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IDMP-O: Drug Safety, Innovation, and Regulatory Compliance with applied Semantics and AI (Feat. Vitality TechNet) | Fluree

About this event

Join Steve Hamby (Vitality TechNet) and Eliud Polanco (Fluree) for a discussion on transforming siloed pharma data into rich semantic knowledge graphs for faster drug discovery and automated global regulatory compliance.

We will cover how the IDMP-O can enhance the Regulatory Information Management function to reduce error in regulatory submissions, streamline the identification of potential risks, and enhance safety monitoring.

We will also cover how pharmaceutical organizations can leverage the semantic alignment that IDMP provides to reduce the time and cost profiles associated with drug discovery and development. Specifically, this solution streamlines the aggregation and analysis of safety and efficacy data for medicinal products, leading to more efficient drug development processes as well as enables the identification of potential risks and safety issues earlier, thereby reducing the time and costs associated with late-stage failures.

What we’ll cover:

  • Challenges to data interoperability and electronic reporting within Pharma and Life Sciences
  • Overview of IDMP-O (Identification of Medicinal Products Ontology)
  • Emerging AI technologies for semantic alignment and integration
  • Emerging digital trust technologies for sharing and compliance

Why is this important?

According to the Pistoia Alliance, The European Medicines Agency (EMA) is poised to become the inaugural health authority to enforce ISO IDMP compliance by Q4 of 2024, with the FDA following closely in its footsteps. Nevertheless, the divergent implementations of IDMP across different geographic regions and jurisdictional domains are already giving rise to disparities in interpretation among implementing entities. Since there is a lack of semantic alignment between regulatory bodies, there is a considerable risk that adhering to regulatory compliance will result in substantial integration and interoperability expenses, potentially impeding the realization of the benefits of IDMP in drug safety, innovation, and other critical domains. Instead of prioritizing the exploration of novel medications, organizations will be confronted with data challenges, such as the imperative to map product data throughout their entire operations during the product lifecycle.

Hosted by

  • Guest speaker
    Steve Hamby Senior Semantic Engineer @ Vitality TechNet

    Steve Hamby is a Senior Semantic Engineer for Vitality TechNet, Inc. In this role, he assists customers in integrating semantic systems to solve business problems. Mr. Hamby brings 35+ years of experience in the information technology industry with a focus on data integration and management. Mr. Hamby is widely regarded as an industry leader in the field of semantic technologies and has authored / co-authored numerous technical and business papers on the subject area. His technical leadership in this field has led to being a past award winner of the American Business Awards™ Technology Executive of the Year, Silver Award; the InfoWorld Technology Leadership Award; and the SmartCXO, CIO/CTO Award for the Mid-Atlantic Region.

  • Team member
    Kevin Doubleday Director of Communications @ Fluree

  • Guest speaker
    Eliud Polanco President @ Fluree

    Eliud Polanco is a seasoned data executive with extensive experience in leading global enterprise data transformation and management initiatives. Previous to his current role as President of Fluree, a data collaboration and transformation company, Eliud was formerly the Head of Analytics at Scotiabank, Global Head of Analytics and Big Data at HSBC, head of Anti-Financial Crime Technology Architecture for U.S.DeutscheBank, and Head of Data Innovation @ Citi. In his most recent role as Head of Analytics and Data Standards at Scotiabank, Eliud led a full-spectrum data transformation initiative to implement new tools and technology architecture strategies, both on-premises as well as on Cloud, for ingesting, analyzing, cleansing, and creating consumption ready data assets.