# Pharmacology Core

> **NIH NIH U19** · HACKENSACK UNIVERSITY MEDICAL CENTER · 2022 · $3,475,988

## Abstract

ABSTRACT - Pharm Core 5
To be tested in efficacy studies and advance to preclinical development, small molecule antivirals must have the
right balance of potency, exposure (pharmacokinetics, PK), and therapeutic index (acceptable ratio between
efficacious and toxic concentrations). The Pharmacology Core will support advancement of promising hits and
leads through tiered absorption, distribution, metabolism, and elimination (ADME) assessment and harmonized
gating criteria, selecting compounds and chemical scaffolds with the essential attributes for efficacy studies and
preclinical development. The Core will leverage a fully integrated analytical platform and state-of-the-art animal
facility available at the Center for Discovery and Innovation, Hackensack Meridian Health (Nutley, NJ) to assist
the assembled team. The Core Leader, Dr Véronique Dartois, has extensive experience in the pharmacological
evaluation of anti-infective compounds, including 8 years supporting anti-Dengue drug discovery programs in
the pharmaceutical industry.
To support hit-to-lead programs, we will carry out physicochemical and in vitro PK profiling as well as basic
formulation development and in vivo snapshot PK in mice via different routes of administration. The data will be
used to establish structure-activity relationships, to nominate leads and guide compound progression towards
efficacy evaluation, according to conventional phase transition criteria. To support lead optimization programs,
we will perform safety screens, full mouse and hamster PK, tissue distribution in pulmonary fluid and nasal
compartments, intracellular uptake, and prodrug conversion studies. In close collaboration with all Projects and
the Animal Model Core, we will integrate (i) plasma and pulmonary PK, (ii) plasma protein binding, (iii) uptake
in relevant cell lines to factor in active transport/efflux processes, and (iv) potency measurements, to calculate
pharmacokinetic-pharmacodynamic indices in plasma and at the site of infection, and to propose doses for
tolerability and efficacy studies. Plasma and tissue concentrations will be monitored during murine and hamster
efficacy studies. Harmonized threshold metrics will guide lead optimization and go-no/go decisions to minimize
the risk of PK- and toxicity-related attrition later in the drug development process.

## Key facts

- **NIH application ID:** 10513919
- **Project number:** 1U19AI171401-01
- **Recipient organization:** HACKENSACK UNIVERSITY MEDICAL CENTER
- **Principal Investigator:** Veronique Dartois
- **Activity code:** U19 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $3,475,988
- **Award type:** 1
- **Project period:** 2022-05-16 → 2026-10-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10513919

## Citation

> US National Institutes of Health, RePORTER application 10513919, Pharmacology Core (1U19AI171401-01). Retrieved via AI Analytics 2026-06-02 from https://api.ai-analytics.org/grant/nih/10513919. Licensed CC0.

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