Addressing “Standards Fatigue” and Driving Data Harmonization: DIA 2024 Workshop Insights

At the DIA 2024 Global Annual Meeting in San Diego, our CEO Heiner Oberkampf participated in the highly regarded workshop “Data Standards SOS: Reducing Burnout and Navigating Through Fatigue – Part 1”. This session, held on June 18, 2024, focused on the critical challenge of “standards fatigue” — the exhaustion and resource strain caused by multiple overlapping data standards, reference models, and industry initiatives.

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The workshop brought together an exceptional panel of industry leaders, including representatives from the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA), emphasizing a truly global perspective on data standardization challenges.

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Learning objectives for the session included:

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• Identifying various data standards and harmonization efforts across pharma and biotech.
• Discussing the challenges and business impacts of implementing and maintaining these standards amid digital transformation.
• Exploring approaches to identify overlapping or competing initiatives and develop synergistic strategies to reduce fatigue.

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Panel Leadership and Speakers:

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• Chair: Venkatraman “Bala” Balasubramanian, PhD, MBA – SVP and Global Head, Industry Solutions, Orion Innovation, U.S.
• Facilitators:
  
  • Sridevi Nagarajan, PhD – Head, Digital Regulatory Strategy, AstraZeneca, U.K.
  • Norman Schmuff, PhD – Associate Director for Science, OPMA, OPQ, FDA, U.S.
  • Hilmar Hamann, PhD – Head of Information Management, EMA, Netherlands
  • Cesar Vinces – EU Interim and International Policy Lead, Accumulus Synergy, U.S.
  • Vanni Carapetian, MPH – Director, Regulatory Data, Genentech, U.S.

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Heiner Oberkampf, PhD – CEO, ACCURIDS, Germany

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The session highlighted the ongoing challenge of implementing IDMP (Identification of Medicinal Products) standards across global pharmaceutical organizations. Heiner shared insights from the IDMP-Ontology project at Pistoia Alliance, emphasizing a domain-focused implementation strategy. By starting with Substance and gradually extending to Pharmaceutical Products, Therapeutic Indications, Packaging, and bridging to CMC data, organizations can demonstrate measurable value quickly, reduce fatigue, and secure support for subsequent initiatives.

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Speakers stressed the importance of structured knowledge graphs as a foundation for standardization, enabling high-impact use cases such as preventing drug shortages, supporting data-driven regulatory submissions, and enhancing cross-border regulatory interoperability.

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Heiner acknowledged the collaborative efforts of his colleagues, including Bala Balasubramanian, Sridevi Nagarajan, Hilmar Hamann, Vanni Carapetian, Cesar Vinces, and Norman Schmuff, who contributed to advancing global data harmonization.

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The workshop reinforced the necessity of strategic standardization, governance, and collaboration as cornerstones for digital transformation in global pharmaceutical operations — and highlighted how concerted efforts between industry and regulators can overcome fatigue and accelerate the adoption of data standards worldwide.