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Newsletter November 2019

News: FDA Official Urges Wealthy Nations to Align Gene Therapy Rules
Patients from low- and middle-income countries will have better access to gene therapies if the U.S. and other high-income countries align their regulations for these potentially curative treatments, the FDA’s biologics chief said. “We really want to see the delivery of safe and effective gene therapies, not just in high income countries but across the globe,” Peter Marks, director of the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration, said Nov. 4 at the American Society for Gene and Cell Therapy’s policy summit.

News: Early Report: Baby Treated With Gene Therapy For Deadly Tay-Sachs Disease Appears To Stabilize
It's a very early report, from just two patients, only a few months after treatment. But UMass Medical School Dean Terence Flotte this week shared at a conference what could be landmark news about a terrible genetic disease: Two young patients with Tay-Sachs disease showed no ill effects from a new gene therapy that aims to correct the defect at the heart of the disease. One of them, treated at just 7 months, has appeared to stabilize instead of following the typical quick slide toward death by age 4. "It seems right now that she's not degenerating," Flotte said. "But I would say it's too early to say that definitively."

Conference: CAR-TCR: Cell Therapy Analytical Development
The explosion in cell therapy development companies has fueled a need to develop well-characterized clinical products which has resulted in the call for robust and validated analytical assays now being louder and more important than ever before.
The inaugural Cell Therapy Analytical Development Summit, 10-12 December 2019 in Boston, brings you the leaders in CMC, analytics and process development to create standardized and automated analytical techniques and technologies for improved therapeutic characterization at scale.
Join over 100 of the world’s experts as we discuss how to navigate a murky regulatory landscape, robustly validate assays and advance the characterization of CAR-T and TCR cell therapy analytics to ensure safe, consistent and quality cell therapy products.

Register here...

Conference: PepTalk event on Cell and Gene Therapies
The inaugural Cell & Gene Therapies pipeline, 20-24 January 2020 in San Diego, features three back-to-back conferences exploring the challenges, advances, and opportunities in gene and cell therapies. The conferences on Vector Design and Development for Gene and Cell Therapies, Gene Therapy Analytics and Manufacturing, and Cell Therapy Analytics and Manufacturing will discuss critical and hot topics like engineering and development of safer and more efficacious vectors, CMC and characterization, manufacturing, scale-up, next-generation production technologies, automation, supply chain, commercialization, and many more practical issues for the success of cell and gene therapies.
Register here...

Conference: Vein-to-Vein Congress EU
The Vein-to-Vein Congress, 28-30 January 2020 in London, will gather manufacturing, operations, site managers and logistical heads from both Biotechs and pharmaceutical companies to address these bottlenecks and facilitate the commercial manufacture of cell therapies.
As the cell therapy industry shifts from manual to automated manufacturing, the Vein-to-Vein Congress will discuss the measures that leading companies have put in place to streamline their manufacturing process, scale-up over time and ensure a water-tight supply chain with tracking and trackability from cell collection to patient.

Register here...

Conference: CAR-T Congress EU
The CAR-T Congress EU, 29-30 January 2020 in London, is bringing together leading biotechs, late-stage researchers and global pharmaceutical leaders to promote and share research that will break down barriers in R&D through novel data. In our fourth annual congress, we are introducing a new pre-day focused on NK Cell Therapy and the event will run alongside our Vein-to-Vein Congress, so you can tailor your agenda and learn more about cell therapies and their manufacturing. 
Having listened to the market demands, this year we will be bringing you even more industry-driven understanding of translational applications of the science that drives R&D in CAR-T. Tackle the next hurdles for allogeneic treatments by limiting graft vs host disease through the use of iPSC, and increase the efficacy of these treatments in solid tumours through combination therapies and solid tumour manipulation.
Talks run by biotechs, pharma and regulatory bodies, will put you in a position to make informed decisions when commercialising your CAR-T therapy.

Register here...

- 19 – 20 November 2019, 1st RNA Editing Summit, Boston, MA
- 19 – 20 November 2019, 3rd Annual Ophthalmic Drugs Conference - gene therapy for eye diseases, London, UK
- 2 – 4 December 2019, 2nd RNA-Targeted Drug Discovery Summit, Boston, MA
- 10 – 12 December 2019, Gene Therapy for Neurological Disorders, Boston, MA
- 10 – 12 December 2019, CAR-TCR: Cell Therapy Analytical Development, Boston, MA
- 20 - 24 January 2020, PepTalk event on Cell and Gene Therapies, San Diego, CA
- 29 - 30 January 2020, CAR-T Congress EU, London, UK
- 29 - 30 January 2020, Vein-to-Vein Congress EU - Manufacturing, scale-up, regulatory and logistical bottlenecks to commercialise cell therapies, London, UK
- 5 - 6 February 2020, Annual Cell and Gene Therapy Innovation Summit, Berlin, Germany
- 6 - 7 February 2020, 4th Edition MarketsandMarkets Genome Editing & Gene Therapy Conference, San Diego, CA
- 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
- 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
- 7 - 8 April 2020, 4th Annual Genome Editing USA Congress, 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
- 29 - 30 April 2020, CAR-T Congress USA, Boston, MA
- 12 - 15 May 2020, American Society of Gene and Cell Therapy (ASGCT) 23th Annual Meeting, Boston, MA
- 15 - 19 June 2020, 9th International Symposium on Monolith - DNA/RNA, vaccines, gene therapy vectors, Portoroz, Slovenia
- 24 - 28 August 2020, 12th annual Bioprocessing Summit, Boston, MA
- 14 - 17 September 2020, CAR-TCR Summit USA, Boston, MA
- 20 – 23 October 2020, XXVIII Congress of the European Society of Gene and Cell Therapy (ESGCT), Edinburgh UK


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