When regulators balk, drug discoverers freeze. Risk aversion will continue to have too great an influence on biotechnology in 2008. I've seen company after company come into creation with a clever business plan designed to avoid risk. Reworking old, reliable (and safe) compounds is a common technique now. And that caution has also helped spawn a rising tide of me-too products.
Risk avoidance is always built around incremental advances in therapeutic benefit. Whenever you see a company striving to meet a serious unmet medical need, you can see some serious risks. But those are the companies that stand to make the greatest gains in 2008, while risking far more serious losses.
There are tangible signs among payers that a backlash against me-too products is in the making. Look for governments and insurers to demand more and better data on a new drug before they cover it. The days when a drug company can muscle a new compound into the market with an aggressive marketing strategy are slowly drawing to an end. 'Show me the data' is becoming the new cry of a more demanding market--and that will reverberate all the way back to preclinical studies.
New "me-too" beta blocker dissed by experts. Report
Industry exec says FDA approval process too strict. Report