Meetings, Webinars and Conferences
Target Health continues to be recognized in the public eye as we are committed to being excellent in all that we do. The following are the Meetings, Webinars and Conferences we will be actively participating in during September and October.
Society for Clinical Research Sites – September 8, 2015 – Webinar
Please join the Webinar on September 8, 2015 addressing The Monitoring Dynamic: An Evolving Process and Relationship with the Site. Craig Wozniak, Vice President, Head Trial Coordination & Site Management – Americas, Janssen Pharmaceuticals and Mitchel Efros of Accumed Research Associates will join Jules Mitchel, President of Target Health for the Webinar. Our goal is to present risk-based monitoring (RBM) from the perspectives of a pharmaceutical company, CRO and clinical site, and to dispel the myths that are currently floating around regarding the burdensome nature of RBM.
Disruptive Innovations – September 10-11, 2015 – Boston Park Plaza Hotel, Boston
Please join us in Boston this week for a very exciting meeting on the future of clinical research at the 5th Annual DPharm: Disruptive Innovations to Advance Clinical Trials Conference. Not only is Target Health a sponsor, but Dr. Mitchel, President of Target Health is on the Advisory Board of the conference and will be interviewed by our friend and colleague, Craig Lipset of Pfizer as part of An Interview Series on Challenging Obsolescence with Disruptive Thinkers. The topics will be Will the Clinical Trial (Operations) be Obsolete? What is the new vision of the clinical trial process? With personalized medicine and adaptive licensing, will we only run small trials in a very narrow patient population, get an early approval then start to expand to other populations with great data on the market?
Inaugural PharmaVOICE 100 Celebration, September 17, 2015 – Alexandria Center for Life Science, NYC
Dr. Mitchel was again identified as a PharmaVOICE 100, this year as a Commander & Chief. The Inaugural PharmaVOICE 100 Celebration, will be held on September 17, 2015 at the Alexandria Center for Life Science in NYC. The PharmaVOICE 100 debuted in 2005 to recognize outstanding leaders across all sectors of healthcare who provide the guiding light of inspiration, motivation, and innovation to their teams, organizations, and communities. Over the past 10 years, the PharmaVOICE 100 has honored more than 1,000 of the industry’s most inspirational and innovative leaders, and this year. The event is open to everyone in the industry and there is limited capacity. In keeping with the philanthropic spirit of the PharmaVOICE 100, please note that a portion of proceeds will be donated to charity.
Site Solutions Summit – October 8-11, 2015, Amelia Island, FL
We will be attending the Global Site Solutions Summit, October 8-11, 2015 at Omni Amelia Island Plantation Resort, Amelia Island, FL. Now in its 10th year is dedicated exclusively to helping clinical research sites reach optimal performance. With a foundation built on strengthening the site – industry partnership, the Summit has grown to be a community dedicated to driving clinical research success. As a participant, you will experience a one-of-a-kind meeting where site executives can collaborate with trusted peers to address their business challenges and gain innovative solutions for their business.
NORD Rare Diseases and Orphan Drug Products Meeting – October 21-22, 2015 – Arlington, VA
Target Health has extensive experience with Orphan Drug Products and will share our experiences on October 21-22 at the NORD Rare Diseases and Orphan Drug Products Breakthrough Summit, being held in Arlington, VA. The 2015 Breakthrough Summit is concentrated with innovative content and convenes the top leaders from the FDA, NIH, Industry, Patient Groups, Payers and Research Institutions to address the progress of rare disease diagnosis, genomics, drug development, patient engagement, patient-centered research models, product approvals, FDA oversight and market access to orphan products.
Risk-Based Trial Management Meeting – November 5-6, 2015 – Philadelphia
Target Health will be presenting a Case Study of Risk-based Monitoring at the Risk-Based Trial Management Meeting at the Hilton Philadelphia City Avenue, November 5-6 2015. We will walk you through a clinical trial and demonstrate real world results from ongoing and completed clinical trials
ON TARGET is the newsletter of Target Health Inc., a NYC-based, full-service, contract research organization (eCRO), providing strategic planning, regulatory affairs, clinical research, data management, biostatistics, medical writing and software services to the pharmaceutical and device industries, including the paperless clinical trial.
For more information about Target Health contact Warren Pearlson (212-681-2100 ext. 104). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel or Ms. Joyce Hays. The Target Health software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website, and if you like the weekly newsletter, ON TARGET, you’ll love the Blog.
Joyce Hays, Founder and Editor in Chief of On Target
Jules Mitchel, Editor
Diagram of a typical myelinated vertebrate motor neuron
Current Target Health Neurology programs include: Autism, ADHD, Epilepsy, Traumatic Brain Injury and Alzheimer’s disease
Neuroscience is the scientific study of the nervous system. Traditionally, neuroscience has been seen as a branch of 1) ___. However, it is currently an interdisciplinary science that collaborates with other fields such as chemistry, cognitive science, computer science, engineering, linguistics, mathematics, medicine (including neurology), genetics, and allied disciplines including philosophy, physics, and psychology. It also exerts influence on other fields, such as neuro-education, neuroethics, and neurolaw. The term neurobiology is usually used interchangeably with the term neuroscience, although the former refers specifically to the biology of the nervous system, whereas the latter refers to the entire science of the 2) ___ system.
The scope of neuroscience has broadened to include different approaches used to study the molecular, cellular, developmental, structural, functional, evolutionary, computational, and medical aspects of the nervous system. The techniques used by neuroscientists have also expanded enormously, from molecular and cellular studies of individual nerve cells to imaging of sensory and motor tasks in the 3) ___. Recent theoretical advances in neuroscience have also been aided by the study of neural networks. During the 20th century, neuroscience began to be recognized as a distinct academic discipline in its own right, rather than as studies of the nervous 4) ___ within other disciplines.
In the 1950s, Francis O. Schmitt established a neuroscience research program within the Biology Department at the Massachusetts Institute of Technology, bringing together biology, chemistry, physics, and mathematics. Stephen W. Kuffler started the Department of Neuroscience at Harvard Medical School in 1966, the first such freestanding department. Beginning in 1966, Eric Kandel MD, PhD, Nobel Prize laureate and Columbia University professor, examined biochemical changes in neurons associated with learning and memory storage in Aplysia. In 1981 Catherine Morris and Harold Lecar combined these models in the Morris-Lecar model. Beginning in 1970, Oliver Sacks MD, wrote of his experience with neurological patients. He was awarded the Lewis Thomas Prize for Writing about Science in 2001. The New York Times said he has become a poet laureate of contemporary (neuroscience) medicine. His descriptions of people coping with and adapting to neurological conditions or injuries often illuminate the ways in which the normal brain deals with perception, memory and individuality.
The scientific study of the nervous system has increased significantly during the second half of the twentieth century, principally due to advances in molecular biology, electrophysiology, and computational neuroscience. This has allowed neuroscientists to study the nervous system in all its aspects: how it is structured, how it works, how it develops, how it malfunctions, and how it can be changed. For example, it has become possible to understand, in much detail, the complex processes occurring within a single 5) ___. Neurons are cells specialized for communication. They are able to communicate with neurons and other cell types through specialized junctions called synapses, at which electrical or electrochemical signals can be transmitted from one cell to another. A nervous system emerges from the assemblage of neurons that are connected to each other. In vertebrates, the nervous system can be split into two parts, the central nervous system (brain and 6) ___ cord), and the peripheral nervous system. In many species – including all vertebrates – the nervous system is the most complex organ system in the body, with most of the complexity residing in the brain. The human brain alone contains around one hundred billion neurons and one hundred trillion 7) ___; it consists of thousands of distinguishable substructures, connected to each other in synaptic networks whose intricacies have only begun to be unraveled. The majority of the approximately 20-25,000 genes belonging to the human genome are expressed specifically in the brain. Due to the plasticity of the human brain, the structure of its synapses and their resulting functions change throughout 8) ___. Thus the challenge of making sense of all this complexity is formidable.
The study of the nervous system can be done at multiple levels, ranging from the molecular and cellular levels to the systems and cognitive levels. At the molecular level, the basic questions addressed in molecular neuroscience include the mechanisms by which neurons express and respond to molecular signals and how axons form complex connectivity patterns. The fundamental questions addressed in cellular neuroscience include the mechanisms of how neurons process signals physiologically and electrochemically. At the 9) ___ level, cognitive neuroscience addresses the questions of how psychological functions are produced by neural circuitry. The emergence of powerful new measurement techniques such as neuroimaging (e.g., fMRI, PET, SPECT), electrophysiology, and human genetic analysis combined with sophisticated experimental techniques from cognitive psychology allows neuroscientists and psychologists to address abstract questions such as how human cognition and emotion are mapped to specific neural substrates.
Ultimately neuroscientists would like to understand every aspect of the nervous system, including how it works, how it develops, how it malfunctions, and how it can be altered or repaired. The specific topics that form the main foci of research change over time, driven by an ever-expanding base of knowledge and the availability of increasingly sophisticated technical methods. Over the long term, improvements in technology have been the primary drivers of progress. Developments in electron microscopy, computers, electronics, functional brain imaging, and most recently genetics and genomics, have all been major drivers of progress. Many believe that in this 21st Century, 10) ___ research discoveries, will be a main driver of advancement.
ANSWERS: biology; 2) nervous; 3) brain; 4) system; 5) neuron; 6) spinal; 7) synapses; 8) life; 9) cognitive; 10) neuroscience
(The Great) Oliver Sacks MD (1933-2015) Dies at 82
Oliver Wolf Sacks MD
Oliver Sacks, the neurologist and acclaimed author who explored some of the brain’s strangest pathways in best-selling case histories like The Man Who Mistook His Wife for a Hat, using his patients’ disorders as starting points for eloquent meditations on consciousness and the human condition, died on Sunday, August 30th 2015, at his home in Manhattan. He was 82. The cause was cancer, said Kate Edgar, his longtime personal assistant. Dr. Sacks announced in February, in an Op-Ed essay in The New York Times, that an earlier melanoma in his eye had spread to his liver and that he was in the late stages of terminal cancer.
As a medical doctor and a writer, Dr. Sacks achieved a level of popular renown rare among scientists. More than a million copies of his books are in print in the United States, his work was adapted for film and stage, and he received about 10,000 letters a year. (I invariably reply to people under 10, over 90 or in prison, he once said.) Dr. Sacks variously described his books and essays as case histories, pathographies, clinical tales or neurological novels. His subjects included Madeleine J., a blind woman who perceived her hands only as useless lumps of dough; Jimmie G., a submarine radio operator whose amnesia stranded him for more than three decades in 1945; and Dr. P. – the man who mistook his wife for a hat – whose brain lost the ability to decipher what his eyes were seeing.
Describing his patients’ struggles and sometimes uncanny gifts, Dr. Sacks helped introduce syndromes like Tourette’s or Asperger’s to a general audience. But he illuminated their characters as much as their conditions; he humanized and demystified them. In his emphasis on case histories, Dr. Sacks modeled himself after a questing breed of 19th-century physicians, who well understood how little they and their peers knew about the workings of the human animal and who saw medical science as a vast, largely uncharted wilderness to be tamed. I had always liked to see myself as a naturalist or explorer, Dr. Sacks wrote in A Leg to Stand On (1984), about his own experiences recovering from muscle surgery. I had explored many strange, neuropsychological lands – the furthest Arctics and Tropics of neurological disorder.
His intellectual curiosity took him even further. On his website, Dr. Sacks maintained a partial list of topics he had written about. It included aging, amnesia, color, deafness, dreams, ferns, Freud, hallucinations, neural Darwinism, phantom limbs, photography, pre-Columbian history, swimming and twins. I am very tenacious, for better or worse, he wrote in A Leg to Stand On. If my attention is engaged, I cannot disengage it. This may be a great strength, or weakness. It makes me an investigator. It makes me an obsessional. He was also a man of contradictions: candid and guarded, gregarious and solitary, clinical and compassionate, scientific and poetic, British and almost American. In 1961, I declared my intention to become a United States citizen, which may have been a genuine intention, but I never got round to it, he told The Guardian in 2005.
Dr. Sacks first won widespread attention in 1973 for his book Awakenings, about a group of patients with an atypical form of encephalitis at Beth Abraham Hospital in the Bronx. When Dr. Sacks started his clinical career there, in 1966, many of the patients had been catatonic, locked inside themselves for decades as a result of their sleeping sickness. Dr. Sacks gave them the drug L-dopa, which was just beginning to be recognized as a treatment for similar symptoms in patients with Parkinson’s, then watched as they emerged into a world they did not recognize. Some responded better than others – both to the drug and to their changed circumstances – and Dr. Sacks used his book to explore the differences and celebrate his patients’ limited rebirth. I love to discover potential in people who aren’t thought to have any, he told People magazine in 1986.
His other books included the best-selling An Anthropologist on Mars (1995), about autistic savants and other patients who managed to thrive with their disorders; The Mind’s Eye (2010), about the ways people compensate for brain injuries; and three books about specific neurological conditions: Migraine (1970), The Island of the Colorblind (1997) and Seeing Voices (1989), a look at language perception among the deaf. He also wrote Oaxaca Journal, a 2002 travelogue about a trip to Mexico with the American Fern Society.
Dr. Sacks began his medical career as a researcher but gave up early, conceding that he had neither the temperament nor the eye-hand coordination for it. I lost samples, he told an interviewer in 2005. I broke machines. Finally they said to me: ?Sacks, you’re a menace. Get out. Go see patients. They matter less. Yet even after he left research for clinical practice, he retained his scientific curiosity and his intuition for asking big questions. Years before it became fashionable to study the chemical and neurological foundations of the mind, for example, Dr. Sacks identified the need for such a field in A Leg to Stand On, where he termed it clinical ontology or existential neurology. Dr. Sacks linked himself to the Soviet founder of neuropsychology, A. R. Luria, whom he considered a mentor. The two never met, but they maintained a long correspondence, and in 1977, Dr. Sacks wrote Dr. Luria’s obituary for The Times of London.
Dr. Sacks’ accounts of neurological oddities found a wide popular audience and were adapted for Hollywood, the theater, even opera. Robin Williams portrayed a Sacks-like doctor in the 1990 film version of Awakenings, and the novelist Richard Powers based a central character on him in his 2006 book, The Echo Maker. The 2011 movie The Music Never Stopped was adapted from The Last Hippie, one of the case studies collected in An Anthropologist on Mars. An opera based on The Man Who Mistook His Wife for a Hat, with music by Michael Nyman and a libretto by Christopher Rawlence, had its premiere in London in 1986 and was staged at Lincoln Center in New York in 1988. The Independent of London called Dr. Sacks the presiding genius of neurological drama. Reviewers praised his empathy and his graceful prose. Scientists could be dismissive, however, complaining that his clinical tales put too much emphasis on the tales and not enough on the clinical. A London neuroscientist, Ray Dolan, told The Guardian in 2005: Whether Dr. Sacks has provided any scientific insights into the neurological conditions he has written about in his numerous books is open to question. I have always felt uncomfortable about this side of this work, and especially the tendency for Dr. Sacks to be an ever-present dramatis persona.
In an otherwise laudatory review of The Man Who Mistook His Wife for a Hat in The New York Times Book Review, the neuropsychologist John C. Marshall took issue with what he saw as Dr. Sacks’ faux-naive presentation (He would have us believe that an experienced neurologist could fail to have read anything about many of the standard syndromes), and called his blend of medicine and philosophy insightful, compassionate, moving and, on occasion, simply infuriating. More damningly, the disability-rights activist Tom Shakespeare accused Dr. Sacks of exploiting the people he wrote about, calling him the man who mistook his patients for a literary career.
A skilled pianist, Dr. Sacks often wrote about the relationship between music and the mind, eventually devoting a whole book, Musicophilia (2007), to the subject. Dr. Sacks disagreed with the Harvard psychologist and author Steven Pinker’s view of music as auditory cheesecake, and pointed to its ability to reach dementia patients as evidence that music appreciation is hard-wired into the brain. I haven’t heard of a human being who isn’t musical, or who doesn’t respond to music one way or another, he told an audience at Columbia University in 2006. I think we are an essentially, profoundly musical species. And I don’t know whether – for all I know, language piggybacked on music. Referring to Nietzsche’s claim that listening to Bizet had made him a better philosopher, Dr. Sacks said, I think Mozart makes me a better neurologist.
Oliver Wolf Sacks was born on July 9, 1933, in London, the youngest of four sons of Samuel Sacks and the former Muriel Elsie Landau, who were both doctors. His father, in Dr. Sacks’ words a moderately Orthodox Jew, read the Bible daily, and Dr. Sacks often demonstrated a spiritual impulse in his books. But in Uncle Tungsten, his 2001 memoir about his childhood love of chemistry, he explained that the inflamed Zionist meetings his parents held before the war helped turn him away from organized religion. In Uncle Tungsten, Dr. Sacks described how growing up in a household of polymaths fostered his interest in science. The thousand and one questions I asked as a child, he wrote, were seldom met by impatient or peremptory answers, but careful ones which enthralled me (though they were often above my head). I was encouraged from the start to interrogate, to investigate. When World War II broke out, his parents sent Oliver and his brother Michael to a rural boarding school that Dr. Sacks described as a sadistic travesty, rife with bullying and cruelty. The horribleness of the school, he wrote in Uncle Tungsten, was made worse for most of us by the sense that we had been abandoned by our families, left to rot in this awful place. Four years later, when he returned home, he immersed himself in the refuge of his basement chemistry lab and the eternal system of the periodic table.
After receiving his medical degree from the Queen’s College, Oxford, Dr. Sacks moved to America in the early 1960s for an internship at Mount Zion Hospital in San Francisco, then did his residency at the University of California, Los Angeles. He embraced the culture he found in California – befriending the poet Thom Gunn, entering weight-lifting competitions and joining the Hells Angels on motorcycle trips to the Grand Canyon, adventures he wrote about in his 2015 memoir, On the Move: A Life. In that book, he also discussed his sexual identity for the first time, describing his adolescent realization that he was gay. After several early flings, he wrote, he settled into a period of celibacy that lasted 35 years before he found love late in life. He is survived by his partner of six years, the writer Bill Hayes.
Dr. Sacks moved to New York in 1965 for a fellowship at the Albert Einstein College of Medicine in the Bronx, and, a year later, began the clinical work at Beth Abraham that led to Awakenings. Over the years, he received many awards, including honors from the Guggenheim Foundation, the National Science Foundation, the American Academy of Arts and Letters and the Royal College of Physicians. In 2008, he was named a Commander of the British Empire. In 1974, Dr. Sacks tore his left quadriceps while running from a bull on a Norwegian mountaintop, an injury he wrote about in A Leg to Stand On. In that book, he recalled an aunt visiting him in the hospital and telling him: You’ve always been a rover. There are rovers, and there are settlers, but you’re definitely a rover. You seem to have one strange adventure after another. I wonder if you will ever find your destination. A prolific journal-keeper, Dr. Sacks compiled more than 600 notebooks. He published his essays in medical journals and magazines like The New Yorker and The New York Review of Books as well as small literary magazines like Antaeus, and he often revised them to add new information even after they had already appeared in book form. Ah, Oliver! he once quoted an exasperated publisher as saying. You’d do anything for a footnote!
For years, Dr. Sacks lived on City Island in the Bronx, where he liked to take long swims around it. More recently, he lived in Greenwich Village. But he remained ambivalent about being called a New Yorker. I rather like the words ?resident alien, he told The Guardian. It’s how I feel. I’m a sympathetic, resident, sort of visiting alien. Dr. Sacks preferred to be an alien in New York rather than in California, he told The Calgary Herald. Living there was too easy and too sweet, he said. I needed ugly and violent, ferocious and challenging. There is a tremendous richness of life here, Tourette’s visibly present on the streets.
Dr. Sacks remained active well into his later years. In 2007, at 74, he severed his 42-year relationship with the Albert Einstein College of Medicine to accept an interdisciplinary teaching position at Columbia. In 2012, he returned to the New York University School of Medicine as a professor of neurology. (He had had an adjunct position there for a couple of years in the 1990s, working mostly with its Tourette’s clinic.) And despite the enormous success of his books, he never gave up his unglamorous medical practice – partly, no doubt, because it provided him with material, but also because he genuinely loved working with patients. In 1989, interviewing him for The MacNeil/Lehrer NewsHour, Joanna Simon asked Dr. Sacks how he would like to be remembered in 100 years. I would like it to be thought that I had listened carefully to what patients and others have told me, he said, that I’ve tried to imagine what it was like for them, and that I tried to convey this. And, to use a biblical term, he added, bore witness. He also bore witness to his own dwindling life, writing reflective essays even in his last days. On Aug. 10, his assistant, Ms. Edgar, who described herself as his collaborator, friend, researcher and editor as well, wrote in an email: He is still writing with great clarity. We are pretty sure he will go with fountain pen in hand. Several days later, a valedictory essay titled Sabbath appeared in The Times. In it, Dr. Sacks considered the importance of the Sabbath in human culture and concluded:
And now, weak, short of breath, my once-firm muscles melted away by cancer, I find my thoughts, increasingly, not on the supernatural or spiritual, but on what is meant by living a good and worthwhile life – achieving a sense of peace within oneself. I find my thoughts drifting to the Sabbath, the day of rest, the seventh day of the week, and perhaps the seventh day of one’s life as well, when one can feel that one’s work is done, and one may, in good conscience, rest.
Source: The New York Times, August 30, 2015, by Gregory Cowles
RIP Oliver Sacks
Phrases taken from the writings of Oliver Sacks:
1. I find my thoughts, increasingly, not on the supernatural or spiritual, but on what is meant by living a good and worthwhile life.
2. As death nears, I am surrounding myself, as I did when I was a boy, with metals and minerals, little emblems of eternity.
3. As my deafness increases, the mistakes that result are a source of both confusion and delight.
4. I am now face to face with dying. But I am not finished with living.
5. At 80, I often feel life is about to begin, only to realize it is almost over.
6. Don’t leave learning to the young. Older brains can grow, too.
Click on the links below, for more information about Oliver Sacks:
Traumatic Brain Injury – Key Protein Found in Long-Term Complications
About one-third of all U.S. military personnel who serve in combat operations experience at least one traumatic brain injury (TBI) and individuals with TBI are more likely to experience ongoing complications such as post-concussive disorder (PCD), post-traumatic stress disorder (PTSD) and depression, and are also more likely to develop chronic traumatic encephalopathy (CTE). However, there is currently no way to identify those who are at greatest risk for developing these chronic symptoms.
Tau is a protein released from nerve cells, and is the protein that helps provide structural support to the axonal cytoskeleton — the framework that helps control the growth of the brain’s neurons. Elevated levels of tau are a known sign of axonal injury — a serious type of TBI in which the brain’s neurons are unable to communicate with other parts of the body, often leading to coma — and can be measured in the cerebrospinal fluid and blood immediately following a severe TBI. Levels of tau in the blood can be elevated in the hours and days following an injury, but were thought to return to normal levels within the months following a TBI. Tau is also known to have a role in the development of Alzheimer’s disease and Parkinson’s disease.
According to a study from the National Institute of Nursing Research (NINR), a component of the NIH, tau may also be responsible for long-term complications that can result from TBI. Using an ultra-sensitive technology, the study was able to measure levels of tau in the blood months and years after individuals (in this case, military personnel) had experienced TBI. Results showed that these elevated levels of tau are associated with chronic neurological symptoms, including PCD, during which an individual has symptoms such as headache and dizziness in the weeks and months after injury. These chronic neurological symptoms have been linked to CTE – progressive brain degeneration that leads to dementia following repetitive TBIs –independent of other factors such as depression and PTSD. The study and an accompanying editorial appeared online in the August 3 issue of JAMA Neurology.
To help identify biomarkers to better pinpoint those at-risk, the authors explored whether elevated levels of tau are related to chronic neurological symptoms in military personnel who had experienced TBI. Included in the study were military personnel, with or without a history of TBI, who had been deployed for combat in Operation Enduring Freedom (Afghanistan) and/or Operation Iraqi Freedom within the previous 18 months. The authors examined participant medical records as well as responses to the Warrior Administered Retrospective Casualty Assessment Tool to determine if participants had been diagnosed with or treated for a TBI. A total of 70 military personnel with a history of TBI and 28 without a history of TBI were enrolled in the study. The authors used standard assessments to measure PTSD, depression, and other neurological and psychological symptoms among participants. Additionally, blood samples were collected from each participant. Study results linked the physical PCD symptoms that can persist after TBI to elevated levels of tau, independent of other psychological symptoms such as PTSD and depression. These findings suggest that long after the primary brain injury, tau accumulations alone may contribute to chronic neurological symptoms. Previously, tau concentrations in the blood of patients who experience chronic symptoms or negative effects of TBI have proven difficult to measure. Because of this difficulty, tau’s role in chronic complications following TBI has been unclear. The investigators hoped that by using a new, ultrasensitive immunoassay technology, they could more easily measure the protein and clarify its role in long-term complications of TBI. The technology’s increased sensitivity (it is about 1,000 times more sensitive than conventional methods of measurement) allowed the authors to accurately measure levels of tau in participants’ blood, finding elevated tau levels in the blood samples of these military participants with a history of TBI compared with participants who had never suffered a TBI. Additionally, it was found that participants with three or more deployment-related TBIs had significantly higher levels of tau compared with participants who had fewer TBIs.
According to the authors, knowledge of the relationship of tau accumulation to chronic complications related to TBI may also someday provide a therapeutic target for treating the causes of CTE and other neurodegenerative and psychological conditions that can result from these types of injury.
New Strategy to Find Huntington’s Disease Therapies
As part of our commitment to the Orphan Disease area, we are pleased that we are involved in a novel therapeutic approach for Huntington’s disease.
Huntington’s disease is an inherited neurodegenerative disorder caused by mutations in a gene that encodes a protein called Huntingtin. Symptoms usually begin in midlife and include uncontrolled movements, emotional disturbances and, eventually, dementia. Although studies in humans and animals have discovered clues as to how the disorder works, there are no effective treatments.
According to a study published online in Cell July 30, 2015, based on a search of chromosomes of more than 4,000 Huntington’s disease patients, it was found that DNA repair genes may determine when the neurological symptoms begin. These results may provide a guide for discovering new treatments for Huntington’s disease and a roadmap for studying other neurological disorders. For the study, the authors employed a novel application of Genome Wide Association Study analysis, a technique that is typically use to search for single letter changes to the DNA code on patients’ chromosomes, which may increase or decrease their chances of having the disease. Here, the authors already knew the disease-causing gene and so they used the technique to search for other changes that determine when the disease starts. They found that at least three sites were associated with symptoms appearing earlier or later than expected, two on chromosome 15 and one on chromosome eight.
The study was conducted by the Genetic Modifiers of Huntington’s Disease Consortium, an international team of scientists devoted to finding treatments for the disorder. Starting more than three decades ago, the consortium has been collecting DNA samples and clinical information from patients, mainly in the United States, Canada and Europe. For the study, DNA and clinical information was used to study the age when movement problems began. Located on chromosome four, the Huntingtin gene is characterized by three letter repeats in the DNA code, called CAG-repeats. Disease-causing versions of the Huntingtin gene contain more than 35 CAG-repeats, which is higher than the six to 34 repeats found in normal versions. The greater number of CAGs a patient has, the greater the chances that symptoms will appear earlier in life. Focusing on patients who had 40 to 55 CAGs, the authors found that some developed the disease earlier than expected while others developed it later. The study then analyzed the patients’ chromosomes using gene chips that contain sites known for having single letter changes to the DNA code in normal human populations. After multiple rounds of searching it was found that two sites on chromosome 15 were strongly associated with disease onset. One site was associated with hastening the disease by, on average, just over six years; another site was associated with slowing the disease by about a year and a half. It was also found that a site on chromosome eight was associated with earlier disease onset by nearly one and a half years.
Although the authors did not identify specific genes, they used several types of genome network analyses to show that disease onset may be controlled by genes that repair DNA, catalyze essential chemical reactions in cells, and assist with the division of mitochondria. In addition, it was noted that a site within the code for MLH1, a DNA repair gene located on chromosome three, may be involved. Finally, it was showed that the sites on chromosomes 15 and eight may be associated with the beginning of psychiatric and cognitive problems caused by the disease.
OpenFDA Makes Medical Device-Related Data Easier to Access and Use
The following was extracted from FDA Voice
OpenFDA is a project that provides easy access to the many large, important, health data sets collected by FDA. Data since 1976 on 30,000 device premarket approvals (PMAs) and approval supplements, and 141,000 device clearances through premarket notifications (510(k)s) and granted de novo requests are now available on openFDA. Additionally, more details about device recalls (9,500 records going back to 2002) and adverse event reports (4.2 million records since 1991) were added. Although this information has been available in our public databases for many years, now developers can more easily access and use the data. OpenFDA’s Application Programming Interface (API) expands on the previous openFDA resources concerning medical device-related adverse events and recalls by incorporating information from the medical device product life cycle. This includes current data on device classification (6,000 records), 24,000registrations of device companies and establishments, and the companies’ listings of more than 100,000 devices.
The flexible openFDA interface works well even when greater demands are made on it and is designed on a common platform so developers can harmonize and integrate data from various sources and build their own applications. For example, developers could develop a smartphone app to search all the recalls associated with a particular type of device or find all companies that manufacture certain types of devices. However, there are some important safeguards to the data released. For instance, the information doesn’t contain anything that potentially could be used to identify individuals or reveal confidential commercial information. Everything available in these datasets should be understood in the appropriate context. FDA has harmonized the data, but there may be instances when a query does not return a full and complete result. For example, if the name of a manufacturer is listed with different spellings, some variations may not be captured in the result.
Some datasets are snapshots in time. The 510(k) dataset, for instance, shows who submitted the 510(k), the device name, and other information at the time of clearance. Moreover, the types of information that FDA has collected has changed over the years, which can make it difficult to look at data over time. Also, the data may not have enough information to establish cause and effect, incidence, or prevalence. By design, openFDA is a research and development project that draws on community involvement. FDA is active in the openFDA communities on GitHub and StackExchange, and encourages researchers, scientists, and developers to participate in those communities. This API is the latest in a series of openFDA releases that has made publicly available data easier to access. FDA believes that one can use these tools to create innovative products that could help protect and promote public health. In fact, over the last year, there have been dozens of tools created using openFDA resources. FDA hopes that these enhanced device data will be put to similar advantageous use, and that together, we can all make openFDA an even more useful and powerful resource for all.
Spinach Pie with Yogurt/Cheese Topping
Making this spinach pie, created such wonderful aromas emanating from our kitchen. The flavor is spectacular! If I do say so myself, this delicious recipe was a great success. ©Joyce Hays, Target Health Inc.
This was a scrumptious meal! ©Joyce Hays, Target Health Inc.
Gather all the ingredients in one place. ©Joyce Hays, Target Health Inc.
2.5 pounds fresh spinach, chopped (you can substitute frozen, thawed well and squeezed dry with paper towels)
1/4 cup olive oil
4 large onions, diced
2 bunches scallions (use white and (tender only) green part
1/2 cup parsley, chopped
1/2 cup fresh dill, chopped
1/4 teaspoon ground nutmeg; buy the whole nutmeg and freshly grate it. I ended up using already ground nutmeg
Pinch black pepper or to taste
Pinch chili flakes
1/2 pound feta cheese, crumbled
4 eggs, lightly beaten
1/2 pound ricotta
Into a medium size bowl add all the ingredients, below and mix together. Set aside, until it’s time to add the topping to the spinach pie.
4 eggs beaten
1 1/4 cups plain Greek yogurt
Pinch black pepper
Pinch paprika or chili flakes
1/2 to 1 cup freshly grated kashkaval cheese (or kefalotyri). I got the kashkaval cheese at FreshDirect
Preheat oven to 350 degrees
Mixing topping ingredients together. ©Joyce Hays, Target Health Inc.
Make the topping first and set aside, until the spinach part has baked.
Wash and drain the chopped spinach at least 3 times, to be sure you get all of the sand and grit out. Nothing ruins a spinach recipe more, than biting down on sand. The last time this happened, I had to throw the whole baked dish, out, after serving it. If using frozen spinach, thaw completely and squeeze out excess water. Spinach should be dry. I cannot emphasize enough, the important of getting the spinach as dry as you can, in this recipe. Otherwise, later, your spinach pie will be too juicy.
Cooking the onions and scallions. ©Joyce Hays, Target Health Inc.
Heat the olive oil in a large pan. Saute the onions and scallions (or chives, or shallots) until tender.
Chopping the scallions ©Joyce Hays, Target Health Inc.
Slowly adding all the greens to the onion mixture ©Joyce Hays, Target Health Inc.
Add the spinach, parsley, and dill and cook for 5 to 10 minutes until the spinach is wilted and heated through. Add the nutmeg and season with salt and pepper.
If using frozen spinach, you will want to cook until excess moisture evaporates. Spinach mixture should be on the dry side.
Remove from heat and set the spinach aside to cool.
All spinach pie ingredients are added together. ©Joyce Hays, Target Health Inc.
In a large mixing bowl, combine the feta cheese, eggs, and ricotta cheese. Add to the cooled spinach mixture and mix until combined.
All spinach pie ingredients are in the baking dish. ©Joyce Hays, Target Health Inc.
Oil a deep bake dish, with 1 teaspoon of olive oil, and pour the spinach mixture in. Use a spatula to scrape all the spinach out of the mixing bowl.
Bake in a preheated 350 degree oven for approximately 20 to 25 minutes of cooking time. You’re going to bake the pie first, without the topping. One reason is to be sure the spinach is well cooked and dry. You don’t want it to ooze all over the bake dish
Topping was just poured over the baked spinach. ©Joyce Hays, Target Health Inc.
When you take the spinach pie out of the oven, let it sit on a counter to set. Wait about 1/2 hour before you pour the topping over the pie. Put it back into the oven at 350 degrees and bake for 10 to 15 to 20 minutes, with your eye on the oven, so the topping doesn’t burn. You want it to turn a golden brown color, so when that happens, take it out of the oven right away. Let the color of the topping guide you, as to when to remove pie from oven.
Topping now on top of the baked spinach and going back into the oven. ©Joyce Hays, Target Health Inc.
Now, bake the topping for approximately 10 to 20 minutes of cooking time, depending on your oven (keep your eye on it, so it doesn’t burn).
Serve nice and warm. You could warm up some pita bread for the last 5 minutes, along with the spinach pie; the two would go well together. Dip the warm pita in some olive oil and forget about butter. Dip the warm pita in some olive oil.
We started dinner with another new recipe (will share it in the future): beet, tangerine salad, topped with figs stuffed with goat cheese. ©Joyce Hays, Target Health Inc.
This is a versatile recipe. You can serve a small sliver and it becomes an appetizer, or great for brunch. ©Joyce Hays, Target Health Inc.
Here, we’re comparing Stag’s Leap Wine Cellars chardonnay, with what we know we like from that vineyard, their sauvignon blanc. If you like chardonnays, much dryer, more tart and crisp than sauvignon blanc, then you would probably like this one. We had this chardonnay with the beet salad and spinach pie. Very nice paring.
Over Labor Day weekend, we went to Sardi’s and splurged on flaming baked Alaska for dessert. You can’t see us; we’re sitting on a banquette in front of our waiters. BTW, Sardi’s is not just for tourists. We are born and bred New Yorkers; have been to Sardi’s thousands of times, by now, and we still love Sardi’s! ©Joyce Hays, Target Health Inc..
From Our Table to Yours!