# Scientific Core - Pharmacology and Drug Development

> **NIH NIH U54** · RBHS-SCHOOL OF PUBLIC HEALTH · 2020 · $438,370

## Abstract

Scientific Support Core: Pharmacology and Drug Development
Key Personnel:
Diane E. Heck, Ph.D., Core Director:
Lauren M. Aleksunes, Pharm.D., Ph.D., Director, Preclinical Science Group
Jules Mitchel, Ph.D., Director, Translational Group
Robert Casillas, Ph.D., Co-Leader, Preclinical Efficacy Focus Team
Michael A. Gallo, Ph.D., Co-leader, Preclinical Efficacy Focus Team
Patrick Sinko, R.Ph., Ph.D., Co-leader, ADME and Toxicology Focus Team
Glen Park, Pharm.D., Co-Leader, Regulatory Affairs Focus Team
Neal Simon, Ph.D., Leader, Translation to Advanced Development Focus Team
Core Summary/Abstract
The Rutgers CounterACT Center Pharmacology and Drug Development Core that facilitates the development
of therapeutics for treatment of skin, cornea and lung injury resulting from exposure to two high priority
chemical threat agents, sulfur mustard and nitrogen mustard. This Core have been working closely with Center
investigators to identify, characterize and prioritize drug candidates, evaluate the toxicological profile and
pharmacokinetic properties of lead drug candidates, and determine optimal drug delivery approaches, with the
aim of generating data to support Investigational New Drug (IND) applications and clinical trials. The Core is
organized into four focus teams, each serving a specific function critical to drug development: Preclinical
Efficacy, ADME and Toxicology, Regulatory Affairs, and Translation to Advanced Drug Development. The
current pipeline coordinated by the Core includes modulators of inflammatory targets including matrix
metalloproteinases (doxycycline) TNFα (anti-TNFα antibody, pentoxifylline), inducible nitric oxide synthase
(aminoguanidine), and COX-2/cholinesterase (NDH4338) that will reduce injury and/or promote healing of the
lung, cornea, or skin following exposure to mustards. Drug products are rapidly progressing with several
approaching readiness to transition to advanced development including clinical studies. These include drug
products that have led to pre-IND meetings with the FDA office on Counter-Terrorism and Emergency
Coordination Staff (CTECS) and the FDA's Center for Drug Evaluation and Research (CDER). The Core
partners with contract research organizations and pharmaceutical companies, as well as regulators to ensure
the timely and efficient progression of products. In this renewal application, we propose the advancement of a
number of first generation drug products (TNFα antagonists, doxycycline, and an NSAID prodrug) towards
regulatory approval. Additional chemical entities in the pipeline continue to be studied as second generation
drug products with improved efficacy. Greater utilization of the Core is anticipated in the next 5 years as the
Center is moving a number of products into advanced development as countermeasures for mustard toxicities.

## Key facts

- **NIH application ID:** 9982796
- **Project number:** 5U54AR055073-15
- **Recipient organization:** RBHS-SCHOOL OF PUBLIC HEALTH
- **Principal Investigator:** DIANE E HECK
- **Activity code:** U54 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $438,370
- **Award type:** 5
- **Project period:** — → —

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9982796

## Citation

> US National Institutes of Health, RePORTER application 9982796, Scientific Core - Pharmacology and Drug Development (5U54AR055073-15). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/9982796. Licensed CC0.

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