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

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Presentation transcript:

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

- 2 - Francois Nader – Aventis Medical Affairs Organization Of The Future 1. The Regulatory Compliance Environment 2. The Medical Affairs Integrated Organizational Model 3. The Medical Affairs Value Propositions 3. The Medical Affairs Value Propositions

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

- 4 - Francois Nader – Aventis Medical Affairs Organizational Model: “One-Stop-Shop” INTEGRATED SCIENTIFIC SUPPORTTHROUGHOUT THE LIFECYCLE HEALTH OUTCOMES MEDICAL RESEARCH MEDICAL EDUCATION MEDICAL COMMUNICATIONS MEDICAL BUSINESS OPERATIONS Therapeutic & Brand MD’s Clinical Supplies Study Management Biometrics National Medical Education Medical Liaison Medical Information. Scientific Publications. E-Medical. REGULATORY SUPPORT Copy Review. Compliance Labeling. Drug Safety IS. HR. Outsourcing. Finance. Program Management. Resource Management.

- 5 - Francois Nader – Aventis Medical Affairs: Organizational Models X

- 6 - Francois Nader – Aventis MEDICAL RESEARCH MEDICAL EDUCATION MEDICAL COMMUNICATIONS OUTCOMES SOLUTIONS Medical Affairs Value Propositions: a Catalyst and a Player in Maximizing The Brand Potential Launch N Years Sales Rapid Uptake Higher Peak Sales Longer Time on the Market REGULATORY SUPPORT

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

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

- 9 - Francois Nader – Aventis 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