The selection of SCRI is unique because the institute is not a typical CRO, and the alliance could signal a willingness in large pharmaceutical companies looking to branch out from the prototypical large CRO to find more niche expertise. SCRI has one division that is a full-service CRO focusing on the early-phase development of cancer drugs, but it also has an autonomous research and development arm.
“The recent development of SCRI’s capabilities in supporting molecular profiling is a key next step to support future clinical research,” Gabrielle Hannafan, senior manager at SCRI, told Outsourcing-Pharma.com.
In terms of the pact with AstraZeneca, Hannafan said, however, that the compounds involved will be early phase oncology compounds selected from AstraZeneca’s pipeline.
“SCRI will be accountable for both the design and interpretation and delivery of the clinical program for selected AstraZeneca molecules… SCRI will also work with representatives from the relevant AstraZeneca program teams to develop clinical and registration plans, and gain necessary approvals from AstraZeneca internal governance committees, as well as regulatory bodies.”
SCRI’s partnerships with molecular profiling laboratories also may be one of the main reasons AstraZeneca sought out such an institute to work with.
"We expect that with this cutting-edge collaboration, we can rapidly and effectively implement clinical trials with greater access to a network of cancer patients for enrollment," Carl Barrett, PhD, VP of translational science in the oncology innovative medicine unit at AstraZeneca told us. he also noted SCRI's "focus on early-phase development of medicinal products that is differentiated by the breadth and depth of the SCRI medical and scientific researchers."
The institute “will correlate patient molecular profiling data with clinical outcome data, and use this information to better inform future clinical trial design and identify new biomarkers of interest," Hannafan said. "Through its partnerships with molecular profiling laboratories, SCRI will develop, validate and conduct biomarker testing using a variety of assays and technologies.”
In regard to CRO trial management, Hannafan said SCRI “will be responsible for the clinical development plan for selected oncology compounds” in terms of “providing support, advice and leadership in regard to the overall clinical strategy and also the operational delivery of clinical trials associated with the agreed plan, including project management, data management, site management and monitoring, pharmacovigilance and medical support.”