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Newsletter November 2021

News: NIH and FDA Lead Coalition to Accelerate Gene Therapy Development for Rare Diseases

The National Institutes of Health (NIH) announced the formation of the Bespoke Gene Therapy Consortium (BGTC) on Oct. 27th, 2021. In partnership with FDA, ten pharmaceutical companies, and five non-profits, this coalition is aimed at accelerating development of gene therapies for rare diseases.

Conference: Pharma Manufacturing Online

Join Pharma Manufacturing Online, 1-2 December 2021, an innovative congress which will explore the latest advancements in drug product manufacturing through emerging technologies and digital transformation efforts across two days of cutting-edge presentations.

Join over 300 senior representatives in CMC, operations, and engineering to discuss process development, continuous manufacturing, and automation, as well as facility development, working towards industry 4.0 and operational excellence through advanced data use.

Key Speakers Include:

Cenk Ündey, Executive Director of Data Science, Amgen
Eda Ross Montgomery, Senior Director/Technical Steward, Takeda
Fei Hong, Vice President, Head of CMC, Cellics Therapeutics
Daniel DeOliveira, Senior Director, Genocea Biosciences
Jun Luo, Director of Process Engineering, Upstream, Genentech
Francisca Gouveia, Senior Process Expert, Novartis

Three Comprehensive Streams:

Stream 1: Biomanufacturing: Cell & Gene Therapy, Biologics & Vaccines
Stream 2: Automation and AI in Manufacturing
Stream 3: Achieving Digitalisation Through Advanced Data Use

Conference: Neurodevelopmental Drug Development Summit

Neurodevelopmental Drug Development Summit (December 14-15, 2021 | Online) is the definitive industry-dedicated forum for large pharma, biotech, academia, and patient advocacy groups paving the way towards symptomatic and successful disease modifying treatments. If you are working towards treatments for rare neurodevelopmental disorders, including (but not limited to) Angelman Syndrome, Rett syndrome, Fragile X, Dravet Syndrome, or discovering new frontiers in anti-epileptic therapeutics, this is the platform you need.

Conference: Cell Therapy Analytical Development Summit

Returning for the 3rd year, the Cell Therapy Analytical Development Summit, 14 - 16 December, 2021, Boston, MA, is the leading industry-defining forum made exclusively for analytical, CMC, QC, and process development experts.

New for 2021, take advantage of two tracks of content showcasing:

Automated analytical processes to reduce turnaround time
Strategies to validate novel assays for next generation therapies
New genomic testing technology to gain a deeper understanding of the cell product
Experience in navigating regulatory guidelines to reduce delays

… To equip your team with the lessons learned to achieve success in analytical submission from IND through to commercialization. Learn from analytical trailblazers at bluebird bio, BMS, Kite, Novartis and more to support your efforts in developing safe and effective cell therapies.

Conference: Pre-filled Syringes and Injectable Drug Devices

SMi’s 14th annual conference will bring you the key insights you need to grow and enhance your pre-filled syringes portfolio and discover what the future holds for the PFS and combination products industry. Topics of discussion will include the latest updates on the EU MDR, Article 117 and UK regulatory guidance, insights into the evolving digital health landscape for connected delivery devices, containment considerations for novel delivery, patient centric approaches to device design and much more including Cell and Gene therapy and the potential benefits and challenges of a parenteral approach to delivery using pre-filled syringes.

As Europe’s first Pre-Filled Syringes Conference of 2022, this event is not to be missed. We look forward to welcoming you to the conference taking place 12-13 January 2022.

Conference: Allogeneic Cell Therapies Summit Europe

Allogeneic therapies are fast becoming the holy grail for cell therapy as they boast the potential to reduce the cost of goods, improve accessibility, reduce turnaround times and have the ability to treat masses of patients. However, in Europe there are critical challenges limiting clinical advancement, with increased complexities with disharmonized European regulations where guidance varies across countries, and challenges in cross-country logistics when running multicentric trials.

The Allogeneic Cell Therapies Summit Europe, 18-20 January, 2022, London, UK, is the only industry-focused forum dedicated to address the specific challenges facing European drug developers in order to advance your pipeline to clinical and commercial success.

Conference: 2nd TGF-β for Immuno-Oncology Drug Development Summit

TGF-β has shown a vast amount of promise in the field of immuno-oncology, but with the complexity of this target, there are still many hurdles to overcome. From limitations of current models to provide insights into the mechanisms of TGF-β inhibitors to high toxicity profiles in clinical trials, the 2nd TGF-β for Immuno-Oncology Drug Development Summit, January 25-27, 2022, will unite world-class speakers from leading big pharma, pioneering biotechs, and key academics

What’s New?

31+ world-class speakers from Scholar Rock, Novartis, Pfizer, Mestag Therapeutics, Takeda, Cue Bio, Genentech, and more
2 Dedicated Tracks of exclusive preclinical and clinical case studies and data for your invaluable lessons learned
A TGF-β Boot Camp Day to provide a comprehensive guide on harnessing the potential of this complex target

This meeting will provide you with the must-know takeaways from biology to translational modeling, from biomarkers to clinical trial design across 3 days.

Upcoming conferences and meetings

16 November 2021 - From Gene To Patient - Online event
16 - 17 November 2021 - Onco Cell Therapy Summit (OCTS) USA 2021 - Boston, MA
16 - 18 November 2021 - CRISPR 2.0 Summit - Gene editing - Online event
18 - 19 November 2021 - Gene and Cell Therapies: CMC, CGT & Vector Manufacturing Summit - Munich, Germany
22 - 23 November 2021 - Ophthalmic Drugs Conference - Gene Therapies - London, UK
22 - 24 November 2021 - Accelerating of Gene & Cell Therapy online training - Online event
29 November - 2 December 2021 - 3rd Annual Gene Therapy Analytical Development - Online event
6 - 9 December 2021 - 3rd Gene Therapy for Neurological Disorders - Boston, MA
7 - 9 December 2021 - Synthetic Biology-Based Therapeutics Summit - Online event
14 - 15 December 2021 - Neurodevelopmental Drug Development Summit - Online event
14 - 16 December 2021 - Cell Therapy Analytical Development Summit - Boston, MA
12 - 13 January 2022 - Pre-filled Syringes and Injectable Drug Devices, Cell & gene therapy - London, UK
18 - 20 January 2022 - Allogeneic Cell Therapies Summit Europe - London, UK
25 - 27 January 2022 - 2nd Multi-Functional Cell Therapies Summit - Online event
25 - 27 January 2022 - 2nd TGF-β for Immuno-Oncology Drug Development Summit - Online event
26 - 27 January 2022 - 5th Antigen-Specific Immune Tolerance Summit - Cell therapy approaches - Online event
1 - 2 February 2022 - Formulation & Delivery US: Gene and Cell Therapies - San Diego, CA
9 - 10 February 2022 - RNA Therapeutics event - London, UK
14 - 16 February 2022 - 4th Bacteriophage Therapy Summit - Online event
15 - 17 February 2022 - Genetic Vaccine Analytical Development Summit - Online event
22 - 24 February 2022 - Next Generation CAR-TCR Summit - London, UK
7 - 10 March 2022 - 5th Annual Gene Therapy for Rare Disorders - Boston, MA
22 - 24 March 2022 - Bioprocessing Summit Europe - Barcelona, Spain
28 - 30 March 2022 - Advancing Gene Therapy 2022 - Boston, MA
29 - 31 March 2022 - 3rd Gene Therapy for Blood Disorders Summit - Boston, MA
4 – 7 April 2022 - 2nd Gene Therapy for Muscular Disorders Summit - Boston, MA
13 – 15 April 2022 - European Society of Gene and Cell Therapy (ESGCT) Spring School - Athens, Greece
21 - 22 April 2022 - Global Bioprocessing Summit - ATMP Development - Berlin, Germany
16 - 19 May 2022 - American Society of Gene and Cell Therapy (ASGCT) 25th Annual Meeting - Washington, D.C.
13 - 17 June 2022 - 9th Monolith Summer Symposium, mRNA, Vaccines, Gene Therapy Vectors - Portoroz, Slovenia
11 – 14 October 2022 - XXIX 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, Zika Virus Net and Corona Virus Net.

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