SBIR Phase I: Agile track and trace system for pharmaceuticals

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.