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Pharmaceutical Industry

Mark Shigihara R.Ph. , CMRAccount Manager

UW Affiliate Faculty

Pharmaceutical Industry

Pharmaceutical Innovation

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What is a Medical Science Liaison (MSL)?

1st Generation Medical Science Liaisons

MSL Roles & ResponsibilitiesMSL is a medical representative in the field for Wyeth.

Provide fair-balanced scientific clinical information, including full scientific data on products in response to unsolicited requests

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A Typical MSL Question

MSLs educate pharmacists on XR dosage forms

MSL Profile ExampleUSC School of Pharmacy– Doctor of Pharmacy (Pharm.D.)

Post Doctoral Residency– Primary Care / Ambulatory Medicine

UCLA - Santa Monica Medical Center– Director of Pharmacology Education and Research &

Assistant Clinical Professor of MedicineResearch - Internal Medicine & Primary Care, Journal ClubP&T CommitteeResident Education - PharmacologyPatient Care- Inpatient Medicine Rounds & Outpatient Clinic

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General MSL Characteristics

Apply the scienceResponsive to inquiriesPrepare Medical Community for new therapiesEducateSupport researchDevelop relationships-internal and external colleagues Facilitate the acceptance and understanding ofWyeth-Ayerst products and assure their optimum use

Pharmaceutical Representative

The Untold Story........

Sales…The world’s oldest profession

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The Art of Selling

Pharmaceutical Sales Candidates

What people used to say about Pharmaceutical

Representatives..“Oh no... not him again....I don’t have the time”“ He would have made a great used car salesman”“ I can’t remember what he said about this product but this pen is really cool”

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Representative role is to provide value for the

customerProduct education - fair balance/ethicalAddress contract/pricing issuesServe as a liaison to home office departments: medical affairs, product quality, product marketing, clinical studies...Meet customer needs: speakers, grants,co-promotion....

Office Based Representatives

Works in private practice setting with MD s and RNs.Calls on chain and or independent pharmacies.The majority of pharmaceutical representatives are in office based roles.

Medical Center Representatives

Works in hospital/academic medical center environment.Audience: MD,residents, pharmacists, RN...Key responsibility- to identify and develop academic thought leaders.

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Representative Benefits

Reward-recognition for individual achievement.The “master of your own destiny”-strategy, time allocation, priority..Customer relationships

Representative Benefits

Guaranteed SalaryBonus plan - matched to performanceStock OptionsCar / Insurance / Gas401 KMedical / Dental coverage

Representative Challenges

Customers with different points of view.TravelRelocation?Good bye to the 40 hour work week...

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Representative opportunities:

Multiple career options- home office, sales management, training...Multiple company options: Wyeth, Ayerst, Robins, Lederle, Genetics Institute...The pharmacy degree is a tremendous asset in the pharmaceutical industry.

Mark Shigihara

Managed Care Area Account Manager

Job responsibilityWork responsibilities and impact on pharmacists.Real life questions/quiz

Managed Care Environment

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Managed Care RAM

Work with managed care health plans-Premera Blue Cross, Group Health, PacifiCare, Kaiser….Offer product information to accounts-influence formulary /reimbursement position of products.Co promote- initiatives with customers

Reimbursement Role

Real Life Quiz

What causes the most complaints from patients regarding their prescriptions?

A) Your typing speed on labelsB) You can not decode the prescriber

handwriting and fill the Viagra prescription with Valium.

C) The COST of pharmaceuticals

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COST

Putting it into perspective

Drugs as % of US Healthcare Costs

8.6% 8.9%9.4% 10.0% 10.6% 10.8% 11.1%

0.0%

2.0%

4.0%

6.0%

8.0%

10.0%

12.0%

1994 1995 1996 1997 1998 1999(est.)

2000(est.)

Source: HCFA, National Center for Health Statistics

New Medicines Price Inflation Increased Utilization

Increased Utilization10.8% Price Inflation

3.8%

Source: IMS Health

Contributors to the 18.8% Increase in Rx Spending in 1999

New Medicines

3.8%

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COSTBut what about other

countries….. Pharmaceutical products cost

less there….

Mc Answer

(Undergraduate Tuition, Books, Room and Board)

One Year: $32,000

(Undergraduate Tuition, Books, Room and Board, Student

Services)One Year: $12,566

Yale University McGill University

Many Costs Are Lower in Canada

Source: Published University Data, 2000

U.S. CanadaFrom Higher Education...

…to Fast Food

$2.43 $1.98

McDonald’s Big Mac

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$0.00

$0.50

$1.00

$1.50

$2.00

$2.50

$3.00

$3.50

$4.00

Switzerl

and

Denmark UK

Sweden

France

German

y

Netherl

ands Ita

ly

Japan U.S.

Spain

Mexico

Canad

a

New Zela

nd

Austra

lia

Hungary

$0.00

$0.50

$1.00

$1.50

$2.00

$2.50

$3.00

$3.50

$4.00

Switzerl

and

Denmark UK

Sweden

France

German

y

Netherl

ands Ita

ly

Japan U.S.

Spain

Mexico

Canad

a

New Zela

nd

Austra

lia

Hungary

International Price VariationMcDonald’s Big Mac(U.S. Dollars, 1999)

Source: Economist, April 3, 1999

0

1

2

3

4

5

6

7

8

Mexico

Irelan

d UK

Sweden

Natherl

ands

Spain U.S.

Canad

a

Finland

Denmark Ita

ly

Belgium

Austri

a

Luxem

bourg

0

1

2

3

4

5

6

7

8

Mexico

Irelan

d UK

Sweden

Natherl

ands

Spain U.S.

Canad

a

Finland

Denmark Ita

ly

Belgium

Austri

a

Luxem

bourg

Approximate Hours of Work Needed to Buy 1 Specific Rx

(50 mg, 30 tablets)

Source: Data on File, Pfizer, Inc and World Fact Book

COSTS

What about some detailed United States perspective…..

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Spending Patterns of ElderlyU.S. Consumers Aged 65+, 1998

Housing

Transportation

Food

Utilities

Cash Contributions

Health Insurance

Entertainment

Clothing

Medical Services & Supplies

Drugs

All Other

Housing

Transportation

Food

Utilities

Cash Contributions

Health Insurance

Entertainment

Clothing

Medical Services & Supplies

Drugs

All Other

Drugs 2.7%

Source: Bureau of Labor Statistics, 2000

Daily U.S. Consumption ExpendituresPer Capita, 1997

$0.00

$1.00

$2.00

$3.00

$4.00

$5.00

$6.00

$7.00

$8.00

$9.00

TobaccoRx DrugsAlcoholElectricityAuto RepairTelephoneGas & OilClothingFoodHousing

Consumption Expenditures per day

Source: U.S.Department of Commerce, Bureau of Economic Analysis, 1998.

COSTSBut what about pharmaceutical

companies…

Are they just trying to price gouge the customer….

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Research-based Pharmaceutical Companies* 20.8%

12.0%7.6%

6.0%5.1%

R&D for Pharmaceuticals and Other Industries (Percent of Sales)

4.9%4.1%

3.7%0.9%0.9%

3.7%

*“Research-based Pharmaceutical Companies” Based on Ethical Pharmaceutical Sales and Ethical Pharmaceuticals R&D Only as Tabulated by PhRMA; “Drugs and Medicine” Sector as Tabulated by Standard & Poor’s Compustat, a Division of McGraw-Hill

Source: PhRMA, 1999, Based on Data From PhRMA Annual Survey and Standard & Poor’s Compustat, a Division of McGraw-Hill

Industrial Sector Comparison:Drugs and Medicine*

Office Equipment and ServicesElectrical and Electronics

TelecommunicationsLeisure Time Products

AutomotiveAerospace and Defense

Metals and MiningPaper and Forest Products

All Industries, Excluding Drugs and Medicine

Source: PhRMA, Based on Data From the Tufts Center for the Study of Drug Development, 1995

Compound Success Rates: 1 in 10,000Reach FDA Approval

0 2 4 6 8 10 12 14 16

1Approved by

the FDA

5Enter Clinical

Testing

250Enter Preclinical

Testing

5,000–10,000Screened

Discovery(2–10 Years)

Preclinical TestingLaboratory and Animal Testing

Phase I20–80 Healthy Volunteers Used

to Determine Safety and DosagePhase II

100–300 Patient Volunteers Used to Look for Efficacy and Side Effects

Phase III1,000–5,000 Patient Volunteers Used to Monitor

Adverse Reactions to Long-term Use

FDA Review/Approval

Additional Postmarketing Testing

Compound Success Rates by Stage

Pharmaceutical Industry Facts

Revenues from approved drugs (1 of 5 to 10,000) must cover the “dry holes” of non approved compounds.Average cost of bringing a drug to market is 500 to 800 million dollars.Average approval time is 12 to 15 years.Time to recoup investment is shrinking-generic drugs and limited patent life

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COST Perspective

What is the cost if pharmaceutical manufacturers did not create revolutionary drugs……..

COST of Uncured Disease States

COST

And this does not even take into consideration…

patient quality of life

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MSL or AAMConsider signing up for our rotation.In depth exposure to our positions.AdvantagesDisadvantagesAnswers the question – “Is the pharmaceutical industry a viable career option for me ?”

Questions?