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Newsletter November 2010

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News: NIH RAC and CliniGene Co-host a Scientific Symposium on 'Retroviral and Lentiviral Vectors for Long-Term Gene Correction: Clinical Challenges in Vector and Trial Design'
In past safety symposia, the NIH Recombinant DNA Advisory Committee (RAC) reviewed clinical and molecular data concerning leukemias caused by insertional mutagenesis at or near oncogenes in two trials for X-linked Severe Combined Immunodeficiency Disease (X-SCID) involving transduction of CD34+ hematopoetic stem cells by retroviral vectors. Since these discussions, investigators have reported advances in the field, including clinical benefits in trials studying other clinical indications (e.g., adenosine deaminase deficient-SCID, adrenoleukodystrophy). In addition, research has focused on alternative vectors, either lentiviral vectors or modified retroviral vectors designed to decrease the risk of enhancer-mediated insertional mutagenesis.
Given these developments, as well as recent reports of myelodysplasia in a trial for chronic granulomatous disease and the finding of a relative clonal population of cells in a trial for thalassemia, the RAC and the European Network for the Advancement of Clinical Gene Transfer and Therapy (CliniGene) are holding this symposium. Registration is free.

Data and location: December 9-10, 2010, Bethesda, USA

Symposium topics:
  • Developments in retrovirus and lentivirus integration and insertional mutagenesis research, including non-enhancer mediated mechanisms of insertional mutagenesis;
  • Modifications to retroviral and lentiviral vectors to enhance their safety;
  • Research on in vitro and animal models to evaluate the safety of human gene transfer; and
  • Clinical and ethical considerations for review of human gene transfer research involving novel retroviral and lentiviral vectors.

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    Conference: International Symposium ‘Genetically modified viruses as medicine’, panacea or pandora's box?'
    The use of genetically modified (GM) viruses to cure diseases is a vast developing and exciting field. In recent clinical trials promising results have been achieved. The application of replicating viral vectors as a treatment modality for cancer patients appears to come within reach. In view of these developments the Netherlands Commission on Genetic Modification (COGEM), organizes an international symposium on the use of replicating viral vectors as medicine.
    This symposium will focus on the upcoming field of cancer treatment. Besides technical information and state-of-the-art developments we also want to give attention to the strengths of replicating viral vectors and the opportunities for patients, the environmental risk assessment and the possible concerns in society about the use of replicating GM viruses. Thereby, this symposium is not solely meant for scientists but also for policymakers and otherwise interested audience.

    Data and location: 20th January 2011, Amsterdam, The Netherlands

    Confirmed Speakers: Prof.dr. Stephen Russell, Mayo Clinic, USA; Dr. Matt Coffey, Oncolytics Biotech Inc., Canada; Prof.dr. Clemens Dirven, Erasmus MC, Dr. Sabine Roeser, TU Delft and Dr. Maria Christina Galli, Gene Therapy Expert Group at CAT, Italy.

    International Symposium ‘Genetically modified viruses as medicine’, panacea or pandora's box?'


    Site Update: Regulatory Affairs
    Gene Therapy Net has updated the information about several national regulatory affairs regarding clinical gene therapy trials. Regulatory issues of gene transfer are usually a secondary preoccupation of researchers. Conducting gene therapy clinical trials with viral vectors presents unique safety and infection control issues. The area is governed by a range of legislation and guidelines, some unique to this field, as well as those pertinent to any area of clinical work. Gene therapy legislation aims at protecting the human subject, the general public and the environment.
    Gene Therapy Net has requested national Competent Authorities to review and revise the given information about gene therapy legislation in their country. Check out the updated information for each country when planning to conduct a gene therapy trial. Below each page you can see when the Comnpetent Authority has reviewed the information. Please contact us in case of inaccurate information or any dead links.


    - 16 November 2010, 3rd annual Workshop on Genome Engineering, Seattle, WA
    - 17 - 19 November 2010, 9th Annual Gene Therapy Symposium for Heart, Lung, and Blood Diseases. Focus Topic: Gene Expression, Sonoma, CA
    - 19 November 2010, 4th Annual Conference of the Korea Society of Gene Therapy (KSGT), Seoul, Korea
    - 9-10 December 2010, Safety Symposium organized by the NIH RAC and Co-hosted by CliniGene: Retroviral and Lentiviral Vectors for Long-Term Gene Correction: Clinical Challenges in Vector and Trial Design, Bethesda, MD
    - 20 January 2011, COGEM Symposium: GM viruses as medicine: panacea or pandora's box?, Amsterdam, The Netherlands
    - 24 - 26 January 2011, Phacilitate 7th Annual Cell & Gene Therapy Forum 2011, Washington DC, MD
    - 27 February - 1 March 2011, Annual meeting of the International Society for Cell & Gene Therapy of Cancer (ISCGT), Doha, Qatar
    - 10 - 11 March 2011, Spring Meeting of the Dutch Society of Gene Therapy (NVGT), Heeze, The Netherlands
    - 16 - 19 March 2011, 6th International Conference on Oncolytic Viruses as Cancer Therapeutics, Las Vegas, NV
    - 7 - 9 April 2011, Clinical Gene transfer: state of the art conference and e-chips European congress on human iPS cells, Paris, France
    - 4 - 6 May 2011, Australasian Gene Therapy Society (AGTS) 7th Meeting, Melbourne, Australia
    - 18 - 21 May 2011, International Society for Cellular Therapy (ISCT) 17th Annual Meeting, Rotterdam, The Netherlands
    - 18 - 22 May 2011, American Society of Gene and Cell Therapy (ASGCT) 14th Annual Meeting, Seattle, WA
    - 29 May - 2 June 2011, Gordon Research Conference: Virusses & Cells, Lucca (Barga), Italy
    - 12 - 14 July 2011, DNA Vaccines 2011, San Diego, LA
    - 15 – 17 July 2011, The 17th Annual Meeting of the Japan Society of Gene Therapy (JSGT), Kyushu University, Fukuoka, Japan
    - 27 - 31 October 2011, European Society Of Gene & Cell Therapy (ESGCT) and the British Society of Gene Therapy (BSGT) collaborative Congress 2011, Brighton, UK


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