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Optimizing Pfizer Inc’s New Product Development Process Transforming Molecules to Medicines AM X50.9252: Mastering New Product & Service Development Sunday,

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Presentation on theme: "Optimizing Pfizer Inc’s New Product Development Process Transforming Molecules to Medicines AM X50.9252: Mastering New Product & Service Development Sunday,"— Presentation transcript:

1 Optimizing Pfizer Inc’s New Product Development Process Transforming Molecules to Medicines AM X : Mastering New Product & Service Development Sunday, November 19, 2006

2 1 Key Questions WHO Pfizer Inc WHAT In Dire Need of a New Product Development Process WHERE Throughout the Entire Organization WHEN Within the Next 5 Years WHY Industry Challenges / Pipeline Concerns: PFE is struggling to maintain its growth in the face of increased competition and the expiration of key patents. HOW By Leveraging Internal Insights & Implementing a New Product Development Process Incorporating the Stage-Gate™ Process

3 2 An Introduction to Pfizer OUR MISSION We will become the world's most valued company to patients, customers, colleagues, investors, business partners, and the communities where we work and live. OUR PURPOSE We dedicate ourselves to humanity's quest for longer, healthier, happier lives through innovation in pharmaceutical, consumer, and animal health products.

4 3 Pfizer Research and Development: Commitment DID YOU KNOW ? Pfizer invests more in pharmaceutical research than any other private institution in the world. 1 This research is aimed at a single goal: to develop new medicines that will enable people to lead healthier, longer and more productive lives. 1 The Department of Trade and Industry (U.K.) The 2005 R&D Scoreboard. Page 96. Available at: Accessed on Oct. 26, 2005.http://www.innovation.gov.uk/rd_scoreboard/

5 4 Pfizer Research and Development: Key Points  The discovery of new drugs and their development into useful pharmaceuticals is central to the concept of medical progress.  The U.S. pharmaceutical and biotech industries invested nearly $39 billion in research and development in 2004, with Pfizer leading the way with $7.7 billion and 12,500 scientists. 2,3 2 PhRMA. Press Release. Feb. 18, Available at: Accessed on Oct. 26, 2005.http://www.phrma.org/mediaroom/press/releases/ cfm 3 Pfizer 2004 Annual Report. Available at: /pfizer/annualreport/2004/financial/p2004fin08.jsp. Accessed on Oct. 26, Also see Pfizer.com Research and Development website, available at: /pfizer/help/index.jsp./pfizer/annualreport/2004/financial/p2004fin08.jsp/pfizer/help/index.jsp  Years to create a new drug: years  Probability of Success: <1%  Costs to create a new drug: Between $800 million and $1.7 billion

6 5 Pfizer Research and Development: Risky Business  Only one in five medicines that enter clinical trials testing in humans is eventually approved for patient use by the U.S Food and Drug Administration (FDA). 6 That's part of the risk involved in Pfizer's business of seeking out new and innovative health solutions. 6 Stanford Medical School's Academic Consortium for Clinical Excellence in Scientific Studies. Clinical Trials FAQ. Available at: Accessed on Oct. 26, 2005.http://clinicaltrials.stanford.edu/patients/ctfaq.html

7 6 Seven Goals of a New Product Process  Goal #1: Quality of Execution  Goal #2: Sharper Focus, Better Prioritization  Goal #3: Fast-Paced Parallel Processing  Goal #4: A True Cross-Functional Team Approach  Goal #5: A Strong Market Orientation with the Voice of the Customer Built In  Goal #6: Better Homework Up-Front  Goal #7: Products with Competitive Advantage Source: Winning at New Products by Robert G. Cooper, p.115

8 7 With Such High Risks and the Vital Importance of New Medicines - New Product Development Systems Must Be Optimized Research and Technical Development  Gate 1: Idea Screen  Stage 1: Technical Assessment  Gate 2: Second Screen  Stage 2: Detailed Investigation  Gate 3: Application Path Gate New Product Development  Gate 1: Idea Screen  Stage 1: Scoping  Gate 2: Second Screen  Stage 2: Building Business Case  Gate 3: Go to Development  Stage 3: Development  Gate 4: Go to Testing  Stage 4: Testing and Validation  Gate 5: Go to Launch  Stage 5: Launch  Post-Launch Review Robert G. Cooper’s Two-Stage Model Project enters the NP Process at Gates 1, 2, or 3

9 8 Robert G. Cooper’s Two-Stage Model STAGE 1 STAGE 2 STAGE 3 STAGE 5 STAGE 4 GATE 3 GATE 4 GATE 2 GATE 5 LAUNCH Scoping Build Business Case Development Testing & Validation Decision to spend Confirm case Review probable execution Revised financials Quality = original def. Work reviewed Go to test Review costs Review profits Review strengths Review weaknesses Review what learned STAGE 1 GATE 2 STAGE 2 GATE 3 GATE 1 Technical Assessment Detailed Investigation Research and Technical Development GATE 1 Legal Technical Sales Involved Marketing Involved Payback period POSTLAUNCHREVIEW New Product Development Project enters the NP Process at Gates 1, 2, or 3 Application Path Gate

10 9 Transforming Molecules to Medicine Phase IPhase II Phase III n = n = n = ,000 ClinicalClinical CH 3 C 1 R 1-10 CH 3 C 1 R 4 Discovery Research Team Many Compounds In vitro & in vivo Screening Drug Candidate Selection Scale Up & Animal Tox File IND PreclinicalPreclinical + + Regulatory Review Phase IV File NDA Regulatory Review & Commercialization Regulatory Approval & Launch Regulatory Approval & Launch Testing the Experimental Drug in People Finding the Right Lead Molecule From Laboratory to the Doctor Establishing the Safety and Efficacy of a New Medicine for Patients Establishing the Safety of a New Molecule for Human Testing Research and Technical Development  New Product Development

11 10 Transforming Molecules to Medicine Discovery Average Years Phase I Phase III Postmarketing Phase II Preclinical Registration Compound Success Rates by Stage 5,000 – 10,000 Screened 5,000 – 10,000 Screened 250 Enter Preclinical 250 Enter Preclinical 5 Enter Clinical 5 Enter Clinical 1 Approved Medicine Research and Technical Development  New Product Development

12 11 Reasons Why Medicine Candidates Fail No. candidates Years Preclin. Phase I Phase II Phase III Registration animal toxicity, PK chemical stability, superior compound animal toxicity, PK chemical stability, superior compound efficacy/safety,differentiation, dose/cost of goods efficacy/safety,differentiation, human PK, safety/toleration,formulation safety/toleration,formulation efficacy, long-term safety non-approvalnon-approval It takes 12 CANs to yield 1 marketed drug on average Research and Technical Development  New Product Development

13 12 The Drug Discovery and Development Process Discovery Exploratory Development FullDevelopment Registration Research and Technical Development  New Product Development

14 13 Drug Discovery: The Overarching Questions  Is there a medical need?  What is prevalence of the disease?  What is the market potential?  Do we have a biochemical target?  Can we synthesis compounds that are target selective, potent in vivo, and bioavailable?  Are the compounds efficacious in disease models, show dose response, and are not toxic? Voice of CustomerResearch Building Business Case Technical Assessment Detailed Investigation Research and Technical Development  New Product Development

15 14 Where Do Potential Leads Come From? LEAD Acquisition Compounds Natural Sources Endogenous Ligand Newly Synthesized Random Screening of Existing Compounds Random Screening of Existing Compounds GlaxoWellcomeAstraZenecaMerck e.g. Natural peptide, hormone, etc. Combinatorial Chemistry Libraries Libraries Research and Technical Development Ideation

16 15 Discovery (3–4 Years) Basic Science Basic Science Medical Literature Medical Literature Medical Need Medical Need Disease Intervention Hypothesis TargetCharacterization Synthesis of Molecules Screening Activity Improved Activity Improved Activity Refinement Initial Safety Testing of Lead Molecule Nomination of Lead Molecule for Additional Investment No Yes + + Research and Technical Development Ideation, Gate 1, Stage 1 Go / Kill Voice of CustomerResearch Gate 2 Detailed Investigation: Stage 2

17 16 Discovery (3–4 Years) Disease Intervention Hypothesis Target Characterization Synthesis of Molecules Screening + Thousands of Potential Disease Targets to Consider Define Target and Structure at Molecular Level Synthesis and Testing of Molecules to Bind to Target Testing Against Target for Biological Effect Identify and Refine a Portfolio of Promising Molecules (“Candidates”) Ideation, Gate 1, Stage 1, and Gate 2 Go / Kill Research and Technical Development Ideation Gate 1 Technical Assessment: Stage 1 Gate 2

18 17 Early Development (3–5 Years) Lead Molecule Endorsed for Additional Investment Manufacture Supplies Required Animal Testing Formulate Doses for Humans IND Application IND Application YES! (Proof of Concept) YES! (Proof of Concept) Metabolism Data Phase I: Human Testing in Healthy Volunteers Phase II: Human Testing in Patients Phase II: Human Testing in Patients Is it safe? How does it behave in the body? Is it safe? Does the drug provide benefit? Is it safe? What is the optimal dose? Safety Data Research and Technical Development  New Product Development Technical Assessment: Ideation, Gate 1, Stage 1, Gate 2 Detailed Investigation: Stage 2 Application Path Gate BuildingBusinessCase: Stage 2

19 18 Early Development (3–5 Years) Required Animal Testing Formulate Doses for Humans Phase I Phase II Preclinical Research Requires Testing Candidates in Animals Determine Dosage Based on Safety and Metabolism Data Dose Healthy Volunteers (Absorption, Distribution, Metabolization, and Elimination) Dose Patients (Efficacy) Test Safety and Efficacy of “Candidates” Under Controlled Conditions Research and Technical Development Detailed Investigation: Stage 2 Go / Kill Gate 2

20 19 Disciplines Involved in Drug Development Research  Product Development  Pharmacology  Safety  Clinical Sciences  Clinical Development  Development Operations  Biostatistics  Medical  Clinical Pharmacy Operations  Library Sciences  Chemical Manufacturing  Regulatory Affairs  Project Management  Marketing  Biomarkers  Informatics  Etc …

21 20 Full Development (3–5 Years) Collect, Verify, & Analyze Data Recruit 1000s of Patients File NDA File NDA Conduct Phase III Testing Recruit Investigators Recruit Investigators Manufacture Drug Supply Manufacture Drug Supply Formulate, Label, & Ship Formulate, Label, & Ship Design Phase III Studies Design Phase III Studies Consult FDA Consult FDA Stability Studies Stability Studies Carcino- genicity Studies Carcino- genicity Studies Full Development Planning Building Business Case: Stage 2 Research and Technical Development  New Product Development Detailed Investigation: Stage 2 Development: Stage 3 Testing & Validation: Stage 4 Gate 5 Full Team Involvement

22 21 Full Development (3–5 Years) Plan Full Development Program Phase III Collect, Verify, & Analyze Data File New Drug Application Plan Phase III Studies, Supply, as well as Investigator Recruitment and Education Extensive Safety and Efficacy Testing with Patients under Real World Conditions Ensure Benefit of Candidate is Clearly Demonstrated in Patient Population Documente d Evidence Concerning the Safety and Efficacy of the new Molecule Full Development Planning File NDA File NDA Demonstrate Efficacy and Safety of a Candidate in Patients Research and Technical Development  New Product Development Gate 5 Gate 4 Gate 2 Testing & Validation: Stage 4

23 22 Registration (1–2 Years) Respond to Questions Approved New Medicine Present to Advisory Committees Other Regulatory Filings Other Regulatory Filings File NDA File NDA RegulatoryApprovals Label Negotiations New Product Development Launch: Stage 5 Gate 5 POSTLAUNCHREVIEW Review costs Review profits Review strengths Review weaknesses Review what learned

24 23 Leverage Internal Resources and Stage-Gate™ Process to Increase R&D Productivity and Maximize Commercial Success Leverage Internal Resources and Stage-Gate™ Process to Increase R&D Productivity and Maximize Commercial Success Molecules to Medicine: Room for Improvement CAN NDA/ MAA Approval Key Commercial Decision Points: Stage:Stage: Type of Testing: NDA/ IRD Filing Laboratory Animals Phase I IIA IIB I IIA IIB Phase III Phase III Phase IIIB Phase IIIB Phase IV Phase IV POC/ R2D2-1 R2D2-2DIC-II Post Launch Post Launch Late Clinical Early Clinical Early Clinical Pre- Clinical Discovery Idea  Accelerate candidate identification and screening  Accelerate development time  Improve labels and market access  Leverage depth of knowledge from exploratory through loss of exclusivity  Ensure global knowledge sharing and collaboration


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