2014 buzzed with discussion on how to make clinical trials more patient centric. We tried to identify key obstacles to patient enrollment and suggested practical solutions on how to overcome them. We also looked at technologies that will revolutionize R&D and celebrated medical breakthroughs.
With drying drug pipelines and increasing competition from generics, the orphan drug sector offers several attractions for pharma. Market exclusivity, protocol assistance, and fee reductions are among some of the benefits offered to the industry on both sides of the Atlantic.
In response to the many pressures to become more efficient and the increasing scrutiny of regulators and payers to demonstrate real-world evidence that new medications are truly effective, pharma are focusing on how to leverage technology to transform clinical trials.
Steve Jobs once said, “We’re here to put a dent in the universe”. We talk to Flemish researcher, Koen Andries, who has succeeded in putting a considerable dent in the progression of multi-drug resistant TB. Here, he discusses the deadly gap that persists in neglected disease drug development.
Patient recruitment and retention has continued to be one of the largest challenges in clinical development for biopharma companies, with most studies experiencing start-up delays and/or completing late.
Over 12 years, 50%new molecular entities (NMEs) failed to obtain approval when first submitted to the FDA. Some new applications were rejected because of inadequate drug performance, other, however, failed because of, what looks at first glance as, sloppiness.