AAPS 2010 - AAPS Workshop on Strategies to Address Therapeutic Protein Drug Interactions during Clinical Development AAPS 2010

To provide participants with a clear understanding on how to develop strategies for assessment of TP-drug interactions.
Workshop objectives are to:
review preclinical tools and in vitro test systems for assessing drug interaction potential of therapeutic proteins such as cytokines and cytokine modulators,
provide an in-depth review of reported and documented clinically relevant TP-drug interactions,
discuss case studies, study designs and acceptance criteria for assessing PK and PD based TP-drug interactions in clinical studies,
provide participants with the skills to develop a science-driven, risk-based approach for assessing the potential of TP-drug interactions.
BACKGROUND
Therapeutic proteins, such as monoclonal antibodies, cytokines, and cytokine modulators, are increasingly being combined with small molecule drugs and/or other therapeutic proteins. Limited scientific and development experience is available in assessing the potential for PK and PD interactions of these TP-drug or TP-TP combination therapies. In this workshop, industry, academic and regulatory speakers will highlight important main themes that have started to emerge for considerations in drug interaction assessment for therapeutic proteins such as: molecule type, target, indication, and disease biology. Speakers will also discuss recent reports regarding the regulation of CYP450 enzymes and transporters in inflammatory states. The use of cytokine, cytokine modulators, and immunosuppressant-containing combinations in inflammatory indications may have potential for drug interactions, in particular when therapeutic proteins are combined with narrow therapeutic range drugs. This workshop will provide the opportunity for participants to interact with industry, academic and regulatory representatives and to participate in roundtable discussions on how to arrive at a science-driven, risk-based approach for assessing the potential for TP-drug interactions.