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Session 4 Part II – 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)
Key Components for Building an Eco-system for CGT: Singapore Experience
Danny Soon
Director, ACTRIS, Singapore
Chief Executive Officer, CRIS, Executive Director, SCRI, Interim Executive
Biotech perspective: Successful Implementation of CGT Clinical Trials and Key Consideration from Sponsor Perspective
Clare Tan
Singapore
Global Clinical Operations Expert
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