The Biotech Regulatory and Cost Phase Shift
A simultaneous collapse in biotech hardware costs and a sudden easing of legacy FDA regulatory requirements are drastically lowering the barrier to entry for biological engineering and therapeutics.
Trajectory
The FDA dropping its decades-old requirement for two clinical trials, combined with the debut of $100 lab-grade whole genome sequencing, signals a massive unlocking of the biotech sector for lean startups and independent researchers.
Timeline (3 events)
The Cassidy Report on the FDA
The FDA dropping its decades-old requirement for two clinical trials, combined with the debut of $100 lab-grade whole genome sequencing, signals a massive unlocking of the biotech sector for lean startups and independent researchers.
Startup debuts DNA Sequencer that can deliver lab-grade whole genome for $100
The FDA dropping its decades-old requirement for two clinical trials, combined with the debut of $100 lab-grade whole genome sequencing, signals a massive unlocking of the biotech sector for lean startups and independent researchers.
FDA Dropping Requirement For 2 Studies For New Drug Approvals
The FDA dropping its decades-old requirement for two clinical trials, combined with the debut of $100 lab-grade whole genome sequencing, signals a massive unlocking of the biotech sector for lean startups and independent researchers.