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Chorus hits high notes for Lilly
February 2010
SHARING OPTIONS:
INDIANAPOLIS, Ind.—Like many other pharmaceutical companies,
Eli Lilly & Co., is looking for ways to streamline its drug development
efforts and make the process more productive as it faces thinning new product
pipelines. One solution to the problem has been to hire contract research organizations
to run tests on its drug candidates.
“Drugs under development” is an area that pharmaceutical
companies have generally kept under tight wraps, conducting vital work
in-house. Lilly is stepping outside the box in its work on a promising molecule
to treat rheumatoid arthritis into late-stage testing, based on mid-stage data
developed by scientists outside of its own research team.
An R&D unit the company calls Chorus takes control of
compounds discovered in company labs, such as the rheumatoid arthritis
molecule. Lilly is counting on a network of outside contractors to help develop
not only the arthritis remedy, but several other drugs it hopes start hitting
the shelves as early as 2013. If the drug eventually wins regulatory approval,
it will compete in a $16 billion annual market.
By outsourcing human tests of such a key drug, Lilly is
among a growing number of pharmaceutical giants adopting out-of-the-box
strategies to revive fallow research-and-development organizations.
According to Dr. Robert Armstrong, vice president of Global
External Research and Development at Lilly, Chorus is a drug development engine
that is charged with getting to clinical proof-of-concept—which is early
evidence that a drug works in humans—more efficiently.
Chorus is comprised of a core team of approximately 30
scientists with cross-disciplinary skills required in early development who
partner with a vast global development, Armstrong says.
“Chorus provides a ‘lean-to-POC’ development archetype
wherein the single focus is to provide a high-quality packet of data that
increases the probability of technical success and enables a go/no go decision
for further development,” he says.
Armstrong says that to date, Chorus has delivered data on 14
molecules, six of which resulted in positive proof-of-concept decisions, and
saved Lilly approximately $100 million in the process.
On the surface, it would seem that pharmas would lose some
control of the process by not handling research and development in-house, but
that isn’t necessarily the case, Armstrong says.
“Certain core internal R&D capabilities and expertise
remain in-house, but to do everything internally in the current environment
simply won’t work,” he adds. “Lilly is openly collaborating with external
experts to innovate faster and at less cost than in the past. Essentially, each
part of Chorus and its partners does what it does best, and Lilly can run a
much larger portfolio with fewer people than if it did all the work internally.
Think of Chorus as an example of a ‘force multiplier’—an approach to provide
Lilly with more innovative molecules for development faster and at less cost.”
There are certain situations where admittedly the CRO
concept can be a little less than perfect, he says.
“Not all molecules in a Big Pharma research and development
pipeline are amendable to development in focused proof of concept studies that
is at the heart of Chorus,” Armstrong notes. “The molecule and molecular target
need to possess a subset of characteristics that provide substantive and
actionable data in moderate sized trials.”
To select an outside contractor to run tests on drug
candidates, Armstrong notes that
Chorus partners with experts in their particular therapeutic
area and based on Chorus’ proven experience with the CRO. The effort gives
Lilly several areas in with savings can be realized, Armstrong adds.
“Chorus is a virtual development engine that relies on our
network of external partners to enable all aspects of the process, from
production of the drug candidate through execution and analysis of clinical
trials,” he says. “A combination of a lean trial design as well as leveraging
the external network is what results in the overall savings.”
So far, five of the 25 molecules studied since Chorus began
in 2004 have shown enough promise to merit further study. The first one likely
to go to late-stage development: the experimental treatment for rheumatoid
arthritis.
Some analysts say Chorus won't help Lilly soon enough. Drugs
accounting for more than half of Lilly’s current revenue will face generic
competition by 2013, as U.S. patents on top-selling treatments expire. The
company recently halted work on late-stage compounds for multiple sclerosis and
osteoporosis that were developed entirely in-house.
“Neither the cost cuts nor the structural changes help
R&D productivity,” Keyur Parekh, a UBS analyst, told the Wall Street Journal recently. He said he
thinks Lilly might need to make acquisitions to replenish its pipeline. Lilly
bought ImClone Systems for $6.5 billion in 2008, and CEO John Lechleiter has
said he’s hunting for more, similarly sized deals.
Code: E021004 Back |
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