Earlier this month the WHO released a report regarding the development trends for antibiotics. There are currently 51 products in the pipeline for antibiotic development. Out of this bunch, eight are considered innovative. The others are likely new variations within antibiotic classes that are already in use. With the continued threat of antibiotic resistance, the outlook is grim.
So, What Can Be Done To Change This Trend?
Both clearer FDA guidelines and BARDA funding has certainly helped increase the number of new antibiotic compounds entering the clinical development process, but pharmaceutical companies still need help navigating through the development pathway. And more than anything, they need an efficient and predictable process. CRO selection can make or break a timeline, and with the staggering rate of studies behind schedule (over 84%), this choice is more important than ever.
For Melinta Therapeutics, a commercial-stage biopharmaceutical company dedicated to introducing new antibiotics that meet the ever-present challenge posed by dangerous and increasingly resistant bacteria, the CRO choice had a direct impact on the success of their study.
Sue Cammarata, Chief Medical Officer at Melinta, noted, “PSI was flexible to meet the various challenges in clinical trial conduct. The rapid enrollment of patients and the quick study close out allowed on-time study completion.”
CROs that can successfully predict timelines and use solid data to formulate trial times can reduce costly risks and help deliver drugs to market without delay.