Cell and Gene Therapy Approvals in Asia Pacific


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ABOUT THE WEBINAR

Join leading regulatory experts from Japan, Singapore, and South Korea for a webinar exploring CGT approval pathways across three key APAC jurisdictions. Based on the recently published ISCT APAC Industry Committee regulatory roadmap in Cytotherapy, this session provides practical insights for navigating complex regional regulatory landscapes.

Our distinguished panelists will share emerging trends and recent updates in APAC cell and gene therapy regulations, including regulated access to unapproved and unproven therapies and real-world case studies from their respective markets. Learn about Singapore's risk-based CTGTP classification system, Japan's innovative conditional approval pathways, and South Korea's advanced biological products regulations.

This is a must-attend webinar for regulatory affairs professionals, clinical developers, and business leaders seeking to unlock APAC opportunities while ensuring alignment between Eastern and Western regulatory approaches. Tune in for actionable insights that propels successful approval strategies, information on submission requirements, and development timelines that can accelerate your CGT programs in these rapidly expanding markets.

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KEY LEARNING OBJECTIVES

  • Introduce the regulatory frameworks for cell, tissue, and gene therapy products (CTGTPs) in Japan, Singapore, and South Korea
  • Identify emerging trends and recent updates in cell and gene therapy regulations, including regulated access to unapproved and unproven therapies
  • Evaluate product development pathways and approval strategies using real-world case studies
  • Apply practical insights to support successful regulatory submissions in APAC markets
 WEBINAR CHAIRS

William Hwang, MBBS, FRCP, FAMS, MBA
ISCT Asia Pacific (APAC) Industry Committee Co-Chair
Professor
Duke-NUS Medical School
Senior Consultant Haematologist, NCCS, SGH
Senior Advisor, SingHealth
Singapore

William serves as a Senior Advisor at SingHealth, Co‑Director of the Regenerative Medicine Institute of Singapore (REMEDIS), and Senior Consultant in the Department of Haematology at Singapore General Hospital and the National Cancer Centre Singapore. He also holds key leadership roles across the region, including APAC Industry Co‑Chair of the International Society for Cell and Gene Therapy (ISCT), Chair of the Singapore Translational Cancer Consortium, Board Organising Committee member of the Advanced Cell Therapy Research Institute of Singapore (ACTRIS), and Chair of the Advisory Board of the Lien Centre for Palliative Care. Additionally, he co‑chairs the MOH Cell, Tissue and Gene Therapy Workgroup, the MOH Tissue Banking Working Committee, and the National Advisory Committee on Cancer.

He previously held numerous senior leadership positions, including Chief Executive Officer of the National Cancer Centre Singapore, Chair of the Oncology Academic Clinical Programme at Duke‑NUS, Head of the SingHealth Duke‑NUS Cell Therapy Centre, Director of SingHealth Transplant, and Medical Director of the Singapore Cord Blood Bank. He has also served in prominent international roles, including President of the World Marrow Donor Association and Vice President of ISCT. His clinical and research focus centres on blood and marrow transplantation.

Eddie Tan, PhD, CABP
ISCT Asia Pacific (APAC) Industry Committee, ESP Subcommittee Member
Assistant Professor, Center of Regulatory Excellence
Duke-NUS Medical School
Singapore

Eddie has a keen interest in integrating scientific advancements into modern medicine. He is currently the co-lead for Health Services Research at the Duke-NUS Centre of Regulatory Excellence (CoRE), where his team manages a project with Singapore’s Ministry of Health to address emerging healthcare topics.

Prior to joining CoRE, he had spent 6 years as the Scientific Officer in the National Cell Therapy Pilot Program housed under the Blood Services Group of the Health Sciences Authority of Singapore (HSA). In his role with HSA, Dr. Eddie Tan is responsible for engaging with medical and scientific leaders to address Chemistry Manufacturing and Controls (CMC) matters to transform pre-clinical research into GMP-compliant manufacturing and early-phase clinical trials. From 2021 to 2024, he also held an appointment as a Cell Therapy Specialist covering Translational Services and Regulatory Management and was involved in the planning and establishment of the Advanced Cell Therapy Research Institute of Singapore (ACTRIS), as an effort to develop a new national GMP Facility for Cell and Gene Therapy Manufacturing.

He graduated with a BSc (Hons in Biological Sciences) and a PhD (Biological Sciences) from Nanyang Technological University in Singapore. He is a member of the inaugural batch of professionals awarded the Certified Advanced Biotherapies Professional (CABP) designation by AABB in 2022. He is also a registered member of The Organization of Professionals in Regulatory Affairs (MTOPRA). 

 WEBINAR SPEAKERS

Yoshiaki Maruyama, PhD
Director, Office of Cellular and Tissue-Based Products
Pharmaceuticals and Medical Devices Agency (PMDA)
Japan

Dr. Yoshiaki Maruyama is currently the Director at the Office of Cellular and Tissue-based Products within the Pharmaceuticals and Medical Devices Agency (PMDA), Japan. He joined PMDA in 2008 as an officer in the Office of Compliance and Standards, where he also served as secretariat for the Japanese Pharmacopoeia until 2012. In his current role, he oversees a broad range of responsibilities, including approval reviews for cell and gene therapy products, tissue-based products, and biologics, as well as post-market surveillance.

He has contributed as the Ministry of Health, Labour and Welfare (MHLW) and PMDA topic leader for the development of ICH guidelines and Annexes on “Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions (Q4B).”

Prior to joining PMDA, he was a research fellow at the University of Calgary, Canada (2001–2005) and at the National Center of Neurology and Psychiatry (NCNP) in Tokyo, Japan (2005–2008). 

Jihye Shin, PhD
 Director of Business Development
Xcell Therapeutics Inc.
South Korea

Dr. Jihye Shin is an accomplished business development executive with a PhD in Molecular Immunology and extensive experience in the pharmaceutical and biotechnology industries. With a strong foundation in drug development, strategic partnerships, and commercialization, Dr. Shin has successfully led initiatives that drive innovation and market expansion.

After earning a bachelor's degree in Molecular Biology and a PhD in Molecular Immunology from Ewha Womans University in Korea, Dr. Shin spent four years as a research scientist specializing in immunology and rheumatology. Transitioning into the pharmaceutical sector, she developed expertise in preclinical development for chemical drugs, gaining a comprehensive understanding of the end-to-end drug development process, from discovery to regulatory approval and commercialization. Throughout her career, Dr. Shin has played a pivotal role in alliance management, licensing deals, joint ventures, and co-development strategies, securing high-value partnerships that accelerate therapeutic advancements. Her ability to bridge scientific expertise with business strategy has been instrumental in fostering collaborations across global biotech and pharmaceutical organizations.

Now serving as Head of Business Development at Xcell Therapeutics, Dr. Shin leads efforts to expand the company’s presence in cell and gene therapy (CGT), focusing on culture media development and strategic industry alliances. Through targeted engagement with researchers and industry stakeholders, she seeks innovative collaborations that drive CGT technologies forward and bring transformative therapies to market.

Sudipto Bari, PhD
ISCT Asia Regional ESP Subcommittee Co-Chair
 Head & Assistant Director, Translational Services & Regulatory Management
Advanced Cell Therapy and Research Institute (ACTRIS)
Singapore

With over six years of experience in translational research, clinical-grade manufacturing, and the application of cell and gene therapy products, Sudipto serves as Head and Assistant Director of Translational Services and Regulatory Management at the Advanced Cell Therapy and Research Institute (ACTRIS). In this role, Sudipto oversees the planning and execution of strategic initiatives, partnerships, and outreach activities that support the institute’s mission and vision. Sudipto holds a PhD in Pharmacy and a BEng in Biomedical Engineering from the National University of Singapore, as well as an MBA from Quantic School of Business and Technology.

Sudipto is also a Senior Research Fellow at the National Cancer Centre Singapore, where he conducts cutting-edge research and collaborates with multidisciplinary teams of clinicians, scientists, and engineers. He holds multiple patents, has received awards, and has published extensively in the field of hematopoietic stem and progenitor cells. Passionate about advancing regenerative medicine, Sudipto is committed to improving the lives of patients with blood disorders and cancers. With strong expertise in management, strategic planning, innovation, and communication, he strives to foster a culture of excellence, innovation, and impact at ACTRIS.