BioCelerate, a subsidiary of TransCelerate BioPharma Inc., 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. By actively collaborating with participating TransCelerate Member Companies and other industry stakeholders, BioCelerate leverages collective knowledge to tackle areas of common challenge and unmet need in the nonclinical research space.
Toxicology & Background Control Data Sharing Initiative (TDS)
The TDS Initiative seeks to design, develop, and maintain a centralized data lake capable of storing, visualizing, analyzing, and linking toxicology and background control data, both in structured and unstructured data formats for member companies. This will enable participating companies to make data-driven decisions on compound progression based on an increased understanding of on-target and off-target toxicity.
Common Templates for Nonclinical Studies Initiative (CTNS)
The CTNS Initiative is focused on, with input from sponsors, CROs and other stakeholders, developing publicly available documents for nonclinical study protocols and study reports that are intended to be used by CRO partners and sponsors. Efforts are focused on improving efficiencies for investigators, sites, CROs, sponsors and regulators by helping to minimize cost, errors, reduce burden for sites and CROs, and improve operational efficiencies during the interpretation and execution of studies.
SEND Implementation for Cross-Study Analysis Initiative (SEND)
In collaboration with the FDA through a public-private partnership, the SEND Initiative is pursuing the development of proposed solutions for the implementation and use of CDISC SEND data packages with the aim of facilitating cross-study analysis of clinical trials. Open-source guidance on SEND as applied to study analysis, intended for use by CROs, regulators, and sponsors, has the potential to contribute to a broader knowledge base across early-stage R&D and support faster, more improved decision-making.
Leveraging the Value of CDISC SEND Datasets for Cross-Study Analysis: Incidence of Microscopic Findings in Control Animals
Co-authored with the FDA under the Public-Private Partnership in Chemical Research in Toxicology’s Computational Toxicology Special Edition, this article highlights the potential of SEND datasets for cross-study analysis and proposes solutions to address the challenges of doing so currently. Through publication of this manuscript, the team seeks to build awareness and cross-stakeholder support for SEND Harmonization to support further cross-study analysis solutions.
The Nonclinical Common Protocol Template (NCPT), along with background and implementation materials, is now available for voluntary adoption. V1.0 is based on feedback and comments which will continue to be key to a robust and well-accepted Template. We invite you to review the Template and Implementation materials, and to share your feedback as the team continues to work towards V2.0 which will be the second major release.
BioCelerate’s V1.0 Nonclinical Common Report Template, is now available for download and public adoptions. The NCRT was developed as companion to the currently available V1.0 Nonclinical Common Protocol Template for the purpose of supporting consistency and efficiencies in the report generation process and reduce the burden on sites, CROs, and sponsors. V1.0 is based on the structure of the NCPT V1.0 and key stakeholder feedback. We invite all stakeholders to review the NCRT and Implementation materials and submit feedback to allow for continuous improvement of the Template.
SEND Harmonization & Cross-Study Analysis: A Proposal to Better Harvest the Value from SEND Data
Published in Regulatory Toxicology and Pharmacology in March 2020, the Initiative’s first manuscript shares development work on harvesting value from SEND data through SEND harmonization & cross-study analysis to benefit early research and development decisions.
Leveraging Data Sharing to Enable Better Decision Making In Research And Development
Read more about BioCelerate’s Toxicology Data Sharing (TDS) Initiative that enables participating companies to share non-clinical toxicology and background control data using the proprietary DataCelerate® technology platform. The platform is intended to enable better decision making on compound progression enabling companies to focus resources towards therapies that have the maximum benefit for patients.