New INDs surged 20% in 2008 so can we expect more clinical trials in the next few years? According to Parexel’s Bio/Pharmaceutical R&D Statistical Sourcebook, there were 5,700 active INDs in various stages of the approval process at the end of 2008, a 20 percent increase over the previous year; and new INDs coming into the FDA surged 20 percent from 2007 to 2008—from 662 to 795.

We are optimistic that 2010 will be a better year for clinical development as the economy stabilizes and capital becomes available.

Of all the new trials tracked in 2008, anti-infective trials (anti-infective/ophthalmic, antiviral and special pathogens/transplant) accounted for 17% of all trials (given pandemic fears this makes perfect sense); oncology represented almost 15%; and anesthesia/analgesia/rheumatology and neurology accounted for about 9% each.

GI saw the biggest annual gain from 2007 to 2008 with with a 208% increase year over year. As expected, special pathogen/transplant starts grew 70 % year over year. oncology represented 14% of all research starts in 2008, a 8% increase over 2007 (oncology had the most starts in 2007). metabolism/endocrine accounted for just over 11% of new starts; and anesthesia/analgesia/rheumatology accounted for about 10%.

For existing programs, cancer accounts for 25% of all investigational drugs, followed by infectious disease (11%), CNS (10%), CV (7%), hormonal system (6%), immune system (5%), GI (4%), musculoskeletal (4%), and other (25%).

Based on our recent project wins and stats like these, we’re bullish! What are you seeing?

Source: Parexel’s Bio/Pharmaceutical R&D Statistical Sourcebook 2009/2010; Biopharm Insights database.

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