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.
The key challenges inherent to CGT expansion are summarized, priority areas for coordinated action are identified, and a call to the field to address these needs with urgency and shared commitment is issued.
Jeffery J. Auletta, Á. Urbano-Ispizua, R. Maziarz et al.· Transplantation and Cellular...· 0 citations
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 are discussed.
Paula Cannon· Cell and Gene Therapy Insigh...· 0 citations
The Regulation on the Administration of Clinical Research and Clinical Translational Application of New Biomedical Technologies, which entered into force in 2026, is interpreted, with a particular focus on its new dual-track regulatory framework that comprises a drug registration pathway and a new biomedical technology...
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 cl...
The translation from mechanistic insight to durable bedside impact remains uneven across disciplines, and the gap between molecular and immunological discovery on one side, and real-world clinical practice on the other is precisely why Clinical Medicine Advances was founded.
Jixin Zhong· Clinical Medicine Advances· 0 citations
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, drawing on the E2CAR program, the first clinical translation of an EphA2-directed CAR T-cell product into pediatric bone sarcoma.
Rui Tan, R. Walsh, G. McCowage et al.· Frontiers in Medicine· 0 citations
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