As new medicines have become more complex, so have the size of their regulatory filings. Consider that the data collected for a single patient enrolled in a complex clinical trial can be dozens of gigabytes. By the time all the data required for a regulatory approval are assembled, the dossier can be enormous, comprising thousands of documents, which can spell months of work of preparation and review.
Regulatory bodies like the European Medicines Agency or the U.S. Food and Drug Administration are responsible for evaluating data about a new medicine before it can go on the market. They have to review all the data and analysis from clinical trials along with other information to determine quality, safety and effectiveness, as well as the label and other information that patients and physicians will see.
“Twenty years ago, you submitted a paper dossier, and today it’s an electronic paper dossier, but the review is identical,” said François-Xavier Routhier, Head of Strategy & Operational Effectiveness, Global Regulatory Affairs at Sanofi. “It takes around three months to build a dossier, around two months for an agency to accept it for review, and at least another six months for the agency to review the complete dossier.”
Part of the delay is the sheer number of these huge applications that agencies process. The FDA routinely refers to handling data by the petabyte. That’s a thousand terabytes, enough space that if you used it to store digital music files, it would take you 2,000 years to listen to them all.
This ever-increasing burden on regulatory agencies means patients have to wait much longer for a new treatment, notes Dave Nestor, Director, Strategy and Operations, Deloitte UK.
“If it were a stack of paper, the average dossier would be more than a kilometer high” said Nestor, who works with companies like Sanofi on streamlining their regulatory processes. “If you consider that there were 30 or 40 thousand approvals in the past year, that’s a lot of paperwork; the stack could form a ring around the entire surface of the earth.”
Technology to revamp approval process
To streamline that process, companies are looking at ways to use the cloud to reduce that burden. New technology has the potential to entirely revamp the approval process for new medicines. That could mean patients get new treatments faster, and that companies would be able to more quickly reinvest in additional research.
One important change: Instead of assembling the data into a dossier and transmitting it to the agency, the cloud enables a company to provide authorities a secure link to its computer servers that offers direct access to all the necessary information and underlying data for analysis.
“With that kind of access, the three months of building the dossier and two months of validation can be reduced to a few days” said François-Xavier Routhier. “Not only that, but when I have new data as the science evolves, or from pharmacovigilance, I can just feed it to the cloud and the agency can run its analysis in real time. It’s basically moving drug reviews from a text-based to a data-based assessment.”
Part of that transformation will involve the introduction of blockchain technology as part of the cloud-based records. Blockchain records contain identifying information and are linked together in a “chain” in the order of creation. Because of the way a blockchain is structured, it’s almost impossible for the data in any record to be altered, providing regulators and the public with assurances that what’s being analyzed is authentic.
“The public will want to be sure of the integrity, authenticity and security of the data” said François-Xavier Routhier. “Blockchain technology can authenticate that this is the actual dataset that was released to the agency. The technology also ensures the security and privacy of electronic patient records and other personal information and will increase trust within all parties.”
This change will take time as well as the cooperation of regulatory agencies, but Sanofi has been working toward deploying the technology in the near term, aiming at the next 24 months.
“Rather than continuing the old way of building dossiers, we are investing in technology and attracting and building new talent. This is where we can build the most value.” said François-Xavier Routhier. “We’re not a publishing company, we’re a research and development company. This kind of change is what our industry needs if we’re going to develop medicines that don’t exist today.”