# Scientific Core - Pharmacology and Drug Development

> **NIH NIH U54** · RUTGERS BIOMEDICAL AND HEALTH SCIENCES · 2022 · $255,127

## Abstract

Scientific Support Core: Pharmacology and Drug Development
Key Personnel:
Diane E. Heck, Ph.D., Core Co-Director; Preclinical Efficacy Team
Lauren M. Aleksunes, Pharm.D., Ph.D., Core Co-Director, Preclinical Science Group, Preclinical Efficacy,
 ADME and Toxicology Team
Patrick Sinko, R.Ph., Ph.D., Co-leader, ADME and Toxicology Focus Team, Regulatory Affairs
Robert Casillas, Ph.D., Co-Leader, Preclinical Efficacy Focus Team, Translation to Advanced Development
Jules Mitchel, Ph.D., Director, Translational Group, Regulatory Affairs Team
Neal Simon, Ph.D., Leader, Translation to Advanced Drug Development Team
Core Summary/Abstract
 The Rutgers CounterACT Center Pharmacology and Drug Development Core 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), and COX-2/cholinesterase (AIDNX, 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). One product, Simponi® (a fully humanized anti-TNFα antibody marketed by Janssen
Pharmaceuticals), has transitioned to advanced development with BARDA funding. Working with Argentum
Biomedical, the Core has also spearheaded efforts refining a dermal minipig model for advanced development
of Silverlon®, a burn dressing that has recently been approved by the FDA for use against mustard skin injury.
The Core partners with contract research organizations and pharmaceutical companies, as well as federal
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. We will continue with refinement of the minipig model for label
expansion of Silverlon®. Thi...

## Key facts

- **NIH application ID:** 10490461
- **Project number:** 7U54AR055073-17
- **Recipient organization:** RUTGERS BIOMEDICAL AND HEALTH SCIENCES
- **Principal Investigator:** DIANE E HECK
- **Activity code:** U54 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $255,127
- **Award type:** 7
- **Project period:** 2006-09-15 → 2025-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10490461

## Citation

> US National Institutes of Health, RePORTER application 10490461, Scientific Core - Pharmacology and Drug Development (7U54AR055073-17). Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/grant/nih/10490461. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*