Quantitative modeling researchers from M&S Decisions, a Skolkovo member company, presented at a scientific seminar on innovative methods in drug development held on October 17, 2016 at the U.S. Food and Drug Administration (FDA) in Washington D.C.
Kirill Peskov and Yuri Kosinsky, lead scientists at M&S Decisions, participated in the scientific seminar at the FDA, a federal agency responsible for the regulation and supervision of pharmaceutical drugs in the U.S.A. The seminar was focused on innovative methods in mathematical modeling, to improve the therapeutic outcome of novel drugs in the treatment of cancer. A new quantitative methodological platform, developed in collaboration between Skolkovo resident M&S Decisions and the pharmaceutical company Astrazeneca, was presented. The platform included a combination of modeling approaches, including systems pharmacology, pharmacometrics, and meta-analyses. It is under further development and validation work to predictively assess the therapeutic potential of novel oncology drug combinations, including the prediction of key endpoints in drug development clinical trials.
Such combination of modeling approaches results in the creation of a ‘modeling continuum’ along the pharmaceutical R&D pipeline, thereby enabling constant support towards decision-making, from preclinical to first-in-human trials, and from such early clinical trials to late-phase and registration trials. ‘How’ and ‘where’ in the pipeline such quantitative modeling may support transition points and decisions, and how it may help better identify patient subpopulations who respond to specific combination therapies, were debated in a lively and interactive Q&A session that followed the presentation, and during which the overall methodology platform was seen as “progressive.”
M&S Decisions lead scientists Yuri Kosinsky (left) and Kirill Peskov (right) at the U.S. Food and Drug Administration, Washington DC, October 17, 2016.