392437 Systems-Based Pharmaceutics - An industrial pre-competitive alliance

Tuesday, November 18, 2014: 10:10 AM
202 (Hilton Atlanta)
Salvador García-Muñoz, Small Molecule Design & Development, Eli Lilly and Company, Indianapolis, IN

The Systems-Based Pharmaceutics industrial alliance seeks to develop a model-based holistic platform for the development and optimization of drug manufacture and delivery. This holistic approach aims to address the various drawbacks associated with the silo thinking approach that is prevalent in many pharmaceutical companies.

Given the many technical challenges in such an endeavor, the current phase of implementation does not primarily focus on the development of new fundamental scientific knowledge (e.g. on drug manufacturing unit operations, or on drugs pharmacokinetics/pharmacodynamics); but rather on the implementation of the current state of the art as published by academic and professional scientists.

SBP is also not prescriptive about the type of mathematical models that it will support. Some of these will be based on first-principles descriptions while others will be statistics-based models or even simple correlations.  Furthermore, component models of different types may be integrated within the same system-level model.

Overall, SBP aims to be an integrating environment facilitating the accelerated transfer of new fundamental knowledge from sources of new science (i.e. academic research or R&D efforts) to industrial practice, while supporting the effective sharing of non-proprietary knowledge across the pharmaceutical industry.

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