Resources

Key Translational Programs

ISCT offers a number of key programs that support the scientific, regulatory, and commercialization pillars of the Society as well as training the next generation of cell and gene therapy leaders. 

Global Regulatory Perspectives

Global Regulatory Perspectives Logo

The ISCT Global Regulatory Perspectives (GRP) represents the diverse activities and partnerships between international regulatory bodies, industry, clinicians and academia. The ISCT GRP steering group is comprised of representatives the Society's Legal and Regulatory Affairs Committees from Asia, Australia, Europe, North America, and South and Central America. The key output from this joint working group is the GRP Workshop.

The flagship GRP Workshop is an annual one-day workshop that is run in tandem with the Society's Annual Meeting. Unique to this program is that it brings together regulators from North America, Europe, Asia, South and Central America, and Australia/New Zealand. The workshop is aimed to provide participants with viewpoints and perspectives from international regulators of cell therapy products. It is also a highly interactive program as speakers and participants are encouraged to participate in various hypothetical case studies throughout the program.

Topics of discussion in past workshops have included:

  • Regulatory Considerations for Gene Therapies incorporating Human Genome Editing
  • Manufacturing Challenges during Accelerated Development of CGT Products
  • Product approvals and market authorization
  • Materials standardization and qualification
  • Characterization and comparability
  • Regulatory updates from emerging markets

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Regulatory

Commercialization

Scientific

Training

FDA Cell Therapy Liaison Meeting (CTLM)

Since 2004, ISCT has been the host organization leading over 20 invited stakeholder organizations in an annual face-to-face meeting with the FDA. These closed meetings enable the cell and gene therapy community, and industry to inform the FDA of specific concerns, challenges and recent developments to advance the regulatory field.

Most Recent Meeting: December 5, 2022

December 5, 2022
Topics included: 

  • Developing Potency Assays for Cell Therapy Products
  • Considerations for increasing access to cord blood for cell therapy applications
  • Taking a Prospective, Risk-Based Approach to Genome Integrity
  • Development of a Sustainable Risk Mitigation Strategy: Standardization of Risk Evaluation and Mitigation Strategies and Sunsetting of REMS for CART-T Cell Therapies

View Summary

November 15, 2021
Topics included: 

  • Roadmap to Address Potency for Complex Products
  • False Positive HIV Patient Results Post Receipt of Genetically Modified CT Products
  • Emerging Donor Testing Requirements
  • Use of Non-US Starting Materials 
  • Challenges with Sourcing Materials

View Summary

November 23, 2020
Topics included:

  • RMAT Program Update, Donor Adverse Events in Cellular Therapies
  • Infectious Disease Lookbacks Related to Blood Product Transfusions
  • Alternative BLA Pathway to Approved Genetically Modified Autologous HCT/Ps,
  • CMC Comparability of CGT
  • Framework for Use of Research Grade Materials in Manufacturing Cellular Therapies

View Summary

November 21, 2019
Topics included:

  • Maternal Donor Screening and Impact on Public Banking
  • RMAT Updates
  • Impact of Unproven Cellular Products in the Field

View Summary

March 5, 2019
Topics included:

  • Regulation of Biobanking Material
  • Collection of MNCs for Immune Effector Cells
  • Minimum Characterization Criteria for Clinical Grade iPSC Products
  • Early Interaction Mechanisms for Tool/Device Developers

View Summary

      January 30, 2018
      Topics included:

      • Comparability of iPSC Lines
      • Long Term Follow-Up of Recipients of Genetically Modified Cells
      • RMAT Designation Update
      • Licensing of CBUs for Indications other than Currently Approved
      • HPL Requirements for Cell Therapy Expansion

      View Summary

      Investigators to Investors Program

      Spearheaded by the ISCT Business Models & Investment Subcommittee, the ISCT Investigators to Investors (I to I) program was created in 2018 with a goal to bridge the knowledge gap between investigators and investors within the cell and gene therapy (CGT) sector. The program strives to educate investigators on how to successfully attract investor attention and capital, as well as support investors in conducting diligence and understanding opportunities within the CGT industry. Ultimately, the ISCT I to I program engages these two stakeholder groups in critical conversations that advance the development and delivery of cell and gene therapies. 

      ISCT Investigator to Investor Initiatives:

      October 6, 2020

      The webinar will explore lessons learned by academic founders of successfully funded academic spin-outs and provide a blueprint for others who are pursuing the creation of a company around their novel science. 

      View Webinar Recording

      April 2019

      In April 2019, the ISCT Business Models and Investment Commercialization Subcommittee championed a webinar which discussed critical learnings of the ISCT-Bloomberg investor survey. The webinar discussed the opinions of various CGT investor groups and explained their perspective regarding awareness, investment exposure, intentions to invest, and key concerns with investment opportunities in the CGT sector at the time of the survey. Additionally, the webinar focused on how the CGT R&D community can leverage this knowledge to improve its ability to secure investments from investors.

      View Webinar Recording

      October 2018

      In October 2018, the ISCT member e-Newsletter, Telegraft, announced the launch of the I to I Program to ISCT’s membership community. The article illustrated the program’s aim and vision. 

      View the Archived Article

      September 2018

      The inaugural event of the I to I Program was an investor survey created in collaboration between ISCT and Bloomberg Intelligence. The survey captured investor perceptions of key opportunities and challenges in the CGT field at the time. Survey results were published in a white paper in Cytotherapy, the Official Journal of ISCT.

      Investor respondents of the ISCT-Bloomberg Intelligence survey were invited to a webinar hosted by Bloomberg featuring ISCT key opinion leaders (KOLs) Catherine Bollard, MD, MBChB (ISCT President 2016-2018), Bruce Levine, PhD (ISCT President 2020-2022), Ohad Karnieli, PhD, MBA (Past Co-Chair, ISCT Process and Product Development Subcommittee), Dawn Driscoll, PhD, MBA (Past Co-Chair, ISCT Market Access and Patient Advocacy Subcommittee) and Karen Nichols, Esq (ISCT Chief Regulatory Officer). Investors had the opportunity to ask the expert panel questions about the state of the industry, challenges, and opportunities for the field looking forward. 

      View webinar recording

      Read the white paper

      Investigators to Investors Program Logo

      Commercialization Signature Series

      The ISCT Commercialization Signature Series is a unique annual event, by invitation only, for experts from academia and industry to discuss the latest challenges and opportunities facing the cell and gene therapy industry.

      Commercialization Signature Series

      Scientific Signature Series

      ISCT Scientific Signature Series offer the unique opportunity to gather key opinion leaders in the chosen field to discuss, present and develop position statements to move the field forward. These events are aimed at driving thought leadership by providing content and building collaboration around concept papers, consensus statements, clinical networks, regulatory proposals, and recommendations for investment in clinical and basic research in cell and gene therapy medicine.

      Scientific Signature Series

      Cellular Therapy Training Course

      The biennial ISCT-ASTCT Cell Therapy Training Course aims to address the unfulfilled need for cell therapy training, covering the process of translational research to cell manufacturing and clinical trials in cellular therapy, including regulatory components. The course spans a full week of intensive teaching, collaboration, and networking amongst the Scholars and Faculty. Covering the full spectrum of the cell and gene therapy field from research through development, the CTTC seeks to expose Scholars to those topics that may not have been part of their formal education. Highly competitive, the program selects twelve international scholars to participate in the program.

      Due to ongoing safety concerns and travel restrictions as a result of the global COVID-19 pandemic, the 2021 CTTC has been deferred until 2023.
      Check back in Fall 2022 for application information.

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      Early Stage Professionals Mentoring Program 

      The ISCT Early Stage Professionals Committee runs an annual Mentoring Program matching mentors with small group mentorship for an 8 month program to guide career and professional development with expertise-driven matching.  The 2020-2021 edition of the program included  participants representing more than 26 countries.

      The application window  for the 2021-2022 ESP Mentoring Program is now closed. 

      Early Stage Professionals logo

      Workforce Development in Biomanufacturing – A Global Partnership with ISCT and CMaT

      Developed by field experts from academic, regulatory, clinical, and commercial domains, this training program will focus on introducing key topics in cell and gene therapy manufacturing and development.

      Registration Now Open

      The program aims to address key topics in CGT manufacturing and development and will include asynchronous lectures (comprised of a theory and an application component) as well as live instructor office hours/ expert panel Q&A sessions. There will be 4 modules:

      • Module 1: Stem Cell and Immune Cell Engineering and Therapies
      • Module 2: Quality Assurance & Regulatory framework & Roundtable
      • Module 3: Cell Bioprocessing and Manufacturing Roundtable
      • Module 4: Cell Product characterization and importance of standards

      Learn More

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