Predictable outcomes: Why do potential winners fail?
30th September – 1st October 2008, Washington DC, USA
A little more than 10% of new compounds that are at the first-human-dose evaluation milestone will reach the market. the costs of pharmaceutical R&D keep spiralling upwards, whilst the rate of new molecular entity (NME) approval applications decreases. The regulatory approval system should be relatively predictable and risk free for medicines developed in accordance with current guidelines. However, it could take 12 to 14 years for a pharmaceutical company to bring a product to the market, and during that time the regulatory guidelines and scientific advice may have changed to keep pace with scientific progress.
Participants in this Workshop focused on identifying critical success factors (CSFs) that are needed for the success of new medicines and examined the best use of scientific advice to provide a predictable outcome for the drug development process. In addition, the results and future directions of the CMR Institute for Regulatory Science’s Scorecard Project, a metric designed to measure the quality of submission dossiers from the perspectives of agencies and companies, were discussed.