Skip to main content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

NIST-FDA Genome Editing Workshop

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

8:00 am

Check-in at registration desk

9:00 am

 

Opening Remarks

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

9:10 am

 

Introduction to NIST Genome Editing Consortium

Samantha Maragh, Ph.D., Leader, NIST Genome Editing Program

9:25 am

 

NIST Measurement Assurance Perspective

Anne Plant, Ph.D., NIST Fellow

9:45 am

 

FDA Regulatory Perspective

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

10:30 am

 

NIH Somatic Cell Genome Editing Program

Colin Fletcher, Ph.D., Program Director, NIH/NHGRI; View Presentation

10:40 am

                                                                           Break

10:50 am

 

Keynote: Reading an Edited Genome

Fyodor Urnov, Ph.D., Deputy Director, Altius Institute for Biomedical Sciences

11:30 am

 

Panel Short Talks

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

12:20 pm

Panel Discussion

12:40 pm

                                           Lunch Break (for purchase at NIST cafeteria)

1:30 pm

 

Lexicon

Brett Robb, Ph.D., Scientific Director, RNA & Genome Editing, New England Biolabs; View Presentation

1:50 pm

 

Assays Qualification

Samantha Maragh, Ph.D., Leader, NIST Genome Editing Program; View Presentation

Shengdar Tsai, Ph.D., Assistant Member, Dept. of Hematology St. Jude Children's Hospital; View Presentation

Kevin Holden, Ph.D., Head of Synthetic Biology, Synthego Corporation; View Presentation

2:25 pm

 

Data & Metadata

Kendell Clement, Ph.D., Research Fellow, MGH/Harvard Medical School; View Presentation

2:45 pm

                                                                          Break

3:00 pm

Discussion of key questions

3:30 pm

Breakout Session Round 1

Assay Qualification: Green Auditorium; Data & Metadata: Portrait Room; Lexicon: LR C

4:20 pm

Breakout Session Round 2

Assay Qualification: Green Auditorium; Data & Metadata: Portrait Room; Lexicon: LR C

5:00 pm

Wrap up of Day 1

5:15 pm

                                                          Adjourn

 

Day 2 - April 24, 2018

9:00 am

Welcome Day 2

9:10 am

 

Tech Talk 1: Developing Meganucleases for Clinical Applications

Derek Jantz Ph.D., CSO, Precision Biosciences; View Presentation

9:25 am

Tech Talk 2: Methods for Gene Editing Measurement and Off-Target Discovery

 

Christopher Wilson Ph.D., Sr. Director, Lead Discovery, Editas Medicine; View Presentation

9:40 am

 

Tech Talk 3: dGH Analysis Tools for Gene Editing

Christopher Tompkins Ph.D., President & General ManagerKromaTiD Inc.; View Presentation

9:55 am

 

Tech Talk 4: Fiber Vision Molecular Combing Platform

Aaron Bensimon Ph.D., CEO, Genomic Vision; View Presentation

10:10 am

                                                                          Break

 

                              

10:30 am

 

Lexicon breakout sessions report with discussion

Brett Robb, Ph.D., Scientific Director, RNA & Genome Editing, New England Biolabs

11:00 am

 

Assay Qualification breakout session report with discussion

Samantha Maragh, Ph.D., Leader, NIST Genome Editing Program

11:30 am

 

Data & Metadata breakout session report with discussion

Kendell Clement, Ph.D., Research Fellow, MGH/Harvard Medical School

12:00 pm

Summary and closing remarks

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. 

*New Visitor Access Requirement: Effective July 21, 2014, Under the REAL ID Act of 2005, agencies, including NIST, can only accept a state-issued driver’s license or identification card for access to federal facilities if issued by states that are REAL ID compliant or have an extension. As of Monday, January 30, 2017, Federal agencies will be prohibited from accepting driver’s licenses and identification cards from the following states for accessing federal facilities: Maine, Minnesota, Missouri, Montana and Washington. For further details, please visit: https://www.nist.gov/about-nist/visit/campus-access-and-security

Acceptable Photo Identification:
For Non-US Citizens: Valid passport for photo identification
For US Permanent Residents: Permanent Resident/Green card for photo identification

Created May 13, 2019, Updated May 16, 2019