SHAPE Society

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