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News: One-time gene therapy injection could provide HIV treatment that may last a lifetime

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A new pre-clinical study in nonhuman primates will evaluate an experimental drug’s potential use as a gene therapy that could prevent people who have HIV from having to take daily antiviral drugs for the rest of their lives. The research will be led by Oregon Health & Science University researcher Jonah Sacha, Ph.D., who also serves as a scientific adviser to CytoDyn, the biotechnology company developing the drug, called leronlimab. The study is funded by a five-year grant of up to $5 million that was recently awarded to OHSU by the National Institute of Allergy and Infectious Disease, which is part of the National Institutes of Health. 

Read more…

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Conference: Bioprocessing Summit 

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Don’t miss keynote presenter Dr. Herbert Runnels (Pfizer) at CHI’s 7th Annual Gene Therapy CMC and Analytics conference (part of the Bioprocessing Summit), 15-16 August in Boston.  He will be discussing the characterization tools for empty vs. full capsid and highlighting how next-generation sequencing is enabling the elucidation of the nucleic acid payload.  

Register now…

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Conference: Vector Development for Cell and Gene Therapy Summit

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The massive success of cell and gene therapies in recent years has made the need for effective, large scale vector engineering greater than ever. Though R&D efforts focussed on reducing immunogenicity and toxicity whilst improving redosing ability and durability are showing promise, companies are still striving to optimise these technologies and develop next-generation targeted, persistent, and tolerable cell and gene therapies.

The Vector Development for Cell and Gene Therapy Summit (24-25 August, Boston) is North America’s only event focused exclusively on addressing challenges in vector improvement for both ex vivo and in vivo approaches. Bringing together key industry leaders and covering a range of topics including capsid optimisation using AAV vectors, process optimisation using lentiviral and adenoviral vectors, innovative non-viral delivery options and the importance of vector serotype for improved durability, it’s a key opportunity to gain the actionable insights you’ll need to optimise your manufacturing process and improve tissue-specific targeting and safety profiles for your pipeline.
Register now…

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Conference: Optimizing AAV Safety Summit

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Hundreds of clinical trials using AAV are underway, with several hundred more in preclinical development. Given the sheer volume of studies in the pipeline, the need to administer high doses, the clinical holds placed on gene therapy trials, and regulatory bodies being increasingly stringent on the safety standards they require; it has never been more important to create and implement an AAV safety strategy that’s fit for purpose!

In this setting, the inaugural Optimizing AAV Safety Summit (6-8 September in Boston) is bringing together key leaders focussed specifically on solving AAV safety challenges across toxicology, pharmacology, non-clinical study leads, clinical development safety specialists and bioanalysis innovators to gain insights on optimizing AAV safety processes and benefit-risk analysis to shorten timelines and prevent potential delays.

Join us in Boston alongside key biotech and pharma leaders from the likes of Spark Therapeutics, Ask Bio, Eli Lilly, Takeda, and more in the AAV space who are prioritizing the development of safe and effective genetic therapies, learn how clinical safety signals have changed how companies are approaching their pipeline progression, and gain immediately implementable insights to sharpen your programs currently in preclinical and clinical development.
Register now…

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Conference: 7th Annual CAR-TCR Summit 

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Back to Boston with a bang! With 1,500 CAR and TCR developers, 200 speakers, 150 live presentations, 20 hours of networking and more surprises in store, the 7th CAR-TCR Summit will be the BIGGEST ever (19-23 September in Boston).

Gain end-to-end insights from industry giants and the innovators bringing disruptive technologies from bench to bedside and from vein to vein.

Discuss everything from novel allogeneic approaches with enhanced safety considerations, the latest in vivo gene engineering techniques, and advances in CMC and analytics to ensure the development of high-quality cell products.

With your industry reuniting in-person for the first time since 2019 to discuss leveraging the powerful potential of iPSC platforms, learnings from our successes and pitfalls, and manufacturing automation innovations for large scale consistent production, you can’t afford to miss the 7th Annual CAR-TCR Summit as we bring you more speakers, more content and more exclusive insights than ever before!
 Register now…

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Conference: Cell & Gene Therapy USA 2022

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With over 20 CGTs projected to be approved by 2025, it’s clear that there are huge commercial and medical opportunities for precision medicine. But despite this unprecedented growth, unstable infrastructure, lack of standardization and novel scientific nuance means that there is still no industry blueprint for successful commercialization.

To realize this potential, precision medicine trailblazers must share lessons of launch success and overcome pain points to allow pharma to reinforce frameworks across manufacturing, market access and reimbursement to build infallible launch strategies across the board. Commercialization networks must go even further, transforming our healthcare system to guarantee scalable and sustainable growth. Don’t get left behind.

Join us at Reuters Events: Cell and Gene Therapy USA (20-21 September, Virtual) where we have leaders from industry front runners to share their successes and pitfalls. With 30+ speakers, 5 case-studies and over 1500+ fellow CGT attendees - we will pioneer a new gold standard for commercialization, readying the world for CGT as a frontline treatment. 
Register now…

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Conference: mRNA Process Development & Manufacturing Summit

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Since the start of the COVID-19 pandemic, mRNA-based vaccines and therapeutics have catapulted into the spotlight as a disruptive technology that could change the future of medicine for decades to come. However, for this growing market to realise its full potential, key process development and manufacturing bottlenecks need to be addressed as they currently remain elusive.

The inaugural mRNA Process Development & Manufacturing Summit (20-22 September in Boston) is the first and only industry dedicated forum solely focused on vital optimizations and standards required for successfully scaling up mRNA process development and drug substance manufacturing from lab to industrial scale.

Whether you are looking to improve your IVT reactions, purification strategies and analytical validation methods, join fellow Heads, VPs and Directors of mRNA Process development, Drug Substance, CMC and Manufacturing from Moderna, BioNTech SE, Sanofi, Genentech and others as they delve deep into pressing topics including but not limited to improving mRNA quality, yield and cost effectiveness for large scale process andnewsletter2go.com manufacturing strategies that are in harmony with up-and-coming regulatory expectations.
Register now…

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Conference: Oligonucleotide Therapeutics and Delivery 2022

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SAE Media Group is delighted to announce the 2nd Annual Conference Oligonucleotide Therapeutics & Delivery, taking place on the 21st and 22nd September 2022 in London, UK. The 2022 Conference theme is on the latest advances in extra-hepatic delivery of oligonucleotides.
Chairs for the conference are Ekkehard Leberer, Senior Consultant, ELBIOCON, and Jim Weterings, Principal Scientist, AstraZeneca. 
New to 2022, are the Oligonucleotide Therapeutics & Delivery Workshops on: ‘‘Oligonucleotide Therapies - Overcoming the Challenges of Delivery’’ and ‘‘Managing CMC Activities for the Development of Oligonucleotide Therapeutics’’ taking place on 20th September 2022. These will explore the latest advances and challenges in the development of Oligonucleotide Therapeutics. 
By attending the conference attendees will have the opportunity to

  • Listen to case studies presenting on the latest candidates undergoing pre-clinical and clinical research and what can be learned for future clinical trials 
  • Deepen your understanding of oligonucleotide therapeutic delivery and explore the latest innovations in extrahepatic oligonucleotide delivery and target specificity 
  • Understand the regulatory and CMC environment surrounding oligonucleotide therapeutic development 
  • Explore developments in oligonucleotide chemistries and examine developments in novel applications of antisense oligonucleotides and siRNA

Building on the success of previous years, the 2nd Annual Oligonucleotide Therapeutics & Delivery Conference will bring together expertise from individuals within the Oligonucleotide field to gain an expert and holistic view on the latest developments of the industry.
Register now…

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Upcoming conferences and meetings

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  • 18 - 20 July 2022 - 2nd Annual Next Generation Gene Therapy Vectors Summit - Boston, MA
  • 26 - 28 July 2022 - 3rd Gamma Delta T Therapies Summit - Boston, MA
  • 26 - 28 July 2022 - 2nd Annual mRNA-Based Therapeutics Summit - Boston, MA
  • 26 - 28 July 2022 - iPSC Manufacturing Summit - Gene and Cell therapies - Boston, MA
  • 15 - 18 August 2022 - Bioprocessing Summit - Gene and Cell therapies - Boston, MA
  • 22 - 23 August 2022 - The Cell Therapy Durability Response Summit - Boston, MA
  • 24 - 25 August 2022 - Vector Development for Cell and Gene Therapy Summit - Boston, MA
  • 6 - 8 September 2022 - Optimizing AAV Safety Summit - Boston, MA
  • 13 - 16 September 2022 - 3rd Annual Gene Therapy for Ophthalmic Disorders - Boston, MA
  • 19 - 23 September 2022 - 7th Annual CAR-TCR Summit - Boston, MA
  • 20 - 21 September 2022 - Cell & Gene Therapy USA 2022 - Online event
  • 20 - 22 September 2022 - mRNA Process Development & Manufacturing Summit - Boston, MA
  • 21 - 22 September 2022 - Oligonucleotide Therapeutics and Delivery 2022 - London, UK
  • 26 - 28 September 2022 - International Human Gene Therapy Conference - Melbourne, Australia
  • 27 - 30 September 2022 - Cell & Gene Therapy Manufacturing & Commercialization US - Boston, MA & Online
  • 11 – 14 October 2022 - XXIX Congress of the European Society of Gene and Cell Therapy (ESGCT) - Edinburgh, UK
  • 13 - 14 October 2022 - Global Bioprocessing Summit and Expo - ATMP Development - Berlin, Germany
  • 18 - 20 October 2022 - 3rd Annual Gene Therapy Immunogenicity Summit - Boston, MA
  • 18 - 20 October 2022 - Innate Killer Summit Europe - London, UK
  • 20 - 21 October 2022 - Reuters Events: Oncology at Total Health 2022 - T-cell therapies - Chicago, USA
  • 24 - 26 October 2022 - 4th TIL Therapies Summit - Boston, MA
  • 25 - 27 October 2022 - 6th Annual Gene Therapy for Rare Disorders Europe Summit 2022 - London, UK
  • 7 – 8 November 2022 - 8th Annual Cell & Gene Therapy Manufacturing Congress - London, UK
  • 16 – 18 November 2022 - Joint meeting of the Australasian Gene and Cell Therapy Society - Melbourne, Australia
  • 5 - 8 December 2022 - Cell & Gene Therapy Manufacturing & Commercialization Europe - Amsterdam & Online

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