A Smarter Strategy For Optimizing Oncology Drug Products

By John McDermott, VP of Scientific Consulting, Quotient Sciences

Drug product optimization is often required to ensure downstream clinical success in patients. Improvements can include increasing oral bioavailability and solubility, reducing pharmacokinetic (PK) variability, overcoming food effects, avoiding adverse events, or reducing dosing frequency by switching administration routes or to a modified-release form.

However, these challenges can often be optimized in oncology drug development programs. Dosing is typically performed directly in patients in Phase I – rather than conducting healthy volunteer studies to establish safety and PK data – resulting in speed and effectiveness hurdles when it comes to identifying improved formulations to deliver improved PK profiles.

Utilizing a robust platform which integrates formulation development, GMP manufacturing, and clinical testing can help to reduce development timelines while delivering significant cost savings and minimizing program risks. John McDermott, VP of Scientific Consulting, shares insights on the benefits of evaluating targeted oncology molecules in healthy volunteers and applying an effective platform to accelerate drug product optimization.