FIGURE 5-1 Visualization of how the current drug development model is growing disaggregated with the involvement of various sectors to reduce risk in innovation.

SOURCE: Skarke and FitzGerald, 2010.

According to FDA Commissioner Margaret Hamburg, FDA has been engaged in regulatory science for years, leading to several accomplishments. For example, as noted in Box 2-2, collaboration between FDA and NIH led to a new method of using gene biomarkers to assess the differentiation in stem cell lines; this was an initial step that will ultimately lead to setting standards for use in patients and for ensuring that undifferentiated lines do not contaminate the final product. In 1997, FDA collaborated with academia and industry to create clinical data standards that could be used universally. In the field of drug-induced kidney toxicity, the agency led joint efforts with European health agencies to identify and qualify novel biomarkers for drug assessment. This partnership led to a more sensitive and noninvasive strategy for detecting kidney toxicity in animal models, enabling regulatory bodies to perform assessments early in drug development to help prevent investments in scientific dead-ends.

Judith Kramer, Executive Director, Clinical Trials Transformative