Clinical Pharmacology & Experimental Therapeutics Center
Clinical Pharmacology & Experimental Therapeutics Center
The center provides pharmaceutical expertise to conduct and support preclinical and clinical/translational trials, and postmarketing assessment of pharmaceutical drugs. The Clinical Pharmacology & Experimental Therapeutics Center consists of three core areas of focused research:
- Pediatric Pharmacology Research & Development Core
- Experimental Therapeutics Core
- North Texas Clinical Pharmacology Cancer Core (funded in part by the Cancer Prevention and Research Institute of Texas)
Primary areas of research focus:
- Pharmacokinetics/Pharmacodynamics
- Drug metabolism
- Drug formulation and delivery
- Biomarker identification
- Chemical characterization
Analytical Instrumentation:
The Center’s analytical laboratory specializes in developing and validating methods for the analysis of both small- and large-molecule pharmaceutical agents, their metabolites, and biomarkers in complex biologic matrices using state-of-the-art bioanalytical techniques.
- A Sciex QTRAP® 6500+ which is interfaced with a UHPLC, nano-LC or micro-LC system.
- A Sciex QTRAP® 5500 which is interfaced with a UHPLC, nano-LC or micro-LC system.
A Sciex TripleTOF™ 5600 which is interfaced with interfaced with a UHPLC, nano-LC or micro-LC system.
The Center’s UHPLC-MS/MS systems can be interfaced with Sciex’s SelexION™ which provides the unique capability to separate analytes with identical molecular weights and retention times.
Faculty Members:
Associate Professor
Departments of Pharmacy Practice
Focus of Research:
Dose Optimization and Outcomes Research
Dr. Hall serves as the Division Head of Clinical and Translational Research, and Director of the Dose Optimization and Outcomes Research (DOOR) program. Dr. Hall work has resulted in over 40 peer-reviewed publications. He has collaborated on grants funded by the Cancer Prevention and Research Institute of Texas, National Institutes of Health, Laura W. Bush Institute for Women’s Health, as well as the pharmaceutical industry.
Assistant Professor
Departments of Pharmacy Practice and Pharmaceutical Sciences
Focus of Research:
Drug Metabolism and Drug Discovery
Dr. Li is a basic science and translational medical researcher who has broad training in analytical chemistry, medicinal chemistry and structural biology. She works closely with the North Texas cancer research community to provide comprehensive analytical support through the North Texas Clinical Pharmacology Cancer core.
Dr. Li's research focuses on combing mass spectrometry-based analytical platforms and cell disease models to explore new drug targets. She has a particular interest in drug targets that potentially link metabolic disorders (such in Type II diabetes, cancer) with neurodegenerative diseases.
Professor
Departments of Pharmacy Practice and Pharmaceutical Sciences
Focus of Research:
Clinical Pharmacology and Metabolism
Dr. Putnam's work in clinical pharmacology and experimental therapeutics over the past 20+ years has led to the development, approval and commercialization of numerous drugs and biologics for various clinical indications. His experiences as a faculty at research-intensive colleges of pharmacy, Group Leader for bioanalytical chemistry at a leading non-for-profit research institute, and General Manager for an international drug-development focused scientific and regulatory consulting firm provide him with a broad, in-depth perspective uncommon in analytical laboratories.
Capabilities
Overall, the Clinical Pharmacology & Experimental Therapeutics Center specializes in conducting pharmacology studies on experimental therapeutics.
Specific capabilities of the Center include:
- Bioanalytical method development
- Bioanalytical method validation
- Blood/Plasma/Serum sample analysis
- Tissue sample analysis / tissue distribution analysis
- Analyte/formulation stability studies
- Automated sample preparation
- Small molecule bioanalytical sample analysis
- Biomolecule bioanalytical sample analysis
- Metals analysis
- Pharmacokinetic determinations
- Targeted metabolite studies
- Chemical characterization of small molecules, biotherapeutics, formulated products and botanical extracts
- Regulatory development input
Additional services provided by Center faculty:
- Program and protocol development and support
- Analyses and interpretation of PK and PK/PD data
- Population PK analysis for optimal dosing
Facilities
- Laboratory space: ~2,500 square feet
- General equipment: analytical balances, pipettes, pH meters, centrifuges, two Labconco CentriVap® systems, two Nitrogen-evaporation systems, two refrigerators (5 ± 3 °C), two freezers (-20 ± 10 °C) and four ultra-freezers (-80 ± 10 °C). The ultra-freezers are continuously monitored and clinical samples are inventoried using FreezerPro® software package. Specialized automated sample preparation equipment includes an Eppendorf epMotion M5073 and a Tomtec Quadra 4® automated liquid handling systems.
- Tissue preparation equipment: Pro Scientific DPS-20 homogenization system (ultrasonic and mechanical homogenization); Leica RM2255 microtome, Leica CM3050S Cryostat, and a Leica LMP6 laser microdissection system.
- Mass spectrometric instrumentation includes: Sciex QTRAP® 6500+, Sciex QTRAP® 5500, Sciex TripleTOF™ 5600, and an Agilent 7700 ICP-MS. The Sciex QTRAP®and TripleTOF™instruments can be interfaced with Shimadzu Nexera UHPLC systems or Eksigent exspert™nano-LC/micro-LC system. Additional gradient liquid chromatographic (HPLC) systems are available with Shimadzu UV/Vis, ELSD and Dionex electrochemical detectors. Specialized analytical software includes Sciex’s Analyst™, PeakView™, SWATH™, and MultiQuant™ software packages.
- Pharmacokinetic modeling software: Certara Phoenix 64 WinNonlin v6.4.
About:
Founded in 2004
Located in Dallas Medical District adjacent fo the UT Southwestern Medical Center
Ronald Hall, Pharm.D., MSCS
Center Director
214-358-9009
5920 Forest Park Rd Dallas, TX
Pricing:
Academic pricing is available for research collaborations where the investigators hold primary appointments with institutions of higher education. Due to external funding from the Cancer Prevention & Research Institute of Texas (CPRIT), special pricing is available to support cancer investigations.
Grant and Contract Funding:
Sustained since 2004
Funders: NIH, NICHD, NCI and others
North Texas Clinical Pharmacology Cancer Core: Significant funding has recently been awarded by the Cancer Prevention and Research Institute of Texas (CPRIT) to further develop the core (second 5-year award).
CTSA core facility