Scaling cryopreservation has become a major obstacle in the path toward commercializing cell and gene therapies. In a recent survey conducted by the ISCT Cold Chain Working Group, respondents identified “ability to process at large scale” as the most significant challenge facing cryopreservation today. As manufacturing expands to support higher volumes, the industry is grappling with key variables—such as batch size, sub-batching risks, CPA incubation timing, and cytotoxicity management—that directly impact product quality and process reproducibility. This webinar will feature a panel of experts offering insights across three critical perspectives: technology innovations, allogeneic therapy workflows, and autologous manufacturing considerations. Each panelist will present a short slide deck to share lessons learned, operational pain points, and potential solutions from their area of focus. The session will conclude with a moderated discussion and audience Q&A, providing attendees with actionable insights into how the field is working to overcome this bottleneck.

Malaysia is one of the top medical tourism and medical research destinations in the world, particularly for early phase clinical trials. It has comprehensive regulations and guidelines that seek to enforce safe product development, safeguard patients, and encourage research. Malaysia has also continued to evolve towards an integrated regulatory environment, covering key aspects of stem cell, and cell and gene therapy development (i.e., regulation of products, medical practices and facilities). Additionally, Malaysia also developing national policies and professional guidelines on cell and gene therapy (CGT). Like many countries, Malaysia is also seeking to combat unproven treatments. Tune in to this open access webinar to hear some of Malaysia's local distinguished pioneers and key experts, discussing stem cells and cell and gene therapy research, as well as development, application, manufacturing, regulation, and law and ethics as we shine a light on this fascinating and highly innovative country.

Join leading regulatory experts from Japan, Singapore, and South Korea for a webinar exploring CGT approval pathways across three key APAC jurisdictions. Based on the recently published ISCT APAC Industry Committee regulatory roadmap in Cytotherapy, this session provides practical insights for navigating complex regional regulatory landscapes. Our distinguished panelists will share emerging trends and recent updates in APAC cell and gene therapy regulations, including regulated access to unapproved and unproven therapies and real-world case studies from their respective markets. Learn about Singapore's risk-based CTGTP classification system, Japan's innovative conditional approval pathways, and South Korea's advanced biological products regulations. This is a must-attend webinar for regulatory affairs professionals, clinical developers, and business leaders seeking to unlock APAC opportunities while ensuring alignment between Eastern and Western regulatory approaches. Tune in for actionable insights that propels successful approval strategies, information on submission requirements, and development timelines that can accelerate your CGT programs in these rapidly expanding markets.

Achieving consistent and effective outcomes in CAR T and other immune effector cell (IEC) therapies relies heavily on getting lymphodepletion “right.” Emerging evidence shows that both under- and over-exposure can impact safety, efficacy, and long-term persistence, making optimized dosing strategies increasingly critical as the field evolves. This webinar will explore how model-informed and data-driven approaches can help identify the optimal lymphodepletion exposure window, improve predictability, and support more standardized practices across patient populations and treatment centers. Speakers will discuss current challenges, scientific rationale, clinical insights, and practical considerations for implementation.

The inaugural Industry Town Hall will introduce the audience to the breadth of priorities being advanced by ISCT’s global membership base. Chaired by Phil Vanek, Chief Commercial Officer at ISCT, the session will outline the core priorities of the Industry Pillar and provide insight into how members can get involved in relevant initiatives. ISCT Chief Regulatory Officer, Bambi Grilley, and Chief Scientific Officer, Massimiliano Gnecchi, will then highlight the strategy and focus areas of their respective pillars, showcasing key member-driven programs across Science and Regulatory Practices. The session will also feature Stephen Majors from The Alliance for Regenerative Medicine, speaking to the current state of the CGT industry. Further, this event will support attendees in building their awareness and understanding of ISCT's strategic focus areas while sharing the impact ISCT members are creating in the global sector. Q&A is encouraged.

The ISCT North America Regional Executive Committee invites you to join your ISCT peers and colleagues for an interactive, member-focused North America Regional Town Hall.

The ISCT Asia Regional Executive Committee invites you to join your ISCT peers and colleagues for an interactive, member-focussed Asia Regional Town Hall.

Business Development and Finance

Asia Regional Executive Committee Webinar on September 3, 2025

This webinar explores how artificial intelligence (AI) is moving from experimentation to operational impact in cell therapy manufacturing, with a focus on machine learning (ML) applications. Through applied case studies, panelists will show how ML can be used in CAR T and iPSC process development to analyse metabolomics and process data, optimise culture conditions, and improve critical quality attributes. The session will also highlight how AI-enabled decision-support tools are being integrated into manufacturing workflows to improve process understanding and decision-making, including early signal detection, anomaly identification, and data interpretation within GMP environments. Attendees will gain insight into practical considerations for implementing AI/ML in cell therapy manufacturing, including regulatory expectations, model trustworthiness, and strategies for integrating AI into existing systems.