Gene Therapy Net Newsletter |
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News: FDA finalizes neurodegenerative disease gene therapy guidance
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The US Food and Drug Administration (FDA) last week finalized guidance to assist sponsors developing human gene therapy (GT) products for neurodegenerative diseases. In the final version, FDA acceded to industry’s requests to modify its language on the use of crossover trials, provided more detail on the use of comparability studies in assessing the effect of post-approval manufacturing changes on products and eliminated limits for residual product-related impurities.
Read more…
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News: Brazilian Association of Cell and Gene Therapy
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The Brazilian Association of Cell and Gene Therapy (ABTCel) was founded in 2006. Gene therapy was incorporated in 2009 and its name changed to the Brazilian Association of Cell and Gene Therapy (ABTCel-Gen). ABTCel-Gen is a non-profit civil association that aims to support scientific, technological, advisory and educational activities in cell therapy, gene therapy and related areas.
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News: 6th Annual Cell and Gene Therapy Innovation Summit
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This summit (15th & 16th Feb 2023 in Berlin) is an exclusive in-person-only gathering for up to 200 decision-makers, intellectual vanguards and captains of industry. With more regenerative medicine products approaching clinical testing and commercialisation, seize this opportunity to hear detailed insights and industry best practices from renowned presenters. #CGTI 2023 programme will highlight the manufacturing challenges facing Cell & Gene Therapy, bringing clear insights and industry best practices from industry leaders. Register now and use code GeneTherapyNet for 20% discount.
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Conference: 3rd CRISPR 2.0 Summit
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CRISPR has opened the floodgates for a new era of gene editing therapies, promising to transform genetic disease treatments. With a well-established early field of genomics research, drug developers and researchers aim to establish the next-generation CRISPR toolkit, including Cas nucleases, base & prime editing technologies, and innovative delivery platforms. The 3rd CRISPR 2.0 Summit (November 29 - December 1, 2022) will take place this month in Boston to showcase the latest innovations by uncovering how the next generation of CRISPR tools are radically enhancing efficacy, minimizing off-target effects & enabling efficient tissue-specific delivery to help you progress your program into and through the clinic. Don’t miss this opportunity to hear from 27+ expert speakers and network with 120+ key players in the space.
Register now…
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Conference: Cell Therapy Analytical Development Summit
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Conference: Synthetic Biology-Based Therapies Summit
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Next month, the Synthetic and Engineered Biology community are uniting at the only meeting (December 13-15, 2022) focused on the technical challenges encountered in Synbio therapeutic development. This is your unique opportunity to hear from and network with those pioneering the space, including MIT, Senti Biosciences, Arsenal Bio, Novome and more. Download the event guide to find out more. Secure your ticket to help bring synthetic and engineered biology therapies closer to patients
Register now…
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Conference: Pre-Filled Syringes and Injectable Drug Devices Europe
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SAE Media Group's 15th Annual Pre-Filled Syringes and Injectable Drug Devices Conference (January 10–12, 2023) will be bigger than ever, with a pre-conference focus day exploring the advances in PFS design for enhanced drug delivery proceeded by a two-day main conference comprising of morning keynote plenaries and parallel afternoon topic streams as detailed below:
• Novel Drug Products and Large Volume Delivery • Sustainability for Injectable Delivery Devices • Primary Packaging Development • Connected Drug Delivery Devices Register now…
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Conference: Transdermal and Microneedle Drug Delivery
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SAE Media Group is proud to present the 2nd annual Transdermal and Microneedle Drug Delivery Conference, taking place on the 23rd to 24th January 2023. SAE’s 2nd annual Transdermal and Microneedle Drug Delivery conference will explore advances in microneedle diagnostics through case studies and real-world examples, whilst engaging in modern strategies for topical and transdermal drug delivery. The two-day agenda offers you peer-to-peer networking with CEO’s, Senior Vice presidents, Directors of Delivery Technologies, Heads of Product Development and many more.
Register now…
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Conference: Next Generation Ophthalmic Drug Delivery Summit
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The inaugural Next Generation Ophthalmic Drug Delivery Summit is coming to San Francisco (January 24–26, 2023) to help ophthalmic drug developers overcome translational challenges of developing novel, long-lasting ophthalmic therapies via novel delivery methods to reduce healthcare burden and increase patient compliance.
Join 21+ expert speakers from the likes of Genentech, Aerie Pharmaceuticals, Novartis, Clearside Biomedical, Janssen, Eyevensys, and EyePoint Pharmaceuticals to overcome your translational challenges and enhance extended drug efficacy while avoiding systemic and local adverse effects. Don’t miss your only opportunity for an industry-specific meeting for networking and sharing extended-duration therapies with the ophthalmic drug development community.
Register now…
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Conference: 2nd Annual mRNA-Based Therapeutics Summit Europe
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The 2nd Annual mRNA-Based Therapeutics Summit Europe is returning in-person to Berlin this January 24-26, 2023. Expect exclusive data from the movers and shakers in mRNA vaccine and therapy development, 40+ world-class speakers, 2 dedicated tracks of content on discovery and development & manufacturing and 7+ hours of networking opportunities.
Here’s a snapshot of the expert speakers you can hear from: • Silvia Aiolli, Head of GRA mRNA Franchise, Sanofi • Raymond Schiffelers, Professor, Nanomedicine, Utrecht University • Giovanna Lollo, Associate Professor, Universite Claude Bernard Lyon • Daniel Tondera, Head of Biology, Pantherna Therapeutic • Andreas Kuhn, Senior Vice President RNA Biochemistry & Manufacturing, RNA Biochemistry & Manufacturing, BioNTech • Cristina Bruno, Program Manager – mRNA Technology Transfer, World Health Organization • Giovanna Lollo, Associate Professor, Universite Claude Bernard Lyon • Mostafa Nakach, Global Head of Process Engineering for Biologic Drug Product Development, Sanofi
Download the official brochure to discover why Sanofi, BioNTech, Pfizer, Gamida Cell, Moderna, the World Health Organisation, and others have already secured their places. Register now…
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Conference: 2nd Allogeneic Cell Therapies Summit Europe
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The Allogeneic Cell Therapies Summit Europe is returning (30th January - 1st February, 2023) to capture the clinical advances of European drug developers whilst addressing the specific challenges they face in development. Join European leaders from Gadeta, Antion Biosciences, TC BioPharm, and many more in London this January! Register now…
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Conference: 3rd TGF-β for Immuno-Oncology Drug Development Summit
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The 3rd TGF-β for Immuno-Oncology Drug Development Summit (January 30 - February 1, 2023) is your one-stop-shop dedicated to equipping you with the knowledge to unlock the potential of successfully targeting TGF-β. Access 3-days of unmissable content, join 80+ immuno-oncology stakeholders to exploit TGF-β’s blockbuster potential to increase viability for future clinical trials.
Register now…
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Upcoming conferences and meetings
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- 16 – 17 November 2022 - 3rd Gene and Cell Therapies: CMC, CGT & Vector Manuf. Summit - Vienna & Online
- 16 – 18 November 2022 - Joint meeting of the Australasian Gene and Cell Therapy Society - Melbourne, Australia
- 17 – 18 November 2022 - 6th Aseptic Processing Summit - Manufacturing ATMPs and vaccines - Vienna & Online
- 28 - 30 November 2022 - 2nd Rare CNS & Neurodevelopmental Drug Development Summit - Boston, MA
- 28 November - 1 December 2022 - 4th Annual Gene Therapy Analytical Development - Boston, MA
- 29 November - 1 December 2022 - 3rd CRISPR 2.0 Summit - Boston, MA
- 5 - 7 December 2022 - Cell Therapy Analytical Development Summit - Boston, MA
- 5 - 8 December 2022 - Cell & Gene Therapy Manufacturing & Commercialization Europe - Amsterdam & Online
- 5 - 8 December 2022 - 4th Annual Gene Therapy for Neurological Disorders - Boston, MA
- 6 - 7 December 2022 - 2nd iPSC-Derived Cell Therapies Summit - Boston, MA
- 6 - 8 December 2022 - 7th Oncolytic Virotherapy Summit - Boston, MA
- 13 - 15 December 2022 - Synthetic Biology-Based Therapies Summit - Boston, MA
- 10 - 12 January 2023 - Pre-Filled Syringes and Injectable Drug Devices Europe - London, UK
- 16 - 20 January 2023 - PepTalk 2023 - Cell & Gene Therapy tracks - San Diego, CA
- 23 - 24 January 2023 - Transdermal and Microneedle Drug Delivery - London, UK
- 24 - 26 January 2023 - Next Generation Ophthalmic Drug Delivery Summit - San Francisco, CA
- 24 - 26 January 2023 - 2nd Annual mRNA-Based Therapeutics Summit - Berlin, Germany
- 30 January - 1 February 2023 - 2nd Allogeneic Cell Therapies Summit Europe - London, UK
- 30 January - 1 February 2023 - 3rd TGF-β for Immuno-Oncology Drug Development Summit - San Francisco, CA
- 31 January - 2 February 2023 - Viral Vector Process Development Summit - Boston, MA
- 8 - 9 February 2023 - 14th Annual RNA Therapeutics - London, UK
- 15 - 16 February 2023 - 6th Annual Cell & Gene Therapy Innovation Summit - Berlin, Germany
- 21 - 23 February 2023 - Retinal Vascular Disease Drug Development Summit - Boston, MA
- 21 - 23 February 2023 - 6th CAR-TCR Summit Europe - London, UK
- 21 - 23 February 2023 - 11th Alzheimer’s & Parkinson’s Drug Development Summit - San Francisco, CA
- 23 - 24 February 2023 - GENAP Summit 2023 - Gene & Cell Therapy Aseptic Processing Technology - Milan, Italy
- 27 February - 1 March 2023 - 6th Antigen-Specific Immune Tolerance Summit - Boston, MA
- 7 - 9 March 2023 - 4th Supply Chain and Logistics for Cell Therapies Summit - Boston, MA
- 14 - 16 March 2023 - 6th Annual Bioprocessing Summit Europe - Barcelona, Spain
- 20 - 22 March 2023 - 12th Spring Meeting of the International Society for BioProcess Technology - Norfolk, VA
- 28 - 29 March 2023 - Reuters Pharma USA 2023 - Cell and Gene Therapies - Philadelphia, PA
- 28 - 30 March 2023 - 8th Innate Killer Summit - San Diego, CA
- 17 - 19 April 2023 - Advancing Gene Therapy 2023 - Boston, MA
- 26 - 27 April 2023 - World Oncology Cell Therapy Congress USA - Boston, MA
- 8 - 10 May 2023 - ISBioTech Nucleic Acids meeting - Production of DNA and RNA Biotherapeutics - Savannah, GA
- 10 - 12 May 2023 - Bioprocessing Events 2023 - Berlin, Germany
- 17 - 20 May 2023 - American Society of Gene and Cell Therapy (ASGCT) 26th Annual Meeting - Los Angeles, CA
- 24 – 27 October 2023 - Annual Congress of the European Society of Gene and Cell Therapy - Brussels, Belgium
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