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Newsletter October 2018

News: FDA Lifts Clinical Hold; Green-Lights Vertex and CRISPR’s Sickle Cell Gene Therapy Trial
The U.S. Food and Drug Administration (FDA) has lifted a clinical hold and accepted an Investigational New Drug Application (IND) for an experimental sickle cell disease treatment being co-developed by Vertex Pharmaceuticals and CRISPR Therapeutics. In May the FDA placed a hold on the trial and IND for CTX001, an investigational gene editing treatment, citing concerns over questions that had not been addressed in the IND. The two companies initially submitted the IND in April in support of a planned Phase I/II trial.

News: Screening Clinical Cell Products for Replication Competent Retrovirus: The National Gene Vector Biorepository Experience
Replication-competent retrovirus (RCR) is a safety concern for individuals treated with retroviral gene therapy. RCR detection assays are used to detect RCR in manufactured vector, transduced cell products infused into research subjects, and in the research subjects after treatment. In this study, we reviewed 286 control (n = 4) and transduced cell products (n = 282) screened for RCR in the National Gene Vector Biorepository. The transduced cell samples were submitted from 14 clinical trials. All vector products were previously shown to be negative for RCR prior to use in cell transduction. After transduction, all 282 transduced cell products were negative for RCR. In addition, 241 of the clinical trial participants were also screened for RCR by analyzing peripheral blood at least 1 month after infusion, all of which were also negative for evidence of RCR infection. The majority of vector products used in the clinical trials were generated in the PG13 packaging cell line. The findings suggest that screening of the retroviral vector product generated in PG13 cell line may be sufficient and that further screening of transduced cells does not provide added value.

Company: Polyplus-transfection
Biotechnology company that develops and sells innovative solutions for the delivery of nucleic acids in research, bioproduction and therapeutics. Our PEIpro product line is currently used for viral vectors (AAV, lentivirus) production for cell & gene therapy. We are the unique providers of a PEI suitable for use as raw material in GMP processes.

Conference: Opthalmic Drugs conference - Gene Therapy for the eye
Join industry experts from Roche, Santen, Aerie Pharmaceuticals, MHRA, Nightstar Therapeutics and more to discuss and analyze the latest advancements and challenges within ophthalmic drug development. Network with industry professionals, explore novel approaches to treatment of ocular diseases, gain insight into ongoing clinical trials, discover how technology is revolutionising pharmaceutical R&D.

The Opthalmic Drugs conference takes place from 26 - 27 November 2018 in London, UK. Register now with code GTNNH100 to receive £100 discount of the advertised price.

pthalmic Drugs conference - Gene Therapy for the eye

Conference: CAR-T Congress EU
CAR-T cell therapy has shown unparalleled success in haematological malignancies, paving the way for the field of immuno-oncology. In 2017 two therapies achieved FDA approval in the USA, and following recent approval by the EMA, it is a landmark time for the industry.

Despite the huge successes there are still a number of hurdles to overcome before CAR-T can be effective in mainstream oncology beyond haematological malignancies. The European CAR-T Congress’ mission is to address the opportunities and challenges that presently face the CAR-T field, to maximise the potential of this ground-breaking therapy.

The CAR-T Congress EU takes place from 30 - 31 January 2019 in London, UK

Register now...

- 15 – 16 October 2018, Rare Diseases and Orphan Products Breakthrough Summit, Washington, DC
- 16 – 19 October 2018, XXVI Congress of the European Society of Gene and Cell Therapy (ESGCT), Lausanne, Switzerland
- 17 – 18 October 2018, Orphan Drugs and Rare Diseases Conference, London, UK
- 22 – 24 October 2018, Gene Therapy for Rare Disorders Europe, London, UK
- 22 – 24 October 2018, Precision CRISPR Drug Development and Gene Therapy Congress, London, UK
- 24 – 25 October 2018, Annual Congress on CRISPR-Cas9 Technology, Boston, MA
- 25 – 26 October 2018, 4th Annual Cell & Gene Therapy Congress, London, UK
- 6-8 November 2018, World Orphan Drug Congress 2018, Barcelona, Spain
- 8-9 November 2018, 4th Annual Genome Editing UK Congress, London, UK
- 9-10 November 2018, 2nd Annual Summit on Cell Therapy and Stem Cell Research 2018 Conference, Atlanta, GA
- 23 November 2018, British Society for Gene and Cell Therapy (BSGCT) Annual Conference Autumn 2018, London, UK
- 26 - 27 November 2018, Opthalmic Drugs conference - Gene Therapy for the eye, London, UK
- 30 - 31 January 2019, CAR-T Congress EU, London, UK
- 30 January - 1 February 2019, Gene Therapy – Ready for the Market?, Frankfurt am Main, Germany
- 6 - 7 February 2019, Annual Cell and Gene Therapy Innovation Summit, Berlin, Germany
- 4 - 6 March 2019, International Society for BioProcess Technology 9th Spring Meeting - Viral vectors and vaccines, Norfolk, Virginia
- 7 - 8 March 2019, Spring Symposium of the Netherlands Society of Gene & Cell Therapy (NVGCT), Lunteren, The Netherlands
- 19 - 21 March 2019, 2nd Annual Bioprocessing Summit Europe - Cell and Gene Therapy, Lisbon, Portugal
- 21 - 22 March 2019, 9th International Conference and Exhibition on Advanced Cell and Gene Therapy, Rome, Italy
- 2 – 4 April 2019, CAR-T Congress USA, Boston, MA
- 3 – 5 April 2019, 4th Spring school of the European Society of Gene and Cell Therapy (ESGCT), Naples, Italy
- 8 – 10 April 2019, 6th World Congress on Human Genetics and Genetic Diseases, Abu Dhabi, UAE
- 29 April - 2 May 2019, American Society of Gene and Cell Therapy (ASGCT) 22th Annual Meeting, Washington, DC
- 25 - 26 May 2019, Gordon Research Conference: Virusses & Cells, Lucca, Italy
- 19 - 21 June 2019, Annual conference of the British Society for Gene and Cell Therapy (BSGCT), Sheffield, UK
- 20 - 23 July 2019, The 25th Annual Meeting of the Japan Society of Gene Therapy (JSGT), Tokyo, Japan
- 21 – 25 October 2019, XXVII Congress of the European Society of Gene and Cell Therapy (ESGCT), Barcelona, Spain


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