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BioCelerate Continues to Help Improve Nonclinical Study Operations through Public Private Partnership with the FDA

Tuesday, June 08, 2021

BioCelerate, a subsidiary of TransCelerate BioPharma Inc. that focuses on identifying and developing pragmatic and tangible solutions to improve efficiencies in nonclinical research, today announced that it has released the first set of its solutions as part of its Public Private Partnership (PPP) with the U.S. Food & Drug Administration’s Center for Drug Evaluation and Research (CDER) Office of Computational Science (OCS).

This PPP was established to better enable analytic approaches and identify solutions to optimize cross-study analysis. One of the goals of this PPP is to help optimize the implementation of the Clinical Data Interchange Standards Consortium’s (CDISC) Standard for Exchange of Nonclinical Data (SEND) so nonclinical data is presented in a harmonized format across the ecosystem.

The CDISC SEND format is growing in adoption across the industry, but variability in its use prevents meaningful and accessible single-study analysis and cross-study analysis on broader scales, limiting the potential value of SEND.

“The implementation and use of CDISC SEND data packages are essential to facilitate cross-study analysis of nonclinical trials and provides a tremendous opportunity to apply large-scale data analytic processes,” said Lars Wichmann Madsen, DVM, Ph.D., Corporate Vice President, Global Discovery and Development Sciences at Novo Nordisk A/S. “Utilizing our already established joint database of anonymized SEND data, BioCelerate has an opportunity to work alongside the FDA to guide companies on how to access these data sets and realize the benefits of cross-study analysis. Open-source guidance on SEND as applied to study analysis has the potential to contribute to a broader knowledge base across nonclinical R&D and provides benefits to Health Authorities, sponsors, and CROs.”

As part of this PPP, BioCelerate and FDA have now released two peer-reviewed publications. The first BioCelerate/FDA co-authored manuscript, “SEND Harmonization & Cross-Study Analysis: A Proposal to Better Harvest the Value from SEND Data,” highlights the potential of SEND datasets for cross-study analysis as well as the challenges that currently exist. This publication is part of broader efforts to develop solutions for the implementation and use of clinical data interchange standards.

“Toxicology data and guidelines for its use are priorities for nonclinical teams,” said Lilliam Rosario, Ph.D., Director at the FDA’s Center for Drug Evaluation and Research Office of Computational Science. “This partnership combines expertise from BioCelerate and the FDA. We are looking forward to seeing the impact that our work will have in the coming months.”

The SEND PPP recently published a second manuscript, "Leveraging the Value of CDISC SEND Datasets for Cross-Study Analysis: Incidence of Microscopic Findings in Control Animals.” This manuscript highlights the practical steps involved in creating a searchable historical control database from a repository of SEND datasets and outlines a proposed solution for a defined cross-study analysis question using historical control data when challenged with SEND variability.

The paper also proposes next steps to leverage learnings and how to continue to share findings. Implementation of these proposals will allow stakeholders to capitalize on the opportunity presented by SEND datasets to increase efficiency and productivity of nonclinical drug development, allowing the most promising drug candidates to proceed towards patients faster.

Additionally, harmonization proposals to address SEND variability that are outlined in the manuscript were submitted to CDISC to be considered for inclusion in the next version of the SEND Implementation Guide (SENDIG).

“As the ecosystem continues to address the pandemic and disruption to Research & Development, enhancing foundational efficiencies in nonclinical research ultimately improves the development of medicines for patients in need,” said Janice Chang, Chief Operating Officer at TransCelerate. “Our ability to work with regulatory authorities and standards developing organizations like CDISC to develop, implement, and foster harmonization, new ways of working, and data-driven decision making has never had more urgency. We look forward to continuing to expand the reach and influence of our initiatives in 2021.”

Other recent successes for BioCelerate include:

  • Common Templates for Nonclinical Studies: BioCelerate launched the Nonclinical Common Report Template (NCRT), a companion template to the Nonclinical Common Protocol Template (NCPT). The NCRT supports generating meaningful efficiencies in the reporting process. In addition, the team has published additional support materials that will streamline the implementation of these solutions. These include a “Why an NCPT?” background and executive summary and supporting materials to assist with implementation. In 2021, participating Member Companies are piloting the BioCelerate materials to obtain feedback on the templates as well as document the experience of using the supporting tools.
  • Toxicology & Background Control Data Sharing (TDS): BioCelerate has focused on a strategy to increase data volume and overall platform usage. The initiative also developed a toolkit that can be used to enable participating Member Companies to share, search, view, and download nonclinical toxicology and background control data.

By sharing these data among companies, BioCelerate has provided biopharma researchers with increased confidence in early-stage decision-making. As data volume increases over time, new insights can emerge to enhance the biopharma community’s collective understanding of toxicology. The toxicology database can reduce animal use by optimizing study design, thereby improving efficiency and speed of nonclinical development.

BioCelerate will continue to provide opportunities to advance the needs of nonclinical studies and deliver real value to Health Authorities, the research and development community, and most importantly, patients in need of life-saving medicine.

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