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160 5th vulnerable plaque symposium


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SHAPE Society

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160 5th vulnerable plaque symposium

  1. 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. 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. 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. 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. 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. 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. 7. Industry ParticipantsIndustry Participants Approximately 80 companies involved inApproximately 80 companies involved in the VP Missionthe VP Mission