P114: Navigating Value Misalignment and Boundary Work in China’s CGT Ecosystem: A Multi-Stakeholder Qualitative Analysis
Poster Presenter
ZIYU YE
Graduate Student
University of Macau China
Objectives
To identify core challenges in China’s CGT industry, analyze the root causes of stakeholder value conflicts, and provide systematic solutions through boundary-spanning frameworks to accelerate the industrial development and foster collaboration in the CGT ecosystem.
Method
Expert views were collected via 15 semi-structured interviews (of 26 participants) and supplemental surveys. Data was processed using open and thematic coding (NVivo) and analyzed through institutional logic and boundary organization theories to map tensions across the CGT lifecycle.
Results
1. The analysis identified six interconnected challenge domains across the CGT lifecycle: (1) Technology (exploration vs. stability); (2) Talent (scientific vs. industrial mindset); (3) Policy (regulatory lag vs. innovation); (4) Clinical (lab data vs. real-world efficacy); (5) Supply Chain (customization vs. industrialization); and (6) Finance (risk tolerance vs. R&D cycles).
2. To explore the root cause of above challenges, we synthesized 7 value dimensions modulated by 8 CGT-specific Moderating factors (e.g., high risk, high-tech irreversibility). Core values of 3 key stakeholders appeared to be different: Enterprises prioritize technological leadership and financial sustainability; Regulators balance national strategic goals with public safety—leading to innovations like the "dual-track" system (differentiating drug-pathway vs. medical-technology-pathway). Clinical institutions face the heaviest burden, grappling with ethical mandates, patient risk, and financial viability. This reveals a "power-responsibility asymmetry" where hospitals, as final executors, have the least creative latitude.
3.When discussing about suggestions and expectations on future CGT industrial development, we noticed that the crucial role of "boundary organizations" (e.g., industry associations, CDMOs, innovation incubators) had been frequently mentioned. Their functions include fostering dialogue and value exchanges among different stakeholders, promoting regional policy pilots, and advancing standards. Case studies of two exemplary boundary organizations included in our interview provided actionable and innovative mechanisms from different organizational levels.
Conclusion
1. This study extends Guston’s science-politics framework into a "science-politics-ethics" triadic model for CGT. Sustainable advancement requires stakeholders to navigate divergent logics while identifying shared ground. Industry must deepen investment in CMC and post-market surveillance; policymakers should create adaptive spaces like regional regulatory sandboxes.
2. Findings spotlight clinical institutions as the central tension field. The power-responsibility asymmetry they face demands urgent attention to protect both physicians and patients. To address this, we advocate for boundary organizations to actively participate in this field to bridge divergent institutional logics. Besides, boundary individuals equipped with interdisciplinary mindsets and skills can also act as “translators” to provide creative solutions and make collaborations among different parties smoother and more efficiently.
3. Ultimately, true innovation must transcend technical breakthroughs to honor the foundational ethos of medicine: that our shared adversary is disease and every life merits equal consideration. Concrete actions, such as advancing international frameworks for shared long-term safety data and regulatory convergence, can transform these principles into a global infrastructure. This ensures that the CGT revolution remains anchored in human-centric values despite fierce global competitions.
