Regulatory science innovation: a rate-limiting step in translation.

An essential part of the translation process, regulatory science is underfunded, undervalued, and in need of innovation. T e Burroughs Wellcome Fund (BWF) has a history of jumpstarting scientif c f elds with targeted funding. In keeping with this tradition, BWF announces an initiative to support regulatory science. T e goal of the new program is to fund academic research on innovative approaches and technologies for assessing the safety and ef cacy of new therapies, and as a result, to promote regulatory policy decisions based on state-ofthe-art science. Here, we describe BWF’s new focus on innovation in regulatory science as a natural extension of our interest in fostering translational research. For scientif c research to drive advances in human health, basic biomedical discoveries must be translated from preclinical studies in cell-based in vitro systems and animal disease models to testing in human subjects, and ultimately to incorporation into medical practice, with subsequent assessment of the resulting health outcomes. Since the mid-1990s, much has been written about the obstacles that block the path between basic and clinical science (1). Major initiatives have been launched with the intention of addressing this “bench-to-bedside” gap and speeding the translation process (2). In 1997, BWF began to dedicate substantial resources to the then-emerging f eld of “T-1” translational research; this investment of more than $72 million in 97 midcareer clinical investigators—who spanned myriad medical subspecialties—produced work that has helped to def ne the f eld (3, 4). For example, BWF grant recipient Brian Druker helped to develop the f rst molecularly targeted treatment for chronic myelogenous leukemia; another grant recipient, Jane Koehler, combined clinical insight with basic microbiological expertise to determine that the cause of a devastating skin lesion appearing in AIDS patients was a zoonotic bacteria and then went on to discover a new bacterial species. In the last decade, translational science has enjoyed growing and substantial public and private investment, which has