In this webinar, we will talk about ensuring a fit-for-purpose bioanalytical strategy for asset optimization and risk management during drug development.
Biomarker-driven drug development is the norm today and has the potential to make drug discovery, development, and approval processes more efficient while improving patient outcomes. This is the reason why biomarkers are used for decision-making throughout the entire drug development pipeline with different purposes: from defining the mode of action, efficacy, and safety of a drug candidate, to patient stratification and evaluation of clinical trial endpoints.
The ultimate aim is to ensure asset optimization and de-risking of the drug development process by ensuring that the right data is obtained at the right time at all project stages. Understanding the analyte, the regulatory demands, the intended use of the data, and/or the specific context-of-use is essential when designing a cost- and time-effective bioanalytical strategy to produce reliable PK, PD, biomarker, and immunogenicity data.
Join the featured speakers as they discuss how to build a fit-for-purpose bioanalytical strategy for asset optimization and risk management, through case studies based on real-life challenges.
Carmen Herrera Hidalgo, PhD, Global Product Manager, Mercodia
Tanja Jarhede, PhD, Senior Scientist, Mercodia
Who Should Attend?
- Clinical Operations
- Preclinical Operations
- Bioanalytical and Product Development Scientists
- Regulatory Teams
What You Will Learn
- Key elements to consider when designing a fit-for-purpose bioanalytical strategy
- How to ensure reliable data for different intended uses during the drug development pipeline