Clinical Research Faculty Thomas B. Casale, M.D. Roger W. Fox, M.D. [email protected] [email protected]

• Director, Clinical & Translational Research • Professor of , Pediatrics, and Public Health • Professor of Medicine • Board certified in Internal Medicine and Allergy and Immunology • Board certified in Internal Medicine and Allergy and Immunology Mark C. Glaum, M.D., Ph.D. Richard F. Lockey, M.D. [email protected] [email protected] • Associate Professor of Medicine and Pediatrics • Associate Director, Clinical Research & Translational Research • Board certified in Internal Medicine and Allergy and Immunology • Director, Division of Allergy and Clinical Immunology • Distinguished University Health Professor • Professor of Medicine, Pediatrics, and Public health Basic Research Faculty • Joy McCann Culverhouse Chair of Allergy and Immunology • Board Certified in Internal Medicine and Allergy and Immunology Michael Teng, Ph.D. University of • Associate Professor of Medicine, Molecular Medicine and Pediatrics Dennis K. Ledford, M.D. South Florida [email protected] Narasaiah Kolliputi, Ph.D. • Professor of Medicine and Pediatrics • Associate Professor of Medicine, Molecular Medicine and Pediatrics Division of Allergy and Immunology • Mabel and Ellsworth Simmons Professor Allergy and Immunology • Board certified in Internal Medicine, Allergy and Immunology, and Rheumatology Jia Wang, Ph.D. Clinical and Translational Research Unit • Assistant Professor of Medicine, Molecular Medicine and Pediatrics The Joy McCann Culverhouse Airway Disease Research Center CLINICAL EXPERTISE CLINICAL PROCEDURES LABORATORY CAPABILITIES

• Allergic rhinitis • Acoustic rhinometry • Pollen counts • Flow cytometry • Real-time quantitative PCR • Allergen immunotherapy • Allergen challenge () • Rhinoscopy ➤➤Cell surface phenotyping of ➤➤Analysis of PBMC cytokine/ Department of Internal Medicine • Angioedema, acute and chronic • Allergen challenge (nasal, using • peripheral blood mononuclear cells chemokine mRNA expression • Asthma acoustic rhinometry) • with pre- and (PBMC), up to 14 parameters (BD (individual cytokines genes or • Atopic eczema • Allergy skin test post- bronchodilation FACS Canto II) PCR arrays) • Bronchitis, acute and chronic • Asthma control test • Sputum induction ➤➤Intracellular cytokine staining of ➤➤Identification and • Contact dermatitis • Blood draw • Study drug infusion PBMC quantification of plasma • COPD • ECG • Urine drug screen ➤➤Apoptosis/cell cycle assays miRNA (proprietary TaqMan • Exercise-induced asthma • End-point skin titration • Urine hCG ➤➤Functional analysis of lymphocyte assay) • Hereditary angioedema • Exercise challenge populations •ELISA • Headaches (migraine and tension) • Exhaled nitric oxide ➤➤Magnetic (Miltenyi Automacs Pro) ➤➤Detection of serum / body • Immunodeficiency • Hypertonic saline challenge or flow cytometric (BD FACS Aria II) fluid cytokine and chemokine • Insect allergy • Impedance oscillometry sorting of lymphocyte subsets levels • Nasal polyps • Mannitol challenge • Antigen-specific and nonspecific ➤➤Detection of serum antibody • Non-allergic rhinitis • Methacholine challenge lymphocyte proliferation/differentiation subtypes • Osteoporosis • Microscopy • Chemokine/cytokine assays • Biomarker assessment • Sinusitis, acute and chronic • Nasal scraping • Cytometric bead arrays for cytokines/ • Temporomandibular joint syndrome • Nasal secretion collection chemokines • Urticaria, acute and chronic We do clinical research; we do it well! CENTER HISTORY CLINICAL AND TRANSLATIONAL RESEARCH UNIT Meeting enrollment requirements The Division of Allergy and Immunology was established in the The Division of Allergy and Immunology Clinical Research Unit is standard practice. Department of Internal Medicine at the University of South is a 1600 square foot facility, located just off the main campus, POPULATION: Florida College of Medicine, Tampa, Florida in 1972, one year in which pharmaceutical industry sponsored, divisional clinical Tampa Bay metropolitan area: after the College of Medicine was founded. Professor Samuel research projects and federal and non-federal grant funded clinical 2.5 million population, C. Bukantz, M.D., founder of the Division, recruited Richard F. research projects are conducted. The main goal of the Center is to Varied ethnic composition, Lockey, M.D. in 1973 as a second faculty member, and these bring together basic and clinical scientists who translate bench and Easily reached with appropriate media exposure. two internationally acclaimed physician scientists established the clinical research into improved treatment of patients who suffer Clinical Research unit in 1977 and a training program for physicians from asthma and allergic and immunologic diseases. All studies MEDICAL PRACTICE to become allergists/immunologists in 1977. The Department of performed are done under the supervision of the physicians 70 new patient and 400 follow-up visits per week Internal Medicine program has five current trainees, and with the and the staff and approved by the University’s Human Research Computerized patient database Pediatric section at All Children’s Hospital in St Petersburg, has Committee. All trainees in allergy and immunology are required to participate in clinical research throughout their training to foster LOCATION trained over 90 allergists/immunologists and numerous American The USF campus is 20 minutes from Tampa International Airport their careers as clinician scientists. Over the past several decades, and foreign post-graduate and graduate research scholars. Many and is easily accessible from Interstate 275. We are three blocks the Clinical Research faculty have conducted over 500 Phase I, of these trainees are now faculty members in academic centers north of Fletcher Ave. on the east side of Bruce B. Downs Blvd. II, III and IV clinical trials and established a working relationship throughout the world. Both the medicine and pediatric sections with more than 40 pharmaceutical sponsors, NIH, ALA, VA and are supported by funds donated for teaching, research, and many other funding sources. patient care and by secured grants for research from the National Institutes of Health (NIH), by the American Lung Association Staffed by five USF clinician scientists, the Division and the Clinical (ALA), various foundations, and industry. The research program Research Unit are affiliated with various institutions in the Tampa expanded in the late 1990s when endowments were donated Bay Area including the H. Lee Moffitt Cancer Center, James A. Haley Veterans’ Hospital, Tampa General Hospital, Florida Hospital, the by grateful friends, Joy McCann Culverhouse and George and University of South Florida Morsani Center for Advanced Healthcare, Sandy Simmons. In June, 2000, the Clinical Research Unit was and All Children’s Hospital. selected as one of 19 American Lung Association’s Asthma Clinical For more information, please contact: Research centers, a network of academic asthma research RESEARCH CAPABILITIES centers dedicated to conduct multicenter clinical research trials • Exceeding enrollment requirements is our commitment to Thomas B. Casale, M.D., Director; any other faculty member in asthma and other airway diseases that are relevant to practical quality research. or Shawna Atha, Clinical Research Unit Administrator at the questions about treatment. • Research is conducted in accordance with Good Clinical Practice Division of Allergy and Immunology, Department of Internal RESEARCH EMPHASIS Guidelines and the highest ethical standards are followed. Medicine, University of South Florida Clinical Research Unit. Basic and clinical research interests include the pathogenesis and • 40 years of experience in over 500 phase I-IV trials. PHONE: (813) 631-4024 treatment of asthma and allergic diseases, aerobiology, primary • Experienced clinical research coordinators. and secondary immunodeficiency diseases, HIV, bone marrow FAX: (813) 631-4030 • Full-time regulatory coordinator which facilitates timely start- transplantation, insect hypersensitivity, allergen immunotherapy, up of new studies. 13801 Bruce B. Downs Blvd., Suite 505 co-morbid conditions affecting asthma and upper airway disease, Tampa, Florida 33613 chronic obstructive lung disease, viral infection • On-site IRB meets weekly for new protocols; expedited review and asthma, asthma and allergy in the elderly, hereditary for amendments and informed consent changes. angioedema, chronic urticaria and angioedema, atopic eczema, • Contracted with Western IRB for multi-center trials. sleep apnea, nasal polyposis, pulmonary artery hypertension and • Contracted with central IRBs: Quintiles, Quorum & Schulman drug allergy.