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At the fourth IBC Personalized
Medicine conference in San Francisco in January 2002, the
attending companies staked their claim to be leading a revolution.
These companies are a diverse lot, ranging from tiny genomics
and bioinformatics companies such as Iceland’s deCODE Genetics
and Connecticut’s Genaissance Pharmaceuticals, to traditional
pharmaceutical companies such as Roche and Abbott, but all
have the same aim in mind – to change the face of human
healthcare in the 21st century.
A diverse universe...
The ideal of personalized
medicine is to move
from the so-called "one size fits all" method
of drug treatment, to providing "the right drug for
the right person at the right time". However, there
are many different approaches being followed to achieve
this vision, and the universe of public and private organizations
involved in the development of personalized medicine can
be split into several segments, depending on which approach
is adopted, and which stage of development they are focused
on.
Perhaps the real vanguard of
the personalized medicine revolution is in the field of
molecular diagnostics. Certainly, diagnostics is where the
impact of the genomic revolution will first be felt, partly
because of the shorter approval period required for diagnostic
tests compared to therapeutics. Already, according to Fred
Ledley, the chairman of Mygenome Inc., around one million
genetic tests are performed every year in the US, a figure
that he expects to rise to 10 million by 2006.
Most approaches to personalized
medicine will involve the detection and identification of
common genetic differences between people, known as single
nucleotide polymorphisms (SNPs). It is hoped that particular
SNPs, or groups of SNPs, can be correlated with particular
diseases, thus allowing the identification of a predisposition
for certain diseases, as well as providing potential targets
for the development of therapeutics. Some companies, such
as deCODE and California’s DNA Sciences, are analyzing relatively
homogeneous populations (in Iceland and Utah, respectively),
to try to identify SNPs and associate them with a multitude
of diseases. By comparing DNA samples from both closely
and distantly-related sufferers of a given disease, the
process of identifying disease-causing genes is made more
efficient.
While most companies are using
the individual SNPs as markers for disease, a slightly different
approach is being taken by Genaissance, which is hoping
to simplify the task by correlating haplotypes, dubbed "genomic
barcodes", with human diseases. Haplotypes are groups
of SNPs organized into one of a limited number of combinations.
Each haplotype contains significantly more information than
individual, unorganized SNPs. Genaissance markets its HAP
Technology to the pharmaceutical industry as a solution
for developing more efficient clinical trials and for differentiating
drugs already on the market.
Providing the tools for this
effort are companies such as Affymetrix and Amersham BioSciences,
which supply the technology with which genes are detected
and identified.
How does Big Pharma fit
in?
Big Pharma’s role in the future
of Personalized Medicine will not be in the detection and
identification of disease-related SNPs or haplotypes, or
the validation of targets, according to Michael Silber,
who gave a keynote address to the January 2002 Personalized
Medicine conference. Silber, who was formerly Pfizer’s Director
of Genomic and Proteomic Sciences, and is now with ALZA
as VP of Research, believes that there is too much risk
involved in this part of the R&D process. However, he
does think that genetic data will help pharma companies
to choose high quality targets, predict drug toxicities
and influence portfolio management in early development.
Perhaps reflecting his new position at ALZA, Silber also
believes that pharmacogenetic data will help physicians
to decide on drug dosages and delivery methods that reflect
the individual patient’s genetic profile.
Of course, many pharmaceutical
industry observers worry that personalized medicine could
fragment the market for blockbuster products in ways that
will drastically reduce profits. However, at least in the
near term, the outlook is likely to be rosier than that
for the pharma companies. For instance, GlaxoSmithKline
hopes to submit for approval a pharmacogenetic
test for the safety of its HIV drug, Ziagen (abacavir).
The test has the potential to identify the 5% or so of patients
who are predisposed to developing a potentially fatal hypersensitivity
reaction to the drug. A similar rate of hypersensitivity
is found in other HIV drugs as well, so if GSK could identify
the at-risk patients in advance, this could not only save
patients’ lives, but also give the company a significant
commercial advantage.
Divisions have been set up at
all of the large pharmaceutical companies to investigate
the potential of personalized medicine. Abbott has a Pharmacogenetics
group, while Bristol-Myers Squibb has its Pharmacogenomics
and Human Genetics Group. Perhaps the furthest ahead in
the field is Roche, which was one of the first to become
involved and, given its strong position in the diagnostics
market, is likely to be a leading player in the future.
An analysis of IMS Health’s R&D
Focus
database suggests that,
of the world’s leading pharmaceutical companies, Roche has
the greatest focus on "gene-based" research, with
around 20% of research projects associated with it having
a genetic component. American Home Products appears to be
involved in the greatest absolute number of gene-based R&D
projects.
Breakdown
of "gene-based" drug R&D programs by company
Source: R&D
Focus
Perhaps surprisingly,
only 10% of the R&D records associated with GSK have
a genetic component. However, since GSK has by far the largest
number of active R&D projects in the industry (close
to 300), this small percentage hides the fact that the company
is one of the most involved in gene-based drug research,
with around 30 projects. In fact, in an interview in January
2002, Roche’s Director of Investor Relations, Richard Simpson,
told IMS Health that Roche saw GSK as its main competitor
in the field.
Copyright IMS HEALTH, 7 Feb 2002
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