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Therapeutic Proteins Drug-Drug Interaction Working Group

The Therapeutic Protieis Drug-Drug Interaction Working Group is a group of scientists from the biopharmaceutical industry and academia who work with FDA to jointly identify critical issues, share resources and exchange experiences (such as discuss industry, regulatory and academic perspectives on therapeutic protein-drug interaction (TP-DI) evaluation), and develop analytical methodology, study design approach and development requirement that are pertinent to TP-DI investigation in TP product development and regulatory approval.

Currently there are two active task forces under the steering guidance of the DDI-TP WG: the In vitro TP-DI Task Force and the Population PK-based TP-DI Task Force. In 2012, the task forces jointly organized a ‘Workshop on Recent Advances in the Investigation of Therapeutic Protein Drug-Drug Interactions: Preclinical and Clinical Approaches’, held in Silver Spring, MD (FDA campus) on June 4-5. The Working Group is also preparing two white papers, one focusing on the critical assessment standard in vitro screening technique/methodology for TP-DI and another focusing on developing a general framework for using population PK-based analysis for TP-DI.