Maturing Pharma 4.0: How Digital Transformation Continues To Reshape Pharmaceuticals

Regulatory interest

It is not only pharmaceutical companies who are driving digital technologies, there are expression of interest from regulators as well, as with undertaking more assessments of new products and clinical trials through digital portals. Perhaps the most important step is the U.S. FDA’s embracing of new methods to enhance the safety and security of the pharmaceutical distribution supply chain under the Drug Supply Chain Security Act (DSCSA). The continual application of the DSCSA initiative is intended to enhance the security of the pharmaceutical distribution supply chain and evaluate any pilot projects conducted prior to enactment of the law.

Blockchain

One example of a new technology that was piloted and evaluated through the process was blockchain. Blockchain is software that provides a digital ledger system for records and log transactions, by grouping them into chronologically-ordered blocks. This makes it ideal for tracking supplies and ensuring that required storage conditions have been achieved and that goods have not been tampered with. Based on success stories relating to other sectors of the economy like financial services and energy suppliers, blockchain became seen as a suitable technology to meet the DSCSA requirement for an interoperable, electronic tracing of pharmaceutical products at the packaging level. This was demonstrated through a pilot program run jointly between IBM, KPMG, Merck and Walmart, who worked closely with the FDA’s DSCSA pilot program. This is leading towards wider adoption in 2023 once the DSCA requirements for medicinal distribution come into force and with it the necessity to demonstrate full unit level traceability across the supply chain.

To facilitate blockchain, competing solutions are available, each of which seeks to integrate directly into a healthcare company’s existing global infrastructure. These integrations allow for the secure exchange of critical and confidential information with authorized partners in an open, interoperable format. the final 2023 DSCSA deadline requiring full unit level traceability across the supply chain.

Outside of regulatory drivers, a number of pharmaceutical companies have been exploring other innovative technologies.