USA "Needs ICH-Style Process To Speed Pharma R&D"

The US Food and Drug Administration, the pharmaceutical industry and academia need to work together "in an International Conference on Harmonization-like process" to bring about improvements in drug delivery times, representatives of all three groups have told a conference in Washington, organized by the FDA's Center for Drug Evaluation and Research, Georgetown University's Center for Drug Development Science and the Food and Drug Law Institute.

CDDS director Carl Peck told the conference that industry, government and academia representatives meeting at the conference had agreed there was "sufficient momentum and motivation" for a discussion of the value of setting up a steering committee to consider the issues.

The panel had also identified six "significant issues" which it felt deserved "further investigation and improvement" by the steering committee, according to Dr Peck. These were: clinical trials; company culture and leadership; data management; FDA standards, requirements and practices; science management; and theory of drug development.