James R. Bosley, PhD, to Join In-silico Trial Strategy Conference in Rome

Pharma/Biotech spends billions of dollars to determine, as early as possible, which compounds in trials are flawed and can be terminated. Still, about 7 of every 8 drugs introduced into trials fails. Each trial introduction commits the sponsor to spending estimated US$103 million. What if we could predict compound efficacy earlier, prior to the even placing a compound into trials? This approach is now being used by some leading pharma sponsors. For example Pfizer (NYSE:PFE), in collaboration with Dr. James R. Bosley and former and current colleagues, used in silico models to predict a sub-threshold effect from the novel GPR119 diabetes target prior to any Pfizer trials. This allowed program termination and resource reallocation. The model prediction was later confirmed by other sponsor’s published trial results for their GPR119 compound. Bosley has been invited to participate the Avicenna conference “A Strategy for in silico Clinical Trials” in Rome on June 5-6. His contributions in the field are in consulting engagements with pharma/ biotech, with innovations in simulation of clinical trials using large scale physiologically-based models. He comments: “NASA doesn’t launch the best ten Mars probe designs to see which one doesn’t crash. That would be costly and foolish. Yet relying on this approach is one reason why pharma R&D’s return on investment is being questioned and budgets are being cut. The Avicenna conference on in silico trial strategy projects an exciting, positive alternative. Causal models, based on disease pathophysiology and drug mechanism, allow predictive trial simulations. We are now finding winners and rejecting losers before costly placement into trials. This is high leverage, and the potential for increased R&D yield and efficiency, both internally and through better acquisitions, is staggering.“ Dr. Adriano Henney, one of the conference co-chairs, agreed. He noted “We expect Dr. Bosley’s unique experience applying in silico trials within pharma progams to add a useful perspective to the discussion, which will facilitate wider adoption”. Dr. Bosley provides decision support to pharma/biotech as Principal of Clermont, Bosley LLC (www.clerbos.com) and a Visiting Scholar at the U of Delaware, where he sits on the committee for the Quantitative Biology major. Dr. Henney is, in addition to serving as conference program co-chair, the Program Director at the German Virtual Liver Network (https://www.virtual-liver.de/wordpress/en/). a national flagship research program in systems biology.

About Clermont, Bosley LLC

Clermont, Bosley LLC provides scientific support for better drug development decisions, using physiologically-based, mechanistic models. The approach exploits a broad range of data, allowing clients to realize improved clinical trial yield and efficiency.