title: Therapeutic protein drug-drug interactions: navigating the knowledge gaps-highlights from the 2012 AAPS NBC Roundtable and IQ Consortium/FDA workshop.
abstract: The investigation of therapeutic protein drug-drug interactions has proven to be challenging. In May 2012, a roundtable was held at the American Association of Pharmaceutical Scientists National Biotechnology Conference to discuss the challenges of preclinical assessment and in vitro to in vivo extrapolation of these interactions. Several weeks later, a 2-day workshop co-sponsored by the U.S. Food and Drug Administration and the International Consortium for Innovation and Quality in Pharmaceutical Development was held to facilitate better understanding of the current science, investigative approaches and knowledge gaps in this field. Both meetings focused primarily on drug interactions involving therapeutic proteins that are pro-inflammatory cytokines or cytokine modulators. In this meeting synopsis, we provide highlights from both meetings and summarize observations and recommendations that were developed to reflect the current state of the art thinking, including a four-step risk assessment that could be used to determine the need (or not) for a dedicated clinical pharmacokinetic interaction study.
authors.affiliation: Department of Drug Metabolism & Pharmacokinetics, Genentech Inc., South San Francisco, California, USA, kenny.jane@gene.com.
authors.forename: Jane R
authors.initials: JR
authors.lastname: Kenny
authors.forename: Maggie M
authors.initials: MM
authors.lastname: Liu
authors.forename: Andrew T
authors.initials: AT
authors.lastname: Chow
authors.forename: Justin C
authors.initials: JC
authors.lastname: Earp
authors.forename: Raymond
authors.initials: R
authors.lastname: Evers
authors.forename: J Greg
authors.initials: JG
authors.lastname: Slatter
authors.forename: Diane D
authors.initials: DD
authors.lastname: Wang
authors.forename: Lei
authors.initials: L
authors.lastname: Zhang
authors.forename: Honghui
authors.initials: H
authors.lastname: Zhou
mesh_terms: D000818:Animals; D035843:Biomedical Research / Q000592:standards* / Q000639:trends; D001709:Biotechnology / Q000592:standards* / Q000639:trends; D002140:California; D004345:Drug Industry / Q000592:standards* / Q000639:trends; D004347:Drug Interactions; D004493:Education / Q000592:standards / Q000639:trends; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration / Q000592:standards* / Q000639:trends