Engineering Virtual Organization for Pharmaceutical Engineering and Science

制药工程与科学工程虚拟组织

• 批准号: 0742760
• 负责人: Gintaras Reklaitis
• 金额: $ 19万
• 依托单位: Purdue University
• 依托单位国家: 美国
• 项目类别: Continuing Grant
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-09-15 至 2009-08-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=0742760&HistoricalAwards=false
• 关键词: Engineering; Virtual; Organization; Pharmaceutical; Science

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.

提案编号：CBET-0742760 首席研究员：Reklaitis，Gintaras 隶属关系：普渡大学提案标题：制药工程和科学的工程虚拟组织 FDA 关键路径倡议已将药品开发和制造领域缺乏创新视为转化的主要障碍之一从新药发现到安全且具有成本效益的药物。这些领域缺乏研发投资也影响了劳动力发展：具有相关专业知识的教师数量正在减少，受过培训的毕业生的输送渠道也在减少。对这一危急状态的认识导致国家制药技术与教育研究所最近成立，这是一个由 11 所大学组成的非营利组织，其目标是促进药物开发和制造方面的研究和教育。此外，2006 年启动的 NSF ERC 结构化有机颗粒系统主要侧重于工程研究，以改进固体剂型药品的开发和制造。虽然这些努力已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取研发成果、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协作研究和教育活动。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，并将促进联合创建和共享用于制药教育和培训的教育材料、模块和经验。技术人员。 pharmaHUB 原型将适应现有 HUB 网络基础设施的功能，该基础设施在普渡大学广受好评的 nanoHUB 中实施。它将借鉴 NSF ERC SOPS、NIPTE 等项目的研发成果以及该领域美国和国际同事的集体工作。它将开发新的功能，以适应设计药品配方、设计加工序列和管理制造运营所需的信息、知识和基于模型的决策过程。将创建图形界面来支持用户导航决策过程的“假设”实验。还将构建界面以允许用户修改决策逻辑和其他流程知识并为其做出贡献。 这些接口的通用设计将允许支持不同格式的知识和过程数据。允许社区访问和改进结构化决策支持流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，该项目将激发制药技术的合作研究，有助于扩大对现代药物的开发和制造至关重要的人才管道，并将有助于创建新的、独立于领域的网络基础设施能力。