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...
Aisha Khan, PhD, MBA University of Miami Miller School of Medicine USA FDA’s Approval of Ryoncil: A Milestone for MSC Therapy or Just the Beginning? The U.S. Food and Drug Administration (FDA) has approved Ryoncil (remestemcel-L-rknd) as the first-ever mesenchymal stromal...
Contributor(s): Fajar Dumadi, BSc International Society for Cell & Gene Therapy (ISCT) Canada Alejandro Barquero, MPharm, MSc Almirall Spain Committee of Advance Therapy (CAT) Agendas for recent meetings Agenda for the meeting on...
Author: Lilia Carolina Leon-Moreno, PhD Centro de Investigación y Asistencia en Tecnología y Diseño del Estado de Jalisco (CIATEJ) México Editor: Fernando E. Figueroa, MD, FACP Universidad de los Andes School of Medicine Chile The field of Advanced Therapy...
by Gerry McKiernan Increment4 Australia Gabrielle O'Sullivan PhD MPH (Hons) Royal Prince Alfred Hospital Institutional Biosafety Committee (RPAH IBC) Australia AUSTRALIAN AND NEW ZEALAND REGULATORY UPDATES AOTEAROA – NEW ZEALAND Medsafe Clinical Trials On 23 Aug 2024...
by Aisha Khan, PhD, MBA Clinical Research Cellular Manufacturing Program Interdisciplinary Stem Cell, University of Miami Miller School of Medicine The FDA has issued a draft guidance aimed at addressing the complex considerations involved in the use of human- and animal-derived...
Laura Mendieta, PhD Asphalion Spain Committee of Advance Therapy (CAT) Minutes of the meetings Minutes for the meeting on 17-19 April 2024 https://www.ema.europa.eu/en/documents/minutes/minutes-cat-meeting-17-19-april-2024 en.pdf Minutes for the meeting...
IMPACT-CGT- ISCT Joint Session: A Roadmap for Accelerating Access to Life-Saving Therapies in South and Central America Author: Maroun Khoury, PhD IMPACT, Center for Interventional Medicine for Precision and Advanced Cellular Therapy Chile Editor(s): Fernando E. Figueroa, MD,...
Author: Alejandro Barquero, MPharm, MSc DanausGT Biotechnology Ltd. Madrid, Spain Committee of Advance Therapy (CAT) Minutes of the meetings Minutes for the meeting on 14-16 February 2024 https://www.ema.europa.eu/en/documents/agenda/agenda-cat-meeting-14-16-february-2024 en...