Welcome back from the Summer! I hope you all have had a relaxing summer and rest over the Labor Day weekend (in the States). We, here at the Center have been busy this summer, Kicking-off one Study and advancing others.
On August 22 we had our official Kick-off of the DSCSA – MDM (Drug Supply Chain Security & Master Data Management) Study (or VirtualPilot). The Study is to explore a number of ways proper Product and Entity/Location Master Data can [continue] to occur as implementations of DSCSA increase throughout the US Pharmaceutical Supply Chain. The goal of the Study is to provide, trading partners who choose to, alternatives to the current situation where certain Product and Entity master data is provided in duplicate data feeds due to the DSCSA law. Our intent is to model a number of scenarios that Trading Partners will find themselves in (especially starting in 2023), establish performance metrics and provide projection on different sizes and types of trading partners. We would like to present our findings to the FDA in order to allow for more efficient and safe management of master data within the supply chain.
We have seen interest from a number of hospitals, manufacturers and solution providers to expand the above Study to explore the DSCSA data and medication as it moves through the hospital environment and ends with the patient. That study will, most likely, kick-off this Fall and take advantage of the ReferenceModel components created in the DSCSA – MDM Study.
One of the Center for Supply Chain Studies overall goals is to build a library of ReferenceModels and ReferenceModel components to aid industry in being able to explore more options in a shorter timeframe.
An idea that has been percolating in the industy and which we have started to socialize as an official Study is the use of Blockchain or public/private ledger technology to address some of the Trust and Security needs in implementing a distributed DSCSA infrastructure.
We are just starting to gage the interest in such a study. If you too have asked yourself “if Blockchain could apply to DSCSA, or are just interested in one or both subjects of Study, please see our information sheet and contact us.
These and other study ideas are moving through the different phases from idea through Study. If you would like to keep up with the growing number of Studies, please consider becoming a Subscriber to the Center. There is no fee and you will be among the first to receive updates on Studies, periodic Study Updates and Newsletters.