ISCT publishes conclusions and consensus from its 2022 Annual Meeting

ISCT provided post-pandemic venue for the entire cell and gene therapy sector to generate solutions to the major barriers to providing therapies to patients

Vancouver, Canada, July 25, 2022 - The International Society for Cell & Gene Therapy (ISCT), the global society of clinicians, researchers, regulators, technologists, and industry partners dedicated to the translation of cell and gene therapy (CGT) into safe and effective therapies to improve patients’ lives, today announces the conclusions and consensus from its international ISCT 2022 Annual Meeting.

The ISCT Annual Meeting, held this year in San Francisco, US, between May 4-7, 2022, is the largest global yearly summit event for all those involved in the cell and gene therapy translation sector. It has set the aims, policies, solutions, and consensus path forward for the sector over each successive 12 months, addressing the biggest bottlenecks in cell and gene therapy development. The ISCT Annual Meeting is designed to connect cell and gene therapy translation professionals to educate, inspire, network and collaborate. 

In total, 1,646 cell and gene therapy experts from 38 countries attended in person the 2022 meeting, representing all stakeholders in the cell and gene therapy field across industry, academic and regulatory spheres. Of these attendees, 59 percent were from industry, including therapy developers, manufacturers, other supply chain providers and investors. 41 percent were from academia, government and non-profit organizations. The largest sector increase in attendance was from manufacturing, with 23 percent of in-person attendees at ISCT 2022, raised from 11 percent in the virtual ISCT 2021 meeting. In addition, there were over 2,000 in-person B2B partnering meetings, a 400 percent increase on previous years.

ISCT 2022 featured a revamped program addressing new translational challenges arising through the rapid and sustained growth of the field. “The exponential growth phase in the field of cell and gene therapy continues as a growing number of therapies are being approved and new innovations are created,” said Anthony Ting, Chief Commercialization Officer, ISCT. “The development of a novel cell or gene therapy for the treatment of patients with high unmet medical needs is a process that requires communication and collaboration across multiple disciplines including scientists, industries including both therapeutic developers and technology enablers, as well as clinicians, regulators, and the patients themselves. The continuation of this cross-sector collaboration is vital.”

The ISCT 2022 scientific program, renamed the Translational Pathway Program, integrated perspectives across the CGT sector to address key topics at the various stages of translation. The program was structured to mirror therapeutic development, launching with addressing barriers to early translational research, proceeding through the various phases of clinical trials, and concluding with patient access and commercialization considerations.

“The new meeting format allowed delegates to attend sessions based not only on cell types but also product development pathways,” said Bambi Grilley, Co-Chair, ISCT 2022. “The success of this new format is largely reflective of the fact that cell and gene therapies now run the gamut of pre-clinical to post-marketing.”

Launching the Translational Pathway Program, the Presidential Plenary provided clarification as to the scale of increases of gene editing and gene modified therapies, including those now commercially available in many countries. In addition, there were extensive discussions on equality of access issues, specifically how to widen patient access within and across countries, and the commercial and regulatory challenges in developing advanced cell and gene therapies for rare diseases.

ISCT hosting the 33 roundtables at the Annual Meeting provided key stakeholders a platform, unique in the cell and gene therapy sector, to debate and provide consensus to guide ISCT and the wider sector on a full range of topics, barriers and milestones currently affecting cell and gene therapy. The roundtables enabled delegates to ask questions, join in debates, and participate in problem-solving to develop impactful solutions that shape their field.

The roundtables covered the full range of therapies, including innovation, clinical translation, product launch and patient access for CAR-Ts, MSCs, iPSCs, and a variety of gene therapies. The topics included the relationship between investors and the CGT sector, expanded access and hospital exemption, managing the CGT workforce and skills crisis, product development, managing risks, potency assays, toxicity, sterility, starting materials and donors, supply chains and chain of custody and identity.

Headline conclusions from debates in the roundtables included the requirement for region, and even country-specific solutions, whilst historically organizations in the cell and gene therapy industry had tried to present single international solutions, with limited efficacy. Similarly, solutions need to be different within different technologies and fields within the CGT sector. It was also agreed that the sector still needs to form more collaborations to serve patient requirements in the future. Finally, standardization across the reporting and qualification of facilities collecting and administering commercially sponsored products is vital.

Workforce development was a central focus of the Roundtable Program, aiming to provide solutions to the dearth of qualified personnel to manufacture cell and gene therapy products. Training programs are limited and most personnel are trained on-the-job. Middle management roles are also particularly challenging to fill because personnel with experience are in high demand and can be lured away to the highest paying opportunity. Delegates shared experiences from their laboratories and participated in outlining solutions to the workforce shortage. The consensus was that the field needs to think ‘outside the box’ to develop hands-on training programs, not only for graduates, but also for experienced individuals looking to change careers. One opportunity to consider is academic collaborations with industry to train personnel. ISCT will look to facilitate these partnerships, utilizing the strong ties that are present with the ISCT Industry Committee.

“The COVID pandemic has provided an ultimate clarification of the urgent need for therapeutic development for a range of therapies at the same time as preventing in-person meetings for these therapies to be discussed. The onus was therefore on ISCT, at its thirtieth anniversary, to provide the platform for the sector to meet again for the first time in three years. This platform enabled all stakeholders in the sector to reach fresh consensus and conclusions about the new priorities for the cell and gene therapy space,” said Bruce Levine, outgoing President, ISCT. “ISCT broadened its focus, through a whole series of roundtables, to cover wider challenges experienced across the industry, from generating return on investment to managing the supply chain. ISCT will continue to monitor the efficacy of solutions generated at the meeting and continue to work with all stakeholders to ensure an increasing number of patients are able to benefit from cell and gene therapies.”