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Accelerating oncology trials
TAMPA, Fla.—In an “unprecedented effort” to accelerate the discovery of life-saving cancer treatments, informatics solutions company M2Gen has launched a unique partnership of pharmaceuticals, academia and the Oncology Research Information Exchange Network (ORIEN)—an alliance of leading cancer centers throughout the United States founded in 2014—to share information and speed up targeted trials to ultimately combat and cure advanced-stage cancers. Celgene Corp. will be the industry’s founding member for a network of participants joining in this new initiative.
The launch of this new ORIEN Avatar Research Program brings together the key decision-makers in healthcare research and development—pharmaceutical companies and academic cancer centers—to find new treatments for millions of Americans battling advanced-stage cancers, says Dr. William S. Dalton, founder and CEO of M2Gen and founding director of the Moffitt Cancer Center’s DeBartolo Family Personalized Medicine Institute.
Managed by M2Gen, the collaboration is expected to “generate massive amounts of genetic and clinical information on patients consenting to the Total Cancer Care protocol, the largest prospective observational study of its kind in cancer,” Dalton says.
“Patient de-identified information generated through the ORIEN Avatar Research Program will be provided to the pharmaceutical partners when searching for eligible individuals to participate in biomarker driven clinical trials,” he says. “Patients identified will have access to groundbreaking therapies in development most suited for their specific type of cancer and the unique molecular features of their disease.”
This initiative “creates a pre-competitive space for pharmaceutical companies and prominent cancer centers nationwide that will benefit all participants involved,” Dalton says. “Patients gain access to new trials and investigational treatments, pharmaceutical companies are provided with unique data analytics to assist them in the development of treatments through this targeted data access approach. Cancer centers can share data to accelerate discovery and expand the clinical trial options for patients while providing critical research in the overarching mission to better understand, treat and ultimately cure cancer.”
The ORIEN Avatar program is constructed as a subscription service for partners so that it can scale to include any number of leading companies in the industry.
“Together, we are creating a unique resource by partnering with multiple stakeholders, including patients who consent to be followed throughout their lifetime so that we can ultimately provide patients with more options with unequalled precision,” Dalton says.
Furthermore, the ORIEN Avatar program represents a collaborative space within the healthcare community to drive new discoveries and shorten clinical development timelines by proactively matching patients to trials, he notes, adding: “This means we are able to identify the most in-need, underserved patients, anticipate their needs and match them to cutting-edge trials. The result: More options for patients, and a more effective means to drive the development of life-saving treatments.”
The program “is a standout in its approach to patient information gathering and sharing to form a more efficient system,” says Michael Pehl, president of Hematology & Oncology at Celgene. “This wealth of clinical and molecular data will potentially lead to a better understanding of molecular properties that are involved in a patient’s disease and what treatment designs might be most successful in battling their cancer. Building this resource in a multipartner collaboration creates a wealth of data, which will potentially lead to better outcomes for patients.”
The ORIEN Avatar Research Program will focus on patients with advanced primary or metastatic disease, those with limited treatment options, as well as patients who are likely to develop progressive disease, and will capitalize on the disease-area expertise of ORIEN’s research scientists, Pehl says.
In addition, the program “helps to solve a systemic challenge in pharmaceutical research and development by dramatically increasing the patient population that can be screened for clinical trials,” he adds.
Data show the cost of bringing a drug to market averages $2.6 billion over a period of time averaging 10 to 15 years, Pehl says. With such large investments in time and capital, many research projects are shelved if they cannot identify a large-enough patient sample size for a trial.
Adds Dalton, “The ORIEN Avatar program will use an in-silico analysis approach to better design clinical trials and match patients to promising clinical trials to achieve their accrual targets so that new and improved treatments can be brought to market more rapidly.”
Dr. Michael Caligiuri, CEO of the James Cancer Center at The Ohio State University, which co-founded ORIEN along with the Moffitt Cancer Center, says, “For far too long, cancer research and treatment have been hampered by an industry standard of individualism. We founded ORIEN in 2014 with the intent to break the mold and usher in a new culture of cooperation and collaboration in healthcare. With the data and information provided by the ORIEN Avatar Program, and support from industry leaders such as Celgene, we stand poised to make the promise of the next generation of cancer treatments a reality.”
Also serving as the director of The Ohio State University Comprehensive Cancer Center, Caligiuri is known as a man who, despite the hurdles of healthcare, is optimistic about the future and views his glass as half-full.
Caligiuri believes ORIEN could play a role in the White House cancer “Moonshot” program President Obama announced in his last State of the Union Address. “Everything big happens through the federal government,” he says, noting that he is optimistic the Moonshot Task Force will spur unprecedented funding for cancer research.
Caligiuri urged a recent audience to let their elected officials know how important cancer research is to them, and vote for candidates who support increased funding for research.
“Complacency won’t get it done,” Caligiuri says. “We put a pittance into cancer research compared to what it costs us.”
M2Gen is an informatics solution company advancing personalized medicine by partnering with key stakeholders using high-quality tissue, clinical data and molecular technology to accelerate the discovery and delivery of personalized medicine. Using a rapid learning approach, M2Gen delivers evidence-based solutions to 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 has partnered with the nation’s leading cancer centers through ORIEN to create a large, cancer-focused data warehouse and biorepository linking clinical and molecular data.