Open Access A New Paradigm for Personalized Medicine and Companion Diagnostics: The Contract Diagnostics Organization

Abstract: In the era of personalized medicine, pharmaceutical companies are actively seeking partners to develop Com-panion diagnostics. Common choices of partners include large diagnostic manufacturers and traditional Contract Research Organizations (CROs), neither of which provides an entire solution. Diagnostics companies have an intrinsic bias toward internal product lines, and are therefore incentivized to direct diagnostics development toward an existing technology plat-form. The expertise of a CRO lies in the monitoring of pharmaceutical programs, not in diagnostics. In addition, few tradi-tional partners have significant clinical laboratory experience or offer accredited clinical laboratories to ensure that the di-agnostic clinical trials are designed for, and conducted in, laboratories that meet regulatory standards. Lastly, these or-ganizations are inexperienced in managing and coordinating the multiple partners required in the development process. The Contract Diagnostics Organization (CDO) is a new concept designed to aid pharmaceutical companies in addressing challenges in companion diagnostics development. This business model provides pharmaceutical companies a complete outsourcing partner to initiate and manage the parallel development of companion diagnostic tests in synergy with drug development. The CDO combines all of the necessary services, including diagnostics research, an accredited clinical labo-ratory, project management and regulatory, manufacturing, and consulting in an integrated, technology-independent man-ner. Thus, the CDO focuses on its pharmaceutical partner’s business objectives and ensures the speediest path to market a valuable, personalized drug for patients