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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


Innovative and Unconventional Concepts

Plague History
  • 200,000,000 deaths
  • Major Pandemics
    • Plague of Justinian
    • “Black Death”
    • Modern Pandemic
Plague Epidemiology

Vector (flea)

  • Bacteria block gut
  • Feeding frenzy

Host (mammal)

  • Rattus rattus (antiquity)
  • Squirrels, cats, coyotes, bobcats

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

—William Osler

Severe Acute Respiratory Syndrome (SARS)

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

SARS Virus

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

common marmoset callithrix jacchus
Common Marmoset (Callithrix jacchus)

Cotton-Top Tamarin(Saguinas oedipus)

world medical association declaration of helsinki june 1964
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
animal testing nuremberg trials
“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
Shortage of acceptable animal models for testing of biological countermeasures

Availability at all

Immunologically naïve

Cost effective


Lack of facilities

Brick and mortar


What—Exactly—Is the Problem?
why now
Anthrax and public awareness

New incentives


Pharmaceutical stockpiles

Public demand for increased safety and efficacy

Multi-drug resistance

Greater susceptible populations


Why Now?
some root causes
Rapidly expanding BW research is increasing demand

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



Some Root Causes
some root causes27
Aging infrastructure

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
other issues
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
what we need
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
one possible path forward
Short Term (1–2 years)

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
Identify and inventory existing stocks of NHPs

Identify and inventory existing facilities






Short Term (1–2 Years)
short term 1 2 years32
Evaluate current and near-term requirements

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)
mid term 3 10 years
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)
mid term 3 10 years34

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)
mid term 3 10 years personnel
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
long term 10 years

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)
long term 10 years37
Artificial Systems

Artificial Grown Tissues

Skin cultures


Artificial Organs

Artificial “organisms”

Not necessarily actual organism, but sufficient for testing

Possibly an “artificial immune system”

Long Term (10+ years)
long term 10 years38
DARPA Engineered Tissue Constructs Program

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)
The world has changed, and so must biomedical research

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