Blogs

ISCT Announces Gabrielle O'Sullivan, PhD as next Chief Regulatory Officer

By Ken Ip posted 2 days ago
June 1, 2026 – The International Society for Cell & Gene Therapy (ISCT) is delighted to announce the appointment of Gabrielle O'Sullivan, PhD, as the new ISCT Chief Regulatory Officer, effective June 1st, 2026 through December 31, 2028. Dr. O'Sullivan is an eminent leader in biosafety and public health, bringing more than 20 years of experience across immunology, genetics and public health education, epidemiology, public health and ethics and biosafety in gene technology. As Executive Officer of the Institutional Biosafety Committee at Royal Prince Alfred Hospital, and as a committee member in the Gene Technology Technical Advisory Committee and the ...

ISCT Announces Jaap Jan Boelens, MD, PhD as inaugural Chief Medical Officer

By Ken Ip posted 2 days ago
June 1, 2026 – The International Society for Cell & Gene Therapy (ISCT) is delighted to announce the appointment of Jaap Jan Boelens, MD, PhD, as the inaugural ISCT Chief Medical Officer, effective June 1st, 2026 through December 31, 2028. Dr. Boelens is a renowned clinical leader specializing in bone marrow and cord blood transplantation to treat blood diseases in children and young adults. Currently, Dr. Boelens serves as Chief of the Pediatric Transplant and Cellular Therapy Service (TCT) at Memorial Sloan Kettering Cancer Center, and was previously the key leader in developing the largest umbilical cord blood transplant program in Europe during his ...

Investment Activity in Cell and Gene Therapy: A Look Back at 2025

By Francheska Juliano posted 14 days ago
Developed by ISCT Business Development & Finance Committee The year 2025 marked a notable period of momentum for the cell and gene therapy (CGT) sector, characterised by significant deal making across multiple therapeutic modalities. In 2025, the field saw approximately USD 12 billion in disclosed investment activity. Series funding remained broadly stable throughout the year, at around USD 1 billion per quarter. In contrast, M&A activity peaked in Q2, driven by acquisitions of several in vivo CAR T companies. The majority of M&A deal value was concentrated in in vivo CAR T assets. Notably, EsoBiotec—an in vivo CAR T company acquired by AstraZeneca ...

ISCT Milestone: Global Regulatory Reports Featured in Springer Handbook

By Francheska Juliano posted 14 days ago
Fajar Dumadi, BSc International Society for Cell & Gene Therapy (ISCT) Canada Following the release of the latest edition of the ISCT CGT Global Regulatory Report —presenting a comprehensive year-end review of 2025—we are proud to share a significant milestone for the Society and its community. ISCT and its Global Regulatory Reports have been featured in the Springer Handbook of Medical Biotechnology , within the chapter titled “ Regulatory and Health Technology Assessment of ATMPs in the European Union: Towards Patient Access .” This recognition highlights the growing impact of ISCT’s thought leadership in addressing some of the most pressing challenges ...

Building a Stronger Foundation for CAR-T Excellence Across Europe: GoCART's Educational Ecosystem

By Francheska Juliano posted 14 days ago
Tuula Rintala Director, Quality of Care and Advocacy EBMT, European Society for Blood and Marrow Transplantation Spain CAR-T cell therapy has transformed the treatment landscape for patients with haematological malignancies, but its promise can only be fully realised when every healthcare professional involved in its delivery is equipped with the knowledge, skills and confidence to act. This is a conviction that sits at the heart of the work of the GoCART Coalition — the multi-stakeholder initiative co-founded by EBMT and EHA to maximise the potential of cellular therapies across Europe. Over the past year, GoCART has made remarkable strides in building ...

How Can We Industrialize Cell Therapy Manufacturing?

By Francheska Juliano posted 15 days ago
Introduction In the rapidly evolving landscape of advanced therapies, few challenges are as complex — or as consequential — as scaling cell therapy manufacturing to meet growing clinical and commercial demand. In this expert analysis, the team at AGC Biologics shares their perspective on the current state of the industry, the technologies shaping its future, and the barriers that must be overcome to make these life-changing treatments more accessible. AGC Biologics brings firsthand experience to this conversation: the team played a pivotal role in achieving the first-ever FDA approval of a gene therapy for early-onset metachromatic leukodystrophy (MLD), ...

Looking Back at ISCT 2025 Roundtable Sessions: Key Takeaways

By Francheska Juliano posted 18 days ago
Madhavi Lakkaraja, MD, MPH Fred Hutchinson Cancer Center, University of Washington School of Medicine United States From ISCT 2025 Roundtable Session: Cell Therapies to Manage GVHD - Learning From Pivotal Approvals 1. How the Biology of Acute Graft Versus Host Disease (GVHD) Makes It Amenable to Specific Treatment With a Focus on Mesenchymal Stromal Cell (MSC) Therapy Introduction of GVHD and how MSCs have been useful for management of GVHD Acute GVHD (aGVHD) mainly comprises of T cell alloreactivity and tissue damage. When host tissues are injured by chemotherapy/conditioning, the injury triggers an inflammatory cascade including trafficking ...

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

By Francheska Juliano posted 25 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 ...

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

By Francheska Juliano posted 25 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 Biomedical 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 25 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 28 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 21 Apr, 2026
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 08 Apr, 2026
ISCT Mesenchymal Stromal 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 administration. A new ISCT MSC Committee-led perspective ( https://doi.org/10.1016/j.jcyt.2025.102007 ) outlines key knowledge gaps and experimental strategies needed to address them. The Questions Every Living Cell Product Must Answer For MSCs, these questions have remained especially persistent. MSCs are being investigated across a broad range of disease indications and delivery routes, yet their  in vivo fate, clearance, ...

North America LRA Watchdog — April 2026

By Francheska Juliano posted 08 Apr, 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 07 Apr, 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 07 Apr, 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 07 Apr, 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 07 Apr, 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 02 Apr, 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 02 Apr, 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 ...