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Sanguine BioSciences Signs Agreements with More than 200 Partners to Enable Efficient Personalized Medicine Research

Sanguine BioSciences, a biotechnology company enabling personalized medicine research, today announced that it has signed commercial agreements with, and received orders from, more than 200 biomedical researchers at academic, biotechnology and pharmaceutical companies, to enable more efficient personalized medicine research. Ongoing agreements are in place with a wide range of organizations, ranging from startups, such as Inhibrx, to contract research organizations, such as Applied Immunology, and major drug developers, such as Vertex Pharmaceuticals.

Sanguine directly engages patients diagnosed with severe and chronic diseases to collect and de-identify biospecimen, medical history and other data that can be used in biomarker research. Traditional methods are to obtain biospecimen through hospitals, but this process can result in months of delays as the focus for physicians and staff is on diagnosis and treatment, not facilitating research efforts. By engaging patients directly, Sanguine can meet the needs of researchers and offer timely turnaround of biospecimen and medical data with diverse ranges for age, race, disease state, gender and treatments underway. The patient engagement tactics used by the company have led to a 95 percent retention rate, which also allow for follow-up draws for longitudinal studies.

“In a very short amount of time, and with only recently hiring our first few sales executives, our company has established agreements with ten of the largest drug developers in the world and continues to see high demand for our offering,” said Brian Neman, founder and chief executive officer of Sanguine. “Researchers have specific needs to complete studies in early discovery work, sometimes run with blood samples drawn the same day and other times requiring follow-up draws on exact time schedules, but traditional strategies to obtain these add months to the timeline. Our commitment to patient engagement, transparency and advocacy removes much of this wait time – accelerating the research and increasing the efficiency of the process overall.”

Sanguine is able to meet, review disclosures and collect blood samples in a patient’s home with its own phlebotomists in multiple major U.S. cities. Patients are also able to track how their de-identified biospecimen and data are used through the donor web portal. The company is able to collect and process blood from patients with any disease and has already built large libraries in multiple chronic and severe conditions, including Huntington’s disease, rheumatoid arthritis, systemic lupus erythematosus, Crohn’s disease, ulcerative colitis and others.

In order to maintain appropriate confidentiality, all samples are de-identified immediately upon collection. Sanguine maintains and reviews internal ethical guidelines for the procedures under high scrutiny from an independent review board.

Source: PR Newswire

A Roadblock to Personalized Cancer Care?

There’s a major roadblock to creating personalized cancer care.

Doctors need a way to target treatments to patients most likely to benefit and avoid treating those who will not. Tumor biomarker tests can help do this.

The problem, according to a new commentary paper, is that, unlike drugs or other therapies, cancer biomarker tests are undervalued by doctors and patients. The authors say that inconsistent regulatory rules, inadequate payment and underfunded tumor biomarker research has left us in a vicious cycle that prevents development and testing of reliable biomarker tests that could be used to personalize clinical care of patients with cancer.

“Right now biomarkers are not valued nearly to the extent that we see with therapeutics. But if a tumor biomarker test is being used to decide whether a patient should receive a certain treatment, then it is as critical for patient care as a therapeutic agent. A bad test is as dangerous as a bad drug,” says Daniel F. Hayes, M.D., clinical director of the breast oncology program at the University of Michigan Comprehensive Cancer Center.

Hayes led a blue-ribbon panel of experts from universities, corporations, insurance and advocacy organizations to outline the issues in a commentary published recently in Science Translational Medicine.

Tumor biomarker tests look at the genetic or molecular make-up of a tumor to determine whether the cancer is likely to progress, and if so, if it is likely to respond to treatment. If the test is good, it can help doctors decide when a patient can safely skip further therapy, or it can be used to direct which drug might be most likely to help. The result: “personalized medicine,” which means patients get treatments that benefit them specifically and they avoid treatments – including their costs and side effects – that are not likely to make a difference for them.

The regulatory process, the research funding, the reimbursement, even the standards for journal publications for tumor biomarker tests are all meager compared to the robust support for drug development, the authors say.

This creates a vicious cycle in which researchers and drug companies don’t invest in tumor biomarker research, tests are not fully evaluated in clinical trials, and tests with uncertain value in terms of predicting the success of treatment are published. This in turn means that few of these tests are included in evidence-based care guidelines, leaving health care professionals unsure of whether or how to use the test, and third-party payers unsure of how much to pay for them.

The authors outline five recommendations and suggest that all five must be addressed to break the vicious cycle:

  1. Reform regulatory review of tumor biomarker tests
  2. Increase reimbursement for tumor biomarker tests that are proven to help determine which therapies will or are working
  3. Increase investment for tumor biomarker research so it’s comparable to new drug research
  4. Increase the rigor for peer review of tumor biomarker publications
  5. Include only proven biomarker tests in evidence-based care guidelines

“These recommendations are not about creating more regulation; they are about creating an even playing field that allows tumor biomarker tests to be developed and proven clinically relevant. We want to stimulate innovation yet hold investigators and clinicians to the highest scientific standards – as we now do for therapeutics,” Hayes says. “We need to change the way we value tumor biomarkers in this country.”

Study: Breaking a Vicious Cycle [Science Translational Medicine]

Source: University of Michigan Health System

Syapse Joins Free the Data! Initiative and Provides Software to Power Participant-centric Hereditary Gene Mutation Database

Syapse, the leader in software for bringing omics into routine medical use, announced that it has joined the Free the Data! initiative. This consortium of policy makers, advocacy organizations, individuals, academic centers, and industry aims to fill the public information gap caused by the lack of available genetic information for the BRCA1 and BRCA2 genes, and plans to expand to provide other types of genetic information in an open, searchable database.

Syapse will provide the software infrastructure for the Free the Data! initiative, enabling powerful data mining, visualization, and reporting. Participants will be able to visualize their own variations and clinical data in comparison to those already in the database, while clinicians will be able to utilize variant interpretation in medical interactions. Researchers, industry, and others can utilize Syapse data mining tools to interrogate the variants, interpretation, and evidence, along with clinical data submitted by participants. Participants will have full control over data sharing and privacy preferences of the data they contribute. The campaign shares all variants with ClinVar, the National Institutes of Health public database, unless the participant dictates otherwise.

“Despite national attention on the patentability of human genes, a ruling against gene patentability doesn’t immediately provide broad access to BRCA1 and BRCA2 variants or place them in a public database that will allow for better diagnosis and care,” said Sharon F. Terry, M.A., president and CEO of Genetic Alliance. “Syapse provides the best platform for integrating complex genomics and clinical data from disparate sources, and reporting it in a dynamic and relevant interface to participants and clinicians. We are excited to be using Syapse software to enable all individuals to access genetic mutations and their clinical interpretations in order to improve care.”

“Syapse is pleased to join Genetic Alliance, University of California San Francisco (UCSF), InVitae Corporation, and advocates in the Free the Data! initiative to crowdsource the interpretation of BRCA1 and BRCA2 variants,” said Jonathan Hirsch, Founder & President of Syapse. “Syapse is committed to the free and open interpretation of the genome, but interpreting the genome requires a larger evidence base than any one entity can develop. Pooling genetic and clinical data will rapidly advance medical knowledge of clinically relevant genetic mutations, leading to more effective diagnosis, treatment, and cures.”

Individuals who have received genetic testing and who are interested in participating are invited to go to the Free The Data! project web site at www.free-the-data.org, and follow the instructions to upload test results, set privacy and sharing settings, and answer a brief questionnaire.

Individuals may also send a scan or PDF of the test report form with the personal identifying information blocked to Genetic Alliance by email at freethedata@geneticalliance.org or by facsimile at 202.966.8553.

We encourage individuals, advocacy groups, research organizations, physicians, policy groups, professional societies and industry to join the cause. For more information, please visit free-the-data.org or contact: 202.966.5557 x201.

Source: Synapse

Firm Hopes Big Data Can Personalize Health Care

When Colin Hill’s father was diagnosed with later-stage prostate cancer last summer, he was treated the same as every other patient with the illness.

This standardized approach bothered Hill, who believes medicine should approach each patient’s illness as unique, with medication tailored to the person’s history and biology.

“You show up to the hospital, and it’s like Groundhog Day,” Hill said, with patients being cared for the same way, over and over again. “It’s this outdated standard of care created for this hypothetical average patient. But no one’s an average patient.”

A genetic analysis of the tumor in his 69-year-old father, Foster Hill, found he had a genetic variant of the cancer that does not usually respond well to the hormone therapy Lupron, the current standard of care. But not knowing what else would work, doctors gave Foster Hill Lupron anyway. Luckily, the treatment seems to be helping, and his father’s outlook is much improved.

Hill hopes a Kendall Square company he founded 13 years ago, GNS Healthcare, will eventually improve medical care for his father — and for countless others — by providing personalized treatment. GNS is among the leaders in using Big Data analytics to learn more about diseases, patients, and treatments.

With data from thousands of cases, GNS uses artificial intelligence to determine what treatment made the crucial difference for each patient.

The company is deploying enormous computing power to produce a more complete understanding of treatments for rheumatoid arthritis, diabetes, cancers, and other illnesses.

For example, it is working with the Dana-Farber Cancer Institute and Mount Sinai Medical School to build a computer model of multiple myeloma, so researchers can better understand what works well for patients today, as well as develop more effective treatments for the blood cancer. It is involved in a similar collaboration with Brigham and Women’s Hospital and several other partners to learn more about multiple sclerosis.

Harvard Medical School recently agreed to use a GNS computing platform to analyze how cells replicate or transform into different types, for insights into­ conditions such as cancer and neurodegenerative diseases, Hill said.

And the company has a partnership with the Centers for Medicare & Medicaid Services and Health Services Advisory Group to assess health care quality measures, as well as other recent deals with pharmaceutical companies, hospitals, and advocacy groups, and the insurance giants Aetna and Blue Cross Blue Shield.

“It’s exciting times for us,” Hill said, after 13 years of developing his approach to analyzing health care. “We are now in the thick of things.”

Hill did not always have such an absorbing interest in science. He went to college at Virginia Tech — mainly to play tennis. “I was more serious than I was good,” he quipped.

But while there, he became fascinated by physics and chaos theory — the idea that complex patterns could result from simple rules.

His imagination was stoked by a summer job in 1996 at Santa Fe Institute, an interdisciplinary research center focused on highly complex issues. Hill then went on to graduate from McGill and then Cornell University.

By then, the Human Genome Project was becoming a reality, capturing the attention of many scientists, including a young Hill.

“That’s when two and two came together,” Hill said. “It was like ‘Oh yeah, the stuff we’re doing, though it’s pretty theoretical, it is going to be the thing that links these pieces together,’ ” including chaos theory, genetics, Big Data, and health care.

Now he’s in the middle of the so-called Big Data revolution in health care. Companies such as GNS have an enormous capacity for crunching troves of information on patients, diseases, and medical outcomes collected by medical providers, insurers, and other big players.

Hill likes to say he wants GNS to capture the “data exhaust thrown off” by every interaction a patient has with the health care system, from the doctor’s office to the hospital to the pharmacy. A bad reaction to medication is a data point worth having; ditto for other side effects, as well as results of all kinds of procedures and interventions — bad or good.

While such data sets are getting easier to find, Hill said, genetic information is still too expensive to be truly useful.

“What we don’t have yet for my dad and for other men with prostate cancer is a large coherent set of data on prostate cancer patients that includes the molecular level,” Hill said.

With information aggregated from thousands of cases, Hill said, GNS uses artificial intelligence algorithms developed out of chaos theory to determine what treatment made the crucial difference for each patient, and with it what is likely to work best for the next patient — rather than simply trying one medication after another, as is often done today.

“What we’re trying to get at is not just patterns and trends, but reverse engineer the mechanisms that gave rise to the data,” he said. “We’re trying to find the cause-effect relationships within the data.”

This ability to predict results is what sets GNS apart, said Dr. Atul Butte of Stanford University, one of the academic leaders of the Big Data movement. That’s the “nifty part of their technology,” Butte said.

Alexis Borisy, a partner at the Boston life sciences venture capital firm Third Rock Ventures, said GNS is in the vanguard of Big Data companies analyzing health care information.

“They’ve had a chance to learn, refine, and they’ve kept with it so they’ve had a lot of experience to build on,” Borisy said.

He and Hill have known each other since they were young business executives more than a decade ago, and he said he has tremendous respect for Hill’s intelligence, persistence, and communication skills.

“He is one of the visionaries in the space,” said Borisy, who also serves as chairman of Foundation Medicine, a molecular information company, and interim chief executive of Warp Drive Bio, both of Cambridge. “I think it’s fair to say he’s kept GNS growing and building by the force of his personality and the force of his efforts.”

Source: The Boston Globe

Head of Nation’s Leading Patient Advocacy Organization Addresses Personalized Medicine and E-Health at BIOVISION Global Conference

Nancy Davenport-Ennis, founder and CEO of the National Patient Advocate Foundation, recently addressed attendees at the BIOVISION conference in Lyon, France on personalized medicine and e-health technology and engaged healthcare stakeholders from across the globe on the future of e-health and the impact technology integration will have on the lives of patients.

“As we continue to make strides in technology and digitize healthcare, we are on the cusp of a digital revolution that will enhance patient access to treatment information, change the paradigm of the patient-provider relationship and create a social contract with those who serve our country,” stated Davenport-Ennis. “Health information technology also stands to significantly reduce costs and provide more coordinated care for patients.”

The Veterans Health Information Systems and Technology Architecture (VistA) program serves as a practical illustration of the social contract to service members. This 160 module program of financial and clinical support is used on the battlefield and for veterans nationally. VistA is one of the most widely used Electronic Health Records (EHR) programs in the United States. The e-health session also included a review of the role of telemedicine and Personal Health Records.

Davenport-Ennis addressed policy advances made in the U.S., including the passage of the Health Information Technology for Economic and Clinical Health (HITECH) Act of 2010. The HITECH Act dedicates $25.9 billion to health information technology in rural settings and community clinics. The Act also increases efforts in all 50 states to pass security legislation protecting consumers’ Personal Health Information from employers and insurers.

Her presentation also highlighted patient requirements to protect Personal Health Information in conformity with the Genetic Information Nondiscrimination Act (GINA) law passed in 2009, while also acknowledging some of the remaining challenges to infrastructure, processes and training within the e-health environment.

Additional presenters included Najeeb Al-Shorbaji of the World Health Organization, Roberto Santoro of Italy, President of the European Society of Concurrent Enterprising Network, Brigitte Trousse, President of France Living Lab , and Veronique Thouvenot , Head of Head of Millennia2015 “Women and eHealth” International Working Group.

Source: PR Newswire