Deep Dive

New approaches to de-risking early drug development

Endpoints News talked with biopharma leaders at Merck, Sanofi, Catalent, Takeda, and J&J about their efforts to improve R&D efficiency

The biopharma industry as a whole is spending more money than ever on drug R&D, but the payback on productivity keeps shrinking. On a longterm basis, that’s unsustainable for the industry and has to change. We spoke with several of the leading experts in clinical trial design and drug development to see what they’re doing to pick the right candidates for clinical development and how they’re revamping projects to achieve approvals as efficiently as possible.

After all, most of a drug’s development costs come late in the process. Running the kind of clinical trials needed to support an approval are expensive, and if they fail, all capital invested is lost.

Much of the problem is based on an incomplete understanding of biology and animal studies often seem to confuse the issues more than they provide fresh insights to researchers.

We know that sticking with animal studies for basic preclinical guidance will limit overall success rates in the clinic to only 5% to 10%. But the emphasis right now is more on evolution than revolution. Organ-on-a-chip technology can enhance preclinical work, just as collaborations among CROs and developers have been relied on to identify preferred dosages and delivery methods.

But you also have to keep things simple, to make sure that you don’t overcomplicate your molecule, making it impossible to produce at a reasonable cost.

And throughout all the changes chronicled in this article, you will hear of case after case where large companies have been stripping down interior walls to allow for more partnering with investigators of all stripes, whether in the industry, government or academia.

In this field, borders are increasingly meaningless obstacles to change. Scientists and developers in North America, Europe and Asia are looking globally for the best solutions to this immense problem. Failure is not an option, as NASA might phrase it. These days, when you’re doing a moon shot of your own, you need to use every important resource available, wherever it is, to avoid a failure to launch.

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