The Certara drug development firm will be using Hedera Hashgraph
Beyond the blockchain, DAG ledgers are gaining traction.
A huge amount of time, money and effort is committed to developing new pharmaceuticals. Developing a new molecular entity, as it's called, is now estimated to cost an average of $1.8 billion. The real costs are difficult to assess cleanly, but it's clear beyond any doubt that it's enormously expensive, and that the costs are increasing quickly.
Minimising those time, money and effort commitments is where firms like Certara come in.
Today, 90% of all novel FDA drugs approved by the FDA in the last 3 years were supported by Certara software or services, and its clients now include hundreds of global biopharmaceutical companies, academic institutions and regulatory agencies across 60 countries.
As new technology opens new doors, investments in improving research and development (R&D) efficiency become more worthwhile, and as costs increase, it becomes more worthwhile to put some of that R&D money towards finding new ways of making R&D more efficient.
Now Certara is eyeing Hedera Hashgraph – a directed acrylic graph-style (DAG) ledger rather than a blockchain – as one of those new technological doors it can open for itself, and its clients, through its regulatory-focused company, Synchrogenix.
A perfect regulatory fit
Blockchain was quickly put forward as a potential solution for managing confidential patient data in the medical industry, but its benefits are equally applicable in pharmaceutical development and the wider life sciences world.
"We are experiencing a period of unprecedented growth in science and technology," said Synchrogenix President Kelley Kendle. "The promise of distributed ledger technologies, such as those used by other highly regulated industries, including financial, legal and insurance, and now in life sciences, is to create an open, transparent and yet confidential infrastructure to reap the many benefits of that explosive growth.
"For example, by digitizing R&D, lifecycle management, and real-world evidence data in a secure and trusted manner, we can identify the right patients at the right time for a given treatment, while maintaining trust and privacy for all stakeholders. We can also enhance patients' ability to manage, engage and control how their data can be used to further innovation or advance the availability of treatments."
The reason Synchrogenix is looking at Hedera Hashgraph, rather than other distributed ledgers, is because it might present a highly-scalable system that's able to operate in near real-time and handle information from a diverse range of sources promptly and confidentially. In the case of pharmaceutical development, where a lot of data needs to be meticulously handled, tracked and appropriately recorded and communicated at various times, elements of automation could go a long way.
"Regulators around the world, including those I have worked with at the Food and Drug Administration and Centers for Disease Control and Prevention, are openly embracing the use of advanced technology to progress their mission," added Synchrogenix VP of Technology and Innovation Jim Nasr. "Public distributed ledger technology, particularly in the manner provided by Hedera, provides a good option for global regulators, allowing them to achieve the compliance and transparency they need in a secure, high-performance network designed for collaboration. I believe this is the future for accountable collaboration and compliance in the life sciences and healthcare."
Synchrogenix has already developed a proof of concept for industry supply chain management in collaboration with Hedera, focused on how to best distribute medications and make them readily available where needed.
Elsewhere, DHL and Accenture have teamed up to fight fake pharmaceuticals with what's probably a broadly similar supply-chain drug-tracking solution, and Intel sharpened its blockchain skills while also aiming to help curb the opiate epidemic in the US.
"Highly regulated industries such as healthcare and life sciences are ripe for the accountability that distributed ledgers like Hedera can bring to their supply chain,” said Jordan Fried, VP of Global Business Development for Hedera. "We are delighted to be working with Certara to usher in a new era of visibility and transparency into a market that touches so many people's lives every day."
There are a number of pharmaceutical supply chain blockchain solutions in the works, but Certara's regulatory-technology side might be looking beyond the blockchain.
Disclosure: At the time of writing, the author holds ETH, IOTA, ICX, VET, XLM, BTC and ADA.