Investigating Endpoint Modeling - Biomarkers Minutes
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This page lists minutes for the Investigating Endpoint Modeling - Biomarkers Group team's meetings.
2015 Minutes
File:Investigating Endpoint Modeling scoping notes CSS meeting.pdf
Investigating Endpoint Modeling - Biomarkers, ADA data and Immunophenotyping Minutes 2015-04-23
Investigating Endpoint Modeling - Biomarkers, ADA data and Immunophenotyping Minutes 2015-05-07
Investigating Endpoint Modeling - Biomarkers, ADA data and Immunophenotyping Minutes 2015-05-21
Investigating Endpoint Modeling - Biomarkers, ADA data and Immunophenotyping Minutes 2015-06-04
Investigating Endpoint Modeling - Biomarkers, ADA data and Immunophenotyping Minutes 2015-06-18
Investigating Endpoint Modeling - Biomarkers, ADA data and Immunophenotyping Minutes 2015-07-16
Investigating Endpoint Modeling - Biomarkers, ADA data and Immunophenotyping Minutes 2015-07-30
Investigating Endpoint Modeling - Biomarkers, ADA data and Immunophenotyping Minutes 2015-08-13
Investigating Endpoint Modeling - Biomarkers, ADA data and Immunophenotyping Minutes 2015-08-27
Investigating Endpoint Modeling - Biomarkers, ADA data and Immunophenotyping Minutes 2015-09-10
Investigating Endpoint Modeling - Biomarkers, ADA data and Immunophenotyping Minutes 2015-09-24
Investigating Endpoint Modeling - Biomarkers, ADA data and Immunophenotyping Minutes 2015-10-08
Investigating Endpoint Modeling - Biomarkers, ADA data and Immunophenotyping Minutes 2015-10-22
Investigating Endpoint Modeling - Biomarkers, ADA data and Immunophenotyping Minutes 2015-11-05
Investigating Endpoint Modeling - Biomarkers, ADA data and Immunophenotyping Minutes 2015-11-19
Investigating Endpoint Modeling - Biomarkers, ADA data and Immunophenotyping Minutes 2015-12-03
Investigating Endpoint Modeling - Biomarkers, ADA data and Immunophenotyping Minutes 2016-01-07
Investigating Endpoint Modeling - Biomarkers, ADA data and Immunophenotyping Minutes 2016-01-12
Investigating Endpoint Modeling - Biomarkers, ADA data and Immunophenotyping Minutes 2016-01-28
Investigating Endpoint Modeling - Biomarkers, ADA data and Immunophenotyping Minutes 2016-02-25
Investigating Endpoint Modeling - Biomarkers, ADA data and Immunophenotyping Minutes 2016-03-10
Investigating Endpoint Modeling - Biomarkers, ADA data and Immunophenotyping Minutes 2016-05-05
Investigating Endpoint Modeling - Biomarkers, ADA data and Immunophenotyping Minutes 2016-07-28
Investigating Endpoint Modeling - Biomarkers, ADA data and Immunophenotyping Minutes 2016-08-11
Investigating Endpoint Modeling - Biomarkers, ADA data and Immunophenotyping Minutes 2016-10-20
Investigating Endpoint Modeling - Biomarkers, ADA data and Immunophenotyping Minutes 2016-12-15
Current Proposed definition of Biomarkers
Biomarkers are anatomic, physiologic, biochemical, or molecular parameters associated with the presence and severity of specific disease states, medical conditions, or other biological characteristics. They are detectable and measurable by a variety of methods including physical examination, microscopic examinations, laboratory assays, and medical imaging.
According to the FDA "Guidance for Industry - Use of Histology in Biomarker Qualification Studies", biomarkers as described as follows: A biological marker or biomarker is defined as a characteristic that is objectively measured and evaluated as an indicator of normal biologic processes, pathogenic processes, or biological responses to a therapeutic intervention. A biomarker can define a physiologic, pathologic, or anatomic characteristic or measurement that is thought to relate to some aspect of a normal or abnormal biologic function. Biomarkers include measurements that suggest the etiology of, the susceptibility to, the prognosis of, or the progression of disease; measurements related to the mechanism of response to treatments; and actual clinical responses to therapeutic interventions. Biomarkers have been broadly applied to describe:
- structural features from the molecular to the anatomic level (e.g., genetic composition, receptor expression patterns, radiographic appearances)
- biochemical measurements (e.g., serum levels of electrolytes, enzyme activity levels, prostate-specific antigen (PSA))
- physiologic organ system function (e.g., creatinine clearance, pulmonary function tests, cardiac ejection fraction, electrocardiography (ECG))
Current TOP Biomarkers
NGAL
Cardiac troponin T
Thrombin clotting time
Sedimentation rate
Uric Acid
Bilirubin (total, direct and/or indirect)
Qualified: cTnI, rat urine KIM1, NGAL, OPN, uALB, Cystatin C, CLU NTproANP, Mky EPO, LCN2, TSP-1, TIMP1, MCP1, VEGFa, KC, Angpt2, ET-1, Sele, NO, Agp1
Cytokines: IL-6, IL-10,IL-13, TNFa
Micro-RNAs: miR-216a-5p, miR-216b-5p, miR-375
Efficacy / Phamacology: glucosylated hemoglobin
Albumin
Alkaline Phosphatase
Amylase
Blood Urea Nitrogen
Calcium
Chloride
Cholesterol
Creatinine
Erythrocytes
Glucose
Hematocrit
Hemoglobin
Leukocytes
Lipase
pH
Phosphorus
Specific Gravity
TGF beta 1
TGF beta 2
TGF beta 3
Total Protein