Cost of Manual Work — Biotech

What this means for Biotech

• R&D timelines are 10-15 years and the cost per approved drug is in the billions — every operating decision is filtered through 'how does this affect time-to-IND, time-to-readout, time-to-NDA'.
• FDA and EMA regulatory readiness is non-negotiable — the IND, the NDA, the BLA, and every clinical trial design has to survive regulator examination, and the documentation infrastructure has to be audit-ready continuously.
• Clinical trial operations are the largest single line of cost — site selection, patient recruitment, monitoring, data management, and trial conduct are operationally intense and the largest leverage on cycle time.

Where it pays to act

• AI for drug discovery and lead optimization — protein structure prediction (AlphaFold-class models), generative chemistry, target identification, and lead optimization that compresses early-discovery timelines.
• AI for clinical trial design and operations — patient recruitment optimization, site selection ML, protocol design support, and trial-monitoring AI that compress the largest single cost line in R&D.