11.08.25 -- Cell & Gene Best Of October

BlueRock Therapeutics has advanced its allogeneic stem cell-derived therapy bemdaneprocel into the pivotal Phase III trial for Parkinson’s disease, aiming to restore regulated dopamine signaling, improve quality of life, and potentially transform the treatment paradigm.

This is Episode 4 of "FDA Fridays," a special series from Cell & Gene: The Podcast, Chief Editor Erin Harris speaks with a regulatory affairs expert about how shifting FDA and CBER priorities under the current administration could influence the trajectory of cell and gene therapy development.

If the science holds true, the implications could be transformative—leading to substantial cost reductions and making engineered T cell therapies more accessible to patients across the globe, regardless of geographic or economic barriers.

Learn about the regulatory frameworks developed by the United States and Australia to provide access to unapproved therapies for patients with serious or life-threatening conditions.

Explore facility cleaning, monitoring, and disinfection strategies to meet standards, emphasizing planning, stakeholder involvement, testing, trending, documentation, and continuous improvement.

Intensified adherent cell culture offers a promising solution to the limitations of traditional suspension culture, with the potential to improve efficiency, reduce costs, and accelerate development.