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Newsletter February 2020

News: FDA Continues Strong Support of Innovation in Development of Gene Therapy Products
This is a pivotal time in the field of gene therapy as the FDA continues its efforts to support innovators developing new medical products for Americans and others around the world. 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of important policies: six final guidances on gene therapy manufacturing and clinical development of products and a draft guidance, Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations.

Conference: 2nd Annual Cell Engager Summit
Welcome to the 2nd Annual Cell Engager Summit, 30 March - 1 April, Boston: Clinically Advancing the Next Generation of Safe & 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.
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.
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.
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.

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Conference: World Advanced Therapies Congress 2020
The Advanced Therapies 2020, 30 March - 1 April, London, 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.
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.

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Conference: 4th Annual Genome Editing USA Congress
The 4th Annual Genome Editing USA Congress will take place from 7 - 8 April in Boston. Over 350 end users representing internationally renowned research & 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.
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Conference: Neuroimmunology Drug Development Summit
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 2nd Neuroimmunology Drug Development 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 15-17 April in Boston.
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.

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Conference: Formulation & Drug Delivery Series UK
Our premiere Formulation and Drug Delivery Congress, 29–30 April in London, 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 & characterisation. Co-located with our Inhalation & Respiratory Drug Delivery congress and Biomanufacturing congress.
The 5th Annual Inhalation & 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.
Our all-new Biomanufacturing congress features the latest developments in biologics manufacturing. Our dedicated streams include cell & gene therapy manufacturing, upstream & downstream processing, continuous biomanufacturing & CMC. Join us to learn more about the futures of biomanufacturing science, technology and facilities!

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- 19 - 20 February 2020, RNA Therapeutics 2020, London, UK
- 22 - 24 February 2020, CAR-TCR Summit Europe, London, UK
- 25 - 27 February 2020, Neurodegenerative Drug Development Summit 2020 - Gene Therapy, Boston, MA
- 26 - 28 February 2020, Immuno-Oncology 360° - Cell & Gene Therapy Day, New York, NY
- 2 - 3 March 2020, Tri-Conference 2020 - Renaissance of Gene Therapy and Genome Editing, San Francisco, CA
- 3 - 5 March 2020, Gene Therapy for Blood Disorders, Boston, MA
- 10 - 12 March 2020, Inborn Errors of Metabolism Drug Development, Boston, MA
- 23 - 25 March 2020, International Society for BioProcess Technology 10th Spring Meeting - Viral vectors and vaccines, Norfolk, Virginia
- 24 - 26 March 2020, Innate Killer Summit 2020, San Diego, CA
- 24 - 26 March 2020, Bioprocessing Summit Europe, Barcelona, Spain
- 30 March - 1 April 2020, 2nd Annual Cell Engager Summit, Boston, MA
- 30 March - 2 April 2020, 4th Annual Gene Therapy for Rare Disorders, Boston, MA
- 31 March - 2 April 2020, 15th Annual World Advanced Therapies Congress, London, UK
- 7 - 8 April 2020, 4th Annual Genome Editing USA Congress, Boston, MA
- 15 - 16 April 2020, Global Cell and Gene Therapy Innovation Leaders Shanghai Forum - Asia Pharma R&D Leaders Summit 2020, Shanghai, China
- 15 - 17 April 2020, Neuroimmunology Drug Development Summit - Translating Neuroimmunological Mechanisms into Clinically Effective Neurodegenerative Targeting Therapeutics, Boston, MA
- 29 - 30 April 2020, Formulation and Drug Delivery conference - Cell & Gene Therapy Biomanufacturing: Insights, Key Strategies & Novel Approaches, London, UK
- 29 - 30 April 2020, CAR-T Congress USA, Boston, MA
- 29 April - 1 May 2020, World Orphan Drug Congress USA, Oxon Hill, Maryland
- 4 - 8 May 2020, PEGS: The Essential Protein Engineering and Cell Therapy Summit - Cell and Gene Therapies, Boston, MA
- 12 - 15 May 2020, Bioanalytical strategies for Cell & Gene Therapies workshop, Málaga, Spain
- 12 - 15 May 2020, American Society of Gene and Cell Therapy (ASGCT) 23th Annual Meeting, Boston, MA
- 3 - 4 June 2020, 2nd Annual Gene and Cell Therapy: Quality Developments to Commercialization Summit, Munich, Germany
- 4 June 2020, Cell & Gene Therapy Strategy Meeting, Boston, MA
- 15 - 19 June 2020, 9th International Symposium on Monolith - DNA/RNA, vaccines, gene therapy vectors, Portoroz, Slovenia
- 20 - 23 July 2020, 2nd Drug Delivery Conference Bridging the Gap between Basic Science and Unmet Clinical Needs, Lisbon, Portugal
- 24 - 28 August 2020, 12th annual Bioprocessing Summit, Boston, MA
- 14 - 17 September 2020, CAR-TCR Summit USA, Boston, MA
- 6 – 7 October 2020, Cell Series UK 2020 - Cell & Gene Therapy Manufacturing, London, UK
- 20 – 23 October 2020, XXVIII Congress of the European Society of Gene and Cell Therapy (ESGCT), Edinburgh UK


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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