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Exclusive Life Science Feature The company has similar initiatives in the United States. For example, Lilly is actively engaged with the NIH's National Center for Advancing Translational Science (NCATS). Edgar explains, "NCATS has created the Clinical and Translational Science Awards, CTSA program." The CTSAs provide support, infrastructure, and resources for clinical research around the country, providing academic homes for translational sciences, which is similar to Lilly's LIFA initiative. The NCATS program is also creating Centers for Clinical and Translational Science (CCTS) throughout the United States, in partnership with academic institutions (e.g. Spectrum: The Stanford Center for Clinical and Translational Education and Research). "The CCTSs have also self-assembled into regional consortia that we have been engaging via the critical unanswered question approach," he states. Under the NCATS program, there is a mandate for academic industry partnerships to help facilitate the translation of research for the benefit of patients. For example, according to Edgar, 20 years ago, the vast majority of molecules in development create a standardized methodology for risk-based monitoring of clinical trials. It also recently established the Clinical Trials Comparator Network to establish reliable and rapid sourcing of quality drug products for use in clinical trials via a master service agreement between TransCelerate members. "It's a very actionoriented consortium," Edgar states. "Everything in TransCelerate is about improving the quality and speed of the drug development process." According to Edgar, the TransCelerate initiative will also help the FDA. For example, by companies collaborating and developing standardized modules within a regulatory submission package, the agency will become familiar with the format. "When industry understands what the FDA needs, it is easier to deliver the information required in a standardized way, making it easier to be processed," he states. Edgar describes P3 engagement as an active process of seeking out the academic pillars of excellence. For example, in 2008, Lilly created a public-private partnership called the Center for Cognitive Neurosciences (CCN). This was a partnership between "MY ADVICE TO ANYONE LOOKING TO BECOME INVOLVED WITH PUBLIC-PRIVATE PARTNERSHIPS IS TO DETERMINE YOUR OBJECTIVES, DEVELOP AND FOSTER RELATIONSHIPS WITH ACADEMIA IN YOUR LOCAL AREA, AND REACH OUT TO THE NIH." Dale Edgar, Ph.D., Lilly would fail for toxicology. Through a number of concerted efforts within industry, different technologies were created that helped reduce the risk of compounds failing for technical reasons. For example, early discovery efforts now include in situ salt screening, preclinical toxicology, in vitro genetic toxicology and metabolism studies, quantitative pharmacology, and other steps to increase development success of candidate molecules. "Nowadays, less than 10 percent of molecules die for toxicology reasons in Phase 2 clinical trials, while considerably more fail for efficacy reasons," he says. "The NCATS program was created to help reduce clinical trial failures due to insufficient efficacy by developing predictive biomarkers and fostering studies to better understand how medicines can be targeted to those patients most likely to benefit. If you help reduce Phase 2 and Phase 3 failures, you can potentially shave years off the drug development process." PARTICIPATING IN THE TRANSCELERATE BIOPHARMA PROGRAM Another program Lilly is actively involved with is TransCelerate BioPharma, which is also designed to develop and share industry research and solutions to simplify and accelerate drug discovery and development. The initiative was started by 10 biopharmaceutical companies, including Lilly, just one year ago, and has already managed to develop common clinical-trial site qualifications and 36 LifeScienceLeader.com November 2013 Lilly and six academic centers in England. "Before this program, not only did these six academic centers not interact with each other, they overtly competed with one another," he states. "We brought them together by focusing on trying to solve tough questions in the area of cognition, which would ultimately help patients with Alzheimer's disease, neuropsychiatric disorders, and Parkinson's disease." By placing a former academic researcher in a position to head up the brokering of peer-to-peer relationships, along with the creation of a postdoctoral science training program, Lilly is well positioned to capitalize on the open-innovation industry trend. "That framework has done a lot to help align academia and industry toward the common goal of really trying to find ways to build science and create a sense of urgency around that science — to take us through the right steps to deliver innovation to patients," Edgar says. As a result of this work, today Lilly is engaged in more than 50 consortia and P3s. "My advice to anyone looking to become involved with public-private partnerships is to determine your objectives, develop and foster relationships with academia in your local area, and reach out to the NIH," says Edgar. "Today's health challenges are vast and complex. There is opportunity for us to all collaborate as a way to help accelerate the delivery of innovative medicines to patients."