BioCompute Object: Difference between revisions

Revision as of 13:52, 21 July 2020

Revision as of 16:16, 22 July 2020

Line 24:

The '''BioCompute Object (BCO) Project''' is a community-driven initiative to build a framework for standardizing and sharing computations and analyses generated from [[High-throughput sequencing]] (HTS -- also referred to as [[next-generation sequencing]] (NGS) or [[massively parallel sequencing]] (MPS)). The project has since been [https://standards.ieee.org/standard/2791-2020.html standardized] as IEEE 2791-2020, and the project files are maintained in an [https://opensource.ieee.org/2791-object/ieee-2791-schema/ open source repository]. <ref>Simonyan V, Goecks J, Mazumder R. Biocompute Objects—A Step towards Evaluation and Validation of Biomedical Scientific Computations. PDA journal of pharmaceutical science and technology. 2017;71(2):136-146. doi:10.5731/pdajpst.2016.006734.</ref> The [https://www.federalregister.gov/documents/2020/07/22/2020-15771/electronic-submissions-data-standards-support-for-the-international-institute-of-electrical-and July 22nd, 2020 edition] of the Federal Register announced that the [[Food and Drug Administration|FDA]] now supports the use of BioCompute (officially known as IEEE 2791-2020) in regulatory submissions, and that the standard will be included in the Data Standards Catalog for the submission of HTS data in NDAs, ANDAs, BLAs, and INDs to [[Center for Biologics Evaluation and Research|CBER]], [[Center for Drug Evaluation and Research|CDER]], and [[Center for Food Safety and Applied Nutrition|CFSAN]].

Originally started as a collaborative contract between the [[George Washington University]] and the [[Food and Drug Administration]], the project has grown to include over 20 universities, biotechnology companies, public-private partnerships and pharmaceutical companies including Seven Bridges and [[Harvard Medical School]].<ref>{{Cite web|url=https://www.europeanpharmaceuticalreview.com/news/67524/biocompute-genomic-data/|title=BioCompute Objects specifications to advance genomic data analysis|website=www.europeanpharmaceuticalreview.com|language=en|access-date=2017-12-21}}</ref> The BCO aims to ease the exchange of HTS workflows between various organizations, such as the FDA, pharmaceutical companies, contract research organizations, bioinformatic platform providers, and academic researchers. Due to the sensitive nature of regulatory filings, few direct references to material can be published. However, the project is currently funded to train FDA Reviewers and administrators to read and interpret BCOs, and currently has 4 publications either submitted or nearly submitted.

== Background ==