SBIR Phase I: Agile track and trace system for pharmaceuticals

SBIR 第一阶段：药品敏捷追踪系统

• 批准号: 1315431
• 负责人: Albert Ho
• 金额: $ 15万
• 依托单位: AgileQR, Inc
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-07-01 至 2014-06-30
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1315431&HistoricalAwards=false
• 关键词: SBIR; Phase; Agile; track; trace

The innovation is the usage of smart packaging technology as a pharmaceutical track and trace (TT) solution deployed on the packaging of consumer drug products. This Small Business Innovation Research Phase I project will determine its feasibility. The problem to be solved is the considerable expense and inefficiency of drug recall and detection of counterfeit drugs in the pharmaceutical industry. Existing solutions simply print a Standardized Numerical Identifier (SNI) on drug packages, leaving it up to each player in the drug supply chain to use and interpret without guidance or communication. For these reasons, TT is not widely adopted, useful, easily accessible, or understandable. The innovation eliminates these challenges by using a URL in place of an SNI, unique to each drug package. Each URL directs to a landing page with data specific to the associated drug that can be updated in real time. This Phase I study aims to ensure that mass-scale creation and updating of these codes is possible and efficient at the manufacturing level of the supply chain. Validating the deployment of smart packaging at the manufacturing level enables the affordable and flexible solution to propagate down the supply chain, an ideal situation for broad market adoption.The broader/commercial impact of track and trace (TT) technology is breaking the pervasive state of inertia in the pharmaceutical industry. This state exists from the FDA's failure to implement TT guidelines despite the 2007 FDA Amendments Act which promised to deliver such guidelines. Firms are hesitant to commit to implementing technologies that might prove to be ill-equipped to manage future changes in regulatory guidelines. Available solutions are focused on providing technology for the developing world as those countries are the most impacted by counterfeit pharmaceuticals. While counterfeiting is a smaller problem in developed nations, there are still many challenges in managing recalls when contamination is discovered in the supply-chain. The innovation has great commercial potential because "smart packaging" is future-proof due to the technology's use of webpages that can be instantly updated to comply with current regulations. The system allows for recalls to be managed more efficiently which not only means less liability but also fewer human lives lost. The innovation provides immediate value to pharmaceutical manufacturers and consumers and can benefit all supply-chain participants in the future. It will provide an opportunity to scientifically understand how different users consume and share information between different points in the supply-chain.

这项创新是使用智能包装技术作为药品跟踪和跟踪(TT)解决方案部署在消费药品产品的包装上。这一小型企业创新研究第一阶段项目将确定其可行性。需要解决的问题是，制药行业在药品召回和假药检测方面的费用相当高，效率低下。现有的解决方案只是在药品包装上打印一个标准化的数字标识符(SNI)，让药品供应链中的每个参与者在没有指导或沟通的情况下使用和解释它。出于这些原因，TT没有被广泛采用、使用、容易访问或理解。这项创新通过使用URL取代SNI来消除这些挑战，每个药物包装都是唯一的。每个URL指向一个登录页，其中包含可以实时更新的相关药物的特定数据。这项第一阶段研究的目的是确保在供应链的制造层面大规模创建和更新这些代码是可能的和有效的。在制造层面验证智能包装的部署使负担得起的灵活解决方案能够向供应链下游传播，这是广泛采用市场的理想情况。跟踪和跟踪(TT)技术的更广泛/商业影响正在打破制药行业普遍存在的惯性状态。这种状态的存在是因为FDA未能实施TT指南，尽管2007年FDA修正案承诺提供此类指南。公司不愿承诺实施可能被证明不具备管理未来监管指导方针变化的能力的技术。现有的解决方案侧重于向发展中国家提供技术，因为这些国家受假冒药品的影响最大。虽然制假在发达国家是一个较小的问题，但在供应链中发现污染时，在管理召回方面仍存在许多挑战。这项创新具有巨大的商业潜力，因为“智能包装”是面向未来的，因为这项技术使用的网页可以立即更新，以符合当前的法规。该系统可以更有效地管理召回，这不仅意味着更少的责任，也意味着更少的生命损失。这项创新为制药制造商和消费者提供了立竿见影的价值，并可以在未来使所有供应链参与者受益。它将提供一个机会，以科学地了解不同的用户如何消费和在供应链的不同点之间共享信息。