The impact of FDA's Final Guidance on the use of Exploratory IND Studies could be profound for firms ranging from start-ups anticipating their first human drug tests to Big Pharmas with thousands of leads to manage and prioritize. Some service organizations may also benefit from the new regs, which may prompt an early clinical assessment of increasing numbers of compounds.

Accium Biosciences provides accelerator mass spectrometry services to pharmaceutical customers for preclinical and early clinical pharmacokinetic and bioavailability analyses of candidate drug compounds. It is currently the only US commercial AMS supplier with an in-house instrument.

A new publication offers up proof of concept that the genetic signatures of microorganisms found in blood and tumor tissue could improve precision medicine cancer diagnostics. The study also bolsters the notion that targeting the microbiome could lead to innovative cancer therapies.