Quotient Clinical, the Translational Pharmaceutics Company, has announced the extension of its Translational Pharmaceutics™ platform into patient-focused cancer drug development. Quotient will employ its real-time, flexible manufacturing capabilities to supply specialist oncology centers with drug products to support first-in-patient and proof-of-concept programs.
Translational Pharmaceutics integrates real-time drug product manufacturing and clinical testing, using processes that significantly reduce the timelines and cost of early stage drug development. To date, Quotient has applied this platform in early development programs at its own manufacturing and clinical facilities in Nottingham, UK.
Clinical trials in cancer patients are becoming increasingly stratified and focused on specific patient sub-groups, which can increase the challenges of patient recruitment and the associated timelines. In turn, this can result in unpredictable drug product requirements and an inefficient supply chain.
Quotient’s real-time manufacturing approach offers a number of advantages in this setting, including:
- flexibility of drug product manufacturing in response to patient recruitment rates, with product typically being supplied in less than three weeks from notification;
- customization of drug product dose and/or composition according to patient/study need, and in response to clinical data emerging from the on-going program;
- increased efficiency of drug substance consumption.
Mark Egerton, Chief Executive Officer of Quotient Clinical, said “Approximately 30% of the industry’s drug development pipeline is focused on cancer. We have developed our real-time manufacturing and supply capabilities to support this specialist area with first-in-patient and proof-of-concept programs. We have already supported multiple development programs in the UK and mainland Europe, and will shortly be embarking on a similar project in North America. In these, and other future programs, we will be helping our clients to accelerate their early development pipelines and increase overall R&D productivity.”