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Newsletter February 2023

News: FDA officials offer advice on gene therapy trials

Officials from the US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) Office of Tissues and Advanced Therapies (OTAT) asserted that the duration of clinical trials for gene therapies depends on the nature of the disease being treated, and that diseases that are more progressive and have a rapid onset may involve shorter trials. This was one of the learnings imparted by officials during a 7 February virtual town hall meeting to answer stakeholder questions on the clinical development of gene therapies for rare diseases outside the hematology and oncology space. The town hall is part of a series to address questions from stakeholders on topics under OTAT’s remit.

News: New gene therapy delivers treatment directly to brain

When Rylae-Ann Poulin was a year old, she didn’t crawl or babble like other kids her age. A rare genetic disorder kept her from even lifting her head. Her parents took turns holding her upright at night just so she could breathe comfortably and sleep. Then, months later. doctors delivered gene therapy directly to her brain. Now the 4-year-old is walking, running, swimming, reading and riding horses — “just doing so many amazing things that doctors once said were impossible,” said her mother, Judy Wei.

Conference: Advanced Therapies 2023

The Advanced Therapies Congress (March 14-15) is Europe’s largest cell and gene therapy conference and exhibition. The event is for the leaders of the world’s ATMP developers and their most senior executives in charge of the latest tech and strategies that are driving the industry forward. Join us in London for 2023!

Conference: 8th Innate Killer Summit

Returning to San Diego at the end of next month with a brand-new look, the 8th Innate Killer Summit (March 28-30), is your industry-led forum, with 4 tracks covering preclinical development through to commercial scale manufacturing of innate immune cell therapies. This meeting is your opportunity to spearhead safe, potent and scalable therapies spanning NK, iNKT, gamma delta, iPSCs and macrophages.

Conference: 3rd Gene Therapy Comparability Summit

In the context of ever-important gene therapy scale-up to achieve commercial goals and mounting regulatory scrutiny, the 3rd Annual Gene Therapy Comparability Summit (March 28-30) is the only event focused on comparability of gene therapy. Join 150+ Quality Assurance, CMC, Regulatory, Analytical and Process Development experts from pharma and biotechs to provide you with hands-on, practical insights into exactly what it takes to ensure you can maintain safety, quality, consistency, and efficacy while adapting manufacturing processes, methods and platforms, to adhere to regulatory demands and avoid costly delays to clinical programs.

Conference: International Bioprocessing and Biologics 2023

The International Bioprocessing and Biologics Forum (March 28-29) will bring together more than 150+ industry experts from Large Pharma with interest in biotech, biotech, biopharmaceutical companies, contract manufacturing organisations, academic & research institutes, regulatory authorities, and solution providers, to discuss the latest developments, cutting-edge technologies, new challenges and opportunities in bioprocessing and best manufacturing practices to make better biologic drugs cheaper and faster.

Conference: 2nd LNP Formulation & Process Development Summit 2023

Every week we hear exciting news about the development of LNPs, from Vertex-Moderna CF pipeline, to Oncorus research collaboration with Daweoong Pharmaceuticals - now is your time to get ahead of the curve. The 2nd LNP Formulation & Process Development Summit (April 17-19, Boston) is your only dedicated end-to-end, industry-led summit focusing on LNP development for different payloads and therapeutic applications, from screening to formulation to process development to manufacturing.
Gain access to exclusive case studies from the likes of ReCode Therapeutics, Lupagen, AstraZeneca, Pfizer and many more to stay at the forefront of science, network with 350+ LNP experts, and to gain a competitive advantage to exploit LNP potential.

Conference: mRNA Process Development & Manufacturing Summit Europe

mRNA therapeutics have catapulted into the limelight amidst the COVID-19 pandemic with multiple EMA approvals to help combat the virus. Hence the community is excited for the newly released inaugural mRNA Process Development & Manufacturing Summit Europe which is coming to Frankfurt, Germany this 18th-20th April.
Join 80+ mRNA enthusiasts from mRNA manufacturing, analytics, process development, CMC, quality control, and drug substance to get key insights on scaling up mRNA drug substances in Europe whilst navigating mRNA process development and manufacturing regulatory guidelines to create commercially successful mRNA vaccines and therapeutics. Be the first to download the event guide here to see the full 3-day agenda & speaker faculty.

Conference: The Economist's Cell & Gene Therapy summit

Join us for the inaugural Cell and Gene Therapy Summit on 24-25th April in Brussels. Industry stakeholders will advance the discussion on accelerating access to transformative products. Cell and gene therapies are redefining the treatment of a host of diseases, giving hope to patients who previously had no therapeutic options. These treatments can be instrumental in the battle against cancer, genetic disorders and rare diseases. Discover how healthcare systems and policies need to evolve before cell and gene therapies can become mainstream.

Conference: Gene Therapy Durability Summit

The Inaugural Gene Therapy Durability Summit (April 25-27 | Boston MA), will cover all challenges associated with durability, from addressing short- and long-term durability, leveraging learnings from existing clinical data, and exploring ways to improve efficacy and resulting durability of current gene therapy approaches.

Uniting the leading minds in gene therapy this April in Boston, join us to:
- Leverage knowledge from current clinical trials with relevant durability data across a range of indication types using AAV

- Better understand what can be extrapolated and how to gain confidence in the data collected

- Build study designs with durability in mind and explore how well preclinical models have predicted clinical durability to date

Conference: World Oncology Cell Therapy Congress USA

The World Oncology Cell Therapy Congress (April 26-27, Boston) is the only annual meeting bringing together drug developers, investors, solution providers and clinicians whose purpose is to deliver safe and effective adoptive cell therapy products to clinical implementation.
Demonstrating the value of innovative cell therapy products and securing access for patients is a key priority for all developers. In 2023, the congress will become the only industry forum to add an exclusive pre-event evening networking session for clinicians looking to overcome barriers to patient access and facilitate clinical distribution of transformative cell therapy products.
The congress will redefine industry networking, with every attendee incentivised to complete a profile, enabling everyone to find and touch base with the pioneers and companies they would like to meet.

Upcoming conferences and meetings

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
21 - 23 February 2023 - 3rd Annual Gene Therapy for Muscular Disorders Summit - Boston MA
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
27 February - 2 March 2023 - Next Generation CAR & T Cell Therapies - San Diego, CA
7 - 8 March 2023 - Cell & Gene Therapy Research & Development Congress Asia - Taipei, Taiwan
7 - 9 March 2023 - 4th Supply Chain and Logistics for Cell Therapies Summit - Boston, MA
8 - 9 March 2023 - Targeted Intracellular Delivery Summit - Boston, MA
14 - 15 March 2023 - Gene Therapy Net & Advanced Therapies 2023 - London, UK
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
20 - 23 March 2023 - 6th Annual Gene Therapy for Rare Disorders 2023 Summit - Boston, MA
28 - 29 March 2023 - Reuters Pharma USA 2023 - Cell and Gene Therapies - Philadelphia, PA
28 - 29 March 2023 - International Bioprocessing and Biologics 2023 - Cell and Gene Therapies - Berlin, Germany
28 - 30 March 2023 - 8th Innate Killer Summit - San Diego, CA
28 - 30 March 2023 - 3rd Gene Therapy Comparability Summit - Boston, MA
17 - 19 April 2023 - 2nd LNP Formulation & Process Development Summit 2023 - Gene Therapy delivery - Boston
18 - 20 April 2023 - mRNA Process Development & Manufacturing Summit Europe - Frankfurt, Germany
24 - 25 April 2023 - The Economist's Cell & Gene Therapy summit - Brussels, Belgium
25 - 27 April 2023 - Gene Therapy Durability Summit - Boston, MA
26 - 27 April 2023 - World Oncology Cell Therapy Congress USA - Boston, MA
26 - 27 April 2023 - 6th Annual Pharmaceutical Microbiology USA Conference - Cell therapies - Boston, MA
27 April 2023 - Influenza mRNA Vaccines - lipid nanoparticle delivery - Online event
2 - 4 May 2023 - 4th Gene Therapy Analytical Development Europe Summit - London, UK
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
16 - 18 May 2023 - 2nd Next Generation RNA Therapeutics Summit - Boston, MA
17 - 20 May 2023 - American Society of Gene and Cell Therapy (ASGCT) 26th Annual Meeting - Los Angeles, CA
23 - 24 May 2023 - Global Biologics Cell and Gene Legal Summit - Brussels, Belgium
23 - 25 May 2023 - World Orphan Drug Congress USA 2023 - Washington, D.C.
6 - 8 June 2023 - Gene Therapy for Neurological Disorders Summit Europe - Amsterdam, The Netherlands
12 - 13 June 2023 - Annual meeting of the Netherlands Society of Gene & Cell Therapy - Lunteren, The Netherlands
13 - 15 June 2023 - 3rd Gene Therapy Patient Engagement Summit - Boston, MA
26 - 29 June 2023 - Gene Therapy & Rare Diseases conference - Boston, MA
27 - 29 June 2023 - Next Generation Gene Therapy Vectors Summit - Boston, MA
9 August 2023 - Drug Discovery and Development - Cell & Gene Therapies - London, UK
24 – 27 October 2023 - Annual Congress of the European Society of Gene and Cell Therapy - Brussels, Belgium

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