A5055567397- Animal testing and alternatives
- Immunotoxicology and immune responses
- Biosimilars and Bioanalytical Methods
- Clinical Laboratory Practices and Quality Control
- Erythrocyte Function and Pathophysiology
- Language, Linguistics, Cultural Analysis
- Library Science and Administration
- Drug-Induced Hepatotoxicity and Protection
- RNA Interference and Gene Delivery
- Hemoglobinopathies and Related Disorders
- DNA Repair Mechanisms
- Library Science and Information Literacy
- Translation Studies and Practices
- Effects of Radiation Exposure
- Computational Drug Discovery Methods
- South Asian Studies and Conflicts
- Immunotherapy and Immune Responses
- Hematological disorders and diagnostics
- Hematopoietic Stem Cell Transplantation
- Epigenetics and DNA Methylation
- Protein purification and stability
- Library Science and Information Systems
- Bacillus and Francisella bacterial research
- Trauma, Hemostasis, Coagulopathy, Resuscitation
- Neutropenia and Cancer Infections
Johnson & Johnson (United States)
2024-2025
Pfizer (United States)
2019-2024
Janssen (United States)
2024
The Bristol-Myers Squibb Children's Hospital
2016-2020
Perrigo (United States)
2016
Envigo (United States)
2016
Huntingdon College
2013-2014
Colorado State University
2008
The emergence of SARS-CoV-2 at the end 2019 required swift development a vaccine to address pandemic. Nonclinical GLP-compliant studies in Wistar Han rats were initiated assess local tolerance, systemic toxicity, and immune response four mRNA candidates encoding immunogens derived from spike (S) glycoprotein SARS-CoV-2, encapsulated lipid nanoparticles (LNPs). Vaccine administered intramuscularly once weekly for three doses 30 and/or 100 µg followed by 3-week recovery period. Clinical...
The purpose of this paper by the Regulatory Affairs Committee (RAC) American Society for Veterinary Clinical Pathology (ASVCP) is to review current regulatory guidances (eg, guidelines) and published recommendations best practices in veterinary toxicologic clinical pathology, particularly pharmaceutical biotechnology industries, utilize combined experience ASVCP RAC provide updated recommendations. Discussion points include (1) instrumentation, validation, sample collection, (2) routine...
The increase in urinary tract infections (UTI) caused by antibiotic-resistant
ABSTRACT Here, we report latent infections with Bartonella quintana and a hemotropic Mycoplasma sp. in research colony of cynomolgus monkeys ( Macaca fascicularis ). Sequence alignments, evolutionary analysis, signature nucleotide sequence motifs the 16S rRNA RNase P genes indicate presence novel organism.
Human adverse drug reactions (ADRs), and in vivo nonclinical nonadverse findings, were identified 27 biotherapeutic programs placed into organ categories to determine translation. The sensitivity of detecting human ADRs was 30.8% with a positive predictive value (PPV) 53.3% for findings; increased 67.3% PPV fell 35.0% when including findings. Nonclinical findings associated greater likelihood ADR that category, especially [positive ratio (LR+) >10 (lower 95% confidence interval [CI] >5)]....
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...
Abstract In preclinical safety assessment, blood volume requirements for various endpoints pose a major challenge. The goal of this working group was to review current practices clinical pathology (CP) testing in toxicologic studies, and discuss advantages disadvantages methods reducing requirements. An industry‐wide survey conducted gather information on CP instrumentation collection hematology, biochemistry, coagulation evaluation laboratory animals involved studies. Based the results...
The Society of Toxicologic Pathology formed a working group in collaboration with the American for Veterinary Clinical to provide recommendations appropriate inclusion clinical pathology evaluation recovery arms nonclinical toxicity studies but not on when perform studies. Evaluation findings is required routinely provides useful information risk assessment and recommended ability organ recover uncertain. study design generally requires concurrent controls separate procedure-related changes...
Polymorphic variants of DNA repair genes can increase the carcinogenic potential exposure to ionizing radiation. Two single nucleotide polymorphisms (SNPs) in Prkdc, gene encoding DNA-dependent protein kinase catalytic subunit (DNA-PKcs), have been identified BALB/c mice and linked reduced DNA-PKcs activity mammary cancer susceptibility. We examined three additional mouse strains better define roles Prkdc SNPs (R2140C M3844V). One is a congenic strain (C.B6) that has C57BL/6 allele on...
Abstract Ipilimumab is a fully human immunoglobulin G1 (IgG1) monoclonal antibody against cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), an inhibitory receptor expressed on activated effector T cells and regulatory (Treg), that inhibits the binding of CTLA4 to B7 ligands. BMS-986218 BMS-986249 are second generation molecules share same amino acid sequence ligand blocking properties as ipilimumab, but mechanistically distinct. non-fucosylated (NF) has increased affinity for activating...
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...
Emerging urinary kidney safety biomarkers have been evaluated in recent years and shown to be superior the serum parameters blood urea nitrogen (BUN) creatinine (sCr) for monitoring injury proximal tubule. However, their potential application differentiating location of initial (eg, glomerulus vs tubule) has not fully explored. Here, we assessed performance two algorithms that were constructed using either an empirical or a mathematical model predict site data set consisting 22 rat toxicity...