BioCelerate to Optimize Non-clinical Studies in Association with FDA

BioCelerate to Optimize Non-clinical Studies in Association with FDA

By Pharma Tech Outlook | Friday, June 21, 2019

Better translations of non-clinical findings enable companies to make efficient and data-driven decisions during the early stages of research and development.

FREMONT, CA: Last week, BioCelerate, a subsidiary of TransCelerate BioPharma, collaborated with Food and Drug Administration (FDA) to formulate a collective working group for more efficient and effective non-clinical analysis. Taking a data-driven approach, the team intends to support the early stages of research and development.

FDA’s Office of Computational Science (OCS) together with the working group of BioCelerate will evaluate and publish dataset related studies for leveraging Clinical Data Interchange Standards Consortium’s Standard for Exchange of Non-clinical Data (CDISC SEND). In addition, the group will examine methods, tools, and common templates for effective analysis or use of non-clinical research data.

In agreement with FDA, BioCelerate launched two new initiatives focusing on non-clinical study optimization:

• SEND initiative is implemented to perform cross-study comparisons and analysis to evaluate future recommendations for CDISC. Dalvir Gill, Ph.D., CEO of TransCelerate BioPharma said, “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. 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.”

• Common Templates initiative for non-clinical studies has produced a protocol template for assisting CROs and sponsors in making error-free decisions improving operational efficiency, and reducing operational cost.

In May 2018 when BioCelerate launched DataCelerate, a technology platform to enable R&D data sharing, the toxicology data sharing (TDS) initiative established effective data sharing agreements across member companies to support the distribution of information.

Raja Mangipudy, Executive Director of Toxicology, 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  

The most recent members of BioCelerate are Pfizer and Janssen Research & Development that are also the founding members of TransCelerate.

Cindy Afshari, Ph.D., DABT, Global Head of Non-clinical 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.” 

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