The quest to shorten time to early clinical development
New paradigms for the exploratory phase of drug development offer encouragement
- Date : 30 Oct 2012
- Topic : Anticancer agents & Biologic therapy
Drug companies looking to increase the efficiency and productivity of their research and development 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 convened by the Tufts Centre for the Study of Drug Development (CSDD).
According to Tufts CSDD Professor and Director Kenneth Kaitin, a growing number of companies, are utilizing biomarkers, modelling and simulation, and advanced statistical methodology. 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.
Non-clinical drug development focuses on identifying potential drug candidates. Early clinical development refers to early phase studies, usually involving small groups of healthy volunteers, to determine how the drug is absorbed, distributed, and eliminated by the body, to assess the drug's safety, and possibly to detect early evidence of effectiveness.
Key points made by the industry leaders, summarised in the Tufts CSDD R&D Management Report, include the following:
There is no single approach to setting development priorities. Some companies set milestones and publicize ranking criteria internally, while others do not share ranking criteria to avoid a premature decision to terminate a project at the discovery stage when much is still in flux.
While new information may make previously terminated projects worthy candidates for further development, most drug developers said they lack a formal process to re-examine rejected compounds; some companies outsource those compounds for others to re-assess.
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