Range of Work of Medical Affairs

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    Michael Conway ([email protected] Conway ([email protected] ))

    David Quigley ([email protected])David Quigley ([email protected])

    2004 Pharma, Biotech2004 Pharma, Biotech

    and Device Colloquiumand Device Colloquium

    Medical AffairsMedical Affairs The NextThe NextSS --Curve in PharmaceuticalsCurve in Pharmaceuticals

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    OVERVIEW

    Medical Affairs is increasingly the third major source ofdifferentiation, after R&D and Commercialization, tosupplement traditional marketing activities

    Medical Affairs creates value and competitive advantageby engaging providers and managed care, and expandingdevelopment

    However, companies are finding it challenging to scale upMedical Affairs, while maintaining internal alignment and acoordinated interface to physicians

    To build a successful Medical Affairs capability,companies must ensure tight collaboration with R&D andSales & Marketing, build in flawless execution, and attractand keep the right talent

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    MEDICAL AFFAIRS IS INCREASINGLY THE THIRDMAJOR COMMERCIAL DRIVER FOR PHARMACOS

    New externalpressures

    Limits of traditionalapproaches

    New complianceguidelines are limitingmarketing degrees offreedom

    Increasing demand foroutcomes data for payors,and drug comparisons forphysicians

    MedicalAffairs

    R&D fully leveragedwith new products andlabel expansion

    Diminishing returnsfrom incrementalexpansion of sales andmarketing tactics

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    WIDE RANGE OF APPROACHES TO U.S. MEDICALAFFAIRS

    From . . . To . . .Dual report to Globaland US

    Fully integrated withbrand teams

    Fully integrated withGlobal Marketing

    Thought partner tobrand teams &development group

    Global R&D

    Support group

    Light touch global orgensures consistency

    Tactical support toclinical & commercial

    Dedicated budget for allactivities

    No separate MAbudget

    Reporting

    Interactionwith brandteams

    Interactionwithglobal

    Budget

    Focus

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    BUT SOME KEY TRENDS EMERGING

    Reporting

    Interactionwith brandteams

    Interactionwithglobal

    Budget

    Focus

    Increasing separation from sales andmarketing

    Most struggle to develop integrated solutionsand specialization

    Stronger linkages with enhanced globalorganizations

    Increasingly strategic

    Increasing MA control over informationdissemination budgets

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    WIDE RANGE OF SCOPE OF MEDICAL AFFAIRSFUNCTIONS

    Company B

    Company C

    Company D

    Company E

    P u b l i

    c a t i o n s

    T r i a l S t r a t e

    g y

    M e d i c

    a l L i a i s

    o n s

    D r u g

    I n f o r m a

    t i o n

    T h o u g h

    t L e a

    d e r

    D e v e

    l o p m e n t

    C M E

    O u t c o

    m e s

    Company A

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    MEDICAL AFFAIRS CREATES COMPETITIVEADVANTAGE ON THREE DIMENSIONS

    Drive appropriate medical use: Educating physiciansbased on all available data

    Early and comprehensive engagement of providers: Allowing early consideration by thought leaders Engaging a comprehensive set of stakeholders Peer to peer discussions Involvement in clinical trials Medical education

    Building a differentiated product profile : Enhancing value

    of a drug to patients, payors, and physicians, e.g., Product attributes (clinical, cost, convenience, comfort) Efficacy in sub-populations Combinations

    Direct comparisons

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    3,0004,000

    600500

    5001,200

    3,600

    600

    1,200

    200

    2001 FTEs 2020 FTEs

    5,500

    9,900

    FOR THESE REASONS SIGNIFICANT GROWTH ISEXPECTED IN MEDICAL AFFAIRS

    Source: Professionally Determined Need for Pharmacy Services in 2020 Conference

    Scientists

    Economists/OutcomeResearchers

    Marketing/Sales/Reg Affairs

    Medical Service Liaison

    Drug Information

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    COMMON CHALLENGES IN SCALING UPMEDICAL AFFAIRS

    Consistently interpreting and complying withguidelines

    Maintaining alignment between MedicalAffairs, Commercial and R&D objectives

    Ensuring interactions with providers areconsistent with objectives and with sales and

    R&D activitiesAttracting and retaining talented scientistsand technical people, particularly mid-levelleaders

    1.

    2.

    3.

    4.

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    POSSIBLE WINNING APPROACH FORSCALING UP MEDICAL AFFAIRS

    Balancing the organization tightly aroundposture

    Building alignment through a shared vision forthe brand that is developed collaboratively withMedical Affairs, R&D, and Sales & Marketing

    Building processes to drive alignment ofactivities at a local market level and consistencywith objectives

    Creating a career proposition and trajectory, and

    ensuring salary commensurate with Commercial

    1.

    2.

    3.

    4.

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    TOUGH QUESTIONS

    Are you doing enough in Medical Affairs?

    How good is the work that is being done?

    What stops you doing more and doing it

    better?How excited are your people?

    How well do you work with R&D andMarketing?

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    Appendix

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    REACHING SATURATION POINT ON TRADITIONALSALES AND MARKETING

    Doctor time allocationPercent

    8

    23

    45

    66

    Restricts numberof reps per dayRestricts times ordays reps can visitRestricts details to

    appts./lunch onlyHave policy

    80% doctorsestimated to haverestrictive policies

    by end of 2002

    Prevalence of policies that restrictrepresentative accessPercent of physicians

    No more than three reps will be seen in a day, and if the doctor is busy, therepresentative must leave samples with the front desk while the staff obtains thephysicians signature. This policy became necessary because there were 10-15reps calling on the office and interfering with our ability to see patients.

    PCP Office Manager

    100% = ~14 hours per day

    5818

    22

    Patient

    care Admini-strativetasks

    Other

    2 Time with reps