Establishing the market-readiness of an in vivo technology for assessing drug toxicity-induced tissue damage
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Principal Investigator: Steven Edward Johnson Organization: DURAMETRIX LLC Fiscal Year: 2024 Award: $1,011,661 Funding agency: National Institute of General Medical Sciences PROJECT SUMMARY There is a substantial and growing need for in vivo toxicity testing, as in drug R&D it is critical to be able to understand toxicity and to identify and eliminate overly toxic candidates. We developed an imaging-based approach that detects toxicity-induced tissue injury in a minimally invasive, whole body and dynamic fashion. The goal of the current Phase II STTR grant is to expand the marketability and market readiness of the technology by demonstrating a broadened scope of utilities including semi-quantitative characterization and drug safety. Overall, this in vivo imaging approach identifies an important marker for drug toxicity on a personalized basis with objective and quantitative metric. The early detection of drug toxicity in susceptible tissues will help make timely decisions in drug R&D by prioritizing safe and efficacious candidates. The technology is applicable to multiple stages in pharmaceutical R&D and is expected to generate a significant impact on drug development and drug safety. Terms: <Address><Adverse effects><Anti-Cancer Agents><Antineoplastic Agents><Antineoplastic Drugs><Antineoplastics><Body Tissues><Business-Friendly Atmosphere><Cancer Drug><Cancer Treatment><Cell Body><Cell Death><Cell Survival><Cell Viability><Cells><Cephalins><Climate><Clinical Trials><Consumption><Cytotoxic agent><Cytotoxic drug><Development and Research><Drug Side Effects><Drug toxicity><Drugs><Early Diagnosis><Entrepreneurial Skill><Entrepreneurship><Ethanolamine Phosphoglycerides><Ethanolamineglycerophospholipids><Extracellular Space><Goals><Grant><Histopathology><Human><Imaging technology><In Vitro><In vivo analysis><Industrialization><Intercellular Space><Intervention><Intervention Strategies><Investigational Drugs><Investigational New Drug Application><Investigational New Drugs><Malignant Neoplasm Therapy><Malignant Neoplasm Treatment><Marketing><Measures><Medication><Meteorological Climate><Methods><Modern Man><Molecular Fingerprinting><Molecular Profiling><Neoplastic Disease Chemotherapeutic Agents><Normal Tissue><Normal tissue morphology><O-(1-beta-acyl-2-acyl-sn-glycero-3-phospho)-ethanolamine><Oncology><Oncology Cancer><Pathologic><Pharmaceutical Agent><Pharmaceutical Preparations><Pharmaceuticals><Pharmacologic Substance><Pharmacological Substance><Phase><Phase I Study><Phosphatides><Phosphatidylethanolamine><Phosphatidylserines><Phospholipids><Predisposition><Preparedness><Process><R & D><R&D><Readiness><Research><Research Resources><Resources><SPECT><SPECT imaging><STTR><Sampling Errors><Science><Serine Phosphoglycerides><Side><Single-Photon Emission-Computed Radionuclide Tomography><Small Business Technology Transfer Research><Survey Instrument><Surveys><Susceptibility><Symptoms><Techniques><Technology><Technology Assessment><Testing><Therapeutic><Time><Tissues><Toxic effect><Toxicities><Toxicity Testing><Toxicity Tests><Toxicology><Tumor-Specific Treatment Agents><anti-cancer drug><anti-cancer therapy><business-friendly environment><cancer therapy><cancer-directed therapy><climatic><clinical relevance><clinically relevant><collaborative atmosphere><collaborative environment><cost><design><designing><dosage><drug detection><drug development><drug market><drug safety><drug testing><drug/agent><duramycin><early detection><imaging approach><imaging based approach><imaging in vivo><in vivo><in vivo evaluation><in vivo imaging><in vivo testing><injury to tissue><innovate><innovation><innovative><interactive atmosphere><interactive environment><interdisciplinary atmosphere><interdisciplinary environment><interventional strategy><medication safety><minimally invasive><molecular profile><molecular signature><necrocytosis><peer-group atmosphere><peer-group environment><pharmaceutical><pharmaceutical safety><pharmacologic><pharmacovigilance><phase 1 study><post-market><pre-clinical><preclinical><programs><rapid growth><research and development><response><safety study><single photon emission computed tomography><spatiotemporal><tissue injury><tool><tumor><whole body imaging><whole body scanning>