Quotient Sciences, a global drug development and manufacturing accelerator, has integrated drug substance into its flagship Translational Pharmaceutics platform. The newly integrated service unites drug substance, drug product and clinical testing activities all within a unified organization and under a single project manager.
 
The full integration of drug substance R&D and manufacturing follows a year after the company’s acquisition of its Alnwick, UK site and provides a more streamlined approach from candidate selection through to commercialization. Quotient Sciences Translational Pharmaceutics approach – combining manufacturing and clinical dosing at a single organization – enables innovators to adjust formulations and dosing in real time.
 
“Our Translational Pharmaceutics platform is now in its 15th year and has accelerated development timelines for more than 500 drug programs. We remain the only outsourcing partner able to offer innovators the ability to manufacture, release, and dose under one organization. This approach is proven to shave 12-months of timelines and, by adding drug substance synthesis, the timeline from candidate selection to clinic can be a further accelerated by 2-4 months,” commented Mark Egerton, CEO of Quotient Sciences.
 
Translational Pharmaceutics was developed in consultation with the MHRA & FDA and employs a rapid “make-test” cycle, where drug products are manufactured, released, and dosed in a clinical study in days rather than months. This means biotechs and pharma companies can fast track molecules from First in Human (FIH) through Proof of Concept (POC). 
 
“By fully integrating drug substance with drug product and clinical testing activities, Quotient Sciences can closely align manufacturing and dosing workflows, greatly improving R&D efficiencies, and increasing the potential for clinical and commercial success,” stated Peter Scholes, CSO of Quotient Sciences. “In fact, an independent study by the Tufts Center of the Study of Drug Development (CSDD) showed Translational Pharmaceutics delivered $200 milllion in drug development cost saving per approved drug.”
 
“Our purpose has always been to bring new medicines to patients faster, and our new capabilities in drug substance continue to break down traditional industry silos.  As we look to the future, Quotient will continue to bring on new services that further integrate drug development and streamline the outsourcing needs of our customers,” added Egerton.