Personalised Medicine: Is Co-Development the Best Method for Companion Diagnostics?

The market potential for personalised medicines is growing, thanks to the opportunities they hold for both patients and drug developers.

Research conducted by Tufts Center for the Study of Drug Development (CSDD) found personalised medicines are now changing the research and development (R&D) "paradigms" of drug developers, including the decision making process for taking a therapy forward.

Christopher-Paul Milne, associate director at Tufts CSDD, commented: "Early indications show that development of personalised medicines is commanding more resources and fomenting more organisational change than is generally appreciated outside the industry."

Central to this development is companion diagnostics, particularly within the field of oncology. The HercepTest, has already proved companion diagnostic tests can be commercially viable.  Herceptin generated revenues of $5.2 billion (£3.3 billion) in 2009.

While previously companion diagnostic tests have been developed separately from the drugs they accompany, this is beginning to change.

Co-development - the way forward

The research conducted by Tufts emphasised that the approach taken to the development of personalised medicines 'varies greatly' between companies.

Co-development with academic research institutions to better understand disease targets and working with diagnostics developers to enhance in-house production were named as two particular methods.

Such a partnership was recently established between Roche and OSI Pharmaceuticals for the development of a PCR- based companion diagnostic for use within oncology.

Through the collaboration the pair will work on a diagnostic test to identify people with non-small cell lung cancer (NSCLC), which includes Epidermal Growth-Factor Receptors (EGFR).

If successful , the test will be used in conjunction with Tarceva, which has been known to produce particular sensitivity in patients with EGFR mutations.

Gabe Leung, president, pharmaceutical business of OSI Pharmaceuticals, commented: "Roche and OSI’s extensive development and clinical experience with Tarceva, combined with Roche's unparalleled experience in molecular assay development, provide an excellent platform to create a robust and valuable companion diagnostic program for NSCLC patients."

The United States National Cancer Institute is also placing its resources in companion diagnostics, naming Insight Genetics as one of four companies to benefit from a Small Business Innovation Research (SBIR) grant.

Working with Dr Stephan W. Morris of St Jude Children's Research Hospital, Insight will use the $200,000 of funding to develop its ALK Screen, a real-time PCR-based test to detect mutations in anaplastic lymphoma kinase, which have been shown to contribute to NSCLC, types of lymphoma and inflammatory myofibroblastic tumors.

Challenges and opportunities for co-development

Yet, such collaborations do not come unaccompanied by challenges. Issues surrounding "project stewardship and intellectual property rights" were two key hurdles identified by Tufts for co-developers to overcome.

Pharmaceutical companies are catching on to the help companion diagnostics can give them when applying for regulatory approval, as the drugs are likely to be of a greater benefit to patients, and the benefits they provide during the clinical trial phrase.

Stephen Little, chief executive officer of DxS, told Genome Web, co-development also holds benefits for diagnostic companies.

"It's pretty straightforward for us to design and develop a good quality assay, but to actually link that assay to drug response needs a clinical trial, and that needs the pharmaceutical industry's buy-in," he explained.

However, there is work to be done on these co-development relationships for them to truly become a successes. Little said better planning and foresight is needed from pharmaceutical companies, while Ed Abrahams, director of the Personalized Medicines Coalition, told the news provider contradictory business models were the largest hurdle.

Little added: "Oftentimes we're involved with a drug company who requires a companion diagnostic, but they need it straightaway and they haven't really given us time to develop that. What would be ideal would be if those co-development programs were initiated earlier."

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