The limited effectiveness of existing oncology drugs requires novel approaches to accelerate the clinical trial process. Accelerated approval pathways (where the NDA application process can begin from Phase II onwards) require earlier delivery of a high-quality CMC package, however this push to get things done in an accelerated time frame can increase the risk of commercialising an unoptimized drug substance and drug product production process.
Thus, demonstrating a need to reduce white space in the development process and this is where the Quotient Sciences’ integrated Translational Pharmaceutics platform is uniquely positioned.
Translational Pharmaceutics is a delivery platform that integrates drug substance, drug product and clinical testing activities under a single organisation and single programme manager. This unique offering ensures a staggered and material sparing approach to the clinic, minimising initial material expenditure and development costs.
When Tox data becomes available, the company can rapidly progress your drug substance into GMP manufacture, which then feeds seamlessly into our unique formulation and clinical “Make-Test” phase, taking further time out of the clinical phase and minimising drug substance needs.
The Translational Pharmaceutics approach also ensures scalability of drug substance and optimal drug product, with the capacity to alter dosage forms for follow-on indications (e.g., paediatrics).
In the past 15 years, Quotient Sciences has successfully completed over 500 Translational Pharmaceutics programmes. Recent oncology successes include a rapid approach to first-in-human with a single ascending dose (SAD) study, where multiple formulations were developed within a single design space, and a lead formulation was identified and validated for patient trials in just 12 months.
New modalities of oncology treatments (e.g immunotherapy) and new chemical entities (NCEs) are demonstrating increasing challenges with physical form, morphology, and chemical complexity, making it even more critical to select a development partner with demonstrated experience in delivering these types of programmes.
Quotient Sciences possesses a deep expertise in process chemistry, analytical technology, and formulation development. Our approach is to understand the biopharmaceutics (DCS classification) early in the development process.
Early understanding of compound druggability de-risks the subsequent development phases and aligns with our “make-test” cycle in ensuring rapid and flexible delivery of scalable and robust drug substance production, ensuring a quality CMC package, that is aligned with the accelerated approval process for oncology trials.
This is the essence of the Translational Pharmaceutics platform, which has been proven to reduce development timelines by >12 months for our customers with oncology programmes.
For more information about how Quotient Sciences’ Translational Pharmaceutics platform can accelerate the development of your oncology programme, visit: https://www.quotientsciences.com/solutions/oncology/