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  • 1.11 John L. LaMattina, Ph.D. President, Worldwide Research Pfizer Global Research and Development John L. LaMattina, Ph.D. President, Worldwide Research Pfizer Global Research and Development Leveraging the Genome Fact, Fiction, and Ethical Implications Leveraging the Genome Fact, Fiction, and Ethical Implications

2. WPI 3/2002 The Global R&D ChallengeThe Global R&D Challenge One Pill Must Be Globally Safe and Efficacious Across Racial and Ethnic Groups Across Age, Weight, and Sex Differences One Pill Must Appeal to Global Markets Different Cultures, Healthcare systems, Distribution systems One Pill to Pass Global Regulatory Review MOST Regulated Industry in the World Must meet regulatory requirements in EVERY country One Pill Must Be Globally Safe and Efficacious Across Racial and Ethnic Groups Across Age, Weight, and Sex Differences One Pill Must Appeal to Global Markets Different Cultures, Healthcare systems, Distribution systems One Pill to Pass Global Regulatory Review MOST Regulated Industry in the World Must meet regulatory requirements in EVERY country 3. WPI 3/2002 Lipid-Lowering Hypertension/Angina Arthritis Depression/Anxiety Antibiotic Erectile Dysfunction Seizure Disorders Antifungal Hypertension/BPH Alzheimers Disease Allergy Cardiovascular Lipid-Lowering Hypertension/Angina Arthritis Depression/Anxiety Antibiotic Erectile Dysfunction Seizure Disorders Antifungal Hypertension/BPH Alzheimers Disease Allergy Cardiovascular ProductsProducts CategoryCategory NeurontinNeurontin Accupril/AccureticAccupril/Accuretic Major Internally Discovered ProductsMajor Internally Discovered Products Broad Portfolio - Number 1 or 2Broad Portfolio - Number 1 or 2 4. WPI 3/2002 A Research-Based Health Care Company CompanyCompany 2000 Total R&D Spending ($ Billions) 2000 Total R&D Spending ($ Billions) Aventis Johnson & Johnson Schering-Plough 4.4 3.8 2.9 3.2 Pfizer Glaxo/SmithKline 1.3 Novartis AstraZeneca Roche Merck Bristol-Myers Squibb Eli Lilly American Home Products 2.7 2.6 2.4 2.3 2.0 2.0 1.7 5. WPI 3/2002 Administrative Support Analytical Chemistry Animal Health Anti-infective Disease Bacteriology Behavioral Sciences Biochemistry Biology Biometrics Cardiology Cardiovascular Science Clinical Research Communication Computer Science Cytogenetics Developmental Planning DNA Sequencing Diabetology Document Preparation Dosage Form Development Drug Absorption Drug Degradation Drug Delivery Electrical Engineering Electron Microscopy Electrophysiology Environmental Health & Safety Employee Resources Endocrinology Enzymology Facilities Maintenance Fermentation Finance Formulation Gastroenterology Graphic Design Histomorphology Intestinal Permeability Law Library Science Medical Services Mechanical Engineering Medicinal Chemistry Molecular Biology Molecular Genetics Molecular Models Natural Products Neurobiology Neurochemistry Neurology Neurophysiology Obesity Oncology Organic Chemistry Pathology Peptide Chemistry Pharmacokinetics Pharmacology Photochemistry Physical Chemistry Physiology Phytochemistry Planning Powder Flow Process Development Project Management Protein Chemistry Psychiatry Public Relations Pulmonary Physiology Radiochemistry Radiology Robotics Spectroscopy Statistics Sterile Manufacturing Tabletting Taxonomy Technical Information Toxicology Transdermal Drug Delivery Veterinary Science Virology X-ray Spectroscopy Pharmaceutical R & D - A Multi-Disciplinary Team Over 100Over 100 DifferentDifferent DisciplinesDisciplines Working TogetherWorking Together 6. WPI 3/2002 Development Process Starts with Many Hypotheses AttenuateAttenuate NeuroNeuro--inflammationinflammation Stop Programmed Cell DeathStop Programmed Cell Death PreventPrevent AmyloidAmyloid PlaquesPlaques Block GlutamateBlock Glutamate NeurotoxicityNeurotoxicity Stabilize Neuronal InfrastructureStabilize Neuronal Infrastructure Alzheimers DiseaseAlzheimers Disease 7. WPI 3/2002 DiscoveryDiscovery Exploratory DevelopmentExploratory Development FullFull DevelopmentDevelopment RegistrationRegistration Large Amounts of Candidate Medicine Synthesized Project Team and Plans Synthesis of Compounds Early Safety Studies Candidate Formulations Developed Extensive Safety Studies Screening Studies in Healthy Volunteers Phase I Candidate Medicine Tested in 3-10,000 Patients (Phase III) Studies in 100-300 Patients (Phase II) Clinical Data Analysis The Long Road to a New Medicine 8. WPI 3/2002 High Risk Process: 11-15 Years, $800MM+ Preclinical Pharmacology Preclinical Safety Millions of Compounds Screened IdeaIdea DrugDrug11 - 15 Years 11 -- 22 ProductsProducts DiscoveryDiscovery Exploratory DevelopmentExploratory Development Full DevelopmentFull Development Phase I Phase II Phase III 00 151555 1010 Clinical Pharmacology & Safety ~100 Discovery Approaches~100 Discovery Approaches~100 Discovery Approaches 9. WPI 3/2002 Innovation Process Difficult Complex Disease Targets Too Long in Body Adverse Reactions Poor Absorption Low Levels in Body Not Effective Enough Not Sufficiently Selective Side Effects Unsafe Unstable Competition Impractical To Make MostMost CompoundsCompounds Do Not BecomeDo Not Become MedicinesMedicines 10. WPI 3/2002 Consolidation TrendsConsolidation Trends Shrinking Ranks - 1988 PMA Members Still Independent Abbott Laboratories G.D. Searle Procter & Gamble American Cyanamid GlaxoSmithKline Rhone Poulenc American Home Products Glaxo Wellcome Rorer A.R. Robins Hoechst Marion Roussel R.P. Scherer AstraZeneca Hoffman-LaRoche Sandoz Aventis ICI Zeneca Schering-Plough Beecham Laboratories Johnson & Johnson SmithKline Beecham Boehringer Ingelheim Eli Lilly Squibb Boots Pharmaceuticals Marion Laboratories Sterling Drug Bristol-Myers Squibb Merck Syntex Carter-Wallace Merrell Dow Upjohn Company Ciba Geigy Novartis Warner-Lambert Connaught Laboratories Pfizer Wellcome Fisons Corporations Pharmacia 11. WPI 3/2002 Opportunity to Do Much MoreOpportunity to Do Much More 12. WPI 3/2002 Molecular Insights into Disease Cell Chromosomes DNA Gene Switch Nucleotide Base Pairs Protein Receptors HormonesEnzymes Nucleus 13. WPI 3/2002 What Are Practical Implications of Human Genome for Drug Development? What Are Practical Implications of Human Genome for Drug Development? Increase in targets from ~ 450 to > 4000. Can Focus on Human Receptors, Ligands. Potentially develop more specific medicines. However: Exploring New Mechanisms takes time and $ New Technologies are very expensive No guarantee that they will lead to new medicines Increase in targets from ~ 450 to > 4000. Can Focus on Human Receptors, Ligands. Potentially develop more specific medicines. However: Exploring New Mechanisms takes time and $ New Technologies are very expensive No guarantee that they will lead to new medicines 14. WPI 3/2002 Implications of the Genome: Insulin Signaling - 1977 15. WPI 3/2002 Glucose transport and storage Signaling pathways - 2000Glucose transport and storage Signaling pathways - 2000 16. WPI 3/2002 Myths about Genomic InformationMyths about Genomic Information It will lower the cost of drug development Technology is expensive Mechanisms poorly understood More targets = More Cost We can use it to develop magic bullets Chronic disease complicated, multifaceted Multiple genes frequently involved Environment, behavior remain important Sometimes determinative It will lower the cost of drug development Technology is expensive Mechanisms poorly understood More targets = More Cost We can use it to develop magic bullets Chronic disease complicated, multifaceted Multiple genes frequently involved Environment, behavior remain important Sometimes determinative 17. WPI 3/2002 Ethical Issues of Genomic InformationEthical Issues of Genomic Information Who owns the data? Government? Individuals? Companies? Who Collects the data? Who pays? How will the data be used? Insurance issues Privacy issues Discrimination Who owns the data? Government? Individuals? Companies? Who Collects the data? Who pays? How will the data be used? Insurance issues Privacy issues Discrimination 18. WPI 3/2002 Ethical Issues: PatentsEthical Issues: Patents Diamond v. Chakrabarty, 1980 Biological organism can be patented The Great Sequence Hunt Positives - competition pushed sequencing Negatives - what value was created? Recent Ruling Sequence not controlling, must have function Diamond v. Chakrabarty, 1980 Biological organism can be patented The Great Sequence Hunt Positives - competition pushed sequencing Negatives - what value was created? Recent Ruling Sequence not controlling, must have function 19. WPI 3/2002 Example of Ethical Issues: SNPsExample of Ethical Issues: SNPs Single nucleotide polymorphisms (SNPs) Can identify individual risk profile for various diseases Could be used to screen patients for clinical trials - improve safety Broad screening can provide important insights into population genetics Each individual could have tailored drugs Single nucleotide polymorphisms (SNPs) Can identify individual risk profile for various diseases Could be used to screen patients for clinical trials - improve safety Broad screening can provide important insights into population genetics Each individual could have tailored drugs 20. WPI 3/2002 Example of Ethical Issues: SNPsExample of Ethical Issues: SNPs Who should pay for the screening? Government? Private companies? Once you have broadly screened the population, what is societal obligation to treat? Should you screen for diseases for which there is no cure? (Huntingtons, e.g.). What about artificial selection? Who should pay for the screening? Government? Private companies? Once you have broadly screened the population, what is societal obligation to treat? Should you screen for diseases for which there is no cure? (Huntingtons, e.g.). What about artificial selection? 21. WPI 3/2002 Some ThoughtsSome Thoughts New Area of Ethical Discussion Need complete transparency HIPPA rules promulgated, now to be implemented Need opt-in system, not opt-out Presumption of privacy should be preserved Education is critical - complex issues with many facets - public good versus private rights Different cultural contexts must be respected New Area of Ethical Discussion Need complete transparency HIPPA rules promulgated, now to be implemented Need opt-in system, not opt-out Presumption of privacy should be preserved Education is critical - complex issues with many facets - public good versus private rights Different cultural contexts must be respected 22. WPI 3/2002 Final ThoughtsFinal Thoughts Genomic Technologies show great promise but require enormous resources. Ethical Issues Real Transparent processes critical to public support Support for Research Critical Price Control Threats We Cant Do it Alone Genomic Technologies show great promise but require enormous resources. Ethical Issues Real Transparent processes critical to public support Support for Research Critical Price Control Threats We Cant Do it Alone 23. WPI 3/2002 Extending our Web of AlliancesExtending our Web of Alliances XX--RayRay UTHSUTHS TransTrans-- genicsgenics HumAbHumAb ChipChip TechnologyTechnology MolecularMolecular ModelingModeling GeneGene TherapyTherapy GenomicsGenomics ChemicalChemical DiversityDiversity CombinaCombina-- torialtorial LibrariesLibraries Mass.Mass. GeneralGeneral CornellCornell Univ.Univ. HarvardHarvard YaleYale MITMIT WashingtonWashington Univ.Univ. RockefellerRockefeller Univ.Univ. Univ. ofUniv. of WashingtonWashington RigeRige ll IBISIBIS NeurogenNeurogen CeleraCelera EvotecEvotec IncyteIncyte XenonXenon ArQuleArQule AuroraAurora AbgenixAbgenix JohnsJohns HopkinsHopkins 24. WPI 3/2002 SummarySummary Genomics will play an important role in developing new medicines Costs will increase, at least in the short term Ethical issues daunting Support for R&D more critical than ever Price controls in the US would devastate innovation Good public health is expensive, and worth it Genomics will play an important role in developing new medicines Costs will increase, at least in the short term Ethical issues daunting Support for R&D more critical than ever Price controls in the US would devastate innovation Good public health is expensive, and worth it

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