“…Several recent workshops have addressed TP-DDIs, including the 2010 American Association of Pharmaceutical Scientists workshop on "Strategies to Address Therapeutic ProteinDrug Interactions during Clinical Development" (Girish et al, 2011), and related roundtables at the National Biotechnology Conference in 2012 . Recent publications from academia, industry, and regulatory agencies have summarized the mechanisms involving TP-DDIs, evaluations of TP-DDIs included in Biologics License Application (BLA) submissions, and current strategies for the evaluation of TP-DDI potential during drug development (Morgan, 2009;Huang et al, 2010;Lee et al, 2010;Girish et al, 2011;Kraynov et al, 2011;Zhou and Mascelli, 2011;Lloyd et al, 2012;Dallas et al, 2013b;Slatter et al, 2013). As a result of discussions at several of these meetings, a collaboration among academia, industry, and regulatory agencies was initiated under the leadership of the TP-DDI Steering Committee (see Appendix) to address knowledge gaps in the mechanisms of TP-DDI, the relevance of in vitro systems, current industry practices for assessing these interactions, and to develop a general framework of risk-based approaches for TP-DDI assessment during drug development.…”