Scientific Program

SCIENTIFIC PROGRAM

Dr. Bruce Levine keynote banner Dr. Bruce Levine keynote banner

Meet a Pioneer in Cell and Gene Therapy at the ISCT Asia 2026 Regional Meeting

The Next Chapter in the Fantastic Voyage of CAR T Cell Therapy: Potency, Access, and Delivery

We are excited to announce that Dr. Bruce Levine (University of Pennsylvania), Founding Director of the Clinical Cell and Vaccine Production Facility and co-inventor of the first FDA-approved CAR T-cell therapy (Kymriah), will deliver the keynote to open the ISCT Asia 2026 Regional Meeting this September.

With a history of first-in-human clinical trials, Dr. Levine’s work has consistently focused on what it takes to make engineered cell therapies reliable, manufacturable, and accessible. Drawing on insights from more than 200 scientific articles and book chapters, and co-invention of over 30 U.S. patents, his keynote will explore how the field can responsibly broaden patient impact by improving cell potency and production while maintaining the quality systems that advanced therapies require.

Key Topics

  1. Next-Gen Manufacturing: Automation, closed systems, analytics, and standardization to improve scalability and consistency across centralized and hybrid models.
  2. Expanding Horizons: Progress and remaining barriers in applying cell therapy to solid tumors and autoimmune diseases.
  3. Beyond Autologous: Realistic paths forward for in vivo strategies, including the hurdles that continue to shape adoption.

Join us at the Suntec Singapore Convention & Exhibition Centre to engage with one of the field’s pioneers and explore what it will take to translate innovation into dependable therapies for patients across the region.

Plenary Sessions

Plenary 2 — From Journal Paper to Patients - Translating CAR T TCR and Gene Therapy Innovation Plenary 2 — From Journal Paper to Patients - Translating CAR T TCR and Gene Therapy Innovation

Session Description

Recent high impact research in CAR T engineering, TCR therapy, and gene therapy platforms is now driving real clinical translation across the Asia Pacific region. This session highlights evidence based advances that expand indications beyond oncology, improve durability and persistence, and strengthen vector design and manufacturability. Speakers will present practical insights to help regional programs translate cutting edge research into scalable, regulator ready therapies.

Session Objectives

  1. Identify key scientific advances in CAR T, TCR, and gene therapy platforms, including CD7 CAR T strategies, CAR T applications beyond oncology, receptor selection principles, and innovations in vector design and delivery.
  2. Understand how recent peer reviewed clinical and translational studies address challenges such as durability, toxicity, fratricide, and manufacturability.
  3. Apply insights from high impact research to develop scalable, regulator-ready cell and gene therapy programs relevant to clinical translation in the Asia Pacific region.
Speakers
He Huang

He Huang, MD, PhD

Zhejiang University, China

Bruce Levine

Bruce Levine, PhD

University of Pennsylvania, United States

Guanping Gao

Guanping Gao, PhD

UMass Chan Medical School, United States

Plenary 3 — Cutting Edge Technologies Transforming Cell Therapy Manufacturing Plenary 3 — Cutting Edge Technologies Transforming Cell Therapy Manufacturing

Session Description

Asia is rapidly adopting advanced cell manufacturing technologies to support the expansion of cell and gene therapies, driven by innovations in AI, automation, and QbD-based manufacturing. This session will highlight practical approaches for automated production, selection of scale up and scale out strategies, and regulatory considerations for implementing new technologies. Speakers will provide insights to help regional programs build efficient, compliant, and scalable manufacturing systems.

Session Objectives

  1. Introduce QbD-based approaches for modern cell manufacturing in the Asia region.
  2. Understand the usability and limitations of AI-based and automated manufacturing technologies from a regulatory perspective.
  3. Learn how to evaluate and select scale up and scale out strategies for efficient and compliant CGT production.
Speakers
Shin Kawamata

Shin Kawamata, MD, PhD

Cyto-Facto Inc., Japan

Chiayi Hsu

Chiayi Hsu, PhD

Dr.SIGNAL, Taiwan

Ji Hyeon Ju

Ji Hyeon Ju, MD, PhD

YiPSCELL, South Korea

Plenary 3 — Cutting Edge Technologies Transforming Cell Therapy Manufacturing Plenary 3 — Cutting Edge Technologies Transforming Cell Therapy Manufacturing

Session Description

Asia has become a global leader in iPSC‑derived cell therapy development and clinical translation, supported by unique regulatory pathways and real‑world implementation frameworks. This session presents the latest clinical progress in Asia and beyond, featuring first‑hand trial experience and evolving regulatory strategies. While challenges in scalability, long‑term safety, and cost remain, participants will gain forward‑looking insights into the scientific and policy foundations needed for sustainable commercialization.

Session Objectives

  1. Compare regulatory pathways for iPSC-derived therapies across Asia and assess their impact on clinical translation.
  2. Identify key scientific, manufacturing, and clinical challenges limiting the timely development and scalability of iPSC-based treatments.
  3. Evaluate strategies to accelerate patient access while maintaining safety standards and enabling sustainable cost structures.
Speakers
Riguo Fang

Riguo Fang, PhD

Theia Therapeutics, China

Mahendra Rao

Mahendra Rao, MBBS, PhD

MD-Bio and NKURE, United States

Plenary 1 — Delivering Clinically Ready MSC-Exosomes for Real-World Use Plenary 1 — Delivering Clinically Ready MSC-Exosomes for Real-World Use

Session Description

MSC-derived exosomes are rapidly moving toward clinical and commercial application, particularly within Asia’s fast-growing regenerative medicine ecosystem. This session provides practical insights into solving core challenges in MSC-exosome development, including MSC source heterogeneity, scalable GMP manufacturing, and defining meaningful potency and identity CQAs. Speakers will present emerging evidence on mechanisms of action and outline regulatory pathways that support consistent, clinically deployable products. Attendees will gain clear, actionable guidance for advancing MSC-exosome therapies from innovation to real-world clinical use.

Session Objectives

  1. Asia has strong political, financial, and institutional investment in regenerative medicine, with MSC-exosome programs moving rapidly toward clinical and commercial use.
  2. The region hosts a large number of early clinical applications and commercial offerings, creating an urgent need for scientific, manufacturing, and regulatory rigor.
  3. Asia is well positioned to shape global standards for scalable manufacturing, potency definition, and regulatory frameworks for MSC-exosomes.
Speakers
Sai Kiang Lim

Sai Kiang Lim, PhD

Paracrine Therapeutics, Singapore

Bernd Giebel

Bernd Giebel, PhD

University Hospital Essen, Germany

Takahiro Ochiya

Takahiro Ochiya, PhD

Institute of Medical Science, Tokyo Medical University, Japan

Concurrent Sessions

Gain a rare, end-to-end view of China's CAR-T landscape, spanning real-world clinical outcomes and manufacturing innovation. This session connects advances in addressing CAR-T durability and safety with scalable manufacturing approaches and emerging indications, including solid tumors, offering practical lessons that extend beyond publications for teams operating in Asia and globally.

Speakers
Kai-Yan Liu

Kai-Yan Liu, MD, PhD

Lu Daopei Hospital, China

Alex Chang

Alex Chang, PhD

YaKe Biotech, China

Changsong Qi

Changsong Qi, PhD

Peking University Cancer Hospital, China

This session examines emerging strategies to make cellular immunotherapy more clinically and economically accessible. It brings together advances that extend cellular therapies beyond oncology, enhance cell function without permanent genetic modification, and streamline manufacturing to reduce cost and shorten vein-to-vein time. By integrating clinical experience, molecular innovation, and process optimization, the session highlights practical pathways to deliver potent therapies at a scale and cost that support broader patient access.

Speakers
Yosef Refaeli

Yosef Refaeli, PhD

Ascensus Therapeutics, Inc., United States

Yuchen Zhou

Yuchen Zhou, PhD

Applied Cells, United States

Explore how iPSC-derived organoids and multicellular tissue models are reshaping preclinical testing and therapeutics development by re-creating complex human organ systems, reducing reliance on animal studies and improving translational predictability. This session reviews scientific maturity, emerging applications, and the evolving regulatory landscape, while candidly addressing current limitations and gaps in developing and producing human-relevant iPSC and organoid-based systems.

Speakers
Maki Kumagai

Maki Kumagai, MSc

Osaka University Division of Stem Cell and Organoid Medicine, Japan

Kyung Jin Lee

Kyung Jin Lee, PhD

OrganoidSciences, South Korea

Yun Xia

Yun Xia, PhD

A*STAR, Singapore

Accelerating the next generation of iPSC-based cell therapies requires shifting from manual laboratory processes to automated, large-scale GMP manufacturing. This session evaluates latest automation technologies and critical regulatory frameworks, contrasting QbD and non-QbD approaches to secure critical quality attributes. Panelists will also explore the integration of AI and advanced IT systems to optimize production beyond the factory floor.

Speakers
Hiroko Hanzawa

Hiroko Hanzawa, PhD

Hitachi, Japan

Atsushi Inoue

Atsushi Inoue, PhD

Cellafa Bioscience Inc., Japan

Masaki Hosoya

Masaki Hosoya, PhD

Sinfonia Technology Co., Ltd, Japan

Assess the state of MSC-derived exosomes as cell-free biologics with multi-indication potential. This session will discuss the scientific rationale underlying the pleiotropic activity of MSC-derived exosomes, linking mechanistic insights and preclinical validation to potency assessment strategies required for successful clinical translation.

Chair
Bernd Giebel

Bernd Giebel, PhD

University Hospital Essen, Germany

Speakers
Wei Seong Toh

Wei Seong Toh, PhD

National University of Singapore, Singapore

Qingling Fu

Qingling Fu, PhD

The First Affiliated Hospital of Sun Yat-sen University, China

Thai-Yen Ling

Thai-Yen Ling, PhD

National Taiwan University College of Medicine, Taiwan

Launching an allogeneic MSC therapy requires navigating divergent regulatory pathways and reimbursement landscapes. This session provides a comparative look at approved products across the U.S., Japan, and South Korea. Drawing on first-hand corporate case-sharing, speakers will address the hard realities of localized hurdles, evolving payer expectations, and industrial manufacturing frameworks needed to sustain cross-border success and future expansion.

Speakers
Silviu Itescu

Silviu Itescu, MBBS, FRACP

Mesoblast, Australia

Keita Mori

Keita Mori, MBA

SanBio, Japan

Tony Lee

Tony Lee, PhD

Medipost, South Korea

Moving past proof-of-concept, tissue-specific regenerative platforms across musculoskeletal, ocular, and cardiovascular systems are now demonstrating meaningful clinical impact. This cross-disciplinary session explores how these emerging cell, gene, and biologic therapies are reshaping chronic disease management, highlighting key translational milestones, regional regulatory progress, and pivotal clinical outcomes.

Speakers
Kenon Chua

Kenon Chua, MBBS, MRCSEd, MMed, MCI, FRCSEd

Singapore General Hospital, Singapore

Jodhbir S Mehta

Jod S Mehta, BSc (Hons.), MBBS, PhD, FRCOphth, FRCS (Ed), FAMS, FARVO

Singapore National Eye Centre, Singapore

Lynn Yap

Lynn Yap, PhD

Lee Kong Chian School of Medicine, Singapore

Transform COGS from a barrier into a competitive advantage. This practical session identifies the primary cost drivers in CGT manufacturing and connects them to actionable levers: high-yield viral vector production, optimized GMP cell banking, and data-driven automated process development. Leave with a prioritized playbook to reduce costs, accelerate time-to-clinic, and ensure your process remains fully GMP-compliant and comparability-ready.

Speakers
Lucas Chan

Lucas Chan, PhD

Lucas Chan Consulting Pte Ltd, Singapore

Sarah Ho

Sarah Ho, PhD

AGeM Bio, Singapore

Jaichandran Sivaligam

Jaichandran Sivaligam, PhD

A*STAR Bioprocess Technology Institute, Singapore

Compare centralized and point-of-care manufacturing through the lenses of cost, safety, release timelines, and system readiness in diverse Asian healthcare settings. Learn where each model excels, what standardization and training require, and how programs are navigating approvals and operational realities to expand patient access.

Speakers
Shin Kawamata

Shin Kawamata, MD, PhD

Kobe University, Graduate School of Science, Technology and Innovation, Japan

Usanarat Anurathapan

Usanarat Anurathapan, MD

Faculty of Medicine Ramathibodi Hospital, Mahidol University, Thailand

Nguyen Thanh Liem

Nguyen Thanh Liem, MD, PhD

Vinmec Healthcare System, Vietnam

This session showcases how New Approach Methodologies (NAMs) and advanced ancillary materials are enabling greater efficiency, consistency, and quality in cell therapy development. Case studies from leading innovators will highlight solutions addressing key bottlenecks, offering practical insights to accelerate development, improve CMC performance, and support scalable, high‑quality CGT production.

Speakers
Hoyoung Yun

Hoyoung Yun, PhD

Curiosis, Inc., South Korea

YongKeun Park

YongKeun Park, PhD

TomoCube, South Korea

Jihye Shin

Jihye Shin, PhD

Xcell Therapeutics, South Korea

This session examines the critical role of artificial intelligence and automation in bridging the gap between discovery and clinical delivery. Experts will discuss the transition toward autonomous, robotic closed-loop manufacturing, AI-augmented prognostic modeling for clinical decision support, and the digital infrastructure required to scale next-generation therapies. By evaluating the Asia-Pacific landscape, the session provides a roadmap for operationalizing precision-built advanced therapies on a global scale.

Speakers
Michael Fehlings

Michael Fehlings, MD, PhD

University of Toronto, Canada

Genki Kanda

Genki Kanda, PhD

Institute of Science Tokyo, Japan

The FDA's Draft Guidance on the Plausible Mechanism Framework signals a major shift toward flexible, mechanistic evidence models for advanced therapies. This session breaks down the core operational implications of this framework and explores how sponsors can merge adaptive trial designs with robust Real-World Evidence (RWE) to accelerate clinical timelines. Bringing together regulatory experts, the discussion highlights practical evidence-generation strategies across the product lifecycle to streamline the path to market.

Speakers
Yun-Kyoung Song

Yun-Kyoung Song, PhD

College of Pharmacy, The Catholic University of Korea, South Korea

Vijay Kumar

Vijay Kumar, MD

US Food and Drug Administration (FDA), United States

Discover how emerging CGT ecosystems across South and Southeast Asia are rapidly building credible advanced therapy capabilities. Through four country‑specific perspectives, this session offers a regional view of progress from laboratory innovation to clinical translation. Discussions will spotlight manufacturing advances and the regulatory reforms reshaping how CGTs are developed, delivered, and expanded for broader global patient access.

Speakers
Chaiyong Koaykul

Chaiyong Koaykul, PhD

Chulalongkorn University, Thailand

Accelerating the next generation of iPSC-based cell therapies requires shifting from manual laboratory processes to automated, large-scale GMP manufacturing. This session evaluates latest automation technologies and critical regulatory frameworks, contrasting QbD and non-QbD approaches to secure critical quality attributes. Panelists will also explore the integration of AI and advanced IT systems to optimize production beyond the factory floor.

Chair
Shin Kawamata

Shin Kawamata, MD, PhD

Kobe University, Graduate School of Science, Technology and Innovation, Japan

Speakers
Hiroko Hanzawa

Hiroko Hanzawa, PhD

Hitachi, Japan

Masaki Hosoya

Masaki Hosoya, PhD

Sinfonia Technology Co., Ltd, Japan

Atsushi Inoue

Atsushi Inoue, PhD

Cellafa Bioscience Inc, Japan

Launching an allogeneic MSC therapy requires navigating divergent regulatory pathways and reimbursement landscapes. This session provides a comparative look at approved products across the U.S., Japan, and South Korea. Drawing on first-hand corporate case-sharing, speakers will address the hard realities of localized hurdles, evolving payer expectations, and industrial manufacturing frameworks needed to sustain cross-border success and future expansion.

Chair
Daniel Weiss

Daniel Weiss, MD, PhD

University of Vermont, United States

Speakers
Antonio Lee

Antonio Lee, PhD

Global President & Board Director, Korea

Keita Mori

Keita Mori, MBA

SanBio, Japan

This session showcases how New Approach Methodologies (NAMs) and advanced ancillary materials are enabling greater efficiency, consistency, and quality in cell therapy development. Case studies from leading innovators will highlight solutions addressing key bottlenecks, offering practical insights to accelerate development, improve CMC performance, and support scalable, high‑quality CGT production.

Chair
Antonio Lee

Antonio Lee, PhD

Global President & Board Director, Korea

Speakers
YongKeun Park

YongKeun Park, PhD

Tomocube Inc., South Korea

Jihye Shin

Jihye Shin, PhD

Xcell Therapeutics, Inc., South Korea

Hoyoung Yun

Hoyoung Yun, PhD

Curiosis, Inc, South Korea

Engage with corporate venture, public, and private investors to uncover the critical factors that make CGT companies fundable in today's market. Panelists will unpack how they evaluate platform technologies, translational readiness, regulatory strategy, and IP—alongside the mounting pressures of scalability and manufacturing. Gain practical guidance to strengthen fundraising, strategic partnerships, and company design within Asia's fast-evolving ecosystem as it advances in lockstep with global therapeutic development.

Chair
Natasha Hui Jin Ng

Natasha Hui Jin Ng, PhD

BetaLife Pte Ltd, Singapore

Speakers
Kim Png

Kim Png, PhD, MBA

Polaris Partners, Singapore

This roundtable explores the three interdependent pillars shaping CGT access in Asia—availability, affordability, and alignment. Panelists will discuss how access pathways and infrastructure influence availability, why conventional affordability models often fall short in heterogeneous markets, and how aligning development, regulatory, and commercialization strategies with local healthcare systems, stakeholders, and patient needs is essential to enabling sustainable and meaningful access.

Chair / Co-Chair
TBD

To Be Announced

TBD

Additional Sessions to be Announced