Ohio State and Moffitt Form World's Largest Cancer Research Collaboration for Big Data; More Than 100,000 Patients Already Participating

In Partnership With:

Partner | Cancer Centers | <b>Moffitt Cancer Center</b>

Two of North America's leading cancer centers announced what is likely the largest collaboration of its kind to accelerate discoveries in cancer research.

(OSUCCC-James)

the largest collaboration

TAMPA, Fla., and COLUMBUS, Ohio — Two of North America’s leading cancer centers, Moffitt Cancer Center and The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute, today announced what is likely of its kind to accelerate discoveries in cancer research.

ORIEN will utilize a single protocol, Total Cancer Care®, to create a collaborative, “rapid learning” environment that will share de-identified data to accelerate the development of targeted treatments, allowing researchers and clinicians to more quickly match eligible patients to clinical trials and conduct larger and richer analysis.

Named the Oncology Research Information Exchange Network (ORIEN), the new partnership will launch with over 100,000 consented patients who have agreed to donate their tissue and clinical data for research to understand cancer at the molecular level.

National System Long Overdue

Leaders of each cancer center emphasized ORIEN’s goal to

develop more precise ways to prevent, detect, diagnose, and treat cancers.

“Cancer is a highly complex disease, and potential breakthroughs have been stalled because we’ve lacked an efficient way to share incremental insights,” said Alan F. List, M.D., president and CEO of Moffitt. “Even more frustrating, until today we’ve had no system to quickly match cancer patients from anywhere in the country with ongoing clinical research with the most potential to help them,” he said. “By partnering with The Ohio State University through ORIEN, we’ve built a cancer research expressway."

“With ORIEN, we’re amassing a true national cancer database for the first time,” said Michael Caligiuri, M.D., director of The Ohio State University Comprehensive Cancer Center and CEO of the James Cancer Hospital.“The collaboration across academic centers and with health care industry will not only help speed discovery, but will also provide patients with more personalized treatment options and ultimately, lead to better outcomes.”

Through data analysis and sharing, ORIEN will provide physicians evidence of the best therapeutic options, including clinical trial treatments, specific to a patient’s biological and epidemiological profile, increasing the likelihood of treatment efficacy, speeding response time, and potentially minimizing side effects while improving outcomes.

Patients are followed throughout their lifetime and can play an active role in the study of their cancer and improve care for future generations.

ORIEN builds upon the strengths of its founders’ National Cancer Institute-designated comprehensive cancer centers: Moffitt’s Total Cancer Care protocol, biorepository and data warehouse of patients’ genotypic and phenotypic data, and OSUCCC-James’s depth and breadth in translating molecular- and genetic-based discoveries into more effective ways to prevent, detect, treat and ultimately cure cancers.M2Gen®, a subsidiary of Moffitt, will serve as ORIEN’s operational and commercial provider for support, bringing expertise in data management and informatics.

The ORIEN collaborative will seek partnerships with other leading cancer centers in North America. More information may be found at ORIENcancer.org.

Clinical Trial Matching

ORIEN’s approach to clinical trial matching also presents a significant opportunity for pharmaceutical companies to modernize trial recruitment and facilitate adaptive clinical trial design. Through M2Gen, industry researchers will be able to match their targeted drugs to participating patients within ORIEN cancer center members based on their molecular profile, promoting greater trial efficiency and flexibility. Ultimately, researchers will be better equipped to identify potential candidates for their drug trials, leading to better outcomes.ORIEN also creates the ability to accelerate and improve efficiencies of clinical trials and the drug approval process, including post-market surveillance.

“M2Gen® will facilitate what we view as the ideal way to conduct cancer research and help patients — an approach that promotes collaborative learning at all levels,” said William S. Dalton, Ph.D., M.D., president and CEO of M2Gen. “The goal of our joint efforts with Moffitt and OSUCCC-James is to connect patients to the best treatment options, including clinical trials, by accelerating the discovery and delivery of personalized medicine.”

About Moffitt Cancer Center

Located in Tampa,

is one of only 41 National Cancer Institute-designated Comprehensive Cancer Centers, a distinction that recognizes Moffitt’s excellence in research, its contributions to clinical trials, prevention and cancer control. Moffitt has been listed in U.S. News & World Report as one of “America’s Best Hospitals” for cancer since 1999. With more than 4,200 employees, Moffitt has an economic impact on the state of nearly $2 billion. For more information, visit MOFFITT.org, and follow the Moffitt momentum on Facebook, Twitter and YouTube.

Moffitt

A

bout The Ohio State University Comprehensive Cancer Center — Arthur G. James Cancer Hospital and Richard J. Solove Research Institute

Ohio State’s Comprehensive Cancer Center — James Cancer Hospital and Solove Research Institute (OSUCCC-James) strives to create a cancer-free world by integrating molecular- and genetic-based discoveries into patient care, a strategy that leads to better prevention, detection and treatment of individual cancers. OSUCCC – James is one of only 41 National Cancer Institute-designated Comprehensive Cancer Centers and one of only four centers funded by the NCI to conduct both phase I and phase II clinical trials. More than 300 cancer researchers from 12 of Ohio State’s 14 colleges collaborate across research programs and disciplines to make some of the world’s most game-changing discoveries.

In December 2014, The Ohio State University Comprehensive Cancer Center will open the doors of the new James Cancer Hospital, a transformational facility that fosters collaboration and integration of cancer

research and clinical cancer care.

The new James will help revolutionize cancer prevention and care by enabling world-class oncologists and researchers to work side-by-side to solve the mysteries of this disease.

About M2Gen®

www.m2gen.com

M2Gen® is Moffitt Cancer Center’s wholly owned, for-profit, informatics solution subsidiary advancing personalized medicine by using high quality tissue, clinical data and molecular technology to accelerate the discovery and delivery of personalized medicine. Using a rapid learning approach, the goal of M2Gen is to accelerate the science of precision medicine by creating evidence and knowledge-based solutions that identify a patient’s susceptibility to disease, predict how the patient will respond to a particular drug, and match patients to the best therapies for an optimal treatment outcome. M2Gen, along with Moffitt and 17 hospitals in a Consortium Network, has created a large, cancer-focused, biorepository linked to clinical and molecular data. For more information, visit .