Paul Quigley, Principal Research Fellow, Drug Substance, highlights how pharma and biotech companies can leverage integrated services to expedite the clinical trial process for oncology small molecule therapeutics.
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 substance and drug product production process that is not fully optimized or scalable.
Over the past 15 years, the Quotient Sciences Translational Pharmaceutics® platform has been able to remove extra time and steps from the oncology drug development process for global pharma and biotech customers. Translational Pharmaceutics® consolidates drug substance, drug product, and clinical testing within a single organization and program to help reduce the burden of outsourcing, ensuring a phased, resource-efficient approach to clinical trials.
We can help ensure the scalability of both the drug substance and the optimal drug product, with the ability to modify dosage forms for additional areas of need, such as pediatric patients. Once toxicology data becomes available, we swiftly progress the drug substance into GMP manufacture, seamlessly transitioning into our distinctive formulation and clinical "Make-Test" phase. This further reduces the time required for the clinical phase and minimizes the amount of drug substance needed. One recent achievement for a customer's oncology program involved a rapid method for conducting first-in-human studies with a single ascending dose (SAD) study. Within this study, multiple formulations were developed within a single design space, and a leading formulation was identified and validated for patient trials in just 12 months.
Emerging modalities of oncology treatments, such as immunotherapy, and new chemical entities (NCEs) present increasing challenges in physical form, morphology, and chemical complexity. Therefore, it is crucial to select a drug development partner with proven experience in delivering these types of programs. Our 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. By gaining early insight into the compound's druggability, we mitigate risks in subsequent development phases and align with our "make-test" cycle to ensure rapid and flexible delivery of scalable and robust drug substance production. This guarantees a high-quality CMC package that aligns with the accelerated approval process for oncology trials.
More about our expert: Dr. Paul Quigley
Dr. Paul Quigley has over 20 years of experience in the fine chemical and pharmaceutical industries in a variety of senior management roles, covering technical management of UK sites, and senior project and operational roles within several international organizations, including ICI, Schering Plough, Clariant, Johnson Matthey, and Rhodia.
More about Translational Pharmaceutics
Quotient Sciences first brought meaningful innovation to the pharmaceutical industry in 2008 with Translational Pharmaceutics® – our unique delivery platform that shortens development times by over 12 months. Contact us today to discuss how it can be applied to your next drug program.