TECHNOLOGY
“ Blockchain may be used to standardise manufacturing and establish a chain of custody for the needle-toneedle delivery of autologous cell and gene therapies ”
ARUL JOSEPH SENIOR DIRECTOR , PHARMACEUTICAL DEVELOPMENT AND CLINICAL SUPPLY CHAIN , AVANIR PHARMACEUTICALS
The Shift to Blockchain in Pharmaceutical Manufacturing As the industry ’ s complexity continues to grow , so does its need for improved traceability and end-to-end visibility , coupled with authority requirements such as the FDA ’ s Drug Supply Chain Security Act ( DSCSA ) - which will come into full enforcement by 2023 - and the General Data Protection Regulations ( GDPR ), “ personal data that is obtained and used as part of clinical trials and pharmaceutical companies must show how it is managed and who has access to it ,” says Joseph .
“ Any potential security gaps in the supply chain become important , making end-toend data visibility helpful when it is time for data audits , which is a key aspect of the GDPR legislation . Blockchain can help address these needs .”
There are many other ways that blockchain is being used in the pharmaceutical industry , including the packaging and supply chain functions . “ For instance , to help meet the FDA ’ s Drug Supply Chain Security Act ( DSCSA ) requirements , pharmaceutical companies participated in a DSCSA pilot program
104 October 2021