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Case Studies , Drug Product Optimization , Formulation Development , Clinical Trial Manufacturing , Commercial Manufacturing

Case Study: Pulmatrix

Overview

Breathing new life into Phase I clinical trials. Read Pulmatrix's case study.

Pulmatrix is a small, clinical-stage biotechnology company based in Lexington, MA, that uses an innovative inhaled dry powder technology, iSPERSE (inhaled small particles easily respirable and emitted), to develop a new generation of inhaled therapeutics.

Initially drawn to Quotient Sciences' to perform a Phase I study based on our deep understanding of the UK regulatory environment, Pulmatrix realized that we are very experienced at designing flexible clinical trials across a broad formulation development space as well as having expertise in inhaled drug development. This was not something that they had come across in the US market which would prove to benefit their drug development timelines. By working with the same team of experts, they were able to streamline many processes and planning lessons allowing their drug program to progress more quickly.

Request a copy of our case study with Pulmatrix today and find out how we can accelerate your drug development timelines.

 

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Translational Pharmaceutics® for integrated drug development

We can apply Translational Pharmaceutics® to your next drug program, whether your goal is getting to first-in-human trials faster, optimizing your drug product further coming out of Phase I studies, or for enabling more successful human ADME programs.

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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 Webinars, Translational Pharmaceutics
How to Accelerate Drug Product Optimization Using Translational Pharmaceutics®
5 October 2023
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Scientific Posters, Translational Pharmaceutics
Application of Translational Pharmaceutics® in Accelerating the Development of MR Dosage Forms
1 April 2021
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