Francois Nader, MD, MBA

AventisJune 6-9, 2004

Princeton, NJ

The Pharma , Biotech and Device Colloquium

Medical AffaiMedical Affairs Organization Of The Futurers Organization Of The Future

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Medical Affairs Organization Of The FutureMedical Affairs Organization Of The Future

1. The Regulatory Compliance Environment1. The Regulatory Compliance Environment

2. The Medical Affairs Integrated Organizational Model2. The Medical Affairs Integrated Organizational Model 3. The Medical Affairs Value Propositions3. The Medical Affairs Value Propositions

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Medical Affairs And The EnvironmentMedical Affairs And The Environment

DEMANDCUSTOMERS

DEMANDCUSTOMERS

ENVIRONMENTENVIRONMENT

ACCESSCUSTOMERS

ACCESSCUSTOMERS

• OIG• Hostile Public Opinion• Medicare Modernization Act

•Critical decision-makers & influencers•Often underestimated•Request Evidence-based Value

INTERNAL INTERNAL

EXTERNALEXTERNAL• Increasingly under pressure• Education vs. Selling• Request Evidence-based Value

R & DR & D

•Higher R&D Cost•Fewer NCE’s•Current brands have to last longer and generate more

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Medical Affairs Organizational Model: “One-Stop-Shop”Medical Affairs Organizational Model: “One-Stop-Shop”

INTEGRATEDINTEGRATEDSCIENTIFIC SCIENTIFIC SUPPORT SUPPORT

THROUGHOUT THROUGHOUT THE LIFECYCLETHE LIFECYCLE

HEALTHOUTCOMES

MEDICAL

RESEARCH

MEDICAL

EDUCATIONMEDICAL

COMMUNICATIONS

MEDICALBUSINESS

OPERATIONS

• Therapeutic

& B

rand M

D’s

•Clinica

l Supplie

s

• Study M

anagement

• Biometrics

• National Medical Education

• Medical Liaison Medica

l Inform

ation .

Scientifi

c Public

ations .

E-Medica

l . REGULATORYSUPPORT

• Copy Review . Compliance• Labeling . Drug Safety

IS .HR .

Outsourcing .

Finance .

Program Management .

Resource Management .

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Medical Affairs: Organizational ModelsMedical Affairs: Organizational Models

MEDICAL AFFAIRS

MEDICAL AFFAIRS

R & D

MEDICAL AFFAIRS

SALES

MARKETING

OTHER

COO

MEDICAL AFFAIRS

MARKETING

SALES

COO

CEO

X

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MEDICALRESEARCH

MEDICALEDUCATION

MEDICAL COMMUNICATIONS

OUTCOMESSOLUTIONS

Medical Affairs Value Propositions:Medical Affairs Value Propositions:a Catalyst and a Player in Maximizing The Brand Potentiala Catalyst and a Player in Maximizing The Brand Potential

Launch 2 3 4 5 - - - - - - N Years

Sales

Rapid Uptake

Higher Peak SalesLonger Time

on the Market

REGULATORYSUPPORT

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Medical Affairs Value Propositions:Medical Affairs Value Propositions: Uniquely Positioned Bridge Between R&D and CommercialUniquely Positioned Bridge Between R&D and CommercialMedical Affairs Value Propositions:Medical Affairs Value Propositions: Uniquely Positioned Bridge Between R&D and CommercialUniquely Positioned Bridge Between R&D and Commercial

Shape the Market Brand Lifecycle

R & D

I II a II b III Filing Approval

Commercialization

Phase III b Phase IV

• New Indications• Special Population

Medical Research

Medical Research

Medical Education

Medical Education

Health Outcomes Research

Health Outcomes Research

Medical Communications

Medical Communications

RegulatorySupport

RegulatorySupport

• Publications• Medical Information

• Opinion Leaders Development• Investigators Selection• Educational Programs• Evidence Based Medicine Paradigm Shift

• Copy Review …………………………• Regulatory Compliance ………………………………………………………..

MedicalAffairs

MedicalAffairs

• Health Ec Dossier (AMCP) …………………………• Health Outcomes Solutions…………………………………………………..

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Medical Affairs Value Propositions:Medical Affairs Value Propositions:Characterize, Generate and Communicate Evidence -Characterize, Generate and Communicate Evidence -Based Value to the Key StakeholdersBased Value to the Key Stakeholders

AccreditationBodies

Academics

GovernmentPayers

Thought Leaders

Providers

Employers

Consumers

MEDICAL AFFAIRS

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In Summary, A Successful Medical Affairs Organization 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