Policy & Regulation
BioCelerate Establishes Working Group with the FDA on Nonclinical Initiatives
12 June 2019 - - US-based BioCelerate, a subsidiary of TransCelerate BioPharma Inc., has forged a collaboration with the Food and Drug Administration to launch a joint working group which will explore methods to enable more effective analysis of nonclinical studies across the research community, the company said.
Discussions are aimed at supporting more efficient and data-driven decision-making during early-stage research and development.
The working group of BioCelerate and the FDA's Office of Computational Science will evaluate and publish findings related to the use of study datasets leveraging Clinical Data Interchange Standards Consortium's Standard for Exchange of Nonclinical Data (CDISC SEND).
The group will also evaluate methods, tools and/or common templates which may contribute to more effective analyses or use of nonclinical research data.
This collaboration between the BioCelerate and FDA stems from conversations around BioCelerate's past work in data sharing and recently launched initiatives that focus on nonclinical study optimization.
The SEND Implementation for Cross-Study Analysis initiative is evaluating barriers and opportunities for using SEND data sets for cross study comparisons and analysis.
Results of the evaluation may serve as future recommendations for CDISC, the standard setting organization governing the SEND data standard.
The Common Templates for Nonclinical Studies initiative has produced a draft protocol template for repeat-dose toxicology studies that is designed to help CROs and sponsors by reducing errors, improving operational efficiencies, and reducing costs during the interpretation and execution of studies.
This team is currently evaluating public feedback on the draft and planning additional discussions with stakeholder groups later this year to further improve upon the template.
Since launching DataCelerate, a technology platform to enable R and D data sharing, in May 2018, BioCelerate's Toxicology Data Sharing initiative has established effective data sharing agreements across participating Member Companies to support sharing of studies.
Nearly 80% of studies within the Toxicology and Nonclinical Background Control modules of DataCelerate are provided in SEND (structured) format.
These First in Human-enabling studies have the capacity to be correlated more directly with early clinical safety data. To date, the initiative has identified eight targets in the database (two for which multiple compounds are available).
TDS will enable companies to perform better translation of nonclinical findings and attempt to close critical gaps that exist in understanding the relationship between patient response and preclinical toxicology findings.
Later this year, the platform will release enhanced functionality including the ability to voluntarily share and search for compound structures.
Pfizer and Janssen Research and Development, LLC, one of the Pharmaceutical Companies of Johnson and Johnson, are founding members of TransCelerate, and the most recent members of BioCelerate.
BioCelerate focuses on the identification and development of pragmatic and tangible solutions to improve efficiencies in nonclinical research, with the end goal of improving overall drug development efficiency to bring new medicines to patients faster.
Initiatives are approved by a Governing Council made up of participating BioCelerate Companies.
BioCelerate is a separate legal subsidiary of TransCelerate BioPharma Inc. with separate funding and support.