john l. lamattina, ph.d. president, worldwide research pfizer global research and development
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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
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
WPI 3/2002
Lipid-Lowering Hypertension/Angina
Arthritis
Depression/Anxiety
Antibiotic
Erectile Dysfunction
Seizure Disorders
Antifungal
Hypertension/BPH
Alzheimer’s Disease
Allergy
Cardiovascular
Lipid-Lowering Hypertension/Angina
Arthritis
Depression/Anxiety
Antibiotic
Erectile Dysfunction
Seizure Disorders
Antifungal
Hypertension/BPH
Alzheimer’s Disease
Allergy
Cardiovascular
ProductsProducts CategoryCategory
NeurontinNeurontin
Accupril/AccureticAccupril/Accuretic
Major Internally Discovered ProductsMajor Internally Discovered Products
Broad Portfolio - Number 1 or 2 Broad Portfolio - Number 1 or 2
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
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
WPI 3/2002
Development Process Starts with Many Hypotheses
Attenuate Neuro-inflammationAttenuate Neuro-inflammation
Stop Programmed Cell DeathStop Programmed Cell Death
Prevent Amyloid Plaques Prevent Amyloid Plaques
Block Glutamate NeurotoxicityBlock Glutamate Neurotoxicity
Stabilize Neuronal Infrastructure Stabilize Neuronal Infrastructure
Alzheimer’s DiseaseAlzheimer’s Disease
WPI 3/2002
DiscoveryDiscovery
Exploratory DevelopmentExploratory Development
Full Full DevelopmentDevelopment
RegistrationRegistration
Large Amounts ofCandidate Medicine
Synthesized
Project Teamand Plans
Synthesisof Compounds
EarlySafety
Studies
CandidateFormulations
Developed
ExtensiveSafety
Studies
Screening
Studies in HealthyVolunteers Phase I
Candidate Medicine Tested in3-10,000 Patients (Phase III)
Studies in 100-300Patients (Phase II)
Clinical DataAnalysis
The Long Road to a New Medicine
WPI 3/2002
High Risk Process: 11-15 Years, $800MM+
Preclinical Pharmacology
Preclinical Safety
Millions ofCompounds Screened
IdeaIdea DrugDrug11 - 15 Years
1 - 2 1 - 2 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~100 Discovery Approaches
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
Most Most
Compounds Compounds
Do Not BecomeDo Not Become
MedicinesMedicines
WPI 3/2002
Opportunity to Do Much MoreOpportunity to Do Much More
WPI 3/2002
Molecular Insights into Disease
Cell Chromosomes
DNA
GeneSwitch
Nucleotide Base Pairs
Protein
Receptors
HormonesEnzymes
Nucleus
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
WPI 3/2002
Implications of the Genome: Insulin Signaling - 1977
WPI 3/2002
Glucose transport and storage Signaling pathways - 2000Glucose transport and storage Signaling pathways - 2000
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
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
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
WPI 3/2002
Example of Ethical Issues: SNP’sExample of Ethical Issues: SNP’s
Single nucleotide polymorphisms (SNP’s)
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 (SNP’s)
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
WPI 3/2002
Example of Ethical Issues: SNP’sExample of Ethical Issues: SNP’s
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? (Huntington’s, 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? (Huntington’s, e.g.).
What about “artificial” selection?
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
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 Can’t 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 Can’t Do it Alone
WPI 3/2002
Extending our Web of AlliancesExtending our Web of Alliances
X-RayX-Ray
UTHSUTHS
Trans-Trans-genicsgenics HumAbHumAb
ChipChipTechnologyTechnology
MolecularMolecularModelingModeling
GeneGeneTherapyTherapy
GenomicsGenomicsChemicalChemicalDiversityDiversity
Combina-Combina-torialtorial
LibrariesLibraries
Mass. Mass. GeneralGeneral CornellCornell
Univ.Univ.
HarvardHarvard
YaleYale
MITMIT
Washington Washington Univ.Univ.
RockefellerRockefellerUniv.Univ.
Univ. ofUniv. ofWashingtonWashington
RigeRigell
IBISIBIS
NeurogenNeurogen
CeleraCelera
EvotecEvotec IncyteIncyte
XenonXenon
ArQuleArQule
AuroraAurora
AbgenixAbgenix
JohnsJohns HopkinsHopkins
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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