Highlights:
- A blockchain is a decentralized way of storing and managing data. A decentralized storage provides open, transparent, and secure transaction of data
- The technology which initiated from digital fund transactions is now impacting every industry that relies on storage and transmission of any kind of digital data. Bio-pharma is certainly no exception
- Immediate impact of the technology can be felt on clinical trial management and supply-chain supervision. Companies like Novartis, Merck, Boehringer Ingelheim etc. are actively investing in the technology
So, what is it?
In simplified terms, blockchain is a way of storing the data. However, rather than storing the data at one centralized server system, blockchain relies on maintaining identical copies of dataset (shared ledger) on multiple computer systems (nodes) that are controlled and managed by different entities.
These individual; and identical data copies can be called ‘Blocks’ of data, that are interconnected on a peer-to-peer network (‘Chains’). Together forming a Blockchain.
While traditional databases can be edited by a central authority, any alteration to dataset in a blockchain requires consensus agreement from all entities (nodes).
Why is it beneficial?
As blockchain is a decentralized and open format of data storage, all parties involved have a transparent view of information. This in turn provides an auditable trail of data changes that are verifiable, accurate, and secure to all stakeholders.
As the bio-pharma sector relies heavily on information storage and transmission right from the drug discovery to its development through clinical trial process, and finally marketing the therapy by involving mammoth supply-chain networks, the impact of blockchain can be immense.
Privacy of data in blockchain can help in better IP protection, and scientific data publication. Improved data sharing on blockchain can avoid duplication of work resulting in accelerated drug development. Authentic data transmission over a single sharing platform for key stakeholders can hugely assist in clinical trial management.
How it is being implemented?
The primary benefit of the technology appears in management of clinical trials where documentation plays a huge role. Right from the informed consent forms, maintaining identical protocols across trial sites, collecting patient outcomes, etc. the technology can assist in avoiding duplication of work, maintaining authenticity, imparting trustworthiness, and making the overall process seamless.
- As per an FDA report, almost 10% of trials face issues with informed consent forms. Blockchain can improve this by authentic timestamping, secure storage, and tracking among authorized parties
- The technology can reduce trial timelines, as clinicians can recruit patients in coordinated manner, and review the outcomes in real time across trial sites
- Secure, timestamped, and auditable change tracking across the chain, helps in mitigating the risks of lost records, wrong entries, incorrect recruitments, etc. Thereby preventing potential litigations
Apart from clinical trials, the other direct impact is on supply-chain management. As several parties are involved in supply-chain, like manufacturers, local logistics provider, distributers, pharmacies, etc. the transaction of data across these parties runs the risk of incoordination. Inconsistencies between involved parties can also results in product recalls.
One of the initial applications of blockchain in effective supply-chain management is being explored by providing digital medical leaflets to patients.
Who is at the forefront of applying this technology?
Blockchain technology, along with artificial intelligence (AI) and machine learning (ML) is being explored by several big-pharma players to improve their processes.
Boehringer Ingelheim in collaboration with IBM Canada is exploring the application of a decentralized blockchain framework in clinical trials. Novartis, has featured in the Forbes ‘Blockchain 50 2021’ list of top 50 corporations that are leading the efforts of implementing this technology across industries.
FDA had selected Merck, along with IBM, KPMG and Walmart to participate in a blockchain pilot project aimed at developing a tracking and tracing system to adhere with the requirements of the Drug Supply Chain Security Act (DSCSA).
AbbVie, AstraZeneca, Pfizer, Roche, GSK, Bayer, Janssen, and UCB are few of the key big-pharma players involved in an EU blockchain consortium – PharmaLedger that’s currently focused upon building scan codes for package inserts, eConsent for remote clinical trials, and improved collection of health data. In essence, while Blockchain technology’s implementation in bio-pharma is only at a nascent stage currently, there is little doubt on its widespread adoption across the pharma drug value chain in immediate future, resulting in shrinkage of both – drug development costs, and timelines.