Cell & Gene Therapy in Malaysia: Opportunities and Challenges

Tongted Das, PhD, MSc, BASc
ISCT ANZ LRA Committee Member
ISCT ESP Leadership Development Program Member
 Quality Officer, Cellular Therapies
Monash Health
Australia

Tongted Das is an experienced cell therapy professional with 15 years in clinical operations and quality-focused roles within stem cell transplantation and blood cancer programs. Originally trained as a postdoc research scientist, Tongted combines a strong foundation in molecular biology and immunology with practical experience in CAR-T clinical trial delivery, from feasibility through to TGA submission and patient recruitment. Currently, Tongted serves as a Cell Therapy Quality Officer at Monash Health, and as a committee member of the ISCT ANZ LRA group, supporting regulatory awareness and collaboration across the cell and gene therapy community.

Dominic Wall, PhD, BSc (Hons), FFSc (RCPA)
ISCT ANZ LRA Committee Co-Chair
ISCT Past ANZ Regional VP (2012-2014)
Chief Scientific Officer
Cell Therapies Pty Ltd.
Executive Director, Business Ventures
Peter MacCallum Cancer Centre
Australia

Professor Dominic Wall is Executive Director Business Ventures at Peter MacCallum (Peter Mac) Cancer Centre, Melbourne. He also oversees the national Centre of Excellence in Cellular Immunotherapy at Peter Mac and leads Peter Mac’s Pathology services, and is the Chief Scientific Officer of Peter Mac’s majority owned and controlled independent and commercial business Cell Therapies Pty Ltd. Cell Therapies provides specialised contract manufacturing and testing of cells for human therapy, predominantly in the field of cellular immunotherapy and gene therapy. Dominic has been directly involved in cell therapy manufacturing since the 1990s and was responsible for manufacturing Australia’s first CAR-T products in 2008. Dominic trained at the University of London School of Pathology at Middlesex & UCH and obtained his PhD at the University of Melbourne. His technical expertise in cell-based therapy, immunology and flow cytometry, alongside deep experience in hospital services and regulatory is invaluable to Australia. Lastly, Dominic co-chair's the ISCT ANZ LRA Subcommittee, and has previously served as an ISCT ANZ Regional Vice-President.

Patrick Foong, PhD, LLM, LLB
ISCT ANZ LRA Committee Member
ISCT ECGT Committee Member
Senior Lecturer, Law
Western Sydney University
Australia

Patrick Foong is a senior law lecturer at Western Sydney University (WSU). He teaches Civil Procedure & Arbitration and Bioethics. His research interests lie in bioethics & health law, including the regulation of stem cell research & therapy (including SCBEMs/embryo models), human genome editing (CRISPR-Cas9), artificial intelligence (AI) in healthcare and research, personalised medicine, biobanking, and other emerging biotechnologies. He has contributed to the Journal of Law & Medicine and Asian Bioethics Review. In his PhD thesis, Patrick compares the Australian regulatory regime on human embryonic stem cell research with the Malaysian regime. Patrick serves on WSU’s Low and Negligible Risk (LNR) research ethics review committee. In addition to serving on the ISCT ANZ LRA Committee and the ISCT ECGT Committee, Patrick is also a member of the International Society of Stem Cell Research (ISSCR). 

Zubaidah Zakaria, MBBS, DCP, FAMM
Haematopathologist
Independent Researcher
Malaysia

Dr. Zubaidah Zakaria is a senior haematopathologist a pioneer of stem cell and cellular therapy development in Malaysia. She obtained her MBBS from the University of Malaya and a postgraduate qualification in Clinical Pathology from the University of London. She further completed subspecialty fellowship training at the Royal Marsden Hospital and the Institute of Cancer Research, London.

Dr. Zakaria served for more than three decades at the Institute for Medical Research (IMR), Malaysia, where she led national programmes in haematology and cancer research. During her tenure, she played a key role in establishing advanced diagnostic services and one of the early GMP-compliant laboratory facilities recognised by the National Pharmaceutical Regulatory Agency (NPRA) to support cellular therapy and biomedical research.
Her work has contributed significantly to the development of haematological diagnostics, and stem cell based therapies in Malaysia. She previously served as President of the Malaysian Stem Cell Research Society for ten years, advocating for responsible development of regenerative medicine and stem cell applications in the region.
Dr. Zakaria currently supports the development of cord blood banking, mesenchymal stem cell (MSC) technologies, and regenerative medicine initiatives aligned with international standards such as the AABB Standards for Cellular Therapy Services. 

She is also a committee member of the Malaysian Medical Council (MMC) involved in the development of national policies and professional guidelines on regenerative medicine and stem cell therapy. Her work contributes to strengthening regulatory frameworks and ensuring safe, ethical and evidence-based implementation of cellular therapies in Malaysia.

With extensive experience in haematopathology, stem cell biology, translational research, and laboratory quality systems including ISO 15189, Dr. Zakaria continues to advise on national and international initiatives in advanced diagnostics, stem cell banking and regenerative medicine. 

James Then, MSc
Managing Director
CryoCord Cell & Gene
Malaysia

James Then is the Managing Director of CryoCord Cell and Gene which was founded in 2002, and is now the leading cell and gene company in Malaysia having grown from stem cell storage to immune cell storage into a comprehensive cell-based technology company, advancing haemopoietic stem cells (HSCs), mesenchymal stem cells (MSCs), induced pluripotent stem cells (IPSCs), immune cells such as natural killer (NK) cells & CAR T-cells, extracellular particles, and other breakthrough innovations. Since the company began, James has contributed enormously to Malaysia’ efforts to develop cell and gene therapy products and the regulations governing cord blood banking and later cell and gene therapy. James is originally an economist by training and has direct experience of developing cell and gene therapies in Malaysia and navigating the regulatory systems required to obtain registration of advanced therapeutic products in Malaysia.

Chin Sze Piaw, MBBS, MRCP, FNHAM
Adjunct Professor
Universiti Tunku Abdul Rahman 
Physician & Co-Founder
Cytopeutics
Malaysia

Chin Sze Piaw is an adjunct professor and honorary fellow with the Centre for Stem Cell Research (CSCR) at Universiti Tunku Abdul Rahman (UTAR) and a co-founder of Cytopeutics in 2007. He is also a consultant cardiologist and physician at CMH Specialist Hospital in Seremban. In 2023 Cytopeutics became the first company in the world to have its stem cells products declared Halal according to Sharia by the International Islamic Fiqh Academy (IIFA) under the Organisation of Islamic Cooperation (OIC). In 2024, Prof Chin was awarded the ISCT Global Trailblazer Award for Emerging Markets for his leadership and impact in advancing cell and gene therapy in Malaysia, promoting and facilitating the scientific and innovation ecosystem in Malaysia and Southeast Asia in line with good regulation, entrepreneurial drive in establishing Cytopeutics, and advocating for allogeneic cell therapy to be accepted universally. 

Publication(s):

SP Chin, SM Tan, KM Chang, SFA Abdul Wahid, A Sharif, et al. Baseline CD4+/CD8+ TEMRA Levels and early response predict survival after umbilical cord-derived mesenchymal stem cells infusion in acute GVHD patients: A randomised double-blinded placebo-controlled multicentre clinical trial. J Blood Med 2025;16:469-481. https://doi.org/10.2147/JBM.S546632. PMCID: PMC12515453  PMID: 41084724. https://pmc.ncbi.nlm.nih.gov/articles/PMC12515453/

Chin SP, Kee LT, Mohd MA, Then KY. Umbilical Cord-Derived Mesenchymal Stem Cells Infusion in Type 2 Diabetes Mellitus Patients: A Retrospective Cytopeutics' Registry Study. Diabetes Metab Syndr Obes. 2025 May 19;18:1643-1659. doi: 10.2147/DMSO.S507801. PMID: 40416928; PMCID: PMC12102742. https://pmc.ncbi.nlm.nih.gov/articles/PMC12102742/ 

Mohammad Firdaus Bin Abdul Aziz , PhD, MA, BSc
Senior Lecturer, Law
Deputy Dean, Research & Innovation
Universiti Malaya
Malaysia

Firdaus Aziz serves as a Senior Lecturer and Deputy Dean of Research and Innovation at the Faculty of Law, Universiti Malaya. His research interests encompass medical law, biosafety law, and the legal and ethical implications of emerging technologies, including stem cell technology, biobanking, and gene editing. He earned his BSc (Hons) in Genetics and Molecular Biology from Universiti Malaya and subsequently received the National Science Fellowship to pursue an MA in Biotechnological Law and Ethics at the University of Sheffield. He later completed a PhD in Public Health at St Edmund Hall, University of Oxford, where he focused on stem cell law and ethics at the Centre for Health, Law and Emerging Technologies (HeLEX). Since 2016, he has been actively involved in promoting bioethics in the region as a UNESCO Bioethics Trainer. Additionally, he is a co-investigator for the Southeast Asian Bioethics Network, supported by the UK Wellcome Trust, with the aim to establishing a bioethics network in the region, and a co-investigator for the NIH Fogarty grant to develop a Master's program in Health Research Ethics at the Faculty of Medicine, Universiti Malaya.

Publication(s):
Mohammad Firdaus Bin Abdul Aziz, Michael Morrison & Jane Kaye (2018) Regulating human stem cell research and therapy in low- and middle income countries: Malaysian perspectives, New Genetics and Society, 37:1, 2-20, DOI: 10.1080/14636778.2017.1415137, https://www.tandfonline.com/doi/full/10.1080/14636778.2017.1415137

Azizah Ab Ghani, PhD
Department Head, Biologics Section
Centre of Product and Cosmetic Evaluation
National Pharmaceutical Regulatory Agency (NPRA)
Malaysia

Azizah Ab Ghani is a distinguished regulatory expert currently serving as the Head of Biologics at the National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health Malaysia. With near 30 years of experience in the Ministry, including 12 years specializing in biological products, she provides technical oversight for the evaluation and approval of biologics and biosimilars in Malaysia. Azizah holds a PhD in Pharmacology from the University of Liverpool and has been a central figure in drafting national guidelines and driving international regulatory harmonization through platforms like the WHO and ASEAN. A prolific contributor to the scientific community, she has co-authored numerous peer-reviewed publications and book chapters on vaccine development, cell and gene therapy products, and biosimilar regulation. Her expertise spans risk-based evaluation, reliance pathways, and strategic policy development for the Malaysian pharmaceutical sector. 

Publication(s):

Loh, E.Y.X., Ab Ghani, A., Ahmad, R. (2023). Regulatory Oversight of Cell and Gene Therapy Products in Malaysia. In: Galli, M.C. (eds) Regulatory Aspects of Gene Therapy and Cell Therapy Products. Advances in Experimental Medicine and Biology, vol 1430. Springer, Cham. https://doi.org/10.1007/978-3-031-34567-8_10

Cell and Gene Therapy Regulation in Malaysia: Current Pathways and International Comparison, Hazureen Mohd Halimi, Meor Mohd Redzuan Bin Meor Mohd Affandi, Mahmathi Karuppannan, Azizah Ab. Ghani, Publisher: Issue: 3 2026 Vol. 16, https://japsonline.com/abstract.php?article_id=4698&sts=2

Asha Thanabalan, MHS
Business Development Lead
Clinical Research Malaysia
Malaysia

Asha is a health science graduate with more than 13 years of experience in the clinical research industry. Prior to her current role in Business Development, she was with the Medical Research and Ethics Committee (MREC) in Ministry of Health, during which she was responsible in managing the review of sponsored research studies as well as maintaining MREC’s relevant accreditation and recognition by both Forum for Ethical Review Committees in the Asian and Western Pacific (FERCAP) and NPRA.

In Business Development, she leads the department, overseeing the feasibility, business relations & corporate communications in Clinical Research Malaysia. This includes engagements with stakeholders, promotional & awareness activities as well as drive strategic communications about clinical research activities in Malaysia. She also currently leads the ASEAN clinical research initiative, aimed at advancing regional collaboration in industry-sponsored clinical research.

In addition, Asha has served as a working committee member for the ISO Quality Management System and Internal Auditor for the ISO Anti-Bribery Management System within CRM. She also supports as secretariat to Malaysia’s First-in-Human Scientific Review Panel. 

Cheong Soon-Keng, MBBS, FRCP, FRCPA, FAMS, FASc
Professor Emeritus
National University of Malaysia
Universiti Tunku Abdul Rahman
Malaysia

Cheong Soon-Keng is both a Professor Emeritus of hematology at the National University of Malaysia (UKM), and of medicine at the Universiti Tunku Abdul Rahman (UTAR). He has established the Diagnostic Laboratory Services and Clinical Bone Marrow Transplant Centre in the UKM Medical Centre. He has also previously served as member of the Malaysian Medical Council and President of Malaysian Haematology Society, and the Dean of Faculty of Medicine & Health Sciences of Universiti Tunku Abdul Rahman (UTAR). 

Currently, Cheong is President of the College of Pathologists, Academy of Medicine, and Senior Fellow of the Academy of Sciences Malaysia. Cheong has been at the forefront of stem cell research for many years. His pioneering work in Mesenchymal Stem Cells (MSCs) and Induced Pluripotent Stem Cells (iPSCs) has placed Malaysia on the global map in stem cell research and therapy. His efforts have led to significant advancements, including the first clinical-grade, GMP-compliant iPSC cell lines in Malaysia. He has mentored many aspiring biologists, scientists and clinicians embarking on cellular research. He is also involved with the National Cancer Council (MAKNA)—a not-for-profit organisation to serve cancer patients and advance research—as a foundation councillor.