International Society for Cell & Gene Therapy
Budget
€200 — €0
EP Access
0
accredited persons
Staff
3
0.45 FTE
EU Grants
None
Mission & Goals
The International Society for Cell & Gene Therapy (ISCT) is a global society of clinicians, regulators, researchers, technologists, and industry partners with a shared vision to translate cell and gene therapy into safe and effective therapies to improve patients' lives worldwide. ISCT is the global leader focused on pre-clinical and translational aspects of developing cell and gene-based therapeutics, thereby advancing scientific research into innovative treatments for patients. ISCT offers a unique collaborative environment that addresses three key areas of translation: Academia, Regulatory, and Commercialization. Comprising over 4,500 cell and gene therapy experts across five geographic regions and representation from over 60 countries, ISCT members are part of a global community of peers, thought leaders, and organizations invested in cell and gene therapy translation.
EU Legislative Interests
Advanced therapy medicinal products, hospital exemption, substance of human origin, health technology assessment
Communication Activities
As part of its commitment to advancing cell and gene therapy in EU, ISCT actively contributes to EU policy development through participation in public consultations and stakeholder meetings. ISCT has engaged in the formulation of key EU guidelines, including concept papers on Health Technology Assessment (HTA), and has taken part in the HTA Stakeholder Meetings, ensuring that the voice of the cell and gene therapy community is represented in policy discussions. To support informed decision-making, ISCT publishes biannual global regulatory reports that provide a comprehensive overview of the cell and gene therapy landscape, including development pipelines, late-stage programs (Phase III and pre-registration), and approved products across cell, genetically modified cell, and gene therapy categories. ISCT also keeps its members updated through a bimonthly regulatory newsletter, which highlights significant regulatory developments in Europe and other regions, helping stakeholders stay aligned with evolving EU policies. In addition to publications, ISCT delivers targeted training programs, such as a specialized course in Paris for clinical researchers, clinicians, and physicians focused on the clinical translation of CAR-T cell therapies. Furthermore, ISCT fosters collaboration and knowledge exchange through its annual and regional meetings in Europe, where critical topics such as hospital exemption and substance of human origin (SoHO) regulation are regularly discussed in sessions which included participation from EU Commission and EDQM, reinforcing its role as a bridge between science, clinical practice, and regulatory policy.
Interests Represented
Promotes their own interests or the collective interests of their members
Member Of
N/A
Organisation Members
https://www.isctglobal.org/about/partner-organizations
Commissioner Meetings
No recorded meetings with EU commissioners.