25 February 2010
The Joint NIH-FDA Leadership Council will concentrate on important public health issues, and seek to integrate regulatory considerations into biomedical research planning. The programme will combine work in translational and regulatory science including efforts not only to develop new clinical tools, but also means to assess the safety and efficacy of these tools. This sort of approach can be very important in making sure that innovation is used appropriately and to the best effect to improve health; for example, the PHG Foundation is currently working with other experts to develop quality standards to allow a fair evaluation and comparison of different disease risk prediction models.
It is expected that the new US partnership will have a particular impact on the development of genetic and pharmacogenetic tests for clinical application, as well as drugs for rare diseases (many of which are genetic in origin) and stem cell therapeutics. Sharon Terry, president and CEO of the Genetic Alliance, said: "The exercise of understanding how to endow discovery science with regulatory sufficiency, and retool the regulatory system to be flexible, iterative, and adaptive, will yield great fruit," (see GenomeWeb news).