440211 Systems Based Pharmaceutics Alliance: Research Opportunities for Academics

Monday, November 9, 2015: 10:55 AM
Ballroom B (Salt Palace Convention Center)
Salvador García-Muñoz, Small Molecule Design and Development, Eli Lilly & Co., Indianapolis, IN

Officially launched in early 2014, the Systems Based Pharmaceutics industrial alliance seeks to close the gap between theoretical developments in process modeling and simulation; and the practical implementation of these technologies into the development and manufacture of new medicines.

” The SbP Alliance aims to develop a single model-based framework for drug substance manufacturing, drug product manufacturing, oral absorption and pharmacokinetics. The Alliance will seek to establish best practices in the application of model-based techniques which will be incorporated in validated commercial-quality computer software for the solution of industrially-important problems.” (PSE Press Release, 20-Mar-2014)

During its two years of operation, the subject  matter experts from the participant companies have implemented models that represent useful and practical  decision making tools for the development of new drugs. The focus of the alliance for its Phase I (years 1 and 2), was the integration of models spanning the crystallization, filtration, wet and dry milling of API; and the resulting performance of the crystal in the drug product in models for dissolution, the ASD apparatus, content uniformity and oral absorption. 

As the teams were implementing existing published models and approaches, several gaps were found to answer key dependencies to properly mimic dependencies and behaviors of interest in these system. This talk will present (primarily to the academic community) those areas of research that were identified as key areas of academic research where advances would make immediate impact to industrial needs.

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