BioCompute Project (#BioComputeObjects)

PLEASE GO TO http://biocomputeobject.org FOR LATEST INFORMATION ON BIOCOMPUTE
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BioCompute is a community driven project to build a framework to standardize bioinformatics computations and analyses communication. This can be achieved by using the BioCompute Object (BCO). BCO aims to facilitate bioinformatic workflow related exchange and communication between regulatory agencies, pharmaceutical companies, bioinformatics platform providers and researchers. To read more about this framework please see the BCO specification (https://www.biocomputeobject.org/specification.html) and publications (http://biocomputeobject.org). FDA's adoption of BioCompute is ongoing. Please see US Federal Register notice "A Notice by the Food and Drug Administration on 07/22/2020 - Electronic Submissions; Data Standards; Support for the International Institute of Electrical and Electronics Engineers Bioinformatics Computations and Analyses Standard for Bioinformatic Workflows." Link to notice: https://www.federalregister.gov/documents/2020/07/22/2020-15771/electronic-submissions-data-standards-support-for-the-international-institute-of-electrical-and

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BioCompute Submission to FDA
The BioCompute project is a community consensus-driven framework to standardize high-throughput sequencing (HTS; also called NGS) computations and analyses. This project is supported by the US Food and Drug Administration (FDA), and its continued growth and development occur, in large part, through technical discussion between FDA and stakeholders from industry and academia. By engaging in technical discussions with these stakeholders, the FDA advances the BioCompute project, and all stakeholders benefit by helping to shape the BioCompute paradigm. BioCompute was conceived to allow more efficient and effective communications of complex computational analyses between interested parties. One application includes communications between FDA reviewers and sponsors.

For sponsor’s developing multiple products, based in part on NGS data, requiring FDA approval or vendors who perform NGS analyses for multiple companies using the same NGS analysis pipeline, a BioCompute Object (BCO) can be submitted to the agency as a Drug Master File (DMF) that can then be referenced with each new submission or product using the same analysis pipeline. Using the DMF, a sponsor or vendor can protect the confidentiality of their analysis pipeline while providing the FDA all of the information necessary for an informed regulatory decision.

Disclaimer: Although the BioCompute project was funded by the US Food and Drug Administration (FDA), it is not a FDA requirement. Technical discussions is encouraged to provide feedback on the scientific or technical merit of the BCO concept. These discussions will not be used in regulatory decision-making. Individual technical discussions with FDA regulatory scientists tied to specific submission should follow existing protocols set by your institution and FDA.

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BioCompute Object Project Contacts:
GW: Dr. Raja Mazumder ([e-mail]) / Dr. Jonathon Keeney ([e-mail])
FDA: Dr. Mark Walderhaug ([e-mail])

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To be added to the community mailing list, please contact Jonathon Keeney ([e-mail])
Mailing list home page: https://hermes.gwu.edu/cgi-bin/wa?A0=BIOCOMPUTE
Subscription page:
https://hermes.gwu.edu/cgi-bin/wa?SUBED1=BIOCOMPUTELS

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Tweet #BioCompute @BioComputeObj

请访问 http://biocomputeobject.org 获取关于生物计算的最新信息。

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生物计算（BioCompute）是一个由社区驱动的项目，旨在构建一个标准化生物信息学计算和分析通信框架。这一目标可通过使用生物计算对象（BCO）来实现。BCO旨在促进监管机构、制药公司、生物信息学平台提供商和研究人员之间与生物信息学工作流程相关的交换和通信。欲了解更多关于此框架的信息，请参阅BCO规范（https://www.biocomputeobject.org/specification.html）和出版物（http://biocomputeobject.org）。美国食品药品监督管理局（FDA）对生物计算的采用正在进行中。请参阅美国联邦登记公告“食品药品监督管理局于2020年7月22日发布的公告——电子提交；数据标准；对国际电气和电子工程师协会生物信息学计算和分析标准以及生物信息学工作流程的支持。”公告链接：https://www.federalregister.gov/documents/2020/07/22/2020-15771/electronic_submissions-data_standards-support-for-the-international-institute-of-electrical-and

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生物计算提交给FDA

生物计算项目是一个由社区共识驱动的框架，旨在标准化高通量测序（HTS；亦称NGS）的计算和分析。该项目得到美国食品药品监督管理局（FDA）的支持，其持续的增长和发展在很大程度上是通过FDA与行业和学术界利益相关者之间的技术讨论来实现的。通过与这些利益相关者进行技术讨论，FDA推进了生物计算项目，所有利益相关者通过帮助塑造生物计算范式而受益。生物计算旨在允许感兴趣的各方之间更高效、更有效地沟通复杂的计算分析。一个应用实例包括FDA审查员与申请人之间的沟通。

对于基于NGS数据开发多个产品、需要FDA批准的申请人，或者为多个公司执行相同NGS分析流程的供应商，可以将生物计算对象（BCO）作为药物主文件（DMF）提交给该机构，然后可以引用每个使用相同分析流程的新提交或产品。使用DMF，申请人或供应商可以在保护其分析流程机密性的同时，向FDA提供所有必要的信息，以便作出明智的监管决策。

免责声明：尽管生物计算项目得到美国食品药品监督管理局（FDA）的资助，但它并非FDA的要求。鼓励进行技术讨论，以提供关于BCO概念的科学或技术价值的反馈。这些讨论将不会用于监管决策。与FDA监管科学家就特定提交进行的个别技术讨论应遵循您机构及FDA设定的现有协议。

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生物计算对象项目联系方式：
GW：Dr. Raja Mazumder（[e-mail]）/ Dr. Jonathon Keeney（[e-mail]）
FDA：Dr. Mark Walderhaug（[e-mail]）

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如需加入社区邮件列表，请联系Jonathon Keeney（[e-mail]）
邮件列表主页：https://hermes.gwu.edu/cgi-bin/wa?A0=BIOCOMPUTE
订阅页面：
https://hermes.gwu.edu/cgi-bin/wa?SUBED1=BIOCOMPUTELS

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关注 #BioCompute @BioComputeObj