Accelerating the speed of innovative anti-tumor drugs to first-in-human trials incorporating key de-risk strategies
Yuqi Wang,
Quan Quan,
Camille Gleason
et al.
Abstract:Pharmaceutical companies have recently focused on accelerating the timeline for initiating first-in-human (FIH) trials to allow quick assessment of biologic drugs. For example, a stable cell pool can be used to produce materials for the toxicology (Tox) study, reducing time to the clinic by 4–5 months. During the coronavirus disease 2019 (COVID-19) pandemic, the anti-COVID drugs timeline from DNA transfection to the clinical stage was decreased to 6 months using a stable pool to generate a clinical drug substr… Show more
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