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

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

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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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Translational Pharmaceutics® for integrated drug development

We offer integrated CRO and CDMO services, unifying 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, optimizing your drug product coming out of Phase I studies, or conducting a successful human ADME program, learn how we can apply Translational Pharmaceutics® to your next program.

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How does Translational Pharmaceutics work?

More information about Translational Pharmaceutics®

Combining services, scientific expertise, operational efficiency, and real-time data, we help reduce timelines by an average of 12 months or more while delivering cost and efficiency savings in drug 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.

Related Resources

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On-Demand Webinar, Translational Pharmaceutics
How to Accelerate Drug Product Optimization Using Translational Pharmaceutics®
5 October 2023
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Scientific Poster, Translational Pharmaceutics
Application of Translational Pharmaceutics® in Accelerating the Development of MR Dosage Forms
1 April 2021
Download Now
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