Understanding M2GEN’s Role in ORIEN

By Dr. Todd Johnson
Chief Growth Officer, M2GEN

Understanding M2GEN’s Role in the Oncology Research Information Exchange Network (ORIEN)

Founded in 2014 by Moffitt Cancer Center and The Ohio State University Comprehensive Cancer Center, the Oncology Research Information Exchange Network® (ORIEN) is a first-of-its-kind alliance among some of the top cancer centers in the United States. Since ORIEN’s founding, numerous other institutions from across the country have joined—including those in both central and coastal regions—and are now working together to advance the fight against cancer. Current membership includes:

- Dartmouth Cancer Center
- Indiana University Melvin and Bren Simon Cancer Center
- John P. Murtha Cancer Center at Walter Reed Bethesda
- Moffitt Cancer Center
- Morehouse School of Medicine Cancer Care & Research Community
- Roswell Park Comprehensive Cancer Center
- Rutgers Cancer Institute of New Jersey
- Stephenson Cancer Center at the University of Oklahoma
- The George Washington University Cancer Center
- The Ohio State University Comprehensive Cancer Center
- University of Colorado Cancer Center
- University of Iowa Holden Comprehensive Cancer Center
- University of Kentucky Markey Cancer Center
- University of New Mexico Comprehensive Cancer Center
- University of Southern California Norris Comprehensive Cancer Center
- University of Utah Huntsman Cancer Institute
- University of Virginia Cancer Center
- Winship Cancer Institute at Emory University

ORIEN is powered by M2GEN, an oncology-focused health informatics solutions company that has been working since 2006 to accelerate the discovery, development, and delivery of precision medicine. In this article, we explore the various ways that M2GEN contributes to ORIEN, and we also discuss what the future may hold for cancer prevention, detection, diagnosis, and treatment.

Implementing the TCC Protocol at ORIEN Member Institutions
One of the most significant recent developments in cancer research involves precision medicine, which the National Cancer Institute (NCI) defines as “[a] form of medicine that uses information about a person’s own genes or proteins to prevent, diagnose, or treat disease.” As the NCI explains, “[i]n cancer, precision medicine uses specific information about a person’s tumor to help make a diagnosis, plan treatment, find out how well treatment is working, or make a prognosis.”

In order to identify actionable biomarkers, create comparator cohorts, and perform other analyses required for the development of new therapies, cancer researchers need access to patients’ clinicogenomic data. M2GEN provides ORIEN members with that access by implementing the Total Cancer Care® (TCC) protocol at member institutions. Patients at these cancer centers have the option to enroll in the IRB-approved TCC protocol. When they do, their de-identified genomic and longitudinal clinical data is shared with other ORIEN members, as well as biopharmaceutical companies and researchers. Not only do researchers gain access to a remarkably large, diverse data platform—one of the most comprehensive in the world, with more than 325,000 patients having opted to participate already—but they also have the ability to re-contact enrolled patients through their providers to invite them to participate in additional studies.

Notably, M2GEN is one of the only companies ensuring that patient data is granted through informed consent. This offers benefits for both scientists (who gain access to more reliable and robust data) and patients (who can take pride in helping other individuals battling cancer and feel like they have more control over their own care). And because the TCC protocol allows for the continued collection of data throughout a patient’s cancer journey, M2GEN is able to develop incredibly robust patient profiles for use in research.

Standardizing Collected Data
Before patients’ genomic and clinical data can be shared with researchers, it first needs to be standardized so that it can be processed and analyzed as efficiently and effectively as possible. M2GEN’s Bioinformatics Support Services team—which is led by bioinformatics and computational biology experts—has developed various tools to help expediate the processing of large volumes of patient data. Our state-of-the-art ORIEN AVATAR data product, for example, builds comprehensive genotypic and phenotypic profiles of consenting patients while using an avatar to shield their identity. In addition to aggregating longitudinal clinical data, we work with leading biospecimen labs to provide robust molecular data from:

• Paired Tumor and Germline Whole Exome Sequencing (WES T/G) analysis with Panel of Normals (PoN) filtering
• Tumor-Only Whole Exome Sequencing (WES T-Only) analysis with Virtual Normal (VN) somatic mutation classification
• Tumor-Only RNA Sequencing (RNA-Seq T-Only) analysis

Tools like these enable ORIEN members to devote their time and efforts to interpreting results rather than processing raw data. What’s more, researchers can feel confident knowing that all of M2GEN’s bioinformatics services are performed in HIPAA-compliant and HITRUST-certified cloud solutions, and that M2GEN’s pipeline analysis is WES and RNA-Seq capture kit agnostic and uses the most up-to-date human genome reference (GRCh38/hg38) and gene build (Gencode V32).

Facilitating Collaborations Among ORIEN Members
In addition to coordinating the collection, standardization, and dissemination of cancer patients’ clinicogenomic data, M2GEN also helps encourage collaboration between the various ORIEN member institutions, with the ultimate goal of breaking down research silos and advancing patient care. One way in which M2GEN accomplishes this is by regularly coordinating research interest group meetings and investigator meetings, as well as an annual scientific retreat. These gatherings provide ORIEN members with the perfect setting to exchange ideas and discuss opportunities for advancement. Many of the relationships formed during these meetings have led to cutting-edge research initiatives.

Looking Toward the Future
Precision medicine has already progressed by leaps and bounds since its relatively recent development, but there is still more work to be done. One of the most efficient and effective ways to advance cancer care is to supply researchers with a broader registry of patient data for them to study, and one of the best ways to accomplish this is to expand the ORIEN network to include additional cancer centers. Each time another one of these institutions joins ORIEN, it expands the database available to oncological researchers, providing them with the critical support they require.

For More Information
M2GEN is committed to breaking down research silos and bringing together leaders in oncology in order to improve outcomes and quality of life for cancer patients around the globe. If you’d like to know more about M2GEN, ORIEN, or any of our other products or services, contact us today.