From the Editors:
Exclusive Training and Educational Opportunities for ISCT Members
Wouter Van’t Hof, PhD
Cleveland Cord Blood Center, USA
One of the unique benefits of ISCT membership is access to a variety of specialized training and educational opportunities organized by ISCT. With relevance for all readership of the Telegraft, below are several upcoming ISCT lectures/webinars and training initiatives through 2022, with relevant dates and registration deadlines. These benefits of your ISCT membership continue through to the end of the year. Another event of great interest to the cell and gene therapy field in the US is a first of its kind Town Hall style meeting organized by FDA/CBER/OTAT, engaging questions from stakeholders around CMC requirements for biologics.
Sep 13, 2022 (14:00 - 15:00 AEST). Improving CAR-T Products through Modified Manufacturing Methods. This is Lecture 4 of the ISCT ANZ Cell & Gene Therapy Translation Lecture Series.
Sept 15, 2022 (08:00 – 09:00 PT). Implementing a new clinical CAR T program: Manufacturing your own! This is the first webinar of the ISCT Americas Webinar Series.
ISCT will be releasing the updated Fall/Winter 2022 calendar of webinars. Access to ISCT webinars is FREE for all members. Background information and links for webinar registration can be found under the Featured Events tab on the ISCT homepage.
ISCT EU Scholarships for Master’s Program in Manufacturing of ATMPs
ISCT offers a second round of opportunity for access to this scholarship program for 3 EU ISCT Members to complete a Master’s or Specialization Degree in the Manufacturing of ATMPs. This is a joint initiative by ISCT, the Andalusian network for the design and translation of Advanced Therapies (And&tAT), and the University of Granada.
The Application Deadline for this exciting and unique opportunity is October 31, 2022. Information can be found at: https://www.isctglobal.org/resources/training-programs/eu-scholarship-program
ISCT-CMaT Workforce Development in Biomanufacturing
Following the inaugural course completed in June 2022, the ISCT has announced future course dates for 2022 and 2023. The registration deadline is Oct 17, 2022 for the Fall 2022 course taking place from Oct 10 through Dec 9. More information is available at: https://www.isctglobal.org/resources/training-programs/workforce-development-in-biomanufacturing (this page will be updated by the time Telegraft launches on August 31)
FDA Town Hall – Sep 29, 2022
The FDA’s Center for Biologics Evaluation and Research (CBER) Office of Tissues and Advanced Therapies (OTAT) will host a virtual town hall to answer stakeholder questions related to gene therapy chemistry, manufacturing, and controls (CMC). The FDA will answer questions from stakeholders about a variety of topics on which OTAT has regulatory oversight. This promises to be a great opportunity to learn about FDA’s current thinking on aligning the rapidly evolving knowledge and technologies that enable novel cellular therapeutics with functional, non-prohibitive regulation. More information can be found at: https://www.fda.gov/news-events/otat-town-hall-gene-therapy-chemistry-manufacturing-and-controls-09292022
The relevance of this direct discourse between regulators and cell/gene therapy developers is underscored by bluebird’s FDA approval of ZYNTEGLO®, a gene therapy approach for transfusion-dependent beta-thalassemia. As commented on in the Telegraft Hub, this is broadly seen as an important trigger for access of patients in need to novel safe and effective cell and gene therapies. https://www.isctglobal.org/telegrafthub/blogs/audrey-le/2022/08/22/isct-marks-bluebird-bios-landmark-fda-approval-a-c
We invite you to follow our updates on new advances in cell and gene therapy. Check us out at https://www.isctglobal.org/telegrafthub, or follow us on Twitter (@telegraft) or on LinkedIn https://www.linkedin.com/company/isctglobal/.