Roundtable 2: Sourcing and Regulation with your iPSC Therapeutic 

Introduction and Overview

1. Welcome and introductions
2. Brief overview of the importance of iPSC therapeutics in the field of cell and gene therapy
3. Explanation of the topic: Sourcing and Regulation with your iPSC Therapeutic

Sourcing iPSCs for Therapeutic Development

1. Discussion on the various sources of iPSCs, such as patient-derived, healthy donor-derived, or commercially available lines
2. Considerations for selecting the appropriate iPSC source for therapeutic development
3. Sharing experiences and best practices in iPSC sourcing, including challenges and strategies to overcome them

Regulatory Landscape for iPSC Therapeutics

1. Overview of the regulatory frameworks governing the development and commercialization of iPSC therapeutics
2. Discussion on the specific regulatory requirements and considerations for iPSC-based therapies
3. Addressing the challenges and potential solutions related to navigating regulatory pathways and ensuring compliance

Intellectual Property (IP) Issues in iPSC Therapeutics

1. Exploring the IP landscape surrounding iPSC technologies and therapeutics
2. Discussion on strategies for protecting and managing IP rights associated with iPSC-based therapies
3. Addressing potential conflicts and collaborations related to IP in the context of iPSC therapeutics

Future Directions and Opportunities

1. Identifying emerging trends and future directions in iPSC therapeutic development
2. Exploring potential collaborations and partnerships to advance iPSC-based therapies
3. Discussing opportunities for innovation and overcoming barriers in the field of iPSC therapeutics

Conclusion:

1. Recap of key discussion points and insights gained during the roundtable
2. Closing remarks and appreciation for participants’ contributions
3. Encouraging continued dialogue and collaboration in the field of iPSC therapeutics

Moderated by: Stephen Sullivan, Chief Operating Officer, iPSirius