This webinar will help attendees obtain the fundamentals of the science, clinical operations and clinical regulatory aspects of biomarker(s) identification, validation and application in clinical trials.
This session will cover the steps from biomarkers’ discovery to its application in drug development. It will discuss the most common sources of biomarkers, i.e. serum, whole blood, tissue biopsy, etc., plus the selection of gene and/or protein expression as biomarkers.
The training program will also discuss some of the key decision points such as:
Identification of potential biomarkers, based on biology.
Role of biomarkers in targeted therapy drug development.
Assay development and validation.
Examples of key role played by biomarker identification in the development of approved drugs.
Exploring biomarker leads in human clinical studies.
Regulatory guidelines on biomarkers’ strategy - dos and don’ts.
Clinical operation aspects of biomarker analysis in clinical studies.
Bio analysis of samples. In house, outsourced, or a combination of both?
Data analysis, in combination with drug levels (PK/PD).
Data analysis in combination with clinical outcome.
Need to develop a companion diagnostic? When is the time to start?
Why Should You Attend:
With the advent of the targeted therapy, the need to identify novel biomarkers has increased dramatically. In addition of the biological rational that associate the biomarker with the mechanism of action of the drug, there are multiple steps to fulfill before apply the measurement of the biomarker in clinical development.This session will cover the steps from biomarkers’ discovery to its application in drug development. It will discuss the most common sources of biomarkers, i.e. serum, whole blood, tissue biopsy, etc., plus the selection of gene and/or protein expression as biomarkers.
The training program will also discuss some of the key decision points such as:
- Timelines of searching for potential biomarkers
- Assay development and validation
- Strategies to validate the biomarker(s) in humans
- Incorporation into clinical trials within regulation
- Data analysis
- Data interpretation
Areas Covered in the Webinar:
What are biomarkers?Identification of potential biomarkers, based on biology.
Role of biomarkers in targeted therapy drug development.
Assay development and validation.
Examples of key role played by biomarker identification in the development of approved drugs.
Exploring biomarker leads in human clinical studies.
Regulatory guidelines on biomarkers’ strategy - dos and don’ts.
Clinical operation aspects of biomarker analysis in clinical studies.
Bio analysis of samples. In house, outsourced, or a combination of both?
Data analysis, in combination with drug levels (PK/PD).
Data analysis in combination with clinical outcome.
Need to develop a companion diagnostic? When is the time to start?
Who Will Benefit:
- Scientists working in drug discovery and development in academia, biotech or pharmaceutical industry
- Preclinical scientists interested in exploring translational medicine research
- Personnel involved in clinical development
- Clinical project leaders and clinical project managers to get an overview of the processes involved
- Bio-tech professionals in preclinical and clinical research
- Biotech companies that are expanding clinical development capabilities
Course Provider
Juan Leal,
