Cell and Gene Therapy Summit

In Session 6, some of the most pressing challenges in advancing cell and gene therapies will be on the table, as global experts engage in three focused discussions covering regulatory, access, and manufacturing issues that are shaping the CGT landscape.

The first discussion will feature the Alliance for Regenerative Medicine (ARM), a multi-stakeholder, international advocacy organization championing the advancement of cell and gene therapies. ARM will share insights on how regulatory frameworks can evolve to keep pace with rapid scientific advancements, foster innovation, and support global regulatory convergence. In the second discussion, a representative from AbbVie will address access barriers in developing countries and share strategies to ensure that patients with urgent and unmet medical needs can benefit from newly approved CGTs. The final discussion, led by a representative from Bayer, will be regarding Chemistry, Manufacturing, and Controls (CMC) challenges in CGT production and issues such as scalability, quality control, and evolving regulatory expectations across global markets will be highlighted.

Attendees will have the opportunity to engage directly with thought leaders, exchange perspectives, and contribute to identifying collaborative solutions that can accelerate the development and global delivery of safe, effective, and accessible cell and gene therapies.