Thought Leadership Events

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

Shaping the Future of Cell and Gene Therapy

For the first time in its history, 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 2024 Vancouver delegates, providing an opportunity to witness first-hand sector-shaping discussions at the 2024 ISCT Exosomes and iPSC Scientific Signature Series Events.

REGISTER NOW FOR THE FULL ISCT 2024 CONFERENCE 

Building on the success of ISCT 2023 Paris, we are thrilled to host the 2nd Annual Global Regulators Summit, convening key regulatory representatives worldwide for candid deliberations on pivotal regulatory questions.

Seize this exclusive opportunity for a front-row seat to the critical discussions shaping the future of cell and gene therapy.

ISCT Global Regulators Summit
Rare Diseases: Overcoming Regulatory Challenges and Optimizing Global Synergies
Tuesday, May 28, 2024

The 2024 Global Regulators Summit brings together representatives of international regulatory organizations to jointly address and better understand the global challenges in regulating the clinical development, manufacture and access of products to treat rare diseases.

The summit will address:

  • Pre-clinical and non-clinical studies to design and set up a platform-developed product
  • How the regulatory impacts of proposed changes could be pre-empted, assessed and managed flexibly across the platform to support the production and clinical use of each of the therapeutic products
  • The possibilities and limitations of non-clinical studies for assessing how new technology and new methods can be incorporated into risk assessments

The unprecedented event in 2023 brought together key regulatory leaders and experts from 14 global regulatory agencies and government organizations to address the borderless issue of unproven cell and gene products. Agencies and organizations included ANVISA (Brazil), CAT-EMA (EU), European Commission (EU), European Directorate for the Quality of Medicines & HealthCare (EU), FDA (USA), HC (Canada), ICMR (India), MHRA (UK), Ministry of Health (Israel), Ministry of Health and Welfare (Korea), PMDA (Japan), and TGA (Australia). 

The Summit is a Closed, Invitation-Only Event

ISCT Commercialization Signature Series
Demystifying Artificial Intelligence and Machine Learning
Tuesday, May 28, 2024

Artificial intelligence (AI) and machine learning (ML) hold immense promise for shaping the future of cell and gene therapy (CGT), offering unprecedented opportunities to streamline manufacturing processes, enhance cost efficiency, and expedite market access. As these technologies are relatively novel, a crucial question emerges: What are the potentials and limitations of these innovations and how can we effectively integrate them into our daily manufacturing and clinical practices? 

The 2024 Commercialization Signature Series will unite influential leaders from global cell and gene therapy organizations to unravel the complexities surrounding these groundbreaking technologies and explore optimal ways to harness their power for advancing the sector. Interactive tabletop discussions with key industry players, academia experts and regulatory representatives will center on developing strategies and identifying challenges, with a specific focus on seamlessly integrating AI and ML into intricate CGT processes.

Join us in this interactive forum where industry pioneers collaborate to pave the way for a future where cutting-edge technologies revolutionize the landscape of cell and gene therapy commercialization.

This exclusive event is reserved for ISCT Patron Industry members.  Become an ISCT Patron today to gain access to this global forum of industry leaders. Contact Simone@ISCTglobal.org

Exclusive to ISCT Patron Industry Members

ISCT iPSCs Signature Series Event 
iPSCs: From Bench to Bedside
Saturday, June 1, 2024

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 2024 Signature Series Event ‘iPSCs: From Bench to Bedside’ will mirror product development, addressing key challenges and questions arising at each stage of the cycle. Global key opinion leaders from academic research labs and clinical centers, regulatory agencies, and industry, will gather in Vancouver to discuss and deliberate on pressing topics, including autologous versus allogeneic starting materials; CMC, translational hurdles and effective preclinical strategies; genomic stability; regulatory requirements and heterogeneity across jurisdictions; and ongoing clinical trial results.

Join us as we develop a roadmap for future regulatory approvals and clinical adoption of iPSC products.

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ISCT Exosomes Scientific Signature Series
MSC-EVs: Paving the Road to Regulatory Approval
Saturday, June 1, 2024

MSC-EV therapeutics have emerged as a pivotal player in the dynamic landscape of cell and gene therapy. However, the pressing question of how we translate this cutting-edge science into therapeutic reality remains unanswered. The 2024 ISCT Exosomes Scientific Signature Series event is your roadmap to achieving the first market approval for an MSC-EV product.

This event will bring together representatives from various stakeholder groups involved in clinical development to exchange insights on the optimal strategy for achieving market approval for the first MSC-EV product. Taking a multidisciplinary approach, this event harnesses the insights of 30 global key opinion leaders including researchers, regulators, investors, sponsors of cell and gene therapy (CGT) products that have successfully navigated all clinical trial phases, and therapeutic EV developers currently in clinical trials, to share their experiences and expertise to overcoming clinical trial challenges. Join us for front-row access to pivotal discussions, where experts present cutting-edge research and explore potential solutions for critical roadblocks in manufacturing, target disease selection, clinical trial design, regulation, and funding. 

Don't miss this opportunity to be at the forefront of shaping the future of EV therapeutics!

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