A roadmap for affordable genetic medicines
Kliegman M, Zaghlula M, Abrahamson S, Esensten JH, Wilson R., Urnov FD, and Doudna JA. Nature
(2024)Genomics
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Genome Editing Policy and Regulation
The IGI Public Impact team strives to advance evidence-based public policy that promotes equitable and affordable access to revolutionary CRISPR-based innovations.
We work diligently to:
- Convene regulatory experts and propose innovative policy solutions
- Build capacity in low- and middle-income countries to ensure communities worldwide can reap the benefits of genome editing technologies
- Provide decision-makers with scientific evidence and multidisciplinary research.
Our science policy and regulatory focus spans all research areas of the IGI, from health to agriculture to emerging technologies.
Working with Regulators
Genome Editing Capacity Building for International Regulators
At the IGI, we aim to empower regulators from low- and middle-income countries (LMICs) with technical knowledge on CRISPR genome editing.
- January 2024 International Agricultural Regulatory workshop at the IGI. Learn more >
- July 2022 regulatory workshop hosted at the International Rice Research Institute in collaboration with Philippines Department of Agriculture. Learn more >
Convening Regulators to Discuss Emerging Technologies
We inform regulators about advances in cutting edge CRISPR technologies to help them prepare for emerging regulatory considerations.
- Genetically engineered microorganisms
Together with the U.S. Department of Agriculture (USDA) and the Phytobiomes Alliance, we organized a virtual workshop on genetically engineered microorganisms (GEMs). Public and private-sector developers shared their research projects with attendees and regulatory officials discussed regulations of GEMs-based products.
Learn more here and find the recordings from the workshop and summary findings here.
- Genomic therapies
The IGI partnered with the American Society of Hematology (ASH) Research Collaborative and the U.S. Food and Drug Administration (FDA) to discuss real-world evidence for genomic therapies. Learn more >
Download the Genomic Therapies Work Group’s final report here
Download the Coordinated Registry Network Work Group’s here
Informing Policy and Regulation
We engage our network of experts to respond to government requests for information (RFIs), proposed rules, and draft regulatory documents that impact gene therapy development and genome editing technologies in the agricultural sector.
Select Publications
Perspectives on Genetically Engineered Microorganisms and Their Regulation in the United States
Shams A, Fischer A, Bodnar A, and Kliegman M. ACS Synthetic Biology
(2024)Opportunities and challenges for innovative and equitable healthcare
Ecker DJ, Aiello CD, Arron JR, Bennett CF, Bernard A, Breakefield XO, Broderick TJ, Callier SL, Canton B, Chen JS, Fishburn CS, Garrett B, Hecht SM, Janowitz T, Kliegman M, Krainer A, Louis CU, Lowe C, Sehgal A, Tozan Y, Tracey KJ, Urnov F, Wattendorf D, Williams TW, Zhao X, and Hayden MR. Nature Reviews Drug Discovery
(2024)Towards affordable CRISPR genomic therapies: a task force convened by the Innovative Genomics Institute
Witkowsky L, Norstad M, Glynn AR, and Kliegman M. Gene Therapy
(2023)Exploring the value of a global gene drive project registry
Taitingfong RI, Triplett C, Vásquez VN ... Marshall JM, Montague M, Morrison AC, Opesen CC, Phelan R, Piaggio A, Quemada H, Rudenko L, Sawadogo N, Smith R, Tuten H, Ullah A, Vorsino A, Windbichler N, Akbari OS, Long K, Lavery JV, Evans SW, Tountas K, Bloss CS. Nature Biotechnology
(2022)Contact Us
Please feel free to reach out to the IGI Public Impact team with any inquiries about genome editing policy and regulations.
Health and innovation policy: Manar Zaghlula, manar.zaghlula@berkeley.edu
Agriculture and climate policy: Elizabeth Njuguna, ewnjuguna@berkeley.edu