A Revolution in R&D

Chapter 1: The Impact of Genomics
Preface
As the science of genomics has advanced, so has the
definition. When the term was coined in 1986, it
referred mainly to the study of the mammalian
genome—specifically, the mapping, sequencing,
and analyzing of all its genes. The scope soon
expanded, focusing not just on the genes’ structure
but on their function as well. More recently, the
scope of the term has broadened further, focusing
no longer just on knowledge of the genome but also
on the exploitation of that knowledge, especially
for health care.
Going beyond dictionary definitions, our interest is
in what genomics means for the economics of pharmaceutical
R&D. On the basis of our extensive
research and many discussions with prominent people
throughout the industry, we suggest characterizing
genomics, for the purposes of this study, as the
confluence of two interdependent trends that are
fundamentally changing the way R&D is conducted:
industrialization (creating vastly higher throughputs,
and hence a huge increase in data), and informatics
(computerized techniques for managing and
analyzing those data). The surge of data—generated
by the former, and processed by the latter—is
of a different order from the data yields of the pregenomics
era.
To elaborate. The new high-tech industrialization
has increased the efficiency of certain activities
beyond recognition. Instead of assigning individual
scientists to work manually on modest individual
experiments, companies now invoke automation
and parallel processing to conduct experiments
much larger in scale and complexity, and at a much
faster pace.
Look around this lab—you have to search high
and low to find a human heartbeat. Now robots
can do the menial things we did in grad school.
—Research leader,
leading biotech company
The data that emerge are immensely greater both
in quantity and in richness. Enormous databases—
detailing gene expression, for example, or homologous
genes across species, or protein structures—
afford unprecedented comprehensive views of
biological processes. Increasingly, researchers can
understand properties of the system rather than
just individual parts, and that holds out the promise
of a more rational approach to drug discovery.
The new technology of informatics serves to handle
and process all these data. Without it, the data
would remain raw material. Informatics was nurtured
by several coinciding factors: the ever-accelerating
power of computers, refined algorithms, the
integration of data and technology platforms, and
the versatility of the Internet. The effect is that
overwhelming masses of information can now be
marshaled, managed, and analyzed as never before.
Data are transformed into knowledge.
We could never have achieved drug development
that fast with traditional techniques. No way—
without the computers we didn’t have a chance.
—VP of chemistry,
biotech company
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