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Drug Diagnostics Co-Development: A Change in the Clinical Trial Design

The personalized medicine market is growing rapidly with a rise in demand for companion diagnostics. Targeted therapies require a reliable and efficient diagnosis, which generates a parallel demand for companion diagnostics. Drug and diagnostics co-development identify a specific set of patients who benefit from personalized treatments.

The co-development of personalized medicine and companion diagnostics (Rx-CDx) is an important part of the product lifecycle, and has a tremendous impact on global market access. This fosters the scope of treatment alternatives for various types of critical diseases, such as cancer.

The RxDx co-development concept was initially implemented during the 1970s for the development of selective estrogen-receptor modulator drug called tamoxifen, used to treat breast cancer.  The adoption of this practice was very slow. However, in the last decade there has been a rise in the demand for personalized treatment, especially in oncology. Drug-diagnostics co-development accelerates the regulatory approvals for drugs as well as diagnostics.

One of the major societal factors fostering the move from traditional clinical development to Rx-Dx co-development includes the need to restrict targeted therapies to those patients who are more likely to benefit. Other factors driving the move include technology advancements enabling more specific measures of efficacy, molecular level of understanding on the disease process and a greater appreciation on the specification of an individual’s tumor. All these considerations require a change in the clinical trial design.

The demand for diagnostics detecting proteomic, genomic or gene expression bio-markers to accompany novel therapeutics is growing. However, the understanding on how to sustain the growth is lagging behind. The reason behind this supply and demand gap is the difference between the development paths for drugs and diagnostics. Drug manufacturers often lack resources with experience in development of diagnostics.

Stakeholders having maximum influence on the drug-diagnostic co-development process include regulators (FDA/EMEA), professional associations, patient advocacy organizations, insurers, formulary committees and reimbursement bodies (NICE).

Regulatory bodies strongly encourage the process of drug-diagnostics co-development. For instance, in March 2010, FDA’s oncology panel refused to grant an approval to a drug for leukemia named Omapro from Australian cancer drug developer ChemGenex. This drug was designed for patients with genetic mutations without a validated diagnostic test. The explicit warning from the FDA to bio-pharmaceutical companies highlights regulatory authorities’ growing concern toward drug-diagnostics co-development.

There has been an emerging interest from the payers in ensuring drugs are administered to the correct set of patients. This interest is likely to foster the shaping of the Rx-CDx landscape in the future. Medco, for example, is sponsoring multiple studies for the comparison of safety and efficacy of new and existing treatments.

Developers need to decide the fastest and most cost-effective route to get the combination of treatment and diagnosis approved. One of the major restraining factors while deciding alternatives for the co-development route is the emerging issue of technology obsolescence. By the time the developer applies for the regulatory approval, the technology supporting the diagnostics kit may be obsolete. 

Early planning and real-time execution of the process are the key to success in this scenario. Drug-diagnostics co-development brings together bio-pharmaceutical and diagnostics firms. Selecting the right diagnostics partner for the co-development process is clearly critical. Various factors influence the choice of correct partner -- technology heritage, experience with regulatory submissions, global distribution channels, GMP capabilities, supply chain, prioritization in the pipeline, post-launch support (including capacity/training users) and appetite for co-development and its timelines.

Summary:

The rise of personalized medicine in the pharmaceutical industry generates a parallel demand for a reliable and accurate means of diagnosis. Precise diagnosis is an important tool in identifying the correct set of patients for the targeted treatment at a molecular level. The drug-diagnostics (RxDx) co-development concept is very useful, especially for various types of cancers. This concept both brings together bio-pharmaceutical and diagnostics firms and accelerates the regulatory approval procedure. It is also encouraged by reimbursement and regulatory authorities.

Pharma
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