Advancing circulating tumor DNA (ctDNA) as a surrogate endpoint is stalled because the necessary large-scale, prospective validation studies are too expensive for any single company. The path forward requires a massive public-private partnership to fund research and establish standards, otherwise progress will remain incremental.
The narrative of China's biopharma industry as an imminent threat to U.S. dominance is often exaggerated. In reality, Chinese biotechs are fundamentally dependent on foreign markets to sustain innovation, as their domestic market is insufficient. This reliance forces collaboration, making them partners as much as competitors and limiting their ability to act independently.
While the need for prospective trials dominates the ctDNA discussion, a more fundamental obstacle is the lack of standardization between assay types (e.g., tumor-informed vs. agnostic). Without a common measurement approach, data from disparate trials cannot be pooled to create a universally accepted surrogate endpoint for regulatory approval.
Despite excitement for in-vivo CAR-Ts, the high response rates and multi-year survival of current autologous therapies create a significant competitive moat. New modalities must not only match this efficacy but also prove long-term durability, a high bar that insulates incumbents in indications like multiple myeloma for the foreseeable future.
The FDA's decision to create a novel split review pathway (standard and accelerated) for a single Moderna vaccine application was a politically motivated maneuver following an initial refusal. This ad-hoc solution is a unique response to intense political pressure and should not be viewed by companies as a new, replicable strategy for overcoming adverse FDA decisions.
Gilead is betting it can overcome the manufacturing and supply chain challenges that have limited J&J's successful Carvykti therapy. While Arcellx's AnitoCell shows similar efficacy, justifying the premium price tag depends on delivering a more reliable and scalable manufacturing process, which remains unproven.
A disconnect exists between the public rhetoric of U.S. pharma leaders, who frame China's growing biotech sector as a threat, and their corporate actions. These same companies are investing heavily in Chinese R&D and manufacturing, revealing a dual strategy of public caution and private commitment to integrating China into the global biopharma ecosystem.