Requirements, Regulatory Strategies and Best Practices for Cell Therapy Clinical Trials in the APAC RegionPresented by the ISCT Australia and New Zealand Legal & Regulatory Affairs Committee (ANZ LRA)December 1, 202212:00 SGT | 13:00 JST/KST | 15:00 AEDT | 17:00 NZDTMember Exclusive Webinar
This webinar will cover key regulatory requirements and considerations when developing clinical trials in APAC countries including Australia, China, Japan, Korea, New Zealand, and Singapore. Key Learning Objectives for Each Country:
Co-Chair and SpeakerGiulia Giunti, PhDQuality ManagerMalaghan Institute of Medical ResearchNew Zealand
Co-Chair and SpeakerKasey Kime, MBADirector, Regulatory AffairsNovotech Health HoldingsNew Zealand
Yoji SATO, PhDHead, Division of Cell-Based Therapeutic ProductsNational Institute of Health SciencesJapan
Dr. Yoji Sato is the Head of Division of Cell-Based Therapeutic Products, Japan National Institute of Health Sciences. As a graduate student at the University of Tokyo and as a postdoc at the University of Cincinnati, he conducted researches on cardiovascular pharmacology, and succeeded in establishing a variety of transgenic mouse models to elucidate mechanisms of cardiac excitation-contraction coupling and heart failure. Dr. Sato’s current research area is in the field of regulatory science for the quality and safety of cell therapy products (CTPs). He is currently leading a public-private partnership initiative (MEASURE Project) in Japan for validation of test methods for tumorigenicity assessment of CTPs, in collaboration with the Committee for Non-Clinical Safety Evaluation of Pluripotent Stem Cell-Derived Therapeutic Products, Forum for Innovative Regenerative Medicine (FIRM-CoNCEPT) and the Cell Therapy-TRAcking, Circulation and Safety Committee, the Health and Environmental Sciences Institute (HESI CT-TRACS). He is also serving as the Vice Chair of the Database Committee, the Japanese Society for Regenerative Medicine, which provides the National Regenerative Medicine Database (NRMD), a nation-wide patient registry system for clinical researches and post-marketing studies on CTPs, and as a topic leader of ICH-Q5A(R2) as well as a member of Technical Committees, Panel on Science and Technology, Health Science Council, the Japan Ministry of Health Labour and Welfare.
Bryan Choi, PhDProfessorInha University College of MedicineKorea
Bryan Choi earned his Ph.D. at Molecular Biology from Seoul National University and was a post-doc fellow at Harvard Medical School, Boston, USA. Since he returned to Korea, he has been working on cell therapies to treat various diseases and is currently focusing on a tissue-engineered product to treat articular cartilage defects in collaboration with ATEMs Inc. He is also involved in the Council for Advanced Regenerative Medicine (CARM), a company alliance in Korea as a Secretary General and is an Asia regional vice-president of the International Society for Cell and Gene Therapy (ISCT).
Gerry McKiernanDirector of Quality Cell Therapies Pty LtdAustralia
Gerry has 20 years’ experience in various Quality roles in R&D and cGMP manufacturing in Europe, Asia and Australia and holds the accountability for the Quality Management System to deliver complex cell therapy products to patients on behalf of Cell Therapies Pty Ltd.
Gerry’s career has included biotechnology, pharmaceutical and medical device industries, where he has overseen quality systems for product development, clinical trials, validation and contract manufacturing. He has led large Quality Management System implementation projects for cell therapy manufacturing in China and Japan and is leading Cell Therapies Pty Ltd Industry 4.0 and digitisation initiatives.
James LEONG BSc(Pharm)(Hons) MClinPharm PhDAssistant ProfessorHead, Health Products & Regulatory ScienceCentre of Regulatory ExcellenceDuke-NUS Medical SchoolSingapore
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