90% of all preclinical drug candidates fail to make the grade. Now novel methods that employ miniaturised organs could help overcome this healthcare hurdle. Researchers and CROs are testing a range of models – whether grown from stem cells or spit out by 3D bioprinters – to identify toxicities, simulate cancer development and identify responders to expensive therapies. The field of 3D microtissue-based screening is just a decade old, but it clearly is soon going to play a key role when it comes to improving productivity in drug development.

Only a small fraction of carefully selected patients are allowed to enroll in randomised controlled trials involving new compounds – the gold standard of drug assessment. But trying to acquire the most significant efficacy and safety results for a new drug is one goal, treating patients every day in hospitals or practices with it is something else entirely. Discrepancies are inevitable. Now “real-world data” that’s been gathered in large observational studies is attempting to close the gap between experimental, artificial study settings and clinical realities.

For over three decades, attempts among drug developers to target the inflammatory pathways and symptoms of sepsis have been fruitless. New rapid diagnostics, rigourous patient stratification and drugs with novel modes of action are now on the horizon for treating the most costly cause of death in the industrialised world. Biotechs are pushing new ideas towards clinical testing, but there just isn’t enough funding available in the EU. Will US investors again pick up European innovation on the cheap?

The European Medicines Agency’s new, accelerated route to approval for innovative drugs seems to be especially attractive for biotech companies. But Health Technology Assessment institutions warn that the lack of substantial data might interfere with reimbursement. 

Amgen’s Imlygic was approved last year – a move that finally added onco­lytic viruses (OVs) to the healthcare toolkit. Although the treatment’s scope of application as a stand-alone therapy is limited, many are viewing the event as Ground Zero for an explosive new age in medicine. Evidence is mounting that the full potential of virotherapies can only be realised in combination with other immuno­therapies, chemotherapies or small-molecule therapies. A number of other European drug developers have now jumped on Amgen’s bandwagon.