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The 5The 5thth
Vulnerable PlaqueVulnerable Plaque
SymposiumSymposium
Industry RoundtableIndustry Roundtable
AnAn
EventEvent
March 29, 2003March 29, 2003
4-6PM4-6PM
9999thth
Floor Sears Tower, Chicago, ILFloor Sears Tower, Chicago, IL
Industry Roundtable MissionIndustry Roundtable Mission
Information, Insights andInformation, Insights and
Innovative Strategies for MeetingInnovative Strategies for Meeting
the Needs of a New Paradigm inthe Needs of a New Paradigm in
Cardiology….Cardiology….
Searching For and Treating theSearching For and Treating the
Vulnerable PatientVulnerable Patient
Desired OutcomesDesired Outcomes
DiscussDiscuss
Regulatory ChallengesRegulatory Challenges
Reimbursement IssuesReimbursement Issues
Identify Areas of Common Interest toIdentify Areas of Common Interest to
IndustryIndustry
Create a Coordinating Committee toCreate a Coordinating Committee to
Develop Guidelines for Developing andDevelop Guidelines for Developing and
Regulating New VP ProductsRegulating New VP Products
Who Should AttendWho Should Attend
CardiologistsCardiologists
ResearchersResearchers
Senior FDA, CMS PersonnelSenior FDA, CMS Personnel
CEOs, Presidents, ExecutiveCEOs, Presidents, Executive
Management from R&D, Regulatory,Management from R&D, Regulatory,
Marketing, Finance and Legal Affairs fromMarketing, Finance and Legal Affairs from
Drug, Medical Device and BiotechnologyDrug, Medical Device and Biotechnology
CompaniesCompanies
Program HighlightsProgram Highlights
Review of Emerging Trends In TreatingReview of Emerging Trends In Treating
Heart Disease Caused by the ParadigmHeart Disease Caused by the Paradigm
Shift of Vulnerable PlaqueShift of Vulnerable Plaque
Scope of Medical Technologies andScope of Medical Technologies and
Market Segments Poised for GrowthMarket Segments Poised for Growth
Current Regulatory Climate; AlternativeCurrent Regulatory Climate; Alternative
Clinical StrategiesClinical Strategies
Reimbursement Considerations of a ShiftReimbursement Considerations of a Shift
to Preventative Careto Preventative Care
Invited PanelistsInvited Panelists
 S. Ward Casscells, M.D.,S. Ward Casscells, M.D., University of Texas Health ScienceUniversity of Texas Health Science CenterCenter
 Ron Waksman, M.D.,Ron Waksman, M.D.,
 Thomas Thompson,Thomas Thompson, Founder, and CEO (ret.) Quest Medical and MDMAFounder, and CEO (ret.) Quest Medical and MDMA
 Ken McDonnell,Ken McDonnell, CEO, InfraReDXCEO, InfraReDX
 CMS representativeCMS representative
 EliasElias Mallis,Mallis, Chief, Cardiac Electrophysiology/Monitoring BranchChief, Cardiac Electrophysiology/Monitoring Branch
CDRH/ODE/DCD,U.S. Food and Drug AdministrationCDRH/ODE/DCD,U.S. Food and Drug Administration
 Leslee Shaw, M.D.,Leslee Shaw, M.D., The American Cardiovascular Research InstituteThe American Cardiovascular Research Institute
 Scott Huennekens,Scott Huennekens, President & CEO, Volcano TherapeuticsPresident & CEO, Volcano Therapeutics
Industry ParticipantsIndustry Participants
Approximately 80 companies involved inApproximately 80 companies involved in
the VP Missionthe VP Mission

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160 5th vulnerable plaque symposium

  • 1. The 5The 5thth Vulnerable PlaqueVulnerable Plaque SymposiumSymposium Industry RoundtableIndustry Roundtable AnAn EventEvent March 29, 2003March 29, 2003 4-6PM4-6PM 9999thth Floor Sears Tower, Chicago, ILFloor Sears Tower, Chicago, IL
  • 2. Industry Roundtable MissionIndustry Roundtable Mission Information, Insights andInformation, Insights and Innovative Strategies for MeetingInnovative Strategies for Meeting the Needs of a New Paradigm inthe Needs of a New Paradigm in Cardiology….Cardiology…. Searching For and Treating theSearching For and Treating the Vulnerable PatientVulnerable Patient
  • 3. Desired OutcomesDesired Outcomes DiscussDiscuss Regulatory ChallengesRegulatory Challenges Reimbursement IssuesReimbursement Issues Identify Areas of Common Interest toIdentify Areas of Common Interest to IndustryIndustry Create a Coordinating Committee toCreate a Coordinating Committee to Develop Guidelines for Developing andDevelop Guidelines for Developing and Regulating New VP ProductsRegulating New VP Products
  • 4. Who Should AttendWho Should Attend CardiologistsCardiologists ResearchersResearchers Senior FDA, CMS PersonnelSenior FDA, CMS Personnel CEOs, Presidents, ExecutiveCEOs, Presidents, Executive Management from R&D, Regulatory,Management from R&D, Regulatory, Marketing, Finance and Legal Affairs fromMarketing, Finance and Legal Affairs from Drug, Medical Device and BiotechnologyDrug, Medical Device and Biotechnology CompaniesCompanies
  • 5. Program HighlightsProgram Highlights Review of Emerging Trends In TreatingReview of Emerging Trends In Treating Heart Disease Caused by the ParadigmHeart Disease Caused by the Paradigm Shift of Vulnerable PlaqueShift of Vulnerable Plaque Scope of Medical Technologies andScope of Medical Technologies and Market Segments Poised for GrowthMarket Segments Poised for Growth Current Regulatory Climate; AlternativeCurrent Regulatory Climate; Alternative Clinical StrategiesClinical Strategies Reimbursement Considerations of a ShiftReimbursement Considerations of a Shift to Preventative Careto Preventative Care
  • 6. Invited PanelistsInvited Panelists  S. Ward Casscells, M.D.,S. Ward Casscells, M.D., University of Texas Health ScienceUniversity of Texas Health Science CenterCenter  Ron Waksman, M.D.,Ron Waksman, M.D.,  Thomas Thompson,Thomas Thompson, Founder, and CEO (ret.) Quest Medical and MDMAFounder, and CEO (ret.) Quest Medical and MDMA  Ken McDonnell,Ken McDonnell, CEO, InfraReDXCEO, InfraReDX  CMS representativeCMS representative  EliasElias Mallis,Mallis, Chief, Cardiac Electrophysiology/Monitoring BranchChief, Cardiac Electrophysiology/Monitoring Branch CDRH/ODE/DCD,U.S. Food and Drug AdministrationCDRH/ODE/DCD,U.S. Food and Drug Administration  Leslee Shaw, M.D.,Leslee Shaw, M.D., The American Cardiovascular Research InstituteThe American Cardiovascular Research Institute  Scott Huennekens,Scott Huennekens, President & CEO, Volcano TherapeuticsPresident & CEO, Volcano Therapeutics
  • 7. Industry ParticipantsIndustry Participants Approximately 80 companies involved inApproximately 80 companies involved in the VP Missionthe VP Mission