NASHVILLE, Tenn.—AstraZeneca PLC and the Sarah CannonResearch Institute (SCRI), a global strategic research organization thatfocuses on advancing therapies for patients, are teaming up in a personalizedmedicine collaboration for the development of new oncology compounds fromAstraZeneca's pipeline. The partners will be working on molecular profiling inorder to classify tissue based on genetic profiles for use in treating cancersand predicting patient response to therapy.
"Building upon this unique collaboration with SCRI allows usto continue honing our capabilities to deliver high-quality research in atimely and cost-effective manner," Prof. Andrew Hughes, vice president of earlyclinical development at AstraZeneca, said in a press release. "Through thiscutting-edge program design, we can rapidly and effectively implement clinicaltrials with greater access to a network of cancer patients for enrollment."
Per the terms of the agreement, SCRI will collaborate withAstraZeneca on identifying potential patients for clinical trials and exploringbiomarkers that could predict patient response to specific treatments. Thisexpansion will now include clinical program development leadership, medicalexpertise and oversight and operational contract research organization trialmanagement for early-phase clinical development of several oncology compounds.
According to Cindy Perettie, president of SCRI DevelopmentInnovations, SCRI will design, interpret and deliver the clinical program forthe chosen molecules, and will work with AstraZeneca representatives to secureapprovals from AstraZeneca's governance committees and the necessary regulatorybodies. SCRI will also develop, validate and conduct biomarker testing, and"correlate patient molecular profiling data with clinical outcome data."
"Through our research, we know how vital and impactful individualizedtreatment options are for patients battling this complex disease," Dee AnnaSmith, CEO of SCRI, commented in a statement. "By partnering with AstraZeneca,we are expanding opportunities to accelerate drug development and deliver moretargeted therapies to patients who urgently need them."
The organizations have worked together since 2005, with SCRI"serving as a contributing site or the sole comprehensive CRO service providerfor studies," says Perettie.
AstraZeneca and SCRI announced an agreement to develop noveloncology compounds in late 2010, with this most recent agreement expandingSCRI's offerings for more of AstraZeneca's compounds. In addition, AstraZenecais one of the first participants in SCRI's molecular profiling program, which isa facet of the latter's personalized medicine initiative in the United Statesand the United Kingdom.
On its website, SCRI identifies molecular profiling as "animportant facet of personalized medicine, classifying tissue based on geneticprofiles for the purposes of diagnosing or treating cancers, or predictingresponse to therapy." As for the future of personalized medicine in indicationsbeyond cancer, Perettie says that with the SCRI's experience in oncology andcardiology, "we certainly see how other therapeutic areas can benefit fromgrowth in personalized medicine. Understanding genetic profiles for diseasessuch as blood disorders, diabetes, heart disease and autoimmune diseases canassist with predicting and tailoring effective treatments for theseindividuals."
"Accurate diagnosis improves patient care and helps to limithealthcare spending. In order to ensure targeted therapies are developed tocombat a greater variety of cancers, new biomarkers need to be identified,"says Perettie. "New diagnostics need to be developed to accurately and reliablyidentify those patients who may benefit from these targeted therapies,initially as part of a clinical trial, and latterly, in the clinic.
"With access to thousands of patients with multiple differenttumor types and with our access to technical capabilities, we are able to morerapidly identify eligible patients for early and late-phase clinical trials andexplore novel biomarkers that predict response to specific treatments. We arealso able to better understand the molecular characteristics of tumors andpre-screen potential candidates for inclusion in early-phase clinical trials,with the potential to significantly reduce enrollment time and increase patientaccess to novel therapies," she adds.