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Newsletter February 2010

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News: Adeno-Associated Virus Type 2 Reference Standard Material is Now Available
The AAV2 vector reference standard material (an AAV2-GFP viral vector) is now available from ATCC (http://www.atcc.org). The AAV2 RSM is intended for use in calibrating internal (laboratory-specific) reference materials and assays for recombinant AAV viral gene transfer products, with the purpose of making data from different pre-clinical and clinical studies more comparable.
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News: Amsterdam Molecular Therapeutics: EMA starts formal review of Glybera dossier
Amsterdam Molecular Therapeutics (Euronext: AMT), a leader in the field of human gene therapy, has reached another important milestone in the official marketing authorisation process for its lead product Glybera, AMT's proprietary product for lipoprotein lipase deficiency (LPLD). The submission of the Glybera Marketing Authorisation Application (MAA), announced earlier, has cleared the validation stage with The European Medicines Agency (EMA, formerly known as EMEA). The EMA will now commence its formal review of Glybera.
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News: The EMA has published a Concept paper on the revision of the note for guidance on the quality, pre-clinical and clinical aspects of gene transfer medicinal products
The European Medicines Agency has published a Concept paper on the revision of the note for guidance on the quality, pre-clinical and clinical aspects of gene transfer medicinal products (EMA/CHMP/GTWP/BWP/234523/2009). This Concept Paper proposes a revision of the Note for Guidance on the Quality, Preclinical and Clinical Aspects of Gene Transfer Medicinal Products (CPMP/BWP/3088/99) that came into effect in 2001. This revision will address the issues identified from clinical experience and provision of Scientific Advice on gene therapy medicinal products and will lay down detailed and updated requirements for the quality, non-clinical and clinical aspects of gene therapy medicinal products.
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Conferences
- 2 - 4 March 2010, DNA Vaccines 2010, New Orleans, LA
- 11 - 12 March 2010, Joint Spring Meeting of the Dutch Society of Gene Therapy (NVGT) and the Belgian Gene Therapy Working Group, Heeze, The Netherlands
- 19 - 21 March 2010, British Society of Gene Therapy (BSGT) 7th Annual Conference, Royal Holloway University London, UK
- 22 - 24 April 2010, 6th International Meeting on Gene Therapy of Arthritis and Related Disorders, London, UK
- 5 May 2010, 7th Annual Conference of the Israeli Society of Gene & Cell Therapy (ISGCT), Tel Aviv, Israel
- 17 – 18 May 2010, ASGCT Clinical Trials Training Course, Washington DC, MD
- 19 – 23 May 2010, American Society of Gene and Cell Therapy (ASGCT) 13th Annual Meeting, Washington DC, MD
- 22 – 26 May 2010, International Society for Cellular Therapy (ISCT) 16th Annual Meeting, Philadelphia, PA
- 13 - 15 June 2010, The 9th Annual Congress of La Société Francophone de Thérapie Cellulaire et Génique (SFTCG), Paris, France
- 26 - 29 June 2010, 3nd International symposium on Cellular Delivery of Therapeutic Macromolecules, Cardiff, UK
- 1 - 3 July 2010, The 16th Annual Meeting of the Japan Society of Gene Therapy (JSGT), Tochigi-ken Sougou Bunka Center, Utsunomiya-city Tochigi, Japan
- 22 - 25 October 2010, European Society of Gene and Cell Therapy (ESGCT) 18th Annual Congress, Milan, Italy
- 24 - 26 January 2011, Phacilitate 7th Annual Cell & Gene Therapy Forum 2011, Washington DC, MD
- 4 - 5 May 2011, Australasian Gene Therapy Society (AGTS) 7th Meeting, Melbourne, Australia
- 18 - 22 May 2011, American Society of Gene and Cell Therapy (ASGCT) 14th Annual Meeting, Seattle, WA

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