Summary: John McDermott, Vice President of Scientific Consulting at Quotient Sciences, explains how Translational Pharmaceutics® accelerates oncology clinical trials by integrating formulation development, manufacturing, and clinical testing as a seamless program. Translational Pharmaceutics® has been applied to support first-in-human programs, formulation optimization, and more efficient ADME studies.
Finding novel approaches to improve oncology drug development
Data from the World Health Organization (WHO) estimates that cancer accounted for nearly 10 million deaths in 2020 with the most common cancers occurring in the breast, lung, colon/rectum, and prostate. The growing demand for new and improved treatments is clear, as is the need to streamline oncology drug development so new treatments can reach those in need, faster.
The limited effectiveness of existing oncology drugs requires novel approaches to accelerate the clinical trial process. Accelerated approval pathways, which allow the NDA application process to commence from Phase II onwards, require the early submission of a high-quality chemistry, manufacturing, and controls (CMC) package. This push to expedite timelines only increases the risk of commercializing a drug product production process that is not fully optimized or scalable.
Benefits and challenges with emerging oncology modalities
Emerging modalities of oncology treatments, such as immunotherapy, and new chemical entities (NCEs) present increasing challenges in physical form, morphology, and chemical complexity. Therefore, selecting a drug development partner with proven experience in delivering these types of programs is crucial.
Quotient Sciences' approach involves an early understanding of the biopharmaceutics (DCS classification) during the drug development process, combined with expertise in process chemistry, analytical technology, and formulation development. We mitigate risks in subsequent development phases by gaining early insight into the compound's druggability, guaranteeing a high-quality CMC package that aligns with the accelerated approval process for oncology trials.
How Translational Pharmaceutics® accelerates oncology therapies
For almost two decades, the Quotient Sciences Translational Pharmaceutics® platform has been able to remove extra time and steps from oncology drug development. Translational Pharmaceutics® consolidates drug product and clinical testing within a single program of work to help reduce the burden of outsourcing while providing a resource-efficient approach to clinical trials.
Other benefits of applying Translational Pharmaceutics® include scaling an optimal drug product, with the ability to modify dosage forms for additional areas of need, such as pediatric patients.
In one customer's recent oncology program, we applied a rapid method for conducting first-in-human studies with a single ascending dose (SAD) study. Multiple formulations were developed within a single formulation design space in the same study, allowing a leading formulation to be identified and validated for patient trials in just 12 months.
Quotient Sciences first brought meaningful innovation to the pharmaceutical industry in 2008 with Translational Pharmaceutics®, a trusted platform for nearly two decades for driving innovation in drug development. Contact us to discuss how it can be applied to your next program.