Ce diaporama a bien été signalé.
Nous utilisons votre profil LinkedIn et vos données d’activité pour vous proposer des publicités personnalisées et pertinentes. Vous pouvez changer vos préférences de publicités à tout moment.

Role of Business Development in Pharmaceuticals (Generic Product Business)

7 119 vues

Publié le

Role of Business Development in Pharmaceuticals (Generic Product Business)

Publié dans : Marketing

Role of Business Development in Pharmaceuticals (Generic Product Business)

  1. 1. Phr_ali91@hotmail.com Role of Business Development in Pharmaceuticals Muhammad Ali email: phr_ali91@hotmail.com
  2. 2. Phr_ali91@hotmail.com Content  Pharmaceutical Company Department  Why Business Development Department  Business Development types in Pakistani Pharmaceutical Market  New Product  New Product Development Process or Cycle  Challenges  Summary Muhammad Ali 2
  3. 3. Phr_ali91@hotmail.com Pharmaceutical Company Departments 3Muhammad Ali
  4. 4. Phr_ali91@hotmail.com Pharmaceutical Company Departments Muhammad Ali 4 Production Quality Control Quality Assurance Technical Services/Validation Dept Regulatory Affairs Medical Affairs Training & Development Research and Development/ New Product Development Administration Human Resources 1-Marketing & Sales 2-International Marketing/Export Business Development Supply Chain 1-Material Purchase/Import 2- Ware House 3-Distribution/Commercial Dept 4-Production planning Engineering
  5. 5. Phr_ali91@hotmail.com Muhammad Ali 5
  6. 6. Phr_ali91@hotmail.com Why Business Development? • To shape the company’s future. • To maintain or build sales. • Customers want new products, which competitors will do their best to provide them. Muhammad Ali 6
  7. 7. Phr_ali91@hotmail.com Role of Business Development Department Purpose To Maintain a ROBUST products pipeline and ENSURE the launch of the RIGHT PRODUCT at RIGHT TIME. Responsibilities The department is responsible to overcome the challenges (external & internal) of bringing new products to market in time in the focused therapeutic areas. Nature & Scope • BD serves as liaison between external partners & internal groups within company including Product development, Creative, Medical, Regulatory, Production, Material Management ,Import and Marketing. • It strategize to identify, prioritize and pursue new opportunities / molecules in the focused therapeutic areas as defined by Organization. • The future business opportunities and direction of business is being driven by the department which means that the efficiency of in time product launch, is the key critical success factor. 7Muhammad Ali
  8. 8. Phr_ali91@hotmail.com Core Functions • Seize Timely Opportunity • Strategic Business Alliance (Licensing) • Strategic Sourcing • Portfolio Management • Pipeline Development • Revitalization (Including Cost Saving) • Process Improvement • Corporate Image • Competitor Analysis • Liaison With Department In Order To Achieve Company Goals Muhammad Ali 8
  9. 9. Phr_ali91@hotmail.com BD Intelligence • Ministry & Medical Publications • International & National weekly, monthly, quarterly subscriptions of Magazines, Newspapers & etc. • Internal developed BD intelligence system • Suppliers & Indenters resources • Specific Internet sites (SRA websites) • Market forces • Competitors activities To keep Organization in top ranking, BD up to date and relevant with next 3 years perspectives, following sources are in practice: 9Muhammad Ali
  10. 10. Phr_ali91@hotmail.com BD Intelligence Stage 1 Stage 1 Search and technical evaluation of opportunities for new products/ R&D molecules/ Technologies Step 1 BD Continuously develop an opportunity list by search & initial scoping Step 2 Medical Medical need? Epidemiology Impact of drug? Medical profile /clinical data presentation for KOLs? 10Muhammad Ali
  11. 11. Phr_ali91@hotmail.com BD Intelligence Stage 2 Stage 2 commercial evaluation Step 1 Market Research Market size? Competition profile ? Market growth rate? Trade Prices of similar drugs? Step 2 Marketing Maximum sales potential? Five years annual sales fore cast TP/DP/MRP Step 3 Finance Financial evaluation NPV, ROI, IRR 11Muhammad Ali
  12. 12. Phr_ali91@hotmail.com  Rectify the dossier & Technical discrepancies in coordination with R&D.  BD assist Regulatory Manager & consultant (external & internal) to overcome the issues raised during & after registration process.  Other regulatory matters like: getting files from MOH, MOM, summaries of MOM and any special assigned regulatory tasks & jobs. Regulatory Affairs Receive the Reg. Letter Provide assistance wherever & whenever needed during registration at MOH Follow-up with Regulatory Manager / outsourced consultant for getting the registration Letter Dossier submission for registration of the Product Pack Size /Form Issues Brand Name Assistance Price committee issues Other issues 12Muhammad Ali
  13. 13. Phr_ali91@hotmail.com Market Placement 1)Identify target markets – Size and growth potential – Ability and ease of reaching segment – Good fit with organizational objectives – Greatest revenue generation with least investment 13Muhammad Ali
  14. 14. Phr_ali91@hotmail.com Market Placement 2)Determine opportunity Segment size Annual usage potential Anticipated annual growth rate Margin Value in use 3)Evaluate competition Strengths/Limitations Implications 14Muhammad Ali
  15. 15. Phr_ali91@hotmail.com Business Development Types in Pakistani Pharmaceutical Market Muhammad Ali 15
  16. 16. Phr_ali91@hotmail.com National Generics - 1 Identification Screening (Patent) Capacity Constraints Market Potential (IMS etc) Owner of the Company Sources of Supply Documentation & Samples Registration Marketing to launch Intuitive behavior followed by many national companies 16Muhammad Ali
  17. 17. Phr_ali91@hotmail.com National Generics - 2 Identification Screening (Patent) Capacity Constraints Market Potential (IMS etc) Product Potential Long-term success New Product Committee (Top-Line & Project Leader) Sources of Supply Documentation & Samples Registration & Launch Planning Marketing to launch Intuitive behavior followed by many national companies 17Muhammad Ali
  18. 18. Phr_ali91@hotmail.com Multinational Generic •Sources of supply: Gradation & selection •Formulation & product development •Dossier & registration •Batch production & validation •Launch planning •Launching DROP Identification & Screening on country basis Gap analysis & financial evaluation Country Head Office Screening on global/regional basis Assessment of financial evaluation Corporate/Regional Head Office GO-AHEAD Process is followed by multinational but limited to generic products 18Muhammad Ali
  19. 19. Phr_ali91@hotmail.com New Product Muhammad Ali 19
  20. 20. Phr_ali91@hotmail.com Why New Products? • New product development is essential to any business that must keep up with market trends and changes. • Approximately one-third of the revenue a business generates is coming from products they did not sell five years ago • Changing environment creates new demands and needs 20Muhammad Ali
  21. 21. Phr_ali91@hotmail.com Why develop New Product ? • To create stars and cash cows for the future • To replace declining product • To take advantage of new technology • To defeat rivals • To maintain/increase market share • To keep up with rivals • To maintain competitive advantage • To fill gap in the market 21Muhammad Ali
  22. 22. Phr_ali91@hotmail.com Product Development • Must be alert to quickly develop opportunities • Focus on markets or product categories consistent with organization’s objectives, resources, capabilities and strengths • Securing a competitive advantage 22Muhammad Ali
  23. 23. Phr_ali91@hotmail.com What is a new product ? • A product that opens an entirely new market • A product that adopts or replaces an existing product • A product that significantly broadens the market for an existing product • An old product introduced in a new market • An old product packaged in a different way • An old product marketed in a different way 23Muhammad Ali
  24. 24. Phr_ali91@hotmail.com New Products necessity • A way of getting new and keeping old customers • Effective way of obtaining a competitive advantage • Source of growth and excitement 24Muhammad Ali
  25. 25. Phr_ali91@hotmail.com Categories of New Products • New product • entirely new market • New line • new product in established market • Addition to existing line • new product in established line • Improvement of existing product • value addition to existing product • Re-positioning • existing product in new market • Cost reduction • similar performance at lower cost 25Muhammad Ali
  26. 26. Phr_ali91@hotmail.com New product can be used to • Increase/defend market share by offering more choice or updating older products • Appeal to new segments • Diversify into new markets • Improve relationship with distributors • Maintain the firm’s reputation a leading edge company • Even out peaks and troughs in demand • Make better use of the organization's resources 26Muhammad Ali
  27. 27. Phr_ali91@hotmail.com NEW PRODUCT DEVELOPMENT PROCESS / CYCLE Muhammad Ali 27
  28. 28. Phr_ali91@hotmail.com New product planning • This is the strategic stage • The firm assesses • It current product portfolio • Opportunities and threats • The firm then determines the type of product which would best fit in with the corporate strategy 28Muhammad Ali
  29. 29. Phr_ali91@hotmail.com New product development • New product development is a process which is designed to develop, test and consider the viability of products which are new to the market in order to ensure the Growth or survival of the organization. 29Muhammad Ali
  30. 30. Phr_ali91@hotmail.com Stages in New product development • Idea Generation • Idea Screening • Concept development and testing • Market strategy development • Business Analysis • Commercialization 30Muhammad Ali
  31. 31. Phr_ali91@hotmail.com Idea Generation • Idea generation is continuous, systematic search for new product opportunities. It involves delineating sources of new ideas and methods for generating them. • Ideas for new products can be obtained from basic research using a SWOT analysis (OPPORTUNITY ANALYSIS), Market and consumer trends, company's R&D department, competitors, focus groups, employees, salespeople, corporate spies. • Stage 1: Idea Generation – Internal idea sources: • R & D – External idea sources: • Customers, competitors, distributors, suppliers 31Muhammad Ali
  32. 32. Phr_ali91@hotmail.com Idea Screening – The object is to eliminate unsound concepts prior to devoting resources to them. – The screeners must ask these questions: • Will the customer in the target market benefit from the product? • What is the size and growth forecasts of the market segment/target market? • What is the current or expected competitive pressure for the product idea? • What are the industry sales and market trends the product idea is based on? • Is it technically feasible to manufacture the product? • Will the product be profitable when manufactured and delivered to the customer at the target price? • Stage 2: Idea Screening – Product development costs increase substantially in later stages so poor ideas must be dropped – Ideas are evaluated against criteria; most are eliminated 32Muhammad Ali
  33. 33. Phr_ali91@hotmail.com Concept testing • Concept testing present the consumer with a proposed product and measure attitudes and intention at this early stage of development. • Concept testing of prototypes can help avoid costly mistakes. • Stage 3: Concept Development and Testing – Concept development creates a detailed version of the idea stated in meaningful consumer terms. – Concept testing asks target consumers to evaluate product concepts. 33Muhammad Ali
  34. 34. Phr_ali91@hotmail.com Market Strategy Development • Includes development of three part strategy plan • Stage 4: Marketing Strategy Development • The target market’s size, structure, behavior, product positioning, and sales, share, and profit goals for the first few years. • Product price, distribution, and marketing budget for the first year. • Long-run sales and profit goals and the marketing mix strategy. 34Muhammad Ali
  35. 35. Phr_ali91@hotmail.com Business & financial Analysis • Estimate likely selling price based upon competition and customer feedback • Estimate sales volume based upon size of market • Estimate profitability and breakeven point • Stage 5: Business Analysis – Sales, cost, and profit projections • Stage 6: Product Development – Prototype development and testing 35Muhammad Ali
  36. 36. Phr_ali91@hotmail.com Commercialization Stage 7: Commercialization Commercialization involves implementing a total marketing plan and full production – Launch the product – Produce and place advertisements and other promotions – Fill the distribution pipeline with product – Critical path analysis is most useful at this stage 36Muhammad Ali
  37. 37. Phr_ali91@hotmail.com BD (Process Flow - NPD) Exploration of New Product from Local or International market through Market Intelligence sources based on R&D Breakthrough, Platform & derivative projects product mix After getting the feasibility approvals from GPAPE working, Filling of Product Identification form except marketing part. BD will Forward the filled forms file to Marketing for business analysis & their ownership with specific time frame to return the filled & signed forms The marketing part comprises of market analysis, sales forecast, projected volume, Proposed price (MRP, TP, DP), Market share, Growth and analysis of Local & International market. BD summarizes the forms and submit for Director approval. BD Integrate the HOC & HOM approved products in the Company product pipeline by submitting all the approved dossier request forms with related docs. to Outsourced consultant or R&D and initiate them for registration process. Listing of major new found products Circulation of list to: • Marketing for Commercial feasibility • Sourcing of API • R&D for Production feasibility • Medical for therapeutic fit • COGS for Financial feasibility After Approval, BD prepares Dossier request forms with Market survey, Leaf insert, Artwork, 3 years forecast and Medical justification. Marketing ownership required Director approval required YES NOdropped NO YES dropped 37Muhammad Ali
  38. 38. Phr_ali91@hotmail.com BD (Process Flow) ….cont.d Follow-up of submitted files for registration from MOH fulfills the queries if any raised by MOH. (Brand name, SKUs, Pricing, technical with support of Regulatory & R&D & any other) After registration, list down the whole new products ready to be launch & circulate for Marketing choice for next 2 quarters with tentative launching date, forecast & approvals of Marketing & Director After getting ownership & tentative launching dates from Marketing, discuss & finalize the production, product to be FG dates, quantities, forecasts with R&D. Follow-up and coordinate with • Creative for artwork • R&D, Planning (Production & QA) for updated status • Import & MM for Raw Material & Packaging Material to be available on time. Product transfer to FG LAUNCH Marketing & Director approval required YES NODropped Cont,d from previous 38Muhammad Ali
  39. 39. Phr_ali91@hotmail.com Challenges in New Product Development Muhammad Ali 39
  40. 40. Phr_ali91@hotmail.com Challenges • New products can be obtained via acquisition or development. • New products suffer from high failure rates. • Several reasons account for failure. 40Muhammad Ali
  41. 41. Phr_ali91@hotmail.com Challenges • Shortage of ideas • Ways to improve products • Fragmented markets • Keen competition • New products in smaller segments • Lower sales & profits • Social & governmental constraints • Consumer safety & environmental concerns • Slow down in innovation of drugs 41Muhammad Ali
  42. 42. Phr_ali91@hotmail.com Challenges • Cost of development process • Ideas to find just one worthy of development • High R&D, manufacture & marketing cost • Capital shortage • Good ideas • Funds needed to research & launch • Short product life cycles • Rivals are quick to copy • Recoup the investments 42Muhammad Ali
  43. 43. Phr_ali91@hotmail.com Challenges • Development time • Compress development time by – Computer aided design – Manufacturing techniques – Strategic partners – Early concept test – Advanced marketing planning – New product development is most effective when there is teamwork among R&D, engineering, manufacturing, purchasing, marketing & finance. The products idea must be researched from a marketing point of view, and a specific cross-functional team must guide the project throughout its development. 43Muhammad Ali
  44. 44. Phr_ali91@hotmail.com SUMMARY Muhammad Ali 44
  45. 45. Phr_ali91@hotmail.com Description of Activities: Idea Generation •Request •Customer Need •Market Studies •Legislation •Competitors Key Deliverables: Product Concept Doc Description of Activities: Assess Market •Segment And Size •Growth Potentials •Customer Need •Legal Issues •Competition Key Deliverables: Market Research Report Market Req Document Product Definition Statement Description of Activities: Product Development •Technical Specs •Prototyping •Trail Production •Testing &QA Key Deliverables: Product Dev. Schedule Product Testing Report Description of Activities: Business Analysis •Cost /Benefit •Resources Required •Capital •Profitability/Margin •Anticipated Sales Key Deliverables: Business Case Profitability Analysis Product Req Doc Description of Activities: Go to Market •Marketing plan •Sales Training •Distribution plan •Collateral Design •Set launch date Key Deliverables: Product Launch Plan Product launch Budget Product ROI forecast Target Launch date set Check point # 1 Check point # 2 Check point # 3 Check point # 4 Check point # 5 Description of Activities: •Review Deliverables Decision: •Go/No Go to Research •Incubate idea or Kill Description of Activities: •Review Deliverables Decision: •Go/No Go to Analysis •Incubate idea or Kill Description of Activities: •Review Deliverables Decision: •Go/No Go to Develop •Incubate idea or Kill Description of Activities: •Review Deliverables Decision: •Go/No Go to Launch Description of Activities: •Review Deliverables Decision: •Go/No Go to Market Concept Research Analysis Develop Launch 45Muhammad Ali
  46. 46. Phr_ali91@hotmail.com Summary • New product development drives growth. • Market research is critical to the success of a new product launch. • Market research is a continuous process as customer needs, your business and the environment changes. 46Muhammad Ali
  47. 47. Phr_ali91@hotmail.com Summary • In general, seven stages are involved in new-product development process; idea generation, screening, concept development & testing, marketing strategy development, business analysis, product development, and commercialization. The purpose of each stage is to determine whether the idea should be dropped or moved to the next stage. • Consumer-adoption process is influenced by many factors beyond the marketers’ control, including the customers’ & organizations’ willingness to try new products, personal influences, and the characteristics of new product or innovation. 47Muhammad Ali
  48. 48. Phr_ali91@hotmail.com “Don’t find customers for your products, find the products for your customers” 48Muhammad Ali

×