The 5The 5thth Vulnerable Plaque Vulnerable Plaque SymposiumSymposiumIndustry RoundtableIndustry Roundtable

AnAn

EventEventMarch 29, 2003March 29, 2003

4-6PM4-6PM9999thth Floor Sears Tower, Chicago, IL Floor Sears Tower, Chicago, IL

Industry Roundtable Industry Roundtable MissionMission

Information, Insights and Information, Insights and Innovative Strategies for Innovative Strategies for Meeting the Needs of a New Meeting the Needs of a New Paradigm in Cardiology….Paradigm in Cardiology….Searching For and Treating Searching For and Treating the Vulnerable Patientthe Vulnerable Patient

Desired OutcomesDesired OutcomesDiscussDiscuss

Regulatory ChallengesRegulatory ChallengesReimbursement IssuesReimbursement Issues

Identify Areas of Common Interest to Identify Areas of Common Interest to IndustryIndustry

Create a Coordinating Committee to Create a Coordinating Committee to Develop Guidelines for Developing Develop Guidelines for Developing and Regulating New VP Productsand Regulating New VP Products

Who Should AttendWho Should AttendCardiologistsCardiologistsResearchersResearchersSenior FDA, CMS PersonnelSenior FDA, CMS PersonnelCEOs, Presidents, Executive CEOs, Presidents, Executive

Management from R&D, Regulatory, Management from R&D, Regulatory, Marketing, Finance and Legal Affairs Marketing, Finance and Legal Affairs from Drug, Medical Device and from Drug, Medical Device and Biotechnology CompaniesBiotechnology Companies

Program HighlightsProgram HighlightsReview of Emerging Trends In Treating Review of Emerging Trends In Treating

Heart Disease Caused by the Heart Disease Caused by the Paradigm Shift of Vulnerable PlaqueParadigm Shift of Vulnerable Plaque

Scope of Medical Technologies and Scope of Medical Technologies and Market Segments Poised for GrowthMarket Segments Poised for Growth

Current Regulatory Climate; Current Regulatory Climate; Alternative Clinical StrategiesAlternative Clinical Strategies

Reimbursement Considerations of a Reimbursement Considerations of a Shift to Preventative CareShift to Preventative Care

Invited PanelistsInvited Panelists S. Ward Casscells, M.D.,S. Ward Casscells, M.D., University of Texas Health ScienceUniversity of Texas Health Science Center Center

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 Branch Chief, 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 The American Cardiovascular Research

Institute Institute Scott Huennekens, Scott Huennekens, President & CEO, Volcano Therapeutics President & CEO, Volcano Therapeutics

Industry ParticipantsIndustry ParticipantsApproximately 80 companies Approximately 80 companies

involved in the VP Missioninvolved in the VP Mission