Informatics
Beyond SEND: leveraging non-clinical data to drive
translational research forward
The Pistoia Alliance (
www.pistoiaalliance.org), a not-for-profit collaboration of life science companies, vendors, publishers and academic groups that work together to lower barriers to innovation in R&D, brought together a cross- functional 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.
T
he Standard for Exchange of Nonclinical Data (SEND) is one of the required stan- dards for data submission to the FDA and
specifies a way to collect and present non-clinical data in a consistent format. For the industry, stan- dardisation on the SEND format offers an oppor- tunity 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 ana- lytics. 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, precompeti- tive 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)1was developed by
Drug Discovery World Winter 2018/19
the Clinical Data Interchange Standards Consortium (CDISC). SENDIG is intended to provide guidance for the organisation, structure and format of non- clinical 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)2. 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 ter- minology. SENDIG Version 3.0 applies to single- dose and repeat-dose general toxicology and carcino- genicity 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. By creating a standard that is now required for
submission of data, CDISC SEND is streamlining the communication between CROs, sponsors and FDA during the process of study conduct as well as at time of submission. CROs are increasingly using these formats to send interim datasets to sponsors.
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By Katherine Briggs, Bob Friedman, Kristen Ferrara, Mark Pinches, Will Drewe, Cheryl Riel, Melody Thompson, Antoinette Hayes, Jason Gratt, Shylah Wyllie and MaryBeth Walsh
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