Tufts Center for the Study of Drug Development (CSDD) today published a white paper sharing study results that indicate Quotient Sciences’ Translational Pharmaceutics® platform reduces development times by more than 12 months and lowers R&D costs by more than $100 million per approved new drug, compared to traditional multi-vendor development paradigms.
The Tufts CSDD study assessed development cycle times and their financial benefits by using data compiled on completed Translational Pharmaceutics projects to benchmark against industry drug development durations. On average, Translational Pharmaceutics was shown to accelerate development by more than 12 months, with each month of development time saved resulting in a $9.5 million reduction in R&D costs per approved new drug. Further gains are achieved from products reaching the market sooner, translating into total financial benefits to drug sponsors of more than $200 million per approved new drug.
Translational Pharmaceutics is a platform that integrates formulation development and real-time adaptive manufacturing and clinical research to accelerate drug development. It has been used widely by pharmaceutical and biotech companies to advance molecules from first-in-human to proof-of-concept and accelerate the development and optimization of clinical formulations.
“Our own studies have demonstrated significant benefits, and we are pleased that Tufts CSDD has accurately quantified the time and cost benefits of our unique Translational Pharmaceutics approach to drug development,” said Mark Egerton, Ph.D., Quotient CEO. “Quotient Sciences has worked hard over the past decade to develop this innovative platform to help our customers lower costs, accelerate development, and improve R&D productivity.”
"Despite long-standing efforts by the pharma industry to operate more efficiently, traditional drug development paradigms and outsourcing models still present a number of challenges for today’s drug developers," said Joseph A. DiMasi, Ph.D., director of economic analysis at Tufts CSDD and principal investigator for the study. "The outcomes from this research indicate that Translational Pharmaceutics can create substantial time savings and financial benefits to pharma and biotech companies."
Peter Scholes, Ph.D., Quotient CSO, said, “Translational Pharmaceutics accelerates the development timeline by integrating drug product manufacturing into the clinical research program. Emerging clinical data are then used in real time to inform the optimization of a clinical formulation and maximize the potential for the drug to achieve its desired therapeutic effect.”
Read the full PDF version here