First in human (FIH) to proof of concept (POC)
To identify molecules with the greatest chance of success, the transition of your molecule from candidate selection to POC needs to be fast and cost-effective.
Quotient Sciences’ Translational Pharmaceutics® approach enables FIH studies by transitioning your drug molecule into clinical development through to POC quickly through the integration of:
- Formulation development, real-time adaptive Good Manufacturing Practice (GMP) manufacturing, and clinical research
- Multiple assessments within a single clinical protocol (e.g. single dose, multiple dose, food effect, gender effect, POC)
For FIH programs, our Translational Pharmaceutics® approach:
- Reduces time to POC
- Minimizes your upfront chemistry, manufacturing, and controls (CMC) investment
- Increases your study flexibility and precision
- Allows changes in formulation compositions in response to emerging clinical data
- Customizes the supply of drug products to the needs of your POC study
- Simplifies your supply chain
What Our Clients Say
“R552 is a potent and selective RIP1 kinase inhibitor that blocks inflammatory cell death downstream of death receptors. It is being developed at Rigel Pharmaceuticals for treatment of autoimmune and inflammatory disorders. We were very delighted to have Quotient Sciences on board and they worked with us on the formulation development as well as the first-in-human study of R552. During the course of project development, we were very impressed by Quotient Sciences’ responsiveness in communication, efficiency/flexibility in project management, and the extensive knowledge/experience in formulation development, early-phase clinical trial conduct, and safety monitoring. Quotient Sciences is one of the best development partners that we have ever worked with and would recommend for future collaborations without any reservation.”
- Dr Lucy Yan, Executive Medical Director at Rigel Pharmaceuticals
First in human (FIH) to proof of concept (POC)
Case studies and fact sheets
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Info SheetFirst-in-Human to Proof-of-ConceptOur Translational Pharmaceutics approach enables First-in-Human studies by re-engineering the transition of your drug molecule into clinical development and shortening the timeline to Proof-of-Concept.
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Case StudiesBioCryst Pharmaceuticals Case StudyBioCryst Pharmaceuticals is taking advantage of Quotient Sciences’ Translational Pharmaceutics® platform and First-In-Human program for the development of BCX4161, a promising candidate for the treatment of hereditary angioedema.
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Case StudiesMEI Pharma Case StudyMEI Pharma has leveraged Quotient's Translational Pharmaceutics® platform to expedite development of its next-generation cancer therapy ME-401.
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Case StudiesCorcept Therapeutics Case StudyAn accelerated approach to clinical trials. Corcept Therapeutics is developing CORT125134, a promising candidate for the treatment of Cushing’s syndrome, a rare disorder associated with significant morbidity and mortality.