Clinical OMICS

MAR-APR 2019

Healthcare magazine for research scientists, labs, pathologists, hospitals, cancer centers, physicians and biopharma companies providing news articles, expert interviews and videos about molecular diagnostics in precision medicine

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28 Clinical OMICs March/April 2019 www.clinicalomics.com SPONSORED CONTENT ANNIVERSARY ISSUE AACR Project GENIE: Powering Precision Medicine Through Data Sharing A Real-world Clinico-Genomic Registry for Clinical and Translational Discovery S hawn M. Sweeney, PhD, Director of the American Association of Cancer Research (AACR) Project GENIE Coordinating Center within the AACR and project lead, has been with the project since its inception. He represents more than 300 individuals who work collaboratively on the project and is grateful to the nearly 70,000 patients and counting who selflessly share their data. What is AACR Project GENIE? AACR Project GENIE (Genomics Evidence Neoplasia Information Exchange) is an international pan-cancer registry of real-world data assembled through data sharing between 19 international cancer centers. Charles L. Sawyers, MD (Chair of the Human Oncology and Pathogenesis Program, Memorial Sloan Kettering Cancer Center, New York, and Howard Hughes Medical Institute (HHMI) investigator) conceived the project in 2014. The idea was to leverage clinical sequencing efforts at cancer centers by pooling their data to create a novel, open- access registry to serve as an evidence base for the entire cancer community. Today, genomic and baseline clinical data from nearly 60,000 tumors is accessible through the efforts of our strategic and technical partners, Sage Bionetworks and cBioPortal. What problem is AACR Project GENIE trying to solve? Precision medicine requires an end-to-end learning healthcare system, wherein treatment decisions for patients are powered by the prior experiences of similar patients who preceded the current patient. Oncology is leading the way in precision medicine because the factors that fuel cancer initiation, progression, and recurrence—genomic and other molecular characteristics of patients and their tumors—are routinely collected at scale. A major challenge, however, is that no single institution can sequence and treat sufficient numbers of patients to improve clinical decision making independently. The solution is to pool data from multiple institutions and share it publicly, which is exactly what GENIE has and continues to accomplish. Why is AACR Project GENIE a solution? The non-profit AACR has funded and assembled a growing consortium of experienced academic institutions that treat a unique and significant number of patients. Because of their commitment to only share clinical-grade data, the GENIE registry contains enough high-quality data to power decision making on rare cancers or rare variants in common cancers. The consortium's activities are driven by openness, transparency, and inclusion to ensure that the project output remains accessible to the global cancer research community and ultimately benefits patients. What are AACR Project GENIE's biggest accomplishments to date? We have achieved several milestones, including the publication of the first landscape manuscript and a popular review article, addition of 11 new participating institutions, and completion of the first sponsored research studies (to be presented at the AACR Annual Meeting 2019). Our public data releases are the most prized accomplishments: In January 2019, we completed our fifth data release, bringing the total number of sequenced tumors within the registry to 59,500 from nearly 57,000 patients, and are eagerly anticipating our next release. Perhaps our crowning achievement is the culture shift to data sharing as the new normal. What can we expect from AACR Project GENIE in the next five years? We are excited to announce a five-year collaborative project consisting of a coalition of nine external stakeholders with the goal of collecting clinical outcomes of 50,000 patients in the GENIE registry. This project will link tumor genomic profiles, drug treatment, and clinical response at an amazing scale. We also anticipate reporting on natural history studies that have the potential to serve as synthetic control arms for patients with rare mutations in single-arm registrational clinical trials. We see GENIE data providing another knowledge turn in the virtuous cycle of research, accelerating the pace of drug discovery, improving clinical trial design, and benefiting cancer patients globally. Shawn M. Sweeney, Ph.D., Director, AACR Project GENIE AACR.org/Genie

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