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Captions will be available by Sept. 20th.
This workshop will focus on the need for standards to support the burgeoning biotech and pharma industries developing clinical applications that target the human microbiome. Informed regulatory decision making requires an understanding of the analytical performance of the assays being used to verify the identity, purity, potency and stability of these biomanufactured Live Biotherapeutic Products (LBPs). Additionally, clinical microbiome laboratory tests must be validated before being used for donor screening, monitoring engraftment or evaluating other changes that occur in a patient’s microbiome before, during and after therapeutic intervention.
While next generation sequencing (NGS)-based (metagenomic) methods will be a major emphasis, other analytical methods, such as those being used for enumeration and viability assessment, will also be addressed.
NIST is currently working with our stakeholder community to develop standards for microbiome measurements that will enable federal, academic and industry labs to reliably reproduce each other’s results and advance the overall field.
Confirmed speakers
- Eric Lin, NIST Materials Measurement Laboratory
- Freyja Williams, FDA Center for Biologics Evaluation and Research
- Raja Mazumder, George Washington University
- Brittney Goldberg, FDA Center for Devices and Radiological Health
- Jennifer Barb, NIH Center for Information Technology
- Ben Callahan, NC State University
- Elisha Wood-Charlson, Lawrence Berkeley National Lab
- Raul Cano, The Biocollective
- Scott A. Jackson, NIST Biosystems and Biomaterials Division
- Daryl Gohl, University of Minnesota
- Christian C. Abnet, NIH National Cancer Institute
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Ricardo Valladares, Siolta
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Dana Walsh, Rebiotix
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Kit Goldman, USP
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Paul Carlson, FDA/CBER
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Jeffrey Heiser, Boston Analytical
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Jennifer Balkus, University of Washington
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Scott Tighe, University of Vermont
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Dieter Tourlousse, AIST
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Gregory C A Amos, NIBSC
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Phil McQueen, NIH Center for Information Technology
Past Workshop
Agenda Updated 9/4
Monday, September 09. 2019
8:00 AM Registration, Poster Set-up, Exhibitor Set-up, Continental Breakfast
9:00 AM Welcome and Introduction Scott Jackson, NIST Eric Lin, Director, Material Measurement Laboratory, NIST
SESSION 1: LIVE BIOTHERAPEUTIC PRODUCTS
9:35 AM Ricardo Valladares, Siolta Therapeutics
9:55 AM Dana Walsh, Rebiotix
10:15 AM Poster and Refreshment Break
10:45 AM Kit Goldman, USP
11:05 AM Paul Carlson, FDA/CBER
11:25 AM Jeffrey Heiser, Boston Analytical
11:45 AM PANEL DISCUSSION: Manufacturing Hurdles for LBPs
12:45 PM LUNCH
1:45 PM Sheila Dreher-Lesnick, FDA/CBER
SESSION 2: MICROBIAL METROLOGY AT NIST
2:05 PM NIST Speakers
- Jason Kralj, NIST
- Sam Forry, NIST
- Stephanie Servatas, NIST
- Nancy Lin, NIST
- Sandra Da Silva, NIST
- Joy Dunkers, NIST
- Heidi Leonard, NIST
- Kirsten Parratt, NIST
- Guilherme Pinheiro, INMETRO
3:05 PM Poster and Refreshment Break
SESSION 3: CONSORTIA MODELS
3:35 PM Elisha Wood-Charlson, Dept of Energy Systems Biology Knowledgebase (KBase)
3:45 PM NIST Consortia Models
- Justin Zook, NIST
- Samantha Maragh, NIST
- Scott Jackson, NIST
4:15 PM PANEL DISCUSSION: Consortium
5:25 PM Closing Remarks Scott Jackson, NIST
5:30 PM ADJOURN
TUESDAY, SEPTEMBER 10, 2019
8:30 AM Continental Breakfast
9:00 AM Opening Remarks
SESSION 4: CLINICAL METAGENOMICS
9:05 AM Raja Mazumder, GWU
9:25 AM Brittney Goldberg, FDA/CDRH
9:45 AM Lightning Talks
- Glen Satten, Centers for Disease Control and Prevention
- Brian Granger, Broad Institute of MIT and Harvard
- Ravi Sheth, Karius, Inc.
- Fred Christians, Columbia University
10:10 AM Poster and Refreshment Break
SESSION 5: DATA ANALYTICS
10:40 AM Daryl Gohl, University of Minnesota Genomics Center
11:00 AM Jennifer Barb and Phil McQueen, NIH
11:20 AM Ben Callahan, NC State
11:40 AM PANEL DISCUSSION: Data Analytics
12:30 PM LUNCH
SESSION 6: STANDARDS FOR MICROBIOME PRODUCTS
1:30 PM Scott Jackson, NIST
1:50 PM Raul Cano, The BioCollective
2:10 PM Gregory C A Amos, NIBSC
2:30 PM Jennifer Balkus, University of Washington
2:50 PM Poster and Refreshment Break
3:20 PM Christian Abnet, NIH/NCI
3:40 PM Scott Tighe, University of Vermont
4:00 PM Dieter Tourlousse, AIST
4:20 PM PANEL DISCUSSION: Standards for Microbiome Products
5:10 PM Concluding Remarks Scott Jackson, NIST
5:15 PM ADJOURN
Courtyard Marriott Washingtonian Center - Gaithersburg
204 Boardwalk Place Gaithersburg, Maryland 20878
The Marriott offers a complimentary shuttle to and from NIST.
From $199/per night
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Start Date: Sunday, September 8, 2019 |
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End Date: Thursday, September 12, 2019 |
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Last Day to Book: Monday, August 5, 2019 |
If you are not registered, you will not be allowed on site. Registered attendees will receive security and campus instructions prior to the workshop.
NON U.S. CITIZENS PLEASE NOTE: All foreign national visitors who do not have permanent resident status and who wish to register for the above meeting must supply additional information. Failure to provide this information prior to arrival will result, at a minimum, in significant delays in entering the facility. Authority to gather this information is derived from United States Department of Commerce Department Administrative Order (DAO) number 207-12.
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