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Lilly, IU expect $25M plan to create new model for drug R&D

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A new research consortium spearheaded by the Indiana University School of Medicine and Eli Lilly and Co. could bring in $25 million to $50 million over five years to create a new approach for developing drugs.

That new model is needed because scientists have discovered over the past two decades that major diseases—such as cancer, heart disease and dementia—are not one disease, but dozens of different diseases, depending on a patient’s genes and other health factors.

The idea of the consortium is to pool data from large numbers of patients from five to 10 academic medical centers to identify small groups of patients who, while they may be diagnosed with the same disease, have different causes of that disease or whose diseases develop differently than the norm.

Identifying these subgroups of patients could yield insights on how drugs might be used to stop or treat a disease.

“The old pharmaceutical R&D model, that model is really becoming increasingly more expensive and impossible to deliver effectively. Because patients are complex,” said Dr. Anantha Shekhar, a professor at the IU medical school. “We can create a new model for finding the next generation of medicines.”

The consortium, formally known as the Strategic Pharma-Academic Research Consortium for Translational Medicine, or SPARC, will receive funding from Indianapolis-based Lilly, Japan-based Takeda Pharmaceuticals International Inc. and potentially one other pharmaceutical company. Funding will likely range from $5 million to $10 million each year, depending on the projects the consortium does each year, said Shekhar, who is also director of the Indiana Clinical and Translational Sciences Institute.

That institute is a federally funded partnership formed by IU, Purdue University and the University of Notre Dame—all three of which will participate in the SPARC effort to develop drugs. About 12 researchers from Indiana will be part of the effort, Shekhar said.

Also participating will be Ohio State University, Northwestern University and Washington University and as many as six other academic medical centers in the Midwest. Shekhar said the University of Wisconsin, the University of Minnesota and the University of Chicago have been invited to join.

All of those universities have similar institutes focused on “translational science,” which focuses on taking basic research discoveries and developing them to the point they could be used for patients, as a new medical procedure or test or drug. The National Institutes of Health has made “translational science” a major focus of its funding, awarding IU, Purdue and Notre Dame $60 million for the next five years.

Shekhar said creating a consortium is key to developing a new R&D model for drug companies because individual companies do not have convenient access to, say, the 1 million patients it may take to identify a subgroup of patients with diseases that do not fit the standard pattern.

It’s also difficult for drug companies to study patients over long periods of time, Shekhar noted, which may also be required to understand how the diseases of different patients, even if caused by the same thing, develop differently.

“There’s wide variation in how well patients do or don’t do,” Shekhar said. “Trying to understanding that kind of variation, and how can you predict who will have a good response and who will not have a good response. Then understand the reason some do better. Is it genetics, is it drug interactions. Then figure out how best to improve the next generation of medicines. That’s the kind of stuff this consortium may work on.”

The consortium’s work won’t, by itself, produce new drugs. So it will be non-competitive between the drug companies.

"Academic collaborations have become an increasingly important component of the pharmaceutical industry’s overall innovation strategy," Andrew Dahlem, vice president of operations for Lilly Research Laboratories, said in a prepared statement. "We are pleased to be partnering on SPARC, which envisions a unique approach to this consortium, focused on creating the ability to identify, fund and implement research projects proposed by scientific teams that span multiple institutions, each with distinct capabilities and strengths."

Shekhar said the involvement of the drug companies is critical, because they spend lots of time understanding what kinds of new medicines would be well received by patients and physicians.

“Pharma brings the industry knowledge of what is the unmet need in terms of the market. And we don’t have that discipline,” Shekhar said.

In its first year, the consortium will focus on autoimmune diseases, such as rheumatoid arthritis or lupus. In future years, the consortium will likely focus on other diseases.

Each year, scientists from the universities and the drug companies will submit project proposals to a common committee, which will choose which ones to fund.

The amount of funding will hinge on the financial needs of the projects selected, which is why Shekhar could not give a precise funding figure.

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  • another try at changing the drug development process and pipeline
    Once again, they are trying to do this, the cost of developing a new drug has increased in amount of time and in development costs significantly. In actuality, the reason they want to do this is to get more years and more money from introducing the drug earlier and reaping more money from time on patent. Early to market means more money, more money and more time on patent protection means billions of dollars. This really has nothing to do with accelerating the process for patients, but for profit and to keep the generics from coming at them too soon with a lookalike product once patent expires.

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