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NIST and FDA are actively collaborating on projects that address regulatory and measurement challenges for regenerative medicine products and advanced therapies. These collaborations leverage NIST expertise in measurement sciences to address specific analytical scientific challenges as well as FDA regulatory science, research and review expertise in regenerative medicine products to ensure that the science and standards developed address significant regulatory challenges that recur across the field.
Targeted genome editing technologies are being leveraged across many sectors including in the development of novel therapeutics. NIST and FDA are convening a public workshop with stakeholders across industry, academia, non-profit, and government to define a path forward for developing pre-competitive measurement and standards solutions to address the wet lab, dry lab and terminology needs for confident use of genome editing technologies, particularly for the development of human therapeutic products. The outcomes of this workshop will help clarify current regulatory perspectives and supply additional information to the newly launched NIST Genome Editing consortium (now accepting members) towards the path forward for developing solutions. The workshop will be organized into both general session talks with discussion as well as breakout sessions to get detailed feedback and engagement.
Agenda(Printable PDF)
Day 1 - April 23, 2018 |
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8:00 am |
Check-in at registration desk |
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9:00 am
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Opening Remarks |
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Sheng Lin-Gibson, Ph.D., Acting Division Chief, Biosystems and Biomaterials Division, NIST; View Presentation Raj Puri, Ph.D., Division Director, Cellular and Gene Therapies Division, FDA |
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9:10 am
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Samantha Maragh, Ph.D., Leader, NIST Genome Editing Program |
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9:25 am
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Anne Plant, Ph.D., NIST Fellow |
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9:45 am
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FDA Regulatory Perspective |
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Anna Kwilas, Ph.D., Biologist, Center for Biologics Evaluation and Research (CBER); View Presentation Stella Lee, Ph.D., Biologist, Center for Veterinary Medicine (CVM); View Presentation Zivana Tezak, Ph.D., Associate Director for Science and Technology, Center for Devices and Radiological Health (CDRH); View Presentation |
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10:30 am
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NIH Somatic Cell Genome Editing Program |
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Colin Fletcher, Ph.D., Program Director, NIH/NHGRI; View Presentation |
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10:40 am |
Break |
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10:50 am
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Keynote: Reading an Edited Genome |
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Fyodor Urnov, Ph.D., Deputy Director, Altius Institute for Biomedical Sciences |
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11:30 am
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Panel Short Talks |
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Matt Porteus, M.D., Ph.D., Assoc. Professor, Dept. Pediatrics, Stanford University; View Presentation Edward Rebar, Ph.D., VP Technology, Sangamo Therapeutics Tom Barnes, Ph.D., Senior VP Innovation, Intellia Therapeutics Will Eyestone, Ph.D., Senior Project Manager, Xeno R&D, Revivicor Inc. Craig Mickanin, Ph.D., Director-Chemical Biology & Therapeutics, Novartis Institutes for Biomedical Research |
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12:20 pm |
Panel Discussion |
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12:40 pm |
Lunch Break (for purchase at NIST cafeteria) |
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1:30 pm
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Lexicon |
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Brett Robb, Ph.D., Scientific Director, RNA & Genome Editing, New England Biolabs; View Presentation |
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1:50 pm
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Assays Qualification |
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Samantha Maragh, Ph.D., Leader, NIST Genome Editing Program; View Presentation Kevin Holden, Ph.D., Head of Synthetic Biology, Synthego Corporation; View Presentation |
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2:25 pm
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Data & Metadata |
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Kendell Clement, Ph.D., Research Fellow, MGH/Harvard Medical School; View Presentation |
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2:45 pm |
Break |
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3:00 pm |
Discussion of key questions |
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3:30 pm |
Breakout Session Round 1 Assay Qualification: Green Auditorium; Data & Metadata: Portrait Room; Lexicon: LR C |
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4:20 pm |
Breakout Session Round 2 Assay Qualification: Green Auditorium; Data & Metadata: Portrait Room; Lexicon: LR C |
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5:00 pm |
Wrap up of Day 1 |
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5:15 pm |
Adjourn |
Day 2 - April 24, 2018 |
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9:00 am |
Welcome Day 2 |
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9:10 am
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Tech Talk 1: Developing Meganucleases for Clinical Applications |
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Derek Jantz Ph.D., CSO, Precision Biosciences; View Presentation |
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9:25 am |
Tech Talk 2: Methods for Gene Editing Measurement and Off-Target Discovery |
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Christopher Wilson Ph.D., Sr. Director, Lead Discovery, Editas Medicine; View Presentation |
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9:40 am
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Tech Talk 3: dGH Analysis Tools for Gene Editing |
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Christopher Tompkins Ph.D., President & General Manager, KromaTiD Inc.; View Presentation |
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9:55 am
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Tech Talk 4: Fiber Vision Molecular Combing Platform |
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Aaron Bensimon Ph.D., CEO, Genomic Vision; View Presentation |
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10:10 am |
Break |
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10:30 am
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Lexicon breakout sessions report with discussion |
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Brett Robb, Ph.D., Scientific Director, RNA & Genome Editing, New England Biolabs |
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11:00 am
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Assay Qualification breakout session report with discussion |
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Samantha Maragh, Ph.D., Leader, NIST Genome Editing Program |
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11:30 am
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Data & Metadata breakout session report with discussion |
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Kendell Clement, Ph.D., Research Fellow, MGH/Harvard Medical School |
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12:00 pm |
Summary and closing remarks |
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12:30 pm |
Adjourn |
(Closed steering committee for NIST Genome Editing Consortium members 1:30 – 5:00 pm)
Hilton - Gaithersburg
620 Perry Pkwy, Gaithersburg, MD 20877
Phone: (301) 977-8900
Block of rooms have been reserved for April 22-24th from $119.00 USD/Night
Book now >>> Book by April 8th to reserve your room!
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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Acceptable Photo Identification:
For Non-US Citizens: Valid passport for photo identification
For US Permanent Residents: Permanent Resident/Green card for photo identification