NDA Using eSource is Under Review and First Patient Signs (Target e*ICF™)

 

Another breakthrough for the pharmaceutical industry and Target Health, as FDA has formally accepted an NDA which includes 7 studies, all of which used Target e*CTR® (eClinical Trial Record; eSource). And yes, it was possible to have more than 90% of the data entered in real time at the time of the office visit. This is the 2nd program submitted to FDA that used Target e*CTR.  The first program, cleared in December 2015 was a de novo 510(k) device indicated for the prevention of hair loss in women undergoing breast cancer chemotherapy.

 

This past week, the first patient electronically reviewed and electronically signed an electronic Informed Consent Form (Target e*ICF™). The software was developed by the best clinical research software group in the industry under the direction of Joonhyuk Choi, Sr. Director of Software Development,  Simultaneously, a meeting request was sent to FDA to enable Target Health to share its approach with FDA and to gain confidence that the Target Health electronic informed consent solution is compliant with FDA’s Procedural Guidance on “Use of Electronic Informed Consent in Clinical Investigations – Questions and Answers“ (March 2015).

 

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.

 

Joyce Hays, Founder and Editor in Chief of On Target

Jules Mitchel, Editor

 

QUIZ

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Defense Against Parasites

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Trophozoites of the amoebic dysentery pathogen Entamoeba histolytica with ingested human red blood cells (dark circles)

 

First used in English 1539, the word parasite is derived from the Latin parasitus, the latinization of the Greek parasitos, derived from para, “beside, by“ + sitos, “wheat“ which ends up to be “one who eats at the table of another.“ Coined in English in 1611, the word parasitism comes from the Greek para + sitismos “feeding, fattening“.

 

In biology/ecology, parasitism is a non-mutual symbiotic relationship between species, where one species, the parasite, benefits at the expense of the other, the 1) ___. Traditionally parasite (in biological usage) referred primarily to organisms visible to the naked eye, or macroparasites (such as helminths; worms). Parasites can also include microparasites, which are typically smaller, such as protozoa, viruses, and bacteria. Examples of parasites include the plants mistletoe and cuscuta, and animals such as hookworms. Unlike predators, parasites typically do not kill their host, are generally much smaller than their host, and will often live in or on their host for an extended period. Parasites show a high degree of specialization, and reproduce at a faster rate than their hosts. Classic examples of parasitism include interactions between vertebrate hosts and tapeworms, flukes, the Plasmodium species, and fleas.

 

The first line of defense against invading parasites is the skin. Skin is made up of layers of dead cells and acts as a physical barrier to invading organisms. These dead cells contain the protein keratin, which makes skin tough and waterproof. Most microorganisms needs a moist environment to survive. By keeping the 2) ___ dry, it prevents invading organisms from colonizing. Furthermore, human skin also secretes sebum, which is toxic to most microorganisms. The mouth contains 3) ___, which prevents foreign organisms from getting into the body orally. Furthermore, the mouth also contains lysozyme, an enzyme found in tears and the saliva. This enzyme breaks down cell walls of invading microorganisms. Should the organism pass the mouth, the stomach is the next line of defense. The stomach contains hydrochloric acid and gastric 4) ___, which makes its pH level around 2. In this environment, the acidity of the stomach helps kill most microorganisms that try to invade the body through the gastric intestinal tract. Parasites can also invade the body through the eyes. The lashes on the eyelid prevents invading microorganisms from entering the eye in the first place. Even if the microorganism do get into the eye, tears contain the enzyme lysozyme, which will kill most invading microorganisms. Should the parasite enter the body, the immune system is a vertebrate’s major 5) ___ against parasitic invasion. The immune system is made up of different families of molecules. These include serum proteins and pattern recognition receptors (PRRs). PRRs are intracellular and cellular receptors that activate dendritic cells, which in turn activate the adaptive immune system’s lymphocytes. Lymphocytes such as the T cells and antibody producing B cells with variable receptors that recognize parasites.

 

Parasitism has arisen independently many times. Depending on the definition used, as many as half of all animals have at least one parasitic phase in their life cycles. Almost all free-living animals are host to one or more parasitic species. Parasites evolve in response to their hosts’ defenses, sometimes in a manner specific to a particular host and specializing to the point where they infect only a single species. Such narrow host specificity can be costly over evolutionary time, however, if the host species becomes 6) ___. Therefore, many parasites can infect a variety of more or less closely related host species, with different success rates. In turn, host defenses co-evolve in response to attacks by parasites. Theoretically, parasites may have an advantage in this evolutionary arms race because their generation time commonly is 7) ___. Hosts reproduce less quickly than parasites, and therefore have fewer chances to adapt than their parasites do over a given span of time.

 

Long-term co-evolution sometimes leads to a relatively stable relationship tending to commensalism or mutualism, as, all else being equal, it is in the evolutionary interest of the 8) ___ that its host thrives. A parasite may evolve to become less harmful for its host or a host may evolve to cope with the unavoidable presence of a parasite to the point that the parasite’s absence causes the host harm. For example, although animals infected with parasitic worms are often clearly harmed, and therefore parasitized, such infections may also reduce the prevalence and effects of autoimmune disorders in animal hosts, including humans. In a more extreme example, some nematode worms cannot reproduce, or even survive, without infection by Wolbachia bacteria. Competition between parasites tends to favor 9) ___ reproducing and therefore more virulent parasites. Parasites whose life cycle involves the death of the host, to exit the present host and sometimes to enter the next, evolve to be more virulent or even alter the behavior or other properties of the host to make it more vulnerable to predators. Parasites that reproduce largely to the offspring of the previous host tend to become less virulent or mutualist, so that its hosts reproduce more effectively.

 

The presumption of a shared evolutionary history between parasites and hosts can sometimes elucidate how host taxa are related. For instance, there has been dispute about whether flamingos are more closely related to the storks and their relatives, or to ducks, geese and their relatives. The fact that flamingos share parasites with ducks and geese is evidence these groups may be more closely related to each other than either is to storks. Parasitism is part of one explanation for the evolution of secondary sex characteristics seen in breeding males throughout the animal world, such as the plumage of male peacocks and manes of male lions. According to this theory, female hosts select males for breeding based on such characteristics because they indicate 10) ___ to parasites and other disease.

 

Drugs are frequently used to kill parasites in the host. In earlier times, turpentine was often used for this, but modern drugs do not poison intestinal worms directly. Rather, antihelmintic drugs now inhibit an enzyme, that is necessary for the worm to make the substance, that prevents the worm from being digested. For example, tapeworms are usually treated with a medicine taken by mouth. The most commonly used medicine for tapeworms is Praziquantel. Praziquantel is also used to treat infections of certain parasites (e.g., Schistosoma and liver flukes).

 

ANSWERS: 1) host; 2) skin; 3) saliva; 4) acids; 5) defense; 6) extinct; 7) shorter; 8) parasite; 9) faster; 10) resistance

 

Public Health in Ancient Rome

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Photo credit: Craig Taylor, Roman latrines from Lepcis Magna in Libya.

 

 

Intestinal parasites such as whipworm became increasingly common across Europe during the Roman Period, despite the apparent improvements the empire brought in sanitation technologies, archaeological evidence shows. The Romans are well known for introducing sanitation technology to Europe around 2,000 years ago, including public multi-seat latrines with washing facilities, sewerage systems, piped drinking water from aqueducts, and heated public baths for washing. Romans also developed laws designed to keep their towns free of excrement and rubbish. However, new archaeological research has revealed that for all their apparently hygienic innovations, intestinal parasites such as whipworm, roundworm and Entamoeba histolytica dysentery did not decrease as expected in Roman times compared with the preceding Iron Age, they gradually increased. The latest research was conducted by Dr. Piers Mitchell from Cambridge’s Archaeology and Anthropology Department and is published in the journal,Parasitology. The study is the first to use the archaeological evidence for parasites in Roman times to assess “the health consequences of conquering an empire.“ Dr Piers Mitchell brought together evidence of parasites in ancient latrines, human burials and coprolites (aka fossilized feces), as well as in combs and textiles from numerous Roman Period excavations across the Roman Empire.

 

Results showed that not only did certain intestinal parasites appear to increase in prevalence with the coming of the Romans, but that despite their famous culture of regular bathing, ?ectoparasites’ such as lice and fleas were just as widespread among Romans as in Viking and medieval populations, where bathing was not widely practiced. Some excavations revealed evidence for special combs to strip lice from hair, and delousing may have been a daily routine for many people living across the Roman Empire. According to Mitchell, “Modern research has shown that toilets, clean drinking water and removing feces from the streets all decrease risk of infectious disease and parasites. So we might expect the prevalence of faecal oral parasites such as whipworm and roundworm to drop in Roman times — yet we find a gradual increase. The question is why?“ One possibility Mitchell offers is that it may have actually been the warm communal waters of the bathhouses that helped spread the parasitic worms. Water was infrequently changed in some baths, and a scum would build on the surface from human dirt and cosmetics. “Clearly, not all Roman baths were as clean as they might have been,“ said Mitchell. Another possible explanation raised in the study is the Roman use of human excrement as a crop fertilizer. While modern research has shown this does increase crop yields, unless the feces are composted for many months before being added to the fields, it can result in the spread of parasite eggs that can survive in the grown plants. “It is possible that sanitation laws requiring the removal of feces from the streets actually led to reinfection of the population as the waste was often used to fertilize crops planted in farms surrounding the towns,“ said Mitchell. The study also found fish tapeworm eggs to be surprisingly widespread in the Roman Period compared to Bronze and Iron Age Europe. One possibility Mitchell suggests for the rise in fish tapeworm is the Roman love of a sauce called garum. Made from pieces of fish, herbs, salt and flavorings, garum was used as both a culinary ingredient and a medicine. This sauce was not cooked, but allowed to ferment in the sun. Garum was traded right across the empire, and may have acted as the “vector“ for fish tapeworm, says Mitchell. “The manufacture of fish sauce and its trade across the empire in sealed jars would have allowed the spread of the fish tapeworm parasite from endemic areas of northern Europe to all people across the empire. This appears to be a good example of the negative health consequences of conquering an empire,“ he said.

 

The study shows a range of parasites infected people living in the Roman Empire, but did they try to treat these infections medically? While Mitchell says care must be taken when relating ancient texts to modern disease diagnoses, some researchers have suggested that intestinal worms described by Roman medical practitioner Galen (130CE – 210CE) may include roundworm, pinworm and a species of tapeworm. Galen believed these parasites were formed from spontaneous generation in putrefied matter under the effect of heat. He recommended treatment through modified diet, bloodletting, and medicines believed to have a cooling and drying effect, in an effort to restore balance to the ?four humors’: black bile, yellow bile, blood and phlegm. Added Mitchell: “This latest research on the prevalence of ancient parasites suggests that Roman toilets, sewers and sanitation laws had no clear benefit to public health. The widespread nature of both intestinal parasites and ectoparasites such as lice also suggests that Roman public baths surprisingly gave no clear health benefit either.“ “It seems likely that while Roman sanitation may not have made people any healthier, they would probably have smelt better.“ Source: University of Cambridge, PIERS D. MITCHELL. Human parasites in the Roman World: health consequences of conquering an empire. Parasitology, 2016; 1; ScienceDaily

 

Lessons from Recovery: The Great East Japan Earthquake of 2011 – Nippon Club, 2016

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One scene, in Japan, after the catastrophic Tohoku earthquake. Source: The Nippon Club, NYC

 

Last Thursday’s Panel discussion and art reception, attended by Target Health Inc. at the Nippon Club, looked back at the 9.0 magnitude earthquake followed by the resulting tsunami in Japan near its five year anniversary. The six panelist, made up of international diplomats and several key business players in Japan relations, opened the reception with a riveting discussion on how Japan’s recovery efforts can be used as a reference for recovery efforts globally.

 

 

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Ernesto Gonzalez Valdivia, UN advisor Mission of Chile and Mui Ying Kwan, Cultural Liaison at Target Health Inc.

 

For example, Mr. Ernesto Gonzalez Valdivia, UN advisor Mission of Chile (pictured above) felt that knowledge is the key concept of the exhibition. He thought the global community should look at the failures and successes of Japan’s recovery efforts in order to learn how to handle a natural disaster in their home country, as Chile has done successfully in the past. Given that the US went through Hurricane Katrina and Hurricane Sandy disasters, this Nippon Club exhibition was very relevant to New Yorkers and all Americans.

 

After the panel discussion there was a lovely catered reception, with a chance to meet and mingle with some of the panelists, architects and artists. Next, the event moved up to the 7th floor to look at the exhibition.

 

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The Meditation Room by Miya Ando, a Japanese American artist who lives in New York City.

 

 

The first visually stunning piece in the space was a floating meditation room. Miya Ando, a NYC based visual artist, created a haunting and ethereal memorial for Japan Tsunami and earthquake using her signature installation of dyed Bodhi “skeleton“ leaves to simulate foliage in nature. Mui Ying Kwan from Target Health Inc. met Miya Ando during the reception. Ms. Ando said that the meditation room symbolized the past and future of Japan. There were also photographs and videos showcasing the recovery effort in east Japan over the five year course. The most striking photographs were the ones that showed the community spirit of both local and international communities, all striving towards the same goal, to help rebuild Japan. It seems that out of this tragedy, came an energy which enabled many innovative projects, out of this effort to revitalize Japan. This disaster created healing and helping, “International Communities“. It also demonstrated the importance of media coverage in disaster recovery.

 

The photography exhibition and panel discussions told many poignant stories of determination, courage and compassion in the effort to rebuild and recover from the tragedy of the tsunami. One narrative that resonated and exemplified Japan’s ability to regenerate after the disaster is the story of the Suisen Brewery, a 75+ years old sake brewery located in the coastal city Rikuzentatka. The brewery was utterly destroyed, with several brewery workers killed, when the terrible Tohoku earthquake struck followed by the massive tsunami. With strong determination and the aid of another sake company, the Suisen Brewery was able to rebuild a new brewery close to its original headquarters in Rikuzentatka. They decided to expand abroad and in 2014 they imported their first sake to the US, KIBO which mean “hope“ in Japanese. The valuable lesson in this story is that not only was Japan able to rebuild after the disaster, they were able to expand and open new opportunities. Because the Suisen Brewery was one of the sponsors of the Nippon Club exhibition, guests at Thursday’s reception were lucky enough to taste the imported Junmai sake. The Kibo sake was excellent, pristine, crisp with a hint of sweetness. The evening ended with a toast to hope!

 

Prenatal Steroids Lower Risk of Respiratory Illness in Late Preterm Infants

 

Steroids are a standard treatment for women likely to deliver before 34 weeks of pregnancy because these drugs are known to reduce respiratory and other complications, as well as death, among infants born early preterm. Previously, it was believed that late preterm infants could thrive without their mothers having received steroid treatment until it was observed that late preterm infants also have a higher risk of respiratory complications compared to infants born at 37 weeks or later. Now, according to results

Prenatal steroid therapy reduces the chance of respiratory complications among infants born at 34-36 weeks, so-called “late“ preterm infants, according to a study funded by the NIH, it was found that steroids also reduce the occurrence of serious respiratory complications in late preterm infants.

 

The study, which randomly assigned 2,831 women, who were in the 34th through the 36th week of their pregnancies, and at high risk for delivering early (before 37 weeks), to receive two injections of the steroid betamethasone or a placebo, 24 hours apart. The study categorized the findings into a single composite measure, a primary outcome derived from the need for any of a number of therapies used to treat difficulty in breathing in the newborns, including:

 

Continuous positive airway pressure (CPAP), use of mild air pressure, so that sufficient air can reach the lungs.

 

Oxygen therapy, in which oxygen at concentrations higher than that in room air is passed into the baby’s lungs.

 

Mechanical ventilation, in which a tube is placed in the infant’s windpipe and used to deliver oxygen to the infant’s lungs.

 

Also included in the primary outcome was whether an infant was stillborn or died before 72 hours of age.

 

At the study’s conclusion, 11.6% of the infants in the betamethasone group met the criteria for the primary outcome, a 20% reduction in the need for respiratory support by 72 hours of age, compared to the placebo group. Two infants in the betamethasone group died before 72 hours, but these deaths were not from respiratory causes. One infant died from a heart defect, and the other from sepsis, a blood infection that frequently occurs in preterm infants. The rate of sepsis (a serious blood infection) was roughly the same for both groups.

 

The study also evaluated the infants according to several secondary outcomes. The first of these, severe respiratory illness, included the need for CPAP therapy or supplemental oxygen for at least 12 continuous hours, a high concentration of oxygen for at least 24 hours, or mechanical ventilation. Again, the betamethasone group fared better, with 8.1% qualifying for this secondary outcome, a 33% reduction in serious respiratory illness compared to the placebo group. Infants in the betamethasone group also were less likely to experience transient tachypnea (fluid in the lungs) or bronchopulmonary dysplasia, tissue damage and scarring that may accompany oxygen or ventilator therapy. Infants in the betamethasone group were more likely to have low blood sugar than those in the placebo group (24% vs. 14.9%). According to the authors, the data support the monitoring of neonatal blood sugar levels when steroids are given in this situation.

 

According to the authors, overall, betamethasone administration for women at risk for late preterm delivery decreased the rate of respiratory complications in their infants. The authors added that although the drug increased the risk of low blood sugar in the infants, there were no other differences in complication rates between infants or their mothers.

 

Vibratory Urticaria – Genetic Cause of Rare Allergy to Vibration

 

In addition to itchy red welts at the site of vibration on the skin, people with vibratory urticaria also sometimes experience flushing, headaches, fatigue, blurry vision or a metallic taste in the mouth. Symptoms usually disappear within an hour, but those affected may experience several episodes per day. Running, hand clapping, towel drying or even taking a bumpy bus ride can cause temporary skin rashes in people with this rare disorder.

 

According to an article published online in the New England Journal of Medicine (3 February 2016) a genetic mutation has been identified that is responsible for vibratory urticaria. By studying affected families, the authors discovered how vibration promotes the release of inflammatory chemicals from the immune system’s mast cells, causing hives and other allergic symptoms. Mast cells, which reside in the skin and other tissues, release histamine and other inflammatory chemicals into the bloodstream and surrounding tissue in response to certain stimuli, a process known as degranulation.

 

The current study involved three families in which multiple generations experienced vibratory urticaria. The authors evaluated the first family under an ongoing clinical protocol investigating urticarias induced by a physical trigger. To assess potential mast cell involvement in vibratory urticaria, the authors measured blood levels of histamine during an episode of vibration-induced hives. Histamine levels rose rapidly in response to vibration and subsided after about an hour, indicating that mast cells had released their contents. The authors also observed increased tryptase, another marker of mast cell degranulation, in skin around the affected area. The authors noted that a small increase in blood histamine levels and a slight release of tryptase from mast cells was observed in the skin of unaffected individuals exposed to vibration suggesting that a normal response to vibration, which does not cause symptoms in most people, is exaggerated in patients with this inherited form of vibratory urticaria. The authors also realized that the first family’s symptoms matched those of a different family described at Yale in 1981. Through a collaboration with Yale, the authors obtained DNA samples from 25 members of that family. Two family members came to NIH for evaluation, and they put the research in contact with a third family with similar symptoms.

 

To identify the genetic basis of the disorder, the authors performed genetic analyses, including DNA sequencing, on 36 affected and unaffected members from the three families. Results showed a single mutation in the ADGRE2 gene shared by family members with vibratory urticaria but not present in unaffected people. The authors did not detect the ADGRE2 mutation in variant databases or in the DNA of more than 1,000 unaffected individuals with a similar genetic ancestry as the three families.

 

According to the authors, the ADGRE2 gene provides instructions for production of ADGRE2 protein, which is present on the surface of several types of immune cells, including mast cells. ADGRE2 is composed of two subunits — a beta subunit located within the cell’s outer membrane, and an alpha subunit located on the outside surface of the cell. Normally, these two subunits interact, staying close together. People with familial vibratory urticaria produce a mutated ADGRE2 protein in which this subunit interaction is less stable. After vibration, the alpha subunit of the mutant protein was no longer in close contact with the beta subunit. When the alpha subunit detaches from the beta subunit, the authors suggest that the beta subunit produces signals inside mast cells that lead to degranulation, which causes hives and other allergy symptoms. According to the authors, the research suggests that the ADGRE2 subunit interaction plays a key role in the mast cell response to certain physical stimuli, which could have implications for other diseases in which mast cells are involved. Next, the authors plan to study what happens to the alpha subunit post-vibration and to unravel the cellular signaling leading to degranulation. They also plan to recruit more families with vibratory urticaria to further study the disorder and look for additional mutations in ADGRE2 and other genes.

 

Dr. Rob Califf, Calls for Sweeping Review of Agency Opioid Policies

 

Opioids are a class of drugs that include prescription medications such as oxycodone, hydrocodone, and morphine, as well as the illicit drug heroin. Drug overdose deaths, driven largely by overdose from prescription opioids and illicit drugs like heroin and illegally-made fentanyl, are now the leading cause of injury death in the United States surpassing motor vehicle crashes.

 

In response to the opioid abuse epidemic, Dr. Robert Califf, the FDA’s Deputy Commissioner for Medical Products and Tobacco, along with other FDA leaders, called for a far-reaching action plan to reassess the agency’s approach to opioid medications. The plan will focus on policies aimed at reversing the epidemic, while still providing patients in pain access to effective relief. The FDA will:

 

Re-examine the risk-benefit paradigm for opioids and ensure that the agency considers their wider public health effects

Convene an expert advisory committee before approving any new drug application for an opioid that does not have abuse-deterrent properties;

Assemble and consult with the Pediatric Advisory Committee regarding a framework for pediatric opioid labeling before any new labeling is approved;

Develop changes to immediate-release opioid labeling, including additional warnings and safety information that incorporate elements similar to the extended-release/long-acting (ER/LA) opioid analgesics labeling that is currently required;

Update Risk Evaluation and Mitigation Strategy requirements for opioids after considering advisory committee recommendations and review of existing requirements;

Expand access to, and encourage the development of, abuse-deterrent formulations of opioid products;

Improve access to naloxone and medication-assisted treatment options for patients with  opioid use disorders; and

Support better pain management options, including alternative treatments.

 

As one of the cornerstones of this plan, the FDA will seek guidance from outside experts in the fields of pain management and drug abuse. For example, the FDA has already asked the National Academies of Sciences, Engineering, and Medicine to help develop a framework for opioid review, approval and monitoring that balances individual need for pain control with considerations of the broader public health consequences of opioid misuse and abuse. In addition, the FDA will convene independent advisory committees made up of physicians and other experts when considering for approval any new opioid drugs that do not contain abuse-deterrent properties. The FDA will also convene a meeting of its standing Pediatric Advisory Committee to make recommendations regarding a framework for pediatric opioid labeling and use of opioid pain medications in the pediatric population. The FDA is also strengthening the requirements for drug companies to generate post-market data on the long-term impact of using ER/LA opioids. The agency expects this to result in the most comprehensive data ever collected in the field of pain medicine and treatments for opioid use disorder. The data will further the understanding of the known serious risks of opioid misuse, abuse, overdose and death.

 

This renewed effort falls within the context of a broad national campaign that includes a major initiative led by HHS. Secretary Burwell has made addressing opioid abuse, dependence, and overdose a priority, and work is underway within HHS on this important issue. The evidence-based initiative focuses on three promising areas: informing opioid prescribing practices; increasing the use of naloxone, building on the FDA’s recent approvals of injectable and intranasal naloxone; and using medication-assisted treatment to move people out of opioid addiction. The FDA’s call to action is also supportive of the Centers for Disease Control and Prevention’s current work on guidelines for prescribing of opioids for the treatment of chronic pain outside of end of life care.

 

Zucchini Salmon Rolls with Tofutti & Dill

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A delicious appetizer! ©Joyce Hays, Target Health Inc.

 

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Here we are, starting the weekend with chilled white wine and zucchini salmon rolls.  ©Joyce Hays, Target Health Inc.

 

 

Ingredients

 

1/2 pound Nova Scotia salmon strips

1 container Tofutti, at room temperature

2 fresh garlic cloves, finely chopped

1 small bunch of chives, chopped

1 Tablespoon, plus 1 teaspoon, + extra, fresh dill, well chopped

Pinch black pepper

Pinch chili flakes

1/2 cup extra virgin olive oil

2 zucchini (about 8 inches long) cut in half (keep it raw)

 

 

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Just a few good ingredients for a wonderful appetizer ©Joyce Hays, Target Health Inc.

 

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This type of peeler is called a Y-peeler and better than a mandolin for this particular recipe. ©Joyce Hays, Target Health Inc.

 

 

Directions

 

1. Clean but don’t peel, then slice zucchini into very thin slices with a vegetable peeler (use a Y-peeler), which is probably easier, or mandolin.

 

 

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From two zucchinis, cut the ends off, then slowly peel long strips. ©Joyce Hays, Target Health Inc.

 

 

2. Lay the long strips of zucchini out on a cookie sheet and drizzle with olive oil and season with salt and pepper. Let the zucchini marinate in the olive oil for 5 minutes or more. Or marinate the strips in a bowl for 5 to 10 minutes.

 

 

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Here, I’m marinating the zucchini strips in a bowl. ©Joyce Hays, Target Health Inc.

 

3. Don’t peel the zucchini because the skin is healthy and thin enough to eat raw. Also, when you serve these delicious appetizers, you want to have the two shades of green for a more colorful presentation, whether you’re eating alone, with a spouse or partner, or giving a party.

 

4. Make the salmon filling: Chop the smoked salmon into very small pieces (smaller than a dime; about as small as the nail on your pinky finger

 

 

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Mixing all ingredients together for the filling. ©Joyce Hays, Target Health Inc.

 

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Save a tiny bit of the salmon for garnishing. ©Joyce Hays, Target Health Inc.

 

 

5. In a large bowl, mix together the smoked salmon, tofutti, garlic, dill, black pepper, chili flakes and chives.

 

 

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Spoon the filling, thinly, over each strip, then roll them up. ©Joyce Hays, Target Health Inc.

 

 

6. Place a spoonful of filling over each zucchini slice and roll up.

 

 

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Roll each strip up and secure with toothpick. Voila, you’re done! ©Joyce Hays, Target Health Inc.

 

 

7. Close each slice with a toothpick. Garnish with tiny pinches of well chopped fresh dill or a tiny piece of salmon. Keep chilled until ready to serve.

 

Serve with a good appetite.

 

 

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This is a slightly different but elegant appetizer and surprisingly easy to do. Quick too! And, btw, they will disappear fast, so have extra in the fridge. (Before garnishing with salmon) ©Joyce Hays, Target Health Inc.

 

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Went very with this chilled Sauvignon Blanc ©Joyce Hays, Target Health Inc.

 

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One of our favorite (if not THE favorite) white wines is Stag’s Leap Cellars, Napa, Sauvignon Blanc.  ©Joyce Hays, Target Health Inc.

 

 

We had such a wonderful weekend, I’m still glowing.  As you see above, Friday night, we started with the above.  These zucchini/salmon appetizers are so good, you could make a whole meal of them.  However, we continued with my recipes for kale/mushroom patties with avocado topping, saffron rice with toasted pine nuts and mulberries, and broccoli stuffed potatoes.  For dessert we had a recipe in progress— butternut puree with marron glace.

 

Saturday, we went to the MetOpera for Cavalleria Rusticana & Pagliacci.  As the MetOpera puts it: Cav & Pag). They are favorites for very good reasons.  Opera houses are places of mystery and beauty.  You enter a world very different from the one you just stepped out of.  Everyone is in an anticipatory receptive mood.  Graciousness is everywhere.  Light dim and the music begins.  You are vaulted elsewhere.  We have been attending operas since we were very young and we love this experience more than ever.  We cannot imagine a life without music.

 

Here’s a link to the gorgeous Intermezzo from Cav; and, since you know the well-known tenor aria from Pag, we will give a link for another golden moment, Tonio’s Prologo, sung here by the great baritone, Leonard Warren. Does this surprise you? We searched for the best rendition of this aria and passed over vigorous Jose Cura and others, for the mellow gorgeous voice of Leonard Warren. Take a few minutes to relax and give yourself over to this beautiful music. Music is like oxygen, you cannot go for very long without it. Music triggers something in the depths of the soul, a soothing balm that sooths, heals and renders us better humans.

 

 

From Our Table to Yours!

 

Bon Appetit!