2011 - NIH Clinical Center - National Institutes of Health

PHARMACEUTICAL DEVELOPMENT SECTION UPGRADES TONEW, TAILOR-MADE SPACEThe unique and groundbreaking work of theClinical Center calls for clinical trial drugs notalways available from a study sponsor, so we makeour own.The CC Pharmacy Department PharmaceuticalDevelopment Section (PDS) was established in1956 and has operated in several areas over the lasthalf-century. Evolving good manufacturing practices,as mandated by the Food and Drug Administration,presented an opportunity to upgrade thePDS environment and equipment in a new spacecreated especially for the section.PDS formulates and analyzes vaccines and medicationsnot able to be purchased from manufacturers.These products account for one-third of the1,000 separate drugs (including placebos andvarying strengths) that the CC uses in its researchprotocols, said PDS Chief George Grimes, Jr.An example is a topical, sterile gel of resiniferatoxin,which PDS is developing for researchinto its utility as a pain treatment in an upcomingNational Institute of Dental and CraniofacialResearch protocol from Dr. Mike Iadarola, chiefof the NIDCR Integrative Neurobiology andNeuronal Gene Expression Unit, and Dr.AndrewMannes, staff clinician in the CC Department ofPerioperative Medicine.The section also registers and packages all drugsobtained from outside pharmaceutical companiesfor use in CC clinical trials.“We handle all investigationaldrugs,” Grimes said.“In the double-blindstudies in particular, all the drugs look alike, so wehave to be really good about record-keeping andprocedures.”In the new facility, there’s a different room forseemingly every step of their process, allowing forbetter air and overall quality control, Grimes said.Where staffers work with HIV-infected blood inthe Clinical Pharmacokinetic Research Laboratory,for example, negative air flow (pulling more air inthan is pumped out) and the use of a biologicalsafety cabinet decreases the risk of contaminationoutside the confines of the laboratory.Clinical Pharmacokinetic Research Laboratorystaff characterize how drugs are excreted andmetabolized, another function of the PDS.Pharmaceutical DevelopmentSection Chief GeorgeGrimes, Jr., does the honorsat a ribbon-cutting onJanuary 8, 2010. With himare CC Director Dr. John I.Gallin (left) and PharmacyChief Robert DeChristoforo.PDS staff (from left) KumiIshida, Scott Hotaling, andRam Agarwal adjust the newautomatic capsule machinein their section’s updatedarea.ANNUAL REPORT 2011• 23