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Whitepapers , Translational Pharmaceutics , First-in-Human , Drug Product Optimization , Drug Product

Assessing the Financial Impact of Translational Pharmaceutics® - Tufts CSDD Report

Overview

Unlock the benefits of the Translational Pharmaceutics® platform for your drug program

Pharmaceutical R&D activity continues to grow significantly year-on-year with increasing numbers of molecules in development. Yet despite increases in spending the industry struggles with poor R&D productivity, citing lengthy drug development times, increasing costs and high rates of molecule attrition. 

The Tufts Center for the Study of Drug Development (CSDD) examined an innovative approach to accelerating drug development, Translational Pharmaceutics®, and quantified the savings to drug developers from applying the approach across the industry portfolio of investigational drugs. 

Translational Pharmaceutics® integrates real-time manufacturing and clinical testing to make drug products available for clinical trials more quickly and flexibly than is the case for traditional drug development. Translational Pharmaceutics® projects were compared to industry benchmarks, and the financial benefits were quantified on reduced industry R&D costs and increased returns from earlier sales. 

In a report from the Tufts Center for the Study of Drug Development (CSDD), data were obtained for different types of Translational Pharmaceutics® projects. Topline results included mean total benefits ranging from $102.6 million to $290.1 million and mean timeline savings of >12 months per approved new drug, compared to traditional multi-vendor development paradigms.

Download a copy of the Tufts Center for the Study of Drug Development (CSDD) white paper sharing study results.

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What is Translational Pharmaceutics®?

Our integrated CRDMO services unify formulation development, GMP manufacturing, and clinical testing as one platform to streamline early drug development: Translational Pharmaceutics®.

Whether your goal is getting to first-in-human trials or optimizing your drug product coming out of Phase I studies, learn how we can apply Translational Pharmaceutics® to your next program.

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How does Translational Pharmaceutics work?

Translational Pharmaceutics® for integrated drug development

Combining CRDMO services with our scientific expertise, operational efficiency, and ability to generate real-time clinical data, we can help reduce timelines by an average of 12 months or more while delivering cost and efficiency savings in development.

Translational Pharmaceutics® is an integrated platform that combines drug product formulation development, drug product manufacturing, and clinical testing within a single program. Translational Pharmaceutics® programs are delivered by Quotient Sciences, a global CRDMO provider with locations in the United States and the United Kingdom.

Translational Pharmaceutics® applies to drug development, integrating drug product formulation and manufacturing with clinical testing. These programs are performed by Quotient Sciences at our manufacturing and clinical sites in the United States and United Kingdom.

Translational Pharmaceutics® applies to drug development, integrating drug product formulation and manufacturing with clinical testing. It can be applied in scenarios including first-in-human, Phase I clinical testing; for drug product optimization in Phase Ib/IIa clinical studies; and for more efficient, integrated human ADME studies. 

Overall, Translational Pharmaceutics® can significantly decrease development timelines by 12 months or more while providing financial benefits, as quantified by the Tufts Center for Drug Development (Tufts CSDD).

Translational Pharmaceutics® helps reduce development timelines, improves formulation selection using clinical data, and minimizes project risk through real-time decision-making. Overall, it can significantly decrease timelines in early drug development, by 12 months or more, while providing financial benefits. This has been quantified by the Tufts Center for Drug Development (Tufts CSDD) in a published report.