As pressure mounts globally on drug pricing and development cost continues to rise, clinicians and translational scientists in biotech, academia and biopharma companies are re-evaluating when, where and how to launch early clinical programs. These initial patient data become critical to de-risk development programs and allow developers to deploy their limited time and resources on the most promising drugs. We evaluate four fundamental shifts in drug development that appear to be unfolding and may well become critical to future global biopharma success: use of large-scale high quality cohort studies, sponsor-driven investigator-initiated trials, the integration of affordable artificial intelligence with extensive high quality data registries, and China’s focus on precision medicine. —
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L.T. developed the basic outline of the article and organized most of the secondary research. B.L and K.S. along with L.T. provided practical examples from their respective roles as an academic (B.L.), US biotech CEO (K.S.) and founder of a global clinical CRO (L.T.).
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L.T. is the founder and chairman of Caidya. K.S. is chairman, president and CEO of Candid Therapeutics. B.L. is the founder and chairman of 4B Technologies.
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Tan, L., Song, K. & Lu, B. China’s innovation in translational medicine: rethinking early-stage clinical development. Nat Biotechnol (2026). https://doi.org/10.1038/s41587-025-02998-x
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DOI: https://doi.org/10.1038/s41587-025-02998-x