Fajar Dumadi, BSc ISCT Canada Committee for Advanced Therapies (CAT) Agendas for recent meetings Agenda for the meeting on 16-18 July 2025 https://www.ema.europa.eu/en/documents/agenda/agenda-cat-meeting-16-18-july-2025_en.pdf ...
Kasey Kime, MBA BioOra New Zealand Giulia Giunti, PhD BioOra New Zealand AOTEAROA – NEW ZEALAND Medsafe Medsafe published their performance statistics for the evaluation of new and changed ...
Dr. Vorapin Chinchalongporn, PhD SC21 Bio-Pharma Laboratories Thailand Dr. Tongted Das, PhD Monash Health Australia Adam Lee, MS Thermo Fisher Scientific United States The 2025 Global Regulatory ...
Mikey Creane, BSc, MSc, PhD. Ethics of Cell and Gene Therapy Committee, ISCT Ireland An ISCT Ethics of Cell & Gene Therapy Committee Write-Up on Roundtable Session: "Is Germline Editing Feasible ...
Adam Lee Thermo Fisher Scientific United States A High-Level Overview of Drug Policies in the House Appropriations Bill The New House appropriations report was released, which provides important ...
Lilia Carolina Leon-Moreno, PhD Postdoctoral Researcher Centro de Investigación y Asistencia en Tecnología y Diseño del Estado de Jalisco (CIATEJ) México María de Jesús Medina Arellano, PhD ...
Contributor(s): Fajar Dumadi, BSc International Society for Cell & Gene Therapy (ISCT) Canada Committee for Advanced Therapies (CAT) Agendas for recent meetings Agenda for the meeting ...
A summary of the guest presentation at the ISCT 3rd Annual Global Regulators Summit (6th May 2025, Ernest N. Morial Convention Center, New Orleans, USA) by Professor Henry (Hank) Greely, Director, Center ...
Contributor: Fajar Dumadi, BSc ISCT Canada The Human Medicines Regulations 2012 (“HMR 2012”) have been amended to take account of the manufacture of a point of care (POC) medicinal product (this includes ...
Fajar Dumadi, BSc International Society for Cell & Gene Therapy (ISCT) Canada This report provides links to the latest updates from European-based regulatory agencies, including CAT quarterly ...
Aisha Khan, PhD, MBA Executive Director, Clinical Research Cellular Manufacturing Program Interdisciplinary Stem Cell, University of Miami Miller School of Medicine ...
Paula Stoddart Clinical Manager, Miltenyi Biotec Australia Jessica Sue Quality Manager, Sydney Cord Blood Bank, Sydney Children’s Hospitals Network AUSTRALIAN AND NEW ZEALAND REGULATORY ...
Author: María de Jesús Medina Arellano, PhD Institute of Legal Research, UNAM México Editor: Lilia Carolina Leon-Moreno, PhD Centro de Investigación y Asistencia en ...
Aisha Khan, PhD, MBA University of Miami Miller School of Medicine United States FDA Releases Draft Guidance on AI Use in Regulatory Submissions In February 2025, the U.S. Food ...
Author: Fajar Dumadi, BSc International Society for Cell & Gene Therapy (ISCT) Canada Committee of Advance Therapy (CAT) Minutes and Agendas for recent meetings ...
Co-Authors: Gabrielle O’Sullivan, PhD, MPH(Hons) Royal Prince Alfred Hospital Australia Paula Stoddart Miltenyi Biotec Australia AUSTRALIAN AND NEW ZEALAND REGULATORY ...
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 ...
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 ...
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 ...
Contributor(s): Fajar Dumadi, BSc International Society for Cell & Gene Therapy (ISCT) Canada Alejandro Barquero, MPharm, MSc Almirall Spain Committee of Advance Therapy ...
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 ...
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- ...
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 & ...
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 ...
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 ...
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: ...
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, ...
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 ...
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 ...
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 ...
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 ...
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 ...
Aisha Khan, PhD, MBA University of Miami USA At the start of 2024, the FDA launched the Support for Clinical Trials Advancing Rare Disease Therapeutics (START) Pilot Program, a significant ...
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 ...
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 ...
Giulia Giunti, PhD 1 1 Regulatory Affairs Manager, BioOra Ltd, New Zealand AUSTRALIAN AND NEW ZEALAND REGULATORY UPDATES AOTEAROA – NEW ZEALAND In May 2024, the New Zealand Government ...
Alejandro Barquero, MPharm, MSc CMC Manager ISCT Legal and Regulatory Affairs Committee: Europe DanausGT Biotechnology Ltd. Madrid, Spain Laura Mendieta, PhD Senior Scientific and ...
Co-Authors : Sita Somara, PhD RTI International Durham, NC United States Aisha Khan, PhD University of Miami Miami, FL United States The U.S. Food and Drug Administration ...
by Fajar Dumadi, BSc Regulatory Program Specialist ISCT Head Office This draft guidance provides recommendations for developing a science- and risk-based strategy to help assure the potency of a human ...
On December 8, 2023, ISCT successfully hosted the landmark 20th FDA Cell Therapy Liaison Meeting (CTLM), a closed gathering strategically designed to facilitate discussions between the cell and gene therapy ...
Fajar Dumadi, BSc Regulatory Program Specialist ISCT Head Office . The second biannual Cell and Gene Therapy Global Regulatory Report from ISCT and Citeline will be released soon. ...
Gabrielle O’Sullivan PhD MPH (Hons) Executive Officer, Royal Prince Alfred Hospital Institutional Biosafety Committee, Royal Prince Alfred Hospital, Australia . AUSTRALIAN AND NEW ZEALAND ...
Laura Mendieta, PhD - Senior Scientific and RA Officer Project Manager ISCT Legal and Regulatory Affairs Committee: Europe Asphalion Barcelona, Spain Alejandro Barquero, MPharm, MSc - ...
Aisha Khan, PhD University of Miami United States The Clinical Trials Transformation Initiative (CTTI), in collaboration with the U.S. Food and Drug Administration (FDA), presents this report. ...
by Fajar Dumadi, BSc Regulatory Program Specialist ISCT Head Office ISCT hosted the 20th FDA CTLM on December 8, 2023 with over 45 participants, comprised of representatives from AABB, ASFA, ASTCT, ...
by Co-Author: Martin Hernán Bonamino, PhD Instituto Nacional de Câncer Brazil Maroun Khoury, PhD IMPACT, Center for Interventional Medicine for Precision and Advanced Cellular Therapy Chile ...
by J. Kaitlin Morrison, PhD Executive Director Clinical Research, UNC Lineberger Comprehensive Cancer Center Assistant Professor of Medicine- Hematology, University of North Carolina- Chapel Hill ...
by Laura Mendieta, PhD ISCT Legal and Regulatory Affairs Committee: Europe Asphalion Spain Alejandro Barquero, MPharm, MSc ISCT Legal and Regulatory Affairs Committee: Europe DanausGT Biotech Ltd. ...
by Gabrielle O’Sullivan PhD MPH (Hons) 1 1Executive Officer, Royal Prince Alfred Hospital Institutional Biosafety Committee, Royal Prince Alfred Hospital, Australia . AUSTRALIAN AND NEW ZEALAND ...
by Author: Darshan Patel, MS Fred Hutch Cancer Center United States Editor(s): Joseph Schwartz, MD, MPH Moffitt Cancer Center and Research Institute United States ...