Jul 2026· Cell and Gene Therapy Insights· Vol 12, pp. 599–605· 0 citations
TL;DR
The career journey from molecular cancer biology through GMP manufacturing and regulatory science into health policy, the evolving regulatory landscape for cell and gene therapies in Singapore and the Asia‑Pacific region, the role of regulatory reliance frameworks in broadening equitable patient access, and the transformative potential of AI are discussed.
Abstract
Wil Rich, Editor, Cell & Gene Therapy Insights, speaks with Eddie Tan Han Pin, Assistant Professor, Centre of Regulatory Excellence, Duke‑NUS Medical School, about his career journey from molecular cancer biology through GMP manufacturing and regulatory science into health policy, the evolving regulatory landscape for cell and gene therapies in Singapore and the Asia‑Pacific region, the role of regulatory reliance frameworks in broadening equitable patient access, and the transformative potential of AI across the cell and gene therapy development value chain.
Cellular and gene therapy (CGT) has fundamentally reshaped the treatment landscape for a growing range of malignant and non-malignant diseases. Yet the rapid expansion of CGT has also exposed critical institutional and system-level pressures, including constraints in infrastructure and workforce capacity, product manufacturing, patient access, regulatory and data reporting compliance, and long-term healthcare affordability and sustainability. These opportunities and challenges framed the joint plenary session sponsored by the American Society for Transplantation and Cellular Therapy (ASTCT), the Center for International Blood and Marrow Transplant Research (CIBMTR), and the European Society for Blood and Marrow Transplantation (EBMT) at the 2026 ASTCT-CIBMTR Tandem Meetings. This proceedings manuscript summarizes the key challenges inherent to CGT expansion, identifies priority areas for coordinated action, and issues a call to the field to address these needs with urgency and shared commitment.
Jeffery J. Auletta, Á. Urbano-Ispizua, R. Maziarz et al.· Transplantation and Cellular...· 0 citations
“Five years from now, when we have treated and cured many people with sickle cell disease, it will begin to feel mundane.” Abi Pinchbeck, Editor, Cell and Gene Therapy Insights, speaks with Paula Cannon, Distinguished Professor of Molecular Microbiology and Immunology, Keck School of Medicine of USC, about the evolution of gene therapy from a bold engineering challenge to an increasingly routine clinical reality. They discuss the financial and regulatory barriers to patient access, the field’s perceived image problem, and what it would take for policymakers to evaluate gene therapy with the same measured risk–benefit lens applied to other medicines.
Paula Cannon· Cell and Gene Therapy Insigh...· 0 citations
Cell and gene therapy (CGT) products have driven a global transformation in medicine, opening new avenues for the diagnosis and treatment of major diseases, while also posing new challenges to regulatory agencies worldwide. In the context of the current global CGT industry landscape, this article systematically reviews the evolution of China's CGT regulatory framework over the past three decades, delves into the stages of regulatory development, and analyzes the profound impact of regulatory policies in different periods on the industry landscape, biopharmaceutical research and development (R&D) activities, and clinical translational application. At present, China ranks among the global leaders in the number of CGT pipelines under development, demonstrating strong momentum for industrial growth. However, under the conventional regulatory paradigm, challenges such as long R&D cycles, inefficient translational application pathways, and unclear delineation of authorities and responsibilities have long constrained the development of the industry. On this basis, this article interprets the Regulation on the Administration of Clinical Research and Clinical Translational Application of New Biomedical Technologies, which entered into force in 2026, with a particular focus on its new dual-track regulatory framework that comprises a drug registration pathway and a new biomedical technology pathway, and its transformative impact on regulatory approval procedures, clinical translational application, and full lifecycle risk management.
Wei Li, Zhen Qin, Xiu'e Wang et al.· Cytotherapy and Longevity· 0 citations
Timothy Yap, MBBS, PhD, vice president and head of clinical development in the Therapeutics Discovery Division and professor in the Department of Investigational Cancer Therapeutics (Phase I Program) at The University of Texas MD Anderson Cancer Center in Houston, spoke with Cancer Discovery's Suzanne Rose about how clinical trials have evolved, the role of AI, and the challenges facing today's drug developers. His research focuses on the first-in-human and combinatorial development of molecularly targeted agents, immunotherapies, antibody drug conjugates, and radioconjugates.
In the past decade, clinical medicine has witnessed a striking acceleration. CAR-T and engineered cell therapies have moved from oncology into autoimmune indications such as systemic lupus erythematosus and idiopathic inflammatory myopathies; next-generation antibody therapeutics, targeted protein degraders, and precision immunomodulators are reshaping both tumor control and immune tolerance. And yet, the translation from mechanistic insight to durable bedside impact remains uneven across disciplines. This gap, between molecular and immunological discovery on one side, and real-world clinical practice on the other, is precisely why Clinical Medicine Advances (CMA) was founded.
Jixin Zhong· Clinical Medicine Advances· 0 citations
Adoptive cell therapies utilizing both gene-modified and unmodified immune cells have revolutionized treatments for cancer and infection. Seven Chimeric antigen receptor (CAR) T cell products have been approved as therapies, providing the momentum to expand their clinical benefit to several cancer types. Many novel receptor-expressing cell therapies remain in preclinical development and require robust clinical testing Translating these into early-phase clinical trials requires navigating manufacturing, quality, and regulatory systems that are often not documented explicitly for academic investigators. This manuscript provides a stage-by-stage roadmap for translating academic CAR T-cell research into an investigator-led Phase I clinical trial in the Australian public sector. It draws on the E2CAR program, the first clinical translation of an EphA2-directed CAR T-cell product into pediatric bone sarcoma, conducted at the Children’s Hospital at Westmead. We present our experience across six stages: construct finalization and vector strategy, manufacturing process development, quality infrastructure, assay development and validation, multi-entity operational coordination, and CTA regulatory engagement and provide recommendations for researchers at each stage. We also present a consolidated program timeline, minimum personnel requirements, and indicative costs to support grant applications and institutional planning. While the operational framework described here was developed specifically for our Health Precinct some of the recommendations we provide are likely to benefit academic groups navigating constraints in comparable settings.
Rui Tan, R. Walsh, G. McCowage et al.· Frontiers in Medicine· 0 citations
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