This document discusses biomarkers, which are measurable indicators of biological states or processes. Biomarkers can take various forms including cellular characteristics, metabolites, molecular variations, or physical symptoms. They are increasingly discovered through molecular biology techniques analyzing DNA, RNA or proteins. Biomarkers can be used for diagnosis, disease staging, monitoring disease or treatment response. Examples of biomarkers include electrocardiograms, brain images, and serum chemistries. Biomarkers are also used in drug development to evaluate safety and activity in animal models and humans. Several companies are working to develop biomarkers for uses such as diagnostics and drug research and development. The GVK BIO Online Biomarker Database provides information on biochemical, genomic, imaging

1. BIOMARKER
Chandra shekhar
Sreekanth

2. INTRODUCTION
 “A biomarker is a characteristic that is objectively measured and
evaluated as an indicator of normal biological processes, pathogenic
processes, or pharmacologic responses to a therapeutic intervention.”
— US National Institutes of Health
 “A biomarker is a substance used as an indicator of a biologic state. It
is a characteristic that is objectively measured and evaluated as an
indicator of normal biologic processes, pathogenic processes, or
pharmacologic responses to a therapeutic intervention.”—Wikipedia
 Biomarkers make take the form of cellular characteristics, metabolites
(e.g. sugars, lipids and hormones), molecular variations, or physical
features (e.g., clinical symptoms) and are assessed accordingly, via
measurement, annotation, documents, and images.
 Increasingly, the discovery of novel biomarkers is closely associated
with the advances in molecular biology techniques that can be accessed
through analysis of DNA, RNA or proteins.

3. INTRODUCTION(CONT)
• Clinical end point : A characteristic or variable that reflects how a
patient feels, functions or survives
• Surrogate Endpoint: A biomarker intended to substitute for a
clinical endpoint. A surrogate endpoint is expected to predict
clinical benefit (or harm, or lack of benefit) based on
epidemiologic, therapeutic, pathophysiologic or other scientific
evidence

4. INTRODUCTION(CONT)
We can discriminate four main types of molecular biomarkers:
• Genomic biomarkers: based on the analysis of DNA
(deoxyribonucleic acid) profiles, especially the analysis of SNPs
(single nucleotide polymorphisms), i.e. identification of punctual
variations in genomic DNA.
• Transcriptomic biomarkers: based on the analysis of RNA
expression profiles.
• Proteomic biomarkers: based on the analysis of the protein
profiles.
• Metabolomic biomarkers: based on the analysis of metabolites
(metabolites are the intermediates and products of metabolism).

6. USE OF BIOMARKERS IN CLINICAL
MEDICINE
• Diagnosis
• Tool for staging disease
• Indicator of disease status
• Predict and/or monitor clinical response to an intervention

7. EXAMPLES OF BIOMARKERS IN CLINICAL
MEDICINE
• Electrocardiogram
• PET brain image
• Serum chemistries
• Auto-antigens in blood
• Bone densitometric measurement
• Pulmonary function test
• Neonatal Apgar score

8. USE OF BIOMARKERS IN EARLY DRUG
DEVELOPMENT AND DECISION MAKING
• Evaluate activity in animal models
• Bridge animal and human pharmacology via proof-of-
mechanism or other observations
• Evaluate safety in animal models
• Evaluate human safety early in development

9. EXAMPLES OF BIOMARKERS IN EARLY DRUG
DEVELOPMENT
• Serum chemistries
• Cell surface protein expression
• Drug pharmacokinetic measurements
• Drug metabolizing isoenzyme phenotype
• Serum transaminases
• Genomic expression profile
• Drug distribution or receptor occupancy via imaging

10. USE OF BIOMARKERS IN LATER DRUG
DEVELOPMENT AND DECISION MAKING
 Evaluate dose-response and optimal regimen for desired
pharmacologic effect
 Use safety markers to determine dose-response for toxicity
 Determine role (if any) of differences in metabolism on above

11. BIOMARKERS IN LATER CLINICAL
DEVELOPMENT
 Psychometric testing
 Pain scales
 Imaging studies
 Culture status (antimicrobials)
 Pulmonary function tests
 Serum chemistries
 Electrocardiogram

12. SELECTED COMPANIES WORKING IN
BIOMARKER-RELATED DRUG AND R&D
Affymetrix, Inc.
Agendia B.V.
Agilent Technologies, Inc., LSCA group
Applied Biosystems
BioSite, Inc.
Caliper Life Sciences, Inc.
Celera Group
Cepheid
CombiMatrix Corp (Acacia Research)
Dako A/S
diaDexus, Inc.
Epigenomics AG
Fluidigm Corporation
Gene Logic, Inc.
NimbleGen Systems, Inc.
Nymox Pharmaceutical Corporation
Orion Genomics LLC
Qiagen NV
Roche Molecular Diagnostics
GVK-BIO

13. ONLINE BIOMARKER DATABASE
 GVK BIO Online Biomarker Database (GOBIOM) is a
comprehensive biomarker database that provides
information on
Biochemical, Genomic, Imaging, Metabolite, Clinical
Scoring scales and Cellular markers for 16 different
therapeutic areas with its reported utilities like
diagnosis, prognosis, monitoring disease
progression, treatment response, surrogate, efficacy and
toxicity. i.e it gives complete information with respect
to a marker’s preclinical, clinical and analytical
qualifications with every data point hyperlinked to a
valid reference.

14. THANK YOU