Newsweek June 15, 2009
by Sharon Begley
Now that President Obama has almost all of his top science picks in place—from the Department of Energy to the FDA—the lack of an appointee for director of the Nation-al Institutes of Health is standing out like a creationist at an evolution conference. I hope the delay means Obama has grasped the need for, and the difficulty of finding, a powerful director who can get beyond the rhetoric about moving discoveries out of the lab and make it a reality. That hasn't happened yet, six years after a much-ballyhooed NIH "road map" declared such bench-to-bedside research a priority and vowed to reward risk-taking, innovative studies, not the same old incremental research that has produced too few cures. Read full article
Applied Clinical Trials Online
June 7, 2016
By Bruce Bloom
The case for supporting off-label use or commercialization in drugs for “unsolved” diseases.
There are over 7,000 “unsolved” diseases for which patients have no universally successful treatment. There are also thousands of generic drugs that can be repurposed to help these patients. Built on knowledge from scientific discoveries, anecdotal evidence, and/or bioinformatics, generic drug repurposing research can often lead to quick and affordable development of “new” medical solutions. Once a generic drug repurposing opportunity has been identified, a key issue is whether the clinical trial validation should focus on supporting a path to commercialization or to physician off-label use. The direction of focus depends on the entity supporting the clinical trial development.