BioCompute Conference and Workshop

2024 BioCompute Conference and Workshop

This workshop provides an opportunity to learn about interoperability between platforms that host BioCompute Objects (BCOs), the FDA’s "Portal" for reading, writing and sharing BCOs, real world applications including intended use in regulatory submissions, and potential implementations, including the use of AI/ML. This conference will have perspectives from both FDA and industry around the use of BioCompute in regulatory submissions, challenges for implementation, and tools designed to work with the standard. Join us for an in-depth discussion of BCO standards and an opportunity to view other projects during our poster session.

Event Registration: Eventbrite

Date & Time: May 10th, 2024, 9 AM - 5 PM

Location: Great Room, White Oak Campus, FDA center

Getting there

By Car

Enter "FDA Building 1" in Google Maps, then follow NW Loop Rd to the closest visitor parking, once reach the T-section turn right onto Michelson Rd to vehicle security screening before parking on the White Oak campus. FDA circulator shuttles are available between visitor parking and Building 1. Refer to the FDA website for the campus map.

By metro Public buses:

Ride On Bus Route 22 - stops at the Silver Spring (Red line) Metro station
BRT Flash Orange Route - stops at the Silver Spring (Red line) Metro station
Metro Bus C8 - stops at the White Flint (Red line), Glenmont (Red Line), and College Park (Green line) Metro stations
Metro Bus K6 - stops at the Fort Totten (Red, Green, and Yellow lines) Metro station
Metro Bus K9 - stops at the Fort Totten (Red, Green, and Yellow lines) Metro station

FDA shuttle to metro:

College Park Metro (Green line)
Glenmont Metro (Red line)
Medical Center Metro (Red line)
Shady Grove Metro (Red line)
Silver Spring Metro (Red line)
Twinbrook Metro (Red line)
More FDA shuttle info can be found here

Please go to the FDA site for more transportation options.

Abstract

Documenting computational workflows has historically been a challenge for researchers and reviewers. Often, there are no clear guidelines for describing these workflows, leading to ad hoc definitions and descriptions that are insufficient for comprehension and reproducibility. BioCompute, an abbreviation for the IEEE standard 2791-2020, offers a structured framework for precisely yet adaptable describing workflows. A BioCompute Object (BCO) represents a workflow that adheres to this standard. This standard breaks down a workflow into its core components, aligning them with established data standards and ontologies. BioCompute significantly aids in streamlining workflow data, managing complexity across multiple versions, and enhancing reproducibility.

As the field evolves, addressing regulatory concerns becomes paramount, necessitating a common language for all stakeholders. The BioCompute community, comprised of over 400 individuals, has crafted a framework that offers guidance without imposing undue burdens on sponsors or reviewers. To date, BCO has been embraced by three FDA centers, effectively reducing delays in regulatory submissions. An ongoing pilot project involving the BioCompute team, FDA, and industry sponsors aims to improve communication efficiency and fluidity during submission and review processes.

The BioCompute Portal, the central platform for creating and submitting BCOs, has seen significant improvements in the past year, including Google and ORCID integration and an enhanced user interface. Furthermore, a new Portal instance at the FDA, along with four tools for authoring BCOs directly from various platforms (BCOnexus, Seven Bridges APP, the HIVE, and Galaxy platforms), and expanded documentation, make it easier to create, share, edit, and publish BCOs online. In addition, the FDA can retrieve BCOs from the public BCODB upon request, and with APIs and authentication tokens, users can directly submit to FDA portal API endpoints and interact with BCOs and their implementations seamlessly. All of the most up-to-date information about BioCompute will be introduced at the workshop and followed by a roundtable discussion to further improve the applicability of BioCompute from the FDA point of view and industry-wise.

Organization Committee

Jonathon Kenney (GWU/Chair); Raja Mazumder (GWU); Mark Walderhaug (FDA); Luis Santana-Quintero(FDA); Charles Hadley King (GWU); Omar Serang (DNAnexus); Sam Westreich (DNAnexus) Dennis A. Dean, II (Velsera); Phil Webster (Velsera); Kostis Karagiannis (Moderna)

Workshop Topics

Updates and future for BioCompute
Need for BCO at FDA
Considerations for Adoption in Industry
Progress Towards Usability
BCODB and Portal's use at the FDA
BCO platform interoperability
Exemplar workflows and real-world applications
BCO-Nextflow
Potential AI/ML-related implementations
FAQ session & Roundtable discussion

Poster Session

Participants are encouraged to submit a poster abstract by April 15th, 11:59 PM (EDT). Posters should describe a computational pipeline or topic related to BioCompute. Up to 5 posters will have their workflows converted into a BCO by the BCO team and published in the BCO Portal, and will be offered a 5-minute lightning talk at the end of the conference. All posters must be printed before the workshop and set up at the start of the event.

Abstract: Any computational workflow of interest, or topic related to BCOs

Poster Content: Posters should highlight or describe a workflow (either in progress or one already in use) and the way it is used.

Size: poster sizes can be up to 4' tall x 6' wide.

Submission Portal: click here.

Schedule

Time	Speaker	Content
9:00am - 10:00am	Introduction and Future for BioCompute
9:00am - 9:10am	Raja Mazumder Professor, George Washington University	Introduction
9:10am - 9:25am	Jonathon Keeney Research Assistant Professor, George Washington University	Future of BioCompute
9:25am - 9:40am	Vahan Simonyan CSO, Embleema	BioCompute vision from an FDA-Industry perspective
9:25am - 10:00am	Peter Marks Director, CBER, FDA	Vision
10:00am - 11:00am	Need for BCO at FDA
10:00am - 10:20am	Mark Walderhaug Associate Director for Risk Assessment, CBER, FDA	Why BCO/RAB updates
10:20am - 10:35am	Luis Santana-Quintero HIVE lead, CBER, FDA	Computational Reviews at CBER
10:35am - 10:50am	Eric Donaldson Clinical Virology Reviewer	Perspectives from a Reviewer: High Throughput Sequencing Data Challenges in FDA Regulatory Review
10:50am - 11:00am	Discussion
11:00am - 11:20am	Break and poster review
11:20am - 12:15am	Considerations for Adoption in Industry
11:20am - 11:35am	UNCONFIRMED	TBD
11:35am - 11:50am	Jun Luo Data Scientist, Novo Nordisk	A computational framework for end-to-end clinical omics analysis: Single cell mechanism of action study in chronic diseases
11:50am - 12:05pm	Jack Baker Scientist, Merck	Considerations for adoption from industry
12:05pm - 12:15pm	Discussion
12:15pm - 1:15pm	Lunch & Poster Session
1:15pm - 4:10pm	Progress Towards Usability
1:15pm - 1:30pm	Susan Gregurick Director of Data Science, NIH	TBD
1:30pm - 1:45pm	Elaine Thompson Vice President Bioinformatics, Embleema	BCO-CDISC: An emerging role for BioCompute: CDISC Standards for Cell and Gene Therapy Product (CGTP) Monitoring.
1:45pm - 2:00pm	Guangzhi Sun	Extending BCO specification into a generic metamodel for computable data
2:00pm - 2:15pm	Break and Poster review
2:15pm - 2:30pm	Regualtory Advisory Board representative	Forthcoming Guidance for BCO Submission
2:30pm - 2:50pm	Dennis Dean Director of Translational Sciences, Velsera	Velsera
2:50pm - 3:05pm	Sam Westreich Sr. Scientific Program Manager, DNAnexus	DNAnexus: Democratizing access to BCOs with the BCOnexus Platform-Free Editor
3:05pm - 3:20pm	Break and Poster review
3:20pm - 3:35pm	Meznah Aloqalaa Ph.D. Student, University of Manchester	BCO and PRIMAD Provenance Models
3:35pm - 3:50pm	Ben Sherman Developer, Seqera Labs	Nextflow-BCO
3:50pm - 4:05pm	Konstantinos Krampis Associate Professor of Biology and Computer Science, CUNY	BCO in AI: Leveraging Large Language Models (aka ChatGPT) for Biocompute Object Generation in Bioinformatics
4:05pm - 4:30pm	Break and Poster review
4:30pm - 5:00pm	Lightning talk and closing
4:30pm - 4:45pm	Chosen speakers	Poster lightning talks
4:45pm - 5:00pm	Closing

Confirmed Presenters


Sam Westreich	Konstantinos Krampis	Elaine E. Thompson, Ph.D.	Eric Donaldson
Jonathon Keeney	Raja Mazumder	Charles Hadley King	Dennis A. Dean, II
Vahan Simonyan	Luis Santana-Quintero	Jun Luo	Jack Baker