By Deb Borfitz
March 1, 2010 | As of this year, Eli Lilly and Company is converting to a new operating model designed to streamline drug development and better “capture the value” of a record-setting number of new medicines in its pipeline. The enablers include a flexible project management approach, routine use of advanced analytics and adaptive trial designs, and a focus on tailored therapies, says Tom Verhoeven, PhD, senior vice president and co-leader of the Development Center of Excellence.
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| Tom Verhoeven |
The fresh approach has integrated all clinical specialties and capabilities necessary to bring innovative medicines to market, says Verhoeven, including the newest functions associated with analytics and medicinal tailoring. “We’re not just changing the organizational chart; we’re building a system that allows [functional] groups to coordinate activities with each other on a single process map across study phases and even post-approval.”The ultimate goal is improved medical outcomes for individual patients with therapies that also create value for payers and providers, says Verhoeven. Starting in 2013, Lilly hopes to be producing two new medicines annually.
The more immediate benefit is eliminating bottlenecks in clinical planning, most notably the “downtime” between clinical trial phases that can slow study start-ups by weeks or months, says Verhoeven. Lilly relies on the “critical chain” project management technique, unfamiliar to most of the pharmaceutical industry, that reflects the way functional specialties are interlinked and responds immediately to incoming data. He compares the approach to a relay race where the focus is as much about the baton pass as a runner’s particular leg of the relay. The idea is to proactively identify and rectify potential “pinch points” in a project. The pharmaceutical industry has traditionally moved milestone to milestone as if on a train schedule which, while somewhat predictable, is largely immutable and “rather antithetical to innovation.”
Lilly put 5% of its clinical projects into pilot testing with the critical chain methodology over the last few years, with “stupendous” results, says Verhoeven. “On all of those projects, 100% of major milestones were met on time or early.” Historically, Lilly hit those targets only 40% of the time. The company now utilizes the critical chain approach across its portfolio of roughly 60 potential medicines and has yet to miss a delivery mark. This has demanded that Lilly’s relationships with clinical research organizations (CROs) and other external providers be more partnered than transactional in terms of study planning and execution, he adds. A hodgepodge of homegrown information technology solutions across functional groups has also been integrated into a single operating system to “increase communication and interdependence.”
Advanced analytics and greater reliance on cloud computing are critical to Lilly’s operational model. Simulation and modeling, using pseudo-data about study outcomes anticipated by disease-state experts, help ensure the company designs trials likely to produce the most relevant information, says Verhoeven. Adaptive trial designs and Bayesian statistical techniques are also embraced, allowing data that accumulates during a trial to redirect its course. A more sophisticated approach to data mining provides visibility to trends and the wherewithal to make inferences.
The search for tailored solutions is now the foundation of drug development at Lilly, says Verhoeven, leading the company to embrace rather than try to expunge heterogeneity in trials. A “tailoring hypothesis” about a compound’s potential benefit to a certain sub-group of patients is tested during all phase I trials.
Lilly has capitalized on those opportunities. For example, clinical trial data has led to regulatory approvals for and the tailored use of Alimta in the treatment of patients with advanced non-small cell lung cancer with a nonsquamous histology.
As part of its new operating model and $1 billion reduction in operating expenses, Lilly will reduce its employee head count from 40,000 to 35,000 by the end of 2011, says Verhoeven. Moving forward, Lilly is interested in longer term relationships and establishing preferred partnerships with CROs and investigative sites, he adds.