Friday, March 6, 2015

Communication Breakdowns Threaten Co-Development of Drugs and Companion Diagnostics

Drug Companies, Diagnostics Makers and Labs Must Align or Risk Millions in Development Delays

By Marc Dresner, Senior Editor, IIR

Drug companies are increasingly co-developing and embracing early evaluation of companion diagnostics in drug development to potentially reduce clinical trial costs and improve study outcomes,
but the way most companies go about it introduces a serious new risk that could potentially frustrate the entire development effort.
David Jackson, PhD

That’s according to Arno Therapeutics VP of Diagnostics and Companion Diagnostics Dr. David Jackson, who says there’s typically no coordination between the sponsor, the manufacturer of the kitted CDx product contracted by the sponsor and the lab that actually deploys it.

“The industry is still keeping these relationships separate.”

“I’m only aware of a handful of relationships that incorporate all three pieces in synchrony,” said Jackson. “By and large, the industry is still keeping these relationships separate.”

That’s a potential liability, Jackson says, because when issues related to the test or to the trial design or enrollment, respectively, crop up, the absence of a collaborative structure between the sponsor, the CDx manufacturer and the lab almost guarantees a costly delay—possibly to the tune of millions per day.

Changes can have “a very serious ripple effect.”

Jackson stressed that due to the less flexible approach for developing a diagnostic—because it is a device not a compound—any changes can have “a very serious ripple effect.”

Moreover, Jackson observed that drug developers are frequently ignorant to problems that can arise around regulatory requirements for companion diagnostics and don’t adequately understand the function of the clinical trial lab supporting development of diagnostics intended to subsequently support the drug.

“The company developing a targeted therapy needs to become more knowledgeable internally,” he said. “There are issues that come up during development of the diagnostic that are influenced heavily by trial design and by anything that may come up with the FDA.”

Editor's note: Last July, the FDA issued new guidance 
to help companies identify the need for companion diagnostics at an earlier stage in the drug development process and to plan for co-development of the drug and companion diagnostic test.

Issues may also occur at the laboratory level.

“Issues may also occur at the laboratory level as they see specimens come through for a trial that necessitate a change to the diagnostic test, or worse, a change to the trial from an enrollment perspective,” he added.

Jackson urged drug developers to stop siloing partnerships with CDx makers, labs and, where applicable, CROs, because there are too many interdependent factors that can cause a delay with a profound financial impact.

“More than half of the cost of developing any compound to approval is associated with the value of time,” Jackson noted. “For just a half-billion-dollar product, for example, every single day lost toward approval amounts to more than $2 million in lost revenue.”

In this podcast for Inside Clinical—the official interview series of the 24th Annual Partnerships in Clinical Trials conference—David Jackson makes a case for a new partnering model between drug developers, CDx makers, labs and CROs, and offers tips for each party.

Editor’s note: David Jackson will be speaking at the Partnering with Central Labs Summit co-located with the 24th Annual Partnerships in Clinical Trials Conference running April 22-24 in Boston.
For more information or to register, please visit

For more information about the co-located Partnering with Central Labs Summit, click here.  

Marc Dresner is IIR USA's senior editor and special communication projects lead. He is the former executive editor of Pharma Market Research Report, a trade publication for market researchers in the pharmaceutical industry. He may be reached at Follow him @mdrezz.

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