Clinical Trials in a Dish: Speeding Up Drug Development

The emergence of various hiPSC-derived cell types (cardiac, neuronal, hepatic) allows, for the first time, to combine the strengths of human diversity with the in vitro assessment of susceptibility to drug-induced toxicity. (Credit: Coyne Scientific)

Developing new drugs isn’t easy. Only around 10% of compounds that reach preclinical development will ever be tested in a human being, and for every drug that reaches the market, the company will have invested, on average, $359 million and 12 years of their time.

Now, a new study provides a unique look at a novel strategy — clinical trials in a dish — that bridges preclinical testing and clinical trials. 

“The pharmaceutical industry is facing unprecedented challenges as the cost of developing new drugs has reached unsustainable levels, fueled in large parts by a high attrition rate in clinical development,” the authors wrote. 

“Strategies to bridge studies between preclinical testing and clinical trials are needed to reduce the knowledge gap and earlier decisions to be made on the continuation or discontinuation of further development of drugs.”

The new platform allows pharmaceutical companies to test, at the population level, novel drugs on patients cells before moving unto actual clinical trials. Because current preclinical strategies don’t follow this principle, the platform offers the potential to significantly impact drug discovery and development. 

 

Drug Development 101: 2018 Edition

 

Recent demonstrations show various human induced pluripotent stem cell-derived (hiPSCs) cell types (cardiac, neuronal, hepatic) recapitulate a specific individual’s drug response (rather than that of a generic human being) and have opened up new avenues that support the concept of screening for cell-based safety and toxicity at the level of a population. 

The concept of clinical trials in a dish is to satisfy, in an in vitro setting, the defining biological truth that establishes the need for a multi-patient clinical trial, which is that drug responses vary by human.

‘Clinical trials in a dish’ studies are efficient, allow the study of a range of clinical doses, and can be executed at a fraction of the cost outside of the rigid and heavily regulated clinical testing environment.

‘Clinical trials in a dish’ studies are poised to revolutionize thinking about practical, immediate and near-term applications in the field of drug discovery and development. They can lead to insights that cannot be obtained so early and economically in drug development by any other approach.

Although still requiring improvements and enhancements, clinical trials in a dish offers to refine the selection of drugs to move into clinical development, leading to reduced attrition and enabling safe drugs that address unmet medical needs to reach patients more quickly.

 


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