Medical Countermeasures

Lovelace Biomedical has extensive experience in evaluating medical countermeasures against biological, chemical, radiological and explosive threats, as well as combat casualty care. Lovelace has the ability to work with agents requiring containment and chemical surety (i.e. meets the minimum requirements for AR50-6 Chemical Surety) and CDC select agents in addition to our Nuclear Regulatory Commission (NRC)-approved facilities. We undertake regulated studies in efforts to complete FDA Animal Rule Investigational New Drugs (INDs) leading to full New Drug Application (NDA)/Biologic License Application (BLA) programs.

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Lovelace Biomedical’s facilities are registered with the CDC/APHIS select agent program. These facilities can work with bacterial agents, viral agents, and toxins that require BSL-3 and/or ABSL-3 enhanced containment.

Approved agents include:

  • anthraces
  • tularensis
  • pestis
  • Brucella abortus
  • Brucella melintensis
  • Brucella suis
  • Burkholdera mallei
  • Burkholderia pseudomallei
  • Coxiella burnetti
  • Monkeypox virus
  • Highly pathogenic avian influenza
  • Eastern equine encephalitis
  • Venezuelan equine encephalitis
  • Ricin
  • Botulinum neurotoxin

Lovelace Biomedical has highly secure, specialized facilities in which we conduct chemical warfare agent (CWA) / toxic industrial chemical (TIC) exposures in compliance with the chemical weapons convention. The laboratory has been conducting research with chemical agents for more than two decades, and can apply novel tools to these studies, such as pulmonary and neurophysiology (ie EEG) and imaging with CT/MRI.
We have worked with a variety highly toxic chemical agents including:

  • sulfur mustard
  • Sarin
  • Soman
  • Vx
  • phosgene
  • methyl isocyanate
  • ammonia
  • formaldehyde
  • hydrogen sulfide
  • chlorine

Lovelace Biomedical has highly specialized models and facilities to mimic injury and polytrauma experienced by the warfighter in austere conditions. Our team is working with technologies that will both widen the post-injury window of life in a far-field environment and provide short and long term beneficial clinical outcome.
Capabilities include:

  • Realistic models of traumatic brain injury, spinal cord injury & hemorrhagic shock
  • Veterinary monitored surgical suite, shock tube, and HYGE™ acceleration-deceleration (reverse acceleration) device
  • Military designed and approved test track and transport vehicle to simulate realistic conditions for en-route care with physiological models
  • Air transport facilities to simulate realistic conditions for en-route care with physiological models
  • Advanced neuroimaging (fMRI, CT, EEG, MEG) to improve diagnosis and understanding of pathology/treatment following TBI and polytrauma

In summary, Lovelace Biomedical offers the medical countermeasure community:

  • Numerous animal models relevant to all aspects of chemical, biological, radiological, and nuclear (CBRN) threats.
  • Single animal model studies to determine the effects of medical countermeasures (e.g., respiratory centers, bronchoconstriction, and lung inflammation) and the efficacy of therapeutic interventions.
  • Extensive experience in developing diagnostic assays for a host of diseases.
  • Physical and biological science capabilities for the generation, collection, and measurement of materials of CBRN interest, including aerosols, nerve gases, and radiological materials. Given New Mexico’s unique regulations, we can manufacture small batches of chemical agents at our South facility.
  • Extensive modeling and simulation capabilities.
  • Extensive experience in technology transition, specifically relevant to drug development.

Our team has developed and validated models of acute radiation syndrome, dermal burn/radiation combinations, and systemic injury models in the gastrointestinal and cardiopulmonary systems, including deep internal expertise in radiation dosimetry, radiation drug countermeasure drug development and risk assessment.

Countermeasures Program

Lovelace has developed animal models and research capabilities for evaluating medical countermeasures to mitigate the health effects from exposure to both internal radionuclides and external irradiation.

Lovelace has a clinical linear accelerator (LINAC), a Philips RT-250 orthovoltage X-ray therapy unit, and Grenz x-Ray irradiator that can perform whole-body or partial-body irradiation in large (swine, nonhuman primates [NHP]), small (mice, rats) animals, and dermal wound exposures, respectively. Differing degrees of supportive care define models for hematopoietic and gastrointestinal syndromes. Understanding these models is essential to define the mechanisms of injury and assist in developing targeted therapeutics. These acute effects models are used to evaluate therapies for ameliorating or preventing the biological effects from high doses of external irradiation. Lovelace has full GLP pharmaceutical R&D capability to bring drugs to approval under the FDA “animal rule” or for standard clinical indications.

Linear Accelerator (NHP &Swine)

  • GLP validated (6.8 Gy) LD 50/60 in NHPs (Rhesus, M); field supportive care; full hematopoietic syndrome; GI
    complications
  • Qualified LD 50/60 in Göttingen (1.94 GY) and Sinclair (2.55 Gy) Minipigs supportive care (M/F); GI complications
  • Qualified PBI Sinclair Swine GI model (14Gy)
  • Combined irradiation thermal burn and wound healing model in Göttingen Minipigs

Philips RT-250 (Mice & Rats)

  • LD 50/60 mice (C57B, M/F)
  • Radiation-induced lung fibrosis

Grenz X-Ray

  • Radiation induced wound healing model (Yorkshire Swine)
  • Chemical, Biological, Radiological, and Nuclear threat animal model and countermeasure testing
  • Full range of pharmaceutical R&D activities
  • Wide Species Range: rodents, rabbits, ferrets, dogs, nonhuman primates, swine
  • Pharmacology
  • Analytical chemistry
  • Bioanalytical chemistry
  • ADME
  • Pharmacokinetics
  • PMPK modeling
  • GLP Safety Studies (acute, 3-8 day, 14-28
  • Day, 60-90 Day, 6mo-2yr chronic)
  • Phase I-IV Clinical Studies

Countermeasures Program

Lovelace has developed animal models and research capabilities for evaluating medical countermeasures to mitigate the health effects from exposure to both internal radionuclides and external radiation.

These animal models are used to understand the unperturbed biokinetics of internally deposited radionuclides in the body with time, whether exposure occurs by inhalation, ingestion, wounds, or absorption through intact skin. Knowing where a radionuclide is retained in the body is essential for understanding the effectiveness of drugs given to decorporate and remove radionuclides from the body. Such models have been developed for internal contamination from the radioactive heavy metals plutonium, americium, cesium, cobalt, and strontium which are both associated with nuclear power and nuclear weapons. Other radionuclides can also be evaluated based on the decorporation of the strategy being tested.

Our Capabilities

  • Animal models of metabolism and biokinetics for a large variety of radionuclides
  • Exposure to radionuclides by inhalation, ingestion, percutaneous wounds, intravenous, intraperitoneal, intratracheal delivery, and absorption through intact skin
  • Broad range of animal species: mice, rat, dog, swine
  • Material balance study designs including complete excreta collection and analysis of biological samples from blood to tissues to organs
  • Analytical radiochemistry capabilities for measuring radionuclides in biological samples
  • Biokinetic and dosimetric modeling of experimental animal data, with or without the effects of medical countermeasures
  • Capability for measuring radionuclides in living animals (whole-body counting)
  • Chemical, Biological, Radiological, and Nuclear threat animal model and countermeasure testing
  • Full range of pharmaceutical R&D activities
  • Wide Species Range: rodents, rabbits, ferrets, dogs, nonhuman primates, swine
  • Pharmacology
  • Analytical chemistry
  • Bioanalytical chemistry
  • ADME
  • Pharmacokinetics
  • PMPK modeling
  • GLP Safety Studies (acute, 3-8 day, 14-28 Day, 60-90 Day, 6mo-2yr chronic)
  • Phase I-IV Clinical Studies