Clinical Pharmacology and Analytical Chemistry Core

About

The overarching goal of the Clinical Pharmacology and Analytical Chemistry (CPAC) Core is to facilitate the development of safe, effective strategies for HIV prevention, treatment, and cure. To achieve this goal, the CPAC Core provides expertise in small molecule drug development to assist investigators in nearly all aspects of HIV pharmacology research. This full-spectrum support, unique to our Core facility, helps advance preclinical and clinical HIV research towards ending the HIV epidemic.

Members of the CPAC Core work with investigators to identify and deliver services that best meet their research needs. Through highly interactive collaboration, the Core helps progress activities at each stage of HIV research, from study design and grant writing, to bioanalysis and mass spectrometry imaging, to data modeling and simulation, to publication and future work. The Core’s activities are augmented by institutional support from the UNC Eshelman School of Pharmacy, which links the Core with faculty renowned for their expertise in specialized fields of pharmacology.

The CPAC Core supports the global community of HIV researchers through fundamental services in drug quantification. These services are performed within a CAP/CLIA-accredited environment using six redundant AB Sciex instruments for LC-MS/MS analysis and two IR-MALDESI systems for small-molecule imaging. Redundancy allows for rapid resulting for studies with large sample numbers, as well as simultaneous assay development and sample analysis activities performed on consistent platforms. The Core’s bioanalytical capacity helps sustain collaborations within every inhabited continent.

Global CPAC Core Collaborations (Since Aug 2016)

Core Services

Clinical Pharmacology Services

Expertise in clinical pharmacology is the bedrock of the CPAC Core and the central mechanism by which the Core executes its Mission. This guiding principle drives the Core’s research agenda, strategic plan, and service framework in effort to advance NIH HIV research priorities spanning prevention, treatment, and cure. Services in clinical pharmacology are available at nearly every stage of preclinical and clinical HIV research, making the CPAC Core a unique resource outside the industry setting.

Bioanalytical Services

The CPAC laboratory provides state-of-the-art, customizable services in bioanalytical chemistry to support the HIV research community. A large portfolio of LC-MS/MS methods are available for quantifying drugs, drug metabolites, and other small molecules in plasma and in a variety of uncommon/complex biological matrices such as tissue, dried blood spots (DBS), and hair. Preclinical and clinical samples analyzed with these methods can be divided into 3 categories (or “Tiers”) based on research needs and bioanalytical criteria:

Tier 1 – Discovery (preclinical data, preliminary data, research studies)
Tier 2 – Qualified (preclinical or clinical research purposes suitable for publication, method qualified by 1 day of Precision and Accuracy)
Tier 3 – Validated (clinical studies for FDA submission, TDM, PT, method fully validated according to FDA guidelines)

The CPAC Core recovers costs through a registered recharge center. Service rates are calculated and reviewed at least every two years and are designed to cover costs without profit. Rates for sample analysis and method development are stratified by level of service. Budgets can be prepared on a per sample basis for a streamlined approach to service requests. Contact Lauren Tompkins for service inquiries.