Once upon a time people wondered whether cell therapies would make it. With that question all but unriddled, the industry is surging forward with new questions and even more creative solutions – takeaways from ISCT 2018, Montreal.
Energized. That is how we sum up the vibe at this year’s International Society for Cell & Gene Therapy (ISCT) meeting in Montreal. At times the meeting reminded us of a rock concert, with photo-snapping phones surfacing at key moments and near-mobbing of some presenters after their talks. During the kick-off, a cord blood recipient coveted her doctor’s autograph over George Clooney’s. Not a rock star, but close.
Ten years ago nobody would have predicted such dedication. With wonder, cell therapy pioneer Carl June remarked that the packed plenary hall would have been just ten people in those early days. But that was before the recent market approvals of several cell and gene therapies. The question ‘Can we make them?’ has been answered with a resounding yes. Next up: ‘How can we make them better?'
This breakfast tutorial was standing room-only.
ISCT 2018 attendees came eager to tackle the new question. With several market successes secured, these topics garnered much discussion.
Increased industrial involvement at ISCT 2018, Montreal
Historically academic, this year’s meeting seemed to attract more industrial delegates than ever before. Speakers from industry and academia presented side-by-side in multiple sessions. Many presenters cited industrial investment early in clinical development, suggesting confidence that drug candidates will reach the market. Industrial exhibitors seem to have exploded from past years, including several new entrants in the cryopreservation and logistics space.
Greater emphasis on cellular therapy production
With several approved therapies under its belt, the cell and gene therapy sector is focusing more intently on manufacturing. To obtain market approvals, cell processing needs to be performed under current good manufacturing practice (cGMP) guidelines. As emphasized by multiple presenters, these requirements pose challenges to academic labs and clinical centers that must modify existing technologies and update facilities. Interest was high at a session on challenges for academic settings. The talks were punctuated by mass photo-clicking when facility designs went on-screen.
Camera phones were at the ready, popping up to catch key shots.
Details rule when manufacturing therapies for multiple patients, as many presenters attested. Coordinating apheresis, cell processing, and therapy infusion gets tricky, especially when protocols such as thawing are not standardized. Working in a hood and eliminating trash might seem trivial when making one cell therapy but become obstacles when making many. Appropriate and ongoing training is a need that came up again and again in sessions.
Science fueled by clinical evidence
The growing number of patients treated with cell and gene therapies provides data not available several years ago. The concept of T cell fatigue, where the cells lose their therapeutic benefit, was a hot topic. Another change from past meetings was the emphasis on recombinant methods to tailor the next generation of chimeric antigen receptor T (CAR T) cells.
GE’s Phil Vanek wonders whether T cell exhaustion and cell engineering are related. He noted, “More and more, I am seeing this sense of the health of the cells when they start the process. But some evidence from the presentations suggests that as we modify the cells, as we increase the modification or start to add multiple genetic changes into the cells, we might actually be setting them up for additional escape or fatigue in the immune system. I think the industry is basically saying, ‘We do not know enough about what is causing T cell fatigue.’ So that is going to be something to keep an eye on in the next year or two.”
Sessions on technology advances were among the most popular, Speakers were often surrounded post-presentation by enthusiasts.
Solutions for the future of cell therapy manufacturing
Many exhibitors showcased equipment or services tailored for gene and cell therapy applications. This is a positive step for an industry used to cobbling along with research tools. However, many of the purpose-built offerings do not address the speed at which the gene and cell therapy sector is moving to get more and better therapies to patients. When asked how GE Healthcare Life Sciences can help, GE’s Madhusudan Peshwa remarked, “We are a consolidator in terms of providing an end-to-end solution. Some of the customers we spoke with here really appreciated us saying ‘We will be your back office. You focus on reducing the clinical risk and reducing the biological risk. Leave the back office to us. We have the ability, we have the corroboration. We have done this before, we know how to do this, and we will take care of that.’ So it is truly a partnership from that perspective that GE brings, not a vendor relationship per se.”
GE’s ISCT 2018 booth, showing the breadth of solutions across the cell therapy manufacturing workflow.