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Mandatory in Constructing a High-fidelity Database Readying for The Downstream Disruptive Technologies, such as for The Artificial Intelligence Training

Frank Leu, Founder and managing member, BioPharMatrix LLC

Blockchain is the foundation layer for the data procured during drug development that are transparent, secure, and traceable. This tamper-proof and decentralised ledger also ensures that data generated during drug development is both robust and accessible to all stakeholders while allowing machine learning and artificial intelligence to harness data effectively and provide accurate solutions.

A blockchain is a simple digital serial ledger of tamper-proof data blocks that are cryptographically protected via peer-to-peer networks (known as validators and/or nodes) and is distributive and decentralised by nature. It contains a record of transactions in a chain of data blocks in a decentralised form with each validator/node storing a copy, meaning with multiple validators/nodes operating in a blockchain making that no single entity or authority could have control over the entire blockchain data and its network in a centralised fashion.

Another important aspect is its immutability, which makes it virtually impossible for malicious actors to alter it. Bitcoin, Ethereum, and many other cryptocurrencies made it well known to the masses. However, its applications have extended far beyond cryptocurrency. Its ability to offer a superior architecture for efficient data management and secure transactions has attracted interest across several sectors, including healthcare and pharmaceutical drug development.

Currently, blockchain has the potential and is on its course to disrupt the drug development landscape profoundly. Blockchain should no longer be referred to as a “future technology”, rather it is the technology that has already been implemented in various business sectors, such as supply chain logistics, product storage management, real estate, and decentralised finance.

Artificial intelligence (AI) can be trained on broad and various databases within the ecosystem of drug development and then allow AI to solve many complicated problems quickly and accurately. Blockchain technology constructs a trustless database, which is highly trustworthy with incredibly high intrinsic fidelity. When AI is trained with a database with low intrinsic fidelity, there is a serious risk that AI would provide solutions that are overly biased, error-prone, and vulnerable to security threats, which can diminish its solutions’ and renders them useless and unreliable. Blockchain provides a secure, transparent means for recording and verifying each transaction and interaction, thus allowing AI to derive machine intelligence from its training through data compiled by blockchain and thus greatly reducing the risk of generating faulty solutions for complicated problems. Blockchain-based solutions can, for example, be used to verify the integrity of each data block added that is used to train AI models, ensuring accuracy, unbiasedness, and representativeness.

Therefore, the blockchain must serve as the foundation layer for the pyramid of downstream disruptive technologies, providing a reliable information source for machine learning and AI training. By achieving high data fidelity using blockchain architecture, hyper-efficient drug development is likely to be achievable. By doing so, AI systems will be functioning more accurately and fairly, and the risk of errors or biases will be reduced. Moreover, blockchain can provide individuals with control over their personal information and ensure that sensitive data is not compromised or misused, thereby ensuring both data security and privacy.

However, while blockchain technology can be an important tool in building a trusted AI system to enhance the process of drug development, it is not the only technical requirement to ensure AI works robustly and accurately. Other technologies and processes, such as robust data governance, explainability, and ethical frameworks, are also important components needed to implement to ensure the trustworthiness and reliability of the data collected during drug development.

In the hope to achieve the overall best efficiency to reduce both drug developmental costs and timespan. An overview of a few specific areas during drug development of how blockchain could impact drug development positively and provide the high fidelity required for AI to be accurately and unbiasedly trained and allow it to best perform is listed below in random order:

1.Data Governance and Assurance. By ensuring that data is managed, stored, and shared consistently and transparently across all parties concerned, blockchain's decentralised nature and consensus mechanisms help improve the governance of data. Because blockchain technology is immutable, it assures the accuracy, reliability, and trustworthiness of the data it records. For pharmaceutical companies, where data quality is crucial to regulatory compliance and decision-making, this characteristic is particularly important.

2.Enhanced Stakeholder Collaboration with Efficient Inventory Management. As blockchains offer real-time visibility into stock levels, expiration dates, and product locations, pharmaceutical inventory management can be optimised. By increasing transparency to all stakeholders, better forecasting is possible, stockouts and waste are reduced, and essential medicines are available to patients in a better way. Blockchain can facilitate secure data sharing, intellectual property management, and collaborative efforts among pharmaceutical companies, research institutions, and regulators. Consequently, new treatments are more likely to be brought to market faster with a lower cost, which promotes innovation, accelerates drug discovery, and accelerates drug discovery.

3.Pharma Supply Chain and Pharmaceuticals Turnover Monitoring. Pharma supply chains can be complex, involving many intermediaries and crossing international borders. As a result of this complexity, transparency can be compromised, logistical bottlenecks can occur, and fraud and theft can be more common, ultimately impacting the availability and affordability of medicines. Pharma supply chains can be significantly more transparent and traceable with blockchain technology. In addition to enabling stakeholders to track and authenticate drugs from their point of origin to their destination, blockchain also prevents counterfeit drugs and ensures patient safety by creating secure, tamper-proof records of sales and product movements. As a result of optimising supply chain processes, reducing waste, and ensuring efficient distribution, blockchain can assist pharmaceutical companies in reducing turnover. Pharma companies can save money and ensure patients have access to medicines on time as a result. This use of blockchain technology could also ultimately enable better monitoring and analysis of prescription drug dispensing patterns, drug utilisation, and concerns about the potential abuse of prescription drugs.

4.Anti-counterfeiting and Safe Plus Secure Distribution of Pharmaceutical Products. As blockchain creates a secure, tamper-proof record of drug provenance and transactions, it will be able to effectively prevent pharmaceutical counterfeiting, preventing patients and manufacturers from receiving unsafe medications. Pharmaceutical products can be accurately tracked and traced using blockchain in real-time, so that they can be tracked from the manufacturing facility to their destination. The product’s whereabouts must be transparent to verify its authenticity and prevent counterfeits from entering the marketplace. An immutable record of transactions and data provided by blockchain technology also improves the safety and security of the pharmaceutical industry, making it nearly impossible to conceal unauthorised alterations. As a result of using blockchain, more efficient allocation of resources will ultimately lead to cost reductions.

5.Clinical Trials and Patient Data Management. Streamlining clinical trial processes with blockchain can be a major benefit for patients by ensuring data integrity and transparency through the secure storage and sharing of trial data. In addition to improving regulatory compliance, this enables faster and more efficient drug development, which ultimately benefits patients. Various sensitive data, including clinical trial results, patient information, and intellectual property, are generated by the pharmaceutical industry. Despite highly fragmented systems, outdated technologies, and evolving cyber threats, secure storage, retrieval, and sharing of this data remains a significant challenge. Through the use of blockchain technology, patient data management can be revolutionised by providing a secure, decentralised way to store and share sensitive patient information. As a result, clinical trial stakeholders and healthcare providers can collaborate better between or among themselves, allowing for more personalised and effective clinical trial execution and/or patient care, meanwhile ensuring data privacy and security.

In a lacklustre drug development data management system, it is understood that blockchain technology may not be necessarily required for downstream analysis in a decentralised drug developmental ecosystem. Downstream analytics refers to the analysis of data generated during drug development, such as using machine learning and training AI to better understand and make the best decisions based on the clinical trial data gathered for drug safety and efficacy. The FDA recognises the current limitations and challenges that exist in the current drug development and has initiated exploratory projects to implement blockchain in drug development. Below are a couple of examples of FDA-sponsored pilot initiatives:

1) To track prescription drugs through the supply chain, the FDA announced an investigation into blockchain technology in February 2019 with Merck, KPMG, Walmart, and IBM. From manufacturer to patient, this pilot study evaluated the effectiveness of blockchain technology in improving traceability and security in drug supply chains. An important focus of the pilot study was the use of blockchain technology to track prescription drugs throughout the production process, dispensing phase, and beyond, particularly drugs at risk of counterfeiting, theft, or diversion. As part of the pilot study, the IBM Blockchain Platform was used to track drug movements securely and transparently throughout the supply chain using a blockchain-based platform. To monitor and verify the movement of drugs, the platform combined blockchain technology with other advanced technologies such as the Internet of Things (IoT) sensors and AI algorithms. There was an improvement in efficiency, security, and transparency in the drug supply chain following the pilot study, which was considered a success. Blockchain technology is a tamper-proof and secure way to track drug movement, enabling all parties to have access to real-time information about drug status and location. In general, the FDA pilot study involving Merck, KPMG, Walmart, and IBM demonstrated the potential of blockchain technology for improving drug supply chain traceability and security. The study may lead to the wider adoption of blockchain-based solutions in the pharmaceutical industry in the future.

2) The FDA has piloted a programme called the MediLedger Project to enhance the security and traceability of the pharmaceutical supply chain through blockchain. Through this pilot programme, blockchain will be evaluated for its potential to enhance security and traceability in pharmaceutical supply chains. Blockchain will be used to track and verify the movement of pharmaceutical drugs from the point of manufacture to the point of dispensing as part of the pilot program. Several major pharmaceutical companies are participating in the pilot programme, including Pfizer, McKesson, and AmerisourceBergen. Furthermore, the FDA has been exploring the use of blockchain in drug development with other organisations, in addition to its pilot programme with MediLedger Project. To develop standards and protocols for the use of blockchain technology in the development of drugs, the FDA has been working with the Institute of Electrical and Electronics Engineers (IEEE). It is evident from the FDA's involvement in blockchain initiatives in drug development that blockchain technology could contribute to improving drug development security, transparency, and efficiency. Besides facilitating innovation in the pharmaceutical industry, the FDA also ensures the safety and efficacy of new drugs by supporting the development of blockchain-based solutions for drug development.
While blockchain can offer advantages such as data immutability and transparency, other approaches can be used to manage and analyse the data generated during drug development securely with elevated efficiency. For example, building a distributed database can provide a similar level of data integrity and security through replication and distributed consensus mechanisms. However, this is limited in its efficiency when compared to using a blockchain data architecture.

Currently, blockchain technology adoption may still depend on the specific requirements and goals of the existing drug developmental sponsor. Overall, blockchain technology has the potential to significantly improve the drug development process by increasing transparency, reducing fraud, and improving access to new therapies. However, implementing these solutions will require collaboration between pharmaceutical companies, regulators, and technology providers to ensure that these systems are effective, secure, and compliant with regulatory requirements.

--Issue 51--

Author Bio

Frank Leu

Frank Leu is the Founder and managing member of BioPharMatrix LLC, providing intelligence in the areas of innovative processes and platforms for biotech, pharmaceutical, and life sciences. Frank has combined around a hundred speaking presentations and publications on disruptive technologies and processes in drug development.

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