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FDA Approves New Epilepsy Drug

Brain wiring illustration

Brain wiring illustration (Courtesy, Human Connectome Project and NIH)

19 February 2016. The U.S. Food and Drug Administration approved a molecular therapy for epilepsy designed to supplement treatments for partial-onset seizures. The drug is brivaracetam, marketed as Briviact by UCB, a pharmaceutical company headquartered in Brussels, Belgium.

Epilepsy is a neurological disorder where nerve cell activity in the brain is disturbed, causing seizures with symptoms ranging from blank stares to tingling sensations to loss of consciousness. Some 150,000 people develop epilepsy each year in the U.S., according to Epilepsy Foundation, with 1 in 26 people developing epilepsy in their lifetimes. Despite advances in medications to control seizures, says the foundation, some 500,000 Americans appear to be resistant to current medications and continue to experience seizures.

Briviact, says UCB, is designed for individuals whose seizures are not adequately controlled by current medications, in this case partial-onset seizures that affect part of the brain and usually last for less than a minute. The drug is a designed molecular compound that binds to a protein in the brain, known as synaptic vesicle protein 2A, associated with transmission activity across neurons. 

FDA’s approval was based in part on results from 3 clinical trials with a total of 1,550 participants, which show statistically reliable reductions over 28 days in the frequency of partial-onset seizures for Briviact taken with other drugs, compared to placebos. The trials also show the most common adverse reactions are drowsiness, dizziness, fatigue, nausea, and vomiting. UCB says Briviact was tested in clinical trials for 8 years with 2,400 participants.

Briviact will be available, says the company, as tablets, an oral solution, and injections in doses of 50 mg, 100 mg, and 200 mg per day. Before sales of the drug can begin, however, the U.S. Drug Enforcement Administration needs to classify Briviact for its abuse or dependency potential, which is expected in the next 90 days. The European Commission approved Briviact for marketing in Europe in January 2016.

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Multiple Myeloma Gene Therapy Trial Underway

Multiple myeloma cells

Multiple myeloma characterized by immature plasma cells (National Library of Medicine, NIH)

19 February 2016. The biotechnology company bluebird bio began testing its experimental gene therapy for multiple myeloma in an early-stage clinical trial. The Cambridge, Massachusetts company — which spells its name in all lower-case letters — is also licensing the technology tested in the trial to the pharmaceutical company Celgene.

Multiple myeloma is a cancer of plasma cells, white blood cells helping fight infections by making antibodies that recognize invading germs. The disorder causes cancerous cells to accumulate in the bone marrow, crowding out healthy plasma cells. Instead of antibodies, the malfunctioning cancer cells produce abnormal proteins that cause kidney problems and other disorders. American Cancer Society expects more than 30,000 new cases of multiple myeloma to occur in the U.S. this year, causing almost 12,700 deaths.

bluebird bio develops treatments for severe genetic and rare diseases with a technology based in part on the work of co-founder Philippe Leboulch, a researcher and lecturer at Paris University School of Medicine, Harvard Medical School, MIT, and Brigham and Women’s Hospital in Boston. Leboulch serves as a scientific advisor to bluebird bio.

The company’s cancer technology takes a patient’s own hematopoietic (bone marrow) stem cells and cultures them outside the body using healthy genes delivered with benign viruses called lentiviruses. The culturing process creates replacement genes for the mutated stem cells causing the disease.

The replacement genes modify the chimeric antigen receptors or CARs on the individual’s T-cells, key white blood cells in the immune system. These CAR T-cells then bind to targeted proteins on the surface of cancer cells and destroy them. In this case, the CAR T-cells aim for B cell maturation antigens, considered a promising target for multiple myeloma.

The clinical trial, conducted at National Cancer Institute, part of National Institutes of Health in Bethesda, Maryland, tests bluebird bio’s immuno-gene therapy candidate code-named bb2121, its first cancer treatment to reach clinical trials. The study is recruiting 50 individuals with multiple myeloma that either relapsed or does not respond to conventional treatments. The trial will first assess the maximum tolerated dose of bb2121, then evaluate the safety, tolerability, and clinical activity of the therapy.

The pharmaceutical company Celgene is partnering with bluebird bio and Baylor College of Medicine on developing CAR T-cell therapies, a collaboration that began in March 2013. Celgene decided to exercise an option on licensing bb2121 that brings bluebird an immediate option fee of $10 million. Under the deal, Celgene receives an exclusive license to develop and commercialize bb2121 following the early stage clinical trials. bluebird will be eligible for further development, regulatory, and commercial milestone payments, as well as royalties on product sales.

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Bayer Funding Studies of Honey Bee Health, Management

Bee on flowers

(Jack Dykinga, Agricultural Research Service, USDA)

18 February 2016. Bayer Crop Science is seeking research ideas for improving the health of honey bee colonies in the U.S. Proposals for studies in the $1 million program addressing urgent needs highlighted by Bayer’s Healthy Hives 2020 initiative are due by 1 March 2016.

Bees, which play a key role in agriculture, are facing increasing stresses, most notably colony collapse disorder, but other pathogens as well affecting their health and the economic stability of U.S. commercial bee keeping and pollination operations. According to the Agricultural Research Service of USDA, American bee keepers reported losses in managed honey bee colonies of 42 percent in 2014-15, although earlier declines in winter months apparently leveled off in recent years.

Bayer Crop Science, in Research Triangle Park, North Carolina, created its Healthy Hives 2020 program in April 2015 to find solutions to health problems facing honey bee colonies in the U.S. In a two-day workshop in June 2015, the company, with experts from academia, government, agriculture, business, and the bee keeping community, identified the most urgent needs for ideas and solutions, reflected in the new call for research proposals.

Among the top bee health research priorities are:

  • Honey bee genetics, to identify traits important for disease resistance of colonies to pests and disease, as well as improving pollination efficiency and honey production
  • Evaluating smart-hive technologies for monitoring bee colony health during commercial migrations; data from sensors in participating colonies are updated to a database in the cloud for viewing and analysis
  • Assessing the economics of commercial bee keeping to better account for production costs and improve the efficiency of their operations
  • Using performance data of colony health to create a set of best management practices for commercial bee keeping.

Proposals are expected to address one or more of these priorities, describe qualifications of researchers, outline timelines and deliverables, and propose a budget. The deadline for proposals is 1 March.

Bayer is collaborating with the not-for-profit organization Project Apis m in Paso Robles, California, which will oversee administration of the research grants. Project Apis m — from Apis mellifera, the scientific name for the European honey bee — funds research studies, purchases equipment for bee labs at universities, supports graduate students, and provides scholarships to new bee scientists.

The following video tells more about the Healthy Hives 2020 program.

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Antibody Treatment Designed for MERS Virus

Row of cows

(Challenge.gov)

18 February 2016. The Middle East respiratory syndrome coronavirus, or MERS virus, is spreading throughout the Middle East and Asia, largely through person-to-person contacts, and with a fatality rate of 36 percent. A research team at University of Maryland, with colleagues from industry and government labs, developed antibodies from genetically-engineered cattle that protect lab mice from the MERS virus, with their results appearing in yesterday’s (17 February) issue of Science Translational Medicine; paid subscription required.

The MERS virus was first spotted in 2012 in Saudi Arabia, and is believed to originally spread from camels. Symptoms often include shortness of breath, cough, and fever, but cases of pneumonia, organ failure, and gastrointestinal symptoms also developed. World Health Organization reports 1,638 cases of MERS in 26 countries in the Middle East and Asia, including Korea and Thailand, leading to 587 deaths. So far no treatments or preventive vaccines are available.

A team from University of Maryland in Baltimore, led by immunologist Matthew Frieman, with associates from the companies SAB Biotherapeutics and Novavax, and Navy Medical Research Center in Silver Spring, Maryland reported on development of new antibodies which can be the basis for treatments or vaccines against the MERS virus. The group aimed to generate the antibodies from immunoglobulin G, found in blood and other bodily fluids, but faced a problem with natural sources of immunoglobulin G that can produce only limited quantities.

To produce these antibodies in the desired quantities, the researchers turned to SAB Biotherapeutics in Sioux Falls, South Dakota. The company produces human antibodies from genetically engineered cattle, with a technology that prevents harm to the animals, which are plentiful and well-studied in agriculture. And because of their large size, cattle can produce large quantities of the desired antibodies.

The SAB cattle in this case were genetically modified to carry an artificial human chromosome containing immunoglobulin genes. The cattle produced human polyclonal antibodies, those addressing multiple targets, that generated a strong immune response. Initial lab tests showed the antibodies destroying various strains of the MERS viruses in cell cultures.

The team then injected the antibodies into lab mice 12 hours before, or 24 hours and 48 hours after infection with the MERS virus. The results show the antibodies lowered MERS virus concentrations in the mice near or below levels of detection.

“This is important,” says Frieman in a university statement, “not only because it gives us a potential way to attack MERS, but also because it provides evidence that using these transgenic cows can rapidly produce therapeutics.” The next step, say the researchers, is development of treatments or vaccines, beginning with safety trials in the next 3 to 6 months.

The MERS virus is a coronavirus, similar to severe acute respiratory syndrome or SARS, which had an outbreak in Asia in 2003 and spread to North America, South America, and Europe. The researchers believe the technology for quickly generating MERS antibodies could also be applied to SARS and other coronaviruses.

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Patch Finds Heart Problems After Holter Monitor Period

EKG graphic

(PublicDomainPictures, Pixabay)

17 February 2016. A review of records of people wearing a single-use heart monitor patch found serious heart rhythm problems occurring well after the 48-hour period recommended for Holter monitors, the device used most often for ambulatory heart monitoring. Results of the study, conducted by researchers at Kaiser Permanente of Northern California, but sponsored by iRhythm Technologies of San Francisco, appear in today’s (17 February) issue of the journal BioMed Central Cardiovascular Disorders.

The study team led by Matthew Solomon, a cardiologist at Kaiser Permanente, reviewed data collected from nearly 123,000 iRhythm Zio heart monitors worn by individuals from 2011 to 2013. The Zio system has a monitor chip, secured with water-resistant adhesive to the chest of the patient, which is worn for up to 14 days. The patch collects heart rhythm data and detects irregular rhythms, such as rapid heart beats known as ventricular tachycardia and abnormally slow heart rhythms called bradyarrhythmias, as well as atrial fibrillation pauses longer than 5 seconds  and blockages of the cardiac conduction system.

After being worn by an individual, the Zio patch is sent back to iRhythm, where technicians analyze the data and highlight potential problems for the person’s doctor to review. Both the patch and the analytical system received FDA clearance in 2009. A prescription is required for an individual to use the system. The company says the Zio system was used so far by more than 400,000 people.

The ambulatory heart monitoring technology used most often today is the Holter monitor. A Holter heart monitor collects heart rhythm data through several electrodes attached to the chest and wired to a battery-powered recording device about the size of a smartphone. The Holter monitor continuously records heart beats for 24 to 48 hours, and is then returned to a technician for data download and analysis.

Solomon and colleagues reviewed 122,815 patch records worn by 122,454 individuals who wore Zio systems for an average 9.6 days, with a quarter of the monitors worn for nearly 14 days. The results show nearly 1 in 5 records (18%) indicated nonsustained ventricular tachycardia, rapid heart rates of less than 30 seconds, considered an indicator of potential underlying structural heart problems.

The findings also show nearly about one-third (34%) of all ventricular tachycardia incidents recorded by Zio devices occurred later than the 48 hour maximum time that the traditional Holter monitor is worn, with nearly a half (47%) of the incidents occurring after the usual 24-hour period for most Holter monitor wearers.

For bradyarrhythmia incidents, about a third (32%) were detected by Zio devices in the first 24 hours of wear, while nearly half (47%) of the total were found in the first 48 hours. It took 3 days of wear for the Zio to detect more than 8 in 10 (83%) of the bradyarrhythmia incidents. In addition, say the researchers, records after 7 days yielded substantial numbers of heart rhythm problems, some considered of high risk to the individuals wearing the device.

iRhythm now offers desktop and iPhone MyZio apps for people using the service to log symptoms they encounter while wearing the Zio patch. The patch does not communicate with the app, but it enables wearers to keep track of symptoms in an automated format rather than keeping a separate logbook.

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Vaccine Developed to Stop Synthetic Opioids

Fentanyl patch products

Fentanyl patch products (Alcibiades, Wikimedia Commons)

17 February 2016. Fentanyl is a synthetic opioid drug for treating severe pain after surgery, and in some cases chronic pain, but is also highly addictive and increasingly abused, with growing numbers of overdose deaths. Researchers from Scripps Research Institute in La Jolla, California developed a vaccine that in lab mice prevents ingredients in fentanyl from reaching the brain, as reported in yesterday’s (16 February) issue of the journal Angewandte Chemie (paid subscription required).

Like other opioids, fentanyl binds to receptors in the brain that control pain, but also emotions, and drives up dopamine levels in these brain regions. Fentanyl alone given as an injection or patch is considered a powerful opioid pain killer — up to 500 times more powerful than morphine — but can become addictive. When mixed with street drugs, like heroin, the drug’s effects are amplified leading to sedation, unconsciousness, and coma, and sometimes death.

In some cases, street versions of fentanyl are so potent, even casual exposure is considered dangerous. In March 2015, the U.S. Drug Enforcement Agency issued an alert for law enforcement on inhaling or making physical contact with some fentanyl derivatives during drug arrests.

The team from the lab of Scripps biochemist Kim Janda devised a vaccine that generates antibodies to block fentanyl’s effects. Janda’s lab investigates immunotherapy approaches to addiction, including synthesis of small hapten molecules that generate an immune response when combined with larger proteins to attack the target.

The authors say their vaccine creates high antibody levels that address a range of different fentanyl compounds. In lab tests, the team gave mice three injections of the vaccine every two weeks, then tested various levels of fentanyl in the mice. Results of blood tests, with an optical analysis technique measuring protein binding, show the vaccine created antibodies that neutralized fentanyl in the mice.

Only at levels 30 times the normal dose of fentanyl did the researchers find neural circuits in the brains of mice activated by the drug. Antibodies produced by the vaccine say the authors, also stopped overdoses from lethal levels of fentanyl.

While the vaccine protects against against a wide range of fentanyl derivatives, it does not inhibit other types opioids, such as oxycodone. As a result, say the researchers, individuals needing opioids as legitimate pain killers could continue taking those drugs.

The team next plans to design a vaccine that addresses combinations of fentanyl and heroin. “We want to stay one step ahead of these clandestine laboratories making illegal opioids for black market demand,” says Janda in a Scripps statement. “The importance of this new vaccine is that it can block the toxic effects of this drug, a first in the field.”

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Biotech Reviewing Stanford Immuno-Stem Cell Technology

Mark Davis

Mark Davis (Stanford University)

16 February 2016. A biotechnology company in Los Angeles is evaluating a technology developed at Stanford University for transferring DNA of immune system cells to a patient’s own stem cells to produce immunotherapies for treating cancer. The agreement with Stanford gives ImmunoCellular Therapeutics Ltd. an option to license the technology from the lab of immunologist Mark Davis, but financial aspects of the deal were not disclosed.

Davis and colleagues at Stanford University’s medical school study structural and biochemical factors that enable T-cell receptors — molecules found on the surface of T-cells, white blood cells in the immune system — to recognize antigens, proteins that generate an immune response by T-cells. The particular technology of interest to ImmunoCellular isolates T-cell receptors, which are then genetically sequenced to produce DNA that can be introduced into hematopoietic or blood-forming stem cells for transformation into healthy immune-system cells.

ImmunoCellular produces therapeutic vaccines that harness the immune system to treat cancer. Its main technology platform engineers dendritic or antigen-presenting cells that induce an immune response from T-cells. The company’s pipeline has treatments for newly diagnosed and recurrent glioblastoma, an aggressive form of brain cancer, now in clinical trials, and a dendritic cell treatment for ovarian cancer ready for clinical trials.

A new ImmunoCellular program aims to use hematopoietic stem cells to create antigen-specific T-cell therapies, which the Davis lab technology would support. If the evaluation leads to licensing the technology from Stanford, the company envisions harvesting a cancer patient’s hematopoietic stem cells, and engineering the cells to include DNA from T-cell receptors, then transforming into T-cells in sufficient quantities for transplant back to the patient. The transformed T-cells would be pre-programed to target, bind to, and destroy specific cancer cells.

Steven Swanson, ImmunoCellular’s vice president for research, calls the option deal with Stanford “a major milestone” for advancing the company’s pipeline of immunotherapies. Swanson says in a company statement, “Our strategy is to integrate complementary breakthrough technologies by using modified stem cells from the patient to develop antigen-specific killer T-cells that can directly attack and potentially eradicate tumors and prevent their recurrence.”

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Company Hosts Cancer Genome Cloud, Raises $45 Million

DNA illustration

(National Heart, Lung, and Blood Institute, NIH)

16 February 2016. Seven Bridges Genomics, a computational biology company, unveiled its cloud-based cancer genome data sets, in one of three pilot tests for National Cancer Institute. The Cambridge, Massachusetts enterprise also raised $45 million in its first venture funding round.

National Cancer Institute, part of National Institutes of Health, aims to make the Cancer Genome Atlas more readily available for clinicians and researchers to better understand the molecular basis of cancer through genomic analytical techniques. Since 2006, the Cancer Genome Atlas collected tissue samples and analyzed 33 different types of cancers, including 10 cancers considered rare. Some 2.5 petabytes of data are expected to reside in the data sets; 1 petabyte equals 1,000 terabytes, and 1 terabyte equals 1,000 gigabytes.

For precision medicine to succeed — where genomic variations are matched to treatments — data in the Cancer Genome Atlas need to be readily available along with the computational resources to be useful. Downloading and local storage of these large data sets, however, would be too impractical, thus the Cancer Genome Atlas resides and will be made available in the cloud. National Cancer Institute is evaluating this approach, with pilot tests at the Broad Institute of Harvard and MIT, Institute of Systems Biology, and Seven Bridges Genomics.

Seven Bridges will host 1 petabyte of data, representing samples from 11,000 individuals in the Cancer Genome Atlas. The company will also make it possible for researchers approved by NIH to add their own data for analysis and comparison to the Cancer Genome Atlas. Seven Bridges is partnering with Google Cloud and Amazon Web Services to provide private virtual cloud capabilities to subscribers, which can be supplemented with local deployments if subscribers have the capacity. In addition, the company says it can provide collaboration environments for distributed research groups, while ensuring security for the data.

Seven Bridges Genomics, founded in 2011, announced it raised $45 million in its first venture financing round. The round is led by Kryssen Capital that funds data-intensive start-up enterprises. The company announced as well the addition of two new members to its board, including Tom Daschle, former U.S. senator from South Dakota and majority leader. Also joining the board is Kai-Fu Lee, founding president of Google China.

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Virtual Reality Seen Helping People with Depression

Scene from virtual reality exercise

Scene from virtual reality scenario. Inset: participant in virtual reality exercise. (University College London)

15 February 2016. Individuals suffering from depression often express a high degree of self-criticism to the point it interferes with recovery from their disorder. Researchers from University College London showed in a pilot study that a virtual reality exercise could increase feelings of self-compassion and reduce the severity of depression, in some cases with enough improvement to be clinically significant.

The team from University College London or UCL, led by clinical psychologist Chris Brewin and computer scientist Mel Slater of UCL and University of Barcelona, reported their findings in the February 2016 issue of British Journal of Psychiatry Open. The study recruited 15 individuals, age 23 to 61, with previous episodes of depression, including 10 taking medication.

Depression is a widespread condition, which when it becomes persistent or severe, is called major depression, and can interfere with normal family and work life, and lead to disability. National Institute of Mental Health estimates in 2014, 15.7 million adults in the U.S., or 6.7 percent of the adult population, suffered a major depressive episode in the previous 12 months. World Health Organization says major depression carries the heaviest burden of disability among mental or behavioral disorders.

The researchers point out severe self-criticism is one of the key indicators of depression, which creates vulnerability and often interferes with recovery among people with the condition. Tools are needed, say the authors, to reduce these high levels of self-criticism in people with depression, and those tools need to be easy to deploy. Brewin, Slater, and colleagues — funded by a grant from the Medical Research Council in the U.K. — are evaluating virtual reality as a way of generating visually powerful exercises that engage people with depression and help develop more self-compassion to support their recovery.

Virtual reality creates computer-generated but life-like environments seen through special headsets, where individuals can navigate in multiple directions and interact with other characters through avatars representing themselves and others. People in virtual reality see themselves expressed in the scenes, moving in the same way as themselves, which makes it possible for participants to identify with their avatars and experience emotional reactions as those individuals.

The team prepared a scenario lasting about eight minutes, where as adult avatars they were trained to express compassion to a child in distress. By talking to and expressing compassion in the exercise, they were able to help the child respond positively and stop crying. The exercise then switched roles, where the individuals became the child avatars, receiving compassion and comfort from the virtual adults. The researchers first tested the approach and scenario for safety among healthy volunteers, which the team reported in November 2014.

In the new study, participants engaged in the exercise once a week for 3 weeks, with a follow-up 1 month later, where they completed self-reported standard scales of depression severity — the main outcome measure — as well as  self-compassion and fear of compassion. The authors report 9 of the 15 participants expressed fewer depressive symptoms after the 1-month follow-up period.

In addition, 4 of the participants showed enough change to be considered clinically significant, with consistent improvement across multiple symptoms. “A month after the study,” says Brewin in a university statement, “several patients described how their experience had changed their response to real-life situations in which they would previously have been self-critical.”

The authors caution that the study is only a pilot test, with a small number of participants and no control group to test for placebo effects. “We now hope to develop the technique further to conduct a larger controlled trial” adds Slater, “so that we can confidently determine any clinical benefit. If a substantial benefit is seen, then this therapy could have huge potential.”

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Harnessing Big Data for Precision Medicine

Big data graphic

(DARPA, Wikimedia Commons)

13 February 2016. Precision medicine aims to match individualized genomic data with therapies to provide personalized treatments for people with disease. A panel today (13 February) at the American Association for Advancement of Science or AAAS 2016 annual meeting, described how big data — finding insights in large data sets — help make precision medicine possible, with Lyme disease as a case study.

Lyme disease is transmitted to humans by bites from the black-legged or deer tick that carries Borrelia burgdorferi bacteria, with symptoms including fever, fatigue, headache, and rash. The disease can be treated with antibiotics, but if left untreated, infections can spread to the joints, heart, and nervous system, and become chronic and debilitating. Centers for Disease Control and Prevention says between 19,000 and 30,000 cases of Lyme disease are reported in the U.S. each year, mainly in northeastern states and the upper Midwest, although new data reported at the AAAS meeting suggest that number could be as high as 300,000 per year.

Because Lyme disease is a complex disorder, often difficult to treat and diagnose in its chronic state, said the panel, it is a good candidate for precision medicine. Lorraine Johnson, a Lyme disease survivor and CEO of LymeDisease.org in Los Angeles, pointed out that traditional research models are not working for Lyme disease, and registries of data from patients can help make the disorder a more visible target for academic and industry scientists.

Johnson called Lyme disease, a “research disadvantaged disease,” meaning it’s generally ignored by pharmaceutical companies, and it is too prevalent a disorder to be classified a rare or orphan disease. While there may be more people with Lyme disease than HIV/AIDS, said Johnson, only three clinical trials of new treatments were undertaken so far, none of which were funded by industry. Conventional clinical trials have strict screening requirements, which limits participation to a relatively few patients, suggesting that those taking part in the trials may not represent the general patient population.

In addition, Johnson noted that conventional trials are “not messy enough” to address the complexities of Lyme disease. Clinical trials generally test one intervention for relatively short periods of time. Lyme disease populations are highly diverse, with those diagnosed early often much different from those whose disease is diagnosed late, and treatment effects often varying widely.

Instead of a few clinical studies with a few participants, Johnson called for large numbers people with Lyme disease to band together and offer their data in a way that gets the attention of the research community. Her organization started MyLymeData, surveys of people with Lyme disease to pool their diagnosis and treatment experiences. MyLymeData, said Johnson, is “patient-powered research” that can reveal disease patterns, identify subgroups, explain differences resulting in slow and non-responders to treatments. She said MyLymeData now has 3,000 participants, and her group is aiming to sign up a total of 10,000.

A SLICE of big data

John Aucott, Director of of the Lyme Disease Clinical Research Center at Johns Hopkins University School of Medicine in Baltimore, showed how big data can enable precision medicine for treating Lyme disease. Aucott gave results from the Study of Lyme Disease Immunology and Clinical Events or SLICE to understand why some people with Lyme disease develop a post-treatment syndrome that can last years, while others respond quickly to treatment and avoid the long-term condition.

The study followed 29 individuals with the disorder for 2 years, amassing large sets of clinical and biological data. To this collection, Aucott and colleagues added DNA sequencing, gene expression, blood protein, and cell analysis from patient blood samples. The results enabled the researchers to identify differences in immune  responses of participants, which suggested different types of treatment strategies.

Beyond the immediate results of the study, Aucott pointed out that big data approaches to understanding Lyme disease and other disorders are readily available, in some cases to anyone with a Web browser. For example, said Aucott, Google Trends reports of Web searches for Lyme disease and tick bites show seasonal patterns similar to epidemiology data. In addition, databases of insurance claims reveal one-third of patients with Lyme disease develop post-treatment symptoms, such as fatigue.

Aucott added, however, that a key requirement for big data investigations is interoperability of data. He plans to extend his analysis to other hospitals in the Johns Hopkins University network, but to really understand Lyme disease, the investigation has to be nationwide. Aucott would also like to extend the research model to other complex diseases, such as chronic fatigue and fibromyalgia, but interoperable data will be required.

D.J. Patil, the U.S. government’s chief data scientist, described the role played by big data in the government’s precision medicine initiative, announced a year ago by President Obama. Big data, Patil noted, enables individuals to contribute their genomic data and electronic health records, thus taking part more actively in their own treatments.

The government’s initiative aims to collect data from the analysis of 1 million individual human genomes from sources such as the Veterans Administration, as well as private sources like Ancestry.com. Having these data encourages explorations that reveal correlations and insights not previously evident. Patil underscored the importance of data ethics from the start, to make the data open and available for research, while at the same time protecting the privacy of individuals.

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