Tripartite alliance

Quintiles, Dako and AstraZeneca aim to speed development of personalized medicine

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DURHAM, N.C. – Quintiles recently announced that it will partner with Dako, a Danish-based developer of tissue-based cancer diagnostics, in a strategic alliance to advance personalized medicine by collaborating on the co-development of targeted therapies and companion diagnostics.

Under the non-exclusive agreement, the two companies will offer integrated drug-diagnostic development services and products. The first such collaboration will support AstraZeneca, with whom Dako had an existing relationship, in the development of one of its leading oncology compounds. At this time, the companies are not disclosing any information about specific compounds or cancer types.

"Traditionally, pharma comes up with a drug, develops a test and then farms it out to a lab, which may or may not run the test properly and/or interpret the results correctly," says Christopher Ung, vice president of strategic business and operations in Quintiles' oncology division. "The successful innovation of targeted therapies and the rise of personalized medicine have generated a parallel demand—to have accurate and reliable means of identifying patients who will benefit from treatment in clinical practice. This trend is drawing biopharma companies closer to the world of companion diagnostics.

Today, biopharma companies must consider options for establishing an accompanying patient-selection diagnostic framework at earlier stages in development. Our goal is to provide an integrated solution to pharma to help physician investigators select the right patients for the right clinical trials in order to accelerate the development of personalized oncology therapies for our customers in the 'new health' landscape."

Ung believes that Quintiles will be the first contract research organization (CRO) to offer tissue biomarker products and services, and the company plans to "pursue the model of providing biomarkers as companion diagnostics in the future," he states, although he notes that the need for other molecular technology might imply other partners.

As is true in the Dako case, Quintiles will conduct the tests as part of the clinical validation and continue to work independently with biopharmaceutical companies and service providers in the industry.

"Dako is a world leader in tissue-based cancer diagnostics," Ung states, "and they have more experience in companion diagnostics than any other provider."

The two companies will initially focus on oncology, and will look to expand into other therapeutics in the future. Ung notes that Quintiles and Dako will continue to collaborate with no end date to the alliance.

"At Dako, we focus on formalin-fixed paraffin-embedded (FFPE) tissue," says Dako CEO Lars Holmkvist. "Tissue-based diagnostics offers a number of advantages. From biopsies, a pathologist is able to determine the type of cancer and at what stage the cancer is, as well as whether it has spread in the body. However, tissue-based testing also sets certain requirements to how testing is done. For instance, it is crucial to follow the correct test protocol for a specific test in the lab and it is important that the lab has stable testing processes.

"The number of cancer incidents is constantly rising around the world," Holmkvist notes. "In many Western countries, cancer is now the most common cause of death, surpassing cardiovascular diseases. I believe that targeted treatment and companion diagnostics will play an increasingly important role in the future. Not only will it benefit the pathologist and doctors who can make a precise diagnosis and more precisely decide on the treatment for the individual patient, it will also benefit the patient who will get the correct treatment from the start. Furthermore, this process reduces unnecessary medication of patients and saves money."

Holmkvist adds that AstraZeneca and Genentech are among the pharmaceutical companies with whom Dako collaborates and that the joint approval of the drug Herceptin from Genentech, and the companion diagnostic test HercepTest from Dako was the first example in history of a drug linked to a companion diagnostic.

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