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WISCONSIN CORP FOR BIOMEDICAL RESEARCH
MILWAUKEE, WI, 53295
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Subcontracting experience
1 record from government sources. Past participation is not evidence of current teaming interest.
| Role | Agency | Description | Vehicle | Obligated | Action date | Period |
|---|---|---|---|---|---|---|
| Subcontractor | Department of Health and Human Services | GENERAL DESCRIPTION: WE PROPOSE TO COLLECT SPUTUM AND BLOOD SPECIMENS FROM 20 RESEARCH PARTICIPANTS (10 ENROLLED IN THE FIRST YEAR AND 10 IN THE SECOND YEAR) WITH ESTABLISHED DIAGNOSIS OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE OR COPD (CHRONIC BRONCHITIS OR MIXED PHENOTYPES, I.E., THOSE WHO REPORT COUGH AND SPUTUM PRODUCTION FOR AT LEAST 3 MONTHS ANNUALLY IN THE PAST 2 YEARS, WITH AND WITHOUT EVIDENCE OF EMPHYSEMA ON IMAGING STUDIES). MALE AND FEMALE SUBJECTS BETWEEN 40 AND 80 YEARS OF AGE WILL BE ENROLLED; WOMEN OF REPRODUCTIVE AGE WILL UNDERGO PREGNANCY TESTING BEFORE THE STUDY PROCEDURES ARE EMPLOYED. IN ORDER TO ELIMINATE POTENTIAL SOURCES OF HETEROGENEITY RELATED TO SMOKING STATUS, WE WILL ENROLL ONLY EX-SMOKERS (I.E., THOSE WHO QUIT SMOKING EITHER REGULAR OR ELECTRONIC CIGARETTES, AT LEAST 6 MONTHS PRIOR TO THE ENROLLMENT DATE), AND AT LEAST 2 WEEKS AFTER A KNOWN COPD EXACERBATION TREATED WITH ANTIBIOTICS AND/OR CORTICOSTEROIDS. SMOKING CESSATION WILL BE DOCUMENTED BY MEASURING COTININE LEVELS IN THE COLLECTED BLOOD SAMPLES.
PROCEDURES: DEMOGRAPHIC, ANTHROPOMETRIC, FUNCTIONAL AND IMAGING DATA RELEVANT TO THE UNDERLYING DIAGNOSIS, AS WELL AS COPD EXACERBATION HISTORY, USE OF MEDICATIONS AND SUPPLEMENTAL OXYGEN WILL BE COLLECTED. NO INTERVENTION IS PLANNED ON THE ENROLLED PARTICIPANTS. IN ORDER TO BETTER CHARACTERIZE FUNCTIONALLY THEIR DISEASE SEVERITY, WE WILL PERFORM FIRST PULMONARY FUNCTION TESTS (PFTS) IN OUR LABORATORY, CONSISTING OF SPIROMETRY (BEFORE AND AFTER INHALED BRONCHODILATOR ADMINISTRATION), LUNG VOLUME AND DLCO MEASUREMENTS. AFTER INFORMED CONSENT IS OBTAINED, PFTS ARE PERFORMED BETWEEN 8 AND 10 AM LOCAL TIME. AFTER THE PFTS ARE PERFORMED, SPUTUM AND BLOOD SPECIMENS ARE OBTAINED IN THE ATLANTA VA CLINICAL RESEARCH CENTER; THE CLINICAL RESEARCH TEAM MEMBERS WILL WEAR APPROPRIATE PPE (PERSONAL PROTECTIVE EQUIPMENT) FOR ALL INDUCTION AND COLLECTION OF RESPIRATORY AND WHOLE BLOOD SPECIMENS. ONCE COLLECTED, THE SPECIMENS WILL BE KEPT ON ICE AND HAND-DELIVERED IMMEDIATELY TO THE PROCESSING LAB AT EMORY UNIVERSITY. THE LOCAL CLINICAL PRINCIPAL INVESTIGATOR OR DESIGNEE WILL ENSURE THAT SAMPLES ARE LABELLED AND SHIPPED IN ACCORDANCE WITH THE LABORATORY MANUAL AND THE BIOLOGICAL SUBSTANCE REGULATIONS. A FULL CHAIN OF CUSTODY WILL BE MAINTAINED FOR ALL SAMPLES, THROUGHOUT THEIR LIFECYCLE. THE SPUTUM AND BLOOD BIOMARKERS WILL BE ANALYZED IN BOTH INDIVIDUAL AND POOLED SAMPLES. AWD-004704-S3 Parent award context Parent award agency: Department of Health and Human Services · Food and Drug Administration Parent award NAICS: 541714 Parent award performance state: MD Parent award description: BAA TOXWP 118/CTP-2022-112800 -EVALUATE AND PROMOTE THE USE OF CELL- AND TISSUE-BASED ASSAYS THAT MORE ACCURATELY REPRESENT HUMAN SUSCEPTIBILITY THAN ANIMAL MODELS TO ADVERSE REACTIONS AND PREDICT THRESHOLD OF TOXICOLOGICAL CONCERNS RESULTING FROM EX View parent award on USAspending | — | $384,838 | May 23, 2024 | — – — |
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