Challenges in the codevelopment of companion diagnostics

Figure 1. Typical components required to develop a companion diagnostic, separate from drug development. This is not applicable to laboratory-developed 'home brew'tests, such as the CCR5 tropism assay.
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Figure 2. Proposed codevelopment of pharmaceuticals and companion diagnostics. Pharma: Pharmaceutical; PMA: Prospective meta-analysis.
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Figure 3. Challenges associated with the codevelopment of companion diagnostics.
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Figure 4. The traditional roles biopharmaceutical companies play in personalized medicine, if a contract research organization is used. CRO: Contract research organizations.
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Figure 5. Various services offered by an integrated partner, with all services housed within one organization.
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The goal of personalized medicine, to effectively customize diagnosis, treatment and prevention of disease to one's genetic composition, is one that has been known and sought for many years. Increasingly, molecular companion diagnostics based on one's inherited or somatic biomarkers are desired to ensure the effective, safe development and application of a personalized drug. This has been reflected in several recent guidance documents from regulatory organizations worldwide, and in a number of instances, the use of a companion diagnostic has been required or recommended prior to administration of a personalized therapeutic.

There have been a number of successes in personalized medicine, but not as many as one might expect based on the historical level of interest [1]. Proposed regulatory documents have attempted to address this shortfall, and in doing so have identified the drug-diagnostic codevelopment process as critical to the success of personalized medicine. Unfortunately, the codevelopment process poses several challenges. Potential barriers are: a relatively low probability of success after a scientific discovery is made; navigating various development objectives for different drugs, targeting appropriate markets and users; the lack of clear regulatory and policy guidance; and partnership challenges between research and diagnostic cultures. Consequently, pharmaceutical and diagnostic companies may be less motivated to invest the substantial amount of time and resources needed to create a successful personalized therapeutic.

The promise & power of personalized medicine

The field of personalized medicine evolved from the discipline of pharmacogenetics, essentially expanding upon the goal of identifying the right treatment, at the right dose, for the right disease/patient [2,3]. Utilizing a stratified approach...