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Major Trends in Biomedical Research

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Major Trends in Biomedical Research – PowerPoint PPT presentation

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Title: Major Trends in Biomedical Research


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Bioethics and Biodefense
Enhance a culture of responsibility for proactive
research to counter potential biological threats
and emerging infections diseases
Achieving Acquisition Excellence
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Expectations
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Bioterrorism - a real and present dangerAnthrax
attacks in the United States, 2001
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Research Impacts from Attacks
  • Awareness
  • Cultural responsibility
  • Broaden - researchers and infrastructure
  • Advance research practical issues
  • Advances innovation in research new technology
  • New methods of detection, treatment, prevention
  • Ability to respond to threats quicker
  • having access to sequence of pathogens
    structures of proteins and shared data with new
    knowledge discovery and other software tools.
  • Restricted publications classified research
  • Dual use research
  • Improve public health

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Topics for Discussion
  • How quickly have we responded?
  • Coordination Planning Funding - Results
  • What is the relative threat?
  • Emerging Microbes and Biothreats
  • Genetically altered and dual use research
  • natural accidental malicious
  • How do we guide dual use research?
  • Why is NIAID doing research to protect against
    radiation exposure?

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How Quickly Have We Responded
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Biodefense Complementary Roles within DHHS
Coordinating Role of OASPHEP
O A S P H E P
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Release of BioShield Funds
  • Interagency Approval of Requirement
  • Findings by Secretaries of DHS and HHS
  • Determination of material threat
  • Suitability of countermeasure
  • No significant commercial market
  • Numbers of doses required and cost
  • Approval by the President

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NIAID Responded Immediately
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Let Us Recognize Acquisition Staff
Program Staff
Contracts Grants Staff
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President Bush Visits the NIAID Vaccine Research
CenterFebruary 4, 2002
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Current Countermeasures
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Development of New Countermeasures
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Topics for Discussion
  • How quickly have we responded?
  • Coordination Planning Funding - Results
  • What is the relative threat?
  • Emerging Microbes and Biothreats
  • Genetically altered and dual use research
  • natural accidental malicious
  • How do we guide dual use research?
  • Why is NIAID doing research to protect against
    radiation exposure?

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Understanding Microbial Threats
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Imagine 1 Human Cell
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Pitcher's Mound 1 Bacteria
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Microbes Emerging Diseases and Bio-threats
  • Bacteria
  • Viruses
  • Toxins

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NIAID is a Global Organization
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NIAID Responds to Emerging Health Needs
(examples)
  • West Nile Virus
  • Use of biological agents in terrorist attacks

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West Nile Virus An Example
Human
Animal
Source CDC Sept. 2002
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West Nile Virus An Example
Human
Animal
Source CDC Sept. 2002
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West Nile Virus An Example
Human
Animal
Source CDC Sept. 2002
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West Nile Virus An Example
Human
Animal
Source CDC Sept. 2002
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West Nile Virus - 2003 An Example
Human
Animal
Source CDC Sept. 2002
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As of Today for 2004 2151 Cases 68
Deaths
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Topics for Discussion
  • How quickly have we responded?
  • Coordination Planning Funding - Results
  • What is the relative threat?
  • Emerging Microbes and Biothreats
  • Genetically altered and dual use research
  • natural accidental malicious
  • How do we guide dual use research?
  • Why is NIAID doing research to protect against
    radiation exposure?

53
Microbes Are Genetically Modified by
  • A natural event
  • Unintended result of experiments
  • Malicious manipulation

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Resistant bacterial infections a public
health problem with global security implications
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Microbial Development of Resistance Natural Event
Antimicrobial drugs in the environment pressure
microbes to develop resistance
Chromosomal mutations transpositions
MICROBE
Extra-chromosomal plasmid acquisition
RESULT Development of drug-resistant strains
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Malicious Manipulation
Not easy
  • Pathogenicity or other characteristics, such as
    stability, may be compromised when multi-drug
    resistance is deliberately engineered.
  • Soviet researchers failed to design
    environmentally stable virulent
    multi-drug-resistant strains of tularemia
    plague.

but still a concern
Designing new or modified virulent pathogens
that could evade drugs current vaccines may be
possible with new, sophisticated technologies.
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Malicious Manipulation Potential Impact
  • Drug resistance
  • Virulence
  • Environmental stability
  • Dissemination potential
  • Ease of Replication
  • Ability to Detect
  • Effectiveness of Countermeasures

Note Possibility of new chimeric organisms
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Topics for Discussion
  • How quickly have we responded?
  • Coordination Planning Funding - Results
  • What is the relative threat?
  • Emerging Microbes and Biothreats
  • Genetically altered and dual use research
  • natural accidental malicious
  • How do we guide dual use research?
  • Why is NIAID doing research to protect against
    radiation exposure?

59
NRC Report on Dual Use Research
Report of the National Research Council of the
National Academies Biotechnology Research in
an Age of Terrorism Confronting the Dual Use
Dilemma (October 2003)
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NRC Criteria for Experiments of Concern
  • Demonstrate how to render a vaccine ineffective
  • Confer resistance to therapeutically useful
    antimicrobials
  • Confer pathogenicity or enhance the virulence of
    a pathogen
  • Increase transmissibility of a pathogen
  • Alter the host range of a pathogen
  • Enable evasion of diagnostic/detection modalities
  • Enable weaponization of a biological agent or
    toxin

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Gene Mutation Leads to Super-Virulent Strain of
TBUC Berkeley Press December 9, 2003
  • Disabling a set of virulence genes led to a
    more deadly form of TB
  • Results were completely unexpected

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Bioterror Researchers Build a More Lethal
MousepoxNew York Times November 1, 2003
  • Gene that suppresses immune system added to
    mousepox virus (close relative to smallpox)
  • Killed all mice, even vaccinated ones or those
    treated with antivirals
  • A combination therapy was protective
  • Effort to learn how to combat genetically
    engineered smallpox

63
Synthetic Polio Virus Made from Mail-Order
KitsCELL July, 2002
  • Scientists synthesized entire polio genome using
    readily available reagents and well-established
    molecular biology techniques
  • Synthetic virus was infectious, capable of
    replication, and pathogenic.
  • In vitro synthesis took 3 years to complete
  • Application could lead to benefits for medicine,
    such as rebuilding other viruses in a weakened
    form to help devise vaccines.

64
Nature News November 14, 2003
Virus Built from Scratch in Two WeeksNew
method accelerates prospect of designer microbes
  • Scientists made Phi-X virus, a harmless
    bacteriophage, in 2 weeks from commercially
    available ingredients
  • Virus was fully functional
  • New method a step toward new lifeforms to clean
    up toxic waste, secrete drugs, produce fuel

65
Life Science Research National Biosecurity
Initiatives
  • USA PATRIOT Act of 2001
  • Public Health Security and Bioterrorism
    Preparedness and Response Act of 2002
  • Agricultural Bioterrorism Protection Act of 2002
  • Promoting and conducting research on the
    development of countermeasures for biologic
    threats
  • Establish the National Science Advisory Board for
    Biosecurity (NSABB)

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Links in the Infrastructure and the Basic and
Clinical Research Agenda
  • To defend against a terrorist biological attack
    and an emergent infectious diseases

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Topics for Discussion
  • How quickly have we responded?
  • Coordination Planning Funding - Results
  • What is the relative threat?
  • Emerging Microbes and Biothreats
  • Genetically altered and dual use research
  • natural accidental malicious
  • How do we guide dual use research?
  • Why is NIAID doing research to protect against
    radiation exposure?

68
Links in the Infrastructure and the Basic and
Clinical Research Agenda
  • To defend against a terrorist biological attack
    and an emergent infectious diseases
  • To help against a radiological attack and
    understanding and enhancing the immune system to
    recover from radiation exposure or treat diseases

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Rad/Nuc Event Planning Challenges
  • Dirty bomb
  • Small affected population
  • Low level exposure
  • Limited tools for isotope identification,
    dosimetry
  • Long-range susceptibility to cancer
  • Small scientific community
  • Improvised nuclear device attack on nuclear
    facility
  • Large affected population
  • High level exposure
  • Acute radiation syndrome, blast injuries,
    hematopoietic and GI syndromes
  • Triage vs. medical care treatment pre- or
    post-exposure

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  • Today, terrorist organizations have access to
    nuclear material which could produce a crude
    weapon with a yield of 0.01 kt to 20 kt in
    size.
  • Hiroshima 12.5 kt

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Health Consequences of a 1 kt Nuclear Bomb (4 Gy
exposure zone)
  • 1 Gy Nausea and vomiting in 10 within 48 hr of
    exposure
  • 2 Gy Nausea and vomiting in 50 within 24 hr of
    exposure marked decrease in WBC and platelet
    counts
  • 4 Gy Nausea and vomiting in 90 within 12 hr,
    diarrhea in 10 within 8 hr 50 mortality in the
    absence of medical care
  • 6 Gy 100 mortality within 30d in the absence of
    medical care, due to BM failure

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Americans see health as integral to national
security, and the need for a strong federal
investment in public health and saftey
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Key Examples
Emerging Diseases
Biodefense
  • Acute to Chronic Conditions

Aging Population
Health Disparities
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NIH
Supporting Discovery to Improve Human Health
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Thanks For Your Time Questions - Comments
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