The President's Council of Advisors on Science and Technology (PCAST) has published a report to the President on propelling Innovation in Drug Discovery, Development and Evaluation.
The Council points out that, despite increasing investments in R&D, the number of new drugs on the market "remained constant for several decades". PCAST has therefore held a lot of discussions with various stakeholders including senior leaders from the pharmaceutical industry, patient advocacy groups but also FDA and the National Institutes of Health. The goal was to identify and develop constructive solutions. As a result, a set of recommendations was made, summarised in the report.
Two major concerns were identified:
1.) A gap between scientific knowledge between research and commercial projects and a mismatch between advances in research and the technologies needed for the development of the drug.
2.) Inefficiency in clinical trials caused for example by complex requirements.
Possible improvement could for example be achieved by:
To achieve the goals, several recommendations were made:
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)