The cell and gene therapy market is booming with several global companies advancing their latest innovations to Phase 2 and late-stage trials.

At the regulatory level, although only a handful of products have been approved hitherto, the FDA expects to review close to 10 to 20 cell and gene therapy IND applications each year by 2025. At this juncture, the industry is striving to strike a balance between a continuous flow of innovations and streamline existing candidates within the manufacturing, regulatory and policy climate of prevailing frameworks. In a BIO Asia-Taiwan session, experts from big pharma, regulatory affairs, and academia discussed the current developments in the field, besides its potential and challenges for the future.