FDA/CDER-AAPS Public Workshop: Therapeutic Drug Monitoring of Biologics

This workshop will explore the current state of the science in the field of therapeutic drug monitoring (TDM) for biologic products and current clinical practice in the United States and Europe. TDM of some small molecules is commonly performed to sustain target drug levels for efficacy and to minimize safety issues. TDM of large molecule biologics has been reported to improve clinical outcomes in some inflammatory diseases by ensuring sustained therapeutic levels and reducing the probability of immunogenicity.  The potential benefits, limitations, and future considerations for TDM of large molecule therapeutics will be discussed.

Workshop Objectives:

1. Discuss the impact of TDM on patient outcomes in inflammatory and other diseases
   
   
2. Discuss the challenges and enabling factors and best practices in the implementation of TDM for biologics as an end-to-end process from evidence generation to point-of-care implementation and evaluation (pre-analytical, analytical, clinical, regulatory, and health-economic consideration)
   
   
3. Explore possible ways all stakeholders could work collaboratively to address these challenges and actualize identified opportunities.
   
   

Learn More!