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that are filled to only a fraction of capacity. Only part of this predicament can be blamed on changing FDA requirements. The industry has collectively failed to do little more than routine maintenance work on its high-powered drug discovery engine, resulting in sub par performance. If the machine that drives your organization was suffering from a major, operator-induced malfunction, would you risk making the repairs yourself, or would you look for an independent “mechanic” to fix the damage? Those in the industry might want to look outside of their ranks for new strategies, advice, and ideas on resolving the various problems detailed above.
Whatever the approach taken, biopharma companies likeliest to prosper are those that do the best job supporting (or buying) innovative science, no matter how it is funded. Whether their management teams can establish (or maintain) a culture that leads to scientific advances, and then combine this with the intestinal fortitude needed to support lengthy development programs, remains to be seen. Gene therapy, antisense biology, and, more recently, RNA interference technologies have all been hot therapeutic approaches that industry largely cooled on when it became apparent that near-term disease treatments were not immediately forthcoming. Immunotherapy, a currently overheated field basking in the glow of a recent first drug approval, has been repeatedly probed, then abandoned by industry over the past century.
The loss of revenue caused by patent expirations, coupled with a dearth of new drug approvals, has forced the industry to implement changes to their business models. Many companies have cut back sharply on the number of disease areas they will explore. Establishing more extensive collaborations with both academic groups and smaller biotech companies has become widespread among Big Pharma companies, as has funding research startups through their own venture capital arms. An initiative has been put forth to pool and share academic and industry pre-clinical research data in neuroscience. One company has even set up a biotech incubator in its unused lab space. Concomitant with all of these strategies is an almost universal interest in pursuing “targeted acquisitions”.
Change in biopharma is being tested in a number of different ways. Some tactics will work, but many are likely to fail. This is not the time to be afraid, though, because “same old, same old” isn’t getting it done, and incremental change isn’t working. Success depends on generating good ideas and successfully implementing them. Keeping abreast of new approaches may be critical in helping your organization separate the drug discovery “wheat” from the failed clinical trial “chaff”.
Revolutionary ideas in biopharma will not be televised or tweeted. Meeting organizers need to bring in the mavericks, air the fanciful ideas of the non-conformists, and recruit speakers with novel approaches. Take steps to change things if you’re not satisfied with the status quo at biopharma conferences. Tell convention organizers that you won’t attend future events unless they bring in more independent voices that can share new ideas and critique what is and isn’t currently working. If you have specific speaker suggestions, please make sure to share them. This is a simple, though admittedly small step, in working towards solving a much larger problem. As former Texas agriculture commissioner Jim Hightower once put it, “the water won’t clear up until you get the hogs out of the creek“.
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