Drugmakers looking to shorten time to early clinical development, says Tufts CSDD

Pharmaceutical companies looking to increase the efficiency and productivity of their R&D pipelines are turning to a host of techniques and approaches aimed at shortening the time from non-clinical to early clinical development-with promising results, according to a panel of leaders from the research-based drug industry recently convened by the USA-based Tufts Center for the Study of Drug Development.

"New paradigms for the exploratory phase of drug development offer encouragement," noted Tufts CSDD professor and director Kenneth Kaitin, adding: "A growing number of companies, for example, are utilizing biomarkers, modeling and simulation, and advanced statistical methodology. And rapid drug prototype creation combined with novel scientific and formulation approaches are creating more predictable outcomes of early stage human testing."

He cautioned, however, that key to managing the transition from non-clinical to early clinical development will be a project management ethos that shuns existing silos and encourages rapid handoffs between teams within the same company, as well as between companies and development partners.