Thought Leadership Events

Global Key Opinion Leaders and Subject Matter Experts All in One Place

Shaping the Future of Cell and Gene Therapy

Following the success of previous Annual Meetings, ISCT will be hosting its flagship Scientific, Industry, and Regulatory thought-leadership events all in one place. True to ISCT’s multi-stakeholder approach, these four events serve as a platform to foster discussions that will propel the sector, ultimately driving access to safe and effective therapies for patients, by leveraging the breadth of expertise of invited global key opinion leaders, spanning academic research labs and clinical settings, industry developers and enablers, and regulatory representatives.

At the pinnacle of our thought leadership program is the ISCT Signature Series Program. Unlike conventional sessions, the Signature Series encourages collaboration by integrating presentations from invited global experts with interactive tabletop discussions involving diverse stakeholders across the translational spectrum. While participation is exclusive for invited guests and speakers, ISCT is excited to open a limited number of audience seats to ISCT 2025 New Orleans delegates, providing an opportunity to witness first-hand sector-shaping discussions at the ISCT Exosomes and iPSC Scientific Signature Series Events.

Register Now: ISCT 2025

ISCT Global Regulators Summit

Optimizing Accelerated Pathways to Fast-Track Product Approvals

Tuesday, May 6, 2025 • Closed, Invitation-Only Event

The 3rd Annual Global Regulators Summit will bring together representatives from international regulatory organizations to jointly address and enhance accelerated regulatory pathways for cell and gene therapy products. The discussion will focus on the evolving regulatory landscape, challenges, and the future directions for accelerated pathways.

The summit will address:

  1. Review current accelerated pathways that are in place for approval of cell and gene therapy products
  2. Examine the key challenges faced by the regulatory agencies in ensuring that these pathways truly accelerate product approval timelines without compromising safety and efficacy
  3. Identify specific areas for enhancing the effectiveness and post-approval validation of expedited regulatory pathways 

The unprecedented event in 2024 brought together key regulatory leaders and experts from 19 global regulatory agencies and government organizations to address and enhance understanding of global regulatory challenges in the development, manufacture, and accessibility of cell and gene therapy products for treating rare diseases while also discussing current global policies and strategies. Agencies and organizations included DOH (United Arab Emirates), EDQM (EU), CAT-EMA (EU), MHRA (United Kingdom), NoMA (Norway), SAM (Estonia), SFDA (Saudi Arabia), Swissmedic (Switzerland), CBER-FDA (USA), Health Canada, British Columbia Provincial MoH (Canada), CDE (Taiwan), HSA (Singapore), ICMR (India), NPRA (Malaysia), PMDA (Japan), TFDA (Taiwan), TGA (Australia), and ISPCH (Chile).


ISCT Commercialization Signature Series

Tuesday, May 6, 2025 • Closed, Invitation-Only Event

The ISCT Commercialization Signature Series is an exclusive, industry-driven event that brings together top experts from across the commercialization pipeline to tackle obstacles hindering the sectors growth. 

Curated by ISCT Industry Leaders, the 2025 CSS program will focus on enhancing efficiencies and driving innovation in process and manufacturing, to accelerate patient access to transformative CGT therapies. Sessions will address existing bottlenecks in industrialization by debating the need for specialized CGT tools and technologies, the role of PAT and AI-driven analytics, and the industry's influence on evolving regulatory expectations.

Industry experts, regulatory authorities, and CGT pioneers will all be in attendance, working to collaborate on actionable solutions that reduce time-to-market and advance the field at scale. 

ISCT Exosomes Signature Series Event

Saturday, May 10, 2025 • Separate Registration Required

The ISCT Exosomes Signature Series will bring together leading experts to address the critical challenges in translating extracellular vesicles (EVs) into effective clinical therapies. Through focused sessions, global leaders will examine the active components driving EV therapeutic efficacy, current technological limitations, clinical trial experiences, and strategies for advancing the field toward regulatory approval and clinical adoption.

Taking a multidisciplinary approach, this event will feature key opinion leaders with expertise in EV biology, manufacturing, clinical trial design, and commercialization. Speakers will present cutting-edge research and real-world insights into standardization, functional characterization, biodistribution, and clinical outcomes. Discussions will be leveraged to develop concrete recommendations for advancing EV therapies through clinical development and into commercial applications.


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ISCT iPSC Signature Series Event

Saturday, May 10, 2025 • Separate Registration Required

The ISCT iPSC Signature Series will bring together leading experts to examine the evolving landscape of iPSC-based therapies, with a particular focus on safety characterization. As iPSC-derived products advance toward clinical translation, establishing robust methodologies to assess their safety remains a critical challenge.

This event will take a structured approach, first exploring current methodologies for characterizing iPSC products, including strategies to assess genomic stability, immunogenicity, and differentiation potential. Once the available technologies are understood, these technologies will be examined in real-world applications, using case studies of iPSC-derived products to develop a framework for tailoring characterization strategies based on key considerations such as autologous vs. allogeneic approaches, gene-edited vs. non-edited products, and different therapeutic applications.

Bringing together experts from academia, industry, and regulatory bodies, this series will foster discussions on standardization, regulatory expectations, and best practices for ensuring the safety and efficacy of iPSC-based therapies as they progress toward clinical and commercial applications.


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