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Goals

The broad, long-term objectives of the Clinical Pharmacology and Analytical Chemistry Core are to provide a full spectrum of pharmacologic support for HIV/AIDS-related research of the UNC CFAR. Members of the Clinical Pharmacology and Analytical Chemistry Core proactively engage UNC CFAR investigators to identify and deliver services essential for highly productive design, management, analysis and publication of HIV/AIDS research. The Core contributes to the framing of hypotheses, development of study designs, preparation of grant applications, selection or creation of best analytical chemistry and pharmacometric methods, facilitating multidisciplinary and translational approaches to the design of and conduct of clinical studies, and delivery of preclinical or clinical analyses. Investigators new to HIV/AIDS research receive highest priority for Core services. Strong institutional support from the School of Pharmacy allows the Core to take full advantage of existing infrastructure, resources and contacts with faculty renowned for their expertise in specialized fields of pharmacology. The Core supports drug quantification in a variety of matrices with 6 AB Sciex 5000 Triple Quadrupole Mass connected to Shimadzu HPLC systems running on Analyst software and an infrared matrix assisted laser desorption electrospray ionization (IR-MALDESI) imaging source coupled to a Thermo QExactive/H-ESI II Bundle mass spectrometer similar to that housed in the inventor of this technology’s laboratory (David Muddiman, North Carolina State University).

CPAC Laboratory Aims

Aim 1

Provide access to a diverse array of cost-effective services for pharmacology research.

Aim 2

Stimulate, develop and disseminate new innovative technologies and services to enhance HIV/AIDS research.

Aim 3

Support priority CFAR initiatives and goals and collaborative research.

Aim 4

Develop and promote synergistic relationships between the UNC CFAR Cores and Working Groups, and other CFAR.

Aim 5

Provide clinical pharmacology, pharmacometric, and analytical chemistry training, mentoring, and education, and outreach.

Aim 6

Engage in evaluation and strategic planning.

CPAC Validates Novel Assay to Measure Antiretrovirals in Dried Blood Spot for Adherence Monitoring

The Clinical Pharmacology Core has recently developed and validated a sensitive, multiplex LC-MS/MS assay to measure the intracellular metabolites of the 3 most commonly prescribed NRTIs (tenofovir, emtricitabine, and lamivudine) in dried blood spots collected from patients on therapy. This assay allows investigators to monitor adherence in clinical trials with the convenience of dried blood spot sampling, storage and shipping. The addition of lamivudine, which is generically available, opens up opportunity for international investigations. Our methods and findings are in press in the Journal of Pharmaceutical and Biomedical Analysis (Schauer et al. Validation of an LC-MS/MS Assay to Simultaneously Monitor the Intracellular Active Metabolites of Tenofovir, Emtricitabine, and Lamivudine in Dried Blood Spots. JPBA. In press).

Acknowledgement, Recognition and Future Service

All work provided by the UNC CFAR Clinical Pharmacology and Analytical Chemistry Core which is included in a publication should acknowledge the contribution of the Core. Proper acknowledgment enables us to obtain financial and other support so that we can continue to provide essential services in the best ways possible. It would be appreciated if you sent a copy of the accepted manuscript, published paper, or title of grant application to mlcottre@email.unc.edu. This will allow us to demonstrate our impact to the research community.

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 Center for AIDS Research Clinical Pharmacology and Analytical Chemistry Core, and director of the Analytical Chemistry Laboratory for the Verne S. Caviness General Clinical Research Center. She is a diplomat of the American Board of Clinical Pharmacology. Research Kashuba’s research interests focus on the clinical pharmacology of antiretroviral agents used in the treatment of HIV infection. Specifically, she is investigating the role of antiretroviral therapy in preventing the transmission of HIV, determining optimal dosing and drug combinations for the treatment of HIV infection, understanding and predicting drug-drug and drug-cytokine interactions and adverse effects, and role of sex and ethnicity in drug disposition.

3318 Kerr Hall
CB# 7569
Chapel Hill, NC
akashuba@unc.edu
Fax: 919-962-0644
Office Phone: 919-966-9998

Mackenzie Cottrell, Pharm.D., MS

Assistant Core Director

 

Mackenzie Cottrell is a Research Assistant Professor in the Division of Pharmacotherapy and Experimental Therapeutics at UNC Eshelman School of Pharmacy. She is a Board Certified Pharmacotherapy Specialist and an American Academy of HIV Medicine™ accredited HIV Pharmacist. Her research focuses on describing pharmacokinetic/pharmacodynamic relationships in mucosal tissues for antiretrovirals being used in HIV prevention and cure interventions.

 

mlcottre@email.unc.edu
Office Phone: 919-843-7806

Elias Rosen, Ph.D.

Imaging Mass Spectrometry Scientist

rosen

 

Elias Rosen’s research focuses on the development of methods to measure intracellular distribution of therapeutics and their metabolites in a variety of biological matrices using mass spectrometry imaging. 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) 966-9998

Jason Pirone, Ph.D.

Pharmacometrician

 

Jason Pirone uses mathematical and statistical techniques to develop pharmacokinetic and pharmacodynamic models for antiretroviral drugs. These models are used to assess the effects of novel regimens and patterns of adherence, as well as to help elucidate aspects of host- and virus-biology relevant to the development of effective treatments.

 

pirone@email.unc.edu
Office Phone: 919-962-5151

Heather Prince, MPA, PA-C

Clinical Study Specialist

 

Heather Prince joined the UNC CFAR in 2008. She holds an AS and BA in Microbial Genetics from Peace College, and an MPA from Eastern Virginia Medical School. She has completed post-graduate surgical training at Eastern Virginia Medical School, Emory University, Harvard University and John Hopkins University. She is a Certified Clinical Research Professional who oversees all clinical aspects of research studies, from protocol development to implementation and patient care.

 

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

 

Lab Management

John H. Dohnal, BS, MBA

Laboratory Operations Manager

J_Dohnal400x400

 

John Dohnal joined the UNC CFAR in 2014 and brings 20 years of management and 13 years of quality experience to the Kashuba Lab. Dohnal received a BS in biochemistry from Florida State University and an Executive Masters of Business Administration with concentration in Health Sector Management from the Duke Fuqua School of Business. Dohnal’s focus is ensuring laboratory safety, supervising work study students and interns, sample chain of custody, streamlining laboratory work flows, automation of data processes, creating and maintaining a robust community outreach and social media presence, and continuous improvement in the lab.

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

Hannah Bryan, BS

QA/QC Officer

 

Hannah Bryan holds a BS in Animal Science from NC State University. Prior to joining the UNC CFAR in 2017, she spent six years conducting both discovery and regulated research for a Clinical Research Organization in Research Triangle Park. Hannah currently oversees all quality control aspects of the analytical study data that is generated in the lab.

 

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

Research Specialists

Craig Sykes, MS

Bioanalytical Method Development Scientist

Craig Sykes

 

Craig Sykes holds a BS in chemistry from UNC-Wilmington and an MS in analytical chemistry from UNC-Chapel Hill. Prior to joining the UNC CFAR in 2011, he spent nine years developing GLP-compliant assays for several contract research organizations (CROs). He has extensive experience in LC-MS/MS method development, method validation, and sample analysis in a regulated environment. He is responsible for the development and validation of bioanalytical assays for the UNC CFAR.

craig_sykes@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. White oversees analytical methods and standard operating procedures in the laboratory. She has been with the UNC CFAR since 2007.

 

nicole_white@med.unc.edu
Office Phone: 919-843-1016

Kimberly Blake, MPH

Bioanalytical Research Specialist

 

Kimberly Blake joined the lab in February 2016.  Prior to joining UNC, she served in public health laboratories performing LC-MS/MS analyses to detect inborn errors of metabolism.  Handy received a BA in Biology from UNC-Chapel Hill and a Master of Public Health from East Carolina University.

 

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

Amanda Schauer, BS

Bioanalytical Research Specialist

 

Amanda Schauer joined the UNC CFAR in January 2015 with a BA in chemistry from NC State University. Before joining UNC in 2015, she worked for a CRO company doing sample analysis and quality control in a GLP-regulated environment. Schauer is responsible for LC-MS/MS analytical methods and sample analysis in the laboratory.

 

aps5@email.unc.edu
Office Phone: (919) 966-9998

 

Clinical Pharmacology Services

Click here to download the CPAC Manifest Template to request analytical services.

Training & Tutorial Consultation
Planning & Study Design
Grant Proposal Support
Pharmacokinetic/Dynamic Computation
Therapeutic Drug Monitoring
Coordination & Project Management
Mentoring
Referrals

Analytical Services

The preclinical and clinical samples that are analyzed in our lab can be divided into 3 categories:

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

The samples the CPAC laboratory analyzes come in a variety of human and animal matrices, including, but not limited to:

-blood
-serum
-plasma
-urine
-feces
-saliva
-sputum
-peripheral blood mononuclear cells (PBMCs)
-red blood cells (RBCs)
-cervical tissue*
-rectal tissue*
-vaginal tissue*
-adipose tissue*
-rectal fluid
-cerebrospinal fluid (CSF)
-breast milk
-cervicovaginal fluid (CVF)
-semen
-dried blood spots (DBS)

Analysis costs start at $80 per sample. *Tissue analysis costs start at $100 per sample. If weights of tissues samples are not provided by the investigator, tissues can be weighed in the CPAC lab for an additional fee. QA/QC charges are calculated based on the service level (Tier 1-3) and added to the base sample analysis costs. Contact john_dohnal@unc.edu for budgeting inquiries.

Available Assays
Analytical Methods R&D

Publications

2017
2015
2014
2013
2012

Abstracts

2017
2016
2015
2014
2013
2012
2011
2010

If any facility personnel makes a substantial intellectual and/or experimental contribution to a publication they deserve recognition just as any other co-author. This is essential for the professional development of our staff. We recommend scientists follow the “ABRF Recommended Guidelines for Authorship on Manuscripts.” Services provided on a fee-for-service basis does not diminish the importance of our scientists impacting your research.