Smart Simulations of Phase III Clinical Trials with Synthetic Crohn’s Disease Patients

BLACKSBURG, Va., Nov. 06, 2015. Developing a new medicine takes an average of 10-15 years, costs $1.2 billion, and the likelihood that a new drug will make it into the market is 1 in over 10,000. Applying big data/modeling strategies to better inform the drug development process is a promising way to address this cost-efficiency problem. Technologies designed to predict how patients with infectious, metabolic or immune-mediated diseases respond to innovative therapeutics can help transform medicine from an art into a more precise science.

Researchers at the Nutritional Immunology and Molecular Medicine Laboratory (NIMML) developed smart simulations to predict how virtual patients respond to a novel drug, hence advancing the drug discovery process at an unprecedented rate1. By using data from published clinical studies, and Advanced Machine Learning techniques, the NIMML team has constructed a large cohort of virtual Crohn’s disease patients that are participating in a phase III Placebo-Controlled, Randomized Clinical Trial.

“Smart simulations of clinical trials hold enormous promise in improving the cost efficiency problem of the lengthy, and costly drug development process.” Said Josep Bassaganya-Riera, Professor of Immunology and Director of the Nutritional Immunology and Molecular Medicine Laboratory. “Applying advanced machine learning methods in combination real-time clinical and immunological data is taking us a step closer to the development of transformative precision medicine treatments for a wide range debilitating and widespread diseases without a cure such as Crohn’s disease.”

The in silico clinical trial study performed by NIMML is a pioneering step toward accelerating the path to cures. In silico clinical trials can optimize innovation and help address unmet clinical needs for more individualized therapeutic and prophylactic approaches.

“NIMML has developed disruptive methods to compare investigational and Food and Drug Administration (FDA)-approved therapeutics for Crohn’s disease, based on 10,000 virtual patients.” said Vida Abedi, an Assistant Professor at the Nutritional Immunology and Molecular Medicine Laboratory. “While the in silico clinical trials in virtual patients will not completely replace clinical testing in humans, it will definitely inform the design of such studies to increase the likelihood of success and help address the efficiency problem in drug development.”

1Abedi, V., P. Lu, R. Hontecillas, M. Verma, G. Vess, C. Philipson, A. Carbo, A. Leber, N.T. Juni, S. Hoops, J. Bassaganya-Riera. Phase III Placebo-Controlled, Randomized Clinical Trial with Synthetic Crohn’s disease Patients to Evaluate Treatment Response. Emerging Trends in Computational Biology, Bioinformatics, and Systems Biology – Systems & Applications. In Press: Elsevier/MK 2015.