Stella Stergiopoulos
Tufts University School of Medicine,USA
Title: Mapping and Characterizing the Non-Clinical Drug Development Pathway
Biography
Biography: Stella Stergiopoulos
Abstract
With many biopharmaceutical companies looking to become more efficient practices behind translating basic research into human tests, more emphasis is being placed on more efficient non-clinical drug development. However, there is little data characterizing the non-clinical development process. In response, the Tufts Center for the Study of Drug Development (Tufts CSDD) organized a working group with seven companies to assess all processes involved in non-clinical to early phase I research. The seven companies provided duration data for key non-clinical and early phase I milestones. Tufts CSDD aggregated the data, mapped the non-clinical and early phase 1 process, and conducted benchmark duration analyses. Results show that on average a company takes 151.4 weeks to get from First Synthesis to First Patient (Subject) / First Dose. Biopharma companies have similar duration data at the aggregate level but not at the individual process level and so can make more informed management decisions and identify opportunities to streamline key activities within non-clinical and phase I development.