Welcome to the valley of death. January to December 2009 is being billed by a host of financial experts as the year that new investment capital will be as hard to come by as positive late-stage data. So picking my top five most important issues for the upcoming year in biotech is relatively simple. It's cash, cash, cash, cash and more cash.
But maybe you knew that already.
Deal making will continue strong into the New Year, but this time many of the companies in distress will be agreeing to terms they wouldn't have thought possible a year ago. Still, if you do have money in the bank, room to maneuver and some exciting science underway, good terms and willing deal-makers are out there. Strong data is the most valuable commodity in biotech--even an economic crisis won't change that fundamental notion.
Take off the financial blinders for a moment and you'll see a year that's likely to deliver major changes on several fronts. A new administration and a large majority of Democrats in the House and Senate will push significant new drug legislation that will heavily influence biotech--for better or worse. The FDA will likely prove even slower at completing drug reviews than it did in 2008, especially as it pushes higher standards for clinical data. And in a burst of new deficit spending, look for research advocates to benefit from fresh funds to back early-stage work, a foundation of the global biotech industry of the future.
Above all, look for the underlying revolution in personalized medicines to keep driving the technology we use to root out what causes illness and what it will take to fix the problems. This is a long journey, one measured in incremental gains and setbacks.
By the end of 2009, we hope to see an end to the recession, greater efficiency on the R&D side of the business, the Darwinian execution of the weak and silly, and a more realistic attitude regarding the future prospects of new therapies. - John Carroll
1. The credit crisis hits home
2. 1-20-09: A new administration takes over
3. More federal research money after years of flat funding?
4. FDA keeps heat on data--but lets itself off the PDUFA hook
5. Personalized medicine comes into its own