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SANTA CLARA, Calif.—Looking to implement patient-centeredapproaches across all stages of translational and clinical research in severalmajor therapeutic areas—an effort it calls the Translational Medicine forPatients (TM4P) program—global pharma leader Sanofi has partnered with NextBioto incorporate patient 'omics and clinical data into the program.
 
 
Sanofi, which has a longstanding partnership with NextBio onits preclinical research programs, announced the new deal on April 30. Thepartnership centers on NextBio Clinical, a state-of-the-art scientific platformthat aggregates and interprets large quantities of molecular and otherlife-science data for research and clinical applications. NextBio's software isused by researchers and clinicians in more than 50 top commercial and academicinstitutions, including the U.S. National Institute of Health, theSanford-Burnham Medical Research Institute, Harvard Medical School, the ScrippsResearch Institute, Pfizer Inc., Novartis, Eli Lilly, Johnson & Johnson,Merck and GlaxoSmithKline PLC, to name just a few.
 
 
For Sanofi, though, NextBio Clinical will enable theaggregation, standardization and analysis of patient clinical data, as well asnext-generation sequencing (NGS) and other molecular data, across public datasources, Sanofi clinical trials and Sanofi hospital partners.
 
 
Saeid Akhtari, president and CEO of NextBio, describes thepartnership as having four components. First, it gives Sanofi access to allavailable and relevant clinical trial content that NextBio curates,standardizes, normalizes and puts in a semantic framework so it can be easilymined.
 
 
"Sanofi works with many hospitals and research centersaround the world, and this platform will allow them to bring this data into themix and integrate it with NextBio's public data. Sanofi can make this datapublic if they choose to do so," Akhtari says.
 
 
Secondly, NextBio will provide analytic capabilities thatwill allow Sanofi to ask questions about biomarkers and patient stratification.The third component involves a user interface that Akhtari explains this way:"If you are a clinician running a Phase III clinical trial, you would want toquery this data and present it in real-time. When you have a query, you don'twant to wait two months to get your results back. In today's world, everyone islooking for instant gratification. If it takes longer than three seconds,people get fidgety."
 
 
And finally, NextBio will provide Sanofi with a privatecloud, "so they don't have to buy any hardware to house the data," saysAkhtari.
 
 
"When you look at a patient's record in a Phase II clinicaltrial, there is a lot more data generated than ever before—clinical lab data,image data and clinical attributes for patients, as well as thousands of dataon glucose levels, blood pressure, MRI tests, etc. We also see 'omics databecoming available—metabolome, epigenome, proteome, etc.—we're literallytalking about billions of data points. If you want to take a single patient andcompare them to all other patients, you have to invest in a huge computinginfrastructure," says Akhtari.
 
 
All of these components will amplify Sanofi's translationalresearch efforts, he says.
"NextBio deals with upstream research," he says. "The wholenotion is to take what you learn from your research and apply it to clinicaldevelopment. Researchers need to look for a subpopulation that will benefitmost from a drug, with the least side effects. We see many pharmas introducingthis, mainly because of the efficiencies that it enables. This is how I believemedicine should work."


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