PHILADELPHIA--(BUSINESS WIRE)--BioCelerate, a subsidiary of TransCelerate BioPharma Inc., today announced a collaboration with the Food and Drug Administration (FDA) to launch a joint working group which will explore methods to enable more effective analysis of nonclinical studies across the research community. 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 (OCS) 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 is another step forward as part of the FDA’s longstanding commitment to advancing a more efficient and data-driven decision-making processes,” stated Janet Woodcock, Director of the FDA's Center for Drug Evaluation and Research.
The 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.
“Both BioCelerate and the FDA see SEND as a critical enabler for both single-study and cross-study analysis, and this collaboration helps the R&D ecosystem further validate decisions and diminish attrition earlier,” said Dalvir Gill, PhD, CEO of TransCelerate BioPharma, Inc. “Given that SEND is one of the FDA’s required standards for data submission, it is critical to maximize the value of datasets using this standard.”
Toxicology Data Sharing Initiative Grows Volume of Data
Since launching DataCelerate®, a technology platform to enable R&D data sharing, in May 2018, BioCelerate’s Toxicology Data Sharing (TDS) initiative has established effective data sharing agreements across participating Member Companies to support sharing of studies. Nearly 80 percent 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.
Raja Mangipudy, Executive Director of Toxicology, Bristol-Myers Squibb and BioCelerate’s Toxicology Data Sharing Initiative Lead, noted, “Having access to this data, participating Members are able to confidently make smarter decisions on compound progression, ultimately helping ensure that viable therapies are brought to patients faster. We are excited about the future for DataCelerate®, which has the potential to connect to numerous other data sources and potentially provide linkages to clinical data to derive analytics in the future.”
BioCelerate Membership Expands
Pfizer and Janssen Research & Development, LLC, one of the Pharmaceutical Companies of Johnson & Johnson, are founding members of TransCelerate, and the most recent members of BioCelerate.
John Burkhardt, DVM, PhD, Senior Vice President, Drug Safety R&D at Pfizer commented, “Given the success of the Toxicology Data Sharing and Nonclinical Study Optimization Initiatives and the great engagement with global regulatory authorities thus far, we saw an opportunity to further improve upon our nonclinical capabilities by joining this collaboration. BioCelerate’s collaborative approach allows us to move toward a higher competency in predicting outcomes that helps us judge feasibility of R&D programs.”
Cindy Afshari, Ph.D., DABT, Global Head of Nonclinical Safety, Janssen Research & Development said, “We believe BioCelerate provides an intuitive database platform and data visualization approach that will enable Janssen toxicologists to begin to glean new insights to data as it is contextualized across the broader data content.”
About 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. To participate in BioCelerate, you must be a Member Company of TransCelerate. TransCelerate membership is available to biopharmaceutical research and development organizations who engage innovative discovery, development and manufacturing of new drugs.
For more information, please visit http://www.transceleratebiopharmainc.com/biocelerate, https://twitter.com/transcelerate, or www.linkedin.com/company/transcelerate-biopharma-inc-.
