Mission

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.

Strategy

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 (Aug 2016-July 2020)

ACKNOWLEDGING THE CPAC CORE

All work provided by the UNC CFAR Clinical Pharmacology and Analytical Chemistry (CPAC) Core that results in a publication should acknowledge the Core’s contributions. Proper acknowledgment helps demonstrate the Core’s impact on the HIV research community and ultimately helps ensure the Core’s sustainability as a resource in HIV pharmacology. When possible, please send a copy of the accepted manuscript or published paper resulting from Core support to Lauren Tompkins or Mackenzie Cottrell. Similarly, please send the title of any grant proposal that the CPAC Core helps develop.

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Faculty

Angela DM Kashuba, B.Sc.Phm., Pharm.D., DABCP, FCP

Core Director

After obtaining her Bachelor of Science in pharmacy at the University of Toronto, Angela Kashuba, Pharm.D., completed a general practice residency at Women’s College Hospital and practiced as a critical care pharmacist at Mount Sinai Hospital in Toronto, Ontario. Kashuba received her Pharm.D. from the State University of New York at Buffalo and completed postdoctoral pharmacology training at the Clinical Pharmacology Research Center at Bassett Healthcare in Cooperstown, New York. Kashuba joined the UNC-Chapel Hill faculty in 1997.

She was named the John and Deborah McNeill, Jr. Distinguished Professor in 2013 and appointed chair of the Division of Pharmacotherapy and Experimental Therapeutics in 2015. She serves as director of the UNC CFAR Clinical Pharmacology and Analytical Chemistry (CPAC) Core, director of the Analytical Chemistry Laboratory for the Verne S. Caviness General Clinical Research Center, and Dean of the UNC Eshelman School of Pharmacy. She is active in the clinical community as a diplomat of the American Board of Clinical Pharmacology and as a member of the PHASES Working Group.

Kashuba’s research interests surround the clinical pharmacology of antiretroviral agents used in the treatment and prevention of HIV infection. Current projects focus on characterizing mechanisms of antiretroviral distribution in tissue reservoirs of HIV, developing mass spectrometry imaging methods for quantifying adherence, and advancing interventions for real-time adherence monitoring (ENLIGHTEN clinical study).

100C Beard Hall
CB# 7355
Chapel Hill, NC
akashuba@unc.edu
Fax: 919-962-0644
Office Phone: 919-966-1122

Mackenzie Cottrell, Pharm.D., MS, BCPS, AAHIVP

Core Co-Director

Mackenzie Cottrell is an Assistant Professor in the Division of Pharmacotherapy and Experimental Therapeutics at the UNC Eshelman School of Pharmacy. She completed an American Board of Clinical Pharmacology-accredited T32 clinical pharmacology fellowship and an American College of Clinical Pharmacy-accredited HIV pharmacology fellowship within the Kashuba Laboratory. Cottrell joined the UNC CFAR in 2015 as the Assistant Director of the CPAC Core and transitioned to Co-Director in 2019. Her research focuses on the pharmacology of antiretrovirals used for HIV prevention in mucosal tissues, on the discovery of new latency-reversing agents for HIV cure, and on developing long-acting formulations of antiretrovirals.

mlcottre@email.unc.edu
Office Phone: 919-843-0321

Elias Rosen, Ph.D.

Director of Mass Spectrometry Imaging

Elias Rosen is an Associate Professor in the Division of Pharmacotherapy and Experimental Therapeutics at the UNC Eshelman School of Pharmacy. He joined the UNC CFAR in 2014 to lead the CPAC Core’s research program designed to translate the fundamental performance of a novel mass spectrometry imaging platform, IR-MALDESI, for clinical applications. His research focuses on the development of methods to measure the intracellular distribution of therapeutics and their metabolites in a variety of biological matrices using IR-MALDESI. He is currently quantifying the penetration of drugs relevant to HIV treatment and eradication into putative viral reservoirs and combining this approach with traditional imaging modalities to evaluate efficacy of experimental treatment regimens.

eli@unc.edu
Office Phone: (919) 843-7806

Staff

Lauren Tompkins, MS, BA

Core Manager

Lauren Tompkins joined the UNC CFAR in 2020 to ensure the scientific agenda of the CPAC Core is executed efficiently and effectively. She brings over 12 years of experience in scientific and medical writing and over 8 years in virology research (with 4 years specifically in HIV) to her role in program management and communications. She liaises with Core users to expedite the planning and execution of their clinical pharmacology needs, coordinates and participates in strategic planning activities and progress reporting, and supports activities in scientific communication, engagement, and outreach.

ltompkins@unc.edu
Office Phone: (919) 843-7806

Craig Sykes, MS

Bioanalytical Method Development Scientist

Craig Sykes joined the UNC CFAR in 2011 to lead LC-MS/MS assay development for the CPAC Core. He holds a BS in chemistry from UNC-Wilmington and an MS in analytical chemistry from UNC-Chapel Hill, and he has >20 years of experience developing methods in complex matrices in a GLP environment. Craig oversees a team of 3 bioanalytical research scientists as they develop and perform customized LC-MS/MS assays to respond to specific research needs. His research focuses on developing LC-MS/MS methods for uncommon biological matrices such as hair, tissue, and dried blood spots (DBS).

craig_sykes@unc.edu
Office Phone: 919-843-2791

Amanda Schauer, BA

Senior Research Scientist

Amanda Schauer joined the CPAC Core in 2015 to support bioanalytical activities. She holds a BA in chemistry from NC State University and has experience working for a clinical research organization performing sample analysis and quality control activities in a GLP-regulated environment. Amanda supports all bioanalytical activities, including LC-MS/MS method development, validation, and application. She pioneered the Core’s development of a method for adherence monitoring using dried blood spots.

aps5@email.unc.edu
Office Phone: (919) 843-2791

Nicole White, BS

Bioanalytical Research Specialist

Nicole White has been an outstanding analytical chemist at UNC since 1994, and she has received awards in recognition of her exceptional service. Nicole joined the UNC CFAR in 2004 and has been heavily involved in the CPAC Core’s bioanalytical functions ever since. In addition to supporting LC-MS/MS activities, she now performs routine sample analysis by IR-MALDESI and is helping to expand applications of the IR-MALDESI platform. She has an extensive record of accomplishments, having contributed to recent publications in mass spectrometry imaging of hair and tissue, and in the characterization of antiretrovirals in HIV tissue reservoirs, including the brain, by LC-MS/MS.

nicole_white@med.unc.edu
Office Phone: (919) 843-2791

Brian van Horne, BS

Bioanalytical Research Specialist

Brian Van Horne received a BS in chemistry from the State University of New York at Oswego. Before joining the Kashuba lab in 2017, he worked as a Lab Technician in toxicology at Syracuse. Brian joined the CPAC Core in 2018 to support bioanalytical activities. His research focuses on LC-MS/MS method development, validation, and application.

bvanhorn@email.unc.edu
Office Phone: (518) 926-8062

Hannah Bryan, BS

QA Manager and Lab Safety Supervisor

Hannah Bryan joined the UNC CFAR in 2017 to lead the CPAC Core’s Quality Assurance/Control (QA/QC) program. She holds a BS in Animal Science from NC State University and, prior to joining the Core, spent six years conducting both discovery and regulated research for a clinical research organization in Research Triangle Park. Hannah currently oversees all quality control and quality assurance aspects of the analytical study data that is generated in the lab, maintains CLIA and CAP certification and standard operating procedures, submits validation reports to the DAIDS-sponsored CPQA program, oversees external proficiency testing, and ensures laboratory safety through training and procedural compliance.

hebryan1@email.unc.edu
Office Phone: 919-843-2791

AMANDA POLISENO, BS

CLINICAL RESEARCH COORDINATOR

Amanda Poliseno graduated from the University of South Florida in 2015 with a BS in public health. She joined the CPAC Core in 2017 as a Clinical Research Assistant and became the Core’s Clinical Research Coordinator in 2020. Amanda brings her previous training as an EMT to support her role overseeing the conduct of clinical pharmacology studies. Additionally, she collaborates with the Clinical Core to source incurred biological specimens for bioanalytical method development.

amanda_poliseno@unc.edu
Office Phone: (919) 962-5344

JUSTIN JONES, BS

Research Assistant

Justin Jones received a BS in biology with a concentration in Health Sciences from High Point University in North Carolina. Prior to joining the CPAC Core in 2019, he worked as a Medical Scribe in an underserved parish of Louisiana. Justin currently oversees procurement and inventory activities, maintains sample chain of custody, and coordinates with investigators for sample shipment and receipt.

jecjones@email.unc.edu
Office Phone: (919) 843-7806

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 budgeting inquiries. All bioanalytical services require completion of a shipment manifest prior to scheduling the shipment with Justin Jones.

The UNC-Duke Collaborative Clinical Pharmacology T32 Postdoctoral Training Program is a collaboration between the UNC Eshelman School of Pharmacy, the UNC Institute for Drug Safety Sciences and the Duke Clinical Research Institute to prepare clinician-scientists to become leaders in clinical pharmacology research. More information about the program can be found here.