Blogs

The Global Thread: Connecting Madrid, Bangkok and Dublin

By Francheska Juliano posted 6 hours ago
Joaquim Vives, PhD Contributing Editor, ISCT Telegraft Ban 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 7 hours ago
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 10 days ago
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 10 days ago
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 10 days ago
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 23 days ago
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 24 days ago
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 24 days ago
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 27 days ago
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 ...

JACIE Launches Dedicated IEC Certification Pathway Under New 3rd Edition Standards

By Francheska Juliano posted 27 days ago
Tuula Rinala Director, Quality of Care and Advocacy EBMT, European Society for Blood and Marrow Transplantation Barcelona, Spain As of 2 February 2026, the FACT-JACIE International Standards for Immune Effector Cells, Third Edition (IEC 3.1), are in effect — bringing with them a formal, dedicated certification pathway for programmes delivering IEC therapies outside of a transplant setting. Background The rapid clinical expansion of immune effector cell therapies — including CAR-T cells, CAR-NK cells, tumour-infiltrating lymphocytes (TILs), and dendritic cell vaccines — has created urgent demand for a quality and accreditation framework that reflects ...

From the Editors—The Fragility of a Global Laboratory

By Francheska Juliano posted 28 days ago
Joaquim Vives, PhD Contributing Editor, ISCT Telegraft Ban de Sang i Teixits Spain The World, viewed through the lens of a microscope, is a place of a delicate elegance. We observe the migration of cells, the effect of cytokines or the kinetics in a validated assay. In the lab, we are somehow the architects of a controlled environment to test our new hypotheses. However, as we step beyond the sterile airlock of our facilities, we find ourselves entering a much more chaotic macro-environment. One where the variables are increasingly volatile. A subtle tension runs through modern science, shaping how we collaborate, travel and advance knowledge. We live ...

ISCT–JSRM 5-Year Joint Strategic Collaboration on Clinical iPSCs Launching Inaugural Joint Collaboration in Kobe, Japan - March 21, 2026

By Ken Ip posted 30 days ago
ISCT–JSRM 5-Year Joint Strategic Collaboration on Clinical iPSCs Launches Inaugural Joint Collaboration in Kobe, Japan - March 21, 2026 VANCOUVER, CANADA and TOKYO, JAPAN – 3 March 2026 -- The International Society for Cell & Gene Therapy (ISCT), the translation-focused global community of cell and gene therapy experts and the Japanese Society for Regenerative Medicine (JSRM), advancing iPSC-based therapies, jointly announce a 5-year strategic partnership to advance iPSC-based therapies globally. The ISCT–JSRM Joint Strategic Collaboration on Clinical iPSCs represents a landmark in the history ...

2026 FACT Education: Empowering the Next Generation of Quality and Safety

By Francheska Juliano posted Feb 11, 2026
Breann Weishaar, BS Foundation for the Accreditation of Cellular Therapy (FACT) United States FACT Education is heading into 2026 with momentum—and a milestone. After an incredible 2025 that saw more than 800 professionals trained through in-person and virtual programs, FACT now celebrates 30 years of service to the cellular therapy community. As we reflect on where we’ve been, we remain focused on what comes next: empowering the next generation of quality and safety leaders across the field. As part of this transition year, FACT would also like to share an important update regarding accredited continuing education credits. In 2025, FACT partnered ...

Celebrating 30 Years of FACT: Advancing Quality, Safety, and Access in Cellular Therapy

By Francheska Juliano posted Feb 11, 2026
Linda Miller, MPA Foundation for the Accreditation of Cellular Therapy (FACT) United States This year marks a significant milestone for the Foundation for the Accreditation of Cellular Therapy (FACT): 30 years of advancing quality and patient safety in cellular therapy and transplantation . What began as a bold vision to standardize excellence in hematopoietic cell transplantation has grown into a global movement that continues to shape the future of cellular therapies. Over the past three decades, FACT has worked in close partnership with the clinical, laboratory, and collection communities to establish consensus, evidence-based standards that promote ...

Highlights of FACT Activities and Outcomes in 2025

By Francheska Juliano posted Feb 11, 2026
David Schmahl, CEO Foundation for the Accreditation of Cellular Therapy (FACT) United States On behalf of FACT’s Board of Directors, volunteer leaders, and headquarters’ staff, I’m privileged to share with you highlights of our efforts and outcomes of the past year. The information is a celebration of the value FACT brings to the quality, safety, and access of cellular therapies to patients who need them. This is also a celebration of the commitment and expertise of FACT’s “army of volunteers” behind our peer-based and consensus-driven efforts. These activities and outcomes reflect the dedication, expertise, and hard work of hundreds of peers who volunteer ...

North America LRA Watchdog—February 2026

By Francheska Juliano posted Feb 11, 2026
Adam Lee, MS Thermo Fisher Scientific United States J. Wade Atkins, MS, MT (ASCP) SBB, CQA (ASQ) National Institute of Health United States With the new year underway, CBER (Center for Biologics Evaluation and Research) continues to discuss and publish their new approaches to bring cell and gene therapy to market. Recently, an ambitious list of guidance documents was published outlining their plans to update, create, or finalize guidance documents in 2026. So far this year, the FDA appears to be focusing on streamlining the review of cell and gene therapies with specific discussion of more flexible review of the CMC of early phase products and discussion ...

From the Editors–Re-Examining Time in Cell and Gene Therapy

By Francheska Juliano posted Feb 11, 2026
C. Russell Y. Cruz, MD, PhD Senior Editor, ISCT Telegraft Associate Professor, Children's National Hospital United States Cell and gene therapies have slowly forced a shift from our understanding of pharmacology. These therapies are no longer passive molecules, but complex, dynamic systems with no straightforward relationship to dose, pharmacokinetics, route of administration, and drug compartments. Recent studies may make us rethink one other element: time. Time, it seems, is an active variable too. Biology, after all, is strongly rhythmic. Recent studies continue to make us rethink our age-old concepts of pharmacology, including how they apply to biological ...

Europe LRA Watchdog—February 2026

By Francheska Juliano posted Feb 06, 2026
Fajar Dumadi, BSc ISCT Canada Committee for Advanced Therapies (CAT) Agendas for recent meetings Agenda for the meeting on 5-7 November 2025 https://www.ema.europa.eu/en/documents/agenda/agenda-cat-meeting-5-7-november-2025_en.pdf Agenda for the meeting on 3-5 December 2025 https://www.ema.europa.eu/en/documents/agenda/agenda-cat-meeting-3-5-december-2025_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 ...

From the President's Desk: Collaborative Competition!

By Francheska Juliano posted Feb 06, 2026
Miguel Forte, MD, PhD ISCT President Kiji Therapeutics Belgium Collaborative competition (often called coopetition ) is the idea that different organizations cooperate in some areas while still competing in others, to create mutual benefit and value. Competition is the driver of innovation, progress and improving outcomes. If competition is done in a constructive and collaborative way it not only accelerates the deliverables but also expands the benefits so that all those involved get incremental benefits. “The Wandering Earth”, a Chinese science fiction book and film, is a good illustration of collaborative competition. The players explicitly merge ...

ISCT Call for Leadership Nominations—Submit by Jan 30

By Francheska Juliano posted Jan 13, 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 upcoming ISCT Elections are just around the corner! The ISCT Nominations Committee is taking applications for candidates for a huge range of leadership positions, both global and regional, who can commit to leading ISCT into the future. Members on the ISCT Board of Directors and Regional Executive Committees work together to serve ISCT and its members and advance the field of cell and gene therapy. For the Global Board of Directors, four positions are open for nominations: Global ...