Avid Bioservices Inc (CDMO)

[biopharm]

Why would Lisa Stepp also be consultant there? ...I guess one never knows what the full circumstances are yet....

Block chain is coming though, to a CDMO near and dear to all of us

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Why the Industry Is Moving Toward Blockchain Technology

December 6, 2019

R&D
Blockchain

Given that blockchain technology allows the secure creation
and sharing of time-stamped records among numerous parties in real time, it isnâ??t surprising that it might be of interest for improving the pharmaceutical supply chain. Pharmaceutical companies arenâ??t stopping there, though. Blockchain technology is being explored for drug discovery, clinical trials and much more.

What Is Blockchain Technology?

Blockchain technology has its origins in the field of cryptocurrency and was originally used to establish Bitcoin, the first viable digital currency. A distributed ledger technology (DLT), blockchain enables proof of ownership and the transfer of ownership from one entity to another without using a bank.1 Today, it is used for many different applications in many industries because it offers a unique combination of features not possible with other digital technologies.

Those features include the creation of permanent, immutable, signed and time-stamped records of ownership of assets of various types, identities, transactions and contractual commitments that can be shared among all members of a business ecosystem in near real time.2 The records are stored on dozens to thousands of computers around the world.

Authorizations can be assigned to specific types of information by specific members. Most importantly, blockchains are â??essentially unhackableâ? for anyone without authorized access. That is because once a record has been added to the â??chain,â? the data cannot be altered or deleted, because new blocks can only be added to the end of the chain.3
In addition to this high level of security, blockchain technology enables supply chain transparency.2

Everyone in the supply chain can access the same data as soon as it is created. The sources of data and records are also more clearly identified and can be readily traced, significantly decreasing the time it takes to identify problems in the supply chain and increasing the ability to manage quality and inventory flows.

Business transactions can also be accelerated when blockchain technology is combined with â??smart contractsâ? and the Internet of Things (IoT).2 For international transactions, the time it takes to transfer ownership of goods can be reduced from 10 days to 10 minutes.

There are many potential uses for blockchain technology in the pharmaceutical industry, including facilitating patient, physician, payer and pharma company access to medical records; prescription sharing, enhancement of the supply chain, tracking and reporting of clinical trial data, provider credentialing, quality-of-care tracking, drug pricing strategy tracking and adverse event tracking and evaluation.3 The primary use for blockchain in the pharma industry, according to KPMG analyst Arun Ghosh, is to serve as a â??ledger of truthâ? for sharing complex information with regulators, pharmacy benefit managers, contract manufacturers, physicians, patients, academic researchers and R&D collaborators, among others.4 In 2018, Accenture estimated that, in the life sciences, blockchain technology could provide a $3 billion opportunity by 2025.5
Focus on Enhancing the Pharmaceutical Supply Chain
Given the ability of blockchain technology to enable secure and rapid transactions around the world, much of the efforts in the pharmaceutical industry to leverage its capabilities are focused around improving the supply chain.

One of the biggest benefits of blockchain technology is the ability to create an auditable trail and establish drug provenance across the entire supply chain. A survey conducted by Pistoia Alliance revealed that nearly 70% of pharmaceutical and life science leaders believe blockchain will have the greatest impact in this area.1
With a decentralized blockchain solution, both manufacturers and their clients would be able to independently verify the quality and point of origin of drugs quickly and securely.6

Transparency and security are two other key benefits of blockchain technology for members of the pharmaceutical supply chain. All of the stakeholders involved in the supply chain must be able to share and update data while also being assured the data is timely and accurate.7 With blockchain technology, the entire supply chain can be managed with one piece of software that is shared between authorized stakeholders. In addition to drug manufacturers and their suppliers, payers, providers, pharmacies, and patients can access the data and see when it is updated in near real time.4
With blockchain technology, these issues can be avoided because the entire supply chain can be managed with one piece of software that is shared between authorized stakeholders. In addition to drug manufacturers and their suppliers, payers, providers, pharmacies, and patients can access the data and see when it is updated in near real-time.4

Blockchain technology also has the potential to help prevent diversion, counterfeiting and tampering, because drug products can be tracked from the time they are produced until the time they reach patients. Any attempts to change records will be visible to all parties immediately.4

As importantly, recalls are much simpler.4,6 The product can be readily traced back to the manufacturer and associated with a production batch, allowing identification of other potentially problematic products and where they had been shipped.
A Note about Blockchain and Serialization

Blockchain technology will play a pivotal role in the industryâ??s ability to comply with various serialization regulations around the world, including the 2013 U.S. Drug Supply Chain Security Act (DSCSA) and the EU Falsified Medicines Directive 2011/62/EU (FMD). Serialization involves the unique identification of every drug product at the level of individual units, as well as in aggregated packaging units. Information on the product, its manufacture (location, date, batch number, etc.), logistics route, and so on, must be shared with all supply chain partners involved in the delivery of the drug to the patient. The intent is to make it possible to trace products back through the supply chain to their point of origin.

The transparency and security of blockchain technology is ideally suited to enabling serialization, not only because it enables data sharing, but also because the records are unchangeable, which facilitates regulatory auditing.8,9


https://www.pharmasalmanac.com/articles/why-the-industry-is-moving-toward-blockchain-technology