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IIT Research Institute

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IIT Research Institute

  1. 1. Over 50 years of Scientific Excellence AAALAC Accredited GLP Service Provider Chicago, IL
  2. 2.  US based research institute and nonclinical CRO, Chicago, IL Over 110 full-time staff, greater than one third with advanced degrees Staff tenure averages 10.4 years Study director tenure averages 18+ years Highly experienced, skilled and tenured animal technicians Published team of experts in their respective fields Onsite veterinary, clinical pathology, histopathology Comprehensive nonclinical services portfolio with niche expertise High volume of repeat work
  3. 3.  Government, academic, and commercial sponsors ◦ Internal grant and contract writing team ◦ Grant writing support and collaborations Complete nonclinical testing and development services Drugs, vaccines, biologics, nutraceuticals, biopesticides Regulatory expertise in EPA and FDA guidelines ◦ Regulatory support Extensive capabilities in inhalation and aerosol sciences Multiple species capabilities and experience ◦ Rodent, rabbit, guinea pig, ferret, nonhuman primate, canine, mini-pig Specialized animal models o Oncology, infectious disease, respiratory, wound Robust bioanalytical capabilities, preclinical-clinical Complete micro and molecular biology capabilities
  4. 4.  Located in Chicago, IL Over 125,000 square feet ABSL/BSL 2-3 Small and Large Animal Facilities Surgical Suites Xenograft Isolation Facilities Inhalation Suites for small and large animals Analytical Chemistry Laboratories Micro-Molecular Biology Laboratories Over $20 million invested in last 7 years
  5. 5.  AAALAC Accredited OLAW Assured Good Laboratory Practice ICH/OECD Compliant Select Agent Registered DoD Security Clearance Active US Army Biosurety Program ABSL-BSL 2/3
  6. 6.  In Vivo Pharmacokinetics and ADME , including radiolabeled ◦ Method development and validation Genetic Toxicology : mutagenesis, cytotoxicity, chromosomal damage ◦ Ames Assay ◦ Micronucleus Assays, in vitro and in vivo ◦ Comet Assays ◦ Neutral Red Cytotoxicity Assay ◦ Mouse Lymphoma Assay ◦ Structural Chromosome Aberration Assay  Cell Lines: CHO, HPBL, CHL, V-79 Safety Pharmacology: Core Battery Assessment ◦ Cardiovascular Physiology: Telemetry ◦ CNS Function: Neurobehavioral Assessment ◦ Respiratory Physiology: Plesmography ◦ Rodent, Canine, Guinea pig, Nonhuman Primate Systemic Toxicology including Aerosol Dosing ◦ Experience with a wide range of administration routes and methods ◦ All technicians have 5 or more years experience and BS/MS degrees ◦ Rodent, rabbit, guinea pig, canine, nonhuman primate, mini-pig
  7. 7.  Immunotoxicology ◦ ELISA Development ◦ Detection of Cytokines ◦ Plaque Forming Cell Assay ◦ Natural Killer Assay ◦ In Vivo Host Defense Models ◦ Murine Local Lymph Node Assay ◦ Lymphocyte Blastogenesis Assay ◦ Cytotoxic T-lymphocyte Assay Complete Analytical Chemistry Services Complete Molecular and Microbiology Services Smooth transition to Phase I ◦ method cross-validation and early clinical PK-TK analysis
  8. 8.  Early clinical phase PK-TK sample analysis Chronic Toxicology ◦ 6-9-12 month studies ◦ Rodent, rabbit, guinea pig, canine, nonhuman primate, mini-pig Developmental and Reproductive Toxicology ◦ Rodents, rabbits Carcinogenicity ◦ 1-2 year studies
  9. 9.  Nonclinical: Complete Assay Development and Validation ◦ Pharmacokinetics and ADME ◦ Drug metabolite profiles ◦ Biomarker identification ◦ Protein binding ◦ Tissue and fluid drug concentrations ◦ Drug-drug interactions ◦ In vitro metabolism ◦ Extractables and leachables Extensive expertise in small molecule trace level analysis ◦ Gas chromatography (GC) and gas chromatography-mass spectrometry (GC-MS) Extensive expertise in elemental trace level analysis ◦ Inductively coupled plasma -mass spectrometry (ICP-MS) Clinical: Smooth transition from pre-IND to Phase I: 30 days ◦ Cross validation of preclinical PK methods for clinical use ◦ Early clinical PK-TK sample analysis Biographies and publications available
  10. 10. Types of Studies PK and ADME Toxicology Pulmonary sensitization Sensory irritation Lung inflammatory studiesExpertise Generation of complex mixtures of vapor/particulate atmospheres Generation and monitoring of nanoparticles Generation of viable aerosols Modeling of pulmonary deposition Custom designs for dispersion of powders, liquids and mixtures Pulmonary function measurements
  11. 11. Aerosol Generation Systems Nebulizers, Spray nozzles, Powder dispersion Custom designed systemsAerosol Atmosphere Monitoring Systems Aerosol concentration Particle size distribution Gas concentration Chemical analysisRespiratory Disease Models Asthma COPD Pulmonary fibrosis Lung cancer
  12. 12. IITRI Process and System Bacterial cells are diluted with PBS to specified concentrations ◦ Osmolarity of cells is maintained ◦ Washing of cells is unnecessary Six simultaneously firing nebulizers require less pressure ◦ Lower pressure - less cellular shearing = higher viability ◦ Lower pressure - less foaming - no antifoam = higher viability 100% humidified air provided to animals without dilution air ◦ Higher humidity – less desiccation = higher viability ◦ No dilution air – higher humidity = higher viability Comparison of Spray Factor with Multiple Concentrations 1e+6 1e+7 1e+8 1e+9Benefits of IITRI System 1e+0 1e+0 1e-1 1e-1 High-efficiency delivery of viable microorganisms 1e-2 1e-2 High accuracy for delivery of specified doses 1e-3 1e-3 Spray Factor (Fs) 1e-4 1e-4 1e-5 1e-5 Biographies and publications available 1e-6 1e-6 1e-7 1e-7 1e-8 1e-8 1e-9 1e-9 1e-10 1e-10 1e+6 1e+7 1e+8 1e+9 Starting culture concentration (CFU/mL)
  13. 13.  Infectious Disease Model Development Vaccines, anti-bacterials, anti-virals ◦ Immunogenicity, Efficacy, PK, Safety-Toxicology ◦ Various dosing routes including aerosol ◦ BSL2-3 Influenza experience specifically ◦ Ferret and guinea pig models, transmission models ◦ Multiple seasonal influenza strains, H3N2 and H1N1 ◦ Pandemic H1N1 and H5N1 strains including highly pathogenic H5N1 Extensive Pathogen and Toxin Library Evaluation of decontamination materials Validation of bio-detection methods
  14. 14.  Microbiology ◦ ELISAs ◦ Hemagglutination inhibition assays ◦ Viral neutralization assays ◦ Bacterial/viral extraction and isolation Molecular Biology ◦ Real-time, quantitative PCR ◦ Microbial forensics ◦ Gene expression, cloning and DNA sequencing ◦ Biomarker identification and detection Biographies and publications available
  15. 15.  IITRI is the largest nonclinical contractor to the NCI ◦ Screening ◦ Efficacy ◦ Pharmacokinetics ◦ Full safety testing, toxicology  Cancer Biology: In Vitro and In Vivo Studies ◦ Mechanism of action ◦ Drug-drug interactions ◦ Drug concentration in tissues ◦ Gene expression, cloning and DNA sequencing ◦ Well established xenograft models ◦ Development of new xenograft models ◦ Highly experienced in the testing of natural compounds ◦ Growth initiative: orthotopic model development  Biographies and publications available
  16. 16.  IITRI and EPA, 1985-1994 ◦ Cooperative agreement with EPA ◦ Assessment of toxicity and pathogenicity testing methods and protocols ◦ This work markedly changed FIFRA, now OPPTS guidelines Well-versed in US and Canadian guidelines Member of the Biopesticide Industry Alliance Complete Safety and Pathogenicity Testing ◦ Acute eye irritation ◦ Acute dermal irritation ◦ Skin sensitization ◦ Dermal toxicity and pathogenicity ◦ Injection toxicity and pathogenicity ◦ Pulmonary toxicity and pathogenicity ◦ Oral toxicity and pathogenicity ◦ Reproductive toxicity ◦ Immunotoxicity ◦ Storage stability  Biographies and publications available
  17. 17.  Incision Site Wound: topical treatment ◦ Models surgical site wounds and cuts, various bacteria Groin Wound: topical treatment ◦ Models MRSA (or other) SC infection with sepsis Deep Puncture Thigh Wound: topical, injectable, PO ◦ Models deep puncture wound often leading to sepsis Peritonitis Wound, two types ◦ Caecal ligature and puncture: to assess direct site treatment ◦ IP injection of bacteria: to assess surgical gels used internally
  18. 18.  Scientific excellence since 1936  Highly experienced, tenured and published team  Hands on study directors for personalized attention  Technical expertise for a variety of complex and diverse programs  Fully integrated nonclinical developmental services  Many long-standing industry relationships including co-authored work  Applied regulatory expertise in support of full program development  Robust analytical capabilities to support nonclinical and early clinical studiesFrom grant writing support to development, efficacy and safety testing, IITRI supports allyour nonclinical in vivo and analytical needs at a single US facility.
  19. 19. Jessica Humphreys, BSN 717-467-5186 717-668-3133www.linkedin.com/in/jessicahumphreys jhumphreys@iitri.org www.iitri.org

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