Diagnostic Partnering is Now an Integral Part of Pharma Strategy

(First published on LinkedIn)

• Phase I/II data can potentially be used to seek approval for oncology indications with high unmet clinical need

• Rx/CDx co-developments come with considerable clinical, technical, regulatory and commercial challenges.

• Both drug and diagnostic development processes have their own rules and regulations. This codependency requires significant adjustments in what can be considered quintessentially clinical (Rx) and technical (Dx) development cultures. These conceptual and organizational differences can be source of significant friction in partnering interactions and are not always understood by management

• Large pharmaceutical companies have increasingly internalized these lessons. Biotech startups are generally more inclined to delay regulated CDx development at risk pending more efficacy data

• Mutual understanding and integration of “Rx and CDx cultures” early in the development process is important to achieving aggressive development timelines and successful registration of a precision medicine compound