A5012325934- Animal testing and alternatives
- Immunotoxicology and immune responses
- Retinal Development and Disorders
- Retinal Diseases and Treatments
- Clinical Laboratory Practices and Quality Control
- Retinal and Optic Conditions
- Biosimilars and Bioanalytical Methods
- Mosquito-borne diseases and control
- Neonatal Respiratory Health Research
- Cardiac Arrest and Resuscitation
- Respiratory Support and Mechanisms
- Malaria Research and Control
- Molecular Biology Techniques and Applications
- Computational Drug Discovery Methods
- Herpesvirus Infections and Treatments
- Virus-based gene therapy research
- Primate Behavior and Ecology
Altasciences (Canada)
2024-2025
LabCorp (United States)
2021-2022
Covance (United States)
2016-2019
University of British Columbia
2014
Applied Genetic Technologies Corporation (AGTC) is developing rAAV2tYF-PR1.7-hCNGB3, a recombinant adeno-associated viral (rAAV) vector expressing the human CNGB3 gene, for treatment of achromatopsia, an inherited retinal disorder characterized by markedly reduced visual acuity, extreme light sensitivity, and absence color discrimination. We report here results study evaluating safety biodistribution rAAV2tYF-PR1.7-hCNGB3 in cynomolgus macaques. Three groups animals (n = 2 males females per...
Nonhuman primates (NHPs) have been and remain a highly valuable animal model with an essential role in translational research pharmaceutical drug development. Based on current regulatory guidelines, the nonclinical safety of novel therapeutics should be evaluated relevant species, which commonly includes NHPs for biotherapeutics. Given practical ethical limitations availability and/or use line widely accepted guiding “3Rs” (replace, reduce, refine) principles, many approaches considered to...
Clinical pathology endpoints are routinely assessed in nonclinical toxicity studies and the magnitude of test article-related changes is frequently expressed using quantitative and/or qualitative severity descriptors. Quantitative descriptors (ie, percent or fold change) easily calculated to express numerical a change but may not adequately convey biological relevance. A specific be associated with vastly different levels pathophysiologic relevance depending on several factors, including...
Toxicologic pathologists assess large data sets from nonclinical studies to identify treatment-related effects assist in predicting human safety hazards. Statistical testing can facilitate interpretation by highlighting group differences that have a low probability of random occurrence based on pre-determined P -value cut-off (eg, < .05). While this method has been used the pathology for decades, appropriateness utilizing statistical way challenged. Here, we discuss common pitfalls...
Applied Genetic Technologies Corporation (AGTC) is developing rAAV2tYF-PR1.7-hCNGB3, a recombinant adeno-associated virus (rAAV) vector expressing the human CNGB3 gene, for treatment of achromatopsia, an inherited retinal disorder characterized by markedly reduced visual acuity, extreme light sensitivity, and absence color discrimination. We report here results study evaluating safety biodistribution rAAV2tYF-PR1.7-hCNGB3 in CNGB3-deficient mice. Three groups animals (n = 35 males females...
The European Society of Toxicologic Pathology (ESTP) organized a panel 24 international experts from many fields toxicologic clinical pathology (e.g., industry, academia, and regulatory) that came together in 2021 to align the use terminology convey importance findings preclinical toxicity studies. An additional goal consisted how identify important standard nonstandard associated endpoints. This manuscript summarizes information opinions discussed shared at ninth ESTP International Expert...
Integrating clinical pathology data with anatomic is a common practice when reporting findings in the context of nonclinical toxicity studies and aids understanding communicating safety profile test articles development. Appropriate integration requires knowledge analyte tissue biology, species differences, methods specimen acquisition analysis, study procedures, an potential causes effects variety pathophysiologic processes. Neglecting these factors can lead to inappropriate or missed...
The loss of alveolar epithelial and endothelial integrity is a central component in acute respiratory distress syndrome (ARDS); however, experimental models investigating the mechanisms injury are lacking. purpose present study was to design develop an porcine model ARDS by inducing lung with intrapulmonary administration sodium polyacrylate (SPA).The performed at Centre for Comparative Medicine, University British Columbia, Vancouver, Columbia. Human cells were cultured several different...
Cynomolgus macaques ( Macaca fascicularis) are commonly used in safety assessment and as translational models for drug development. Recent supply chain pressures, exportation bans, increased demand studies exacerbated by the COVID-19 pandemic have prompted investigation of utilizing different geographic origin preclinical toxicity studies. This study compares routine hematology, coagulation, clinical chemistry endpoints 3 distinct subpopulations mainland Asia (Cambodia, China, Vietnam) with...
Integrating clinical pathology data with anatomic is a common practice when reporting findings in the context of nonclinical toxicity studies and aids understanding communicating safety profile test articles development. Appropriate integration requires knowledge analyte tissue biology, species differences, methods specimen acquisition analysis, study procedures, an potential causes effects variety pathophysiologic processes. Neglecting these factors can lead to inappropriate or missed...
Background: AGTC is developing a recombinant adeno-associated virus (rAAV) vector expressing the human CNGB3 gene, for treatment of achromatopsia, an inherited retinal disorder characterized by markedly reduced visual acuity, extreme light sensitivity and absence color discrimination. Here we report results toxicology biodistribution study this administered subretinal injection in CNGB3-deficient mice. Methods: Three groups mice (n= 35 per sex group) received one eye 1 µL vehicle (balanced...
Background: AGTC is developing a recombinant AAV vector expressing the human CNGB3 gene for treatment of achromatopsia, an inherited retinal disorder characterized by markedly reduced visual acuity, extreme light sensitivity and absence color discrimination. Here we report results toxicology biodistribution study this administered subretinal injection in cynomolgus macaques. Methods: Three groups animals (n=2 males 2 females per group) received one eye 300 µL containing either vehicle or...