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Gene Therapy Net Newsletter

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To date, the FDA has approved four gene therapy products, which insert new genetic material into a patient’s cells. The agency anticipates many more approvals in the coming years, as evidenced by the more than 900 investigational new drug (IND) applications for ongoing clinical studies in this area. The FDA believes this will provide patients and providers with increased therapeutic choices. In that spirit, today, the FDA is announcing the release of a number of important policies: six final guidances on gene therapy manufacturing and clinical development of products and a draft guidance, Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations.</span><br /> <a style="font-weight: normal; font-size: 12px; color: #000000; font-family: Geneva, Arial, Helvetica, sans-serif; text-decoration: underline;" href="https://www.genetherapynet.com">Read more...</a></td> </tr> </tbody> </table> <hr /> <table style="margin-bottom: 10px;" width="100%" align="center"> <tbody> <tr> <td height="25"><span style="font-family: Geneva, Arial, Helvetica, sans-serif; color: #000000; font-size: 16px; font-weight: bold;"> Conference: 2nd Annual Cell Engager Summit</span></td> </tr> <tr> <td><span style="font-family: Geneva, Arial, Helvetica, sans-serif; color: #000000; font-size: 12px; font-weight: normal;"> Welcome to the <a href="https://ter.li/j7zrrj">2nd Annual Cell Engager Summit</a>, <b>30 March - 1 April, Boston</b>: Clinically Advancing the Next Generation of Safe &amp; Effective Multi-Specific Immune Cell Engaging Antibody Therapies for Solid Tumor Indications. The Cell Engager Summit is the only meeting focused on developing multi-specific cell engaging therapies in liquid and solid tumor indications, accelerating early discovery innovation into the clinic.<br /> Understand the very latest in construct design, immune cell biology, tumor associated activation, toxicity assessment, solid tumor targeting strategies, clinical insights and more. Discover how to effectively scale complicated manufacturing of multi-specific cell engagers to reduce production costs and time whilst ensuring purity and quality of antibodies.<br /> With 22+ hours of content, 2 interactive workshops and over 5 hours of networking with key industry leaders, this conference will focus solely on cell engaging drugs and how to tackle key clinical and commercial challenges.<br /> Join us as we unite experts from across large pharma, innovative biotech and solution and service providers to harness the power of immune cell engagement to advance next generation cancer treatment to market. Use the code GTN10 to receive 10% discount. </span><br /> <a style="font-weight: normal; font-size: 12px; color: #000000; font-family: Geneva, Arial, Helvetica, sans-serif; text-decoration: underline;" href="https://ter.li/j7zrrj">Register now...</a></td> </tr> </tbody> </table> <hr /> <table style="margin-bottom: 10px;" width="100%" align="center"> <tbody> <tr> <td height="25"><span style="font-family: Geneva, Arial, Helvetica, sans-serif; color: #000000; font-size: 16px; font-weight: bold;"> Conference: World Advanced Therapies Congress 2020</span></td> </tr> <tr> <td><span style="font-family: Geneva, Arial, Helvetica, sans-serif; color: #000000; font-size: 12px; font-weight: normal;">The <a href="https://www.terrapinn.com/congress/advanced-therapies/index.stm">Advanced Therapies 2020</a>, <b>30 March - 1 April, London</b>, brings together the life science community to meet, do business and solve the challenges preventing ATMPs getting to market and saving patient lives. By hosting the most cutting-edge content and highest level of speakers in the premium conference and showcasing the latest technologies and solutions in the expo, Advanced Therapies 2020 supports attendees to tackle the latest challenges whilst exploring the hottest topics in the ATMP space.<br /> The event covers each stage of development of cell, gene and immunotherapy - from bioprocessing through clinical translation to reimbursement, market access and delivery to patient.</span><br /> <a style="font-weight: normal; font-size: 12px; color: #000000; font-family: Geneva, Arial, Helvetica, sans-serif; text-decoration: underline;" href="https://www.terrapinn.com/congress/advanced-therapies/index.stm">Register now...</a></td> </tr> </tbody> </table> <hr /> <table style="margin-bottom: 10px;" width="100%" align="center"> <tbody> <tr> <td height="25"><span style="font-family: Geneva, Arial, Helvetica, sans-serif; color: #000000; font-size: 16px; font-weight: bold;"> Conference: 4th Annual Genome Editing USA Congress</span></td> </tr> <tr> <td><span style="font-family: Geneva, Arial, Helvetica, sans-serif; color: #000000; font-size: 12px; font-weight: normal;">The <a href="https://bit.ly/2Kg3BYF">4th Annual Genome Editing USA Congress</a> will take place from <b>7 - 8 April</b> in <b>Boston</b>. Over 350 end users representing internationally renowned research &amp; academic institutions, clinical research institutions, healthcare organisations as well as leading pharmaceutical and biotech companies. Latest advances in the application of gene editing across different therapeutic fields. Experts will discuss their latest and most exciting work on the application of #genomeediting in therapeutic areas such as #oncology, hereditary diseases and neuromuscular diseases. Latest innovations in genome editing technologies, including #CRISPR and #ZFNs. Presentations will cover the advancements in guide/donor modifications, leveraging peculiarities in the #Cas9 nuclease release reaction and base editing. Find out how gene editing is being used to accelerate #drugdiscovery. Hear from leading organisations such as @Sangamo, @Broad Institute and @Cellectis on how gene editing is transforming drug discovery. </span><br /> <a style="font-weight: normal; font-size: 12px; color: #000000; font-family: Geneva, Arial, Helvetica, sans-serif; text-decoration: underline;" href="https://bit.ly/2Kg3BYF">Register now...</a></td> </tr> </tbody> </table> <hr /> <table style="margin-bottom: 10px;" width="100%" align="center"> <tbody> <tr> <td height="25"><span style="font-family: Geneva, Arial, Helvetica, sans-serif; color: #000000; font-size: 16px; font-weight: bold;"> Conference: Neuroimmunology Drug Development Summit</span></td> </tr> <tr> <td><span style="font-family: Geneva, Arial, Helvetica, sans-serif; color: #000000; font-size: 12px; font-weight: normal;"> More and more pharma and biotech companies are investing in research focused on neuroimmunology and neuroinflammation’s relation to neurodegenerative diseases in the challenge to develop clinically effective therapeutics.The <a href="https://ter.li/tgvacn">2nd Neuroimmunology Drug Development</a> Summit’s agenda has specifically designed alongside neuroimmunology experts from the likes of Denali, AbbVie and Biogen to help these drug developers to overcome their translational challenges and successfully translate their drug candidates into the clinic. The summit will take place from <b>15-17 April</b> in <b>Boston</b>.<br /> Immerse yourself in the field’s cutting-edge scientific advances and take this unrivaled opportunity to join over 23 expert industry speakers and over 80 drug developers from the neuroimmunological community for over 7 hours of dedicated networking time and 2 deep-dive workshops.</span><br /> <a style="font-weight: normal; font-size: 12px; color: #000000; font-family: Geneva, Arial, Helvetica, sans-serif; text-decoration: underline;" href="https://ter.li/tgvacn">Register now...</a></td> </tr> </tbody> </table> <hr /> <table style="margin-bottom: 10px;" width="100%" align="center"> <tbody> <tr> <td height="25"><span style="font-family: Geneva, Arial, Helvetica, sans-serif; color: #000000; font-size: 16px; font-weight: bold;"> Conference: Formulation &amp; Drug Delivery Series UK</span></td> </tr> <tr> <td><span style="font-family: Geneva, Arial, Helvetica, sans-serif; color: #000000; font-size: 12px; font-weight: normal;">Our premiere <a href="https://bit.ly/2N7VZZJ">Formulation and Drug Delivery Congress</a>, <b>29–30 April</b> in <b>London</b>, features the latest development in biologics and small molecule formulation and delivery. Learn from our dedicated streams on drug product manufacturing, innovative therapies of the future and bioanalysis &amp; characterisation. Co-located with our Inhalation &amp; Respiratory Drug Delivery congress and Biomanufacturing congress.<br /> The 5th Annual Inhalation &amp; Respiratory Drug Delivery Congress will host key industry and academic leaders presenting on innovative solutions to the challenges in developing inhaled therapies, with discussions on cutting-edge device breakthroughs, including digital health.<br /> Our all-new Biomanufacturing congress features the latest developments in biologics manufacturing. Our dedicated streams include cell &amp; gene therapy manufacturing, upstream &amp; downstream processing, continuous biomanufacturing &amp; CMC. Join us to learn more about the futures of biomanufacturing science, technology and facilities!</span><br /> <a style="font-weight: normal; font-size: 12px; color: #000000; font-family: Geneva, Arial, Helvetica, sans-serif; text-decoration: underline;" href="https://bit.ly/2N7VZZJ">Register now...</a></td> </tr> </tbody> </table> <hr /> <table style="margin-bottom: 10px;" width="100%" align="center"> <tbody> <tr> <td height="25"><span style="font-family: Geneva, Arial, Helvetica, sans-serif; color: #000000; font-size: 16px; font-weight: bold;"> Conferences </span></td> </tr> <tr> <td><span style="font-family: Geneva, Arial, Helvetica, sans-serif; color: #000000; font-size: 12px; font-weight: normal;"> <table> <tbody> <tr> <td valign="top">-</td> <td><span style="font-family: Geneva, Arial, Helvetica, sans-serif; color: #000000; font-size: 12px; font-weight: normal;">19 - 20 February 2020, RNA Therapeutics 2020, London, UK</span></td> </tr> <tr> <td valign="top">-</td> <td><span style="font-family: Geneva, Arial, Helvetica, sans-serif; color: #000000; font-size: 12px; font-weight: normal;">22 - 24 February 2020, CAR-TCR Summit Europe, London, UK</span></td> </tr> <tr> <td valign="top">-</td> <td><span style="font-family: Geneva, Arial, Helvetica, sans-serif; color: #000000; font-size: 12px; font-weight: normal;">25 - 27 February 2020, Neurodegenerative Drug Development Summit 2020 - Gene Therapy, Boston, MA</span></td> </tr> <tr> <td valign="top">-</td> <td><span style="font-family: Geneva, Arial, Helvetica, sans-serif; color: #000000; font-size: 12px; font-weight: normal;">26 - 28 February 2020, Immuno-Oncology 360° - Cell &amp; Gene Therapy Day, New York, NY</span></td> </tr> <tr> <td valign="top">-</td> <td><span style="font-family: Geneva, Arial, Helvetica, sans-serif; color: #000000; font-size: 12px; font-weight: normal;">2 - 3 March 2020, Tri-Conference 2020 - Renaissance of Gene Therapy and Genome Editing, San Francisco, CA</span></td> </tr> <tr> <td valign="top">-</td> <td><span style="font-family: Geneva, Arial, Helvetica, sans-serif; color: #000000; font-size: 12px; font-weight: normal;">3 - 5 March 2020, Gene Therapy for Blood Disorders, Boston, MA</span></td> </tr> <tr> <td valign="top">-</td> <td><span style="font-family: Geneva, Arial, Helvetica, sans-serif; color: #000000; font-size: 12px; font-weight: normal;">10 - 12 March 2020, Inborn Errors of Metabolism Drug Development, Boston, MA</span></td> </tr> <tr> <td valign="top">-</td> <td><span style="font-family: Geneva, Arial, Helvetica, sans-serif; color: #000000; font-size: 12px; font-weight: normal;">23 - 25 March 2020, International Society for BioProcess Technology 10th Spring Meeting - Viral vectors and vaccines, Norfolk, Virginia</span></td> </tr> <tr> <td valign="top">-</td> <td><span style="font-family: Geneva, Arial, Helvetica, sans-serif; color: #000000; font-size: 12px; font-weight: normal;">24 - 26 March 2020, Innate Killer Summit 2020, San Diego, CA</span></td> </tr> <tr> <td valign="top">-</td> <td><span style="font-family: Geneva, Arial, Helvetica, sans-serif; color: #000000; font-size: 12px; font-weight: normal;">24 - 26 March 2020, Bioprocessing Summit Europe, Barcelona, Spain</span></td> </tr> <tr> <td valign="top">-</td> <td><span style="font-family: Geneva, Arial, Helvetica, sans-serif; color: #000000; font-size: 12px; font-weight: normal;">30 March - 1 April 2020, 2nd Annual Cell Engager Summit, Boston, MA</span></td> </tr> <tr> <td valign="top">-</td> <td><span style="font-family: Geneva, Arial, Helvetica, sans-serif; color: #000000; font-size: 12px; font-weight: normal;">30 March - 2 April 2020, 4th Annual Gene Therapy for Rare Disorders, Boston, MA</span></td> </tr> <tr> <td valign="top">-</td> <td><span style="font-family: Geneva, Arial, Helvetica, sans-serif; color: #000000; font-size: 12px; font-weight: normal;">31 March - 2 April 2020, 15th Annual World Advanced Therapies Congress, London, UK</span></td> </tr> <tr> <td valign="top">-</td> <td><span style="font-family: Geneva, Arial, Helvetica, sans-serif; color: #000000; font-size: 12px; font-weight: normal;">7 - 8 April 2020, 4th Annual Genome Editing USA Congress, Boston, MA</span></td> </tr> <tr> <td valign="top">-</td> <td><span style="font-family: Geneva, Arial, Helvetica, sans-serif; color: #000000; font-size: 12px; font-weight: normal;">15 - 16 April 2020, Global Cell and Gene Therapy Innovation Leaders Shanghai Forum - Asia Pharma R&amp;D Leaders Summit 2020, Shanghai, China</span></td> </tr> <tr> <td valign="top">-</td> <td><span style="font-family: Geneva, Arial, Helvetica, sans-serif; color: #000000; font-size: 12px; font-weight: normal;">15 - 17 April 2020, Neuroimmunology Drug Development Summit - Translating Neuroimmunological Mechanisms into Clinically Effective Neurodegenerative Targeting Therapeutics, Boston, MA</span></td> </tr> <tr> <td valign="top">-</td> <td><span style="font-family: Geneva, Arial, Helvetica, sans-serif; color: #000000; font-size: 12px; font-weight: normal;">29 - 30 April 2020, Formulation and Drug Delivery conference - Cell &amp; Gene Therapy Biomanufacturing: Insights, Key Strategies &amp; Novel Approaches, London, UK</span></td> </tr> <tr> <td valign="top">-</td> <td><span style="font-family: Geneva, Arial, Helvetica, sans-serif; color: #000000; font-size: 12px; font-weight: normal;">29 - 30 April 2020, CAR-T Congress USA, Boston, MA</span></td> </tr> <tr> <td valign="top">-</td> <td><span style="font-family: Geneva, Arial, Helvetica, sans-serif; color: #000000; font-size: 12px; font-weight: normal;">29 April - 1 May 2020, World Orphan Drug Congress USA, Oxon Hill, Maryland</span></td> </tr> <tr> <td valign="top">-</td> <td><span style="font-family: Geneva, Arial, Helvetica, sans-serif; color: #000000; font-size: 12px; font-weight: normal;">4 - 8 May 2020, PEGS: The Essential Protein Engineering and Cell Therapy Summit - Cell and Gene Therapies, Boston, MA</span></td> </tr> <tr> <td valign="top">-</td> <td><span style="font-family: Geneva, Arial, Helvetica, sans-serif; color: #000000; font-size: 12px; font-weight: normal;">12 - 15 May 2020, Bioanalytical strategies for Cell &amp; Gene Therapies workshop, Málaga, Spain</span></td> </tr> <tr> <td valign="top">-</td> <td><span style="font-family: Geneva, Arial, Helvetica, sans-serif; color: #000000; font-size: 12px; font-weight: normal;">12 - 15 May 2020, American Society of Gene and Cell Therapy (ASGCT) 23th Annual Meeting, Boston, MA </span></td> </tr> <tr> <td valign="top">-</td> <td><span style="font-family: Geneva, Arial, Helvetica, sans-serif; color: #000000; font-size: 12px; font-weight: normal;">3 - 4 June 2020, 2nd Annual Gene and Cell Therapy: Quality Developments to Commercialization Summit, Munich, Germany</span></td> </tr> <tr> <td valign="top">-</td> <td><span style="font-family: Geneva, Arial, Helvetica, sans-serif; color: #000000; font-size: 12px; font-weight: normal;">4 June 2020, Cell &amp; Gene Therapy Strategy Meeting, Boston, MA</span></td> </tr> <tr> <td valign="top">-</td> <td><span style="font-family: Geneva, Arial, Helvetica, sans-serif; color: #000000; font-size: 12px; font-weight: normal;">15 - 19 June 2020, 9th International Symposium on Monolith - DNA/RNA, vaccines, gene therapy vectors, Portoroz, Slovenia</span></td> </tr> <tr> <td valign="top">-</td> <td><span style="font-family: Geneva, Arial, Helvetica, sans-serif; color: #000000; font-size: 12px; font-weight: normal;">20 - 23 July 2020, 2nd Drug Delivery Conference Bridging the Gap between Basic Science and Unmet Clinical Needs, Lisbon, Portugal</span></td> </tr> <tr> <td valign="top">-</td> <td><span style="font-family: Geneva, Arial, Helvetica, sans-serif; color: #000000; font-size: 12px; font-weight: normal;">24 - 28 August 2020, 12th annual Bioprocessing Summit, Boston, MA</span></td> </tr> <tr> <td valign="top">-</td> <td><span style="font-family: Geneva, Arial, Helvetica, sans-serif; color: #000000; font-size: 12px; font-weight: normal;">14 - 17 September 2020, CAR-TCR Summit USA, Boston, MA</span></td> </tr> <tr> <td valign="top">-</td> <td><span style="font-family: Geneva, Arial, Helvetica, sans-serif; color: #000000; font-size: 12px; font-weight: normal;">6 – 7 October 2020, Cell Series UK 2020 - Cell &amp; Gene Therapy Manufacturing, London, UK</span></td> </tr> <tr> <td valign="top">-</td> <td><span style="font-family: Geneva, Arial, Helvetica, sans-serif; color: #000000; font-size: 12px; font-weight: normal;">20 – 23 October 2020, XXVIII Congress of the European Society of Gene and Cell Therapy (ESGCT), Edinburgh UK</span></td> </tr> </tbody> </table> </span></td> </tr> </tbody> </table> <br /> <a style="font-weight: normal; font-size: 12px; color: #000000; font-family: Geneva, Arial, Helvetica, sans-serif; text-decoration: underline;" href="/conferences.html">Read more...</a></td> </tr> <tr style="line-height: 0px;"></tr> </tbody> </table> <table style="margin-bottom: 20px; text-align: center;" width="100%" bgcolor="#e3e5e6" align="center"> <tbody> <tr> <td><center><hr /><a style="font-weight: normal; font-size: 11px; color: #000000; font-family: Geneva, Arial, Helvetica, sans-serif; text-decoration: none;" href="https://www.genetherapynet.com/"><strong>Gene Therapy Net</strong> 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. 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