Editorial Catalysts

I’m not going to lie to you — some of the articles in this issue may make you … well, nervous. But that may be a good thing. Let me explain.

This month we have a number of articles that are not only forward-thinking but are chock-full of advice on ways you can either avoid potential business problems or improve your existing business processes. For instance, on page 22 Rick Farris talks about how pharma companies should make a “radical departure from standard practice” when preparing their RFPs for CROs. In Kate Wilber’s article on page 24, she discusses the standardization of global regulatory submissions and says that “pharmaceutical organizations have little choice but to … introduce new efficiencies to their international regulatory submissions activities.” And when James Hamilton notes on page 26 that “the issuance of guidance from the Food & Drug Administration is a wake-up call for the biopharma industry,” he isn’t kidding, citing a list of actual reasons why warning letters were issued last year to investigators, sponsors, and investigator review boards.

There are other examples, too, but my point is that being confronted with the type of information in these articles may make you feel as though you are “behind the curve” in a certain area. You may feel compelled to conduct a spot-check of your existing processes. For example, are your researchers using cloud computing (p. 30) or ePRO (electronic patient-reported outcome) systems (p. 42), and would these technologies speed up your time to market? My hope is that these articles serve as a catalyst for you to institute some sort of change for the better at your organization — that’s always our goal here at Life Science Leader.

Personally, the article that moved me the most was Bill Tauzin’s “Industry Outlook for 2010” (p. 8) where he stressed the need for healthier diets and more exercise in his discussion of preventative healthcare. Looks like it’s back to the treadmill for me.