The Pharma Biotech and Device Colloquium Medical Affairs

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

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

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

Medical Affairs Organizational Model: “One-Stop-Shop” P Ou Re rogr IS tso so am. H ur u rc R. ce Ma F Ma nag ina ing M na em nce. B ED ge en. OP USI ICA m en t. ER NE L t. A S TIO S NS n. o i at ns. m. o r fo icati ical n l I ubl ed a M c di fic P Ee M nti ie Sc S AL ION C DI AT E M NIC MU M CO HEALTH OUTCOMES INTEGRATED SCIENTIFIC SUPPORT THROUGHOUT THE LIFECYCLE M ED EDI UC CA AT L IO N REGULATORY SUPPORT • Copy Review • Labeling Francois Nader – Aventis L CA CH I D R ME EA S RE -4 - . Compliance. Drug Safety ’s D M d an Br & ic ies nt t e l u pe upp gem a r S he cal ana T i • lin y M ics • C tud etr • S iom • B • N • M ati ed ona ica l M l L ed iai ica so n l Ed uc at ion

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

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

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

Medical Affairs Value Propositions: Characterize, Generate and Communicate Evidence Based Value to the Key Stakeholders Employers t n me Pa ye rs ern v o G MEDICAL AFFAIRS Thought Leaders Ac s r ide ov Pr Consumers Francois Nader – Aventis Accreditation Bodies -8 - ad em ics

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 Francois Nader – Aventis -9 -