Coordinated development of companion diagnostics and drugs
Biopharmaceutical therapeutics increasingly are designed to target specific genetic abnormalities. Determining whether those abnormalities exist in a given patient subpopulation – or whether the proposed therapy is effective on them – requires a companion diagnostic device to identify specific genetic, proteomic, or gene expression markers.
The companion diagnostic is usually an in vitro medical device, and without it the development of targeted therapeutics would be impossible.
That’s where the close collaboration between Premier Research’s Medical Device and Diagnostics and drug development teams pays off for sponsors. The devices generally are developed separately from the drug, but they have to be designed from the start to work with that specific compound. Our device development team works with the drug development team from day one so the diagnostic device and the drug are literally made for each other.
Submitting both simultaneously for regulatory approval can increase the compound’s chances for approval, especially when it is safe and effective only on a subsection of the patient population with a particular genetic mutation.