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Leveraging the Genome Fact, Fiction, and Ethical Implications. John L. LaMattina, Ph.D. President, Worldwide Research Pfizer Global Research and Development. The Global R&D Challenge. One Pill Must Be Globally Safe and Efficacious Across Racial and Ethnic Groups

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Presentation Transcript
slide1

Leveraging the GenomeFact, Fiction, and Ethical Implications

John L. LaMattina, Ph.D.

President, Worldwide Research

Pfizer Global Research and Development

the global r d challenge
The 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
broad portfolio number 1 or 2

Products

Category

Lipid-Lowering Hypertension/Angina

Arthritis

Depression/Anxiety

Antibiotic

Erectile Dysfunction

Seizure Disorders

Antifungal

Hypertension/BPH

Alzheimer’s Disease

Allergy

Cardiovascular

Neurontin

Accupril/Accuretic

Broad Portfolio - Number 1 or 2

Major Internally Discovered Products

a research based health care company
A Research-Based Health Care Company

Company

4.4

Pfizer

3.8

Glaxo/SmithKline

3.2

Aventis

2.9

Johnson & Johnson

2.7

Novartis

2.6

AstraZeneca

Roche

2.4

2.3

Merck

Bristol-Myers Squibb

2.0

2000 Total R&D Spending($ Billions)

Eli Lilly

2.0

American Home Products

1.7

Schering-Plough

1.3

slide5

Pharmaceutical R & D -

A Multi-Disciplinary Team

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

Over 100

Different

Disciplines

Working Together

slide6

Development Process Starts with Many Hypotheses

Prevent Amyloid Plaques

Block Glutamate Neurotoxicity

Attenuate Neuro-inflammation

Stabilize Neuronal Infrastructure

Stop Programmed Cell Death

Alzheimer’s Disease

slide7

Registration

Clinical Data

Analysis

Full

Development

Studies in 100-300

Patients (Phase II)

Candidate Medicine Tested in

3-10,000 Patients (Phase III)

Large Amounts of

Candidate Medicine

Synthesized

Extensive

Safety

Studies

Candidate

Studies in Healthy

Volunteers Phase I

Formulations

Developed

Exploratory Development

Early

Safety

Studies

Project Team

and Plans

Synthesis

of Compounds

Screening

Discovery

The Long Road to a New Medicine

slide8

~100 Discovery Approaches

High Risk Process:

11-15 Years, $800MM+

Millions of

Compounds Screened

Preclinical

Pharmacology

Preclinical Safety

1 - 2

Products

Clinical Pharmacology

& Safety

Discovery

Exploratory Development

Full Development

Phase I

Phase II

Phase III

0

15

10

5

Idea

Drug

11 - 15 Years

slide9

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

Compounds

Do Not Become

Medicines

slide11

Molecular Insights into Disease

Nucleus

Cell

Chromosomes

Nucleotide Base Pairs

DNA

Gene

Switch

Protein

Hormones

Enzymes

Receptors

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
glucose transport and storage signaling pathways 2000
Glucose transport and storage Signaling pathways - 2000

IR

Glucose

PI3P

PI3K

Muscle

Contraction

IRS-P

PTP-1B

PTEN

SHIP

?

PDK-1

?

Other Ser/Thr

kinases

?

?

AMPK

NOS

PKB

PKC

z, l

[NO]

GSK3

Guanylyl

Cyclase

GS [active]

GS-PP [inactive]

PP1

[cGMP]

PDE

Glycogenin

Glycogen

Synthesis

myths about genomic information
Myths 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
ethical issues of genomic information
Ethical 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
ethical issues patents
Ethical 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
example of ethical issues snp s
Example 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
example of ethical issues snp s1
Example 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?
some thoughts
Some 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
final thoughts
Final 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
extending our web of alliances

IBIS

Mass.

General

Cornell

Univ.

Aurora

Neurogen

Washington

Univ.

Trans-

genics

X-Ray

HumAb

Yale

Abgenix

UTHS

Chip

Technology

Harvard

Rigel

Gene

Therapy

ArQule

Rockefeller

Univ.

Molecular

Modeling

Xenon

Combina-

torial

Libraries

Celera

Univ. of

Washington

Genomics

MIT

Chemical

Diversity

Johns

Hopkins

Incyte

Evotec

Extending our Web of Alliances
summary
Summary
  • 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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