The Ohio State and Moffitt Collaborate on ORIEN: Using Big Data to Accelerate Trials With a Cancer Research ‘Expressway’


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Jeff A. Walker, MBA

This is a collaborative effort that will speed drug discovery and provide patients with even more personalized treatment options—and better outcomes.

—Jeff A. Walker, MBA

The Ohio State University Comprehensive Cancer Center and Moffitt Cancer Center have joined forces to create the Oncology Research Information Exchange Network (ORIEN), the largest collaboration of its kind designed to accelerate discoveries in cancer research. Members of this alliance of cancer centers will agree to use a common protocol and share data, primarily for research, that ultimately will lead to evidence-based decisions for clinical care. Patients are active participants.

The endeavor was launched in May 2014, said Jeff A. Walker, MBA, Senior Executive Director for Administration, Arthur G. James Cancer Hospital–Richard J. Solove Research Institute, The Ohio State University, at the Turning the Tide Against Cancer Annual Conference, held recently in Washington, DC.

Mr. Walker described the three guiding principles:

  • Inclusiveness: Participation by member cancer centers and their respective community networks
  • Data accessibility: Real-time access to research data through a hybrid model of a federated and central data warehouse. ORIEN members maintain ownership of their own data but agree to share limited data and may participate in projects that require more extensive data sharing.
  • Partnership building: Establishment of trusted business relationships across the public-private sector to achieve long-term program sustainability

He explained that since the collaboration was formally announced, “We have received requests from several other [National Cancer Institute]–designated cancer centers to join. We are actively meeting with and evaluating each center and are anticipating that we will be able to announce others joining ORIEN in the coming months.”

More Than 100,000 Patients So Far

As of the end of September, ORIEN has amassed donated tissue and clinical data from 113,370 people who provided 37,570 tumor or tissue samples and 16,279 gene-expression profiles. Data generated from these specimens include CEL files (created by Affymetrix DNA microarray image analysis software), targeted exome sequencing, whole-exome sequencing, whole-genome sequencing, single-nucleotide polymorphisms/copy-number variations (lung, breast, and colon cancer), and RNA sequencing (breast cancer, myeloma).

This all contributes to a program called Total Cancer Care. It is, said Mr. Walker, “a rapid learning environment that shares de-identified data to accelerate development of targeted treatments and allows researchers and clinicians to quickly match eligible patients to clinical trials in order to conduct larger and richer analyses.”

Rapid learning is the ability to access a large, shared data warehouse to ask new research questions, develop more effective and competitive grant submissions, and participate in cross-institutional collaborations and biomarker discovery projects with academic institutions and pharmaceutical companies.

Total Cancer Care, established by Moffitt in 2006, also tracks patients’ molecular, clinical, and epidemiologic data and follows them throughout their lifetime. ORIEN thus has access to one of the world’s largest clinically annotated cancer tissue repositories in the world.

National Cancer Database

Up until now, there has been no efficient way to share insights gleaned from clinical and research data and no system to match cancer patients with the most effective ways to treat them.

ORIEN has the potential to become a true national cancer database. It can provide physicians with evidence of the best therapeutic options, including clinical trial treatments specific to patients’ biologic and epidemiologic profiles. This will increase the likelihood of treatment efficacy, speed response time, and potentially minimize side effects.

Mr. Walker noted that ORIEN will build upon Moffitt’s Total Cancer Care warehouse of genotypic and phenotypic data, as well as Ohio State’s depth and breadth in translating molecular- and genetic-based discovery protocols into more effective ways to detect and treat cancers.

Business Management

ORIEN will be managed by M2Gen, a wholly owned for-profit subsidiary of Moffitt that will serve as its operational and commercial provider of informatics. M2Gen is in the business of informatics, data management, clinical trial matching, and biobanking. It works with the pharmaceutical industry to identify new biomarkers and to seek opportunities for drug development and delivery.

To this end, it can analyze data from all participating ORIEN centers to quickly match patients with molecular and genomic target-based clinical trials. It also performs pharmacovigilance and comparative effectiveness studies.

ORIEN members can earn revenue through collaborations that would not otherwise be available to single cancer centers, such as grant funding, revenue stemming from shared intellectual property, and participation in M2Gen-industry projects with biopharmaceutical companies.

Mr. Walker said that ORIEN’s approach to clinical trial matching will provide an opportunity for pharmaceutical companies to modernize trial recruitment and design. Through M2Gen, industry researchers will be able to match their targeted drugs to patients who participate in ORIEN for the purpose of trial efficiency and flexibility. This should enable better identification of potential candidates for drug trials.

He added that ORIEN means that, for the first time, there is a true national cancer database. “This is a collaborative effort that will speed drug discovery and provide patients with even more personalized treatment options—and better outcomes. Patients will be active partners in the lifelong study of their disease.” ■

Disclosure: M2Gen, which is managing ORIEN, is a wholly owned for-profit subsidiary of Moffitt that will serve as its operational and commercial provider of informatics. M2Gen is in the business of informatics, data management, clinical trial matching, and biobanking. It works with the pharmaceutical industry to identify new biomarkers and to seek opportunities for drug development and delivery.

 



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