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.

ISCT Global Regulators Summit

Optimizing Accelerated Pathways to Fast-Track Product Approvals

Tuesday, May 7, 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 7, 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

EV therapeutics have emerged as a pivotal player in the dynamic landscape of cell and gene therapy (CGT). However, the pressing question of how we translate this cutting-edge science into therapeutic reality remains unanswered. The 2025 ISCT Exosomes Scientific Signature Series event will breakdown this question and leverage global expertise to build consensus that will drive development.

This event will bring together a selection of invited subject matter experts from across the translational pathway to identify through a series of discussions what is needed to move EV therapeutics towards clinical translation. Researchers, regulators, investors, and experts in EV and CGT translation will take a multidisciplinary approach to work towards solutions that will shape the future of the field.  

Join us for front-row access to pivotal discussions, where experts will collaboratively address the most pressing challenges in the field to advance the translation of EV therapeutics.


ISCT iPSC Signature Series Event

Saturday, May 10, 2025 • Separate Registration Required

Since induced pluripotent stem cells (iPSCs) were first developed, in 2006, they have represented an area of immense potential in disease modeling, drug discovery, and therapeutics. In recent years, advances in biology and technology have accelerated their entry into the clinical arena, and leading researchers globally are now progressing iPSC products across a wide range of indications. Despite these recent advances, significant manufacturing and regulatory hurdles stand between promising iPSC research and their entry into the market as viable solutions for patients.

The 2025 iPSC Scientific Signature Series Event will bring together global key opinion leaders from academic research labs and clinical centers, regulatory agencies, and industry. These experts will discuss and deliberate on solutions that need to be found for the barriers that are impeding iPSC therapies’ clinical translation.

Join us for front-row access to pivotal discussions, where experts will collaboratively address the most pressing challenges in the field to advance the translation of iPSC therapeutics.