Non-regulated and unproven stem cell therapies continue to pose risks to patients, and aggressive and deceptive marketing tactics often blur the line between hope and fraud. In this webinar, you will gain insights from a landmark class action lawsuit against a clinic that falsely claimed to regenerate lung tissue. Despite lacking scientific evidence, the clinic used deceptive marketing to mislead patients—until legal action shut it down and secured a multi-million-dollar verdict for those affected. This session will also explore the vital role of scientific and medical experts in litigation. Learn how researchers and clinicians can contribute to legal proceedings, provide expert opinions, and uphold ethical standards in the rapidly evolving field of cell and gene therapy. We will discuss the litigation process, protections for expert witnesses, and how expert testimony can safeguard patient trusts and drive regulatory improvements.

One of the biggest headlines for our field was the recent approval of Ryoncil - we're delighted to have Silviu Itescu, MBBA, FRACP, CEO of Mesoblast, as the featured presenter for this town hall meeting. This is your chance to not only get the inside details from the Mesoblast breakthrough, but to also connect with the ISCT Community and meet our North America leadership team in this virtual forum - if you're a cell and gene therapy therapy professional, there's a lot of value for you! Among key updates for the region, you'll hear of some exciting highlights from our team - selected sessions and programs that they (and you!) don’t want to miss at the ISCT 2025 Annual Meeting in New Orleans.

Organized by the ISCT ESP Committee: Mentoring & Career Development Working Group. Are you seeking to unlock funding opportunities for your projects but unsure of where to start? Register for the ISCT Early-Stage Professionals’ informative webinar designed to equip you with essential skills in grant writing. Whether you’re new to grant writing or looking to refine your skills, in this interactive session, we will cover the essentials of navigating the world of grants and funding opportunities from USA and EU perspectives. You will learn the ins and outs of the grant application process, from understanding different funding sources to crafting compelling proposals that resonate with funders. In addition, you will receive guidance on developing a funding plan, along with career strategies that can significantly improve your chances of securing competitive research funding. Our expert speakers will share their knowledge and experiences, helping you navigate common challenges and pitfalls in grant writing. Take charge of your career development and don't miss an opportunity to gain valuable insights and practical tips that can help you navigate the grant writing process with confidence.

WEBINAR DESCRIPTION: Join the International Society for Cell & Gene Therapy (ISCT) for an in-depth webinar on the evolving reimbursement landscape for CAR-T therapy. This session is essential for professionals navigating the complexities of cost, coverage, and regulatory considerations associated with CAR-T treatments. The webinar will be led by industry experts discussing recent developments in CAR-T reimbursement. Participants will explore case studies showing how policies impact patient access to CAR-T therapy, highlighting challenges and opportunities. Additionally, participants will gain knowledge and evidence to engage with policymakers and stakeholders for equitable reimbursement policies, ensuring timely and affordable access for patients.

Hosted by the ISCT Asia Regional Leadership, this Town Hall offers the opportunity to learn about key priorities in the region, how to get the most out of your membership with ISCT, and ways you can actively participate and contribute. Gain insights directly from our current leaders into resources and initiatives aimed at supporting our members in the region. This recording also features presentations from our guest speakers: Shin Kawamata, MD, PhD, CEO of Cyto-Facto Inc. and Huji Xu, PhD, Professor of Medicine at Tsinghua University.

WEBINAR DESCRIPTION: In October 2023, the FDA issued a guidance document on Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies. This guidance describes a standards recognition program for regenerative medicine therapies (SRP-RMT) at FDA’s Center for Biologics Evaluation and Research (CBER) designed to identify and recognize Voluntary Consensus Standards (VCS) to facilitate the development and assessment of regenerative medicine therapy (RMT) products regulated by CBER when such standards are appropriate. Standardization bodies such as Standards Coordinating Body (SCB) and the American National Standards Institute (ANSI) have helped to introduce and facilitate the VCS process, however, many stakeholders are unclear about the process. This webinar will discuss the VCS process, what the stakeholders need to know, and how to develop one. A case study of an actual international consensus standard development of tissue-specific MSC biobanking, characterization, terminology with extensive and iterative input from ISCT will also be presented.

WEBINAR DESCRIPTION: In October 2023, the FDA issued a guidance document on Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies. This guidance describes a standards recognition program for regenerative medicine therapies (SRP-RMT) at FDA’s Center for Biologics Evaluation and Research (CBER) designed to identify and recognize Voluntary Consensus Standards (VCS) to facilitate the development and assessment of regenerative medicine therapy (RMT) products regulated by CBER when such standards are appropriate. Standardization bodies such as Standards Coordinating Body (SCB) and the American National Standards Institute (ANSI) have helped to introduce and facilitate the VCS process, however, many stakeholders are unclear about the process. This webinar will discuss the VCS process, what the stakeholders need to know, and how to develop one. A case study of an actual international consensus standard development of tissue-specific MSC biobanking, characterization, terminology with extensive and iterative input from ISCT will also be presented.

WEBINAR DESCRIPTION: Join us for a deep dive into the world of CAR-T cell therapy development with our webinar titled "Navigating CAR-T Cell Therapy Development: Insights from Leading SCA Academic Centers." Organized by the ISCT South & Central America (SCA) Regional Executive Committee and the South and Central America (SCA) Regional ESP Subcommittee. The event will be co-chaired by Samuel Couto and Lilia León Moreno. The webinar will open with Virginia Picanço-Castro sharing her experience from one of Brazil's leading institutes on the complete developmental journey of a CAR-T cell product, from bench to bedside. She will provide a detailed overview of the unique manufacturing challenges faced and the innovative strategies implemented to bring CAR-T cell therapies to clinical practice in Brazil. Andres Gomez will offer valuable insights from Mexico, discussing the development and implementation of CAR-T cell therapies within the local academic and clinical landscape. He will highlight the regulatory environment and the steps required to advance this novel treatment in Mexico. Chase Mccann will conclude the session by discussing the role of clinical trials in the development of CAR-T cell therapies, drawing from his experience at Children's National Hospital. He will focus on the latest advancements in pediatric applications and share real-world insights from ongoing clinical trials. This exclusive event offers members of the International Society for Cell & Gene Therapy (ISCT) an opportunity to explore the diverse paths of CAR-T therapy development across the South & Central America region. Engage with leading experts and discover the future of CAR-T therapy, from clinical trials to regulatory challenges and beyond.

WEBINAR DESCRIPTION: While an increasing number of regulatory approvals in the Cell and Gene Therapy (CGT) field has fueled optimism for potential treatments and cures for debilitating and fatal conditions, constant challenges to US FDA oversight – by courts, federal and state legislatures, and rogue “stem cell clinics” - pose serious risks for individual patients and for the entire industry. This webinar begins with an overview of the U.S. legal landscape governing development and therapeutic usage of stem cell and gene therapies, including several recent, highly-consequential court rulings impacting the FDA and other federal agencies. The webinar then addresses recent state developments that have attracted little public attention, including new iterations of “Right-To-Try” and “Medical Freedom” laws, and their legal and practical impact on experimental stem cell and gene therapies. After exploring the wide-spread availability of unproven stem cell and regenerative interventions currently being offered by stem cell clinics and in other unregulated settings, the webinar will highlight existing risks for individual patients and the entire CGT sector, and ways these may be further exacerbated in the near future. The area of unproven stem cell and regenerative medicine clinics will be discussed in more depth as an exemplar of complex legal, policy and ethical challenges to federal and state regulators. The webinar will conclude with an interactive panel discussion and an open Q&A for attendees to raise issues and contribute to the discussion.

In Conversation with Asia CGT Startups