Blogs

Make the Most of Your ISCT Membership Beyond the Scientific Annual Meeting

By Francheska Juliano posted 5 days ago
Hannah Song, PhD Contributing Editor, ISCT Telegraft National Institutes of Health United States It is my great honor and privilege to write to you today as a newly-minted Telegraft Editorial Board member! I’ve been part of the ISCT community for 5 years and involved in cell and gene therapy for almost 10 years, as well as an avid reader of Telegraft and Cytotherapy publications. I’m excited to help spread the news and build community through the Telegraft feature, designed to help members connect to each other and ISCT resources. My first introduction to ISCT was the 2022 Annual Meeting in San Francisco, California. I had never been to a meeting with ...

LPC Snapshot: The HLA Bottleneck — Can Off-the-Shelf Cancer Therapies Become “For Everyone”?

By Francheska Juliano posted 5 days ago
Rajdeep Das, MD, PhD, FIBMS Member, ISCT Lab Practices Committee University Hospitals Cleveland Medical Center United States Karen E. Martin, PhD Department of Biomedial Engineering Tufts University United States Medhat Askar, MD, PhD, MSHPE, FRCPath Member, ISCT Lab Practices Committee Texas A&M College of Medicine United States Consider this scenario: a patient with relapsed, refractory disease has exhausted standard options. A promising allogeneic CAR-T trial has opened nearby. The product is engineered, potent, and available now. No apheresis delay. No manufacturing wait. Then, the HLA typing comes back. The patient does not carry HLA-A*02:01 ...

Leadership Spotlight: Mary Laughlin, MD, ISCT Past President 2008-2010

By Francheska Juliano posted 5 days ago
Shyam Bhakta, MD, MBA Contributing Editor, ISCT Telegraft United States Dr. Mary Laughlin grew up in Buffalo, NY, where the Roswell Park Cancer Center and Institute is located and where she also completed an internship while in high school. Dr. Laughlin says that at the time, Roswell Park was just one of three cancer centers nationwide, with Memorial Sloan-Kettering Cancer Center (New York, NY) and Fred Hutchinson Cancer Center (Seattle, WA) being the other two. According to Dr. Laughlin, allogeneic bone marrow transplants were experimental. When the first such transplant was performed at the Fred Hutchinson Cancer Center, the concept of human leukocyte ...

Early-Phase Advanced Therapy Development is Breaking Under Its Own Momentum

By Francheska Juliano posted 8 days ago
Advanced therapy development is no longer limited by whether the science can work. Platform technologies are established, translational pathways are better understood, and the distance between discovery and first-in-human continues to shrink. What now limits progress for many programs is the ability to operate effectively. Execution, more than feasibility, has become the constraint much earlier in development than most organizations anticipate. Early-stage teams are finding that they’re being asked to support a level of operational sophistication that frequently outpaces how the organization and program are structured. In the early phases, teams are often ...

ISCT Announces Inaugural CGT Clinical Applications Program for Clinical Fellows

By Ken Ip posted 22 days ago
VANCOUVER, British Columbia, April 21, 2026 — The International Society for Cell & Gene Therapy (ISCT) Institute of Training & Development announces the launch of its inaugural Clinical Applications Program for Fellows. Exclusively for clinical fellows interested in cell and gene therapy (CGT) applications, this new educational initiative is designed to provide the highest level of clinical CGT knowledge direct from experts in the field to the next generation of clinical leaders. The program will equip clinical fellows with practical, clinic-facing skills to help advance cell and gene therapies from bench to bedside. The inaugural program will ...

After Administration: What Really Happens to MSCs, and Why the Field Needs Better Answers

By Francheska Juliano posted Apr 08, 2026
ISCT Mesenchymal Stroma Cell (MSC) Committee Mesenchymal stromal cells (MSCs) are among the most widely used cellular products worldwide, yet the field still lacks shared, testable answers about what happens to these cells after they are administered/delivered. A new ISCT MSC Committee-led perspective outlines the most urgent research/knowledge gaps and the experimental strategies needed to close them. The Questions Every Living Cell Product Must Answer For MSCs, these questions have been especially persistent. MSCs are being investigated across a wide range of disease indications and administration/delivery routes, but in vivo fate, clearance, ...

North America LRA Watchdog — April 2026

By Francheska Juliano posted Apr 08, 2026
Andrew Haskell, PhD, MLS, CT(ASCP)CM, MBCM, QLSCM ISCT North America LRA Committee United States Lynn Csontos, RAC ISCT North America LRA Committee STEMCELL Technologies Canada Kevin Bosse, PhD, RAC-US, CABP(H) Chair, ISCT North America LRA Committee ISCT North America Regional Executive Committee Nationwide Children's Hospital United States FDA Guidance Leverages New Approach Methodologies to Spare Animal Research Requirements The FDA Center for Drug Evaluation and Research (CDER) released draft guidance to provide a framework for drug developers to use nonclinical evidence generated in new approach methodologies (NAMs) to support investigational ...

Europe LRA Watchdog — April 2026

By Francheska Juliano posted Apr 07, 2026
Fajar Dumadi, BSc ISCT Canada Committee for Advanced Therapies (CAT) Agendas for recent meetings Agenda for the meeting on 18-20 March 2026 https://www.ema.europa.eu/en/documents/agenda/agenda-cat-meeting-18-20-march-2026_en.pdf Agenda for the meeting on 18-20 February 2026 https://www.ema.europa.eu/en/documents/agenda/agenda-cat-meeting-18-20-february-2026_en.pdf Agenda for the meeting on 21-23 January 2026 https://www.ema.europa.eu/en/documents/agenda/agenda-cat-meeting-21-23-january-2026_en.pdf CAT quarterly highlights and approved ATMPs CAT quarterly highlights and approved ATMPs – December 2025 https://www.ema.europa.eu/en/documents/committee-report/cat-quarterly-highlights-approved-atmps-december-2025_en.pdf ...

Australia and New Zealand LRA Watchdog Report – April 2026

By Francheska Juliano posted Apr 07, 2026
Mirja Krause-Onwukwe, PhD, MSc ISCT ANZ LRA Committee Member Australia Gabrielle O'Sullivan, PhD ISCT ANZ LRA Committee Co-Chair Australia Australia and New Zealand Regulatory Updates Medsafe Medsafe Guidance on Advanced Therapies – As an outcome of the consultation by the Ministry of Health to the Guideline on the Regulation of Therapeutic Products in New Zealand, ongoing updates to secondary guidance documents are being published in 2026: Considerations for first-in-human (FIH) and early phase clinical trials is active as of July 2026. TGA TGA Consultation: Conformity Assessment Procedures for Medical Devices ...

ISCT Publishes the Fifth Global Regulatory Report

By Francheska Juliano posted Apr 07, 2026
Fajar Dumadi, BSc Specialist, Regulatory Program ISCT Canada With great excitement, the International Society for Cell & Gene Therapy (ISCT) publishes its fifth Global Regulatory Report in collaboration with Clarivate ™. This report offers a comprehensive global overview of the cell and gene therapy regulatory landscape, including pipeline, late-stage (Phase III and pre-registration), and approved products (Cell, Genetically-Modified Cell, and Gene Therapies). Highlights from this issue include: First Approval BBM H901 , the first gene therapy for the treatment of adult patients with moderate to severe hemophilia B (congenital coagulation ...

From the President’s Desk: It’s That Time of the Year Again!

By Francheska Juliano posted Apr 07, 2026
Miguel Forte, MD, PhD ISCT President MC4TX Belgium As a well-established tradition, ISCT will hold its annual meeting at the beginning of May. This year we will gather in Dublin from the 6th to the 10th of May. It is an unmissable event as the largest global cell and gene therapy translation conference. We are expecting around 3,000 delegates, enabling more than 7,000 partnering and networking meetings, with over 60 countries represented and more than 250 speakers. The number of accepted abstracts has reached a record level for ISCT, with more than 650 submissions accepted. Under the theme of the “Golden Age of Cell and Gene Therapy,” the scientific ...

The Global Thread: Connecting Madrid, Bangkok and Dublin

By Francheska Juliano posted Apr 02, 2026
Joaquim Vives, PhD Contributing Editor, ISCT Telegraft Banc de Sang i Teixits Spain Today, as I reflect on our recent milestones in Madrid and Bangkok, I am struck by a linguistic duality: while the world outside our labs feels like a threat , the scientific community we have built is a thread—one that is resilient, interconnected and durable. Our "strength" is not just found in the potency of our cells, but in the tenacity of our global network. This spring, that thread has pulled us from the wide-reaching pavilions of IFEMA of Madrid to the vibrant energy of Bangkok, and it now leads us toward our ultimate gathering in Dublin . Madrid: The Precision ...

From the Editors—Beyond the Frontier: Q1 2026 and the Shift to Scalable CGT Reality

By Francheska Juliano posted Apr 02, 2026
Dr. Adaeze Ekwe, PhD Junior Associate Editor, ISCT Telegraft Australia The first quarter of 2026 has been a pivotal period for the global cell and gene therapy (CGT) sector, defined by clinical milestones, regulatory reforms and the launch of next-generation manufacturing hubs. These advancements signal an industry transitioning from a promising frontier toward commercial scalability and expanded patient access. At the centre of this momentum, ISCT has spearheaded global actions to bridge the gap between innovation and global care. Here are the key highlights of Q1 2026. In a historic first for rare diseases, market authorisation was issued by the European ...

2026 ISCT Elections - Voting Now Open

By Ken Ip posted Mar 22, 2026
Voting is now open for nominees to the ISCT Board of Directors and Regional Leadership Committees, exclusive to ISCT members, until April 21, 2026. As the Society grows exponentially, this slate of leaders has been selected from wide range of nominations for their strong depth of knowledge, diversity of expertise, and proven commitment. Each of them has been a strong steward for the CGT community, and has earned strong standing as an aspiring leader able to drive ISCT onwards to new heights. The ISCT Board of Directors is pleased to present the 2026 slate of global candidates, with the mandate to implement strategies that strengthen our Society and ...

2026 ISCT Elections - Voting Now Open

By Ken Ip posted Mar 22, 2026
Voting is now open for nominees to the ISCT Board of Directors and Regional Leadership Committees, exclusive to ISCT members, until April 21, 2026. As the Society grows exponentially, this slate of leaders has been selected from wide range of nominations for their strong depth of knowledge, diversity of expertise, and proven commitment. Each of them has been a strong steward for the CGT community, and has earned strong standing as an aspiring leader able to drive ISCT onwards to new heights. The ISCT Board of Directors is pleased to present the 2026 slate of global candidates, with the mandate to implement strategies that strengthen our Society and ...

2026 ISCT Elections - Voting Now Open

By Ken Ip posted Mar 22, 2026
Voting is now open for nominees to the ISCT Board of Directors and Regional Leadership Committees, exclusive to ISCT members, until April 21, 2026. As the Society grows exponentially, this slate of leaders has been selected from wide range of nominations for their strong depth of knowledge, diversity of expertise, and proven commitment. Each of them has been a strong steward for the CGT community, and has earned strong standing as an aspiring leader able to drive ISCT onwards to new heights. The ISCT Board of Directors is pleased to present the 2026 slate of global candidates, with the mandate to implement strategies that strengthen our Society and ...

Navigating CGT Approvals in Asia Pacific: Regulatory Insights from Japan, Singapore and South Korea

By Francheska Juliano posted Mar 10, 2026
Eddie Tan, PhD, CABP ISCT Asia Pacific (APAC) Industry Committee Member ESP Subcommittee Member Center of Regulatory Excellence, Duke-NUS Medical School Singapore On behalf of the ISCT Asia Pacific (APAC) Industry Committee Webinar Co-Chairs William Hwang, MBBS, FRCP, FAMS, MBA ISCT APAC Industry Committee Co-Chair Singapore Eddie Tan, PhD, CABP ISCT APAC Industry Committee Member ESP Subcommittee Member Singapore Speakers/Panelists Jihye Shin, PhD Xcell Therapeutics Inc. South Korea Sudipto Bari, PhD ISCT Asia Regional ESP Subcommittee Co-Chair Advanced Cell Therapy and Research Institute (ACTRIS) Singapore ...

LPC Snapshot: Minimal vs More Than Minimal Manipulation

By Francheska Juliano posted Mar 09, 2026
Karin Hermans, PhD ISCT Lab Practices Committee Member The Hospital for Sick Children (SickKids) Canada Monica Klein, MD ISCT Lab Practices Committee Member Mayo Clinic United States This month’s LPC Snapshot offers an in-depth exploration of the regulatory framework distinguishing minimally manipulated products from those that undergo more extensive manipulation. It also examines the current Good Manufacturing Practices (cGMPs) that must be followed to guarantee the safety, identity, purity, potency, and overall quality of drug products. By delving into these regulatory considerations, the Snapshot aims to clarify the requirements and standards ...

A New Standard of Care? Integrating Multiantigen-Targeting T Cells Into Frontline Solid Cancer Treatment

By Francheska Juliano posted Mar 09, 2026
Adaeze Ekwe, PhD, MSc Junior Associate Editor, ISCT Telegraft Queensland University of Technology (QUT) Australia Joaquim Vives, PhD Contributing Editor, ISCT Telegraft Banc de Sang i Teixits (BST) Spain Topic Overview Solid tumours have long resisted immunotherapy through a combination of antigenic heterogeneity, physical barriers, and immunosuppressive microenvironments 1 . The failure mode of many early solid tumour immunotherapies is now well understood. When immune pressure is focused on a single antigen, cancer cells simply downregulate or lose that target, a process known as “antigen escape”. In highly heterogeneous tumours such as pancreatic ...

Cord Blood Inventory: Future Opportunities

By Francheska Juliano posted Mar 06, 2026
Jessica Sue, BSc, MHSM Junior Associate Editor (ESP Leadership Development Program), ISCT Telegraft Sydney Cord Blood Bank, Sydney Children’s Hospitals Network Australia The World Marrow Donor Association (WMDA), a global organization that operates the world’s largest hematopoietic stem cell database, currently lists 755, 016 cord blood units (CBU) as part of the inventory, allowing clinical programs worldwide to identify CBU for patients requiring a hematopoietic stem cell transplant via their Search & Match service 1 , 2 . These CBU, which are manufactured from cord blood (CB) collected by public cord blood banks (CBB), are donated voluntarily and ...