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Clinical Research

A grim statistic is driving Steven Rosenberg’s mission to find new cancer treatments—and his partnership with Frederick National Laboratory (FNL) to do so. “Every year in the United States, about 600,000 people die of cancer, 90% of whom die of the solid epithelial cancers,” said Rosenberg, the M.D., Ph.D., chief of the National Cancer…
Since its inception, the Biopharmaceutical Development Program has manufactured more than 250 lots of 100 different biopharmaceuticals to support human clinical studies, including: Proteins and peptides Recombinant proteins Monoclonal antibodies (murine/humanized/chimeric) Immunotoxins Cytokines Immunocytokines Nucleic acids…
The Virus Isolation and Serology Laboratory performs sequential serologic, virus detection and quantification, and genotyping studies for the National Institute of Allergy and Infectious Diseases.   The results of these studies provide information to further research and support ongoing drug efficacy and epidemiology studies.   The Virus…
The Neutrophil Monitoring Laboratory performs testing to assess neutrophil dysfunction in patients with various primary immunodeficiencies.  We develop state-of-the-art assays to evaluate a variety of neutrophil functions such as reactive oxygen species production, chemotaxis, cell shape change and spreading, exocytosis, and alterations in…
The Immunological Monitoring Laboratory monitors clinical trials of viral diseases, processes clinical specimens, and analyzes immune system responses.  The laboratory processes and archives blood products from patients enrolled in numerous ongoing clinical trials at the National Institutes of Health Clinical Center. This extensive archive…
The Flow Cytometry Support Laboratory is a clinical laboratory that provides state-of-the-art diagnostic clinical flow cytometric testing and immunophenotyping.  We support the National Cancer Institute Flow Cytometry Laboratory in the Laboratory of Pathology. The majority of flow cytometric testing we perform involves detecting minimal residual…
The Clinical Support Laboratory provides clinical trial processing support to the National Cancer Institute and performs sample testing with an emphasis on immune function.  We work with National Cancer Institute investigators on immune status of clinical trial subjects treated with anti-cancer immune modulators.    The laboratory provides…
The Blood Processing Core monitors viral load in patients with HIV and performs sequential studies using samples obtained from patients with cancer, AIDS, chronic granulomatous disease, or other diseases associated with immunologic dysfunction.  The core collects clinical specimens from inpatient units and clinics within the National Institutes…
The Bioprocessing Laboratory integrates clinical and laboratory activities through full specimen lifecycle management.  The Bioprocessing Laboratory and Trial Logistics Support Group partners with intramural and extramural investigators to translate clinical workflows into practical specimen collection, processing, and storage procedures.  These…
The AIDS Monitoring Laboratory provides clinical trial support by performing sequential studies of immune function in individuals with HIV or other emerging or re-emerging infectious diseases throughout the patient’s treatment.  Our work helps assess the efficacy and mode of action of investigational treatment agents and guides determination of …