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Event Title
FDA/CDER and American Association of Pharmaceutical Scientists (AAPS) Hybrid Public Workshop
February 26, 2024

Therapeutic Drug Monitoring of Biologics: Current Practice, Challenges and Opportunities


Date:
February 26, 2024
Time:
9:00 AM - 4:30 PM ET

Location

Hybrid | Great Room, Building 31, FDA White Oak Campus & Zoom

Workshop Objectives

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.

  • Discuss the impact of TDM on patient outcomes in inflammatory and other diseases
  • 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 considerations)
  • Explore possible ways all stakeholders could work collaboratively to address these challenges and actualize identified opportunities

Meeting Information

This is an in-person/virtual hybrid event. For those who wish to attend in person, the workshop will take place in the Great Room, Building 31, FDA White Oak Campus at 10903 New Hampshire Avenue, Silver Spring, MD. To register, visit the AAPS website.

Visit the Workshop website for more information.

Contact

For questions regarding this event, please email meetings@aaps.org or OCPWorkshops@fda.hhs.gov.

 
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