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  • Regulatory NewsRegulatory News

    WHO Panel Calls for Global Gene Editing Registry

    The World Health Organization’s (WHO) newly-formed advisory panel on human genome editing is calling for the creation of a central registry for all human genome editing studies following a two-day meeting that concluded in Geneva on Tuesday.   WHO established the panel in December following reports that Chinese scientist He Jiankui had modified the genomes of a pair of twin girls to make them resistant to HIV infection. Jiankui’s claims prompted swift international b...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: China Floats Tighter Clinical Trial Oversight Following Gene Editing Scandal

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   China Floats Tighter Clinical Trial Oversight Following Gene Editing Scandal   China is planning to introduce a risk-based regulatory system for cell and gene therapies in the wake of the germline modification scandal. The system would require developers of high-risk therapies to get state-level clearance for clinical trials, while leaving local authorities to sign o...
  • Feature ArticlesFeature Articles

    Resolving Gene Editing Technology's Ethical and Regulatory Challenges

    This article provides an overview of biomedical applications of gene editing technology, addresses ethical and regulatory challenges associated with its implementation for therapeutic development, and proposes approaches for overcoming these challenges. Introduction Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR) technology is a genetic "editing" tool aimed at altering DNA sequences and modifying gene function. It offers promising opportunities for ...
  • Regulatory NewsRegulatory News

    Experts Tell Senate Committee Current Gene Editing Regulations are Appropriate

    At a Senate Health, Education, Labor and Pensions (HELP) hearing in Washington, D.C. on Tuesday, experts explained that the current regulatory framework for gene editing in the US is appropriate and cautioned that an overly strict approach could drive research to other countries. Specifically, the hearing focused on CRISPR/Cas9, which is a gene editing tool that scientists can use to quickly and accurately edit DNA in a variety of applications. While there are curr...
  • Regulatory NewsRegulatory News

    FDA Authorizes First Human Study to Use In Vivo Genome Editing Application

    The US Food and Drug Administration (FDA) broke new ground last week when it authorized the world’s first human clinical trial for an  in vivo  genome editing application. The investigational new drug (IND) application approval for California-based Sangamo, which is the first and only company to put a gene editing therapy into clinical trials, allows the company to begin conducting in 2016 a Phase 1/2 open-label, dose-escalation study in up to nine male adults with sever...
  • Regulatory NewsRegulatory News

    Human Gene Editing, CRISPR and FDA: How Will They Mix?

    A number of the world’s top scientists, policy experts and bio-ethicists met this week in Washington, DC to discuss the implications of human gene editing, and though the focus of the summit was centered more on ethical considerations than regulations, opinions flew on Wednesday over how some new technologies will likely be regulated. Background As Jennifer Doudna, a molecular and cell biologist at University of California, Berkeley, and a leader in the field notes in a...
  • Massive Genome, Cancer Databases Made Public

    • 30 March 2012
    The National Institutes of Health (NIH) and a consortium of cancer research groups both announced this week they are releasing their respective databases-NIH's 1000 Genomes Project and the group's Cancer Cell Line Encyclopedia (CCLE) project-to the public. The moves open the world's largest set of human genetic variation and more than 1,000 cancer cell lines to public and industry use. NIH's announcement on 29 March said its 200-terabyte 1000 Genomes Project would be mad...
  • Genome Sequencing Costs Set To Plunge Below $1,000 For The First Time

    • 10 January 2012
    A Connecticut company, Life Technologies Corp, is announcing that they have manufactured a machine that has  broken the $1,000 genome sequencing barrier that has long been seen as a milestone in providing affordable sequencing technologies to the public. The machine itself is set to cost between $99,000 and $149,000-well below the $750,000 that some current genome sequencing models cost. The machine reportedly uses materials that can sequence the an entire human ge...