With great excitement, the International Society for Cell & Therapy (ISCT) publishes its fourth bi-annual Global Regulatory Report in collaboration with Citeline. Similar to the previous editions, this report offers a comprehensive global overview of the cell and gene therapy regulatory...
ISCT hosted the 21st FDA Cell Therapy Liaison Meeting (CTLM) on November 19, 2024 - a closed forum dedicated to fostering knowledge exchange and dialogue between the cell and gene therapy (CGT) community and the FDA to address concerns, challenges, and recent advancements to drive progress in...
The International Society for Cell & Gene Therapy , ISCT, hosted the 21 st FDA Cell Therapy Liaison Meeting (CTLM) on November 19, 2024. Led by Olive Sturtevant, MHP, MT(ASCP)SBB, SLS, CQA(ASQ) from the ISCT North America Legal and Regulatory Affairs (NA LRA Committee), this meeting...
By Lilia Carolina Leon-Moreno, PhD Postdoctoral Researcher Centro de Investigación y Asistencia en Tecnología y Diseño del Estado de Jalisco (CIATEJ) México On November 5th, 2024, the ISCT South & Central America (SCA) Regional Executive Committee and the SCA Regional ESP Subcommittee...
Co-Author(s): J. Kaitlin Morrison, PhD Executive Director Clinical Research, UNC Lineberger Comprehensive Cancer Center Assistant Professor of Medicine- Hematology, University of North Carolina- Chapel Hill Aisha Khan, PhD, MBA Executive Director, Clinical Research Cellular...
Author: Fajar Dumadi, BSc International Society for Cell & Gene Therapy (ISCT) Canada Committee of Advance Therapy (CAT) Agendas for recent meetings Agenda for the meeting on 9-11 October 2024: https://www.ema.europa.eu/en/documents/agenda/agenda-cat-meeting...
Kasey Kime Director, Regulatory Affairs, Thermo Fisher Scientific Jessica Sue Quality Manager, Sydney Cord Blood Bank, Sydney Children’s Hospitals Network AUSTRALIAN AND NEW ZEALAND REGULATORY UPDATES AOTEAROA – NEW ZEALAND Medsafe Regulatory collaboration and reliance...
Author: Danielle DiTirro, PhD Milipore Sigma USA The roundtable session on "Demonstrating Comparability: Are Potency Assays Necessary?" was moderated by Scott R. Burger, MD and the panelists included: Lee Lee Ong , PhD, Regulatory Consultant, Health Sciences Authority (HSA) –...
Ashley Krull, Ph.D. Associate Director, Cell Therapy Manufacturing and Engineering James Cancer Hospital Cellular Therapy Laboratory Assistant Professor, Hematology The Ohio State University Columbus, Ohio, United States Disclaimer: This article reflects the author's notes from attending...
With great excitement, the International Society for Cell & Therapy (ISCT) publishes its third bi-annual Global Regulatory Report in collaboration with Citeline. Similar to the previous editions, this report offers a comprehensive global overview of the cell and gene therapy regulatory...