BioCelerate—a company that works on various solutions to improve efficiencies in nonclinical research to elevate drug development--has released its first set of resources created via its public-private partnership (PPP) with the US Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research (CDER) Office of Computational Science.
The entities reportedly formed the PPP to assist life-sciences companies and organizations by enabling improved analytic approaches, and pinpointing solutions to optimize cross-study analysis. Its goals include optimizing the implementation of the Clinical Data Interchange Standards Consortium’s (CDISC) Standard for Exchange of Nonclinical Data (SEND), in order to ensure nonclinical data can be presented in a harmonized format across the ecosystem.
Leigh Anne Minnier, communications manager for BioCelerate parent company TransCelerate Biopharma, told Outsourcing-Pharma that standardization is important for drug development and other life-sciences areas, as is support from agencies like the FDA.
“If processes are harmonized among stakeholders, it allows them to focus on the science and ingenuity,” she said. “R&D cannot evolve and modernize without the support and acceptance from health authorities.”
The FDA and other agencies, Minnier added, are vital sources of information and support for nonclinical and clinical research.
“Health authorities have some of the best subject matter expertise in our areas of focus – i.e., areas that can drive positive and meaningful transformative change for the industry,” she commented. “Tapping into the FDA’s expertise and having them actively involved helps us develop and deliver better quality solutions; moreover, having the FDA or other major health authorities as a sponsor of a solution gives it automatic credibility, which increases the likelihood that the industry will embrace it.”
While adoption of the CDISC SEND format is increasing throughout the industry, inconsistency in use may bar meaningful, accessible single-study analysis and cross-study analysis on broader scales, limiting the potential value. To that end, BioCelerate and FDA have released two peer-reviewed publications:
- “SEND Harmonization & Cross-Study Analysis: A Proposal to Better Harvest the Value from SEND Data” discusses the potential of SEND datasets for cross-study analysis, and outlines current challenges
- "Leveraging the Value of CDISC SEND Datasets for Cross-Study Analysis: Incidence of Microscopic Findings in Control Animals” highlights practical steps involved in creating a searchable historical control database from a repository of SEND datasets; it also puts forth a solution for a defined cross-study analysis question using historical control data when challenged with SEND variability.
Lars Wichmann Madsen, vice president of global discovery and development sciences for Novo Nordisk A/S, said, “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. 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.”
Lilliam Rosario, director of the CDER Office of Computational Science, said, “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.”
Janice Chang, TransCelerate chief operating officer, said improving nonclinical research is vital because the effort ultimately leads to improved drug development.
“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,” Chang commented. "We look forward to continuing to expand the reach and influence of our initiatives in 2021.”