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Grand Copthorne Waterfront Hotel, Singapore

Jul 12, 2022 8:30 AM - Jul 13, 2022 5:30 PM

392 , Havelock Road, Singapore 169663, Singapore

DIA CoRE Singapore Annual Meeting 2022

Aspirations for the Future of Healthcare - From Ideas to Actions

Session 3 - Balancing Science and Operations for Better Access to Cell and Gene Therapy

Session Chair(s)

Finny  Liu, MSc, RPh

Finny Liu, MSc, RPh

APAC Regional Regulatory Policy Lead

Roche, Singapore

Senthil  Sockalingam

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)

Wen-Yi  Hung, PhD

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

Ralf  Altenburger

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

Shinichi  Okudaira

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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