ddn Online

The Blog of Drug Discovery News

Becoming companions

In our October issue of ddn, on which we’re just putting the finishing touches before the printing plant takes up its work (hence the relative silence here at the blog the first half of this week), we have some notable coverage of companion diagnostics.

The most prominent story is the lead article in our latest Trends in Cancer Research feature (the third installment of a five-part series), which looks at the challenges and rewards of developing companion diagnostics for cancer therapies by focusing on Eli Lilly & Co.’s efforts to build a companion diagnostics capability, and Genentech Inc.’s continuing efforts in this arena. Along with that is a story on cancer diagnostic trends for the near future, with Kalorama Information noting, in part, that by 2025, one in five new drugs could be labeled with a companion test, many of which will be cancer drugs.

So, when I saw an e-mail in my inbox from the organizers of the upcoming World Companion Diagnostics Summit (Nov. 30 to Dec. 3 in Boston), it seemed an apt time to share with you something they shared with me: an excerpt from an interview with Cecilia Schott, business development director of personalized healthcare at AstraZeneca.

Q. What do you feel is the major difficulty with drug-diagnostic co-development?

A. Timing. The science is great, the technology is great. For all to be synchronized is a challenge. To make sure that everything is aligned is a challenge. The development of a diagnostic tool, using  a biomarker is complex but getting that into a stable diagnostic assay that is robust enough to be used on a selection of patients that respond to a therapy is the real difficulty. At the same time as developing a compound making sure that the two things are aligned developmentally is a great challenge.

On the business side, which is where I sit, I think it’s understanding each others business models that is often difficult and I think we are trying to understand how to be better partners and work together: pharma and diagnostic companies. You have a diagnostic industry and a pharma industry, and you become an integral part of each other’s businesses. So we need to learn more about our partners needs as we move forward.

Q. How do you see drug development changing over the next 5 years, specifically looking at personalized medicine?

A. I hope that I’m right in saying that it will become more and more efficient. If we can predict which patients will respond, this would make us more efficient at developing medications and the industry as a whole will become more cost-effective. We will be working with our diagnostics partners much earlier in the discovery and development stages. This will be a paradigm shift in the way that clinical trials and drug development is conducted. Trial designs will be more focused. We are used to conducting trials in thousands of patients and you cannot necessarily predict who will respond to your drug, but in the future you may require less patients. This will be a far more efficient drug development process and will undoubtedly lead to more drugs getting approval and better care for patients.

There’s more at the website for the event, but in this excerpt, I see what may be the key issue going forward.

There isn’t much question of the value of companion diagnostics. And no doubt the FDA will get better at figuring out how to approve them more efficiently in the future as they become ever more critical.

I don’t even see it as a matter of science. With increasing knowledge of biomarkers, for example, we will likely see a point in the foreseeable future at which companion diagnostic capabilities will explode, as with so many other transformative technologies and methodologies.

No, the problem, I think, will be (as Schott notes) getting pharma and diagnostics to fit together better. It will no doubt happen, but I suspect the biggest impediment to companion diagnostics will be these two very different (but intertwined) industry forces getting past the “getting to know you stage” in their courtship and becoming…well…very constant and devoted companions.

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October 6, 2010 - Posted by | Corporate, Dealmakers

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