Leading the pharmaceutical development (CMC – chemistry, manufacturing, and controls) and clinical supply chain function at Avanir Pharmaceuticals, Arul Joseph – alongside his team – manages the development, manufacturing, testing, and packaging of drug substances and drug products, and the distribution of drug products to sites supporting clinical studies.
“My involvement is one of a pharmaceutical industry participant who evaluates new technologies and tools such as blockchain for their utility and impact in terms of improving productivity, efficiency, compliance, patient safety, and process robustness. As an invited speaker at industry conferences, I have shared the impact of emerging technologies such as blockchain on the CMC development, manufacture, testing, packaging, and distribution of drug products in the pharmaceutical industry,” says Joseph.
Blockchain in Pharmaceutical Manufacturing
Blockchain – an open, decentralized, secure, public ledger that stores every single record, event, or transaction sequentially in a verifiable way, as ‘blocks’. Each ‘block’ has a timestamp and is linked to a previous block which is added to the existing blockchain when the majority of users validate its authenticity. Once added, it cannot be altered or deleted and is visible to all participants.
“Blockchain can provide a safe and easy way to share authenticated information across organizations,” explains Joseph. “For instance, in the pharmaceutical supply chain, many different organizations are involved in making a pill and getting it to a patient such as manufacturers, packagers, distributors, logistics providers, shipping companies, clinical sites for clinical studies and wholesalers and pharmacies for a commercial supply chain.
“Blockchain can improve traceability by increasing end-to-end visibility of the supply chain with data. As the stakeholders themselves verify the authenticity of the record, blockchain has the advantage of not requiring any single central owner of all information, so organizations don’t need to share their internal systems or proprietary information, only data shared for that record or transaction to be verified need be shared transparently across all participants in the supply chain.”
The Benefits of Blockchain in Pharmaceutical Manufacturing
“Blockchain can help ensure that there is reliable, accurate data and a single reliable version of the truth that is shared by every participant in the pharmaceutical manufacturing and supply chain. It can increase end-to-end visibility of the supply chain with data. Blockchain can bridge barriers between stakeholders by giving all parties the same, real-time, accurate view of the supply chain. This is an important factor for ensuring manufacturing and supply chain robustness,” says 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-to-end 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 initiated by the FDA in 2019 to evaluate product track, trace, and verification technologies in the pharmaceutical supply chain. Several of these DSCSA pilot projects, such as MediLedger, DSCSA blockchain interoperability pilot, Tracelink, and UCLA-LedgerDomain, evaluated the use of blockchain. Overall, the pilot programs found that blockchain can be used to meet the DSCSA requirements that continue to be phased in and will be fully enforced by 2023 so that it can help improve transparency and increase patient safety,” explains Joseph.
Another example of the technology being used in pharmaceutical manufacturing given by Joseph is “a PharmaLedger project to provide patients with electronic medical inserts, which are digital versions of the paper inserts, using blockchain. Blockchain-based electronic medical inserts are expected to allow pharmaceutical companies to provide secure and accurate updates directly to patients in near real-time. The patient can use an app to scan a code outside of the drug product package, which allows the patient to access the most current updated and accurate information for that drug. The advantage of using blockchain-based digital or electronic medical inserts is it can reduce mislabeling issues from incorrect paper inserts and improve efficiencies, as well as reduce costs and delays associated with printing paper inserts on the packaging line.”
When it comes to the future of the industry, Joseph sees the pharmaceutical industry continually evolving to become more technology and data-driven. “More emphasis will be placed on supply chain transparency, with traceability stretching to the furthest reaches of a product’s supply chain. With the increasing use of biologics such as cell and gene therapies that require more complex manufacturing and supply chain compared to small molecule drugs, blockchain may be used to standardize manufacturing and establish a chain of custody for the needle-to-needle delivery of autologous cell and gene therapies.”
Blockchain and COVID-19
Covid-19 has revealed some of the fragilities in supply chains and has hastened the process of adoption of technologies such as blockchain to improve the robustness of supply chains. This acceleration of the adoption of technology is expected to continue in the coming years,” says Arul Joseph, Senior Director, Pharmaceutical Development and Clinical Supply Chain, Avanir Pharmaceuticals.
The Challenges of Adopting Blockchain Technology
“Some challenges with data include having a linear flow of material and data across manufacturing and supply chain. In such cases, data flows linearly, one partner up and one partner down. For end-to-end traceability, a request would be made by a trading partner through the supply chain. Each partner then provides the electronic information back to the requesting entity, which is slow, inefficient, and may be outdated by the time the information is received by the requesting entity. The systems used by different organizations may be isolated and not communicate across organizations due to issues with trust and concerns with security in sharing data and access to systems with other organizations.
With blockchain, as information of each transaction or record is visible transparently to all stakeholders in the supply chain, there is near real-time access to data. Also, as discussed above, as organizations verify the authenticity of the record, blockchain has the advantage of not requiring any single central owner of all information, so organizations don’t need to share their internal systems or proprietary information, only the record or transaction to be verified need be shared transparently across all participants in the supply chain alleviating any concerns with trust and security of data and systems,” says Arul Joseph, Senior Director, Pharmaceutical Development and Clinical Supply Chain, Avanir Pharmaceutical.