# Scientific Core - Pharmaceutics and Midicinal Chemistry

> **NIH NIH U54** · RBHS-SCHOOL OF PUBLIC HEALTH · 2020 · $731,127

## Abstract

Scientific Support Core: Pharmaceutics and Medicinal Chemistry Scientific Support Core
Key Personnel:
Patrick J. Sinko, Ph.D., Core Co-Lead, Co-Leader, Innovative Drug Delivery Team
Ned D. Heindel, Ph.D., Core Co-Lead, Co-Leader, Scale-up and Manufacturing Support Team
Christophe Guillon, Ph.D., Co-Leader, Scale-up and Manufacturing Support Team
Laurie Joseph, Ph.D., Leader, Pre-clinical Formulations Team
C. Jeffrey Lacey, Ph.D., Leader, Compound Library Support Team
Zoltan Szekely, Ph.D., Co-Leader, Innovative Drug Delivery Team
Core Summary/Abstract
The Pharmaceutics and Medicinal Chemistry Scientific Support Core works closely with Center investigators
within the Research and Development Projects and the Pharmacology and Drug Development Core to
discover and optimize lead agents and prospective formulations/drug delivery systems (DDS) that can be used
to treat vesicant poisoning, and to assist in their development into drug products for approval by the FDA. In
order to rapidly translate mechanistic discoveries from the research projects to the clinic, our Center has
identified drug products approved by the FDA for other therapeutic indications and has proposed their use for
treating vesicant toxicity, a new indication. We currently have IND applications in process and are working with
Center investigators to complete IND-enabling studies in support of Pre-IND FDA meetings. The Pre-clinical
Formulations Focus Team works closely with the Pharmacology and Drug Development core and the
Research project teams to produce stable preclinical formulations for initial efficacy and toxicological
assessment. The Innovative Drug Delivery Focus Team is developing novel DDS in order to overcome
biopharmaceutical barriers (e.g., protein instability, poor permeability, or high clearance) or physiochemical
limitations such as poor aqueous solubility or instability. Analytical chemistry support is provided for stability
studies on formulated Active Pharmaceutical Ingredients (APIs), metabolite identification, and pharmacokinetic,
toxicokinetic and pharmacodynamics studies. The Compound Library Support Team is optimizing API
compound classes with previously identified leads and new compound classes are in development. The Scale-
up and Manufacturing Support Team assures the scalability of synthetic processes, process improvements,
optimization of multi-step pathways, availability of clinical grade material and confirmation of the stated
certificate of purity by Contract Manufacturing organizations. In order to promote a countermeasure API to full
pre-IND status, the Medicinal Chemistry team works closely and iteratively with the research projects to
determine the most efficacious therapeutic compounds and backup candidates. This Scientific Support core
then develops the preclinical regimen specifications including dose required, dosing interval, and
pharmacokinetics. Using these specifications, the Pharmaceutics team refines the DD platform technologies
for the s...

## Key facts

- **NIH application ID:** 9982792
- **Project number:** 5U54AR055073-15
- **Recipient organization:** RBHS-SCHOOL OF PUBLIC HEALTH
- **Principal Investigator:** Patrick J. Sinko
- **Activity code:** U54 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $731,127
- **Award type:** 5
- **Project period:** — → —

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9982792

## Citation

> US National Institutes of Health, RePORTER application 9982792, Scientific Core - Pharmaceutics and Midicinal Chemistry (5U54AR055073-15). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/9982792. Licensed CC0.

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