Abandoning linear thinking

Why new preclinical model systems could improve clinical success rates

Drug developers are coming to believe that a major rethink of the traditional bench-to-bedside model in early drug discovery might be the best way to bring down the high rates of clinical trial failures. At an FDA meeting on improving productivity in R&D, stakeholders from industry, academia and government advocated a shift towards validating targets from the outset by incorporating new technologies, patient samples and systems pharmacology, instead of the linear process used today that's based on a series of assays far removed from clinical relevance.

Last month, the Brookings Institution's Center for Health Policy joined with FDA and the International Consortium for Innovation & Quality in Pharmaceutical Development to host a meeting that discussed interventions to improve clinical trial success at each stage of drug development from target validation to clinical outcomes.

While areas for improvement were flagged at all steps in the process, many stakeholders argued that the biggest payoff could come from changing preclinical efficacy and toxicity assessments to incorporate new technologies, with organ-on-a-chip platforms emerging as one of the key advances likely to make a difference.

James Barrett, chair of the Department of Pharmacology and Physiology at Drexel University, who was at the meeting, told BioCentury, "Target identification and validation is one of the earliest commitments made by pharma and biotech companies in the whole drug development process, and it is important not to build a superstructure on a weak foundation."

He added while target validation is sometimes laborious, "if you don't do it right, years later you will find

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