Personalized Medicine: The need for collaborative business models
Iain Miller, executive
director of theranostics at French in vitro diagnostics company bioMrieux, on
the importance of partnerships in personalized medicine
bioMrieux is one of the largest global specialist
diagnostics companies, with yearly sales of over $1.7 billion.
Miller's title as head of theranostics-or diagnostic
testing for individual patients' response to therapy-highlights the firm's emphasis
on personalized therapeutics.
Speaking at the
2010 Personalized and Translational Medicine USA conference, Miller presented three core messages: progress in the
development of companion diagnostics for personalized medicine has been modest
in the face of high unmet need; recent developments highlight disincentives for
investment, particularly by diagnostics companies; and innovative collaboration
models may lead to commercial as well as clinical success.
Miller illustrated the scale of the unmet medical
need by stating that only 50% of prescribed medicines are effective.
So, with a global pharmaceutical spend of $600 billion,
about $300 billion yearly is being spent on, at best, placebos.
The situation is even worse in some therapeutic areas,
most notably oncology, where patient stratification is considered to be
particularly promising for improving efficacy levels.
However, despite extensive research, few novel
biomarkers or companion diagnostics are entering the market.
If a novel diagnostic test is to stand a chance of
market success it must be a valid analytical and clinical tool.
But it must also be of practical utility in the
clinic, and the economics must make sense for all players.
It is the last point that poses particular
difficulties for diagnostics companies.
In vitro
diagnostics for personalized medicine rarely make significant profits for their
developers as they are both low volume and relatively cheap.
Although the market for a typical "theranostic" is
similar to that for an orphan drug, there is no equivalent of orphan drug
legislation to protect its development. (For more on orphan drugs, see Forecasting
for orphan drugs: The data challenge'.)
Success
stories
Miller illustrated these points using case studies generally
regarded as "success stories".
Neither the combination of K-ras gene mutation
testing with EGFR inhibitors such as Erbitux to treat certain solid
tumors, nor even the use of Her2 testing to rule out the use of
Herceptin in breast cancer, both well established clinical tests,
have made significant profits for the diagnostics companies involved.
These companies are unlikely to invest significant
effort in the development of this type of product when they can reap large
profits from traditional diagnostic products that are much cheaper to develop.
Miller suggested, however, that success in this
market was possible for diagnostics companies if they were prepared to "think
outside the box" with innovative, collaborative business models.
Depending on the nature of the products and companies
involved, these successful deals between diagnostics and pharma companies may
take place at any point between Phase I and Phase IV (post-registration).
bioMrieux has established criteria for successful
partnerships between pharma and diagnostics companies, in which much of the
assay development cost is borne by the pharmaceutical partner and the companies
develop strategies for commercialization, regulation, development and marketing
together.
It has recently entered partnership deals along these
lines with GSK, Merck, Ipsen, and Transgene, and is also collaborating with
patient advocacy groups and within trade bodies such as the European
personalized medicine organization EPEMED. (For more on patient advocacy groups,
see The
patient's view: Patients with a (re)purpose' and How
Patient Advocacy Groups can Boost Patient Compliance').
Miller reiterated the challenge involved in developing
companion diagnostics.
However, he concluded on an optimistic note by
highlighting the growing willingness of pharma companies to form innovative
partnerships that may speed the growth of this important market.
For all the latest advances in personalized medicine,
join the sector's key players at Personalized
Medicine & Diagnostics Europe on March 9 and 10 in London.