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