Engineering Virtual Organization for Pharmaceutical Engineering and Science

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Proposal Number: CBET-0742760Principal Investigator: Reklaitis, GintarasAffiliation: Purdue UniversityProposal Title: Engineering Virtual Organization for Pharmaceutical Engineering and Science The FDA Critical Path Initiative has identified the lack of innovation in pharmaceutical product development and manufacturing as one of the key impediments to the translation of novel drug discoveries to safe and cost-effective medicines. The lack of R&D investment in these domains has also impacted workforce development: the number of faculty with relevant expertise is declining and the pipeline of trained graduates diminishing. The recognition of this critical state has led to the recent formation of the National Institute for Pharmaceutical Technology and Education a non-profit organization of 11 universities with the goal of promoting research and education in pharmaceutical development and manufacturing. Moreover, the NSF ERC on Structured Organic Particulate Systems, launched in 2006, is largely focused on engineering research to improve the development and manufacture of solid dosage form drug products. While these efforts are beginning to address the R&D and education gaps, the process must be accelerated through effective shared creation and access to R&D results, new methodologies, and educational materials. This project will create a cyberinfrastructure to support and enhance the collaborative research and education activities of the interdisciplinary but widely scattered community of researchers in pharmaceutical engineering and sciences. Specifically, the web portal pharmaHUB.org, will facilitate collaborative development and sharing of information, knowledge, modeling tools and decision support methods and will promote the joint creation and sharing of educational materials, modules and experiences for use in the education and training of pharmaceutical technologists. The pharmaHUB prototype will adapt the functionalities of the existing HUB cyberinfrastructure, implemented at Purdue in the highly acclaimed nanoHUB. It will draw on the R&D output of projects such as the NSF ERC SOPS, NIPTE, and the collective work of US and international colleagues in the field. It will develop new functionalities for accommodating the information, knowledge- and model-based decision processes required to design drug product formulations, design processing trains, and manage manufacturing operations. Graphical interfaces will be created to support "what-if" experiments for users navigating the decision processes. Interfaces will also be built to allow user to modify and contribute to the decision logic and other process knowledge. The generic design of these interfaces will allow knowledge and process data in different formats to be supported. The capability to allow community access and improvements to structured decision support processes will not only address needs in the pharmaceutical technology domain but will be of broad applicability to other EVO developments. This project will thus energize collaborative research in pharmaceutical technology, will help to grow the pipeline of talent vital to the development and manufacturing of modern drugs and will contribute to the creation of new, domain-independent, cyberinfrastructure capabilities.