Pharmaceutical Industry Mark Shigihara R.Ph. , CMR Account Manager UW Affiliate Faculty

Pharmaceutical Industry

Pharmaceutical Innovation

What is a Medical Science Liaison (MSL)? 1

1st Generation Medical Science Liaisons

MSL Roles & Responsibilities MSL 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 3

A Typical MSL Question

MSLs educate pharmacists on XR dosage forms

MSL Profile Example USC School of Pharmacy Post Doctoral Residency 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 Medicine Research - Internal Medicine & Primary Care, Journal Club P&T Committee Resident Education - Pharmacology Patient Care- Inpatient Medicine Rounds & Outpatient Clinic 2

General MSL Characteristics Apply the science Responsive to inquiries Prepare Medical Community for new therapies Educate Support research Develop relationships-internal and external colleagues Facilitate the acceptance and understanding of Wyeth-Ayerst products and assure their optimum use 4

Pharmaceutical Representative The Untold Story........

Sales… The world’s oldest profession

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”

Representative role is to provide value for the customer Product education - fair balance/ethical Address contract/pricing issues Serve 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.

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

Representative Benefits Guaranteed Salary Bonus plan - matched to performance Stock Options Car / Insurance / Gas 401 K Medical / Dental coverage

Representative Challenges Customers with different points of view. Travel Relocation? Good bye to the 40 hour work week...

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 responsibility Work responsibilities and impact on pharmacists. Real life questions/quiz

Managed Care Environment

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? Your typing speed on labels You can not decode the prescriber handwriting and fill the Viagra prescription with Valium. The COST of pharmaceuticals

COST Putting it into perspective

Drugs as % of US Healthcare Costs Drugs represented an estimated 11.1% of total U.S. health care costs in 2000, a small fraction of total health care spending. Source: HCFA, National Center for Health Statistics

Contributors to the 18.8% Increase in Increased Utilization Rx Spending in 1999 New Medicines 3.8% Increased Utilization 10.8% Price Inflation 3.8% U.S. spending on drugs has been increasing in recent years but this is due primarily to the increased use of drugs, not drug prices. Volume growth and new innovation account for the majority of the increase in drug spending. The increase in drug prices accounts for only about 1/5 of the growth in spending. Source: IMS Health

COST But what about other countries….. Pharmaceutical products cost less there….

Mc Answer

Many Costs Are Lower in Canada From Higher Education... U.S. Canada Yale University McGill University (Undergraduate Tuition, Books, Room and Board) One Year: $32,000 (Undergraduate Tuition, Books, Room and Board, Student Services) One Year: $12,566 …to Fast Food There has been much discussion about the lower prices of drugs in Canada and other countries. The argument is that since Canadians pay less for drugs, Americans must be paying too much. However many items cost less in Canada, from college tuition to a hamburger. The truth is, prices vary from country to country and prices are sometimes the highest in the U.S. and sometimes they are higher elsewhere. McDonald’s Big Mac $2.43 $1.98 Source: Published University Data, 2000

International Price Variation McDonald’s Big Mac (U.S. Dollars, 1999) Take the McDonald’s Big Mac as an example. The same product is priced differently in 16 countries with the U.S. price falling somewhere in the middle. Source: Economist, April 3, 1999

Approximate Hours of Work Needed to Buy 1 Specific Rx (50 mg, 30 tablets) Different prices across countries are often reflective of different standards of living. In Canada for example, the average income is about 30% lower than it is in the U.S. (World Fact Book 1999). When drug prices are considered in the context of local wages, they take on a different look. This chart illustrates that the cost of a drug in the U.S. and in Canada is relatively equal in terms of earning power. Source: Data on File, Pfizer, Inc and World Fact Book

COSTS What about some detailed United States perspective…..

Spending Patterns of Elderly U.S. Consumers Aged 65+, 1998 Drugs 2.7% Some seniors spend an inordinate amount on drugs but for most seniors, drug spending constitutes a very small percentage of their overall spending. As this chart shows, drugs account for only 2.7% of elderly spending, less than is spent on entertainment or clothing. Source: Bureau of Labor Statistics, 2000

Daily U.S. Consumption Expenditures Per Capita, 1997 Consumption Expenditures per day In fact, the average American spends very little on drugs. In terms of daily consumption expenditures, the amount spent on drugs is less than what is spent on alcohol, utilities, auto repair and clothing. Source: U.S.Department of Commerce, Bureau of Economic Analysis, 1998.

COSTS But what about pharmaceutical companies… Are they just trying to price gouge the customer….

R&D for Pharmaceuticals and Other Industries (Percent of Sales) Research-based Pharmaceutical Companies* 20.8% Industrial Sector Comparison: Drugs and Medicine* 12.0% Office Equipment and Services 7.6% Electrical and Electronics 6.0% Telecommunications 5.1% Leisure Time Products 4.9% Automotive 4.1% Aerospace and Defense 3.7% Metals and Mining 0.9% Paper and Forest Products 0.9% The research pharmaceutical industry invests a tremendous amount of money in R&D. As a percentage of sales, more than any other industry. The cost of discovering and developing a new drug costs upwards of $500 million and takes nearly 14 years before it reaches patients. All Industries, Excluding Drugs and Medicine 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

Compound Success Rates: 1 in 10,000 Reach FDA Approval Compound Success Rates by Stage Discovery (2–10 Years) 5,000–10,000 Screened Preclinical Testing Laboratory and Animal Testing Phase I 20–80 Healthy Volunteers Used to Determine Safety and Dosage 250 Enter Preclinical Testing Phase II 100–300 Patient Volunteers Used to Look for Efficacy and Side Effects Phase III 1,000–5,000 Patient Volunteers Used to Monitor Adverse Reactions to Long-term Use 5 Enter Clinical Testing FDA Review/Approval As this chart illustrates, drug discovery is a complex, costly and risky venture with only 1 of 5,000-10,000 compounds screened making it to FDA approval. Along the way many promising leads fail and the time and money invested in them is lost. Additional Postmarketing Testing 1 Approved by the FDA 2 4 6 8 10 12 14 16 Source: PhRMA, Based on Data From the Tufts Center for the Study of Drug Development, 1995

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

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

MSL or AAM Consider signing up for our rotation. In depth exposure to our positions. Advantages Disadvantages Answers the question – “Is the pharmaceutical industry a viable career option for me ?”

Questions?