Translational Pharmaceutics®

Translational Pharmaceutics® brings innovation to early drug development by integrating formulation development, real-time manufacturing and clinical testing.

Drug products are manufactured in real-time immediately prior to clinical testing, creating the opportunity to modify dose and formulation compositions in response to emerging clinical data (safety, pharmacokinetic or pharmacodynamic). The platform can be applied to a wide range of drug products, including oral, inhaled, dermal and IV, and encompasses simple and complex formulation types.

The benefits of the Translational Pharmaceutics platform include:

  • reducing timelines and cost;
  • conserving drug substance;
  • increased precision in real-time dose selection;
  • in-protocol modification of formulation composition;
  • adaptive clinical protocol design;
  • decision making based on human clinical data;
  • mitigation of development risks.

Translational Pharmaceutics applications

Translational Pharmaceutics accelerates key stages of the drug development process:

  • Enabled-FIH – transition into clinical development through to Proof-of-Concept;
  • RapidFACT – screening and selection of drug products for downstream development.