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Newsletter May 2019

News: Novartis Says Baby's Death May Be Tied to Gene Therapy
Novartis AG said the death of a six-month-old baby in a study evaluating its experimental gene therapy Zolgensma was considered by the clinical trial investigator to be potentially related to the treatment. The death of the patient with a devastating disease known as spinal muscular atrophy occurred in a late-stage trial in Europe that’s still enrolling patients, the Swiss drugmaker said in an emailed statement. Initial findings show it involved a severe respiratory infection followed by neurological complications. The results of an autopsy are pending, and details have been reported to regulators, the company said.

News: NIH Streamlines Gene Therapy Oversight and Charts a Course for Considering Emerging Technology
In August 2018, the National Institutes of Health and the Food and Drug Administration (FDA) announced a joint proposal to streamline duplicative and burdensome oversight over gene therapy. As part of this effort and following public input, NIH today released the amended NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules. The amendments remove the requirement to register and report on human gene therapy protocols under the NIH Guidelines to the NIH. Robust oversight continues under the FDA, which has regulatory oversight of all human gene therapy clinical trials. In addition, NIH-funded human gene therapy research remains subject to the usual NIH oversight that applies to all NIH-funded research, and oversight by local authorities such as Institutional Review Boards and Institutional Biosafety Committees.

- 15 - 17 May 2019, World Advanced Therapies & Regenerative Medicine Congress 2019, London, UK
- 21 - 23 May 2019, 5th Annual Precision CRISPR Congress Boston, Boston, MA
- 21 - 23 May 2019, NDD Europe - Neurodegenerative Drug Development - Focus on gene therapy, Paris, France
- 25 - 26 May 2019, Gordon Research Conference: Virusses & Cells, Lucca, Italy
- 4 - 5 June 2019, Advanced Therapy Medicinal Products conference, Vilnius, Lithuania
- 18 - 20 June 2019, CAR-TCR Summit Asia 2019, Shanghai, China
- 18 - 20 June 2019, Next generation CAR & T Cell Therapies, San Francisco, CA
- 19 - 21 June 2019, Annual conference of the British Society for Gene and Cell Therapy (BSGCT), Sheffield, UK
- 25 - 26 June 2019, 4th PDA Europe Annual Meeting - gene therapy regulatory issues, Amsterdam, The Netherlands
- 20 - 23 July 2019, The 25th Annual Meeting of the Japan Society of Gene Therapy (JSGT), Tokyo, Japan
- 9 - 12 September 2019, Cell & Gene Therapy Manufacturing and Commercialization, Boston, MA
- 10 - 13 September 2019, CAR-TCR Summit Boston 2019, Boston, MA
- 9 October 2019, The Cell & Gene Therapy Strategy Meeting Europe, Zurich, Switzerland
- 21 – 25 October 2019, XXVII Congress of the European Society of Gene and Cell Therapy (ESGCT), Barcelona, Spain


Gene Therapy Net is the information resource for basic and clinical research in gene therapy, and the site serves as a network in the exchange of gene therapy information and breaking news items. Visitors can keep track of the latest scientific papers, conference announcements, gene therapy jobs, regulations and guidelines. Other information websites created and maintained by the owner of Gene Therapy Net are Dengue Virus Net, Influenza Virus Net, Ebola Virus Net, Chikungunya Virus Net and Zika Virus Net.
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