Cross-Border Access to Approved CGT

ABOUT THE WEBINAR

Access to approved cell and gene therapies remains highly uneven across the globe, often requiring patients to travel across borders to receive potentially life-changing treatments. This webinar will bring together expert perspectives from Europe, the Middle East, Asia-Pacific, and Australia to explore how different regions are addressing the challenges and opportunities of cross-border access. Through regulatory, clinical, and patient-centered lenses, speakers will examine diverse models of access, ranging from established regulator-driven frameworks in Europe to grassroots referral networks in the Middle East and collaborative regional approaches emerging in Asia. Participants will gain insight into the key barriers limiting patient access, including regulatory, logistical, financial, infrastructure, and follow-up care challenges, while also learning about successful strategies that are helping patients connect with approved therapies. The session will conclude with a powerful patient perspective, highlighting the real-world impact of cross-border treatment pathways and the ongoing need for collaboration to improve equitable access to cell and gene therapies worldwide.

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KEY LEARNING OBJECTIVES

  • Describe the current landscape of cross-border access to approved cell and gene therapies (CGTs) across established and emerging regions, including Europe, the Middle East, Asia-Pacific, and Australia.
  • Compare different models of cross-border CGT access, including regulator-driven, institution-led, and collaborative regional approaches, and identify their respective advantages and limitations.
  • Recognize key barriers to patient access to approved CGTs across regions, including regulatory, logistical, clinical, financial, infrastructure, and follow-up care challenges.
  • Understand the patient experience of navigating cross-border access, including the practical, emotional, and healthcare-system challenges faced by patients seeking potentially life-saving therapies.
 WEBINAR CHAIR

Elena Maryamchik, MD, MBA
ISCT Regional Treasurer, North America (NA)
Director of Cell Therapy Laboratory, Attending Physician in Transfusion Medicine
Memorial Sloan Kettering Cancer Center
United States

Dr. Elena Maryamchik earned a dual MD/MBA degree from the University of Miami in 2016. She subsequently completed a residency in Clinical Pathology at Massachusetts General Hospital, followed by fellowships in Cell and Gene Therapy at the University of Pennsylvania/Children’s Hospital of Philadelphia and in Transfusion Medicine at Harvard Medical School. She currently serves as Director of the Cell Therapy Laboratory and Assistant Attending Physician in Transfusion Medicine at Memorial Sloan Kettering Cancer Center. Her work encompasses direct patient care, laboratory leadership, and the development of point-of-care manufacturing platforms for advanced cell therapy products, including CAR T cells, antigen-specific T cells, virus-specific T cells, gamma-delta T cells, and dendritic cell (DC) vaccines.

Dr. Maryamchik is an active member of the International Society for Cell & Gene Therapy (ISCT) Laboratory Practices Committee and the Ethics in Cell and Gene Therapy Committee, and serves as the ISCT North America Regional Treasurer for the 2026–2029 term. Through collaborative cell and gene therapy (CGT) working groups involving ISCT, AABB, ASTCT, and other leading professional organizations, she contributes to the development of laboratory standards, operational best practices, and quality frameworks that support the safe and effective delivery of cell and gene therapies. She also leads initiatives focused on advancing ethical practices and promoting equitable access to innovative cellular therapies worldwide.

 WEBINAR SPEAKERS

Michela Gabaldo, MD, PharmD
VP & Head of ATMP Global Regulatory Affairs
Scientific Director
Evotec SE
Italy

Dr. Michela Gabaldo is Vice President and Head of ATMP Global Regulatory Affairs at Evotec and a recognized expert in the development, regulation, and patient access of advanced therapies. With more than 25 years of experience in global regulatory affairs and over a decade dedicated to gene and cell therapies, she has played a key role in the translation of pioneering treatments from research to patients. During her tenure at SR-TIGET/Telethon Foundation, she contributed to the regulatory strategy, European approval, and implementation of cross-border access pathways for Strimvelis® and Libmeldy®, two landmark gene therapies for ultra-rare diseases available in a single treatment center in Milan. Her experience at the intersection of regulation, innovation, and healthcare delivery has made her a leading voice on cross-border healthcare access and equitable patient access to advanced therapies worldwide.

Syed Osman Ali Ahmed, MD
Consultant Hematologist
CAR-T Director
King Faisal Specialist Hospital and Research Centre
Saudi Arabia

Dr. Syed Osman Ahmed completed his undergraduate and postgraduate medical training in London and has since been a Consultant Hematologist and Director of the CAR-T Program in King Faisal Specialist Hospital and Riyadh. He led the establishment of the first CAR-T therapy program in Saudi Arabia and has played a pivotal role in advancing access to cellular therapies across the region. In addition to his clinical and program leadership responsibilities, Dr. Ahmed is actively involved in developing a provider-driven referral network aimed at improving patient access to cell and gene therapies throughout the Middle East. His experience navigating regional healthcare systems, referral pathways, and cross-border access challenges provides a unique and practical perspective on expanding equitable access to advanced therapies.

Sudipto Bari, PhD
ISCT Chair, Asia Regional ESP Subcommittee
Assistant Director
Head, Strategy & Organizational Affairs
Advanced Cell Therapy and Research Institute, Singapore
Singapore

Dr. Sudipto Bari is the Head and Assistant Director of Strategy and Organisational Affairs at the Advanced Cell Therapy and Research Institute (ACTRIS), and a Senior Research Fellow at the National Cancer Centre Singapore. With over ten years of experience in translational research and development of cell and gene therapies along with organizational-level strategic planning, he holds a PhD in Pharmacy and a BEng in Biomedical Engineering from the National University of Singapore, as well as an MBA from Quantic School of Business and Technology. He has multiple patents, awards, and publications in the area of haematopoietic stem and progenitor cells, reflecting his commitment to advancing cell and gene therapy and improving the lives of patients with blood disorders and cancers.

Kaela Graham-Bowman
 Patient Perspective
Australia

Kaela Graham-Bowman is a mother, a Registered Nurse, an Army veteran, and a patient living with synovial sarcoma, whose determination has helped pave the way for others facing the same diagnosis. She became the first patient in Australia to successfully navigate the Cross-Border Access pathway to receive TECELRA, an autologous genetically modified immune effector cell therapy that is not currently available in her home country, by accessing treatment in the United States. In doing so, Kaela broke new ground for future patients seeking access to this potentially life-saving therapy, establishing a pathway that others may now follow. Beyond her own treatment journey, she continues to advocate for patients by raising awareness of the disease and the treatment options available, including access through the Cross-Border Access pathway.