In January 2020, 12 global pharmaceutical companies and 17 public and private entities; including technical, legal, regulatory, academia, research organisations and patient representative organisations, got together to form PharmaLedger, the pharmaceutical blockchain consortium.

Joining us for this podcast is Daniel Fritz, PharmaLedger Industry Project Leader and Supply Chain Domain Architect at Novartis and Marco Cuomo, Manager Applied Technology Innovation at Novartis, a team that brings in new technologies, such as blockchain, into Novartis. Marco is also the co-lead architect at PharmaLedger for the blockchain platform.

 What is blockchain?

Daniel likes to introduce blockchain with the five A’s:

Assets, too often blockchain is associated with cryptocurrencies as assets but assets can also be data and medicinal products that can be exchanged on a distributed ledger technologyAudit, the immutability aspect of blockchain is good for audit.Automation, use of smart contracts eliminate non-value adding stepsAnonymize, especially important in the healthcare care industry to protect the patient’s data by keeping it confidential and protecting their privacyAuthority, no central authority where authority is distributed amongst the participants

For Marco the real strong added value blockchain provide at its core is the immutability function. Whatever you store on the blockchain, transactions and data are immutable so no one can change it.

 An introduction to PharmaLedger

PharmaLedger, launched in January 2020 as a public private partnership under (IMI) the Innovative Medicines Initiative, a joint undertaking between the European Union and the (EFPIA) European Federation of Pharmaceutical Industries and Associations. It’s a three project with over €22m of public private funding. There are 29 partners in the consortium which includes 12 pharmaceutical companies whose goal is to accelerate blockchain adoption. Its aim is to prove that this technology can bring value to patients, increase trust amongst all of the different ecosystem stakeholders and enable new capabilities around supply chain clinical trial and health data. In addition it aims to demonstrate that blockchain can address some of the key challenges the industry has around identity and governance.

The whole idea of the IMI is actually about building consortiums to address problems or challenges that are too risk for any one company or too expensive for any one company and which would benefit from having public partnerships.

 PharmaLedger use casesPharmaLedger has launched with 8 use cases broken down into three domains:

Clinical trialsHealth dataSupply chain

Within the supply chain domain, you have two versions of supply chain traceability: clinical supply and finished good traceability. There is electronic project information (ePi) which is also known as an e-leaflet, or an e-patient information leaflet. It’s a digital version of the leaflet you find in a medicine box. It contains the latest approved version of that leaflet in a manner that preserves the patient’s privacy. In the future it will have the capability to send out recall notification, if there was a quality issue of that product, to send updated product information and also to apply some additional checks on the provenance of that medicine to help reduce the risk of counterfeits.

On the clinical trial side, they have eRecruitment which is clinical trial recruitment so that patients can share their health profile and be matched through an algorithm to open clinical trials. Clinical trial eConsent aims to reduce the very administrative process for agreeing to undergo procedures and processes for any clinical trials. Clinical trial for IoT devices is for getting data from devices. Personalised medicines is putting it all together with some advanced digital technologies like machine learning and artificial intelligence to help predict what ki...