Beyond SEND: Leveraging non-clinical data to drive translational research forward
The Pistoia Alliance, brought together a crossfunctional life science industry group to review common challenges and opportunities in non-clinical drug development.
The group focused their discussion on the challenges and opportunities for leveraging non-clinical datasets in support of translational research. This paper provides a summary of their opinions and conclusions.
The Standard for Exchange of Nonclinical Data (SEND) is one of the required standards for data submission to the FDA and specifies a way to collect and present non-clinical data in a consistent format. For the industry, standardisation on the SEND format offers an opportunity to move beyond submission readiness to extract significant scientific and operational insights from the data. Increasingly, organisations are recognising the potential of leveraging this high-value information for improving research operations both internally and with partners via data mining, visualisations and AI/advanced analytics.
This paper will discuss some of the potential use cases that SEND datasets can support, both to advance translational research across multiple research sites and also to drive efficiencies with research partners including contract research organisations (CROs). In addition, the authors will explore applications of consolidated, precompetitive data sharing to support cross-industry safety and toxicology applications.
SEND as a regulatory data submission format
The Standard for Exchange of Nonclinical Data Implementation Guide (SENDIG) was developed by the Clinical Data Interchange Standards Consortium (CDISC). SENDIG is intended to provide guidance for the organisation, structure and format of nonclinical tabulation datasets intended for regulatory submission and for exchange between organisations. Pharmaceutical companies and CROs are now required to submit SEND datasets for certain types of studies when filing Investigational New Drugs (INDs) and New Drug Applications (NDAs).
SENDIG sets the standard for non-clinical dataset files containing electronic records of protocol design, animal demographics, animal exposure and animal observation data and detailing their content and terminology. SENDIG Version 3.0 applies to singledose and repeat-dose general toxicology and carcinogenicity studies. SENDIG Version 3.1 adds standards for the electronic data records for certain types of safety pharmacology studies and SENDIG Developmental and Reproductive Toxicology (DART) Version 1.1 adds standards for embryo-fetal developmental toxicity studies...
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