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Chorus hits high notes for Lilly
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.