Monday, June 4, 2012

Cancer Survivor on N-of-One’s Direct-to-Patient Ombudsman Model

Kevin Davies
Posted 5/31/12 on Bio-IT World
The long-term success of N-of-One, a Waltham Mass.-based company offering personalized cancer information, will undoubtedly be shaped by the vision of its newly appointed CEO, Christine Cournoyer, and strategic partnerships with companies like Foundation Medicine, announced this week.
But ultimately it comes down to whether the company’s original direct-to-patient strategy works for cancer patients like Elaine Waples.
In April 2010, the 65-year-old Waples was diagnosed with primary Stage III peritoneal cancer. After surgery, she underwent six months of first-line chemotherapy, along with some targeted therapy in the form of Avastin. After eight treatments, she went into remission, but her particular cancer frequently recurs and has a poor survival rate over five years.
“We did extensive research on my cancer,” Waples told Bio-IT World from her home in Jacksonville, Florida. “There are new things happening in cancer research, but where do you begin to learn this information?”
With extensive contacts in the healthcare industry, Waples’ husband, healthcare analyst and blogger Brian Klepper, jumped into the fray.  He was referred to Jeffrey Gelfand, an oncologist at Mass General Hospital whose wife had died of peritoneal cancer. Gelfand put Klepper in touch with N-of-One founder and president, Jenifer Levin Carter.
Waples and her husband held a lengthy phone conversation to learn about the N-of-One services, joined by their doctor, gynecological oncologist Stephen Buckley. “We needed him to be part of the process,” says Waples. “He’s highly trained, very open minded, and thrilled to be involved in this,” adds Klepper.
After several months, they decided to hire N-of-One to perform molecular testing of her tumor tissue and produce personalized management recommendations. ““N-of-One had a unique approach. I loved the name of the company. I felt they were looking strictly at me. They were focusing on me as an individual,” says Waples.
“They’re an ombudsman, they’re traffic controllers. They have tumor tissue sent to labs of their choosing, signed off by my doctor.” The ensuing reports are sent to Waples and her oncologist. “My preference was, when the data came back to N-of-One, it was sent to me and copied to my oncologist,” she says.
The raw information looks like alphabet soup, says Waples, including insights into genetic mutations and cancer biomarkers, gene expression levels and copy number variants. She’s no expert and it would be easy to misinterpret the data, Waples admits, and she has treated the early findings with caution.
“The range of testing is pretty vast,” says Klepper. “It’s beyond the capability of people at our level to really make sense of it.” “The more I learn on my own, the better questions I can ask N-of-One,” says Waples. “This is a group decision – it has to be your medical team, the data you seek, and then your own common sense and ability to understand what’s going on. That’s how you make decisions.”
Waples expects to receive the all-important summary report from N-of-One in the next week or two.  Waples and Klepper hope that the N-of-One report will provide some definitive conclusions, either in helping formulate a treatment plan or alternatively refute other treatment approaches because the no longer make sense based on the new information.
Regardless of her own personal outcome, Waples praises the ombudsman role that N-of-One is playing. “The future of medicine has been cracked wide open,” she says.
Precision Medicine
N-of-One was founded in 2008, providing diagnostics and treatment services and advice to patients and working with their oncologists. The business has grown organically largely by word-of-mouth and referrals from oncologists. N-of-One offers a menu of biological tests performed in a variety of CLIA-certified and esoteric labs. “We’re being compensated by the patient. We look for the best testing for that patient,” says Carter.
Cournoyer was formerly president and chief operating officer of Picis, a popular provider of health information software solutions that was acquired by United Healthcare in 2010.  She is also a former vice president and chief information officer of IBM’s software group. Carter, N-of-One’s founder, remains as president and chief medical officer.
“I’m very impressed with the technology platform, the practices to synthesize information and transform it into patient-specific, molecularly targeted strategies,” says Cournoyer. While the company’s early focus was on the direct-to-consumer needs of individual cancer patients, the company’s new oncology informatics platform, PrecisionWorks, enables doctors and healthcare providers, including the new marquee partnership with Foundation Medicine, to individualize diagnostic and treatment decisions.
Cournoyer will be looking for ways to introduce molecular profiling strategies in a cost-effective manner. “That’ll be our target market. We’ll be offering PrecisionWorks in a software-as-a-service business model.”
“We have evolved and optimized PrecisionWorks from a direct-to-patient approach into an integrated, systematized platform that enables us now to expand access to much larger groups of patients through oncologists, regional cancer centers, and provider networks, while still providing our direct-to-patient solutions,” says Carter.
In the newly announced non-exclusive partnership with Foundation Medicine, N-of-One provides all the clinical and molecular interpretation from a next-gen sequencing (NGS) panel of some 200 genes that leads to a personalized therapeutic strategy and relevant clinical trial information. “We take the test data and turn it into clinically actionable information,” says Cournoyer.
“We’ve been building PrecisionWorks for a couple of years,” says Carter. “Our scientists and oncologists have been synthesizing different types of information — patient-relevant data down to relevant tissue components — to create all the key components that will make this the ideal platform to identify the key biomarkers to be evaluated.”
The platform mines molecular data to identify relevant biomarkers in the patient’s tumor, links those biomarkers to relevant targeted therapies, and matches patients with current clinical trials that are relevant to their disease. “We bring the data back and our team synthesizes the individual molecular data in context of other sources to create treatment strategy roadmaps,” says Carter.
The final decision making, she stresses, is in the hands of our expert oncology council.  “All the interpretation is being created by scientists/oncologists. All the content is reviewed. We just don’t press a button to create the content,” she says.
Near and Far
While Foundation Medicine specializes in NGS data, Carter says N-of-One takes a very agnostic approach to partnering companies, integrating many other data sources, from copy number and gene expression to protein biomarkers, as new technologies become available. “We do the interpretation across many types of technology. How do you take complex molecular data and integrate them into a coherent treatment strategy?”
Carter says N-of-One has already worked with hundreds of patients and multiple providers in half-a-dozen different countries. About one third of the patients come from referrals from academic and regional cancer centers. While N-of-One is prepared to expand to many other types of technology, including whole-genome sequencing, the key question in the near term remains: how meaningful is the assay for patients today? What’s the turnaround time? And how can the data be interpreted in an actionable manner?
“We’re not chasing the diagnostics companies; we want to provide a solution for today,” says Cournoyer. “Most providers are at a very elemental level providing these [diagnostics] strategies.”
No doubt Cournoyer and colleagues will be wrestling with the bigger picture, neatly summed up by Klepper: “What’s the relative efficacy of this for purchasers of healthcare? If we increase rate of positive response of therapy from 6 percent to 22 percent, how does that pay out to ROI if I’m Walmart and I have thousands of cancer patients in my population every year?”
Those questions will be solved one patient at a time.

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