Presented at EuPFI 2023, "Taste Assessment Study of Tenapanor Pediatric Solution Formulations". Find out about how we can help accelerate your Pediatrics drug development program.
Presented at ASCP 2023, "A Phase 1 SAD and MAD Trial of EVX-101, a Novel Gastro-Retentive Prolonged Release". Find out about how Quotient Sciences can help accelerate your drug development program.
This white paper describes the benefits of our approach to poorly soluble drugs in terms of drug product performance and clinical decision-making, including case studies that demonstrate significant time and cost savings.
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.
For formulators, they enable drugs to be released in the optimal gastrointestinal (GI) locations to achieve and maintain desirable plasma concentrations for extended periods, avoiding undesirable excursions outside the therapeutic range.
Learn more about our capabilities for modified-release.
| Modified-release format | Objective | Formulation technology |
|---|---|---|
| Gastro-retention |
| Swellable tablets (monolithic, bilayer, trilayer) |
| Gastro-resistant |
| Enteric-coated tablets or capsules |
| Sustained or extended release |
| Matrix tablets, coated tablets, or multiparticulates |
| Targeted or controlled delivery |
| Tablets, capsules, or multiparticulates |
| Biphasic release |
| Bilayer tablets or multiparticulates |
| Pulsatile release |
| Bilayer tablets or multiparticulates |
Oncology drugs dominate today’s research focus with over >5500 molecules in development, representing over 35% of the total industry pipeline. 10 new oncology drugs were approved by the FDA in 2019, of which half had an orphan indication and all had been granted priority review. Given the number of molecules in development, there is increasing pressure on development
teams to identify successful drug candidates as quickly as possible, and accelerate patient access, particularly where no effective therapies are currently available.
There are approximately 7,000 rare diseases, affecting an estimated 30 million people in each of the US and EU. Worldwide, there are over 300 million people living with one or more identified rare diseases, representing 3.5% - 5.9% of the global population.
The development of new treatments to address these unmet clinical needs clearly represents an important global health priority. Historically, commercial pressures meant the challenges and cost of developing such medicines were not cost-effective given the projected financial returns. In recent years, however, there has been a sea change in industry activity as evidenced by the increasing prevalence within drug development pipelines and the numbers of new molecules reaching the marketplace. Between 2016-2019, 82 of the 175 new FDA approvals were for rare diseases. Regulatory authorities have sought to encourage and motivate industry to develop drugs for these serious medical conditions through the creation of a supportive infrastructure.
This white paper will discuss four principal CMC challenges for the developers of orphan drugs and the potential solutions which are emerging:
Modified-Release (MR) drug delivery can also have commercial benefits and is prevalent as part of product life-cycle management (LCM). Modest reformulation of an already approved drug from an IR to MR format allows both line and patent extension opportunities and continued market exclusivity.
Highly sensitive bioanalytical techniques enable the identification and quantification of analytes such as small molecules, peptides, proteins, nucleic acids, and metabolites, all from very small volumes of biological samples. Delivering rapid bioanalytical data is critical to meeting milestones in drug development. From drug discovery through to preclinical and clinical studies, understanding drug exposure, safety, and metabolism is essential in accelerating drugs to clinic and commercialization.
At Quotient, we are experts in the development, validation, and application of bioanalytical assays. Our industry-leading bioanalytical team has more than 40 years of experience in supporting all stages of drug development, from early preclinical through to FIH, and onwards to Phase II and III patient studies.
We pride ourselves on our relationships with customers, and the speed with which we report our bioanalytical data. Over the past 5 years, we have supported bioanalysis projects for almost 100 customers globally, ranging from virtual companies and biotech to mid-sized and large Pharma. To date, we have developed and validated more than 400 bioanalytical methods.
Contact us to discuss how we can help you gain a clear understanding of the biological fate of your molecules and accelerate your development programs.
The Quotient Sciences Synthesis-to-Clinic® approach seamlessly delivers human ADME studies, from radiosynthesis of the 14C-labeled drug substance through all the required steps of the human study and the final clinical report, in an integrated program of work.
Our Nottingham, UK clinical site includes a dedicated ADME ward that is fully integrated with our dedicated pharmaceutical sciences facilities for the development, real time Good Manufacturing Practice (GMP) manufacture, and qualified person (QP) release of 14C labeled drug products. Coupled with our excellent volunteer recruitment, retention, and completion record, this has enabled us to conduct studies with a 100% success rate.
We are also able to develop, manufacture, and release GMP drug products at our Alnwick, UK, facility, which has the capability to produce radiolabeled 14C drug substances for both clinical and non-clinical studies.
As well as conventional human ADME studies, where the radiolabeled dose is selected following appropriate dosimetry assessment, Quotient Sciences are experts in microADME studies, where the radiolabeled dose is no more than 1 microcurie (µCi) and no dosimetry studies are required to support the radiolabeled dose selection.
Download our whitepaper to continue reading about the benefits of the Quotient Sciences Synthesis-to-Clinic® approach to conducting human ADME programs.