Clinical Pharmacology

UZ Center of Excellence in HIV Clinical Pharmacology: The University of Zimbabwe academic leadership have designated the UZ Center of Excellence in HIV Clinical Pharmacology as a high priority initiative. The HRTP trains clinical pharmacology investigators and laboratory scientists to expand the capacity of the Center of Excellence and increase the competitiveness of the grant applications submitted. The UZ clinical pharmacology laboratory was implemented in 2011 with funding from NIAID with the goal of establishing an academic research laboratory that would provide a core resource for UZ clinical researchers. The laboratory is focused on innovative drug assay development, clinical pharmacology training and becoming a source of UZ investigators for NIAID HIV research network protocols. The laboratory has made great progress, and in December 2014 received designation as an ACTG International Pharmacology Specialty Laboratory. The UB-UZ HRTP has used the laboratory for training UZ graduate students to become independent investigators with a long-term goal of establishing a leading center in HIV Clinical Pharmacology.

Key points in the laboratory development include:

* Transitioning the laboratory from its initial site in the UZ College of Health Sciences to a new facility in the Zimbabwe Medicines Control Authority (MCAZ) with a ten–year lease agreement.

* The UZ Pharmacology Specialty Laboratory collaborates with the African Institute of Biomedical Science and Technology (AiBST). AiBST provides another highly qualified HRTP mentor, Prof. Collen Masimirembwa (DPhil, PhD), the President and Chief Scientific Officer. In addition, current trainees have access to additional mass spectrometry instrumentation to conduct the proposed HRTP clinical pharmacology research projects.

* The New Partnership for Africa’s Development which is the planning and coordinating technical body of the African Union recently designated the MCAZ as a Regional Center of Regulatory Excellence in drug laboratory analysis. The regional center is receiving support from the European and Developing Countries Clinical Trials Partnership.

UZ International Pharmacology Specialty Laboratory - NIAID ACTG Laboratory Center Network: In 2014, the UZ HIV Clinical Trials Unit (CTU) successfully competed to be a NIAID CTU with a 7 year award period. The CTU conducts research protocols developed by the NIH’s AIDS Clinical Trials Group (ACTG), International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT), HIV Prevention and Treatment Network (HPTN), Microbicide Trials Network (MTN) and Vaccine networks and utilizes the clinical pharmacology laboratory for bioanalysis, protocol development and pharmacokinetic analysis and modeling.

* The UZ Pharmacology Specialty Laboratory is the only NIH specialty laboratory at the UZ CTU site. 

* The UZ Pharmacology Specialty Laboratory was initially funded through a competitive award by the NIAID AIDS Clinical Trials Group in 2012 as a “developmental” laboratory. The funds were used to establish the laboratory and begin to train laboratory staff.

* In December 2014, the UZ pharmacology laboratory was elevated in status by NIAID to a fully implemented International Pharmacology Specialty Laboratory. This designation provides funding to support full-time laboratory technicians, and a supply budget.

NIAID HIV Clinical Pharmacology Laboratory Proficiency Testing Program: In 2010, NIAID added the UZ Clinical Pharmacology Laboratory to the network of labs that are eligible to participate in semi-annual proficiency testing through the NIAID Clinical Pharmacology Quality Assurance (CPQA) Program. Inclusion in the proficiency testing program is accompanied by technical guidance from the CPQA and is a valuable resource for the UZ Center of Excellence in HIV Clinical Pharmacology as it expands the number of drug assays as well as the inclusion of new cells/tissue samples for bioanalysis.