The Hamner has developed extensive resources to provide sponsored research services as well as support and services to the research programs aligned with its Institutes and Centers. Extensive capabilities in inhalation exposure and aerosol sciences, pharmacokinetics, and general toxicology are available to conduct preclinical safety studies of chemical compounds and drug candidates. Quality assurance (QA) and quality control (QC) procedures are an integral component of The Hamner’s Research Services. If necessary, preclinical safety studies can be conducted under Good Laboratory Practice (GLP) standards as defined by U.S. EPA regulations.
The Hamner’s Research Services are broadly categorized into areas of Preclinical Safety, Inhalation Exposure and Aerosol Sciences, and Additional Capabilities. Preclinical Safety includes general toxicology, pharmacokinetics, toxicokinetics, and carcinogenicity studies. Inhalation projects are conducted in a dedicated and specialized facility. Gases, vapors, dusts, aerosols, and nanoparticles are generated and characterized in whole-body or nose-only animal exposure chambers. Additional Capabilities at The Hamner include necropsy, histology, histopathology, and specialized instrument (e.g., flow cytometry, electron microscopy, confocal microscopy, laser-scanning capture microscopy) expertise.
Representative Research Services and Capabilities
- Fibrogenicity study of inhaled amphibole asbestos in rats
- Rodent carcinogenicity study of methyl tert-butyl ether in drinking water
- Mode-of-action (genomics) study of naphthalene vapor in rats
- In vitro/in vivo mode-of-action study of chromium VI (high-content imaging in cells and genomics in rat tissues)
Dan Kemp, Ph.D., DABT, Director
Daniel C. Kemp Ph.D., DABT, serves as Director of Preclinical Toxicology Services, and is a Hamner Associate Investigator. Dr. Kemp has over 11 years of experience designing and reporting GLP and non-GLP in-life studies in a variety of species. His background is in general toxicology and quality/risk management. He has served as a project representative for diabetes, obesity, cognition, HIV, HCV, and smoking cessation. In addition he has prepared regulatory packages for US and European regulatory submissions. His background includes work with sandwich-cultured hepatocytes, hepatic transport, pharmacokinetic modeling, and leading a gastrointestinal and dermal safety training program. Dr. Kemp has received numerous awards while at GlaxoSmithKline (GSK) for his work in gastrointestinal safety and injury, third party oversight, dermal safety, and assistance with regulatory inspections. Dan received his Ph.D. in toxicology from the University of North Carolina (UNC) at Chapel Hill and his DABT from the American Board of Toxicology. He is currently president of the Drug Discovery Toxicology specialty section and councilor of the Toxicologic and Exploratory Pathology specialty section of the Society of Toxicology, as well as member of the program committee for the American College of Toxicology. He has over 70 proprietary GLP and Non-GLP reports published for GSK, as well as 10 peer reviewed journal articles. In addition, Dan has lectured on biotransformation, gastrointestinal toxicity, and study monitoring at Wake Forest University, UNC, and the Society of Toxicologic Pathology respectively.
For more information on Hamner Research Services, please submit the form on the Contact Us page, with “Research Study Capabilities” selected from the drop-down menu under “Interest.”