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 ...
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 ...
by Alejandro Barquero, MPharm, MSc DanausGT Biotech Ltd. Spain . Committee of Advance Therapy (CAT) Minutes of the meetings Minutes of the meeting on 15-17 ...
by Gabrielle O’Sullivan PhD MPH (Hons) 1 1 Executive Officer, Royal Prince Alfred Hospital Institutional Biosafety Committee, Royal Prince Alfred Hospital, Australia . AUSTRALIAN ...
Summary of Session 5 : Regulatory Updates 17 August 2023 Gabrielle O’Sullivan and Craig Wright, Session Co-Chairs Royal Prince Alfred Hospital, Sydney TGA Presentation: Regulation of cell and ...
Write-up on a Roundtable Session: “Regulating MSC Clinics: Are we doing enough to protect patients” at the ISCT 2023 Annual Meeting in Paris Sowmya Viswanathan, PhD University Health Network ...
Alejandro Barquero, MPharm, MSc DanausGT Biotech Ltd. Spain Simona Stankeviciute, MD, MSc Parexel Lithuania Committee of Advance Therapy (CAT) Minutes of the ...
Michelle Hudson 1 and Kasey Kime 2 1 Clinical Trials Practice Educator, Parkville Cancer Clinical Trials Unit, Australia 2 Director of Regulatory Affairs, Thermo Fisher Scientific, New Zealand ...
Ashley Krull, Ph.D. Associate Director, Cell Therapy Manufacturing and Engineering James Cancer Hospital Cellular Therapy Laboratory Assistant Professor, Hematology The Ohio State University ...
Darshan Patel, MS Fred Hutch Cancer Center United States FDA Seeks Input on Boosting Data and Technology Capabilities: The US Food and Drug Administration (FDA) is requesting ...
Alejandro Barquero, MPharm, MSc DanausGT Biotech Ltd. Spain Simona Stankeviciute, MD, MSc Parexel Lithuania . Committee of Advance Therapy (CAT) Minutes of the meetings: Minutes ...
Michelle Hudson 1 and Kasey Kime 2 1 Clinical Trials Practice Educator, Parkville Cancer Clinical Trials Unit, Australia 2 Director of Regulatory Affairs , Thermo Fisher Scientific, New Zealand ...
Sita Somara, PhD, MBA RTI International United States FDA has recently shared the news that it is taking steps to help gene therapies get accelerated approval. According to Dr. Marks, ...
Fajar Dumadi Regulatory Program Specialist ISCT Head Office The TGA's Good Manufacturing Practice (GMP) Forum was held in Sydney on 21 March 2023 at the International Convention Centre in Darling ...
Updates and regulatory news Health Canada What’s new in Biologics, radiopharmaceuticals and genetic therapies can be found at: https://www.canada.ca/en/health-canada/services/drugs-health-products/biologics-radio-pharmaceuticals-genetic-therapies/what-new-biologics-radiopharmaceuticals-genetic-therapies-health-canada.html ...
Alejandro Barquero, MPharm, MSc ISCT Legal and Regulatory Affairs Committee: Europe DanausGT Biotech Ltd. Spain Laura Mendieta, PhD ISCT Legal and Regulatory Affairs Committee: Europe Asphalion Spain ...
Gabrielle O’Sullivan PhD MPH 1 and Giulia Giunti PhD 2 1 Executive Officer, Royal Prince Alfred Hospital Institutional Biosafety Committee, Royal Prince Alfred Hospital, Australia 2 Quality ...
by Fajar Dumadi, BSc Regulatory Program Specialist ISCT Head Office . The FDA’s Center for Biologics Evaluation and Research (CBER) Office of Tissues and Advanced Therapies (OTAT) hosted ...
Alejandro Barquero, MPharm, MSc ISCT Legal and Regulatory Affairs Committee: Europe DanausGT Biotech Ltd. Spain Hind Al Belushi, PhD ISCT Legal and Regulatory Affairs Committee: Europe Royal Hospital ...