W13. Structuring Data for Drug Development and Regulatory Submissions: The Role of Standards and Ontology

TUESDAY, APRIL 21 | 12:30 - 3:30 PM


Although the amount of chemical, biological, genetic and clinical data is rapidly increasing and the techniques for analyzing data are advancing, the lack of data standards and consistent data structures and ontologies often limits the utility and use of this data in drug development, regulatory and clinical decisions. This workshop will focus on four areas:

The development of global ISO data standards and tools to describe medicinal products, particularly the description of substances in and related to medicinal products and the structuring of this data in regulatory submissions. It will discuss the ISO Identification of Medicinal Product Standards, particularly the ISO 11238 standard for defining substances. The session will also discuss and demonstrate the Global Substance Registration System (GSRS), a freely distributable software application and dataset developed by NIH/NCATS and the US FDA in collaboration with the EMA and European regulators.

The standardization and development of data structures and ontologies for bioassay data, particularly in vitro assays relevant to clinical pharmacology to be used in regulatory submissions, will be discussed. Standards for regulatory submissions would simplify efforts for both submitters and reviewers. If done in a FAIR format, it would also have the benefit of reuse by other researchers. In a collaborative public private partnership, technologies are being developed to make it easier to create and use standardized semantic data.

NCATS is establishing the Biomedical Data Translator, which will serve as a resource for computationally-assisted exploration of knowledge and construction of new research hypotheses. The program will develop community standards for data reuse, support the integration of existing medical and biological data sources, build and disseminate common services for Translator, and produce tools that augment human reasoning and inference for understanding the pathophysiology of human disease.

The standardization of clinical laboratory data will focus on the SHIELD effort. SHIELD is a collaborative multi-agency/stakeholder network, consisting of: FDA, CDC, NIH, ONC, CMS, VA, IVD manufacturers, EHR vendors, laboratories, College of American Pathologists (CAP), standards developers, Pew Charitable Trusts, National Evaluation System for healthcare Technology (NEST), academia and others. As an FDA-led NEST demonstration project, SHIELD has grown to include over 70 different stakeholder institutions and operates in a public-private partnership forum under the Medical Device Innovation Consortium (MDIC).


  • ISO IDMP Standards
  • Global Substance Registration System
  • Preclinical in vitro Pharmacology Data Standardization
  • NCATS Translator Tools
  • Shield (Clinical Laboratory Data Standards in Clinical Trials and Electronic Health Records)


Callahan_LawrenceLawrence Callahan, PhD, Chemist, Office of Health Informatics, Global Substance Registration System/Office of Health Informatics, Office of Chief Scientist, FDA

Larry is a chemist at the FDA responsible for the development of ISO data standards and the Global Substance Registration System (GSRS). He collaborates with the NIH and other leading researchers in industry and academia on standards and ontologies for regulatory submissions.

Kucuk_HandeHande Kucuk McGinty, PhD, Research Scientist, Collaborative Drug Discovery

Hande is a research scientist at CDD. She has been working with the BioAssay Express development team. Her most recent research focuses on bio-ontologies and their applications for artificial intelligence and machine learning.

Waters_MichaelMichael Waters, Team Lead, System Harmonization and Interoperability Enhancement for Laboratory Data, U.S. Food and Drug Administration

Dr. Waters is the team lead for the multi-agency/stakeholder Systemic Harmonization and Interoperability Enhancement for Laboratory Data (SHIELD) effort and the Real-World Evidence representative for the Office of In Vitro Diagnostics and Radiological Health (OIR) at FDA.

Gregory Pappas, Associate Director, National Surveillance, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration


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