Pharmacokinetics, Pharmacodynamics, & Drug Metabolism Community

On Monday, February 26, 2024, in Silver Spring, MD, the U.S. Food and Drug Administration Center for Drug Evaluation and Research (FDA/CDER) and the American Association of Pharmaceutical Scientists (AAPS) present the in-person workshop, Therapeutic Drug Monitoring of Biologics - Current Practice, Challenges and Opportunities.

This workshop explores 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.

Discussions include the potential benefits, limitations, and future considerations for TDM of large molecule therapeutics.

Conference 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 (preanalytical, analytical, clinical, regulatory, and health-economic considerations)
3. Explore possible ways all stakeholders could work collaboratively to address these challenges and identify opportunities.

Please find the link for more information: TDM of Biologics - American Association of Pharmaceutical Scientists (aaps.org)

Enjoy Science and learn direct from regulators and get you questions answered.

Let me know what you learned and if you find such workshops useful at your work.

Best regards