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Translational Research Core

转化研究核心

基本信息

批准号：
10514151
负责人：
Colin Osborne
金额：
$ 688.95万
依托单位：
UNIVERSITY OF TEXAS MED BR GALVESTON
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-05-16 至 2025-04-30
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10514151
关键词：
Binding Proteins Biological Assay Biophysics Cardiovascular system Clinic Clinical Clinical Pharmacology Data Data Scientist Development Dose Drug Delivery Systems Drug Interactions Drug Kinetics Ensure Enzymes Excretory function Formulation Funding Guidelines Human In Vitro Knowledge Machine Learning Metabolic Biotransformation Metabolism Modeling Nature Neuraxis Organ Pathology Patients Pharmaceutical Preparations Pharmacodynamics Pharmacology Pharmacology and Toxicology Phase Phototoxicity Plasma Proteins Play Process Regimen Role Safety Science Specialist Techniques Technology Therapeutic Toxic effect Toxicokinetics Toxicology Translational Research Translations Ursidae Family Work absorption base candidate selection clinical candidate clinical development design drug candidate drug discovery drug disposition drug metabolism first-in-human genotoxicity hazard in silico in vivo in vivo Model models and simulation multidisciplinary pandemic preparedness patient safety pharmacokinetic model pharmacokinetics and pharmacodynamics pre-clinical preclinical development preclinical safety safety assessment screening small molecule success translational model

项目摘要

TRANSLATIONAL RESEARCH CORE – ABSTRACT The Translational Research Core will support Project Teams to select and advance promising clinical candidates by conducting essential in vitro and in vivo ADMET (absorption, distribution, metabolism, excretion and toxicology) studies. This will be achieved primarily by specialist teams in Pharmacokinetic Sciences (PKS) and Preclinical Safety (PCS) housed at Novartis. PKS teams will provide in vitro and in vivo absorption, distribution, metabolism, and excretion (ADME) data. To achieve this, they will contribute in depth knowledge of preclinical pharmacokinetics, drug metabolism, and clinical pharmacology to inform compound design, formulation development, and optimal human dosing regimens. Specifically, the Translational Research Core will bring to bear a cross-disciplinary team (including expertise in biotransformation, transporters, drug-drug interactions, plasma protein binding, in vivo models, and more) to help select and optimize potential candidates for drug delivery. The PKS function will also conduct toxicokinetics studies to calculate therapeutic margins and determine safe starting doses for first-in-human studies. Further, it will deploy cutting edge machine learning, translational, biophysical and other modelling techniques to predict human efficacious exposures based upon available in vitro and in vivo pharmacokinetics, pharmacology and toxicology data. PCS teams will provide in vitro and in vivo preclinical safety data from early discovery to registration trials and assure patient safety is fully compliant with requirements by stringent regulatory agencies. PCS specialists will conduct a wide range of in vitro and in vivo exploratory/mechanistic and regulatory toxicology studies tailored to the specific needs of each project, eventually assembling a complete regulatory toxicology package to identify hazards and establish safety margins. This group will conduct non-GLP screening assays and GLP studies to determine genotoxicity, phototoxicity, and safety pharmacology liabilities at the Development Candidate (DC) selection stage and as part of IND applications. In summary, the Translational Research Core will play a pivotal role in bridging drug discovery and translation to the clinic by helping evaluate, differentiate, and ultimately select the best molecules.

翻译研究的核心——摘要