FAQs

This meeting is designed for professionals actively working in iPSC-derived therapy development.

This includes teams across preclinical research, process development, CMC, analytical development, QC, and regulatory affairs. It is also relevant for translational academics, CDMOs, and investors focused on advanced therapies.

If you are involved in taking an iPSC program toward the clinic or scaling an existing process, the content is directly applicable.

The summit is highly technical and experience led.

Sessions focus on real development challenges rather than high-level overviews, with the content particularly relevant for those dealing with process design, manufacturing scale-up, assay development, and regulatory strategy.

Most large CGT events cover a wide range of modalities, including viral vectors, gene editing, and autologous cell therapies.

This summit is focused specifically on iPSC-derived approaches, creating more targeted and practical conversations.

That focus allows for deeper discussion of topics such as:

• Differentiation strategies
• iPSC manufacturing workflows
• Comparability challenges
• Allogeneic scalability
• iPSC-specific regulatory considerations

The program has a two-track design to cover both Preclinical and CMC & Process Development topics evenly.

You can expect coverage of:

• Preclinical model design and assay development
• Process development and manufacturing strategy
• Analytical and QC considerations
• Regulatory alignment across the development lifecycle

This reflects how iPSC development actually happens in practice.

Attendees will be able to use the summit to benchmark approaches and learn now insights, typically gaining:

• A clearer understanding of key development challenges
• Insight into how peers are addressing similar issues
• Greater confidence in their own strategy and decision-making
• Practical ideas that can be applied to ongoing programs

Yes, particularly because many of the most important decisions are made early. Teams at discovery or preclinical stages can benefit from understanding:

• How early choices impact manufacturability
• What regulators will expect later
• Where common bottlenecks arise

This helps reduce risk as programs progress.

Regulatory topics are addressed through practical case-based discussion, with focus on real experience.

Sessions explore how teams are:

• Structuring regulatory submissions
• Managing comparability
• Defining potency and quality attributes
• Aligning development strategy across functions

The summit is structured to allow for dedicated networking opportunities with all of the speakers, sponsors and attendees. There are speed networking sessions, poster sessions and networking breaks all designed to foster interactions with peers.

In particular, the poster session allows attendees to showcase their research and gain meaningful feedback from those experiencing challenges first-hand.

Find out more here.

iPSC-derived therapies are entering a more advanced stage of development. With this comes increased focus on:

• Manufacturing readiness
• CMC discipline
• Regulatory confidence
• Clinical translation

Attending now allows teams to align their approach with the current state of the field.

You can review the full agenda and speaker faculty by accessing the event program here.

If you are a Drug Developers, Academics, or Research Institutes, you can claim your complimentary ticket* here.