FDA/CDER and AAPS workshop addresses therapeutic drug monitoring of biologics
AAPS and the U.S Food and Drug Administration Center for Drug Evaluation and Research (FDA CDER) announce the FDA/CDER – AAPS public workshop, ‘Therapeutic drug monitoring of biologics – current practice, challenges and opportunities’.
The workshop will take place on February 26 at the FDA White Oak Campus in Silver Spring (MD, USA) and 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.
Objectives for the event include discussing the impact of TDM on patient outcomes in inflammatory and other diseases; discussing 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; and exploring possible ways all stakeholders could work collaboratively to address the challenges and actualize identified opportunities.
“We are pleased to present this workshop in collaboration with AAPS. While TDM is guided by the clinical pharmacology principles, the evaluation and implementation of TDM of biologics is a complex process and involves multidisciplinary stakeholders”, commented Yow-Ming Wang, PhD, Associate Director for Biosimilar and Therapeutic Biologics, FDA, CDER, Officer of Clinical Pharmacology and Chair of the workshop. “We look forward to the experts’ insights on the current state and future opportunities for TDM of biologics.”
2024 AAPS President Gopi Shankar, PhD, M.B.A, FAAPS, also noted:
“I’m excited about partnering with FDA/CDER on this workshop. TDM is critical to ensuring optimal outcomes during administration of biologics. This workshop is an opportunity to see the latest innovative thinking in this area along with regulatory perspectives.”
To learn more and to register, visit the event website.
About AAPS
American Association of Pharmaceutical Scientists (AAPS) is a non-profit association of more than 7000 scientists and professionals employed in academia, industry, regulatory and other research related to the pharmaceutical sciences worldwide. Its mission is to advance the capacity of pharmaceutical scientists to develop products and therapies that improve global health, which members pursue through four peer-reviewed journals and a variety of events in person and online.
