical Path Focus on Obligatory Drug-Device Interactions: FDA CDRH View: Drug-Device Safety | Bram D. Zuckerman, MD (Speaker)
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| 2:10 PM | Novel Critical Path Focus on Obligatory Drug-Device Interactions: FDA CDER View: Drug-Device Safety | Karen A. Hicks, MD (Speaker)
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| 2:15 PM | Novel Critical Path Focus on Obligatory Drug-Device Interactions: The DAPT Study: Does DAPT make DES Safer? | Laura Mauri, MD (Speaker)
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| 2:20 PM | Novel Critical Path Focus on Obligatory Drug-Device Interactions: The DAPT Study: Industry View | Richard E Kuntz, MD (Speaker)
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| 2:25 PM | Novel Critical Path Focus on Obligatory Drug-Device Interactions: The TREAT Study: Can Devices Lower Bleeding Rates | Sunil V. Rao, MD (Speaker)
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| 2:30 PM | Novel Critical Path Focus on Obligatory Drug-Device Interactions: The TREAT Study: Industry View | Rosean M. White, (Speaker)
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| 2:35 PM | Novel Critical Path Focus on Obligatory Drug-Device Interactions: Panel Discussion & Questions from the Audience | Karen A. Hicks, MD (Panelist) Mitchell W. Krucoff, MD (Panelist) Richard E Kuntz, MD (Panelist) Laura Mauri, MD (Panelist) Roxana Mehran, MD (Panelist) Sunil V. Rao, MD (Panelist) Charles A. Simonton, MD (Panelist) Bram D. Zuckerman, MD (Panelist)
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| 3:30 PM | Hot Topics Discussion Session 4:Barriers and Synergies in Japan-USA Device Evaluation | Koji Ikeda, PhD (Moderator) Mitchell W. Krucoff, MD (Moderator) Bram D. Zuckerman, MD (Moderator)
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| 3:30 PM | Lessons Learned: Past Present and Future Japan-USA Regulatory Interactions - FDA View | Erica Takai, PhD (Speaker)
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| 3:35 PM | Lessons Learned: Past Present and Future Japan-USA DES Evaluation - Academic View | Shigeru Saito, MD (Speaker)
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| 3:40 PM | Lessons Learned: Past Present and Future Japan-USA Regulatory Interactions - MHLW/PMDA View | Koichi Aizawa, PhD (Speaker)
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| 3:45 PM | Lessons Learned: Past Present and Future Japan-USA DES Evaluation - Industry View I |
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| 3:50 PM | Lessons Learned: Past Present and Future Japan-USA DES Evaluation - Industry View II | Takahiro Uchida, Other (Speaker)
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| 3:55 PM | Building Synergy Between US and Japan: DES Clinical Trial Designs - Academic View | Mitchell W. Krucoff, MD (Speaker)
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| 4:00 PM | Building Synergy Between US and Japan: DES Clinical Trial Designs - FDA View |
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| 4:05 PM | Building Synergy Between US and Japan: DES DES Clinical Trial Designs - MHLW/PMDA View | Koji Ikeda, PhD (Speaker)
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| 4:10 PM | Building Synergy Between US and Japan: DES Clinical Trial Designs - Industry View | Rosean M. White, (Speaker)
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| 4:15 PM | Global Clinical Trials Focus - Japan-USA Barriers to Device Evaluation: Panel Discussion & Questions from the Audience | Koichi Aizawa, PhD (Panelist) Kenneth J. Cavanaugh, PhD (Panelist) Michael Halper, (Panelist) Koji Ikeda, PhD (Panelist) Mitchell W. Krucoff, MD (Panelist) Shigeru Saito, MD (Panelist) Yuka Suzuki, PhD (Panelist) Erica Takai, PhD (Speaker) Takahiro Uchida, Other (Panelist) Rosean M. White, (Panelist) Bram D. Zuckerman, MD (Speaker)
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| 5:00 PM | Adjourn |
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