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60
53
50
New molecular entities
Biologics license applications
39
40
35
31
30
30
27
24
21
21
19
20
18
18
17
16
15
10
7
7
6
6
6
6
5
5
4
3
3
3
2
2
2
0
1996 1997 1998 1999 2000 2001 2002 2003
Year
2004 2005 2006 2007 2008 2009 2010
FIGURE 1.1
Number of drug approvals, small molecules and biologics.
From
[2]
.
100
95%
2002-2004
2003-2005
2004-2006
2005-2007
2006-2008
90
84%
80
70
66%
60
51%
50
40
30
20
17%
10%
11%
10
5%
0
Phase I
Phase II
Phase III
Submission
FIGURE 1.2
Probability of success to market from key clinical development milestones.
From
[3]
.
Paradoxically, it seems that there has never been a better time in biomedical research with
all the innovations we are currently witnessing. The Human Genome Project and ancillary
efforts, the development of next-generation sequencing and other large scale genome analy-
sis tools have transformed our understanding of diseases, especially cancer
[4]
. Not a day
goes by without news of identification of a 'gene for' a common disease or new insight into
a pathway that drives a common cancer. One of the key challenges for pharma R&D will be
to translate this explosion in genomic knowledge and new insights into disease pathways
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