The promise of drugs targeting defined disease mechanisms and patient populations based upon the successes of drugs such as Herceptin and Xalkori has directly greatly redirected biopharma development strategies. However, the success of these efforts requires the development, approval and adoption of CDx to identify patients who will benefit. The biopharma and diagnostic (Dx) industries are currently learning how to best address that reality in the context of the regulatory, commercial and clinical systems in place in various global markets.

This review describes the challenges facing the industries and stakeholders and possible approaches or solutions. The challenges range from technical, such as choice of platform, to health technology assessment (HTAs) and strategies to obtain reimbursement. Rapidly emerging technologies or models, such as next-generation sequencing or direct to consumer genetic testing, may suggest the need to rapidly recognize and address challenges as opportunities rather than barriers. Various biopharma companies are looking to address the broader issues of misalignment of development timelines and value distribution between the therapeutic (Rx) and diagnostic developers by bringing CDx development or management in house. We have yet to see the results of these alternative models. Therefore, it is important to consider a range of approaches and solutions.

Many of these are discussed in this paper, including the identification of stakeholders, tools for driving uptake and reimbursement, and strategies for building organizations that can take advantage of these approaches. The ultimate success of personalized or precision medicine to improve drug development productivity will require standardization of these approaches consistent with regulatory and HTA standards.