BioCompute Project (#BioComputeObjects)

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Description: : ************ BioCompute Workshop 2019 has been scheduled for March 25th. Please block this day off on your calendar! Details regarding place and times will be posted here when they are available. ************ 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 document and publications located under the "Links to Project Website and Resources". Many people from a variety of institutions came together to form the BioCompute Consortium to create these documents that outlines the BioCompute paradigm. BioCompute project is funded by FDA. ---------------------------------- BioCompute Submission The BioCompute project is a community consensus-driven framework to standardize high-throughput sequencing (HTS; also called NGS) computations and analyses. This project is funded 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 is 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. =========================================================================== *************************************** ** IEEE P2791 Working Group Meeting Info ** *************************************** Working Group Meeting Minutes for 8.29.2018: https://osf.io/nuy8g/ Next meeting: October 5th, 2018 Agenda: TBD ---------------------------------- JOIN WEBEX MEETING https://gwu.webex.com/gwu/j.php?MTID=m2fa3b67829d47364b5da26604bc690d3 Meeting number (access code): 737 291 844 Host key: 456294 Meeting password: BioCompute JOIN FROM A VIDEO SYSTEM OR APPLICATION Dial sip:737291844@gwu.webex.com You can also dial 173.243.2.68 and enter your meeting number. JOIN BY PHONE +1-415-655-0003 US TOLL +1-855-282-6330 US TOLL FREE Global call-in numbers: https://gwu.webex.com/gwu/globalcallin.php?serviceType=MC&ED=659379002&tollFree=1 Toll-free dialing restrictions: https://www.webex.com/pdf/tollfree_restrictions.pdf Can't join the meeting? Contact support here: https://gwu.webex.com/gwu/mc For questions and WebEx call details contact Jonathon Keeney at: keeneyjg@gwu.webex.com ---------------------------------- Resources: IEEE Standards Overview: https://osf.io/u3ybe/ IEEE Best Practices: https://osf.io/946sb/ Robert's Rules of Order: https://osf.io/q7abh/ IEEE Standards University: https://www.standardsuniversity.org/tag/standards-insights-for-executives/ =========================================================================== *********************** ** Miscellaneous Notes ** *********************** Important documents (these and all other documents related to BioCompute can also be found in the document system below): BioCompute Technical Discussions: https://osf.io/qxwe2/ BioCompute User Requirements survey: https://osf.io/cekdj/ BioCompute Objects Specification document Version 1.2 - https://github.com/biocompute-objects/BCO_Spec_V1.2/blob/master/BCO_Spec_V1.2.pdf BCO community manuscript - https://osf.io/9kvgf/ aka https://doi.org/10.1101/191783 BCO concept paper - https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5510742/ aka https://doi.org/10.5731/pdajpst.2016.006734 BCO Brochure - https://osf.io/r46jb/ BCO Community Suggestion Space (FAQs) - https://osf.io/h59uh/wiki/FAQ%20and%20Community%20BCO%20Suggestions/ 2018 BioCompute Workshop - https://hive.biochemistry.gwu.edu/htscsrs/workshop_2018 FAQ Is BioCompute CFR 21 article 11 compliant? https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11&showFR=1 By adhering to CFR 21 article 11 requirements, BioCompute provides the mechanisms for such compliance. ---------------------------------- BioCompute Object Project Contacts: FDA: Dr. Mark Walderhaug (mark.walderhaug@fda.hhs.gov) GW: Dr. Raja Mazumder (mazumder@gwu.edu) ---------------------------------- To be added to the community mailing list, please contact Jonathon Keeney (keeneyjg@gwu.edu) Mailing list home page: https://hermes.gwu.edu/cgi-bin/wa?A0=BIOCOMPUTE Subscription page: https://hermes.gwu.edu/cgi-bin/wa?SUBED1=BIOCOMPUTELS ---------------------------------- IEEE Standards Working Group page: http://sites.ieee.org/sagroups-2791/ http://sites.ieee.org/sagroups-2791/meetings/ ---------------------------------- Tweet #BioCompute

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BioCompute Object Project *Links to Project Website and Resources:* Project Website: http://biocomputeobject.org BioCompute Object Specification Document V 1.0 https://github.com/biocompute-objects/BCO_Spec_V1.0/blob/master/BCO_STU_v1.0.pdf BioCompute Object Specification Document DRAFT V 1.2 https://docs.google.com/document/d/1w7PxAHbv5C-VNbLfelIQUFa6jDxnocaTjDwwUuG0eeY BCO Proof of Concept (PoC...

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  • BCO community meeting notes

    Minutes, action items, and Questions from the Monthly BCO community meeting

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