APAC’s Premier CGT Congress - Uniting Leaders, Innovation, and Quality

Chethan A J is currently working as Assistant Director Quality Assurance and Regulatory Affairs at Center for Ocular Regeneration (CORE), LV Prasad Eye Institute, Hyderabad, India specializing in Quality Management System, Risk Management and Indian Regulatory Affairs. With over 13 years of experience in Cell and Gene therapy field, Chethan has involved and led the team in various aspects of CMC such as manufacturing, Quality Assurance and Regulatory Affairs. Under his leadership the CORE GMP manufacturing facility could achieve to get manufacturing and test license in form CT-11 for 5 unique cell therapy based products and Clinical trial license for Phase I trial for 2 unique cell therapy products in for CT-06 from Indian FDA, CDSCO. He is expert in deriving Quality Management System in Cell therapy products which meets the compliance to the required cGMP standards. He holds a master degree in Medical Biochemistry from Manipal University, MBA in Total Quality Management, Diploma in GMP, Six Sigma Green belt and certified Internal Auditor for ISO 9001:2015 QMS. He is an active member of Society of Quality Assurance (SQA) and Indian Society for Clinical Research (ISCR). Outside of work Chethan enjoys hiking, photography, sports & fitness.

‍

Ryuichi Morishita, M.D., Ph.D., graduated Osaka University Medical School in 1987, and received Ph. D. from Osaka University in 1991. After following postdoctoral Fellow at Stanford University School of Medicine, he served as an Assistant Professor, Department of Geriatric Medicine, Osaka University Medical School from 1994 to 1998. Then, from 1998 to 2003, he was Associate Professor, Division of Gene Therapy Science, Osaka University Medical School. Then, he became Professor & Chairman of Division of Clinical Gene Therapy, Graduate School of Medicine, Osaka University Medical School from 2003 to present.

Professor Dr Chin Sze Piaw is the co-founder of Cytopeutics, a biotech company in Malaysia that is spearheading research in cell and gene therapy products. Prof Chin and Cytopeutics were the first in Malaysia to be awarded the CTX license for stem cell manufacturing for clinical investigational use under Malaysia’s strict Cell and Gene Therapy Products (CGTP) regulations and the only group to have successfully passed Phase 2 screening for CGTP registration. Prof Chin and his team have successfully completed 6 randomized controlled clinical trials including a First-In-Human safety study, severe stroke, heart failure, osteoarthritis and acute graft versus host disease (GVHD) with other multicenter trials currently underway (wound healing, diabetes and colorectal cancer). Prof Chin has over 60 full-paper publications in international peer-reviewed journals and has received numerous government grants for his research. He also holds 3 US and 9 Malaysia patents and was recently nominated by the MOSTI and MOE for the UNESCO Life Science Researcher’s award for his pioneering work on secretomes. Prof Chin is also the first Asian recipient of the major global International Society for Cell Therapy (ISCT) award from the International Society for Cell Therapy.

Biography - A leader with 20+ years of experience in aseptic manufacturing and quality excellence, inspiring innovation and continuous improvement in the pharmaceutical industry.

I bring over 20 years of experience in the biopharmaceutical and pharmaceutical industry, specializing in Quality functions, Commissioning & Qualification, and Formulation Development. My career has focused on aseptic manufacturing of bulk and final fill operations, where I have successfully led the setup of new facilities, managed regulatory audits, and driven technology transfers across diverse dosage forms. I am passionate about operational excellence, digital innovation, and continuous improvement—transforming complex challenges into opportunities for growth. Over the years, I have guided teams through critical projects that strengthened compliance, enhanced efficiency, and elevated standards in manufacturing.

As I share my journey, my goal is not only to highlight the importance of quality and innovation but also to inspire the next generation of professionals to embrace excellence, adaptability, and a forward-looking mindset in shaping the future of our industry.

Chimeric Therapeutics CEO Dr Rebecca McQualter joined the Company in May 2024, bringing senior experience from a range of big pharma roles. Dr McQualter holds a Doctor of Philosophy in Cell Therapy and Regenerative Medicine from Monash University. Dr McQualter has an extensive commercial career with exposure to many aspects of international pharmaceutical operations. This included as the Head of Strategic Access at Novartis Australia, where Dr McQualter developed new commercial partnerships, built external networks spanning policy makers, research institutes and NGOs, and engaged with federal and state government, trade associations and other stakeholders to implement policy and process improvements. Other previous roles include Country Medical Head for Bioverativ ANZ, a $5 billion Biogen spinout focusing on rare diseases, and leadership roles at Amgen and GSK.

Dr. Seokjoong Kim is the Chief Strategy Officer at GenEdit, leading platform development, portfolio strategy, and partnerships across genome medicine. He previously served as Executive Director at ToolGen, where he oversaw genome editing R&D programs, strategic alliances, and major licensing deals. With a background spanning CRISPR, non-viral delivery platforms, and translational immunology, he has built multidisciplinary programs from early discovery to clinical planning. Dr. Kim received his Ph.D. in Molecular Medicine from the University of Texas Health Science Center and began his genome editing research at Seoul National University. He works at the intersection of science, strategy, and innovation.

Wonil Kim, Ph.D., is Chief Scientific Officer at Aston Sci, Inc., where he leads the development of mRNA-based vaccines for oncology and infectious diseases using the AI-driven Th-Vac® platform. He earned his Ph.D. in Molecular, Cellular, Developmental Biology and Genetics from the University of Minnesota and completed postdoctoral fellowships at Harvard Medical School and the NIH. Dr. Kim has served as a Staff Scientist at St. Jude Children's Research Hospital, where he pioneered cancer biology programs, and has held senior R&D positions at GeneOne Life Science and Cyrus Therapeutics. He is recognized for his expertise in mRNA vaccine design and cancer immunology.

Dr. H. Fai Poon is a distinguished leader in the biopharmaceutical industry, currently serving as the CEO of Sirnaomics. His impressive career includes founding Quacell, which was later acquired by Lepure, and holding key positions at Hisun Biopharm, Merck (SAFC), and the Roskamp Institute in the USA. Dr. Poon's academic credentials are equally notable, with a Ph.D. in Biological Chemistry from the University of Kentucky and an MBA from the University of South Florida.

With extensive experience in biological therapeutics, analytical research, bioinformatics and proteomics, Dr. Poon has over a decade of expertise in cell culture, particularly focusing on biopharmaceutical products. His scholarly contributions are substantial, having published more than 30 peer-reviewed articles and contributing to over 5 book chapters.

Dr. Poon's influence extends to the editorial realm, where he serves as the managing editor for a biomedical and pharmacology journal, and as an associate editor for the Journal of Chemistry, Biochemistry, and Molecular Biology, as well as the Journal of Bioinformatics and Biometrics. His leadership and expertise continue to drive innovation and excellence in the field of RNA therapeutics and beyond.

Dr. Xian Zeng, the Co-Founder and CEO of Byterna Therapeutics, leads this enterprising startup at the vanguard of groundbreaking circular mRNA-based immunotherapies.

Holding a PhD in pharmaceutical science from the National University of Singapore, he previously served as Associate Professor at Fudan University School of Pharmacy, spearheading interdisciplinary research in AI-empowered mRNA drug discovery.

Under his visionary leadership, Byterna is pioneering SEAA (Safe, Effective, Accessible, Affordable) in vivo CAR-T therapies for global patients, leveraging proprietary circular mRNA platforms and targeted delivery systems.

Jin Li is Head of the Research Department at CanSino (Shanghai) Biological Research Co., Ltd., where she leads research and development in mRNA vaccine and therapeutic innovation. She graduated from Columbia University with a degree in Biomedical Engineering, and has over nine years of experience in the biopharmaceutical industry.

Jin has been with CanSino for eight years, and was among the first scientists in China to enter the mRNA vaccine field, playing a foundational role in building the company’s mRNA R&D capabilities from the ground up.

She was the chief designer of CanSino’s monovalent and bivalent COVID-19 mRNA vaccines, CS-2034 and CS-2602. Both candidates received IND approvals and successfully completed five clinical trials, demonstrating strong safety profiles, robust immunogenicity, and protective efficacy.

Currently, her focus includes the development of inhalable mRNA vaccines, as well as expansion into prophylactic and therapeutic human vaccines, veterinary vaccines, and mRNA-based therapeutic products. She is also spearheading innovation in self-amplifying RNA platforms and the ISL-3C-LNP delivery system, with the goal of improving expression efficiency, safety, and immune response.

‍

Nori Shiraishi is Chief Scientific Officer at NANO MRNA Co., Ltd., where he leads research and development (R&D) of mRNA therapeutics. He focuses on establishing a robust pipeline by combining internal research with external collaborations with academia, venture companies, and pharmaceutical companies. Prior to joining NANO MRNA Co., Ltd., he served in senior management roles in corporate planning at Kyowa Kirin Co., Ltd., and as global clinical project lead for multiple programs in global clinical drug development, including low molecular weight compounds, antibodies, and other biologics, across oncology, hematology, and nephrology. His research background covers microbiology, bioinformatics, and molecular biology.

Dr. Chuang earned his Ph.D. in Biochemistry, Molecular and Cell Biology from Cornell University. In 2023, he joined Immunwork to lead the clinical development of TE-8214 (a therapeutic candidate for neuroendocrine tumors) and TE-8105 (a therapeutic candidate for weight management). At Immunwork, he successfully completed the first-in-human clinical trials of TE-8214 and TE-8105 in Australia, demonstrating preliminary safety and efficacy, and is currently advancing both programs into Phase II clinical trials.

Dr. Zhao is among the first class graduate graduating class from Biological Science and Biotechnology department at Tsinghua University in 1990. He received his Ph.D in molecular biology from University of Pittsburgh School of Medicine and MBA from University of Chicago in the United States. Dr. Zhao was a senior manager at Pfizer in US. After returning to China in 2003, he founded Beijing LongMed Inc. and later became partner of CASH and C-Bridge Capital. Dr. Zhao has over 30 years of industry experience and excellent investment achievements, invested in Innovent, BerryGenomics, ASLETIS, I-Mab, Laekna and GKHT. Dr. Zhao is the founding Chairman of Tsinghua Alumni Association for School of Life Sciences, School of Medicine and School of Pharmaceutical Sciences, a senior member of BayHelix group. AnlongMed is a leading venture fund in Chinese life sciences and Biotech, focusing on biotech & biopharma, medical devices, life sciences and medical services in China. Dr. Zhao also founded AnlongBio in 2019, a leading player in genetic medicine discovery in China, focusing on gene therapy, iRNA, mRNA, and other genetic medicines, with a leading product in gene therapy for ophthalmology already in clinical stages. Outside of his professional life, Dr. Zhao is a DJ, soccer player, ski lover and has three lovely daughters.

Madhavan obtained his PhD at Jacobs University Bremen, Germany and completed postdoctoral research at Radboud University Nijmegen, The Netherlands before moving to Singapore. Over more than 15 years at Institute of Materials Research and Engineering (IMRE, A*STAR) and as an Asst. Professor at Nanyang Technological University (NTU) Singapore, he pioneered polymersome (polymer/lipid nanoparticle) technology and translated it into a clinical platform.

Under his leadership, ACM Biolabs has built a diversified pipeline spanning vaccines, immuno-oncology and mRNA therapeutics.  The company’s first product, a second-generation COVID vaccine, successfully completed Phase 1 studies. ACM’s lead oncology program, ACM-CpG is in clinical development and leverages ACM’s nanoparticle delivery technology to fundamentally reshape the mechanism of action of well-established TLR-9 agonist for solid tumors. ACM is collaborating with CEPI to advance next-generation mRNA vaccines for global health and developing targeted mRNA therapeutics as a stable and flexible alternative to Lipid Nanoparticles (LNPs).

Dr. Chang Jia-Ming is the Chairman and General Manager of Vacino Biomedical Co., Ltd. He obtained his Ph.D. from the Institute of Biochemistry, National Taiwan University School of Medicine in 1996.

Dr. Chang has held various key positions in Taiwan’s biomedical and regulatory sectors, including Executive Director of the Institute of Drug Platform Technology at the Biotechnology Development Center, and advisory member of the Genetically Modified Food Review Committee under the Ministry of Health and Welfare (MOHW). He also serves on the Editorial Committee of the Chinese Pharmacopoeia of the Ministry of Health and Welfare, the Standard-setting Committee of the National Bureau of Standards, Ministry of Economic Affairs, and the TAF ISO Medical Laboratory Technical Review Committee.

In academia, Dr. Chang has contributed as an Adjunct Assistant Professor at several institutions, including the Institute of Pathology and Parasitology and the Institute of Medical Sciences at the National Defense Medical Center, as well as the Department of Applied Chemistry at National Chiao Tung University.

Dr. Horak brings more than 20 years of experience in the global pharmaceutical industry, predominantly focused on oncology drug development, and is a board-certified medical oncologist. Prior to funding Tikva Allocell, Dr. Horak was Head of Global R&D and Chief Scientific at Tessa Therapeutics, a mid-stage cell therapy company in Singapore. For eight years, he was Chief Medical Officer and Chief Scientific Officer at Symphogen, a clinical-stage antibody company, and President of R&D at Enzon Pharmaceuticals, Inc. Dr. Horak has also held a number of senior research leadership positions in various pharmaceutical companies as well as at the National Cancer Institute (NCI), National Institutes of Health in US. During his career, Dr. Horak has advanced multiple oncology treatments into the clinic, and has successfully led a number of FDA new drug applications. 

Dr. Mohamed ElSayed is the Executive Director of NATi, where he previously served as its inaugural Chief Scientific Officer. He brings over 25 years of leadership experience across the pharmaceutical, biotech, and academic sectors. Prior to NATi, he was the Executive Vice President and Chief Technology Officer at RVAC Medicines and formerly the Vice President of Biotechnology at Eli Lilly, where he led the development of oral biologics and mRNA platforms, advancing multiple assets from discovery to clinical proof-of-concept. He has also held senior roles at Abbvie, Samyang, and Guilford Pharmaceuticals, and was a tenured professor at the University of Michigan. Dr. ElSayed holds a Bachelor of Pharmacy from Cairo University and a Ph.D. in Pharmaceutical Sciences from the University of Maryland. He completed his postdoctoral research at the University of Washington with fellowships from the National Cancer Society and the Susan G. Komen Foundation.

Dr. Li Lietao (Victor) builds ventures that translate scientific discoveries into first-in-class immunotherapy clinical assets. He has led the BioIP Group since 2021.

Previously, as Founding CEO, he led the development of PIKA adjuvant vaccines and TCR/CAR-T cell therapies for viral infections and related cancers. Multiple lead assets have since advanced to Phase I and Phase III clinical trials.

Dr. Arvind K Jain is a Formulation Scientist with over 15 years of experience in nanomedicine, mRNA therapeutics, and advanced drug delivery systems. Currently working as DGM, R&D (mRNA Therapeutics) at Biological E. Limited, Hyderabad, leading formulation development for RNA therapeutic formulations, including LNPs. His work focuses on building RNA therapeutic platform capabilities, scaling up formulation processes, and supporting the establishment of state-of-the-art vaccine research/manufacturing facilities.

Before joining Biological E., Dr. Jain worked at Sun Pharma, India, for the development of oncology and ophthalmic products, focusing on complex injectables, liposomal and micellar formulations, and supporting technology transfer and regulatory filings for global markets.

Earlier in his career, Dr. Jain served as a Postdoctoral Scientist at the University of Oxford, where his research involved designing and developing targeted nanoparticulate systems for the intracellular delivery of therapeutic molecules such as mRNA, siRNA, and antibody fragments, focusing on cancer-related pathways. He also gained research experience as a Research Associate at IIT Kanpur, developing polymeric nanoparticles and electrosprayed microparticles for oral and cancer therapeutics. Dr. Jain holds a Ph.D. in Nanomedicine (Gene Delivery) from Queen’s University Belfast.