Promotions at Target Health

 

MR. YONG JOONG KIM has been promoted to Executive Director at Target Health. Yong Joong has been a key member of the Target Health team since May 1999. Yong Joong will continue to run the Data Management Department and work closely with Joonhyuk Choi, Leigh Ren and Glen Park to support their department’s activities. Yong Joong will also be a key member of the newly established Executive Committee at Target Health which includes Dean Gittleman, Glen Park, Mark Horn, Joyce Hays and Jules Mitchel. The Executive committee will help guide the growth of Target Health as we champion the “paperless“ clinical trial.“

 

MR. JOONHYUK CHOI, who joined our company in July 2001, has been promoted to Sr. Director, Software Development. Joonhyuk will have the software programmers, testers and IT reporting directly to him. Joonhyuk will be responsible for the development of new software products at Target Health as well as all operations requiring programming and support for Target Health’s software products.

 

View From Greensboro, North Carolina

 

Our friend and colleague, James Farley, Clinical Data Manager at TransTech Pharma LLC and subscriber to ON TARGET newsletter, is sharing some wildlife from Greensboro, NC. He tells us that “Believe it or not, the Green Heron lives at a pond which is in walking distance of our TransTech office!

 

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Green Heron, Greensboro, NC ©JFarleyPhotography.com

 

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. Mitchelor Ms. Joyce Hays. The Target Health software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website.

 

Joyce Hays, Founder and Editor in Chief of On Target

Jules Mitchel, Editor

 

Ebola Virus

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Electron micrograph of an Ebola virus virion

 

“The single biggest threat to man’s continued dominance on this planet is the virus,“ the Nobel Prize-winning biologist Joshua Lederberg once wrote. “There is no bomb, no poison, no plan of attack with the potential to do as much damage.“

 

Ebola virus disease (EVD) or Ebola hemorrhagic fever (EHF) one of the most dreaded human diseases, is caused by the ebola virus. Symptoms typically start two days to three weeks after contracting the virus, with a fever, throat and muscle pains, and headaches. Following the first symptoms, there is typically, nausea, vomiting, and diarrhea, along with decreased functioning of the liver and 1) ___. At this point, some people begin to have problems with bleeding. The disease is usually acquired when a person comes into contact with the blood or bodily 2) ___ of an infected animal such as a monkey or fruit bat. Fruit bats are believed to carry and spread the virus without being affected by it. Once infection of a human occurs, the disease may be spread from one person to another. Survivors may be able to transmit the disease via their semen for nearly two months. To make the diagnosis, typically other diseases with similar symptoms such as malaria, cholera and other viral hemorrhagic fevers are first excluded. The blood may then be tested for 3) ___ to the virus, or the viral RNA, or the virus itself, to confirm the diagnosis.

 

Prevention includes decreasing the spread of the disease from infected monkeys and pigs to humans. This may be done by checking these types of animals for infection and killing and properly disposing of the bodies, if the disease is discovered. Properly cooking meat and wearing protective clothing when handling meat may also be helpful, as is wearing protective clothing and washing 4) ___ when around a person who has the disease. Samples of bodily fluids and tissues from people with the disease should be handled with special caution. There is no specific treatment for the virus. Efforts to help persons who are infected include giving them either oral rehydration therapy or intravenous fluids. The disease has a high mortality rate: often between 50% and 90% of those who are infected with the virus. It typically occurs in outbreaks in tropical regions of Sub-Saharan Africa. Between 1976, when it was first identified, and 2014, fewer than 1,000 people a year have been infected. The largest outbreak to date is the ongoing 2014 West Africa Ebola outbreak, which is affecting Guinea, Sierra Leone, and Liberia. The disease was first identified in the Sudan and the Democratic Republic of the Congo. Efforts are ongoing to develop a vaccine; however, none exists as of 2014.

 

Manifestation of Ebola begins abruptly with a sudden onset of an influenza-like stage. Respiratory tract involvement is characterized by pharyngitis with sore throat, cough, dyspnea, and hiccups. The central nervous system is affected by the development of severe headaches, agitation, confusion, fatigue, seizures, and sometimes coma. Cutaneous presentation may include: maculopapular rash, petechiae, purpura, ecchymoses, and hematomas (especially around needle injection sites). In general, development of hemorrhagic symptoms is indicative of a negative 5) ___. However, contrary to popular belief, hemorrhage does not lead to hypovolemia (decreased blood volume) and is not the cause of death (total blood loss is low except during labor). Instead, death occurs due to multiple organ dysfunction syndrome (MODS) due to fluid redistribution, hypotension, disseminated intravascular coagulation, and focal tissue necroses. The average time between contracting the infection and the onset of symptoms is 13 days, but can be as long as 25 days.

 

 

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Bushmeat being prepared for cooking in Ghana, 2013. Human consumption of equatorial animals in Africa in the form of bushmeat has been linked to the transmission of diseases to people, including Ebola.

 

The natural maintenance hosts of ebola viruses are unidentified. Primary infection may not necessarily be preventable in nature. Fruit bats are thought to be the natural hosts, as well as other wild animals. Thus, to avoid EVD, risk factors such as contact with bats, nonhuman primates, and 6) ___ meat should be avoided.

 

 

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The cytosol is a crowded solution of many different types of molecules that fills much of the volume of cells. The cytosol or intracellular fluid (ICF) or cytoplasmic matrix is the liquid found inside cells. It is separated into compartments by membranes. For example, the mitochondrial matrix separates the mitochondrion into compartments.

 

The ebola virus life cycle begins with virion attachment to specific cell-surface receptors, followed by fusion of the virion envelope with cellular membranes and the concomitant release of the virus nucleocapsid into the cytosol. Endothelial cells, mononuclear phagocytes, and hepatocytes are the main targets of infection. After infection, a secreted glycoprotein (sGP) known as the Ebola virus glycoprotein (GP) is synthesized. Ebola replication overwhelms protein synthesis of infected cells and host immune defenses. The GP forms a trimeric complex, which binds the virus to the endothelial cells lining the interior surface of blood vessels. The sGP forms adimeric protein that interferes with the signaling of neutrophils, a type of 7) ___ blood cell, which allows the virus to evade the immune system by inhibiting early steps of neutrophil activation.

 

These white blood cells also serve as carriers to transport the virus throughout the entire body to places such as the lymph nodes, liver, lungs, and spleen. The presence of viral particles and cell damage resulting from budding causes the release of cytokines, which are the signaling molecules for fever and inflammation. The cytopathic effect, from infection in the endothelial cells, results in a loss of vascular integrity. This loss in vascular integrity is furthered with synthesis of GP, which reduces specific integrins responsible for cell adhesion to the inter-cellular structure, and damage to the liver, which leads to coagulopathy.

 

One ray of hope, for the management of this terrible disease, is the knowledge that, Niemann-Pick C1 (NPC1) appears to be essential for Ebola infection. Two independent studies reported in the same issue of Nature showed that Ebola virus cell entry and replication requires the cholesterol transporter protein NPC1. When cells from Niemann-Pick disease, type C1 patients (who have a mutated form of NPC1) were exposed to Ebola virus in the laboratory, the cells survived and appeared immune to the virus, further indicating that Ebola relies on NPC1 to enter cells. This might imply that 8) ___ mutations in the NPC1 gene in humans could make some people resistant to one of the deadliest known viruses affecting humans. The same studies described similar results with Ebola’s cousin in the filovirus group, Marburg virus, showing that it too needs NPC1 to enter cells. Furthermore, NPC1 was shown to be critical to filovirus entry because it mediates infection by binding directly to the viral envelope glycoprotein. A later study confirmed these findings, and also showed that the second lysosomal domain of NPC1 mediates this binding. In one of the original studies, a small molecule was shown to inhibit Ebola virus infection by preventing the virus glycoprotein from binding to NPC1. In the other study, mice that were heterozygous for NPC1 were shown to be protected from lethal challenge with mouse adapted Ebola virus. Together, these studies suggest NPC1 may be potential therapeutic target for an Ebola anti-viral drug.

 

Because Ebola 9) ___ are highly infectious as well as contagious, governments and individuals respond quickly to quarantine the outbreak areas; while the lack of roads and transportation in many parts of Africa helps to contain the outbreak of the disease. Airline crews are trained to spot the symptoms of Ebola in passengers flying from places where the virus is found. Crews are told to quarantine anyone who looks infected. During the summer of 2014, some international airlines have already halted flights to and from affected areas in Africa.

 

No Ebola virus-specific treatment exists. Treatment is primarily supportive in nature and includes minimizing invasive procedures, balancing fluids and electrolytes to counter dehydration. Administration of anticoagulants early in infection may help to prevent or control disseminated intravascular coagulation. After the disease has taken hold, administration of procoagulants late in infection, is used to control hemorrhaging, to maintain oxygen levels, to manage pain. The administration of antibiotics or antimycotics are given to treat secondary infections. According to Doctors Without Borders, early treatment may increase the survival chance, since there is no known cure. Their treatment focuses on replenishing fluids, maintaining proper blood pressure, replacing lost blood, and treating related infections.

 

In late 2012, Canadian scientists discovered that the deadliest form of the virus could be transmitted by air between species. The scientists managed to prove that the virus was transmitted from pigs to monkeys without any direct contact between them, leading to fears that airborne transmission could be contributing to the wider spread of the disease in parts of Africa. Researchers from the U.S. Army Medical Research Institute of Infectious Diseases found that FDA-approved estrogen receptor drugs used to treat infertility and breast cancer (clomiphene and toremifene) inhibit the progress of Ebola virus in infected mice. Ninety percent of the mice treated with clomiphene and 50% of those treated with toremifene survived the tests. The authors of the study concluded that given their oral availability and history of human use, these drugs would be excellent candidates for repurposing efforts to treat 10) ___ virus infection in remote geographical locations, either on their own or together with other antiviral drugs. Now, human clinical trials are needed.

 

ANSWERS: 1) kidneys; 2) fluids; 3) antibodies; 4) hands; 5) prognosis; 6) bush; 7) white; 8) genetic; 9) viruses; 10) Ebola

 

David Baltimore MD, PhD (1938-Present)

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David Baltimore: In 1975, at the age of 37, he shared the Nobel Prize for Physiology or Medicine

 

David Baltimore MD, PhD, an American virologist, university administrator, and Nobel laureate in Physiology or Medicine, is considered one of the world’s most influential biologists. He served as president of the California Institute of Technology (Caltech) from 1997 to 2006, and is currently the President Emeritus and Robert Andrews Millikan Professor of Biology at Caltech. He also served as president of Rockefeller University from 1990 to 1991, and was president of the American Association for the Advancement of Science in 2007. Dr. Baltimore has profoundly influenced international science, including key contributions to immunology, virology, cancer research, biotechnology, and recombinant DNA research, through his accomplishments as a researcher, administrator, educator, and public advocate for science and engineering. He was awarded the U.S. National Medal of Science in 1999.

 

Dr. Baltimore was born to Gertrude (Lipschitz) and Richard Baltimore in New York City. Raised in the Queens neighborhoods of Forest Hills and Rego Park, Queens, he moved with his family to suburban Great Neck, New York while he was in second grade because his mother felt that the city schools were inadequate. His father had been raised as an Orthodox Jew and his mother was an atheist. Dr. Baltimore observed Jewish holidays and would attend synagogue with his father through his Bar Mitzvah. He graduated from Great Neck High School in 1956, and credits his interest in biology to a high-school summer spent at the Jackson Laboratory’s Summer Student Program in Bar Harbor, Maine.

 

He earned a BA at Swarthmore College in 1960, and received his Ph.D. at Rockefeller University in 1964. After postdoctoral fellowships at Massachusetts Institute of Technology (MIT) and Albert Einstein College of Medicine and a non-faculty research position at the Salk Institute, he joined the MIT faculty in 1968. He was elected a Fellow of the American Academy of Arts and Sciences in 1974. In 1975, at the age of 37, he shared the Nobel Prize for Physiology or Medicine with Howard Temin and Renato Dulbecco. The citation reads, “for their discoveries concerning the interaction between tumor viruses and the genetic material of the cell.“ At the time, Baltimore’s greatest contribution to virology was his discovery of reverse transcriptase (RTase or RT). Reverse transcriptase is essential for the reproduction of retroviruses such as HIV. Working independently, Baltimore and Temin discovered reverse transcriptase, an enzyme that synthesizes DNA from RNA. Baltimore also conducted research that led to an understanding of the interaction between viruses and the genetic material of the cell. The research of all three men contributed to an understanding of the role of viruses in the development of cancer. Baltimore and Temin both studied the process by which certain tumor-causing RNA viruses (those whose genetic material is composed of RNA) replicate after they infect a cell. They simultaneously demonstrated that these RNA viruses, now called retroviruses, contain the blueprint for an unusual enzyme – a polymerase called reverse transcriptase – that copies DNA from an RNA template. The newly formed viral DNA then integrates into the infected host cell, an event that can transform the infected cell into a cancer cell.

 

In 1975, Baltimore was an organizer of the Asilomar conference on recombinant DNA. In 1982, Baltimore was appointed the founding director of MIT’s Whitehead Institute, where he remained through June 1990. In 1981, Baltimore and Vincent Racaniello, a post-doctoral fellow in his laboratory, used recombinant DNA technology to generate a plasmid encoding the genome of poliovirus, an animal RNA virus. The plasmid DNA was introduced into cultured mammalian cells and infectious poliovirus was produced. The infectious clone, DNA encoding the genome of a virus, is a standard tool used today in virology. Other important breakthroughs from Baltimore’s lab include the discovery of the transcription factor NF-?B and the recombination activating genes RAG-1 and RAG-2.

 

Baltimore became president of Rockefeller University in New York City on July 1, 1990. After resigning on December 3, 1991, Baltimore remained on the Rockefeller University faculty and continued research until spring of 1994. He then rejoined the MIT faculty.

 

Dr. Baltimore’s present research focuses on control of inflammatory and immune responses, on the roles of microRNAs in the immune system, and on the use of gene therapy methods to treat HIV and cancer in a program called “Engineering Immunity.“ He has become Director of the Joint Center for Translational Medicine, an activity that joins Caltech and UCLA in a program to translate basic science discoveries into clinical realities and where an active clinical program is under way. Baltimore has several outstanding administrative and public policy achievements to his credit. In the mid-1970s, he played an important role in creating a consensus on national science policy regarding recombinant DNA research. He served as founding director of the Whitehead Institute for Biomedical Research at MIT from 1982 until 1990. An early advocate of federal AIDS research, Baltimore co-chaired the 1986 National Academy of Sciences committee on a National Strategy for AIDS and was appointed in 1996 to head the National Institutes of Health AIDS Vaccine Research Committee.

 

Baltimore served as a member of the Independent Citizen’s Oversight Committee to the California Institute for Regenerative Medicine until 2007 and on the Board of Directors for both MedImmune until 2007 and Cellerant until 2008.He has played an important role in the development of American biotechnology since his involvement in the 1970s in the formation of Collaborative Genetics. He helped found other companies such as Calimmune and Immune Design and most recently s2A Molecular, Inc. He presently serves on the Board of Directors at several companies and non-profit institutions including the Broad Foundation and Broad Institute, and Amgen and Regulus Therapeutics. He is a member of numerous Scientific Advisory Boards, including the Broad Institute, Ragon Institute, Regulus Therapeutics, and Immune Design. He is a Scientific Partner to the venture capital firm, The Column Group, and until recently, he was a Director of the Swiss investment company BB Biotech.

 

Baltimore’s numerous honors include the 1970 Gustave Stern Award in Virology, 1971 Eli Lilly and Co. Award in Microbiology and Immunology, 1999 National Medal of Science, and 2000 Warren Alpert Foundation Prize. He was elected to the National Academy of Sciences in 1974, and is also a fellow of the American Academy of Arts and Sciences, and a foreign member of both the Royal Society of London and the French Academy of Sciences. He is past-President and Chair of the American Association of the Advancement of Science (2007-2009) and was mostly recently named a Fellow of the American Association for Cancer Research (AACR). He has published 680 peer-reviewed articles.

 

Baltimore has influenced national policy concerning recombinant DNA research and the AIDS epidemic. He has trained many doctoral students and postdoctoral fellows, several of whom have gone on to notable and distinguished research careers. Baltimore is a member of The Jackson Laboratory’s Board of Trustees, the Bulletin of the Atomic Scientists’ Board of Sponsors, the National Academy of Sciences USA (NAS), the NAS Institute of Medicine (IOM), Amgen, Inc. Board of Directors, the BB Biotech AG Board of Directors, the National Institutes of Health (NIH) AIDS Vaccine Research Committee (AVRC), and numerous other organizations and their boards.

 

Baltimore is a member of the USA Science and Engineering Festival’s Advisory Board and the Pontifical Academy of Sciences

 

During Baltimore’s tenure at Caltech, United States President Bill Clinton awarded Baltimore the National Medal of Science in 1999 for his numerous contributions to the scientific world. In 2004, Rockefeller University gave Baltimore its highest honor, Doctor of Science (honoris causa).

 

Baltimore remains the Millikan Professor of Biology at Caltech and is an active member of the Institute’s community. He is married and has one child.

 

 

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The Baltimore Classification of viruses is based on the method of viral mRNA synthesis.

 

Among huge accomplishments, David Baltimore, devised the Baltimore classification system. The ICTV classification system is used in conjunction with the Baltimore classification system in modern virus classification.

 

EBOLA

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Rabies Vaccine Protects Nonhuman Primates Against Deadly Ebola Virus

 

From The New York Times: ABUJA, Nigeria 31 July 2014:

 

West African leaders quickened the pace of emergency efforts on Thursday in response to a mounting tally of fatalities from the worst known outbreak of the deadly Ebola virus, canceling travel plans and authorizing measures to combat the disease including house-to-house searches and the deployment of the army and the police. The World Health Organization said the death toll had risen to 729 from 672, after 57 more people died during a four-day period between July 24 and 27 in Guinea, Liberia, Sierra Leone and Nigeria, Africa’s most populous nation. In the same period, 122 new cases were detected, bringing the total of confirmed and probably infected patients to 1,323. The toll is the highest in a single outbreak since the virus was identified almost four decades ago.

 

This following is from 2013 and is so timely with the current outbreak of Ebola in West Africa.

 

Ebola virus causes severe hemorrhagic fever in humans and nonhuman primates, which may lead to shock, bleeding, multi-organ failure, and death. Since it first appeared in 1976 in two simultaneous outbreaks in the Sudan and Zaire (now the Democratic Republic of the Congo), Ebola virus has infected roughly 1,800 people and caused nearly 1,300 deaths. According to the World Health Organization, Ebola infection has a fatality rate of up to 90%. There is no licensed treatment or vaccine.

 

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An electron microscopic view of Ebola virus particles. Credit: NIAID

 

Increased Ebola virus outbreaks – including the 2012 outbreaks in Uganda and the Democratic Republic of the Congo – and the virus’ potential for use as a bioterrorism agent have spurred research and development to develop a safe and effective vaccine. Although several vaccine strategies, such as those involving DNA, adenovirus, and recombinant vesicular stomatitis virus, have shown promise in protecting nonhuman primates, various factors have served to slow progress in their continued development. Recent investigations have focused on identifying the vaccine-induced immune responses that may serve as indicators of protection against Ebola infection.

 

Researchers from NIAID and Thomas Jefferson University, in Philadelphia, developed a vaccine based on the established rabies virus vaccine that, when tested in mice, proved safe and provided protection against both rabies and Ebola infection. As the next step to that success, three different types of the novel rabies/Ebola vaccine was tested in nonhuman primates to determine their protective effect.

 

The study, published online in PLoS Pathogens (30 May 2013), tested a replication-competent rabies virus vaccine, a replication-deficient rabies virus vaccine, and a chemically inactivated rabies virus vaccine expressing Ebola glycoprotein. Fifteen rhesus macaques, divided into four groups, were immunized intramuscularly with one of the three vaccines or a control vaccine. All of the animals were followed for both rabies and Ebola-specific immune responses. After 42 days, all of the nonhuman primates were transferred to NIAID’s biosafety level-4 facility at Rocky Mountain Laboratories in Hamilton, Montana, for challenge with the Ebola virus.

 

Results showed that all 3 vaccines produced potent immune responses against both rabies and Ebola. In terms of protection, the live replication-competent vaccines provided 100% protection following challenge with the Ebola virus. The replication-deficient and inactivated vaccines afforded 50% protection. According to the authors, the protection of the immunized animals against Ebola virus infection was largely dependent on the quality of the B-cell driven immune response rather than the quantity of the response. These humoral immune responses as well as high glycoprotein-specific antibodies were particularly helpful in controlling Ebola virus infection after immunization.

 

According to the authors, the results of these studies further support the concept that a successful Ebola vaccine needs to induce strong antibodies to the virus, and that a dual-purpose vaccine to protect against rabies and Ebola virus is possible and, perhaps, more readily marketable. The authors are pursuing the inactivated rabies/Ebola vaccine for use in humans. The live vaccine is being developed for use in protecting wildlife at risk of Ebola virus infection in Africa, which could also serve to prevent transmission into the human population.

 

According to the authors, advance testing among nonhuman primates involving higher levels of Ebola virus glycoprotein and, perhaps, an additional immunization dose could bring the protection rate to 100%. In addition, the research team is using the vaccine platform to develop a multivalent filovirus vaccine and other vaccine candidates against high consequence pathogens.

 

Six New Genetic Risk Factors Identified For Parkinson’s Disease

 

Parkinson’s disease (PD), affecting millions of people worldwide, is a degenerative disorder that causes movement problems, including trembling of the hands, arms, or legs, stiffness of limbs and trunk, slowed movements and problems with posture. Over time, patients may have difficulty walking, talking, or completing other simple tasks. Although nine genes have been shown to cause rare forms of PD, there has been a continued search for genetic risk factors to provide a complete genetic picture of the disorder.

 

According to a study published online in Nature Genetics (27 July 2014) using data from over 18,000 patients, more than two dozen genetic risk factors involved in PD have been identified, including six that had not been previously reported. The study collected and combined data from existing genome-wide association studies (GWAS), which allowed the authors to find common variants, or subtle differences, in the genetic codes of large groups of individuals. The combined data included approximately 13,708 PD cases and 95,282 controls, all of European ancestry. The study also identified potential genetic risk variants, which increase the chances that a person may develop PD. The results suggest that the more variants a person has, the greater the risk, up to three times higher, for developing PD, in some cases.

 

To obtain the data, the authors collaborated with multiple public and private organizations, including the U.S. Department of Defense, the Michael J. Fox Foundation, 23andMe and many international investigators. The study confirmed the results in another sample of subjects, including 5,353 patients and 5,551 controls. By comparing the genetic regions to sequences on a state-of-the-art gene chip called NeuroX, it was confirmed that 24 variants represent genetic risk factors for PD, including six variants that had not been previously identified. The NeuroX gene chip contains the codes of approximately 24,000 common genetic variants thought to be associated with a broad spectrum of neurodegenerative disorders.

 

Some of the newly identified genetic risk factors are thought to be involved with Gaucher’s disease, regulating inflammation and the nerve cell chemical messenger dopamine as well as alpha-synuclein, a protein that has been shown to accumulate in the brains of some cases of PD. According to the authors, further research is needed to determine the roles of the variants identified in this study.

 

The following is profoundly impressive and shows what can happen when people work together:

 

Additional support was provided by the NIH, Department of Defense, the Michael J Fox Foundation for Parkinson’s Research, American Parkinson Disease Association, Barnes Jewish Hospital Foundation, Hersenstichting Nederland, the Prinses Beatrix Fonds, the German Federal Ministry of Education, Science, Research and Technology, the German Federal Ministry of Education and Research, the State of Bavaria, the Initiative and Networking Fund of the Helmholtz Association, the French National Agency of Research, France-Parkinson Association, “Investissements d’avenir“, Assistance Publique-Hopitaux de Paris, the Landspitali University Hospital Research Fund, Icelandic Research Council, European Commission, University of Helsinki, Helsinki University Central Hospital, University of Eastern Finland, the Medical Research Council and Wellcome Trust, National Institute for Health Research (NIHR) Biomedical Research Centre, Parkinson’s UK, Coriell Cell Repositories, the King Faisal Specialist Hospital and Research Centre, National Institute for Health Research (NIHR) Biomedical Research Centre, Cure Alzheimer’s Fund (CAF), Prize4Life, the National Alliance for Research on Schizophrenia and Depression, EMD Serono, Fidelity Biosciences Research Initiative, the Parkinson’s disease foundation, University of Thessaly,the Hellenic Secretariat of Research and Technology, GlaxoSmithKline Greece, the Bumpus foundation, the Internationaal Parkinson Fonds, Netherlands Organization for Scientific Research, Netherlands Organization for Health Research and Development, Parkinson’s UK.

 

TARGET HEALTH excels in Regulatory Affairs. Each week we highlight new information in this challenging area.

 

Mini-Sentinel

 

Mini-Sentinel is a pilot project sponsored by the U.S. Food and Drug Administration (FDA) to create an active surveillance system – the Sentinel System – to monitor the safety of FDA-regulated medical products. Mini-Sentinel uses pre-existing electronic healthcare data from multiple sources. Collaborating Institutions provide access to data as well as scientific and organizational expertise. Mini-Sentinel is part of the FDA’s Sentinel Initiative, which is exploring a variety of approaches for improving the Agency’s ability to quickly identify and assess safety issues.

 

Most Mini-Sentinel activities focus on assessments, methods, or data. Visit the following links to learn more about each type of activity:

  • Assessments – Medical product exposures, health outcomes, and links between them
  • Methods – Techniques for identifying, validating, and linking medical product exposures and health outcomes
  • Data – Mini-Sentinel Distributed Dataset and tools used to access the data

 

The information contained on this website is provided as part of FDA’s commitment to place knowledge acquired from the Mini-Sentinel Pilot in the public domain as soon as possible. FDA will continue to communicate information about the safe use of medical products using existing channels, such as FDA’s press announcements, MedWatch AlertsDrug Safety Communications, and Safety & Availability (Biologics) Communications.

 

Information obtained through Mini-Sentinel are intended to complement other types of data and information compiled by FDA scientists, such as adverse event reports, published study results, and clinical trials, which can be combined with Mini-Sentinel data and used by FDA to inform regulatory decisions regarding medical product safety. FDA may access the data available through Mini-Sentinel for a variety of reasons beyond assessing potential safety risks for a specific product (e.g., estimating the background rate of health outcomes, examining medical product use, and evaluating research methods).

 

Stuffed Zucchini

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Here’s an example of delicious comfort food, that’s relatively low in calories and healthy – ©Joyce Hays, Target Health Inc.

 

 

Ingredients

  • 1/4 cup farro
  • Pinch Salt
  • Olive oil
  • 3 large zucchini (about 3/4 pound each)
  • Salt
  • 1 onion, chopped
  • 1 red bell pepper, cored, seeded and diced
  • 1/4 cup chopped basil, plus more for topping
  • 1/4 pound mushrooms, chopped
  • 4 cloves garlic, minced
  • Pinch red pepper flakes
  • 1/2 cup white wine
  • 1/4 cup pine nuts, toasted at home
  • 1/2 cup crumbled feta, plus more for topping
  • 1 cup chicken stock or broth

 

 

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Get all ingredients ready – ©Joyce Hays, Target Health Inc.

 

Directions

  • Cook farro in plenty of rapidly boiling salted water until tender, about 30 minutes. Drain and cool.
  • Heat the oven to 400 degrees. Grease a 5-quart gratin dish with olive oil.
  • Cut the zucchini in half lengthwise and use a small melon baller or serrated spoon to remove the insides of the zucchini to make what looks like a boat. Leave about one-quarter inch of the flesh at the sides and a little more at the bottom. Collect the pulp on a cutting board and chop coarsely.
  • Season the inside of the zucchini boats lightly with salt and steam over rapidly boiling water about 3 minutes. If you don’t want to spend the time doing this, leave the stuffed zucchini in the oven a little longer, but watch carefully, so they don’t burn.
  • Heat 2 tablespoons olive oil in a large skillet and add the onion. Cook until it softens, about 5 minutes. Add the red bell pepper and cook until soft, about 5 minutes. Add the chopped zucchini pulp and basil and cook until dry, about 10 minutes.
  • Increase the heat to high. Add the mushrooms and cook until soft, 5 minutes. Add the garlic and red pepper flakes and cook until fragrant, about 3 minutes. Add the white wine and cook until dry. Set aside to cool.
  • Stir the cooked farro, pine nuts and feta into the cooled vegetable mixture. Season to taste with salt and freshly ground black pepper, and spoon the mixture into the hollowed-out zucchinis, mounding on top. Itwill take 4 to 6 tablespoons per each zucchini boat.

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About to go in the oven ©Joyce Hays, Target Health Inc.

 

1. Arrange the stuffed zucchini in the gratin dish; it’s okay if they fit quite tightly. Sprinkle the tops with more crumbled feta. Pour the chicken stock or broth, into the baking dish so it just covers the bottom. Bake until the tops have browned, about 15 to 20 minutes.

 

2. Drizzle the top of each zucchini with a little more olive oil, transfer to a serving platter and scatter over more slivered basil. Serve warm or at room temperature.

 

We had these stuffed zucchini over a delicious pasta (new for us, called, campanelle) that I cooked in chicken stock (instead of water) with one tablespoon of olive oil added to the water, so the pasta doesn’t stick together. We also had a simple fresh tomato/Vidalia salad and icy Pino Grigio wine. Fresh juicy peaches for dessert. This was an absolutely lip smacking meal, simple, healthy, satisfying and not at all hard to put together.

 

 

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©Joyce Hays, Target Health Inc.

 

For dessert we had fresh juicy peaches, at their peak right now. If you feel like it, add some of your favorite brandy, just pour it over the peaches. If you’re in an adventurous mood, light the brandy after you pour it over the peaches (it flares up so be careful) for a sort of peach flambe well, not exactly, but certainly, flambe.

 

We rarely go to B’way musicals, but we did see “Newsies“ because it’s based on a true story, it’s set in Manhattan, and because we like the composer, Alan Menken, who wrote the best song in the show, IMO, called, “Santa Fe“, city of clay, (where we’re about to spend our August vacation). In fact, right after, “Newsies“ we had dinner at Sardis and sat next to one of the directors at the Roundabout Theater Company, who knows Alan Menken. We contribute to at least 6 or 7 theater groups in Manhattan, including Roundabout Theater, so lots of theater chatter followed and a good time was had by all. (the salmon there is wonderful).

 

Click below for the great Alan Menken on piano with the show’s lead, singing, “Santa Fe“, which is my second favorite place on the planet, so this song touches my heart.

 

 

From Our Table to Yours!

 

Bon Appetit !