Requirements, Regulatory Strategies and Best Practices for Cell Therapy Clinical Trials in the APAC

When:  Dec 1, 2022 from 15:00 to 16:30 (AU)


Requirements, Regulatory Strategies and Best Practices for Cell Therapy Clinical Trials in the APAC Region

Presented by the ISCT Australia and New Zealand Legal & Regulatory Affairs Committee (ANZ LRA)

December 1, 2022
12:00 SGT | 13:00 JST/KST | 15:00 AEDT | 17:00 NZDT

Member Exclusive Webinar 

 

Webinar Description:

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:

  • Describe the cell therapy landscape, regulations and classifications
  • Review the clinical trial pathways (IND requirements and comparison of clinical research vs. clinical trials)
  • Describe expedited approval pathways
  • Review key challenges for developers

 

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Co-Chair and Speaker
Giulia Giunti, PhD

Quality Manager
Malaghan Institute of Medical Research
New Zealand

Giulia holds a doctorate degree in Cancer Immunotherapy from King’s College London and has been involved in the development and delivery of several cell and gene therapy products in Europe and in the Unites States. She currently serves as the quality manager at the Malaghan Institute of Medical Research (Wellington, NZ), where she has helped setting up the first CAR T-cell clinical trial in New Zealand.







 

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Co-Chair and Speaker
Kasey Kime, MBA

Director, Regulatory Affairs
Novotech Health Holdings
New Zealand

Kasey Kime has over fifteen years of global quality and regulatory affairs experience in Life Sciences. She is the Director of Regulatory Affairs at Novotech. Her areas of expertise include CMC for Advanced Therapies, regulatory compliance for cell and gene therapy automated equipment, and IVD development including companion diagnostics. Kasey holds a bachelor’s degree in Medical Laboratory Science and post-graduate degrees in Medical Microbiology, Quality Systems Management, and Business Administration. Kasey serves on the Australia and New Zealand ISCT Regulatory Committee and the early-stage professionals sub-committee.

Speakers:

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Yoji SATO, PhD

Head, Division of Cell-Based Therapeutic Products
National Institute of Health Sciences
Japan

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.

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Bryan Choi, PhD
Professor
Inha University College of Medicine
Korea

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).

















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Gerry McKiernan
Director of Quality
Cell Therapies Pty Ltd
Australia

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.

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James LEONG BSc(Pharm)(Hons) MClinPharm PhD
Assistant Professor
Head, Health Products & Regulatory Science
Centre of Regulatory Excellence
Duke-NUS Medical School
Singapore

At the Centre of Regulatory Excellence, James is in-charge of identifying the educational needs for the various stakeholders involved in regulatory affairs in the Asia Pacific region, and establishing education roadmaps, priorities and deliverables in facilitating access to health products. Besides working closely with health regulators around the world, James also initiates and conducts training projects supporting the World Health Organisation, International Council of Harmonisation, and other regional platforms. He draws his regulatory experience from his years as a senior regulatory specialist with the Health Sciences Authority of Singapore, where he was a clinical reviewer in addition to managing the post-market benefit-risk assessments and regulatory actions. Across the years, James has contributed as a member to various advisory committees and programme committees for initiatives at APEC Regulatory Harmonisation Steering Committee. His previous clinical experiences include leading the hospital drug information services and heart failure clinic. He obtained his PhD from Cardiff University, focusing on benefit-risk assessment frameworks, communication of regulatory decisions and innovation of regulatory approaches. James has strong interests in the implementation of regulatory cooperation and regulatory systems strengthening.

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