Summary: Oncology drug development continues to be a major focus in the pharmaceutical industry, with over 5,500 molecules in development—representing more than 35% of the global pipeline. Despite the high unmet medical need, oncology programs face low success rates and extended clinical timelines due to complex trial designs and patient recruitment hurdles. In this Q&A, John McDermott, VP of Scientific Consulting at Quotient Sciences, discusses the challenges and trends shaping the oncology landscape.
Oncology development trends and drug product manufacturing
A: Oncology drugs dominate today’s research focus with over >5500 molecules in development, representing over 35% of the total industry pipeline. In 2019, 10 new oncology drugs were approved by FDA, of which half had an orphan indication and all had been granted priority review.
With over 300 oncology projects completed in our drug development history, Quotient Sciences offers end-to-end support to bring oncology therapeutics from drug product formulation development through to commercial manufacturing. Our high-potency API (HPAPI) capabilities, flexible batch sizes, and global regulatory approvals make it us trusted partner for oncology drug developers.
In this Q&A, John McDermott, VP of Scientific Consulting at Quotient Sciences, discusses the challenges and trends shaping the oncology landscape.
Q: What are some of the trends and challenges in the development of oncology therapeutics?
A: Given the number of molecules in development, there is so much pressure on development teams to identify successful drug candidates as quickly as possible, and accelerate patient access, particularly where no effective therapies are currently available.
However, the oncology therapeutic area remains a challenging one to navigate and success rates are low. The likelihood that a molecule entering Phase I trials will reach market is around 10%, with the average duration of an oncology clinical trial taking 40% more time than other therapy areas due to the difficulty in patient recruitment.
Oncology drug development has seen a significant shift in focus as molecule chemistries and drug technologies have improved. Historically, most oncology drugs were cytotoxic compounds with poor safety profiles. In recent years, a better understanding of cancer aetiology has improved drug target specificity of oncology compounds, leading to the advent of molecular target agents (MTA), with more favorable safety profiles.
Targeted small molecules currently make up around 40% of the global oncology pipeline, whereas cytotoxins have fallen to just 7%. This movement has opened the opportunity to use more convenient dosage forms, with oral administration considered the gold standard for patient compliance.
Understandably, compared to the intravenous dosage forms, the move to oral solid dosage forms brings a different set of biopharmaceutics challenges that need to be overcome.
Q: What types of development and manufacturing services does Quotient Sciences provide for oncology therapeutics?
A: We've worked on more than 300 projects and over 91 different oncology drug candidates across different indications. As a fully integrated drug development, clinical testing and manufacturing organization, we're well positioned to address the challenges associated with developing small molecule oncology therapeutics.
Our extensive formulation development capabilities and flexible approach to clinical drug product manufacturing, with capabilities to also manufacture drug product up to commercial scale, makes us a valued partner for anyone looking to advance oncology therapies.
Additionally, for almost two decades, the Translational Pharmaceutics® platform has been able to remove extra time and steps from oncology drug development. Consolidating drug product and clinical testing within a single program of work helps reduce the burden of outsourcing, while providing a resource-efficient approach to clinical trials.
We've demonstrated that formulation flexibility in Phase I healthy volunteer trials can be used to develop “patient ready” formulations for oncology molecules in less than half the time of the industry standard through applying the Translational Pharmaceutics® platform. Another benefit is the ability to modify dosage forms for additional areas of need, such as pediatric patients.
Q: Are there any other specialized drug product manufacturing services that Quotient Sciences provides for oncology therapeutics?
A: Global demand and growth for targeted oncology therapeutics has led to an increase in the manufacturing of high potent active pharmaceutical ingredients (HPAPIs). This has driven the need for high potency handling capabilities, particularly high-containment manufacturing facilities.
Handling these ingredients in the drug supply chain requires specialized equipment and enclosure systems in order to avoid cross contamination, product protection and to ensure operator and environmental safety. Our facilities have the necessary handling and containment capabilities, and our teams are trained as well on safe handling procedures to minimize EHS risk.
We use the PBLEC system to classify HPAPIs at Quotient Sciences. We look at the type of compound, dosage form, manufacturing process, and batch size required. Our cGMP manufacturing suites are outfitted with the necessary engineering controls to handle PBLEC system 1-5 rated compounds.
Our facilities have been inspected and approved by all major regulatory bodies, including the FDA and MHRA. From design of experiments (DoE), to registration batches and process validation, our formulation and manufacturing scientists have the experience needed in order to ensure a scalable drug product and successful commercial launch.