Optimizing Pfizer Inc’s New Product Development Process Transforming Molecules to Medicines AM...

Optimizing Pfizer Inc’s Optimizing Pfizer Inc’s New Product Development ProcessNew Product Development Process

Transforming Molecules to Transforming Molecules to MedicinesMedicines

AMAMX50.9252: Mastering New Product & Service X50.9252: Mastering New Product & Service DevelopmentDevelopmentSunday, November 19, 2006Sunday, November 19, 2006

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Key QuestionsKey Questions

WHOWHO Pfizer IncPfizer Inc

WHATWHAT In Dire Need of a New Product Development ProcessIn Dire Need of a New Product Development Process

WHEREWHERE Throughout the Entire Organization Throughout the Entire Organization

WHENWHEN Within the Next 5 YearsWithin the Next 5 Years

WHYWHYIndustry Challenges / Pipeline Concerns: PFE is struggling Industry Challenges / Pipeline Concerns: PFE is struggling to maintain its growth in the face of increased to maintain its growth in the face of increased competition and the expiration of key patents. competition and the expiration of key patents.

HOWHOWBy Leveraging Internal Insights & Implementing a New By Leveraging Internal Insights & Implementing a New Product Development Process Incorporating the Product Development Process Incorporating the Stage-Stage-Gate™Gate™ Process Process

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An Introduction to PfizerAn Introduction to Pfizer

OUR OUR MISSIONMISSION

We will become the world's most valued company to We will become the world's most valued company to patients, customers, colleagues, investors, business patients, customers, colleagues, investors, business partners, and the communities where we work and live.partners, and the communities where we work and live.

OUR OUR PURPOSPURPOS

EE

We dedicate ourselves to humanity's quest for longer, We dedicate ourselves to humanity's quest for longer, healthier, happier lives through innovation in healthier, happier lives through innovation in pharmaceutical, consumer, and animal health products.pharmaceutical, consumer, and animal health products.

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Pfizer Research and Development: CommitmentPfizer Research and Development: Commitment

DID YOU KNOW ?DID YOU KNOW ?

Pfizer invests more in Pfizer invests more in pharmaceutical research than any pharmaceutical research than any

other private institution in the other private institution in the world. world. 1 1

This research is aimed at a single This research is aimed at a single goal: to develop new medicines that goal: to develop new medicines that will enable people to lead healthier, will enable people to lead healthier, longer and more productive lives.longer and more productive lives.

1 The Department of Trade and Industry (U.K.) The 2005 R&D Scoreboard. Page 96. Available at: http://www.innovation.gov.uk/rd_scoreboard/. Accessed on Oct. 26, 2005.

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Pfizer Research and Development: Key PointsPfizer Research and Development: Key Points

The discovery of new drugs The discovery of new drugs and their development into and their development into useful pharmaceuticals is useful pharmaceuticals is central to the concept of central to the concept of medical progress. medical progress.

The U.S. pharmaceutical and The U.S. pharmaceutical and biotech industries invested biotech industries invested nearly $39 billion in nearly $39 billion in research and developmentresearch and development in in 2004, with 2004, with Pfizer leading the Pfizer leading the way with $7.7 billion and way with $7.7 billion and 12,500 scientists12,500 scientists. . 2,32,3

2 PhRMA. Press Release. Feb. 18, 2005. Available at: http://www.phrma.org/mediaroom/press/releases/18.02.2005.1128.cfm. Accessed on Oct. 26, 2005.3 Pfizer 2004 Annual Report. Available at: /pfizer/annualreport/2004/financial/p2004fin08.jsp. Accessed on Oct. 26, 2005. Also see Pfizer.com Research and Development website, available at: /pfizer/help/index.jsp.

Years to create aYears to create anew drug: new drug: 12-15 years 12-15 years

Probability of Success: Probability of Success: <1% <1%

Costs to create aCosts to create anew drug: new drug: Between $800 Between $800 million and $1.7 billionmillion and $1.7 billion

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Pfizer Research and Development: Risky Pfizer Research and Development: Risky BusinessBusiness Only Only one in fiveone in five medicines that enter clinical trials testing in humans medicines that enter clinical trials testing in humans

is is eventually approvedeventually approved for patient use by the U.S Food and Drug for patient use by the U.S Food and Drug Administration (FDA). Administration (FDA). 6 6 That's part of the risk involved in Pfizer's That's part of the risk involved in Pfizer's business of seeking out new and innovative health solutions. 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: http://clinicaltrials.stanford.edu/patients/ctfaq.html. Accessed on Oct. 26, 2005.

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Seven Goals of a New Product ProcessSeven Goals of a New Product Process

Goal #1: Quality of ExecutionGoal #1: Quality of Execution

Goal #2: Sharper Focus, Better PrioritizationGoal #2: Sharper Focus, Better Prioritization

Goal #3: Fast-Paced Parallel ProcessingGoal #3: Fast-Paced Parallel Processing

Goal #4: A True Cross-Functional Team ApproachGoal #4: A True Cross-Functional Team Approach

Goal #5: A Strong Market Orientation with the Voice of the Goal #5: A Strong Market Orientation with the Voice of the Customer Built InCustomer Built In

Goal #6: Better Homework Up-FrontGoal #6: Better Homework Up-Front

Goal #7: Products with Competitive AdvantageGoal #7: Products with Competitive Advantage

Source: Winning at New Products by Robert G. Cooper, p.115

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With Such High Risks and the Vital Importance of New With Such High Risks and the Vital Importance of New Medicines - New Product Development Systems Must Be Medicines - New Product Development Systems Must Be OptimizedOptimized

Research and Technical Research and Technical DevelopmentDevelopment Gate 1: Idea ScreenGate 1: Idea Screen Stage 1: Technical Stage 1: Technical

AssessmentAssessment Gate 2: Second ScreenGate 2: Second Screen Stage 2: Detailed Stage 2: Detailed

InvestigationInvestigation Gate 3: Application Path Gate 3: Application Path

GateGate

New Product DevelopmentNew Product Development Gate 1: Idea ScreenGate 1: Idea Screen Stage 1: ScopingStage 1: Scoping

Gate 2: Second ScreenGate 2: Second Screen Stage 2: Building Business Stage 2: Building Business

CaseCase Gate 3: Go to DevelopmentGate 3: Go to Development Stage 3: DevelopmentStage 3: Development Gate 4: Go to TestingGate 4: Go to Testing Stage 4: Testing and ValidationStage 4: Testing and Validation Gate 5: Go to LaunchGate 5: Go to Launch Stage 5: LaunchStage 5: Launch Post-Launch ReviewPost-Launch Review

Robert G. Cooper’s Robert G. Cooper’s Two-Stage ModelTwo-Stage Model

Project enters the NP Process at Gates 1, 2, or 3

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Robert G. Cooper’s Robert G. Cooper’s Two-Stage ModelTwo-Stage Model

STAGE 1STAGE 1

STAGE 2STAGE 2

STAGE 3STAGE 3

STAGE 5STAGE 5

STAGE 4STAGE 4GATE 3GATE 3 GATE 4GATE 4GATE 2GATE 2 GATE 5GATE 5

LAUNCHLAUNCH

Scoping Build Business Case Development Testing &

Validation

Decision to spendConfirm case

Review probable execution

Revised financialsQuality = original def.

Work reviewedGo to test

Review costsReview profits

Review strengthsReview weaknessesReview what learned

STAGE 1STAGE 1 GATE 2GATE 2

STAGE 2STAGE 2

GATE 3GATE 3GATE 1GATE 1

TechnicalAssessment

DetailedInvestigation

Research and Technical DevelopmentResearch and Technical Development

GATE 1GATE 1

Legal Technical

Sales InvolvedMarketing Involved

Payback period POST POST LAUNCHLAUNCHREVIEWREVIEW

New Product DevelopmentNew Product Development

Project enters the NP Process at Gates 1, 2, or 3

Application Path Gate

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Transforming Molecules to MedicineTransforming Molecules to Medicine

Phase I Phase II Phase IIIn = 10 - 30 n = 20 - 200 n = 500 - 10,000

ClinicalClinicalClinicalClinical

CH3

C1

R1-10

CH3

C1

R4

DiscoveryResearch Team

Many Compounds

In vitro & in vivo Screening

Drug Candidate Selection

Scale Up & Animal Tox

File IND

PreclinicalPreclinicalPreclinicalPreclinical

++

Regulatory ReviewPhase IV

File NDA

Regulatory Review & CommercializationRegulatory Review & CommercializationRegulatory Review & CommercializationRegulatory Review & Commercialization

RegulatoryApproval & Launch

RegulatoryApproval & Launch

Testing the Experimental Drug in Testing the Experimental Drug in PeoplePeople

Finding the Right Lead MoleculeFinding the Right Lead Molecule

From Laboratory to the DoctorFrom Laboratory to the Doctor

EstablishinEstablishing the g the

Safety and Safety and Efficacy of Efficacy of

a New a New Medicine Medicine

for for PatientsPatients

EstablishiEstablishing the ng the Safety of a Safety of a New New Molecule Molecule for for Human Human TestingTesting

Research and Technical Development Research and Technical Development New Product New Product DevelopmentDevelopment

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Transforming Molecules to MedicineTransforming Molecules to Medicine

DiscoveryDiscovery

0

2

4

6

8

10

12

14

16

0

2

4

6

8

10

12

14

16

Average YearsAverage YearsAverage YearsAverage Years

Phase IPhase I

Phase IIIPhase III

PostmarketinPostmarketingg

Phase IIPhase II

PreclinicalPreclinical

RegistratioRegistrationn

Compound SuccessCompound SuccessCompound SuccessCompound Success

Rates by StageRates by Stage

5,000 – 10,000Screened

5,000 – 10,000Screened

250Enter Preclinical

250Enter Preclinical

5Enter

Clinical

5Enter

Clinical

1 Approved 1 Approved MedicineMedicine


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Reasons Why Medicine Candidates FailReasons Why Medicine Candidates Fail

0

2

4

6

8

10

12

No.

can

did

ate

s

0 1 2 3 4 5 6 7 8 9YearsPreclin. Phase I Phase II Phase III Registration

animal toxicity, PKanimal toxicity, PKchemical stability,chemical stability,superior compoundsuperior compound

animal toxicity, PKanimal toxicity, PKchemical stability,chemical stability,superior compoundsuperior compound

efficacy/safety,efficacy/safety,differentiation,differentiation,

dose/cost of goodsdose/cost of goods

efficacy/safety,efficacy/safety,differentiation,differentiation,

dose/cost of goodsdose/cost of goods

human PK,human PK,safety/toleration,safety/toleration,

formulationformulation

human PK,human PK,safety/toleration,safety/toleration,

formulationformulation

efficacy, long-term safetyefficacy, long-term safetyefficacy, long-term safetyefficacy, long-term safety non-approvalnon-approvalnon-approvalnon-approval

It takes 12 CANs to yield 1 marketed drug It takes 12 CANs to yield 1 marketed drug on averageon average

It takes 12 CANs to yield 1 marketed drug It takes 12 CANs to yield 1 marketed drug on averageon average


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The Drug Discovery and Development ProcessThe Drug Discovery and Development Process

DiscoveryDiscovery

Exploratory DevelopmentExploratory Development

Full Full DevelopmentDevelopment

RegistrationRegistration


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Drug Discovery: The Overarching QuestionsDrug Discovery: The Overarching Questions

Is there a medical need?Is there a medical need?

What is prevalence of the disease?What is prevalence of the disease?

What is the market potential?What is the market potential?

Do we have a biochemical target?Do we have a biochemical target?

Can we synthesis compounds that are Can we synthesis compounds that are target selective, potent target selective, potent in vivoin vivo, and bioavailable?, and bioavailable?

Are the compounds efficacious in disease Are the compounds efficacious in disease models, show dose models, show dose response, and are not toxic?response, and are not toxic?

Voice of Voice of CustomeCustome

r r ResearchResearchBuilding Building Business Business

Case Case

Technical Technical Assessment Assessment

Detailed Detailed Investigation Investigation


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Where Do Potential Leads Come From?Where Do Potential Leads Come From?

LEADLEADLEADLEAD

Acquisition CompoundsAcquisition CompoundsAcquisition CompoundsAcquisition Compounds Natural SourcesNatural SourcesNatural SourcesNatural Sources

Endogenous LigandEndogenous LigandEndogenous LigandEndogenous Ligand Newly SynthesizedNewly SynthesizedNewly SynthesizedNewly Synthesized

Random Screening Random Screening of Existing Compoundsof Existing Compounds

Random Screening Random Screening of Existing Compoundsof Existing Compounds

GlaxoWellcomeGlaxoWellcome

AstraZenecaAstraZeneca

MerckMerck

e.g. Natural e.g. Natural peptide, hormone, peptide, hormone, etc.etc.

Combinatorial ChemistryCombinatorial ChemistryLibrariesLibraries

Combinatorial ChemistryCombinatorial ChemistryLibrariesLibraries


IdeationIdeation

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Discovery (3–4 Years)Discovery (3–4 Years)

BasicScienceBasic

Science

MedicalLiteratureMedical

Literature

MedicalNeed

MedicalNeed

Disease Disease InterventioInterventio

n n HypothesisHypothesis

TargetTargetCharacterizatioCharacterizatio

nn

Synthesis of Synthesis of MoleculesMolecules

ScreeninScreeningg

ActivityActivity

ImprovedActivity

ImprovedActivity

RefinemeRefinementnt

Initial Initial Safety Safety

Testing of Testing of Lead Lead

MoleculeMolecule

Nomination Nomination of Lead of Lead

Molecule for Molecule for Additional Additional InvestmentInvestment

NNoo

YeYess

++ ++


Ideation, Gate 1, Stage 1Ideation, Gate 1, Stage 1

Go / KillGo / Kill

Voice of Voice of CustomeCustome

r r ResearchResearch

Gate 2Gate 2

Detailed Detailed Investigation: Investigation:

Stage 2Stage 2

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Discovery (3–4 Years)Discovery (3–4 Years)

Disease Interventi

on Hypothesi

s

TargetCharacterizati

on

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 Identify and Refine a Portfolio of Promising Molecules (“Candidates”)Promising Molecules (“Candidates”)

Identify and Refine a Portfolio of Identify and Refine a Portfolio of Promising Molecules (“Candidates”)Promising Molecules (“Candidates”)

1111

2222

3333

4444

++

Ideation, Gate 1, Stage 1, and Ideation, Gate 1, Stage 1, and Gate 2Gate 2

Go / KillGo / Kill


IdeationIdeation Gate 1Gate 1

Technical Technical AssessmenAssessment: Stage 1t: Stage 1

Gate 2Gate 2

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Early Development (3–5 Years)Early Development (3–5 Years)

Lead Lead Molecule Molecule Endorsed Endorsed

for for Additional Additional InvestmenInvestmen

tt

ManufacturManufacture Suppliese Supplies

Required Required Animal Animal TestingTesting

FormulatFormulate Doses e Doses

for for HumansHumans

INDApplicatio

n

INDApplicatio

n

YES!(Proof ofConcept)

YES!(Proof ofConcept)

MetaboliMetabolism Datasm Data

Phase I:Phase I:Human Human Testing Testing

in in Healthy Healthy

VolunteerVolunteerss

Phase II:Phase II:Human Human Testing Testing

in in PatientsPatients

Phase II:Phase II:Human Human Testing Testing

in in PatientsPatients

Is it Is it safe?safe?

How How does it does it behave behave in the in the body?body?


Does Does the the

drug drug provide provide benefit?benefit?


What is What is the the

optimal optimal dose?dose?

Safety Safety DataData


Technical Assessment:Technical Assessment:Ideation, Gate 1, Stage 1, Ideation, Gate 1, Stage 1,

Gate 2Gate 2

Detailed Investigation: Detailed Investigation: Stage 2Stage 2

Application Path GateApplication Path Gate

Building Building Business Business

Case: Case: Stage 2Stage 2

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Early Development (3–5 Years)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”Test Safety and Efficacy of “Candidates”Under Controlled ConditionsUnder Controlled Conditions

Test Safety and Efficacy of “Candidates”Test Safety and Efficacy of “Candidates”Under Controlled ConditionsUnder Controlled Conditions

1111

2222

3333

4444


Detailed Investigation: Stage 2Detailed Investigation: Stage 2

Go / KillGo / Kill

Gate 2Gate 2

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Disciplines Involved in Drug Development Disciplines Involved in Drug Development ResearchResearch

Product DevelopmentProduct Development

PharmacologyPharmacology

SafetySafety

Clinical SciencesClinical Sciences

Clinical DevelopmentClinical Development

Development OperationsDevelopment Operations

BiostatisticsBiostatistics

MedicalMedical

Clinical Pharmacy OperationsClinical Pharmacy Operations

Library Sciences Library Sciences

Chemical ManufacturingChemical Manufacturing

Regulatory AffairsRegulatory Affairs

Project ManagementProject Management

MarketingMarketing

BiomarkersBiomarkers

InformaticsInformatics

Etc …Etc …

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Full Development (3–5 Years)Full Development (3–5 Years)

Collect, Collect, Verify, & Verify, &

Analyze DataAnalyze Data

Recruit Recruit 1000s of 1000s of PatientsPatients

File NDAFile NDA

Conduct Conduct Phase III Phase III TestingTesting

RecruitInvestigators

RecruitInvestigators

ManufactureDrug SupplyManufactureDrug Supply

Formulate,Label, &

Ship

Formulate,Label, &

Ship

Design Phase IIIStudies

Design Phase IIIStudies

ConsultFDA

ConsultFDA

StabilityStudiesStabilityStudies

Carcino-genicityStudies

Carcino-genicityStudies

Full Development

Planning

Full Development

Planning

Building Business Case: Building Business Case: Stage 2Stage 2


Detailed Detailed InvestigatioInvestigatio

n: n: Stage 2Stage 2

DevelopmeDevelopment: nt:

Stage 3Stage 3

Testing & Testing & ValidatioValidatio

n: n: Stage 4Stage 4

Gate 5Gate 5

Full Team Full Team InvolvementInvolvement

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Full Development (3–5 Years)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

Documented Evidence Concerning the Safety and Efficacy of the new Molecule

Full Developme

nt Planning

Full Developme

nt Planning

File NDAFile NDA

11

22

33

44

Demonstrate Efficacy and Safety of a Candidate in PatientsDemonstrate Efficacy and Safety of a Candidate in PatientsDemonstrate Efficacy and Safety of a Candidate in PatientsDemonstrate Efficacy and Safety of a Candidate in Patients

1111

2222

3333

4444


Gate 5Gate 5Gate 4Gate 4

Gate 2Gate 2Testing & Testing &

Validation: Validation: Stage 4Stage 4

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Registration (1–2 Years)Registration (1–2 Years)

Respond Respond to to

QuestionsQuestions

Approved New

Medicine

Approved New

Medicine

Present to Present to Advisory Advisory

CommitteeCommitteess

Other Regulator

yFilings

Other Regulator

yFilings

File NDAFile NDA

RegulatoryRegulatoryApprovalsApprovals

Label Label NegotiatioNegotiatio

nsns

New Product DevelopmentNew Product Development

Launch: Stage 5Launch: Stage 5

Gate 5Gate 5

POST POST LAUNCHLAUNCHREVIEWREVIEW

•Review costs•Review profits•Review strengths•Review weaknesses•Review what learned

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Leverage Internal Resources and Leverage Internal Resources and Stage-Gate™Stage-Gate™ Process to Process to Increase R&D Productivity and Maximize Commercial SuccessIncrease R&D Productivity and Maximize Commercial Success

Leverage Internal Resources and Leverage Internal Resources and Stage-Gate™Stage-Gate™ Process to Process to Increase R&D Productivity and Maximize Commercial SuccessIncrease R&D Productivity and Maximize Commercial Success

Molecules to Medicine: Room for ImprovementMolecules to Medicine: Room for Improvement

CAN CAN

NDA/ NDA/ MAA MAA

ApprovalApprovalKey Commercial Key Commercial Decision Points:Decision Points:Key Commercial Key Commercial Decision Points:Decision Points:

Stage:Stage:Stage:Stage:

Type of Testing:Type of Testing:Type of Testing:Type of Testing:

NDA/ NDA/ IRD IRD

FilingFiling

LaboratoryLaboratory AnimalsAnimalsPhasePhase

I IIA IIBI IIA IIBPhase IIIPhase IIIPhase IIIBPhase IIIB Phase IVPhase IV

POC/POC/R2D2-R2D2-

11R2D2-R2D2-

22DIC-IIDIC-II

PostPostLaunchLaunch

Late Late ClinicalClinicalClinicalClinicalEarly Clinical Early Clinical Pre-Pre-

ClinicalClinicalDiscoveryDiscovery

IdeaIdea

Accelerate candidate identification and screeningAccelerate candidate identification and screening Accelerate development timeAccelerate development time Improve labels and market accessImprove labels and market access Leverage depth of knowledge from exploratory through loss Leverage depth of knowledge from exploratory through loss

of exclusivityof exclusivity Ensure global knowledge sharing and collaborationEnsure global knowledge sharing and collaboration

Optimizing Pfizer Inc’s New Product Development Process Transforming Molecules to Medicines AM...

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