FDA and BioCelerate Join Forces on Nonclinical Research

Regulatory NewsRegulatory News | 13 June 2019 |  By 

The US Food and Drug Administration (FDA), under a new collaboration, is poised to explore how to provide better support for early-stage research and development.

FDA tapped industry group TransCelerate BioPharma’s subsidiary BioCelerate for the joint working group tasked with exploring methods, tools and/or templates that provide for greater efficiency in the analysis of datasets generated from nonclinical studies.

“This collaboration is another step forward as part of the FDA’s longstanding commitment to advancing a more efficient and data-driven decision-making processes,” FDA Center for Drug Evaluation and Research Director Janet Woodcock said on Monday.

The joint working group is comprised of BioCelerate and FDA’s Office of Computational Science (OCS). It intends to publish findings related to the use of nonclinical research datasets that leverage a required standard for data submissions to FDA, known as the Standard for Exchange of Nonclinical Data (SEND).

TransCelerate BioPharma CEO Dalvir Gill told Focus that participating companies “are looking for solutions to enable earlier prioritization and decision-making on compound viability” and SEND “is central to this effort because it has become the de facto standard for cross-study analysis and comparisons.” The team will “explore variabilities in the implementation of SEND that prevent more robust analysis across studies originating from different sources” to then enable organizations to “gain insights across a wide variety of datasets into toxicity profiles, off-target toxicity, vehicle effects, class trends, among others. ”

Gill added that one of BioCelerate‘s goals is to help make informed decisions earlier. “Better information and analysis at early stages should help reduce drug attrition at later stages of development,” he said.

The collaboration builds on two BioCelerate initiatives on optimizing nonclinical studies. The SEND Implementation for Cross-Study Analysis initiative is focused on barriers to and opportunities for SEND datasets in cross-study comparisons and analysis, while the Common Templates for Nonclinical Studies initiative looks to engage stakeholder groups on a protocol template for repeat-dose toxicology studies.

The collaboration coincides with FDA’s 2016 commitment to developing staff capacity to support discussions on pre- and post-submission of standardized datasets, including those leveraging SEND.


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