Mapping and Characterizing the Development Pathway from Non-Clinical through Early Clinical Drug Development

Abstract

The translation of basic research knowledge into human testing is widely regarded as an inefficient and lengthy process, yet there is no detailed, quantitative information characterizing this early drug development pathway. The Tufts Center for the Study of Drug Development (Tufts CSDD) conducted a study to derive a generalizable granular process map of the non-clinical to early clinical drug development pathway and associated duration metrics. Tufts CSDD constituted a working group of seven small and mid-sized pharmaceutical and biotechnology companies to identify pathway milestones and to provide duration metrics. Tufts CSDD then analysed duration data between each process step in the development pathway. Data for Investigational New Drug (IND) submissions are reported overall and stratified by therapeutic area, phase II transition success and modality. Duration metrics (mean and standard deviation [SD]; median and interquartile range [IQR]) are provided for each milestone along the early drug development and regulatory pathways (e.g. time to IND submission). The overall process from First Synthesis — Medicinal Chemistry to First Patient (Subject) First Dose took on average 151.4 weeks (n = 17; SD = 90.0 weeks) and a median duration of 133.0 weeks (IQR = 89.6 weeks) overall. There were no statistically significant differences between stratified data. Key pathway steps, their respective durations and variation across programmes are presented. The results of this Tufts CSDD study provide a detailed representative mapping of the early drug development research pathway and baseline duration metrics summarizing the overall process and distinct process stages. To our knowledge, this is the first time such a mapping has been completed. Observed duration areas with wide variation between key steps in the process suggest acceleration opportunities. Large variation in duration data may be due to differences in molecule size and structure, as well as strategic decisions made by management teams. Best practices from faster companies also indicate that they perform many activities in parallel, moving forward even before certain milestones have been achieved, and they tend to have more frequent and substantive cross dialogue across different functional areas earlier in the process. It is hoped that the results of this study will assist research and development professionals in making more informed management decisions and in identifying opportunities to streamline and improve the non-clinical to early-stage clinical process.