Addressing Challenges in Oncology Drug Development
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.
Learn how pharma and biotech companies can leverage integrated services from a small molecule CRDMO partner to expedite the clinical trial process for oncology small molecule therapeutics.
The role of accelerated approval pathways and how Translational Pharmaceutics® further accelerates oncology therapies
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.
For almost two decades, the Quotient Sciences Translational Pharmaceutics® platform has been able to remove extra time and steps from the oncology drug development process. Translational Pharmaceutics® consolidates 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 an optimal drug product, with the ability to modify dosage forms for additional areas of need, such as pediatric patients. This further reduces the time required for the clinical phase and minimizes the amount of drug substance needed.
A 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.
Overcoming challenges in 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.
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. 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.
Quotient Sciences first brought meaningful innovation to the pharmaceutical industry in 2008 with Translational Pharmaceutics®. Contact us today to discuss how it can be applied to your next drug program.