Presentation on theme: "Key Questions WHO WHAT WHERE WHEN WHY HOW Pfizer Inc"— Presentation transcript:
0 Optimizing Pfizer Inc’s New Product Development Process 4/4/00Optimizing Pfizer Inc’s New Product Development ProcessTransforming Molecules to MedicinesAMX : Mastering New Product & Service DevelopmentSunday, November 19, 2006
1 Key Questions WHO WHAT WHERE WHEN WHY HOW Pfizer Inc 4/4/00WHOPfizer IncWHATIn Dire Need of a New Product Development ProcessWHEREThroughout the Entire OrganizationWHENWithin the Next 5 YearsWHYIndustry Challenges / Pipeline Concerns: PFE is struggling to maintain its growth in the face of increased competition and the expiration of key patents.HOWBy Leveraging Internal Insights & Implementing a New Product Development Process Incorporating the Stage-Gate™ Process
2 An Introduction to Pfizer 4/4/00OUR MISSIONWe will become the world's most valued company to patients, customers, colleagues, investors, business partners, and the communities where we work and live.OUR PURPOSEWe dedicate ourselves to humanity's quest for longer, healthier, happier lives through innovation in pharmaceutical, consumer, and animal health products.
3 Pfizer Research and Development: Commitment 4/4/00DID YOU KNOW ?Pfizer invests more in pharmaceutical research than any other private institution in the world. 1This 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.
4 Pfizer Research and Development: Key Points 4/4/00The 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. 2,3Years to create a new drug: yearsProbability of Success: <1%Costs to create a new drug: Between $800 million and $1.7 billion2 PhRMA. Press Release. Feb. 18, Available at: Accessed on Oct. 26, 2005.3 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.
5 Pfizer Research and Development: Risky Business 4/4/00Only 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.
6 Seven Goals of a New Product Process 4/4/00Goal #1: Quality of ExecutionGoal #2: Sharper Focus, Better PrioritizationGoal #3: Fast-Paced Parallel ProcessingGoal #4: A True Cross-Functional Team ApproachGoal #5: A Strong Market Orientation with the Voice of the Customer Built InGoal #6: Better Homework Up-FrontGoal #7: Products with Competitive AdvantageSource: Winning at New Products by Robert G. Cooper, p.115
7 Project enters the NP Process at Gates 1, 2, or 3 With Such High Risks and the Vital Importance of New Medicines - New Product Development Systems Must Be Optimized4/4/00Robert G. Cooper’s Two-Stage ModelResearch and Technical DevelopmentGate 1: Idea ScreenStage 1: Technical AssessmentGate 2: Second ScreenStage 2: Detailed InvestigationGate 3: Application Path GateNew Product DevelopmentGate 1: Idea ScreenStage 1: ScopingGate 2: Second ScreenStage 2: Building Business CaseGate 3: Go to DevelopmentStage 3: DevelopmentGate 4: Go to TestingStage 4: Testing and ValidationGate 5: Go to LaunchStage 5: LaunchPost-Launch ReviewProject enters the NP Process at Gates 1, 2, or 3
8 Robert G. Cooper’s Two-Stage Model 4/4/00Research and Technical DevelopmentGATE 1GATE 2GATE 3STAGE 1STAGE 2TechnicalAssessmentDetailedInvestigationApplication Path GateGATE 1Project enters the NP Process at Gates 1, 2, or 3New Product DevelopmentGATE 2GATE 3GATE 4GATE 5STAGE 1STAGE 2STAGE 3STAGE 4ScopingBuildBusiness CaseTesting &ValidationDevelopmentSTAGE 5Review probable executionRevised financialsQuality = original def.Work reviewedGo to testDecision to spend Confirm casePOSTLAUNCHREVIEWLegalTechnicalSales InvolvedMarketing InvolvedPayback periodLAUNCHReview costsReview profitsReview strengthsReview weaknessesReview what learned
9 Transforming Molecules to Medicine 4/4/00Finding the Right Lead MoleculePreclinicalCH3C1R1-10CH3C1R4++Establishing the Safety of a New Molecule for Human TestingFileINDDiscoveryResearch TeamManyCompoundsIn vitro & in vivoScreeningDrug CandidateSelectionScale Up &Animal ToxTesting the Experimental Drug in PeopleClinicalEstablishing the Safety and Efficacy of a New Medicine for Patientsn =n =n = ,000Phase IPhase IIPhase IIIFrom Laboratory to the DoctorRegulatory ReviewPhase IVFileNDARegulatory Review & CommercializationRegulatoryApproval & LaunchResearch and Technical Development New Product Development
10 Transforming Molecules to Medicine 4/4/00Average YearsCompound Success246810121416Rates by StageDiscovery5,000 – 10,000ScreenedPreclinicalPhase IPhase II250Enter PreclinicalPhase IIIRegistrationPostmarketing5EnterClinical1 Approved MedicineResearch and Technical Development New Product Development
11 Reasons Why Medicine Candidates Fail 4/4/00It takes 12 CANs to yield 1 marketed drug on average24681012animal toxicity, PKchemical stability,superior compoundhuman PK,safety/toleration,formulationNo. candidatesefficacy/safety,differentiation,dose/cost of goodsefficacy, long-term safetynon-approval123456789YearsPreclin. Phase I Phase II Phase III RegistrationResearch and Technical Development New Product Development
12 The Drug Discovery and Development Process 4/4/00RegistrationFullDevelopmentExploratory DevelopmentDiscoveryResearch and Technical Development New Product Development
13 Drug Discovery: The Overarching Questions 4/4/00Voice ofCustomerResearchIs 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?Building Business CaseTechnical AssessmentDetailed InvestigationResearch and Technical Development New Product Development
14 Where Do Potential Leads Come From? 4/4/00IdeationAcquisition CompoundsNatural SourcesGlaxoWellcomeAstraZenecaMerckEndogenous LigandNewly SynthesizedLEADe.g. Natural peptide, hormone, etc.Random Screeningof Existing CompoundsCombinatorial ChemistryLibrariesResearch and Technical Development
15 Discovery (3–4 Years) Ideation, Gate 1, Stage 1 Gate 2 Go / Kill 4/4/00Ideation, Gate 1, Stage 1Gate 2NoBasicScienceGo / KillMedicalLiterature+Activity+YesDisease Intervention HypothesisTargetCharacterizationSynthesis of MoleculesScreeningMedicalNeedRefinementVoice ofCustomerResearchImprovedActivityNomination of Lead Molecule for Additional InvestmentInitial Safety Testing of Lead MoleculeDetailed Investigation:Stage 2Research and Technical Development
16 Discovery (3–4 Years)4/4/00Ideation, Gate 1, Stage 1, and Gate 2Identify and Refine a Portfolio of Promising Molecules (“Candidates”)+1Thousands of Potential Disease Targets to Consider3Synthesis and Testing of Molecules to Bind to TargetDisease Intervention HypothesisSynthesis of MoleculesIdeationGate 124Define Target and Structure at Molecular LevelTesting Against Target for Biological Effect+Gate 2TargetCharacterizationTechnical Assessment: Stage 1ScreeningGo / KillResearch and Technical Development
17 Early Development (3–5 Years) 4/4/00Technical Assessment:Ideation, Gate 1, Stage 1, Gate 2Detailed Investigation: Stage 2Safety DataINDApplicationLead Molecule Endorsed for Additional InvestmentManufacture SuppliesRequired Animal TestingMetabolism DataFormulate Doses for HumansApplication Path GateIs it safe?Is it safe?Is it safe?YES!(Proof ofConcept)Phase I:Human Testing in Healthy VolunteersPhase II:Human Testing in PatientsPhase II:Human Testing in PatientsBuildingBusinessCase:Stage 2How does it behave in the body?Does the drug provide benefit?What is the optimal dose?Research and Technical Development New Product Development
18 Early Development (3–5 Years) 4/4/00Detailed Investigation: Stage 2Test Safety and Efficacy of “Candidates” Under Controlled Conditions1Preclinical Research Requires Testing Candidates in Animals3Dose Healthy Volunteers (Absorption, Distribution, Metabolization, and Elimination)Required Animal TestingPhase IGate 22Determine Dosage Based on Safety and Metabolism Data4Dose Patients (Efficacy)Formulate Doses for HumansPhase IIGo / KillResearch and Technical Development
19 Disciplines Involved in Drug Development Research 4/4/00Product DevelopmentPharmacologySafetyClinical SciencesClinical DevelopmentDevelopment OperationsBiostatisticsMedicalClinical Pharmacy OperationsLibrary SciencesChemical ManufacturingRegulatory AffairsProject ManagementMarketingBiomarkersInformaticsEtc …
20 Full Development (3–5 Years) 4/4/00Testing & Validation:Stage 4Full Team InvolvementDesign Phase IIIStudiesCarcino- genicityStudiesDetailed Investigation:Stage 2Development:Stage 3ConsultFDAFull Development PlanningFileNDAFormulate,Label, & ShipRecruit 1000s of PatientsConduct Phase III TestingCollect, Verify, & Analyze DataGate 5ManufactureDrug SupplyBuilding Business Case:Stage 2StabilityStudiesRecruitInvestigatorsResearch and Technical Development New Product Development
21 Full Development (3–5 Years) 4/4/00Demonstrate Efficacy and Safety of a Candidate in Patients11Plan Phase III Studies, Supply, as well as Investigator Recruitment and Education33Ensure Benefit of Candidate is Clearly Demonstrated in Patient PopulationFull Development PlanningCollect, Verify, & Analyze DataPlan Full Development ProgramTesting & Validation:Stage 4Gate 222Extensive Safety and Efficacy Testing with Patients under Real World Conditions44Documented Evidence Concerning the Safety and Efficacy of the new MoleculeFileNDAPhase IIIFile New Drug ApplicationGate 4Gate 5Research and Technical Development New Product Development
22 Registration (1–2 Years) 4/4/00Gate 5Other RegulatoryFilingsApproved New MedicineFileNDARespond to QuestionsPresent to Advisory CommitteesRegulatoryApprovalsLabel NegotiationsPOSTLAUNCHREVIEWLaunch: Stage 5Review costsReview profitsReview strengthsReview weaknessesReview what learnedNew Product Development
23 Molecules to Medicine: Room for Improvement 4/4/00NDA/ MAA ApprovalPOC/ R2D2-1NDA/ IRD FilingKey Commercial Decision Points:IdeaCANDIC-IIR2D2-2Stage:DiscoveryPre-ClinicalEarly ClinicalClinicalLateClinicalPost LaunchType of Testing:LaboratoryAnimalsPhaseI IIA IIBPhase IIIPhase IIIBPhase IVAccelerate candidate identification and screeningAccelerate development timeImprove labels and market accessLeverage depth of knowledge from exploratory through loss of exclusivityEnsure global knowledge sharing and collaborationLeverage Internal Resources and Stage-Gate™ Process toIncrease R&D Productivity and Maximize Commercial Success
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