A UK-based specialty pharma company required a biochemical assay for their regulatory non-clinical safety study, our bioanalysis experts were able to build & validate an assay to measure non-haem iron in tissues.

This assay supported one of the pivotal objectives for a regulatory non-clinical safety study.

Request to download a copy of our biochemical assay optimization, validation, and application today.

A US biotech client was developing combined small molecule and biologic immunotherapy treatments and called on our expertise in API development.

In this API development case study, we detail the rapid development of a scalable route towards an analog of a new drug substance, with the definition of an optimal salt form for formulation.

Download a copy of our API development case study today and contact our experts to find out even more.

A US Biotech was seeking to improve the yield and purity of an intermediate using flow chemistry.

By utilizing our growing expertise in flow chemistry, significant time and cost savings were a major benefit for our customer.

Download a copy of our flow chemistry case study today.

Solving insolubility. Read Xspray Pharma's drug development case study.

Xspray Pharma is a drug delivery company based in Stockholm, Sweden that concentrates on solving a common problem in the pharmaceutical industry today, that of variable bioavailability due to poor solubility in gastric fluid, pH-dependent absorption, and food interactions. Protein kinase inhibitors (PKIs) are used in the treatment of cancer and inflammation, but food interactions are a common problem with this class of drugs. Swedish drug delivery company Xspray Pharma has used its Hybrid Nanoparticle (HyNap™) technology to improve the bioavailability of the PKI nilotinib, reducing the required dose and significantly lowering the food interaction of the drug compared with the marketed product.

Working closely with Quotient Sciences', Xspray Pharma took advantage of our integrated approach in their Phase I study. They were able to go back to the lab, change the dose, transfer the new formulation to the manufacturing facilities, and be back testing in the clinic, all in a very short space of time. This approach made a significant difference to the speed of the results that they gained and reduced their program timelines.

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

Read our case study on how Clovis Oncology leveraged our unique integrated programs to efficiently meet their program goals.

Clovis Oncology was a US-based biopharmaceutical company that focused on acquiring, developing, and commercializing cancer treatments for global markets. Their development programs were targeted at specific subsets of cancer, and combined personalized medicine with companion diagnostics, aiming to create therapeutics that were directed at the patients most likely to benefit from them.

They chose to work with Quotient Sciences' to take advantage of our Translational Pharmaceutics® platform for rociletinib, a promising oral candidate drug for the treatment of EGFR-resistant non-small cell lung cancer. Performed on healthy volunteers, this flexible, data-driven Phase I development study enabled the rapid development of an optimized salt formulation.

Request a copy of our case study with Clovis Oncology today to find out more about the real-world benefits of our integrated approach.

Our Translational Pharmaceutics® platform was the cost-effective, rapid delivery solution that Stealth BioTherapeutics needed to accelerate its drug development program

Stealth BioTherapeutics is an innovative biopharmaceutical company based in Massachusetts, USA, focused on developing targeted therapies for diseases linked by a common aetiology of mitochondrial dysfunction. There are more than 270 inherited orphan mitochondrial diseases that are characterized by known genetic defects. Relatively recently, research has shown that mitochondrial dysfunction is associated with conditions including heart failure, kidney disease, age-related macular degeneration, cardiovascular and metabolic diseases, neurodegeneration, and some musculoskeletal disorders.

Stealth BioTherapeutics was looking for a partner to reformulate a drug target, initially in the US, but found that option to be cumbersome in its approach to clinical manufacturing and timely potentially adding months onto their timeline. Hearing about Quotient Sciences which can offer on-site clinical manufacturing and a project design with a turnaround of 72 hours for pharmacokinetic (PK) and safety data, a site visit followed and within three days, Stealth BioTherapeutics accepted our proposal. After taking everything into account the manufacturing costs of a traditional CMO who creates multiple lots of clinical trial material that may never get used, our Translational Pharmaceutics® platform was the cost-effective option they needed.

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.

A formulation for success. Read MEI Pharma's novel cancer therapy development case study.

MEI Pharma, headquartered in San Diego, is a clinical-stage pharmaceutical company. They are committed to the development of best-in-class cancer therapies, intended to improve outcomes for patients.

MEI Pharma leveraged Quotient Sciences’ Translational Pharmaceutics® platform to expedite the development of its next-generation cancer therapy ME-401. This is an oral PI3K delta inhibitor currently undergoing clinical trials for the treatment of recurrent chronic lymphocytic leukemia (CLL) and follicular non-Hodgkin’s lymphoma (fNHL).

Quotient Sciences' scientific experts have worked on over 400 oncology drug development projects. We offer the significant benefit of evaluating targeted oncology molecules in healthy volunteers. We can apply our Translational Pharmaceutics® platform to accelerate drug product optimization by integrating real-time drug product manufacturing and clinical assessments.

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

Request a copy of our case study with BioCryst Pharmaceuticals who were looking for a partner with expertise and experience to provide certainty that the delivery timelines for the program could be achieved

A small biotech company, BioCryst Pharmaceuticals was founded in Birmingham, Alabama. BioCryst is a pharmaceutical company that has stayed true to its commitment to discovering, developing, and delivering treatments to patients that may have an extraordinary impact on their lives. BioCryst Pharmaceuticals specializes in structure-guided small molecule drug design, using detailed knowledge of the structures of active sites of clinically significant enzymes to develop novel agents that interfere with the progression of the disease. Founded in 1986, the company’s development pipeline currently includes inhibitor-based treatment programs for hereditary angioedema (HAE), hemorrhagic fevers, influenza, and gout.

Quotient Sciences was approached to help BioCryst Pharmaceuticals in their development of BCX4161, a promising candidate for the treatment of hereditary angioedema. They took advantage of our Translational Pharmaceutics® platform and First-In-Human program for the development to accelerate their timelines and hit key deadlines. Request a copy of the case study today here.

A case study on Quotient Sciences' accelerated approach to integrated clinical manufacturing and Phase 1 clinical trials

Corcept Therapeutics, based in California, USA, is a pharmaceutical company focused on the impact of cortisol on health and the development of glucocorticoid receptor (GR) antagonists. Following its foundation in 1998, the company successfully developed Korlym® (mifepristone), a dual GR and progesterone receptor (PR) antagonist for the treatment of endogenous Cushing’s syndrome (Hypercortisolism), a disorder associated with significant morbidity and mortality. However, the dual action of mifepristone limited the circumstances in which the drug could be used, and there was a need for a selective 'next generation' medication offering all of the benefits but without the associated risks.

Quotient Sciences was approached to help Corcept Therapeutics in their development of CORT125134. This was contracted out to us due to our ability to integrate clinical manufacturing and clinical trial dosing at the same location. Request a copy of our case study today and contact us to find out how we can accelerate drug development timelines saving as much as 12 months in the process with our Translational Pharmaceutics® platform.