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Francois Nader, MD, MBA Aventis June 6-9, 2004 Princeton, NJ

The Pharma , Biotech and Device Colloquium. Medical Affai rs Organization Of The Future. Francois Nader, MD, MBA Aventis June 6-9, 2004 Princeton, NJ. 1. The Regulatory Compliance Environment 2. The Medical Affairs Integrated Organizational Model 3. The Medical Affairs Value Propositions.

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Francois Nader, MD, MBA Aventis June 6-9, 2004 Princeton, NJ

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  1. The Pharma , Biotech and Device Colloquium Medical Affairs Organization Of The Future Francois Nader, MD, MBA Aventis June 6-9, 2004 Princeton, NJ

  2. 1. The Regulatory Compliance Environment • 2. The Medical Affairs Integrated Organizational Model • 3. The Medical Affairs Value Propositions Medical Affairs Organization Of The Future

  3. Medical Affairs And The Environment ENVIRONMENT • OIG • Hostile Public Opinion • Medicare Modernization Act EXTERNAL DEMAND CUSTOMERS • Increasingly under pressure • Education vs. Selling • Request Evidence-based Value ACCESS CUSTOMERS • Critical decision-makers & influencers • Often underestimated • Request Evidence-based Value INTERNAL R & D • Higher R&D Cost • Fewer NCE’s • Current brands have to last longer • and generate more

  4. HEALTH OUTCOMES • Therapeutic & Brand MD’s • Clinical Supplies • Study Management • Biometrics IS . HR . Outsourcing . Finance . Program Management . Resource Management . MEDICALRESEARCH MEDICAL BUSINESS OPERATIONS MEDICAL EDUCATION MEDICAL COMMUNICATIONS REGULATORYSUPPORT Medical Information . Scientific Publications . E-Medical . • National Medical Education • Medical Liaison • Copy Review . Compliance • Labeling . Drug Safety Medical Affairs Organizational Model: “One-Stop-Shop” INTEGRATEDSCIENTIFIC SUPPORT THROUGHOUT THE LIFECYCLE

  5. Medical Affairs: Organizational Models    X

  6. Sales Higher Peak Sales Longer Time on the Market Rapid Uptake Launch 2 3 4 5 - - - - - - N Years Medical Affairs Value Propositions:a Catalyst and a Player in Maximizing The Brand Potential MEDICALEDUCATION MEDICALRESEARCH MEDICAL COMMUNICATIONS OUTCOMES SOLUTIONS REGULATORY SUPPORT

  7. Medical Affairs Value Propositions:Uniquely Positioned Bridge Between R&D and Commercial R & D I II a II b III Filing Approval Commercialization Medical Affairs Shape the Market Brand Lifecycle Medical Research • Phase IV • New Indications • Special Population Phase III b • Opinion Leaders Development • Investigators Selection • Educational Programs • Evidence Based Medicine Paradigm Shift Medical Education Health Outcomes Research • Health Ec Dossier (AMCP) ………………………… • Health Outcomes Solutions………………………………………………….. • Publications • Medical Information Medical Communications Regulatory Support • Copy Review ………………………… • Regulatory Compliance ………………………………………………………..

  8. Medical Affairs Value Propositions:Characterize, Generate and Communicate Evidence -Based Value to the Key Stakeholders Employers Payers Government MEDICAL AFFAIRS Thought Leaders Accreditation Bodies Providers Academics Consumers

  9. In Summary, A Successful Medical Affairs Organization • Positions itself as the primary source of scientific support throughout the lifecycle • Plays within the evolving rules of regulatory compliance and take advantage of the external & internal drivers • Is built on a sound organizational model that is compliant and integrated in a “one-stop-shop” approach • Develops unique Value Propositions • As a catalyst and a player in maximizing a brand potential • As a unique bridge between R&D and Commercial • As a leader in characterizing, generating and communicating evidence-based value to key stakeholders

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