WIKIMEDIA; ROBERT M. HUNT, ANDREATELETRABAJOToday, academic and nonprofit institutions are embracing entrepreneurial endeavors with private industry in a big way. The straight line once dividing academia from the biopharma industry has all but disappeared, with universities now housing about one-third of the more than 1,200 so-called business or technology incubators in North America. But despite all the cross-fertilization occurring between academia and industry, the melding of these two philosophies has a ways to go, particularly when it comes to advancing stem cell therapies, one of the most promising, although yet to be fully realized, new treatments.
Potential cell therapy products are being investigated and developed at an astonishing rate. Investigational New Drug (IND) and Investigational Device Exemption submissions to the FDA for cell-based therapies nearly doubled in the last five years—from 60 to around 100—and the expectation is that we will see more clinical trials related to these products. Much of the initial work behind these therapies—from embryonic stem cells (ESCs), mesenchymal stem cells (MSCs), and induced pluripotent stem cells (iPSCs)—emerged from university labs. However, researchers at academic labs may not be so comfortable navigating the more regulatory-driven requirements of preclinical testing. Nevertheless, to ensure these discoveries find their way to patients, stem-cell researchers must consider the development and manufacturing of their products, in addition to their safety and efficacy. Right ...
