PLEASE GO TO http://biocomputeobject.org FOR LATEST INFORMATION ON BIOCOMPUTE
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
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.
BioCompute Object Project Contacts:
GW: Dr. Raja Mazumder (email@example.com) / Dr. Jonathon Keeney (firstname.lastname@example.org)
FDA: Dr. Mark Walderhaug (email@example.com)
To be added to the community mailing list, please contact Jonathon Keeney (firstname.lastname@example.org)
Mailing list home page: https://hermes.gwu.edu/cgi-bin/wa?A0=BIOCOMPUTE
Tweet #BioCompute @BioComputeObj
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