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Organization of a "Typical" Pharmaceutical Company

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1 Organization of a "Typical" Pharmaceutical Company
2/21/2019 Organization of a “Typical” Pharmaceutical Company Jim Geddes

2 Organization of a "Typical" Pharmaceutical Company
2/21/2019 Topics to be Discussed Business Goals Organizational Structures Core Functions Sample Organization/Key Responsibilities Case Study

3 Organization of a "Typical" Pharmaceutical Company
2/21/2019 Business Goals The Key Business Goal of the company is to create financial value for the shareholders Other Business Goals include: Discover, develop, and bring to market products to improve human health, patient satisfaction, and the quality of life around the world, as well as to reduce the overall cost of health care.

4 Organizational Structures
Organization of a "Typical" Pharmaceutical Company 2/21/2019 Organizational Structures The two most important issues when deciding how to organize a pharmaceutical company are: Personnel - individuals in the organization Functions - activities that must be accomplished to achieve the company’s goals

5 Organizational Structures (cont.)
Organization of a "Typical" Pharmaceutical Company 2/21/2019 Organizational Structures (cont.) Common organizational structures of a pharmaceutical company include: Functional Structure Product-Oriented Structure Matrix Structure

6 Organizational Structures (cont.)
Organization of a "Typical" Pharmaceutical Company 2/21/2019 Organizational Structures (cont.) Functional Structure This organizational structure is present to some extent in most major pharmaceutical companies Each function within the company is organized separately Each function reports to a specific function/department head

7 Organizational Structures (cont.)
Organization of a "Typical" Pharmaceutical Company 2/21/2019 Organizational Structures (cont.) Functional Structure (cont.) - Major advantages: expertise is concentrated and individuals deal with common issues and interact with others with common skills - Major disadvantages: less communication with groups in other functional areas and fewer people have a thorough understanding of the whole organization and how what they do “fits”

8 Organizational Structures (cont.)
Organization of a "Typical" Pharmaceutical Company 2/21/2019 Organizational Structures (cont.) Functional Structure (cont.)

9 Organizational Structures (cont.)
Organization of a "Typical" Pharmaceutical Company 2/21/2019 Organizational Structures (cont.) Product-Oriented Structure This structure organizes a company into self-contained business units focused around specific products, therapeutic areas, customers, etc. (e.g., Prilosec, Gastrointestinal Business, Hospital Products, etc.)

10 Organizational Structures (cont.)
Organization of a "Typical" Pharmaceutical Company 2/21/2019 Organizational Structures (cont.) Product-Oriented Structure (cont.) - Major advantages: individuals are expert in their specific business and have clear and full responsibility for all aspects of their business - Major disadvantages: individual expertise is limited to one area and there is duplication of functions (and expenses) that could be centralized

11 Organizational Structures (cont.)
Organization of a "Typical" Pharmaceutical Company 2/21/2019 Organizational Structures (cont.) Product-Oriented Structure (cont.)

12 Organizational Structures (cont.)
Organization of a "Typical" Pharmaceutical Company 2/21/2019 Organizational Structures (cont.) Matrix Structure Incorporates both the Functional and Product-Oriented structures Recognizes business interdependencies and may offer greater flexibility than other structures Is now the most common structure in the Pharmaceutical Industry

13 Organizational Structures (cont.)
Organization of a "Typical" Pharmaceutical Company 2/21/2019 Organizational Structures (cont.) Matrix Structure (cont.) - Major advantages: addresses functions and products collectively, less duplication of effort, and increased efficiency - Major disadvantages: lack of direct control and requires full cooperation of “function” managers

14 Organizational Structures (cont.)
Organization of a "Typical" Pharmaceutical Company 2/21/2019 Organizational Structures (cont.) Matrix Structure (cont.) Head of President Business Areas Research & Marketing Production Finance Development Business Area A x x x x Business Area B x x x x Business Area C x x x x Business Area D x x x x

15 Organization of a "Typical" Pharmaceutical Company
2/21/2019 Core Functions Regardless of the organizational structure, certain functions must exist All functions have specific key responsibilities At times, the responsibilities of one function may overlap with another function The quality of interaction between functions strongly influences company performance

16 Organization of a "Typical" Pharmaceutical Company
2/21/2019 Core Functions (cont.) “Corporate Functions” Functions which are responsible for meeting overall Corporate goals and providing consistent direction and support across the entire Corporation.

17 Organization of a "Typical" Pharmaceutical Company
2/21/2019 Core Functions (cont.) “Corporate” Functions Shareholders Board of Directors Chairman/Chief Executive Officer (CEO) Public Relations (PR) Investor Relations (IR) President/Chief Operating Officer (COO) Finance Legal Human Resources (HR) Information Technology (IT) “Line Functions”

18 Sample Organization/Key Responsibilities
Organization of a "Typical" Pharmaceutical Company 2/21/2019 Sample Organization/Key Responsibilities “Corporate Functions” Shareholders Board of Directors Chairman/ Chief Executive Officer President/ Chief Operating Officer Investor Relations Public Relations Finance Human Resources Information Technology “Line Functions” Legal

19 Organization of a "Typical" Pharmaceutical Company
2/21/2019 Core Functions (cont.) “Line Functions” Operational functions which are responsible for implementing the strategies required to achieve the overall Corporate goals.

20 Organization of a "Typical" Pharmaceutical Company
2/21/2019 Core Functions (cont.) “Line” Functions U.S. Pharmaceuticals International Pharmaceuticals Research and Development (R&D) Regulatory Marketing Sales Medical Affairs Manufacturing

21 Sample Organization/Key Responsibilities
Organization of a "Typical" Pharmaceutical Company 2/21/2019 Sample Organization/Key Responsibilities “Corporate Functions” (cont.) Shareholders Board of Directors Chairman/ Chief Executive Officer President/ Chief Operating Officer Investor Relations Public Relations Finance Human Resources Information Technology “Line Functions” Legal

22 Sample Organization/Key Responsibilities (cont.)
Organization of a "Typical" Pharmaceutical Company 2/21/2019 Sample Organization/Key Responsibilities (cont.) “Corporate Functions” (cont.) Shareholders The individual and institutional investors who own stock in the company and are looking for Earnings Per Share (EPS) and share price appreciation.

23 Sample Organization/Key Responsibilities
Organization of a "Typical" Pharmaceutical Company 2/21/2019 Sample Organization/Key Responsibilities “Corporate Functions” (cont.) Shareholders Board of Directors Chairman/ Chief Executive Officer President/ Chief Operating Officer Investor Relations Public Relations Finance Human Resources Information Technology “Line Functions” Legal

24 Sample Organization/Key Responsibilities (cont.)
Organization of a "Typical" Pharmaceutical Company 2/21/2019 Sample Organization/Key Responsibilities (cont.) “Corporate Functions” (cont.) Board of Directors (BOD) Key Responsibilities: Oversee the company’s financial progress to ensure that shareholder’s expectations are met Approve the selection of Chairman/Chief Executive Officer Approve and monitor the company’s strategic direction As appropriate, address major business issues and allocation of resources Add value to the company

25 Sample Organization/Key Responsibilities
Organization of a "Typical" Pharmaceutical Company 2/21/2019 Sample Organization/Key Responsibilities “Corporate Functions” (cont.) Shareholders Board of Directors Chairman/ Chief Executive Officer President/ Chief Operating Officer Investor Relations Public Relations Finance Human Resources Information Technology “Line Functions” Legal

26 Sample Organization/Key Responsibilities (cont.)
Organization of a "Typical" Pharmaceutical Company 2/21/2019 Sample Organization/Key Responsibilities (cont.) “Corporate Functions” (cont.) Chairman/Chief Executive Officer (CEO) Key Responsibilities: Chairman of the Board of Directors Head of the organization Sets the overall strategic direction Main spokesperson to the shareholders Must be a strategic thinker, plus understand finance, product discovery and development, marketing, and sales

27 Sample Organization/Key Responsibilities
Organization of a "Typical" Pharmaceutical Company 2/21/2019 Sample Organization/Key Responsibilities “Corporate Functions” (cont.) Shareholders Board of Directors Chairman/ Chief Executive Officer President/ Chief Operating Officer Investor Relations Public Relations Finance Human Resources Information Technology “Line Functions” Legal

28 Sample Organization/Key Responsibilities (cont.)
Organization of a "Typical" Pharmaceutical Company 2/21/2019 Sample Organization/Key Responsibilities (cont.) “Corporate Functions” (cont.) Public Relations (PR) Key Responsibility: Set and manage overall Corporate PR strategy Support the achievement of business goals Manage the external image of the company

29 Sample Organization/Key Responsibilities
Organization of a "Typical" Pharmaceutical Company 2/21/2019 Sample Organization/Key Responsibilities “Corporate Functions” (cont.) Shareholders Board of Directors Chairman/ Chief Executive Officer President/ Chief Operating Officer Investor Relations Public Relations Finance Human Resources Information Technology “Line Functions” Legal

30 Sample Organization/Key Responsibilities (cont.)
Organization of a "Typical" Pharmaceutical Company 2/21/2019 Sample Organization/Key Responsibilities (cont.) “Corporate Functions” (cont.) Investor Relations (IR) Key Responsibility: Set and manage overall Corporate IR strategy Support the achievement of business goals Ensure individual and institutional investors understand the company’s strategic and financial goals and performance vs. those goals

31 Sample Organization/Key Responsibilities
Organization of a "Typical" Pharmaceutical Company 2/21/2019 Sample Organization/Key Responsibilities “Corporate Functions” (cont.) Shareholders Board of Directors Chairman/ Chief Executive Officer President/ Chief Operating Officer Investor Relations Public Relations Finance Human Resources Information Technology “Line Functions” Legal

32 Sample Organization/Key Responsibilities (cont.)
Organization of a "Typical" Pharmaceutical Company 2/21/2019 Sample Organization/Key Responsibilities (cont.) “Corporate Functions” (cont.) President/Chief Operating Officer (COO) Key Responsibilities: Operational head of organization Manage “Line Functions” Implement operational plans to achieve overall strategic direction Achieve financial targets Primary interface with employees Must know how to get things done Must know the products, the marketplace, the customers, the competition, etc. Should be candidate for Chairman/Chief Executive Officer position

33 Sample Organization/Key Responsibilities
Organization of a "Typical" Pharmaceutical Company 2/21/2019 Sample Organization/Key Responsibilities “Corporate Functions” (cont.) Shareholders Board of Directors Chairman/ Chief Executive Officer President/ Chief Operating Officer Investor Relations Public Relations Finance Human Resources Information Technology “Line Functions” Legal

34 Sample Organization/Key Responsibilities (cont.)
Organization of a "Typical" Pharmaceutical Company 2/21/2019 Sample Organization/Key Responsibilities (cont.) “Corporate Functions” (cont.) Finance The head is the Chief Financial Officer (CFO) Key Responsibilities: Set and manage overall Corporate Financial strategy Support the achievement of business goals Work with Corporate and Line management to set, manage, and achieve financial targets Report financial performance (externally - Shareholders, SEC, etc. and internally - Board of Directors, Corporate and Line managers, etc.) Evaluate new business opportunities, mergers, acquisitions, licensing agreements, etc.

35 Sample Organization/Key Responsibilities (cont.)
Organization of a "Typical" Pharmaceutical Company 2/21/2019 Sample Organization/Key Responsibilities (cont.) Functions within Finance include: Finance Accounts Payable Accounts Receivable Accounting Payroll Auditing Budgeting and Planning

36 Sample Organization/Key Responsibilities
Organization of a "Typical" Pharmaceutical Company 2/21/2019 Sample Organization/Key Responsibilities “Corporate Functions” (cont.) Shareholders Board of Directors Chairman/ Chief Executive Officer President/ Chief Operating Officer Investor Relations Public Relations Finance Human Resources Information Technology “Line Functions” Legal

37 Sample Organization/Key Responsibilities (cont.)
Organization of a "Typical" Pharmaceutical Company 2/21/2019 Sample Organization/Key Responsibilities (cont.) “Corporate Functions” (cont.) Legal The head is usually the General Counsel Key Responsibilities: Set and manage overall Corporate Legal strategy Support the achievement of business goals Provide legal advice to the organization on strategic direction and business activities Review key business documents e.g. (licensing agreements, acquisition contracts, etc.) Review marketing and sales materials Review regulatory submissions Provide liability insurance, develop and file patents, etc. Often serves as Secretary to the Board of Directors

38 Sample Organization/Key Responsibilities
Organization of a "Typical" Pharmaceutical Company 2/21/2019 Sample Organization/Key Responsibilities “Corporate Functions” (cont.) Shareholders Board of Directors Chairman/ Chief Executive Officer President/ Chief Operating Officer Investor Relations Public Relations Finance Human Resources Information Technology “Line Functions” Legal

39 Sample Organization/Key Responsibilities (cont.)
Organization of a "Typical" Pharmaceutical Company 2/21/2019 Sample Organization/Key Responsibilities (cont.) “Corporate Functions” (cont.) Human Resources (HR) Key Responsibility: Set and manage overall Corporate HR strategy Support the achievement of business goals Maximize effectiveness of employees

40 Sample Organization/Key Responsibilities (cont.)
Organization of a "Typical" Pharmaceutical Company 2/21/2019 Sample Organization/Key Responsibilities (cont.) Functions within Human Resources include: Human Resources (HR) Recruiting Employee Relations Benefits Compensation

41 Sample Organization/Key Responsibilities
Organization of a "Typical" Pharmaceutical Company 2/21/2019 Sample Organization/Key Responsibilities “Corporate Functions” (cont.) Shareholders Board of Directors Chairman/ Chief Executive Officer President/ Chief Operating Officer Investor Relations Public Relations Finance Human Resources Information Technology “Line Functions” Legal

42 Sample Organization/Key Responsibilities (cont.)
Organization of a "Typical" Pharmaceutical Company 2/21/2019 Sample Organization/Key Responsibilities (cont.) “Corporate Functions” (cont.) Information Technology (IT) The head may be the Chief Information Officer (CIO) Key Responsibilities: Set and manage overall Corporate IT strategy Support the achievement of business goals Manage and support IT systems

43 Sample Organization/Key Responsibilities
Organization of a "Typical" Pharmaceutical Company 2/21/2019 Sample Organization/Key Responsibilities “Corporate Functions” (cont.) Shareholders Board of Directors Chairman/ Chief Executive Officer President/ Chief Operating Officer Investor Relations Public Relations Finance Human Resources Information Technology “Line Functions” Legal

44 Sample Organization/Key Responsibilities (cont.)
Organization of a "Typical" Pharmaceutical Company 2/21/2019 Sample Organization/Key Responsibilities (cont.) “Line Functions” (cont.) Key Responsibility: Implement the strategies required to achieve the overall Corporate goals

45 Sample Organization/Key Responsibilities (cont.)
Organization of a "Typical" Pharmaceutical Company 2/21/2019 Sample Organization/Key Responsibilities (cont.) “Line Functions” “Line Functions” U. S. Pharmaceuticals International Pharmaceuticals Research and Development

46 Sample Organization/Key Responsibilities (cont.)
Organization of a "Typical" Pharmaceutical Company 2/21/2019 Sample Organization/Key Responsibilities (cont.) “Line Functions” (cont.) U.S. Pharmaceuticals President/ General Manager Medical Affairs Manufacturing Marketing Sales “Local” Human Resources Regulatory Affairs “Local” Finance

47 Sample Organization/Key Responsibilities (cont.)
Organization of a "Typical" Pharmaceutical Company 2/21/2019 Sample Organization/Key Responsibilities (cont.) “Line Functions” (cont.) U.S. Pharmaceuticals (cont.) President/ General Manager Medical Affairs Manufacturing Marketing Sales “Local” Human Resources Regulatory Affairs “Local” Finance

48 Sample Organization/Key Responsibilities (cont.)
Organization of a "Typical" Pharmaceutical Company 2/21/2019 Sample Organization/Key Responsibilities (cont.) “Line Functions” (cont.) U. S. Pharmaceuticals (cont.) The head is the President/General Manager of U.S. Pharmaceutical Business Key Responsibilities: Full Profit and Loss (P&L) responsibility for the business in the U.S. (could include all of North America e.g. Canada, Mexico, etc.) Locally implement Corporate Strategies

49 Sample Organization/Key Responsibilities (cont.)
Organization of a "Typical" Pharmaceutical Company 2/21/2019 Sample Organization/Key Responsibilities (cont.) “Line Functions” (cont.) U.S. Pharmaceuticals (cont.) President/ General Manager Medical Affairs Manufacturing Marketing Sales “Local” Human Resources Regulatory Affairs “Local” Finance

50 Sample Organization/Key Responsibilities (cont.)
Organization of a "Typical" Pharmaceutical Company 2/21/2019 Sample Organization/Key Responsibilities (cont.) “Line Functions” (cont.) U.S. Pharmaceuticals - Marketing Key Responsibilities: Set and manage overall Marketing strategy Develop and implement product Marketing Plans to maximize market share, sales, and profits Identify market needs/demands Identify new product opportunities Develop strategies, messages, and materials for sales force

51 Sample Organization/Key Responsibilities (cont.)
Organization of a "Typical" Pharmaceutical Company 2/21/2019 Sample Organization/Key Responsibilities (cont.) U.S. Pharmaceuticals - Marketing (cont.) Key Responsibilities (cont.): Develop and implement advertising campaigns (journal ads, mail, direct to consumer campaigns, etc.) to targeted customer groups Identify opportunities to expand product use e.g. new indications, new strengths and forms, etc.

52 Sample Organization/Key Responsibilities (cont.)
Organization of a "Typical" Pharmaceutical Company 2/21/2019 Sample Organization/Key Responsibilities (cont.) Functions within Marketing include: Marketing Product Management Marketing Research Advertising

53 Sample Organization/Key Responsibilities (cont.)
Organization of a "Typical" Pharmaceutical Company 2/21/2019 Sample Organization/Key Responsibilities (cont.) “Line Functions” (cont.) U.S. Pharmaceuticals (cont.) President/ General Manager Medical Affairs Manufacturing Marketing Sales “Local” Human Resources Regulatory Affairs “Local” Finance Often Sales and Marketing are combined.

54 Sample Organization/Key Responsibilities (cont.)
Organization of a "Typical" Pharmaceutical Company 2/21/2019 Sample Organization/Key Responsibilities (cont.) “Line Functions” (cont.) U.S Pharmaceuticals - Sales Key Responsibilities: Set and manage overall Sales strategy Implement product Marketing Plans to achieve market share and sales objectives with target customers “Detail” products to customers Provide literature and samples of products to customers Answer customer questions

55 Sample Organization/Key Responsibilities (cont.)
Organization of a "Typical" Pharmaceutical Company 2/21/2019 Sample Organization/Key Responsibilities (cont.) Functions within Sales include: Sales National Account Managers Sales Directors Sales Support Sales Administration Regional Account Managers Sales Managers Sales Representatives

56 Sample Organization/Key Responsibilities (cont.)
Organization of a "Typical" Pharmaceutical Company 2/21/2019 Sample Organization/Key Responsibilities (cont.) “Line Functions” (cont.) U.S. Pharmaceuticals President/ General Manager Medical Affairs Manufacturing Marketing Sales “Local” Human Resources Regulatory Affairs “Local” Finance

57 Sample Organization/Key Responsibilities (cont.)
Organization of a "Typical" Pharmaceutical Company 2/21/2019 Sample Organization/Key Responsibilities (cont.) “Line Functions” (cont.) U. S. Pharmaceuticals - Medical Affairs Key Responsibilities: Set and manage overall Medical Affairs strategy Provide medical support to the marketing of products Respond to customer and sales force inquiries on marketed products Conduct Phase IV clinical trials to track safety and identify new/additional indications for marketed products Review marketing and sales materials

58 Sample Organization/Key Responsibilities (cont.)
Organization of a "Typical" Pharmaceutical Company 2/21/2019 Sample Organization/Key Responsibilities (cont.) “Line Functions” (cont.) U.S. Pharmaceuticals President/ General Manager Medical Affairs Manufacturing Marketing Sales “Local” Human Resources Regulatory Affairs “Local” Finance

59 Sample Organization/Key Responsibilities (cont.)
Organization of a "Typical" Pharmaceutical Company 2/21/2019 Sample Organization/Key Responsibilities (cont.) “Line Functions” (cont.) U. S. Pharmaceuticals - Manufacturing Key Responsibilities: Set and manage overall Manufacturing strategy Manufacturing of Clinical and Commercial Supplies Ensure that products meet manufacturing regulations (Good Manufacturing Practices - GMPs) Produce products as cost effectively as possible to minimize Cost of Goods Sold (CGS) and maximize profitability Produce sufficient quantities of products to meet demand Distribute products (wholesales, hospitals, etc.)

60 Sample Organization/Key Responsibilities (cont.)
Organization of a "Typical" Pharmaceutical Company 2/21/2019 Sample Organization/Key Responsibilities (cont.) Functions within Manufacturing include: Manufacturing Chemical Production Pharmaceutical Production Packaging Quality Warehousing and Distribution Facilities/ Engineering Materials

61 Sample Organization/Key Responsibilities (cont.)
Organization of a "Typical" Pharmaceutical Company 2/21/2019 Sample Organization/Key Responsibilities (cont.) “Line Functions” (cont.) U.S. Pharmaceuticals President/ General Manager Medical Affairs Manufacturing Marketing Sales “Local” Human Resources Regulatory Affairs “Local” Finance

62 Sample Organization/Key Responsibilities (cont.)
Organization of a "Typical" Pharmaceutical Company 2/21/2019 Sample Organization/Key Responsibilities (cont.) “Line Functions” (cont.) U.S. Pharmaceuticals - Regulatory Affairs Key Responsibilities: Set and manage overall Regulatory strategy Manage interaction with regulatory agencies Develop submissions and negotiate approval and product labeling with regulatory authorities Interpret regulations and provide regulatory advice to organization (e.g. R&D, Marketing, etc.) Review marketing and sales materials

63 Sample Organization/Key Responsibilities (cont.)
Organization of a "Typical" Pharmaceutical Company 2/21/2019 Sample Organization/Key Responsibilities (cont.) “Line Functions” (cont.) U.S. Pharmaceuticals President/ General Manager Medical Affairs Manufacturing Marketing Sales Regulatory Affairs “Local” Finance “Local” Human Resources

64 Sample Organization/Key Responsibilities (cont.)
Organization of a "Typical" Pharmaceutical Company 2/21/2019 Sample Organization/Key Responsibilities (cont.) “Line Functions” (cont.) U.S. Pharmaceuticals - “Local” Finance (same as “Corporate Function” except on “local” level) Key Responsibilities: Set and manage local Finance strategy and ensure compliance/consistency with Corporate Finance strategy Work with “local” management to set, manage, and achieve financial targets Report financial performance to Corporate Finance Evaluate local new business opportunities, etc.

65 Sample Organization/Key Responsibilities (cont.)
Organization of a "Typical" Pharmaceutical Company 2/21/2019 Sample Organization/Key Responsibilities (cont.) “Line Functions” (cont.) U.S. Pharmaceuticals - “Local” Human Resources (same as “Corporate Function” except on “local” level) Key Responsibilities: Set and manage local HR strategy and ensure compliance/consistency with Corporate HR strategy Maximize effectiveness of “local” employees

66 Sample Organization/Key Responsibilities (cont.)
Organization of a "Typical" Pharmaceutical Company 2/21/2019 Sample Organization/Key Responsibilities (cont.) “Line Functions” (cont.) “Line Functions” U. S. Pharmaceuticals International Pharmaceuticals Research and Development

67 Sample Organization/Key Responsibilities (cont.)
Organization of a "Typical" Pharmaceutical Company 2/21/2019 Sample Organization/Key Responsibilities (cont.) “Line Functions” (cont.) International Pharmaceuticals President/ General Manager Medical Affairs Marketing Sales Manufacturing “Local” Human Resources Regulatory Affairs “Local” Finance Area/Country Managers

68 Sample Organization/Key Responsibilities (cont.)
Organization of a "Typical" Pharmaceutical Company 2/21/2019 Sample Organization/Key Responsibilities (cont.) “Line Functions” (cont.) International Pharmaceuticals President/ General Manager Medical Affairs Marketing Sales Manufacturing “Local” Human Resources Regulatory Affairs “Local” Finance Area/Country Managers

69 Sample Organization/Key Responsibilities (cont.)
Organization of a "Typical" Pharmaceutical Company 2/21/2019 Sample Organization/Key Responsibilities (cont.) “Line Functions” (cont.) International Pharmaceuticals The head is President/General Manager International Pharmaceuticals Key Responsibilities: Full Profit and Loss (P&L) responsibility for the business outside the U.S. (Europe, Asia, Rest of the World (ROW), etc.) Locally implement Corporate Strategies Manage Area/Country Managers

70 Sample Organization/Key Responsibilities (cont.)
Organization of a "Typical" Pharmaceutical Company 2/21/2019 Sample Organization/Key Responsibilities (cont.) “Line Functions” (cont.) International Pharmaceuticals (cont.) Area/Country Managers Medical Affairs Marketing Sales Manufacturing “Local” Human Resources Regulatory Affairs “Local” Finance

71 Sample Organization/Key Responsibilities (cont.)
Organization of a "Typical" Pharmaceutical Company 2/21/2019 Sample Organization/Key Responsibilities (cont.) “Line Functions” (cont.) “Line Functions” U. S. Pharmaceuticals International Pharmaceuticals Research and Development

72 Sample Organization/Key Responsibilities (cont.)
Organization of a "Typical" Pharmaceutical Company 2/21/2019 Sample Organization/Key Responsibilities (cont.) “Line Functions” (cont.) Research and Development (R&D) The head is the President (or Vice President) of Research and Development (R&D) Key Responsibilities: Discover, develop, and register new products to maximize market share, sales, and profits Identify licensing/collaboration/acquisition opportunities

73 Sample Organization/Key Responsibilities (cont.)
Organization of a "Typical" Pharmaceutical Company 2/21/2019 Sample Organization/Key Responsibilities (cont.) “Line Functions” (cont.) Research and Development (R&D) - Research Key Responsibilities: Identify and screen new potential products Internal candidates External candidates Transfer lead candidates to Development

74 Organization of a "Typical" Pharmaceutical Company
2/21/2019 Sample Organization/Key Responsibilities “Research and Development (R&D) –Project Management Key Responsibilities: -Facilitate Project Teams Agendas, Minutes, Reports, follow-up -Interface with Non-team functions e.g. legal -Project Historian -Project Leader

75 Sample Organization/Key Responsibilities (cont.)
Organization of a "Typical" Pharmaceutical Company 2/21/2019 Sample Organization/Key Responsibilities (cont.) “Line Functions”(cont.) Research and Development (R&D) - Development Key Responsibilities: Conduct trials to determine the safety and efficacy of potential new products Decide if “outsourcing” is appropriate Ensure that trials are conducted according to Good Clinical Practices (GCPs) Ensure trials are conducted in a way to achieve marketing goals With Regulatory Affairs, develop submission of clinical trial data to regulatory authorities Provide marketable formulation for product Assure data are available to support product

76 Organization of a "Typical" Pharmaceutical Company
2/21/2019 Questions?

77 Organization of a "Typical" Pharmaceutical Company
2/21/2019 Organization of a “Typical” Pharmaceutical Company Case Study

78 Organization of a "Typical" Pharmaceutical Company
2/21/2019 Case Study Key Business Objective: To create financial value for the shareholders

79 Organization of a "Typical" Pharmaceutical Company
2/21/2019 Case Study (cont.) What has to happen, who has to do what to achieve that Key Business Objective ? Successfully develop, register, and launch a new “breakthrough” product.

80 Organization of a "Typical" Pharmaceutical Company
2/21/2019 Case Study (cont.) “Corporate Functions” Shareholders Board of Directors Chairman/ Chief Executive Officer President/ Chief Operating Officer Investor Relations Public Relations Finance Human Resources Information Technology “Line Functions” Legal

81 Organization of a "Typical" Pharmaceutical Company
2/21/2019 Case Study (cont.) “Line Functions” “Line Functions” U. S. Pharmaceuticals International Pharmaceuticals Research and Development

82 Organization of a "Typical" Pharmaceutical Company
2/21/2019 Case Study (cont.) “Line Functions” (cont.) U.S. Pharmaceuticals President/ General Manager Medical Affairs Manufacturing Marketing Sales “Local” Human Resources Regulatory Affairs “Local” Finance

83 Organization of a "Typical" Pharmaceutical Company
2/21/2019 Case Study (cont.) “Corporate Functions” “If I’m going to buy your stock, I want to see EPS of about $3.00 and the stock price go up from $63.00 per share to around $75.00 over the next several years.”

84 Organization of a "Typical" Pharmaceutical Company
2/21/2019 Case Study (cont.) “Corporate Functions” (cont.) “Shareholders are looking for an EPS of around $3.00 and an increase in share price of about $12.00 per share. What are our plans to deliver that?”

85 Organization of a "Typical" Pharmaceutical Company
2/21/2019 Case Study (cont.) “Corporate Functions” (cont.) “Our strategy is to continue to focus on our Pharmaceutical Business and our gastrointestinal franchise. New products in that area should provide the growth the Shareholders and the Board are looking for.”

86 Organization of a "Typical" Pharmaceutical Company
2/21/2019 Case Study (cont.) “Corporate Functions” (cont.) “We have a number of potentially interesting gastrointestinal leads in Research and several exciting products are in Development. We feel at least one of these products could be developed and approved in the next year. We estimate it could achieve peak year sales of $2 billion.”

87 Organization of a "Typical" Pharmaceutical Company
2/21/2019 Case Study (cont.) “Line Functions” “We’ve screened several interesting leads. We also have one product in the clinic. Marketing feels that a product with the profile we’ve targeted could achieve peak year sales of $2 billion. Phase III trials are almost finished. We expect to be able to submit an NDA in 6 months. We feel the FDA will approve the product within 6 months* from submission. A Project Team is in place.”

88 Organization of a "Typical" Pharmaceutical Company
2/21/2019 Case Study (cont.) “Line Functions” (cont.) “We feel there’s a significant unmet medical need for a product with the targeted profile. We’ve developed an “ideal” product profile and Development has designed studies to achieve the profile. Phase III trials are almost finished. A product with the targeted profile could achieve peak year sales of $2 billion. We’re working closely with R&D and the Project Team to get this product developed, approved, and launched as quickly and correctly as possible.”

89 Organization of a "Typical" Pharmaceutical Company
2/21/2019 Case Study (cont.) Project Team A specific Project Team has been organized to oversee the product development, submission, and launch. Members include: - Development - Marketing - Medical - Manufacturing - PR - IR - Finance

90 Organization of a "Typical" Pharmaceutical Company
2/21/2019 Case Study (cont.) Project Team “Data from the clinical trials are in and have been analyzed. Even though the “ideal” product profile wasn’t achieved, we feel the product has demonstrated a high level of safety and efficacy Regulatory Affairs feels the FDA will approve the product. Marketing feels it will achieve a necessary level of market share, sales, and profits.”

91 Organization of a "Typical" Pharmaceutical Company
2/21/2019 Case Study (cont.) “Line Functions” (cont.) “We’ve developed our submission strategy. The NDA has been finalized and submitted to the FDA. An Advisory Board meeting has been scheduled to review our NDA. We feel we’re still on target for approval by the end of the year.”

92 Organization of a "Typical" Pharmaceutical Company
2/21/2019 Case Study (cont.) “Line Functions” (cont.) “A New Product Launch Plan has been developed. All of the key launch materials (e.g. Mail Campaign, Journal Ads, Sales Pieces, Pricing, etc.) are ready to go. As soon as we get final FDA approval*, we’re ready to launch the product.”

93 Organization of a "Typical" Pharmaceutical Company
2/21/2019 Case Study (cont.) “Line Functions” (cont.) “The Sales Force is trained in the disease area, the product, and the competition. Target customers have been identified. Sales goals have been established. Key Managed Care Accounts have been identified. Sales materials and samples are all set. We’re ready.”

94 Organization of a "Typical" Pharmaceutical Company
2/21/2019 Case Study (cont.) “Line Functions” (cont.) “We’ve been able to successfully manufacture the active chemical. We’ve made clinical supplies. We’ve made pilot batches and scaled up according to GMPs. Marketing asked to have the product available in tablets in bottles of They also want an injectable form at launch. Our estimate of CGS is $5.00 for a bottle of 100 tablets. We have manufactured sufficient supplies to meet Marketing’s first year sales estimate. We have a plan in place to ship initial quantities to wholesalers as soon as the product is approved. We’re also ready.”

95 Organization of a "Typical" Pharmaceutical Company
2/21/2019 Case Study (cont.) “Line Functions” (cont.) “We have our Plan in place to support the launch. We’ll help with sales representative training and we’ll be able to answer questions from sales representatives and/or doctors. We have an adverse reaction tracking system in place to monitor safety. Phase IV studies are planned to look at safety and to potentially expand use.”

96 Organization of a "Typical" Pharmaceutical Company
2/21/2019 Case Study (cont.) “Corporate Functions” “A PR Plan announcing the clinical results, the submission, the FDA approval, and that the product is now available has been developed. All of the necessary components (e.g. Press Releases, News Clips, etc.) are ready to go.”

97 Organization of a "Typical" Pharmaceutical Company
2/21/2019 Case Study (cont.) “Corporate Functions” (cont.) “A Plan to announce the clinical results, the submission, and the approval has been developed and is ready to go to the Shareholders and the investment community.”

98 Organization of a "Typical" Pharmaceutical Company
2/21/2019 Case Study (cont.) “Corporate Functions” (cont.) “If the sales of current products meet expectations and the sales of this new product hit the targets, $3.00 EPS and $12 per share should be achieved.”

99 Organization of a "Typical" Pharmaceutical Company
2/21/2019 Case Study (cont.) “Line Functions” “The FDA just sent us our approval letter and the final product labeling. They’ve approved our launch materials. We’re good to go.”

100 Organization of a "Typical" Pharmaceutical Company
2/21/2019 Case Study (cont.) “Line Functions” (cont.) “Let’s launch!!”

101 Organization of a "Typical" Pharmaceutical Company
2/21/2019 Case Study (cont.) “Corporate Functions” “Tell the Board and the Shareholders the product has been approved and sales forecasts are being achieved. And for guidance, tell the investment community that we think $3.00 is a good number (and the share price should go up).”

102 Organization of a "Typical" Pharmaceutical Company
2/21/2019 Questions?


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