Let a thousand signals bloom

FDA has taken two more steps along its Critical Path with initiatives to help academic and NIH researchers validate discoveries in the clinic. The policies could address challenges posed by changes in the biotech marketplace and by the explosion of advances in biology.

Based on the valuations given to new public companies, industry and venture capital are increasingly unwilling to invest in unvalidated targets, so non-corporate researchers have bigger incentives than ever to get quick, early human data on investigational drugs before seeking industry collaborations...