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Clinical Pharmacology Core

1) Analytical Laboratory

The Alan Bernstein Laboratories have 2,500 ft2 of newly-renovated space and are well equipped for processing and analyzing samples obtained in human studies. This includes equipment for sample processing (four centrifuges, two SpeedVacs, tissue microtome), sample storage (three -20°C and four -80°C freezers), reagent preparation (two fume hoods), and tissue culture (three biosafety cabinets, four incubators).

Analytical methodologies include:

Wizard II gamma counter, Liquid TriCarb2810 scintillation counter, Guilford spectrophotometer, Guava® EasyCyte Plus System flow cytometer, Kinetic Microplate reader, Nikon Labophot-2 microscope, two complete Alliance-controlled HPLC systems, one Alliance-controlled UPLC systems, inline fluorescence and radioisotope detectors. An Applied Biosystems API4000 LC/MS/MS system, Applied Biosystems API5000 UPLC/MS/MS system, and their supporting nitrogen generator and computers occupy a dedicated 300 ft2 of climate-controlled lab space. In 2010, we acquired two additional UPLC/MS/MS systems (API4000 and API5500). Analytical laboratory space is regularly utilized for investigational drug studies, and the staff adheres to Good Laboratory Practice in processing and analyzing samples. The facilities are approved by the Johns Hopkins University Biosafety Office for work involving cells and fluids from HIV-infected subjects, and are also approved for work with live recombinant vaccinia viruses, herpes simplex viruses, adenovirus, human cytomegalovirus, African trypanosomes and malaria parasites.

2) Pharmacokinetic/Pharmacodynamic Laboratory

This laboratory is equipped with three semi-automated pharmacokinetic/pharmacodynamic systems. At the heart of these "cartridge systems" is a bundle of hundreds of semipermeable hollow fibers that traverse a closed cylinder, effectively dividing the cylinder contents into two compartments (intrafiber and extrafiber) between which small molecules freely exchange. Cells and/or pathogens of interest are introduced and maintained in the extrafiber compartment and medium containing the desired concentrations of study drug flows continuously through the fibers. Dynamic drug levels are obtained by a series of programmable pumps and reservoirs. Throughout the experiment aliquots of cells/pathogens may be tapped and assayed for the pharmacodynamic endpoint(s). The system can mimic first order human pharmacokinetics and it allows the simulation of doses and dosing regimens of choice, against microbes of interest (including intracellular viruses, mycobacteria, and protozoa). The lab also includes a biosafety cabinet and four tissue culture incubators.

3) Drug Development Laboratory

The Drug Development Unit is headed by Dr Craig Hendrix and housed in 800 ft2 of office space immediately adjacent to the inpatient Clinical Research Unit (CRU). The clinical staff implement, under Good Clinical Practice guidelines, research directed by faculty and fellows in the Division. Edward Fuchs, PA-C, MBA serves as the Associate Director of the Unit; a Research Associate serves as Quality Assurance Specialist; a Research Nurse Coordinator, two Clinical Research Coordinators and one additional clinical research recruiter/staff person assist in the development of clinical protocols, manage all Institutional Review Board and CRU regulatory requirements.

4) Statistical and Analytical Support

The Division has substantial capacity for computerized pharmacokinetic and pharmacodynamic data analysis (performed by Hendrix and Dooley; see also Information systems, below). A back-up of clinical research data on the Medical Institution LAN is performed daily. A hard copy of all protocol-specific information is also maintained in a secure location. For larger or more complex studies, the CRU provides readily-available support at the faculty level and several collaborations have been established with faculty in the Department of Biostatistics in the School of Public Health.

5) School of Medicine Core Facilities

  • Oligonucleotide and peptide synthesis. Two locations on campus offer these services at cost.
  • Microscopy. This extensive facility provides training on and use of transmission and scanning electron microscopes and confocal microscopes.
  • High throughput center. The School maintains a robotics laboratory for enzymatic and biologic assays, and a microarray facility.
  • Flow cytometry. Provides training, use of facilities, and assistance with data interpretation.

Institute for Cell Engineering encompasses core research programs in stem cell biology and the McKusick-Nathans Institute of Genetic Medicine dedicated to understanding human heredity and genetic medicine and using this knowledge to treat and prevent disease.

6) High throughput assays

The lab of Dr Liu occupies six rooms (about 2,300 s.f.) located on the fifth floor of the Hunterian Building, which is connected to the rest of the Hopkins Basic Science Complex and to the Johns Hopkins Clinical Research Complex. It has a dark room and a shared cold room. The lab is fully equipped to perform experiments in synthetic organic chemistry, molecular biology, protein biochemistry, cell biology. A separate room is designated for organic synthesis with the capacity of housing three synthetic chemists. The Johns Hopkins Drug Library is housed in a separate room of ca 150 s.f. with five -20 degree C freezers.

See also Dr Bumpus' lab.


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