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Advanced Cell Therapy and Research Institute, Singapore (ACTRIS)

Post CRIS Connect - Navigating Cell, Tissue and Gene Therapy Product (CTGTP) Development in ACTRIS

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21 July 2026

Close to 190 participants joined the CRIS Connect Webinar to gain insights into the regulatory, project management and manufacturing considerations that support successful CTGTP development in Singapore.

CRIS Connect Webinar Banner for Navigating Cell, Tissue and Gene Therapy Product (CTGTP) Development in ACTRIS

Behind every cell, tissue and gene therapy product (CTGTP) that reaches a patient lies a complex journey involving regulatory, scientific and manufacturing excellence.

Last month, close to 190 attendees joined the CRIS Connect Webinar, "Navigating Cell, Tissue and Gene Therapy Product (CTGTP) Development in ACTRIS", and gained valuable insights into the pathways that support the development of these innovative therapies.

Key takeaways include:

  1. Regulatory Frameworks for CTGTPs in Singapore
    Dr Lee Lee Ong (opens in new tab), Regulatory Consultant, Advanced Therapy Products Branch, Medicinal Products Pre-Market Cluster, Health Products Regulation Group, Health Sciences Authority (opens in new tab)(HSA), shared how Singapore's regulatory framework supports innovation while safeguarding patient safety.

    Dr Ong emphasised that early engagement with regulators is critical to product development, as it helps align development plans with regulatory expectations, identify potential gaps upfront and support a smoother path to clinical translation.

  2. Project Lifecycle Management at ACTRIS
    Mr Vincent Jong, PMP® (opens in new tab), Senior Manager, Project Management Office, ACTRIS, walked participants through the end-to-end development pathway, from technical feasibility and process development to GMP manufacturing readiness. He highlighted that successful GMP manufacturing begins way before a product enters the cleanroom, requiring robust process development, analytical readiness, trained personnel, supplier readiness and a strong quality framework.

  3. Expert Q&A: Enabling the Path to Patients
    Moderated by Dr Lip Kun Tan (opens in new tab), Senior Consultant, Haematology Division, Department of Laboratory Medicine, National University Hospital (opens in new tab) (NUH), the Q&A session tackled some of the most pressing challenges in CTGTP development — from GMP requirements and CMC readiness to manufacturing timelines and supply chain considerations.

One message came through clearly, that early regulatory engagement, proactive planning and close collaboration with stakeholders are essential. Getting these right from the start helps identify potential gaps upfront, minimise downstream rework, and ultimately accelerates patient access to the innovative therapies that matter most.

A big thank you to Dr Ong Lee Lee, Mr Vincent Jong and Dr Tan Lip Kun for sharing their insights, and to all attendees for contributing to an engaging discussion.

Together, we are strengthening Singapore's advanced therapy ecosystem and translating research into safe, effective treatments that can benefit patients

Screenshot of the webinar presenters - Dr Ong Lee Lee, Mr Vincent Jong and Dr Tan Lip Kun.
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