Mark Stewart, Vice President of Friends of Cancer Research, shared a post on LinkedIn about an article he and his colleagues authored:
“What practical steps can help ensure that genetically modified cell therapies for rare cancers move efficiently from clinical promise to patient access?
Our new Friends of Cancer Research commentary developed with the Parker Institute for Cancer Immunotherapy in the Journal for ImmunoTherapy of Cancer outlines practical strategies to modernize manufacturing, regulatory expectations, and financial pathways so that promising therapies can move from early development to clinical impact.
Key approaches we highlight:
- Flexible CMC frameworks that maintain rigor while recognizing the realities of low-throughput manufacturing
- Adaptable regulatory models to support centralized, decentralized, and point-of-care production
- Sustainable financial mechanisms to help bridge pre-approval development gaps for small or ultra-rare populations
Full article available here.
Appreciate the insights and collaboration from my coauthors: Chris Cabanski, Jeff Allen, John Connolly, Ben Beneski, Boro Dropulić, Steven Feldman, Lee Fleisher, Patrick Hanley, Ph.D., Kristen Hege, Natasha Kekre, Holly Fernandez Lynch, JD, MBE, and Crystal Mackall.”
Kristen Hege, Member Board of Directors at KSQ Therapeutics, Inc., shared this post, adding:
“I encourage everyone to read this provocative white paper focused on strategies to enhance R&D and patient access to cell therapies for rare cancers. It was a pleasure to participate in this important initiative.”
Title: Enabling access to genetically modified cell therapies through flexible approaches to manufacturing and cost recovery
Authors: Mark D Stewart, Christopher R Cabanski, Jeff D Allen, John E Connolly, Ben M Beneski, Boro Dropulić, Steven A Feldman, Lee A Fleisher, Patrick J Hanley, Kristen Hege, Natasha Kekre, Holly Fernandez Lynch, Crystal L Mackall
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