# ADME/FORMULATION Core

> **NIH NIH U19** · SCRIPPS RESEARCH INSTITUTE, THE · 2022 · $1,292,962

## Abstract

SUMMARY
The ADMET/Formulation Core (Core C) provides ADME, formulation, pharmacokinetics, and toxicology
information to inform project teams for optimizing hits and leads from screening campaigns all the way through
good laboratory practice (GLP) and into investigational new drug (IND) status for further testing in humans. This
core is centered within Calibr in the CAMPP consortium and will interface closely with investigators within Scripps
and other institutions who have complementary capabilities in drug discovery assays to provide standardized
and comprehensive drug profiling services. All programs within the medicinal chemistry core spectrum from
formal hit assessment to late lead optimization and preclinical candidate characterization will have
ADME/Formulation/PK work conducted in this core. Determination of drug-like properties of the CAMPP projects
in the lead optimization and hit to lead stages is essential for optimization of early hits to drug candidates. The
ADME/Capabilities include in vitro absorption, distribution, metabolism, elimination (ADME) profiling (cell
permeability, plasma protein binding, hepatic microsomal stability, drug-drug interaction assay and in vivo
pharmacokinetics in rodents and non-rodents, formulation development, in vitro safety pharmacology, and non-
GLP toxicology. In vitro safety assays including cardiotoxicity and mutagenicity will be employed. In vitro ADME
assays are important and will be geared toward higher throughput assays for in vitro assessment for SAR
purposed (Tier 1 ADME) followed by more complex assay for later stage profiling, like mutagenicity assays
including Ames and micronucleus testing (Tier 2 ADME). This core will be thoroughly integrated with Core D to
determine drug exposure pharmacokinetic/pharmacodynamic (PK/PD) relationship of compounds and
formulation assessment of compounds coming from Med Chem Core B. Finally, this core will be able to prepare
an IND for a drug candidate given the extensive experience in filing small molecule INDs that require GLP
toxicology studies in rodents and non-rodents through external lab auditing by FDA and on-site visits by Calibr
staff. The data generated by this core using drug development assays and pharmacokinetic data will be made
available to project teams in real-time along with raw data on assays and mass spectroscopy methods. There is
>50 years of collective drug discovery pharmacology and toxicology experience under the direction of Dr. Sean
Joseph. This includes facilities with four triple quadrupole mass spectrometers for the intensive bioanalysis
capabilities needed to support multiple parallel chemistry programs.

## Key facts

- **NIH application ID:** 10514321
- **Project number:** 1U19AI171443-01
- **Recipient organization:** SCRIPPS RESEARCH INSTITUTE, THE
- **Principal Investigator:** Sean B. Joseph
- **Activity code:** U19 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $1,292,962
- **Award type:** 1
- **Project period:** 2022-05-16 → 2026-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10514321

## Citation

> US National Institutes of Health, RePORTER application 10514321, ADME/FORMULATION Core (1U19AI171443-01). Retrieved via AI Analytics 2026-06-02 from https://api.ai-analytics.org/grant/nih/10514321. Licensed CC0.

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