Biomarkers play a crucial role in enhancing drug development by providing objective, measurable indicators of biological processes, disease progression, and treatment effects. These indicators can help researchers and pharmaceutical companies make informed decisions at various stages of clinical trials, leading to more efficient and successful drug development. Here's how biomarkers contribute to enhancing drug development in clinical trials:

1. Welcome
BIOMARKERS IN CLINICAL TRIALS
ENHANCEMENT OF DRUG DEVELOPMENT
M Yashwanth Reddy
M.Pharm
146/072023
10/18/2022
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2. Index
• Introduction
• Types of Biomarkers
• Limitations of Biomarkers in
Clinical trials
• Enhancement of drug development
• Preclinical
• clinical
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3. Introduction
• The role of Biomarkers has been exponentially increasing in guiding decisions
in every phase of drug development. From drug discovery and pre clinical
evaluations through each phase of clinical trials and into post marketing
studies.
• The biomarker is a molecular, cellular, or biochemical change that can be
accurately and repeatably measured and can be used to identify and monitor
physiological and pathogenic processes or responses to pharmacological
interventions.
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Recent years, biomarkers have become increasingly important in
pharmaceutical discovery, identifying a drug's mechanism of action,
investigating toxicity and efficacy signals at an early stage of the
development process, and identifying patients who are likely to
respond to therapy. Furthermore, in various fields of science.

4. Types of Biomarkers
• Type 0 biomarkers are markers of the natural history of Biomarkers and can be
measured in phase 0 clinical studies of a disease and is correlated with clinical
outcomes overtime .
• Type 1 biomarkers is a drug activity biomarker that indicates interventions,
therapeutic effects, mechanism action and toxicological effects of a drug .
• Type 2 biomarkers are considered to be the surrogate biomarkers and is
considered a substitute for clinical outcome assessments of disease and it helps
in the prediction of the responses to a therapeutic intervention.
• Safety biomarkers
• Efficacy biomarkers
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• Biomarkers play major roles in medicinal biology. Biomarkers help
in early diagnosis, disease prevention, drug target identification,
drug response etc. Several biomarkers have been identified for
many diseases

5. Biomarkers
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6. Limitations of Biomarkers
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• Measurement of errors
• Imperfect measurement of Biomarkers would naturally lead to decreased
validity of the relation to the disease.
• Bias occurs in any study including those with biomarkers
• Cost
• Acceptability
• Precision of errors
Advantages Disadvantages
Precision of measurement Timing is critical
Economical Expensive (cost for analyses)
less bias than questionnaires Storage (longevity of sample)
Rapid warning signal Normal range difficult to establish
Reliable; validity can be established Ethical responsibility
Homogeneity of risk or disease Laboratory errors

7. Enhancement of drug development
• Drug development is the process of bringing a new drug
to the market.
• Once a lead compound is identified through the process
of discovery.
• It includes pre clinical research on microorganisms and
animals filing for regulatory status such as FDA for
investigational purpose new drug initiate clinical trials on
humans.
• Including regulatory approval with a new drug
application to market the drug.
• The entire process from the concept through preclinical
testing in laboratory to Clinical development .
• The approval of drug takes typically more than decade.
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9. Pre clinical
• Drug have activity against a particular biological target that
is important in disease. Little known about the safety,
toxicity, pharmacokinetics, metabolism in humans.
• In development asses all the parameters to human clinical
trials
• A further major development is recommended the dose in
first use of clinical trial.
• In addition to the development must establish the physico
chemical properties of drug such as chemical makeup,
stability, solubility etc.
• The drug must optimize for the manufacturer from mg to
ton scale they further examine to package in tablets,
capsules, injections etc.
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10. Clinical phase
• Phase-1 conducted usually in healthy subjects to
determine safety and dosing.
• Phase-2 conducted to get an initial reading of efficacy
and safety in small number of subjects having disease.
• Phase-3 Trails are large .To determine safety and
efficacy in sufficient large numbers of subjects with
the targeted disease.
• If efficacy and safety proved trails are stopped drug
goes to new drug application stage.
• Phase-4 Trails are post approval trails that are
sometimes a condition attached by FDA also called
post market surveillance studies.
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13. Thank You!
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