Engineering Virtual Organization for Pharmaceutical Engineering and Science

提案编号：CBET-0742760主要研究者：Reklaitis，Gintaras附属机构： 普渡大学提案标题：制药工程和科学的工程虚拟组织FDA关键路径计划已确定药品开发和制造缺乏创新是将新药发现转化为安全和具有成本效益的药物的主要障碍之一。在这些领域缺乏研发投资也影响了劳动力的发展：具有相关专业知识的教师人数正在下降，受过培训的毕业生的渠道正在减少。认识到这一关键状况，导致最近成立了国家制药技术和教育研究所，这是一个由11所大学组成的非营利组织，其目标是促进制药开发和制造方面的研究和教育。此外，2006年启动的NSF结构化有机颗粒系统ERC主要侧重于工程研究，以改善固体剂型药物产品的开发和制造。虽然这些努力正在开始解决研发和教育差距，但必须通过有效的共享创造和获得研发成果、新方法和教育材料来加速这一进程。该项目将创建一个网络基础设施，以支持和加强跨学科但广泛分散的制药工程和科学研究人员社区的合作研究和教育活动。具体而言，门户网站pharmaHUB.org将促进信息、知识、建模工具和决策支持方法的协作开发和共享，并将促进共同创建和共享用于制药技术人员教育和培训的教育材料、模块和经验。pharmaHUB原型将适应现有HUB网络基础设施的功能，这些功能在普渡大学备受赞誉的nanoHUB中实施。它将借鉴项目的研发成果，如NSF ERC SOP，NIPTE，以及美国和国际同行在该领域的集体工作。它将开发新的功能，以适应设计制剂配方、设计加工系列和管理生产操作所需的基于信息、知识和模型的决策过程。图形界面将被创建，以支持“假设”的实验，为用户导航的决策过程。还将建立界面，以允许用户修改和贡献决策逻辑和其他过程知识。 这些接口的通用设计将允许支持不同格式的知识和流程数据。允许社区访问和改进结构化决策支持过程的能力不仅可以满足制药技术领域的需求，而且可以广泛适用于其他EVO开发。因此，该项目将推动制药技术的合作研究，将有助于培养对现代药物开发和制造至关重要的人才，并将有助于创造新的、独立于领域的网络基础设施能力。

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.