A few years ago, most conversations around iPSCs focused on the potential of the technology itself: Could iPSCs provide a renewable source of therapeutic cells? Could they support off-the-shelf therapies? Could they address diseases where treatment options remained limited?
Now, as more iPSC programs move into and through the clinic, the conversation has become much more practical.
At conferences, investor meetings, and regulatory interactions, discussions increasingly center on manufacturing strategy, analytical characterization, process control, and scalability. The scientific promise of iPSCs remains compelling, but there's growing recognition that even the most promising therapy will struggle if it cannot be manufactured consistently and at a meaningful scale. That shift is reflected throughout the agenda for the 6th iPSC Drug Development Summit.
Success is Creating New Questions
Recent years have seen continued advances in iPSC-derived therapies across Parkinson's disease, ophthalmology, oncology, and regenerative medicine. Clinical datasets are expanding, investors remain active in the sector, and developers have gained a much clearer picture of what successful translation might look like.
The result is that manufacturing is no longer viewed as a downstream exercise. Questions that might once have been deferred until later stages of development are appearing much earlier:
- How should a development team think about donor selection?
- Which assays will ultimately support potency claims?
- At what point should scalability influence process design?
- How much comparability risk is introduced every time a process evolves?
These decisions are becoming increasingly interconnected. For example, a change in cell line strategy can affect manufacturing, then manufacturing decisions can affect analytical requirements, and analytical limitations can influence regulatory strategy.
The further programs advance, the harder it becomes to separate one discipline from another.
The Industry is Learning Where Scale Gets Difficult
Every cell therapy company wants a process that works in larger volumes than the one used in early research, but actually getting there is another matter.
One topic that recurs in industry discussions is the gap between demonstrating technical feasibility and establishing a robust manufacturing process capable of supporting clinical development.
Small-scale success does not automatically translate into commercial success. Expanding iPSC cultures while maintaining consistency introduces new variables. Differentiation protocols that perform well in development may behave differently when transferred to larger systems. Cryopreservation, transportation, and batch-to-batch reproducibility become increasingly important as manufacturing networks expand.
None of this is particularly surprising. The same pattern has played out across multiple advanced therapy modalities. What feels different today is the level of attention being paid to these issues.
Developers are talking about manufacturing far earlier than they were five years ago, largely because they have seen where programs encounter friction as they mature.
Looking Across the 2026 Agenda
This year, conversations surrounding manufacturing are spread throughout the agenda. You see CMC considerations showing up in discussions about cell line selection, analytical characterization, gene editing, quality control, regulatory readiness, and investment strategy.
For example, BlueRock Therapeutics and Thymmune Therapeutics will discuss donor and line selection strategies. Those sound like research-stage topics on the surface, yet the downstream manufacturing implications are significant.
Astellas Pharma's session on characterization frameworks addresses another area receiving increasing attention across the industry. Many developers are discovering that generating data is not necessarily the difficult part. Deciding which data will ultimately support quality, consistency, and regulatory confidence can be much harder.
Similarly, discussions from Century Therapeutics, Aspen Neuroscience, Cartherics, Vertex Pharmaceuticals, and others focus on questions that manufacturing teams are actively working through today: potency assessment, scale-up strategies, comparability, and the development of processes that remain workable beyond early clinical studies.
These are not future concerns waiting on the horizon. For many organizations, they're already part of everyday development work.
Explore the agenda below to learn more about this year's sessions:
Manufacturing is Now Becoming a Strategic Decision
Perhaps the biggest change is that manufacturing is no longer viewed primarily as an operational function.
Increasingly, it influences investment decisions, partnership opportunities, regulatory planning, and program timelines.
Investors want confidence that products can be produced at scale. Regulators want confidence that quality attributes remain consistent. Development teams want confidence that today's process will still make sense two years from now. This reality is pushing discussions about manufacturing closer to the center of iPSC development.
The field has spent years demonstrating what is scientifically possible. Now there is growing attention on the practical work required to turn promising therapies into products that can reliably reach patients.
That shift is one of the clearest indicators of how far the iPSC sector has matured, and it is a theme that runs through nearly every conversation at the 6th iPSC Drug Development Summit.
Explore the Agenda
See where the bottlenecks really are and how teams are solving them.
This agenda goes beyond theory to highlight the decisions shaping real iPSC programs, from line selection and genome integrity to late stage scale up, comparability, and regulatory confidence.
Partner With Us
Shape the discussion at the point where priorities are being set.
Partnering with the summit gives you a unique opportunity to position your organization at the heart of the iPSC community, build meaningful connections, and become the go-to partner for the iPSC community.
Join the iPSC Community
Connect with a field that has moved past experimentation.
Meet a focused community of leaders working through the realities of clinical translation, manufacturing scale, and regulatory alignment. Biopharma and academics can attend for free!