Investigating Endpoint Modeling - Biomarkers Minutes

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

Investigating Endpoint Modeling - Biomarkers Minutes

Contents

2015 Minutes

Current Proposed definition of Biomarkers

Current TOP Biomarkers

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