Chorus hits high notes for Lilly

Special R&D unit takes control of compounds discovered in other companies’ labs

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INDIANAPOLIS, Ind.—Like many other pharmaceutical companies,Eli Lilly & Co., is looking for ways to streamline its drug developmentefforts and make the process more productive as it faces thinning new productpipelines. One solution to the problem has been to hire contract research organizationsto run tests on its drug candidates.
"Drugs under development" is an area that pharmaceuticalcompanies have generally kept under tight wraps, conducting vital workin-house. Lilly is stepping outside the box in its work on a promising moleculeto treat rheumatoid arthritis into late-stage testing, based on mid-stage datadeveloped by scientists outside of its own research team. 
An R&D unit the company calls Chorus takes control ofcompounds discovered in company labs, such as the rheumatoid arthritismolecule. Lilly is counting on a network of outside contractors to help developnot only the arthritis remedy, but several other drugs it hopes start hittingthe 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 isamong a growing number of pharmaceutical giants adopting out-of-the-boxstrategies to revive fallow research-and-development organizations.
According to Dr. Robert Armstrong, vice president of GlobalExternal Research and Development at Lilly, Chorus is a drug development enginethat is charged with getting to clinical proof-of-concept—which is earlyevidence that a drug works in humans—more efficiently.
Chorus is comprised of a core team of approximately 30scientists with cross-disciplinary skills required in early development whopartner with a vast global development, Armstrong says.
"Chorus provides a 'lean-to-POC' development archetypewherein the single focus is to provide a high-quality packet of data thatincreases the probability of technical success and enables a go/no go decisionfor further development," he says.
Armstrong says that to date, Chorus has delivered data on 14molecules, six of which resulted in positive proof-of-concept decisions, andsaved Lilly approximately $100 million in the process.
On the surface, it would seem that pharmas would lose somecontrol of the process by not handling research and development in-house, butthat isn't necessarily the case, Armstrong says.
"Certain core internal R&D capabilities and expertiseremain in-house, but to do everything internally in the current environmentsimply won't work," he adds. "Lilly is openly collaborating with externalexperts to innovate faster and at less cost than in the past. Essentially, eachpart of Chorus and its partners does what it does best, and Lilly can run amuch 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 provideLilly with more innovative molecules for development faster and at less cost."
There are certain situations where admittedly the CROconcept can be a little less than perfect, he says.
"Not all molecules in a Big Pharma research and developmentpipeline are amendable to development in focused proof of concept studies thatis at the heart of Chorus," Armstrong notes. "The molecule and molecular targetneed to possess a subset of characteristics that provide substantive andactionable data in moderate sized trials."
To select an outside contractor to run tests on drugcandidates, Armstrong notes that
Chorus partners with experts in their particular therapeuticarea and based on Chorus' proven experience with the CRO. The effort givesLilly several areas in with savings can be realized, Armstrong adds.
"Chorus is a virtual development engine that relies on ournetwork of external partners to enable all aspects of the process, fromproduction of the drug candidate through execution and analysis of clinicaltrials," he says. "A combination of a lean trial design as well as leveragingthe external network is what results in the overall savings."
So far, five of the 25 molecules studied since Chorus beganin 2004 have shown enough promise to merit further study. The first one likelyto go to late-stage development: the experimental treatment for rheumatoidarthritis.
Some analysts say Chorus won't help Lilly soon enough. Drugsaccounting for more than half of Lilly's current revenue will face genericcompetition by 2013, as U.S. patents on top-selling treatments expire. Thecompany recently halted work on late-stage compounds for multiple sclerosis andosteoporosis that were developed entirely in-house.
"Neither the cost cuts nor the structural changes helpR&D productivity," Keyur Parekh, a UBS analyst, told the Wall Street Journal recently. He said hethinks Lilly might need to make acquisitions to replenish its pipeline. Lillybought ImClone Systems for $6.5 billion in 2008, and CEO John Lechleiter hassaid he's hunting for more, similarly sized deals.

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