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Too Many Germs, Too Few Monkeys The Need for Artificial Organisms for Testing and Validating Pharmaceuticals. Drug Information Association 2003 Annual Meeting Counter-Terrorism Session San Antonio, Texas June 17, 2003. Unconventional Concepts, Inc. 425 E. Hollywood Blvd, Suite A

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Too Many Germs,Too Few MonkeysThe Need for Artificial Organisms for Testing and Validating Pharmaceuticals

Drug Information Association

2003 Annual Meeting

Counter-Terrorism Session

San Antonio, Texas

June 17, 2003

Unconventional Concepts, Inc.

425 E. Hollywood Blvd, Suite A

Mary Esther, FL 32569

(850) 243-4411, Fax (850) 243-5279

[email protected]

Michael J. Hopmeier

Chief,

Innovative and Unconventional Concepts



Mediastinal lymph node microcolonies of b anthracis giemsa stain www phil cdc gov l.jpg

“Anthrax Letters”

Mediastinal Lymph Node:Microcolonies ofB. anthracis (Giemsa stain)(www.phil.CDC.gov)



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Tularemia York City




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Bubonic York CityPlague


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Plague History York City

  • 200,000,000 deaths

  • Major Pandemics

    • Plague of Justinian

    • “Black Death”

    • Modern Pandemic


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Plague Epidemiology York City

Vector (flea)

  • Bacteria block gut

  • Feeding frenzy

    Host (mammal)

  • Rattus rattus (antiquity)

  • Squirrels, cats, coyotes, bobcats


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Smallpox York City

“The patient presents an image that fully justifies the horror and fright that is associated with smallpox in the public’s mind.”

—William Osler


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Severe Acute Respiratory Syndrome (SARS) York City

Crisis CenterThe lobby of Block E of Amoy Gardens was turned into a field headquarters for Hong Kong police and health officials after a SARS outbreak in the housing development.

Time Magazine, April 7, 2003


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SARS Virus York City

Source: Department of Microbiology, The University of Hong Kong andthe Government Virus Unit, Department of Health, Hong Kong SAR China

Coronavirus from SARS isolated in FRhK-4 cells. Thin section electron micrograph and negative stained virus particles


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African Green Monkey ( York CityCercopithecus aethiops)AKA vervet


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Olive York CityBaboon (Papio anubis)


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Rhesus Macaque ( York CityMacaca mulatta)


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Cynomolgus Macaque ( York CityMacaca fascicularis),AKA crab-eating or long-tailed macaque


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Squirrel monkey ( York CitySaimiri sciureus)


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Common Marmoset ( York CityCallithrix jacchus)

Cotton-Top Tamarin(Saguinas oedipus)


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Northern Owl Monkey ( York CityAotus trivirgatus)


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The Declaration of Geneva of the World Medical Assembly binds the physician with the words, “The health of my patient will be my first consideration.”

“The purpose of biomedical research involving human subjects must be to improve diagnostic, therapeutic and prophylactic procedures and the understanding of the aetiology and pathogenesis of disease.”

Special caution must be exercised in the conduct of research which may affect the environment, and the welfare of animals used for research must be respected.

Biomedical research involving human subjects must conform to generally accepted scientific principles and should be based on adequately performed laboratory and animal experimentation and on a thorough knowledge of the scientific literature.

World Medical AssociationDeclaration of HelsinkiJune 1964


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“2. The experiment should be such as to yield fruitful results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature.

“3. The experiment should be so designed and based on the results of animal experimentation and a knowledge of the natural history of the disease or other problem under study that the anticipated results will justify the performance of the experiment.”

Animal Testing—Nuremberg Trials

THE NUREMBERG CODE [from Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10. Nuremberg, October 1946–April 1949. Washington, D.C.: U.S. G.P.O, 1949–1953.]


What exactly is the problem l.jpg

Shortage of results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature. acceptable animal models for testing of biological countermeasures

Availability at all

Immunologically naïve

Cost effective

Efficacious

Lack of facilities

Brick and mortar

Personnel

What—Exactly—Is the Problem?


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Anthrax and public awareness results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature.

New incentives

Bioshield

Pharmaceutical stockpiles

Public demand for increased safety and efficacy

Multi-drug resistance

Greater susceptible populations

MARKET PRESSURE!

Why Now?


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Rapidly expanding BW research is increasing demand results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature.

No-cure diseases mandating animal trials

Lots of federal money

Purpose-raised supplies are being tapped out and are insufficient to meet needs

Increased regulatory involvement and more rigorous controls

China and India have greatly curtailed exports

SARS

Politics

Some Root Causes


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Aging infrastructure results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature.

Reduced funding to Primate Center System

Continued pressure on available primates for other research

FDA requirements on the pharmaceutical industry

Increasing pressure from eco-terrorists and animal rights groups reducing participation from organizations

Human encroachment reducing environment and population sizes

Restrictions on exportation in countries of origin

Increasing difficulty in animal transportation

Modes (commercial airlines, ground)

Regulatory issues (IATA)

Politics (Interim Guidelines, CDC; pressure on carriers)

Some Root Causes


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Biological sciences becoming more rigorous and demanding more control

Increasing need for “standardized” tests and subjects

More subtle and sensitive techniques increasingly being used

Science is becoming more “sensitive”

Biology is moving from “art” to “science” and requires more rigorous “controls” on experiments

Other Issues


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Ability to scale and adapt to changing volume and quantity demands

Support ever more rigorous scientific challenges and research

Provide efficacious data that can be validated for use in human models

Meet the challenges of today and tomorrow

What We Need


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Short Term (1–2 years) demands

Better and more effective utilization of current resources

Better coordination between public/private organizations

Mid Term (3–10 years)

Rebuild “brick and mortar” infrastructure to modern standards and predicted needs

Increase training and education to address shortfalls in skilled personnel

Design and implement special-purpose breeding programs

Long Term (10 years and out)

Enhanced tissue constructs

One Possible Path Forward


Short term 1 2 years l.jpg

Identify and inventory existing stocks of NHPs demands

Identify and inventory existing facilities

Breeding

Experimentation

Isolation

Transportation

Worldwide

Short Term (1–2 Years)


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Evaluate current and near-term requirements demands

Public and private

Based on both national security and economic pressures

Prioritize efforts within the U.S. government

Coordinate with industry (to the extent possible)

Maintain updated information for continuous predictions

Short Term (1–2 Years)


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Design and construct “modern” facilities for breeding, housing and experimenting with NHPs

Design and implement large-scale breeding programs to meet predicted needs

Set aside colonies to meet demand during periods of national emergency or pandemics

Centralize colonies and animal processing facilities, as well as specialized experimentation resources

Built around academic organizations

“Centers of Excellence”

Public/private venture

Mid-Term (3–10 Years)


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Personnel! housing and experimenting with NHPs

Significant Shortage of skilled technicians

Effects all levels of research

Instrumentation design and manufacture

Facility design and manufacture

Experimental design and implementation

Institute aggressive training and recruiting programs

Mid-Term (3–10 Years)


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Alarming potential for large vacancy rate in laboratory positions

Over the next 5 years, an estimated availability of 45,000 positions for clinical laboratory professionals (increased demand plus retirement/change of job)

Only 20,000 lab graduates expected across the same time period; potential downfall of 25,000

The current 12% vacancy rate in these positions compounds the deficit

Education and number of science students decreasing despite increasing need

Educational programs for clinical laboratory scientists and technicians dropped from 617 in 1995 to 480 in 2001

10% decline in science-related bachelor’s degrees

Reduction in the number of foreign science graduates due to U.S. visa restrictions and increasing incentives from their home countries

Mid-Term (3–10 Years)Personnel


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ALTERNATIVES TO ANIMAL MODELS positions

Models and Simulations

Increase sophistication and efficacy

Develop new techniques for measurement and diagnostics

Move from specific mechanisms to tissues to organs to organisms

Develop agreed-on standards for creating and interfacing models (similar to the Human Genome Project)

Artificial systems

Long Term (10+ Years)


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Artificial Systems positions

Artificial Grown Tissues

Skin cultures

Cloning

Artificial Organs

Artificial “organisms”

Not necessarily actual organism, but sufficient for testing

Possibly an “artificial immune system”

Long Term (10+ years)


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DARPA Engineered Tissue Constructs Program positions

Explores the technologies and science leading to the creation of a 3-D ex vivo human immune system.

To be used for testing new vaccine constructs and immunomodulators that provide superior protection against threat agents.

Brings together a combination of science and engineering communities

Long Term (10+ Years)


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The world has changed, and so must biomedical research positions

We are going to hit major bottlenecks very soon in research

Infrastructure and especially NHP research will become a major impediment soon

We must be smarter in our use of our current resources

We must find alternatives, not only to do better science, but also from an ethical standpoint

Summary


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