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SLAS Discovery, a leading peer-reviewed scientific journal, today announced the publication of a ground-breaking new article by Coyne Scientific co-authors Bernard Fermini, Ph.D., Kevin P. Coyne, MBA and Shawn T. Coyne, MBA titled, “Clinical Trials in a Dish: A Perspective on the Coming Revolution in Drug Development”.  The article – which describes a novel drug safety testing paradigm that bridges the worlds of preclinical testing and clinical trials – can be accessed for free ahead-of-print on the publisher’s website at: http://journals.sagepub.com/doi/full/10.1177/2472555218775028.

According to Bernard Fermini, Chief Scientific Officer: “The cost of developing new drugs has reached unsustainable levels, fueled in large part by high attrition rates in clinical development. Recent studies have shown that individual drug susceptibility in a population of volunteers with unknown genetic background can be recapitulated in human induced pluripotent stem cells (hiPSCs) derived from these same individuals, providing a proof of concept for in vitropreclinical trials, and enabling cell-based screening for safety and toxicity at the level of a population, similar to clinical trials.  This new platform, termed “Clinical Trials in a Dish”, or CTiD, allows researchers to define the incidence and distribution of effects of drugs (whether beneficial or adverse) across a population long before actual clinical trials, so that a pharma company can curtail development of ‘future failures’ early on while continuing development of safe compounds that might not have met traditional safety margins.” 

 Added Kevin Coyne, CEO: “CTiD studies, which first became commercially available earlier this year, can also help pharma companies address such important issues as repurposing shelved compounds, reducing adverse drug-drug interactions, protecting underserved ethnic populations, and protecting children and geriatric patients – economically, and without regulatory complications.”

To discover how this new platform offers the potential to revolutionize safety and toxicity testing of new drugs, and/or for more information, please contact Shawn Coyne, President, at scoyne@coynesci.com. 

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 ABOUT COYNE SCIENTIFIC, LLC:  Coyne Scientific conducts in vitrosafety and toxicity testing on pharmaceutical compounds.  We use human stem cell-based models to estimate the distribution of incidence and severity of reactions to candidate drug compounds across a population as a result of that population’s genetic diversity.  We can help clients dramatically reduce drug development costs through early identification of compounds that may negatively affect a portion of clinical trial participants despite appearing to be safe to the “average” human.  We can also help improve the safety of drugs in cases where clinical trials are infeasible, such as in the development of compassionate use drugs or orphan drugs, or in the entry of drugs into small national markets with genetically-distinct populations. 

ABOUT SLAS:  The Society for Laboratory Automation and Screening is an international community of nearly 20,000 professionals and students dedicated to life sciences discovery and technology.  The SLAS mission is to bring together researchers in academia, industry and government to advance life sciences discovery and technology via education, knowledge exchange and global community building. 

ABOUTSLAS DISCOVERY :  Editor-in-Chief Robert M. Campbell, Ph.D., Eli Lilly and Company, Indianapolis, IN (USA).  SLAS Discovery(Advancing Life Sciences R&D) was previously published (1996-2016) as the Journal of Biomolecular Screening(JBS).