Fluree, Vitality TechNet Partner to Enable Pharma Regulation & Drug Discovery

What You Should Know:

• Fluree, which has developed a knowledge graph database and semantic data pipeline toolset for secure and trusted data sharing, today announced a partnership with Vitality TechNet to build a semantic data infrastructure for pharmaceutical organizations looking to enable digital Regulatory Information Management and accelerate drug discovery.
• Fluree — which recently closed its $10M Series A funding round — provides data infrastructure technology to enable trusted, linked, and composable data management and sharing. Fluree provides first-class data security, audit and sharing capabilities needed by pharma organizations as they look to implement IDMP standards and build data collaboration platforms. 

Accelerating the Adoption of IDMP-O to Simplify and Standardise data Assets

“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.

The pharmaceutical industry has long grappled with lengthy timelines and low success rates for new drugs and treatments. A recent report found that drug development processes take an average of 10.5 years, with only a 7.9% probability of a drug candidate in “Phase I Discovery” receiving approval. But 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’s technology provides an alternative to disparate pharma data silos, allowing organizations to implement an AI-driven data strategy for semantic alignment with the IDMP ontology, promoting ongoing collaboration across internal departments, external partners and regulatory offices.

Through this partnership, Fluree and Vitality TechNet will enable RIM (Regulatory Information Management) functions to reduce error in regulatory submissions, streamline the identification of potential risks and enhance safety monitoring. This will allow for more efficient drug development processes and reduce the time and costs associated with late-stage failures.

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.

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