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Session 3 - Balancing Science and Operations for Better Access to Cell and Gene Therapy
Session Chair(s)
Finny Liu, MSc, RPh
APAC Regional Regulatory Policy Lead
Roche, Singapore
Senthil Sockalingam
M.D, Head of IQVIA Biotech, JAPAC, Chief Medical Officer, IQVIA, APAC
IQVIA, Singapore
The last two decades have seen significant growth in cancer research with considerable advancements made in this field. Cell and gene therapy (CAGT) represents the pinnacle of this innovation in managing cancer. This, in turn, led to innovative and novel approaches for managing cancer. The therapy delivers genetic material directly to the malignant cells or to effector-immune response cells. to address DNA abnormalities within the cancer tissue itself, or to induce an immune response against the malignant cells. The clinical development of CAGT products is challenging given the logistical challenges in drug manufacturing and diversity of regulatory framework across Asia Pacific. Besides the standard GCP and GMP requirements there are several other regulations that come into play when considering clinical development depending on the countries involved, these include; good tissue practice, regenerative medicine regulations and in some countries sites need special accreditation to run CAGT studies. In this session you will hear from Asia Pacific regulators and CAGT industry leaders perspective on the direction of CAGT drug development and associated regulatory framework as the field becomes an integral part of cancer care.
Speaker(s)
Regulatory Framework on Cell and Gene Regulation in Taiwan
Wen-Yi Hung, PhD
TFDA, Taiwan
Senior Reviewer, Section of New Drugs, Division of Medicinal Products
Cell & Gene Therapy Products - Comparability Considerations for a Diversifying Landscape
Ralf Altenburger
F. Hoffmann La-Roche Ltd, Switzerland
Global Head Cell and Gene Therapy and Global Head Pharma Technical Regulatory
Current Status and Future Perspective of CAR-T product in Japan
Shinichi Okudaira
Pharmaceuticals and Medicals Devices Agency (PMDA), Japan
Division Director Division of International Cooperation
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