Enforcing Authenticity: The Application of Blockchain Technology by the FDA and Others.
Let's Talk Blockchain and Pharma: A Technological Solution for the FDA
Meet Chris, the CTO and Co-Founder of Scientist.com, a platform revolutionizing drug discovery. In a world where the U.S. Food and Drug Administration (FDA) is shelling out approximately $2 billion on New Drug Applications (NDAs), Biologics License Applications (BLAs), and Investigational New Drug applications (INDs), it's no joke that our technological solutions are a lifesaver.
The FDA's shift to electronic Common Technical Document (eCTD) submissions for evaluations, back in 2017, raised a few eyebrows over data integrity due to the modifiable nature of digital files compared to traditional paper records. And rightly so! To protect against potential cyber meddling, the FDA rolled out the 21 CFR Part 11 regulation in 1997, ensuring that digital records and signatures are as secure as their paper counterparts.
This doggedly process-based approach, while effective in theory, has made the regulatory game feel more like a Rubik's cube than a pharmaceutical lab! But the good news is, we've got some smarter tools, and blockchain technology, at our disposal.
As a technology trailblazer in the biotech industry, Chris has wrestled with 21 CFR Part 11 firsthand. Additionally, he's deeply delved into blockchain tech, even becoming the inventor of a blockchain-based innovation! So, it's only natural that he'd champion using blockchain to beef up the FDA's regulatory game.
Now, you might be wondering, "How does blockchain ensure data integrity?" Well, buckle up, because it's simple yet somewhat cryptic! Imagine you've got a chunk of data – that could be anything from your latest crypto transaction to a cutting-edge study report for an IND. With blockchain, you "send" that data to a public network, called a blockchain, where it's recorded in a virtually unalterable manner. In contrast, if your study report is too big or secret sauce-y to share on a public blockchain, you can generate a unique digital fingerprint using a hash or checksum. Any tinkering done to the original document will create a new, distinguishable checksum. Once the hash or checksum is added to the blockchain, it's game over, Mr. Faker!
The best part? The FDA could easily whip this blockchain-backed data integrity into its 21 CFR Part 11 without burning through a stack of red tape. By adding an attribute to confirm blockchain verification and specifying the employed blockchain, the eCTD format could support automated authenticity and integrity verification. Reviewers can then breeze through verifications, ensuring a speedy, smooth process.
In short, ditching the process-based approach for a technology-based solution could shave off some red tape, making regulatory compliance less of a hassle. By embracing blockchain, we can usher in a happier, more efficient FDA submission process without having to read War and Peace!
And blockchain's benefits don't stop at the FDA. The tech's promise stretches across multiple sectors, from digital signatures and electronic lab notebooks (ELNs) to electronic health records (EHRs) and supply chain processes. Executives would be wise to explore these blockchain applications where data immutability is gold!
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Chris Petersen, as the CTO and Co-Founder of Scientist.com, offers a solution for the FDA's concern about data integrity in electronic Common Technical Document (eCTD) submissions using blockchain technology. By adding blockchain verification to the eCTD format, the FDA could enable automated authenticity and integrity verification, thereby ensuring immutability and potential speedier reviews. Furthermore, this technology-based approach could extend across various sectors, including digital signatures, electronic lab notebooks, electronic health records, and supply chain processes, where data immutability is crucial.
