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FORUM 30: Exploring the Future of Medical Products of Human Origin

Joaquim Vives, contributing editor
Banc de Sang i Teixits
Barcelona, Spain

Last month, the historic city of Rome played host to a remarkable gathering of experts at the FORUM 30 Global Conference. Convened by the International Council for Commonality in Blood Banking Automation (ICCBBA) in partnership with the Italian national authorities for blood (CNS) and cells/tissues (CNT), with the support of the World Health Organization (WHO), this exclusive invitation only event was a cornerstone in the global effort to enhance the safety and traceability of Medical Products of Human Origin (MPHO).

The conference brought together 102 distinguished delegates from 36 countries, representing all World Bank regions. This diverse cohort included specialists in blood, cells, tissues, organs, human milk, and medically assisted reproduction, alongside regulatory authorities, developers of quality management standards, government officials, and industry representatives. The geographic diversity of attendees underscored the global relevance of the issues discussed:

The agenda was as diverse as the attendees, tackling safety and traceability across all MPHO groups. I participated as speaker in Session 10, entitled “MPHO-based Therapies in the Next 20 Years: What is Coming That We Need to Think About Now?” This forward-looking session invited participants to imagine the future of MPHO-based therapies while grounding their visions in the imperatives of safety, efficacy, and regulatory alignment. From advanced cell and gene therapies to organ bioengineering and emerging uses of human milk in neonatal care, participants were encouraged to envision therapies now emerging in laboratories that could revolutionize patient care within two decades. A key goal was to help regulators in attendance to view the session as an “express” horizon-scanning exercise. This was particularly critical for regions where advanced therapies are still in nascent stages, ensuring that frameworks can be put in place to support their eventual adoption. Central to the discussion was the ongoing international effort to harmonize regulatory frameworks to expedite therapy authorization without compromising patient safety. Using a format of 8 moonshots and challenges I took the opportunity to present our EU Task force ISCT committee paper on Current challenges in cell and gene therapy: a joint view from the European Committee of the International Society for Cell & Gene Therapy (ISCT) and the European Society for Blood and Marrow Transplantation (EBMT), published recently in Cytotherapy. The topics of the moonshots were:

1. Data Ecosystem for Real-World Evidence
2. Quality Standards for Manufacturing & Hospital Exemption
3. Equitable & Outcome-based Reimbursement Models
4. Collaborative Networks for Academic Manufacturing
5. Public-Private Partnerships to Accelerate Developments
6. Workforce Training Program
7. Public Awareness of Unproven Therapies
8. Improve Patient Access & Innovation

Beyond the presentations, the conference fostered meaningful dialogue among attendees, setting the stage for future collaborations. The shared commitment to advancing patient care and ensuring donor well-being resonated throughout the event, reinforcing the value of global unity in addressing the challenges posed by MPHO. Indeed, the Rome meeting was not merely a discussion of current practices but a pivotal moment in charting a path toward the future of MPHO. By uniting a wide spectrum of stakeholders, the conference underscored the importance of collaboration in addressing the multifaceted challenges of MPHO. As therapies evolve, the need for robust safety measures, innovative tracking technologies, and international regulatory alignment will only mature.

In short, FORUM 30 was a transformative event for all involved, offering a unique opportunity to exchange insights among all of us dedicated to advancing the future of medicine for the benefit of patients and donors worldwide as well as to build networks and contribute to a shared vision. The insights gained in Rome will undoubtedly shape the trajectory of MPHO safety and traceability initiatives for years to come.

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