The pairing of personalized medicine, including targeted drug therapy, and in vitro diagnostic (IVD) companion devices (ie, “companion diagnostics”) allows treatment decisions to be tailored for each patient. However, development of companion diagnostics and personalized medicine still faces challenges in clinical development as regulatory policy tries to keep up with and accommodate this growing field. To assist industry and regulators, the DIA provided a forum for the discussion of current challenges and opportunities for progressive alignment approaches to regulating personalized medicine and IVD devices.
DIA Hosted Medical Devices and Combination Products Initiative. Global Forum. 2012;4(3):85–86.
5.
DonnellyET.Simultaneous approval of a therapeutic and companion diagnostic: XALKORI case study. Paper presented at: Drug Information 2012 Annual Conference; June 25, 2012; Philadelphia, PA.
6.
GerberN.Zelboraf™ (vemurafenib) case study of co-development of a drug and companion diagnostic. Paper presented at: Drug Information 2012 Annual Conference; June 25, 2012; Philadelphia, PA.
7.
Furst-LadaniS.Overview of the current and future European requirements for in vitro and companion diagnostics. Paper presented at: Drug Information 2012 Annual Conference; June 25, 2012; Philadelphia, PA.
