Oncology drugs dominate today’s research focus with over >5500 molecules in development, representing over 35% of the total industry pipeline1. 10 new oncology drugs were approved by FDA in 2019, of which half had an orphan indication and all had been granted priority review2.
Given the number of molecules in development, there is increasing 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 will reach market is around 10%, with the average duration of an oncology clinical trial taking 40% more time than other therapy areas.
Oncology drug development has seen a significant shift in focus over the past 20 years as molecule chemistries and drug technologies have improved. Historically most oncology drugs were cytotoxic compounds with poor safety profiles. However, 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%3. 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 form, this move to oral administration brings a different set of biopharmaceutics challenges that need to be overcome.
As a fully integrated drug development and manufacturing organization, Quotient Sciences is well positioned to address the challenges associated with developing small molecule oncology therapeutics, supporting biotech and pharmaceutical companies in accelerating drug development timelines from candidate selection through to commercial manufacture and supply. This white paper will discuss five areas for consideration by oncology drug developers and the potential solutions which are emerging:
- Formulation development
- Clinical development: accelerating to POC
- Formulation optimization and validation of product performance in humans
- Process development, “scale-up” & clinical manufacturing for Phase II/III
- Commercial manufacturing & supply