SBIR Phase I: Agile track and trace system for pharmaceuticals

创新是使用智能包装技术作为药品跟踪和追踪（TT）解决方案，部署在消费者药品的包装上。这个小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成本相当高，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。由于这些原因，TT没有被广泛采用、使用、容易获得或理解。这项创新通过使用URL代替SNI来消除这些挑战，每个药物包都是独一无二的。每个URL都指向一个登录页面，其中包含相关药物的特定数据，可以实时更新。第一阶段的研究旨在确保这些代码的大规模创建和更新在供应链的制造层面是可能的和有效的。在制造层面验证智能包装的部署，可以使经济实惠且灵活的解决方案在供应链中传播，这是广泛市场采用的理想情况。追踪和追踪（TT）技术的广泛/商业影响正在打破制药行业普遍存在的惯性状态。这种状态的存在是由于FDA未能实施TT指导方针，尽管2007年FDA修订法案承诺提供这样的指导方针。企业不愿承诺实施技术，因为这些技术可能被证明不足以应对未来监管指导方针的变化。现有的解决方案侧重于为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。虽然假冒在发达国家是一个较小的问题，但在供应链中发现污染后，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，因为该技术使用的网页可以立即更新，以符合当前的法规。该系统允许更有效地管理召回，这不仅意味着更少的责任，还意味着更少的生命损失。这项创新为制药商和消费者提供了直接的价值，并可以在未来使所有供应链参与者受益。它将为科学地了解不同用户如何在供应链的不同点之间消费和共享信息提供机会。

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.