Accelerating the Development of New Drugs from Preclinical Testing Through First in Human to Proof of Concept

Accelerating the Development of New Drugs from Preclinical Testing Through First in Human to Proof of Concept 

The transition of new chemical entities from preclinical testing through the first in human study to proof-of-concept assessments is a well-established process but requires many risk based decisions in formulation and dose strength selection, protocol design and strategy to move to proof-of-concept.

A Translational Pharmaceutics® project integrates formulation development, on demand drug product manufacture, and clinical testing to improve the conduct and outcomes from this key stage in any molecule’s development.

In this presentation, John McDermott will describe how Translational Pharmaceutics® enables development teams to:

• Identify and select optimal formulations for preclinical and clinical testing
• Simplify the CMC process needed to transition the drug into clinical development
• Design and execute successful FIH protocols
• Support switches of drug product type to meet emerging patient study needs
• Enable seamless clinical trial supply to phase 2 and beyond

 This integrated approach not only mitigates risks but also accelerates the pathway to proof-of-concept, ultimately enhancing the likelihood of success for new drug candidates.  

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