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Novartis Launches Molecular Dx Unit to Get Jump on Companion Diagnostics

SAN FRANCISCO – Novartis has formed an in-house molecular diagnostics unit in order to improve the co-development of companion diagnostics and drugs, a company official told GenomeWeb Daily News today.

The group, co-located in Cambridge, Mass., and Basel, Switzerland, was created in January and should have around 50 to 60 staffers by the end of the year, said Michael Nohaile, head of Novartis Molecular Diagnostics.

While many of its pharma peers have turned to external partners to develop companion diagnostics for their drugs, Novartis decided to move some of that work in house in an effort to "minimize the friction" of working with third parties, Nohaile said. In addition, he said, the company realized that many of the "important decisions" regarding potential diagnostics happen very early in drug development — well before an external partner would be involved — presenting the opportunity for an internal team to exploit that information to Novartis' advantage.

Nohaile stressed that Novartis is not looking to reinvent the wheel, however. While the group will perform some diagnostic development internally, it will also partner with third parties with expertise in particular technology areas, such as imaging, that would not be practical for Novartis to reproduce in house.

In addition to developing companion diagnostics for Novartis drugs, Nohaile said the group is charged with developing "standalone" diagnostics "that have no relationship with our drugs whatsoever." Rather than serve solely as a support group for the company's drug business, Novartis expects that the molecular diagnostics unit could grow into "a great business" in its own right over time, he said.

While the group is new, Nohaile noted that it has been able to hit the ground running because it is built upon the investment the firm has made in biomarker research over the years. The molecular diagnostics unit, while distinct from the biomarker research groups, will be charged with "translating those discoveries into clinically useful tests." For standalone diagnostics, the unit will perform its own research, he said.

Nohaile said that the group is still assessing its project portfolio and disclosed few details on its development plans. He noted that oncology is "obviously a very opportune place" for the drugmaker to begin developing companion diagnostics, but stressed that the company is not limiting its efforts to that area. While acknowledging that the group is faced with a "big canvas" in terms of potential tests, he said that any diagnostics it develops must have clear clinical utility in terms of improving efficacy or safety, and would ideally "change the way medicine is done."

"We're not looking for small tweaks" for existing diagnostic tests, he said.

Nohaile noted that technology has only just gotten to the point where it's possible for pharmaceutical developers to use biomarkers as part of the drug development decision-making process. While conceding that "not every medicine" is a candidate for a companion diagnostic, he noted that drugmakers now "have to ask, with every medicine, can this improve the efficacy or safety?"

Some in the industry view companion diagnostics as a threat to the blockbuster drug model because it limits the available market for a drug, but Nohaile said that Novartis's experience with Gleevec was "instructive" because it proved that even a therapy for a narrow population can have an "enormous" benefit for those patients.

"We don't fear taking drugs to smaller populations" in cases where the potential upside for those patients may be "fantastic," he said.