Francois Nader, MD, MBA

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

• OIG
• Hostile Public Opinion
• Medicare Modernization Act

DEMAND CUSTOMERS
EXTERNAL

• 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 RD Cost
• Fewer NCEs
• Current brands have to last longer
• and generate more

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Medical Affairs Organizational Model
One-Stop-Shop
INTEGRATEDSCIENTIFIC SUPPORT THROUGHOUT THE
LIFECYCLE
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Medical Affairs Organizational Models
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X
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Medical Affairs Value Propositionsa Catalyst
and a Player in Maximizing The Brand Potential
MEDICALEDUCATION
MEDICALRESEARCH
MEDICAL COMMUNICATIONS
OUTCOMES SOLUTIONS
REGULATORY SUPPORT
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Medical Affairs Value Propositions Uniquely
Positioned Bridge Between RD and Commercial
R D I II a II b III
Filing Approval
Commercialization
Medical Affairs
Shape the Market
Brand Lifecycle

• Phase IV
• New Indications
• Special Population

Medical Research
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 ..

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Medical Affairs Value PropositionsCharacterize,
Generate and Communicate Evidence -Based Value to
the Key Stakeholders
Employers
Payers
Government
MEDICAL AFFAIRS
Accreditation Bodies
Thought Leaders
Providers
Academics
Consumers
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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 RD and Commercial
• As a leader in characterizing, generating and
  communicating evidence-based value to key
  stakeholders