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Session 4 Part I – Cell and Gene Therapies Challenges and Opportunities - Perspectives from Regulators, Industry and Healthcare Professionals from Asia
Session Chair(s)
Helene Sou, MSc, RAC
Director, Growth and Emerging Markets
Takeda, Singapore
Senthil Sockalingam
M.D, Head of IQVIA Biotech, JAPAC, Chief Medical Officer, IQVIA, APAC
IQVIA, Singapore
Over the past few years, the Cell and Gene Therapies (CGT) field have gained strong momentum with recent approvals of several high-profile therapies. Clinical research has been increasingly active including in Asia-Pacific such as South Korea, China and Japan. In general, development of CGT is complex due to advanced scientific considerations that current regulatory frameworks may not adequately address. In addition, CGT are presently often developed to treat rare genetic diseases leading to additional obstacles to meet the evidentiary requirements for approval. In this session, we will provide an overview of the challenges from the perspectives of regulators, industry, healthcare professionals in Asia and discuss innovative solutions to accelerate access of these novel exciting therapies to patients.
Speaker(s)
Challenges Around Cell Therapies from the Clinical and HCP Perspective
Soh Shui Yen
KK Women's and Children's Hospital (KKH), Singapore
Head and Senior Consultant - Paediatric Haematology/Oncology Service
Challenges and Opportunities in CAR-T Cell Therapy Development – Industry Perspective
Serena Foo
Head, Janssen Asia Pacific , Singapore
Director- Asia Pacific Regulatory Affairs and Southeast Asia Regulatory Affairs
Regulatory Landscape for Gene Therapies in South Korea
Daehyun Baek
Ministry of Food and Drug Safety, Korea, Republic of
Senior Scientific Officer at Cell and Gene Therapy Products Division,
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