Translational Pharmaceutics® for First-in-Human Studies
A novel way to do drug development: Quotient Sciences’ Translational Pharmaceutics® platform.
Quotient Sciences’ Translational Pharmaceutics® platform enables first-in-human (FIH) studies by re-engineering the transition of your drug molecule into clinical development and optimising the timeline to proof-of-concept (POC). Translational Pharmaceutics® is applicable to all drug molecules, routes of delivery, and formulations.
What can Quotient Sciences do for me?
- Review your biopharmaceutics data package
- Develop formulations suitable for FIH and beyond
- Use in-silico modelling and simulation to predict human dose and pharmacokinetics (PK)
- Generate and compile the regulatory data package
Conventionally, to achieve the shortest timeline to first-subject-first-dose (FSFD), formulation development and clinical drug product manufacture are conducted before completion of pivotal toxicology studies. With Translational Pharmaceutics®, key pharmaceutical development activities and costs can be deferred until after completion of toxicology studies, with no negative impact on FSFD date.
Translational Pharmaceutics®
Accelerate molecules through development by integrating traditionally siloed services.
Translational Pharmaceutics® is a disruptive approach to drug development that helps you forge your own path to success and optimise every step by redefining the complementary, interconnected relationship between drug product design, supply and clinical testing. The Quotient Sciences Translational Pharmaceutics® platform integrates activities and adapts solutions to help you reach key milestones as quickly and efficiently as possible.
We’ve pioneered the integration of CRO and CDMO solutions, merging operational efficiencies, scientific rigour, and clinical insights into a single programme of work that is delivered under a single project manager and organisation.
We bypass drug-development silos. Our comprehensive approach to formulation development, on-demand GMP manufacturing, and clinical testing leverages actionable data to empower successful outcomes, manufacturing and releasing drug products in less than seven days and reducing overall development timelines by up to 12 months.
Close integration between drug manufacturing and clinical testing enables better decision-making while reducing time and waste. Our phase-appropriate expertise anticipates and overcomes challenges to create a personalised path for your molecule.
Benefits of Translational Pharmaceutics® include:
- Streamlined and simplified vendor management and supply chain
- Better decisions based on emerging human clinical data
- Accelerated timelines by up to 12 months on average
