1. 1 Marketing and Sales Roles in the Pharmaceutical Industry

2. 2 MARKETING

3. 3 The “Marketing Concept” - Key Principles It is easier to change the products and services of the individual manufacturer to fit the needs of the market than it is to convince the entire market to use the products and services as the individual manufacturer prefers them –“You can have any color car you want as long as it’s black” Henry Ford All the resources of the firm should be organized into a total system aimed at meeting the needs of the consumer The role of marketing is to influence or direct activities from the manufacturer to the patient: –The right products –In the right quantity –At the right place –For the right price –At the right time

4. 4 Marketing as an “Actualizing Process” Markets can be viewed as “gaps” that separate parties interested in an exchange Marketing removes the gaps between the parties through various actualization processes Source: McInnis; “A Conceptual Approach to Marketing” MARKET SEPARATORS TIME SPACE VALUE OWNERSHIP QUANTITY ASSORTMENT EXCHANGE FLOWS PRODUCT FLOW: toward the consumer INFORMATION FLOW: both ways PAYMENT FLOW: toward the provider USE RIGHT: toward the consumer MARKETING ACTIVITIES Assembly, transportation storage, packaging, grading Advertising, personal selling, publicity, labeling, sales promotions, marketing research, consumer complaints, drug education programs Credit and cash payments Purchasing and selling, pricing, post transactional rights PRODUCERSCONSUMERS

5. 5 IT’s Role in the “Actualizing Process” IT can assist marketing in closing the “gaps” that separate parties interested in an exchange IT can make some of the “gaps” irrelevant (e.g., space and time) Source: McInnis; “A Conceptual Approach to Marketing” MARKET SEPARATORS TIME SPACE VALUE OWNERSHIP QUANTITY ASSORTMENT IT Connectivity across geographically dispersed regions 24 x 7 Availability Enabling information access Enhancing personalization Right use Right amount Right need Increasing the number of available options

6. 6 Unique Aspects of Pharmaceutical Marketing and Sales Influence of non-purchasers on the purchasing habits of the consumer Veto/authorization power of physicians – consumers need an authorized document to purchase a prescription drug Importance of the disease to identifying and classifying markets Professional licensing required to stock and sell pharmaceutical products Records of every transaction are kept that are specific to: –Patient –Physician –Product

7. 7 Definitions Market Research: –Determination and assessment of qualitative and quantitative dimensions of a market Marketing Research: –Analysis of the effects of various marketing activities of a company or its competitors

8. 8 Market Research Environmental scanning: –Physicians –Pharmacists –Pharmacies –Hospitals Data gathering and analysis Influence of unique aspects of the pharmaceutical market on market research: –Known list of entities –Knowledge-based decisions –Similarities in education and thinking (professionalization) –Availability of records for transactional activity Significant use of outside vendors for market research –Syndicated services –Custom services

9. 9 Questions Answered by Market Research Strategic Level: –What diseases or product areas should be considered for long-term investment? –Short-term? –Market size or potential? –Availability and utilization of therapies? –Next logical steps in therapy? –Potential market segments to be exploited: Disease conditions (e.g., migraine sufferers) Dosing preferences (inhalants vs. injections vs. patches) –Prevalence of disorder? –Shared conditions? –Potential development partners? –Potential acquisitions?

10. 10 Questions Answered by Market Research Clinical trial Planning: –Seasonality –Regionality –Specialty Premarketing Planning: –What physician specialties are important in a given therapy or diagnosis? –What patient characteristics are important? –Who are our competitors in this market? –How do our competitors promote their product? –Are there unsatisfied portions of the market? –How do physicians perceive a proposed product?

11. 11 Questions Answered by Market Research Post-marketing Monitoring: –Adverse events –Product sales –Patient information (medical history) This can be critical in product defense situations! Example: Pfizer’s defense of Viagra when suits were filed alleging an increased risk of stroke.

12. 12 Types of Market Research Periodic Surveys Retail Pharmacy Purchases Retail Pharmacy Purchases Hospital Purchases Hospital Purchases Warehouse Withdrawals Warehouse Withdrawals Promotional Media Promotional Media Physician Panels Physician Panels Retail Pharmacy Prescriptions Retail Pharmacy Prescriptions Retail Pharmacy Sales Retail Pharmacy Sales

13. 13 Types of Market Research Periodic Surveys Retail Pharmacy Purchases Retail Pharmacy Purchases Measures the “inflow” of products from the manufacturer to the pharmacy OTC Prescription drugs Indirect (through wholesalers) Direct purchases from manufacturers

14. 14 Types of Market Research Periodic Surveys Hospital Purchases Hospital Purchases Measures the “inflow” of products from the manufacturer to the hospital OTC Prescription drugs Indirect (through wholesalers) Direct purchases from manufacturers Growth of pharmaceutical purchases by hospitals has greatly exceeded purchases from pharmacies on a proportional basis In many communities, the hospital has become more important in routine care

15. 15 Types of Market Research Periodic Surveys Warehouse Withdrawals Warehouse Withdrawals Measures the “outflow” of products from the warehouse to all purchasers –OTC –Prescription drugs) Does not reflect direct purchases from manufacturers Provides ability to analyze small segments of the marketplace such as zip code or territories Can be valuable in dealing with questions of individual territory performance and potential or different selling techniques

16. 16 Types of Market Research Periodic Surveys Retail Pharmacy Prescriptions Retail Pharmacy Prescriptions Measures the “outflow” of prescription drugs from the pharmacy to consumers Most sensitive indicator of prescription product performance (factual) Reflects mindset of prescribers and consumer demand Best indicator of marketing or promotional effort effectiveness Data available at national and sub-national levels

17. 17 Types of Market Research Periodic Surveys Physician Panels Physician Panels Specialized research services to identify patient product usage along specific variables: –Diagnosis –Patient characteristics –Location of visit –Drugs used –Action desired from drugs used Tracking of new prescriptions over time and monitors changes in doctor prescribing habits

18. 18 Types of Market Research Periodic Surveys Retail Pharmacy Sales Retail Pharmacy Sales Historically used for non- prescription pharmaceuticals Data typically collected for products of interest Collect unit and dollar information at the package size level Main use is to obtain prescription counts by product Used for pricing analysis and cross-tabulation analysis using data warehouses

19. 19 Types of Market Research Periodic Surveys Promotional Media Promotional Media Monitoring of detailing visits to physicians by sales representatives Monitoring of journal advertising Monitoring of direct mail advertising Physician sampling

20. 20 Generic Stages of Market Research Marketing Problem Marketing Objectives Reviewed Problems Defined Alternative Marketing Options Considered Exploratory research Formulation of data requirements, sources Research objectives defined Research Design Research Proposal Select Sample Design Survey & Feedback Design coding, analysis instructions Interpret Present Findings Take Action and Monitor Written marketing brief Costing Was this what was requested? Source: Smith, “Pharmaceutical Marketing”

21. 21 Market Research Organizations IMS Health Datamonitor Healthcare Consulting Frost.com Reuters Also check out: –Eyeforpharma.com –FDA.gov –Journal of the American Hospital Association –AMA Drug Evaluations

22. 22 Market Research Industry Associations EphMRA – European Pharmaceutical Research Association (www.ephmra.org) BHBIA – British Healthcare Business Intelligence Association (www.bhbia.org.uk) PhRMA – Pharmaceutical Research and Manufacturers Association (www.phrma.org)

23. 23 SALES

24. 24 Sales Roles Detailing –Face-to-face visits to physicians or purchasing managers (e.g., hospitals, HMOs) to present new prescription drugs –Influence prescribing habit –Increase current prescription usage –Deliver samples –Build relationships with doctors –Get drug into a formulary; “pull through” Sample Management –Track delivery of prescription drug samples to physicians or other purchasers

25. 25 Effective Detailing Influences on Physician Prescribing Habits Source: IBM Analysis Side Effects Drug delivery method Cost of drug Efficacy Potential drug- drug interactions Dosage Payor formulary status Brand Personal preference Patient request

26. 26 Detailing’s Value to the Physician “I like the good, tangible information about a new drug” “The samples determine what I prescribe for the long term” “Samples are extremely valuable” “I value the relationships with them. Overall, I am satisfied with their service” “I rely on them to keep me aware of what’s happening in the drug industry” “I like their presence to break up my stressed schedule” “Everybody likes perks” Comments From Physician Interviews Learn new drug information Get drug samples Connect with peers or physician thought leaders Receive ‘‘the perks’’ Establish personal contact with the drug company Provide “stress release” Value of Relationship with PharmaCos to Physicians Source: IBM Analysis

27. 27 Detailing - Physician Concerns 20% Not enough samples 28% Not enough medical expertise 40% Take too much time 44% Too many from the same company Inconvenient timing Biased information “ What are your top complaints about detailers? Source: The Forrester Report: “Pharma’s Detailing Overhaul”, February 2001 (IMS Health, Scott-Levin, Forrester Research, Inc); (Ziment/WebSurveyMD.com); IBM Analysis “I view them as the liaison but I don’t take them at their word all the time” “I hate negative marketing. The lack of objectivity is a big turnoff for me” “If they keep coming back with the same information, it’s a waste of both parties’ time” “I appreciate the information, but the reps can be pushy” “The thing I dislike the most is when the rep doesn’t appreciate that I am busy and still tries to pitch the drug to me” “I don’t believe that someone with a bachelor’s degree knows more about how a drug works than I do” Physician Comments 78% 47%

28. 28 Companies Are Experimenting with e-Detailing Source: IMS Health, iPhysicianNet website, Aptilon.com website, IBM Analysis There have been promises made about the benefits of e-Detailing Benefits to Physicians Benefits to PharmaCos Cost-effective: an online sales session costs about $110 on average, compared with about $200 for a field rep’s office visit Cost effective: Increased contact time per visit allows for higher information content Better control of detailing content: as a result, e-Detailing can be used as an efficient way to train less-skilled sales reps Capture relevant physician practice data: with this information, Companies can identify potential high prescribers that sales reps can target later Counter detailing and off-the-label discussion: with e-Detailing, the company’s medical experts can speak with physicians about competing drugs’ clinical trial flaws and off- the-label prescription, which is normally not allowed in a sales rep’s visit Increased sales of under-marketed drugs Allows physicians to see sales reps, gather information they deem important, and to have the flexibility and control to do it in their own schedule Offers physicians a range of convenient interactive channels Provides timely updated drug information Provides simpler sample ordering and delivery Provides quality peer-to-peer discussions on a topic that interests a physician.

29. 29 Sample Management The pharmaceutical industry in America distributed $6.7 billion worth of samples to physicians in 1999 * During a typical month, the average pharmaceutical sales representative will visit 150 physicians, distribute thousands of packages of drug samples, obtain FDA required signatures on 150 sample distribution forms and receive scores of new sample cartons to their home-based office, and expend as much as 25% of their time tediously managing a paper-based process * Source: IMS Health

30. 30 Sample Management and Regulatory Requirements PDMA (“Prescription Drug Marketing Act”) –Designed to minimize the threat to the public health posed by prescription drug diversion and counterfeiting –Requires that samples distributed by pharmaceutical representatives be signed for and tracked to create audit trails –Helps to ensure that the correct physician receives the correct samples. If a pharmaceutical company is found to be non-compliant, they could face significant penalties, fines, and possibly even prison terms Source: FDA

31. 31 Typical Sample Distribution Process The pharmaceutical sales representative (rep) arrives at a physician’s office. The rep manually fills out a pre-printed sample distribution form including physician information, sample product information, and the proper quantity of all samples to be distributed. The representative conducts a 3-5 minute presentation with the doctor about the product he or she is promoting, encouraging the physician to write more scripts for the product. The rep ends the detail by giving the physician the intended samples, and asks the physician to manually sign for the samples on the distribution form. At the end of the day, the rep will review each distribution form to check for accuracy, and then manually type all of the data from every form into their laptop Sales Force Automation (SFA) system. The rep then removes a copy of the triplicate form for his or her own records which must be kept for seven years, and mails a copy to a central processing location. The data sent to the central processing location is then manually entered for a second time into a database by a team of data processors. Since this is a manual process, there is an increased chance for the data to be full of errors. Each discrepancy found must later be reconciled during an audit to meet PDMA standards. It can often take weeks before this information is matched to the sales representative’s inventory, and even longer for the marketing manager to gain access to it. Finally, the representative will place a manual order, writing everything out on yet another pre-printed form, to replenish their own sample inventory Source: Pharmiweb

32. 32 OTHER MARKETING & SALES TECHNIQUES

33. 33 Key Opinion Leader Management Expert physicians -- often called "opinion leaders" or "thought leaders" -- play critical roles in driving pharmaceutical sales –Participate in ongoing R&D –Have privileged access to R&D information –Company-sponsored featured speaking engagements at prestigious conferences Exchange ideas with other physicians regarding new products or indications or adverse events Helps convince other doctors to prescribe new products and can make the difference between a successful product launch and a major disappointment Program is actively integrated with marketing program: –Physician recruitment (specialty, “name recognition”, etc.) –Matching to appropriate R&D efforts –Matching to appropriate marketing programs

34. 34 Medical Science Liaisons (“MSLs”) Scientific professionals –Pharmaceutical PhD’s –Pharmacists –Physicians –Nurses Generally have more scientific knowledge than sales representatives Roles: –Support and expand sales representatives’ marketing of a product –Be able to speak to the purchaser on a more scientific (peer) level; not on a marketing level –Will focus on clinical information Focus on key opinion leaders –Typically will only see more knowledgeable sales reps –Organize symposia, conferences, focus groups, etc. –Training and continuing education programs May be involved in setting up Phase IV trials (post launch)