The Drug Discovery World Podcast Overcoming barriers to patient access
Oct 15, 2025
Discover how novel techniques in human cell manufacturing are breaking down barriers to cell therapies, promising wider patient access. The conversation dives into the cost challenges of current autologous therapies and explores the allogeneic approach, which could revolutionize treatment availability. Transitioning to blockchain, discover how decentralized identities can enhance informed consent processes, making them more efficient and secure, while addressing privacy concerns. The potential applications of these advancements could reshape the future of clinical trials.
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Scaling Cell Therapies Requires New Models
- Cell therapies are transformative but current autologous processes make them prohibitively expensive and logistically complex.
- Allogeneic, scalable stem-cell approaches can reduce costs by one to two orders of magnitude and broaden patient access.
OptiOX Reprogramming From One Donor
- BitBio uses its OptiOX platform to reprogram iPSCs into specific human cell types at scale from a single donor line.
- Kathryn Golden says one OptiOX run could potentially supply a thousand patients versus single-use autologous batches.
Off-The-Shelf Hepatocyte Therapy
- BitBio's lead program BBHEP01 uses allogeneic iPSC-derived hepatocyte-like cells to support liver function until transplant or recovery.
- The cells can be cryopreserved to enable off-the-shelf treatments for many patients from one donor-derived line.