John McDermott, VP of Scientific Consulting, shares his insights on the benefits of evaluating targeted oncology molecules in healthy volunteers and applying our Translational Pharmaceutics® platform to accelerate drug product optimization.
To ensure downstream clinical success in patients, drug product optimization is often required, whether to increase oral bioavailability and solubility, reduce pharmacokinetic (PK) variability, overcome food effects, avoid adverse events, or reduce dosing frequency by switching administration routes or to a modified-release form.
The majority of new chemical entities (NCEs) in today’s drug development pipelines present formulation challenges that are independent of therapeutic area.
Writes John McDermott, VP of Scientific Consulting
For oncology drug development programs these challenges can be magnified, as dosing is typically performed directly in patients in Phase I, rather than conducting healthy volunteer studies to establish safety and PK data. The approach of going directly into patients is known to be inherently problematic when it comes to the speed and effectiveness of identifying improved formulations to deliver improved PK profiles.
Over the past 8+ years, Quotient Sciences has delivered over 400 projects with oncology drugs, including 80 clinical programs in healthy volunteers. These clinical programs have included first-in-human single-ascending-dose/multiple-ascending-dose, relative bioavailability, and 14C human absorption, distribution, metabolism, and excretion (ADME) programs.
Using our flagship platform, Translational Pharmaceutics®, which integrates formulation development, Good Manufacturing Practice (GMP) manufacturing, and clinical testing, we reduce development timelines by more than 12 months while delivering significant cost savings and minimizing program risks.
Our Translational Pharmaceutics platform removes the white space in development by enabling real-time drug product manufacturing to be integrated with clinical assessments, reducing stability data requirements and batch sizes, and accelerating program delivery.
Using Translational Pharmaceutics, drug products can be manufactured, released, and dosed in days rather than weeks or months.
Rapid access to real-time human clinical data from one study period determines the formulation composition that is then made and dosed in the next.
The economies can be even more significant as multiple formulations can be evaluated with lean chemistry, manufacturing, and controls (CMC) data package, and if appropriate, formulation design spaces can be applied to provide a flexible range of drug product compositions to make and dose in the clinical study.
Finally, studying oncology molecules in healthy volunteer studies, where safe to do so, can also mean:
- Study recruitment is not as complex and achieved faster
- Cohorts of subjects can be dosed together to improve formulation decisions
- There is less risk from co-medications and co-morbidities
- Variability in clinical data due to disease state is removed
- Study timelines are reduced, and studies are more cost-effective to conduct
following rapid identification of an optimized drug product quotient sciences is also able to scale up and supply the formulation into your next-stage global patient studies provide seamless program continuity.
For further information on our expertise and capabilities for oncology drug development programs, visit: Oncology Drug Development