# Translational Research Core

> **NIH NIH U19** · UNIVERSITY OF TEXAS MED BR GALVESTON · 2022 · $6,889,473

## Abstract

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.

## Key facts

- **NIH application ID:** 10514151
- **Project number:** 1U19AI171413-01
- **Recipient organization:** UNIVERSITY OF TEXAS MED BR GALVESTON
- **Principal Investigator:** Colin Osborne
- **Activity code:** U19 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $6,889,473
- **Award type:** 1
- **Project period:** 2022-05-16 → 2025-03-24

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10514151

## Citation

> US National Institutes of Health, RePORTER application 10514151, Translational Research Core (1U19AI171413-01). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10514151. Licensed CC0.

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