Fluree, which has developed a knowledge graph database and semantic data pipeline toolset for secure and trusted data sharing, today (August 15) announced the partnership to build a ‘semantic data infrastructure’ for pharmaceutical organizations looking to enable digital regulatory information management and accelerate drug discovery.
Series A funding
The tech company — which recently closed its $10M Series A funding round — provides technology to enable trusted, linked, and composable data management and sharing. The company also provides data security, audit and sharing capabilities needed by pharma organizations as they look to implement Identification of Medicinal Products (IDMP) standards and build data collaboration platforms.
"Fluree is a perfect fit for pharmaceutical organizations seeking to balance regulatory compliance with innovation and accelerate drug discovery, efficacy and efficiency,” said Eliud Polanco, Fluree president.
“Our ML-based data transformation pipelines and secure knowledge graph technology makes it easier to share data across silos in a very safe and privacy-preserving way. This is what will enable more efficient regulatory reporting, faster discovery and continuous collaboration that can yield life-changing results.”
Success rates for new drugs
The pharma industry has traditionally struggled with long, slow timelines and low success rates for new drugs and treatments, the companies found in its research.
The pharmaceutical industry has long grappled with lengthy timelines and low success rates for new drugs and treatments. They looked at a report and found that drug development processes take an average of 10.5 years, with only a 7.9% probability of a drug candidate in phase 1 discovery receiving approval. They say efficient and credible data sharing can spur better processes with the potential to save lives, cut costs, and enable more collaboration across the pharmaceutical industry.
Fluree says its technology provides ‘an alternative to disparate pharma data silos, allowing organizations to implement an artificial intelligence (AI)-driven data strategy for semantic alignment with the IDMP ontology, promoting ongoing collaboration across internal departments, external partners, and regulatory offices’.
Potential risks
Through this partnership, Fluree and Vitality TechNet say it will enable RIM (Regulatory Information Management) functions to reduce error in regulatory submissions, streamline the identification of potential risks and enhance safety monitoring. They say this will allow for more efficient drug development processes and reduce the time and costs associated with late-stage failures.
Steve Hamby, semantic engineer at Vitality TechNet, said: “We are thrilled to partner with Fluree on this groundbreaking effort to shorten the development timelines, especially in an industry in which time is truly of the essence.
“The joint solution promotes better data management, sharing and collaboration, leading to faster decision-making, increased success rates and ultimately, the development of more effective drugs to improve patient outcomes.”
The European Medicines Agency (EMA) is expected to become the first health authority to enforce ISO IDMP compliance before the end of 2024, and the FDA will likely follow shortly after that, according to the Pistoia Alliance. But poor alignment between regulatory bodies could prompt integration problems that lead to significant expenses, impede drug safety and stifle innovation.
