Dr. Gabrielle O’Sullivan is the Executive Officer of Royal Prince Alfred Hospital Institutional Biosafety Committee and has extensive experience in the regulation and risk assessment of gene technology, particularly in the contexts of biosafety, biomedical research, clinical trials, and cell and gene therapies. She is a member of the Australian Government Department of Health Gene Technology Technical Advisory Committee (GTTAC) and Gene Technology Ethics and Community Consultative Committee (GTECCC), co-chair of the ANZ Legal and Regulatory Affairs Committee of the International Society Cell & Gene Therapy (ISCT), and a member of the Ausbiotech & Medicines Australia Cell & Gene Therapy Catalyst Expert Working Group on policy and advocacy. 

Dr. 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). 

Dr. 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.

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.

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. 

Mr. 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.

Professor 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. 

Dr. 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.

Dr. 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. 

Ms. Asha Thanabalan 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. 

Professor 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.

Andrés Caicedo earned his PhD with Honors in Biomedicine in 2013, supported by a scholarship from the French Ministry of National Education, Higher Education, and Research. He holds specializations in Regenerative Medicine from the Biomedicine Research Institute and Biotherapies (IRMB) and in Management, both from the University of Montpellier. Since 2016, he has been an Associate Professor and Principal Investigator at the School of Medicine at San Francisco University of Quito (USFQ), where he leads the "Biomedical Discovery" team. His research group focuses on developing innovative therapies for repairing tissue damaged by aging, environmental stress, or injury.

In 2017, Andrés was named one of the Innovators Under 35 in Latin America by the MIT Technology Review for his groundbreaking work on "Artificial Mitochondria Transplantation for Medical Purposes, MitoCeption." That same year, he won the "Ecuador Changes the World" Innovation Call from the Alliance for Entrepreneurship and Innovation of Ecuador (AEI) for his project on predicting susceptibility to diabetes and metabolic syndrome using circulating mitochondrial DNA.

From 2018 to 2023, Andrés led the R&D department at “Sistemas Médicos USFQ” and founded the Dragon BioMed Initiative at USFQ, focusing on mitochondria as a "Living Drug." In 2019, he served as Chairman of the Scientific Commission at the National Institute of Transplantation of Tissue, Organs, and Cells (INDOT). He currently serves as the Vice-President for the ISCT South and Central America Regional Executive Committee. In 2023, Andrés was honored with the ISCT Trailblazer Award for Emerging Markets, and in 2024, he received the Best Innovation of the Year and Best Inventor Awards from the Ecuadorian Corporation for the Development of Research and Academia (CEDIA).

Throughout his career, Andrés has been awarded multiple grants to advance intellectual property rights for innovations in regenerative medicine and cancer, primarily funded by CEDIA. He remains committed to fostering collaboration between the private sector, academia, and government to position Ecuador and the region as leaders in safe and effective stem cell-based therapies.

Virginia Picanço e Castro, PhD, is a prominent researcher at the Regional Blood Center of Ribeirão Preto in Brazil, where she focuses on pluripotent stem cells and cell reprogramming. After earning her degree in Biological Sciences from the University of São Paulo, Dr. Picanço e Castro pursued a Ph.D. in Genetics at the Medical School of Ribeirão Preto, followed by postdoctoral fellowships at both the Regional Blood Center and Indiana University. Her research explores the complex pathways involved in cell reprogramming, specifically aiming to generate pluripotent stem cells from human somatic cells. She also investigates the molecular mechanisms that regulate the differentiation of hematopoietic and pluripotent stem cells, with the ultimate goal of developing effective in vitro differentiation protocols.

Dr. Picanço e Castro’s work aims to create a comprehensive database of genomic proto-proteins involved in hematopoietic differentiation, which could lead to new gene overexpression techniques that enhance cell differentiation and reprogram fibroblasts into adult blood cells. Her research is highly relevant to Brazil's burgeoning biotechnology sector, with the potential to offer safer and more efficient stem cell-based therapies. She collaborates with leading national and international researchers and guides a team of students at the Biotechnology Laboratory Group, contributing to significant advancements in regenerative medicine and therapeutic innovation.

Samuel C. F. Couto, PhD, currently serves as Manufacturing Lead at Instituto Butantan, and also as an associate researcher at the University of São Paulo in Brazil. After earning his degree in Biological Sciences from PUC-Campinas University, Samuel pursued a PhD in Biotechnology at the University of São Paulo, followed by postdoctoral fellowships at both the University of São Paulo's Medical School and Children’s National Hospital in Washington, D.C. He is particularly interested in increasing access to cellular and gene therapies in lower-middle-income countries. 

Lilia C. León-Moreno, PhD, is a posdoctoral researcher focused on the study of exosomes and mesenchymal stromal cells as a potential therapy for neurodegenerative diseases. She is interested in increasing the knowledge of the medical and scientific communities, and general public about advanced therapies and establishing a regulatory framework that enables the development of these therapies in Latin America. She is currently involved in the planning of a CDMO for cell therapy in Jalisco. 

Phil is responsible for technical due diligence and evaluation of potential investments, as well as guiding operational, R&D and strategic initiatives carried out at portfolio companies. An entrepreneurial and strategic international business leader, Phil joins Gamma from GE Healthcare’s Cell and Gene Therapy business unit where he directed strategy and portfolio growth. Phil received his Ph.D. in Biochemistry and Molecular Biology at Georgetown University Medical Center followed by an IRTA fellowship at the National Cancer Institute in Maryland, and at the Hollings Cancer Center in Charleston, SC. Phil was an instructor for Johns Hopkins University Advanced Academic Programs teaching Biotechnology Marketing in the Masters of Biotechnology / MBA program, and has held leadership positions in a number of life sciences companies including Life Technologies, Becton Dickinson, and Lonza. Phil is a Board Member of CCRM in Toronto Canada and a Board Member of the ARM Foundation.

Massimiliano Gnecchi, ISCT Chief Scientific Officer, brings over 25 years of expertise in cardiology, serving as Associate Professor of Cardiology at the University of Pavia, Italy, and Director of the Molecular and Translational Cardiology Unit at IRCCS San Matteo Hospital. Clinically, he focuses on acute myocardial infarction, post-AMI secondary prevention, and cardiac sudden death. His translational research spans molecular and cellular therapies for heart disease, precision medicine, and includes pioneering work with cardiomyocytes, iPSCs, miRNAs, and MSCs.

Stephen Majors is a communications and media professional specializing in investor relations, with a diverse background spanning biotechnology, public policy, international affairs, and journalism. He excels at transforming complex scientific, business, and policy information into clear, engaging narratives for audiences around the world, including executives, investors, and the press. At ARM, Stephen serves as the organization’s global media spokesperson and social media strategist, supporting policy and advocacy initiatives in Washington, state capitals, and Brussels. He communicates intricate scientific concepts to both the public and policymakers, highlighting the policy changes needed to ensure patients benefit from the innovative work of ARM’s members.

Dr. Mohammad A. (Mo) Heidaran, Ph.D. is Owner and Chief Regulatory Scientist at Cellx Inc., where he advises on regulatory strategy, product development, and FDA submissions for advanced therapies. With more than 35 years of experience spanning government, industry, and academia, he has held leadership roles at FDA/CBER, Celgene, Becton Dickinson, and Parexel, and most recently led translational and regulatory strategy at GC Therapeutics.

Dr. Heidaran spent nine years at FDA’s Center for Biologics Evaluation and Research (CBER), where he served as Acting Branch Chief in the Office of Tissues and Advanced Therapies and was recognized as a subject matter expert in CMC policy, GMP compliance, and regulatory review of cell and gene therapies. Earlier in his career, he conducted research at the National Cancer Institute, contributing to the understanding of growth factor signaling and oncology.

He is an active member of professional organizations including ISCT and USP, contributes to regulatory and legal committees, and has authored over 50 publications and more than 25 issued patents. A frequent invited speaker, Dr. Heidaran is recognized globally for his expertise in regulatory strategy, CMC development, and advancing cell and gene therapies from research to the clinic.

Ksenia Bezverbnaya is a Manager, Technology & Venture Development, at the company creation unit at the Centre for Commercialization of Regenerative Medicine (CCRM), Canada. She helps academic and clinical investigators derisk novel cell and gene therapy technologies and spin out start-up companies across a variety of therapeutic indications. Ksenia has extensive experience in immune cell engineering, preclinical development, and indication selection, and brings an early-stage translational industry perspective to the discussion.

Asthika Goonewardene is a Managing Director at Truist Securities, where he focuses on equity research in immune-oncology, cell therapy, and antibody technologies. He has over two decades of experience in biotech intelligence and investment with previous roles at Bloomberg Intelligence, Datamonitor, Piper Jaffray, Amba Research, and OSI Pharmaceuticals. Asthika has been a long-standing member of the ISCT Business Development & Finance Committee, where he championed previous iterations of the Investor Survey and gathered valuable insights on the CGT investment trends.

Bambi is the Director of the Clinical Research and Early Product Development Center, Cell and Gene Therapy, at the Baylor College of Medicine. She is a world-renowned expert in Clinical Research and Regulator Affairs with over 25 years of experience in protocol development, study submissions, execution, and oversight of over 1,600 studies. Bambi has been leading cell and gene therapy regulatory guidance, protocol development, quality assurance and quality control programs for over 15 years and currently serves as the Chief Regulatory Officer at ISCT. 

Wilson Bryan is a regulatory veteran in the regenerative medicine space, who served as the FDA’s Chief of the Clinical Evaluation Branch in the Office of Cellular, Tissue, and Gene Therapies (OCTGT) between 2009 and 2016, and subsequently as the Director of the Office of Tissues and Advanced Therapies (part of CBER) between 2016 and 2023. He brings a wealth of knowledge in regulation of cell and gene therapies, tissue-engineered products, plasma protein therapeutics, and xenotransplantation. Prior to leading the CGT regulation with the FDA, Wilson was an active clinician, clinical investigator, and faculty in the neurology and neuromuscular space for over a decade.