This free white paper contains our expert insights on creating a credible biomarker strategy for accelerated drug development and approval.
A biomarker is a characteristic that is measured and evaluated as an indicator of normal biological processes, pathogenic processes, or pharmacological responses to a therapeutic intervention. The use of biomarkers is key to understanding drug mechanisms. While biomarkers can play a crucial role in informing drug label claims, this white paper will explain why the inclusion and assessment of biomarkers within drug development can also inform many critical research decisions.
What you will learn
- Incorporate hypothesis testing into trial design: Use biomarkers to validate drug targets and avoid costly clinical trial failures
- Set safety thresholds for clinical trial subjects: Establish “do-not-exceed” limits to mitigate drug safety risks
- Align with regulators regarding your clinical development plan: Select surrogate endpoints that meet FDA guidances
With this knowledge, you’ll be able to:
- Select the most promising drug candidates
- Demonstrate proof of biology and concept
- Optimize drug dosing and select the right patient population for your drug
- Accelerate your path to regulatory approval
- Make data-driven decisions to enhance drug safety and efficacy
Get your free white paper for insights on creating a robust biomarker strategy
Submit the form below to download your white paper and learn the essential components of a drug development program’s biomarker strategy!