Clinical Trials of the Future

 

Target Health Inc. is the industry leader and champion of the fully integrated paperless clinical trial. We also “put our money where our mouth is“ with an FDA approval last December that used our web-based eSource solution for data entry at the time of the patient encounter, and an NDA program with 7 studies where 90% of the clinical trial data needed for FDA review was entered in real time. Many ongoing programs including pivotal trials in ADHD and autism.  Next year you will see programs with full integration with the electronic health record and the “virtual clinical trial.

 

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Sunrise to Sunset the Big Apple: View From Target Health’s Offices at 261 Madison Avenue (24th Floor)

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Sunrise to Sunset:  View from Target Health ©Jules Mitchel

 

How beautiful it is watching the greatest city in the world wake up and go to sleep each day. Photographed using the iPhone 6. 

 

For more information about Target Health contact Warren Pearlson (212-681-2100 ext. 165). 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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Biometrics: Wearable Tattoo Sends Alcohol Levels to your Cell Phone Contributes to the Public Health

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Credit: American Chemical Society; ScienceDaily.com

 

Engineers funded by the National Institute of Biomedical Imaging and Bioengineering (NIBIB) have developed a small monitoring device, worn on the 1) ___, that detects alcohol levels in perspiration. It was designed as a convenient method for individuals to monitor their alcohol intake, which could help reduce unsafe drinking that can lead to vehicle crashes, violence, and the degeneration of the health of heavy 2) ___. The wearable sensor uses a method called iontophoresis to induce perspiration. The unit then measures the alcohol content and sends it to the user’s cell 3) ___.

 

A collaboration of nanoengineers and electrical and computing engineers at the University of California, San Diego in La Jolla combined their expertise to create the small device that detects 4) ___ levels and transmits that information to a cell phone or other monitoring station. Their work is reported in the July issue of the journal ACS Sensors. Seila Selimovic, Ph.D., director of the NIBIB Program in Tissue Chips, explains the new technology. “It resembles a temporary 5) ___, but is actually a biosensor patch that is embedded with several flexible wireless components. One component releases a chemical that stimulates perspiration on the skin below the 6) ___. Another component senses changes in the electrical current flowing through the generated sweat, which measures alcohol levels and sends them to the user’s cell phone.“

 

Approximately 88,000 people in the U.S. die from alcohol-related causes including driving fatalities, which accounted for nearly 10,0007) ___ in 2014. This significant problem has been addressed by the use of blood tests or breathalyzers by law enforcement.

 

The new wearable monitor has the advantage of being non-invasive and unseen by others, for example, in a bar — features that could make its use more attractive to individuals. Given these features, the researchers believe the device has great potential for people to self-monitor their alcohol intake and avoid 8) ___ if they have had too much to drink. Patrick Mercier, Ph.D. at UCSD’s Jacobs School of Engineering and co-senior author elaborates on the advantages of their technology design. “Measuring alcohol in 9) ___ has been attempted before, but those technologies took 2-3 hours to measure alcohol levels. Our patch sends alcohol levels to your smartphone in just 8 minutes, making real-time alcohol monitoring possible, practical, and personal.“

 

This work was supported by the National Institutes of Health through the National Institute of Biomedical Imaging and Bioengineering grant # EB019698. Additional funding was provided by the Defense Threat Reduction Agency, the UCSD Center of Wearable Sensors, and the Thai Development and Promotion of Science and Technology Talents.

Sources: National Institute of Biomedical Imaging and Bioengineering; Authors: Jayoung Kim, Itthipon Jeerapan, Somayeh Imani, Thomas N. Cho, Amay Bandodkar, Stefano Cinti, Patrick P. Mercier, Joseph Wang. Noninvasive Alcohol Monitoring Using a WearableTattoo-Based Iontophoretic-Biosensing System. ACS Sensors; ScienceDaily.com

 

ANSWERS: 1) skin; 2) drinkers; 3) phone; 4) alcohol; 5: tattoo 6) patch; 7) deaths; 8) driving; 9) sweat

 

Tracing the History of Biometrics

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Fingerprint being scanned. Credit: Rachmaninoff – Own work, CC BY-SA 3.0; Wikimedia Commons (Wikipedia)

 

 

While in today’s world biometrics uses cutting-edge technologies to identify terrorists and criminals, the practice of distinguishing humans based on intrinsic physical or behavior traits goes back thousands of years.

 

Fingerprints have been found on ancient Babylonian clay tablets, seals, and pottery, as early as 500 BCE. They have also been found on the walls of Egyptian tombs and on Minoan, Greek, and Chinese pottery, as well as on bricks and tiles from ancient Babylon and Rome. Some of these fingerprints were deposited unintentionally by the potters and masons as a natural consequence of their work, and others were made in the process of adding decoration. However, on some pottery, fingerprints have been impressed so deeply into the clay that they were possibly intended to serve as an identifying mark by the maker. Fingerprints were used as signatures in ancient Babylon in the second millennium BCE. In order to protect against forgery, parties to a legal contract would impress their fingerprints into a clay tablet on which the contract had been written. By 246 BCE, Chinese officials were impressing their fingerprints into the clay seals used to seal documents. With the advent of silk and paper in China, parties to a legal contract impressed their handprints on the document. Sometime before 851 CE, an Arab merchant in China, Abu Zayd Hasan, witnessed Chinese merchants using fingerprints to authenticate loans. By 702, Japan allowed illiterate petitioners seeking a divorce to “sign“ their petitions with a fingerprint.

 

Although ancient peoples probably did not realize that fingerprints could uniquely identify individuals, references from the age of the Babylonian king Hammurabi (reigned 1792-1750 BCE) indicate that law officials would take the fingerprints of people who had been arrested. During China’s Qin Dynasty, records have shown that officials took hand prints, foot prints as well as finger prints as evidence from a crime scene. In China, around 300 CE, handprints were used as evidence in a trial for theft. By 650, the Chinese historian Kia Kung-Yen remarked that fingerprints could be used as a means of authentication. In his Jami al-Tawarikh (Universal History), the Persian physician Rashid-al-Din Hamadani (also known as “Rashideddin“, 1247-1318) refers to the Chinese practice of identifying people via their fingerprints, commenting: “Experience shows that no two individuals have fingers exactly alike.“ In Persia at this time, government documents may have been authenticated with thumbprints.

 

In 1665, the Italian physician Marcello Malpighi (1628-1694) briefly mentioned the existence of patterns of ridges and sweat glands on the fingertips. In 1684, the English physician, botanist, and microscopist Nehemiah Grew (1641-1712) published the first scientific paper to describe the ridge structure of the skin covering the fingers and palms. In 1685, the Dutch physician Govard Bidloo (1649-1713) published a book on anatomy which also illustrated the ridge structure of the fingers. A century later, in 1788, the German anatomist Johann Christoph Andreas Mayer (1747-1801) recognized that fingerprints are unique to each individual. Jan Evangelista Purkinje (1787-1869), a Czech physiologist and professor of anatomy at the University of Breslau, published a thesis in 1823 discussing 9 fingerprint patterns, but he did not mention any possibility of using fingerprints to identify people.

 

By the mid-1800s, the industrial revolution sparked rapid city growth, and a standard form of identifying the general public – and criminals – was necessary. Some police adopted the Bertillon system (a.k.a. anthropometrics), invented in France, which recorded arm-length, height and other body measurements on index cards. However, with no standards in place, errors were frequent. Measuring one metric – a fingerprint – became the method of choice in the late 1800s when Edward Henry, inspector general of police in Bengal, India, created the Henry System, a classifying system that’s still used today. In 1840, following the murder of Lord William Russell, a provincial doctor, Robert Blake Overton, wrote to Scotland Yard suggesting checking for fingerprints but the suggestion, though followed up, did not lead to their routine use by the police for another 50 years. Some years later, the German anatomist Georg von Meissner (1829-1905) studied friction ridges, and five years after this, in 1858, Sir William James Herschel initiated fingerprinting in India. In 1877 at Hooghly (near Calcutta) he instituted the use of fingerprints on contracts and deeds to prevent the then-rampant repudiation of signatures and he registered government pensioners’ fingerprints to prevent the collection of money by relatives after a pensioner’s death. Herschel also fingerprinted prisoners upon sentencing to prevent various frauds that were attempted in order to avoid serving a prison sentence.

 

In 1863, Paul-Jean Coulier (1824-1890), professor for chemistry and hygiene at the medical and pharmaceutical school of the Val-de-Grace military hospital in Paris, discovered that iodine fumes can reveal fingerprints on paper. In 1880, Dr. Henry Faulds, a Scottish surgeon in a Tokyo hospital, published his first paper on the subject in the scientific journal Nature, discussing the usefulness of fingerprints for identification and proposing a method to record them with printing ink. He also established their first classification and was also the first to identify fingerprints left on a vial. Returning to the UK in 1886, he offered the concept to the Metropolitan Police in London but it was dismissed at that time. Faulds wrote to Charles Darwin with a description of his method but, too old and ill to work on it, Darwin gave the information to his cousin, Francis Galton, who was interested in anthropology. Having been thus inspired to study fingerprints for ten years, Galton published a detailed statistical model of fingerprint analysis and identification and encouraged its use in forensic science in his book Finger Prints. He had calculated that the chance of a “false positive“ (two different individuals having the same fingerprints) was about 1 in 64 billion. Juan Vucetich, an Argentine chief police officer, created the first method of recording the fingerprints of individuals on file, associating these fingerprints to the anthropometric system of Alphonse Bertillon, who had created, in 1879, a system to identify individuals by anthropometric photographs and associated quantitative descriptions. In 1892, after studying Galton’s pattern types, Vucetich set up the world’s first fingerprint bureau. In that same year, Francisca Rojas of Necochea, was found in a house with neck injuries, whilst her two sons were found dead with their throats cut. Rojas accused a neighbor, but despite brutal interrogation, this neighbor would not confess to the crimes. Inspector Alvarez, a colleague of Vucetich, went to the scene and found a bloody thumb mark on a door. When it was compared with Rojas’ prints, it was found to be identical with her right thumb. She then confessed to the murder of her sons.

 

A Fingerprint Bureau was established in Calcutta (Kolkata), India, in 1897, after the Council of the Governor General approved a committee report that fingerprints should be used for the classification of criminal records. Working in the Calcutta Anthropometric Bureau, before it became the first Fingerprint Bureau in the world, were Azizul Haque and Hem Chandra Bose. Haque and Bose were Indian fingerprint experts who have been credited with the primary development of a fingerprint classification system eventually named after their supervisor, Sir Edward Richard Henry. The Henry Classification System, co-devised by Haque and Bose, was accepted in England and Wales when the first United Kingdom Fingerprint Bureau was founded in Scotland Yard, the Metropolitan Police headquarters, London, in 1901. Sir Edward Richard Henry subsequently achieved improvements in dactyloscopy.

 

In the United States, Dr. Henry P. DeForrest used fingerprinting in the New York Civil Service in 1902, and by 1906, New York City Police Department Deputy Commissioner Joseph A. Faurot, an expert in the Bertillon system and a finger print advocate at Police Headquarters, introduced the fingerprinting of criminals to the United States. The Scheffer case of 1902 is the first case of the identification, arrest and conviction of a murderer based upon fingerprint evidence. Alphonse Bertillon identified the thief and murderer Scheffer, who had previously been arrested and his fingerprints filed some months before, from the fingerprints found on a fractured glass showcase, after a theft in a dentist’s apartment where the dentist’s employee was found dead. It was able to be proved in court that the fingerprints had been made after the showcase was broken. A year later, Alphonse Bertillon created a method of getting fingerprints off smooth surfaces and took a further step in the advance of dactyloscopy.

 

Many criminals wear gloves to avoid leaving fingerprints. However, the gloves themselves can leave prints that are as unique as human fingerprints. After collecting glove prints, law enforcement can match them to gloves that they have collected as evidence or to prints collected at other crime scenes. In many jurisdictions the act of wearing gloves itself while committing a crime can be prosecuted as an inchoate offense. As many offenses are crimes of opportunity, assailants do not always possess gloves when they commit their illegal activities. Thus, assailants have been observed using pulled-down sleeves, pieces of clothing, and other fabrics to handle objects and touch surfaces while committing crimes. With the widespread use of computers in the late 20th century, new possibilities for digital biometrics emerged. Although the idea to use the iris for identification purposes was suggested in the 1930s, the first iris recognition algorithm wasn’t patented until 1994 and became available commercially the next year. At the 2001 Super Bowl in Tampa, Fla., face recognition was used to capture an image of each of the 100,000 fans via a security camera and checked electronically against mug shots from the Tampa police. Federal government coordination started in 2003 with the National Science and Technology Council establishing an official subcommittee on biometrics, and a year later the Department of Defense implemented the Automated Biometric Identification System (ABIS) to help track and identify national security threats.

 

Elevated Basal Serum Tryptase

 

Elevated basal serum tryptase levels are present in 4-6% of the general population, but the cause and relevance of such increases are unknown. Previously, NIAID researchers had observed that a combination of chronic and sometimes debilitating symptoms, such as hives, irritable bowel syndrome and overly flexible joints, runs in some families and is associated with high tryptase levels. Many affected family members with high tryptase also reported symptoms consistent with disorders of autonomic nervous system function (dysautonomia), including postural orthostatic tachycardia syndrome (POTS) , which is characterized by dizziness, faintness and an elevated heartbeat when standing up.

 

According to a paper published online in Nature Genetics (17 October 2016), the search for the genetic cause of high tryptase was identified by studying severely affected families. The study identified a genetic explanation for a syndrome characterized by multiple frustrating and difficult-to-treat symptoms, including dizziness and lightheadedness, skin flushing and itching, gastrointestinal complaints, chronic pain, and bone and joint problems. Some people who experience these diverse symptoms have elevated levels of tryptase — a protein in the blood often associated with allergic reactions. Multiple copies of the alpha tryptase gene drive these tryptase elevations and may contribute to the symptoms. Other studies have indicated that 4-6% of the general public has high tryptase levels. While not all of these people experience symptoms, many do, raising the possibility that this mildly prevalent trait in some cases drives the symptoms, although how it does so remains unclear.

 

In the current study, the authors describe how they identified a genetic cause of high tryptase by studying these severely affected families. Initial analyses pointed the authors to the alpha tryptase gene, and they designed a novel laboratory test to detect the number of alpha tryptase gene copies. Analysis of 96 affected and 41 unaffected members from 35 families confirmed that all affected family members had inherited multiple copies of the alpha tryptase gene. Laboratory experiments suggested that the additional copies were leading to increased production and release of alpha tryptase protein from immune cells. Moreover, the authors found that additional gene copies were associated with more severe effects. Family members with three copies of the alpha tryptase gene had higher tryptase levels and reported experiencing more symptoms than those who had two copies.

 

The authors next investigated this genetic change in a general population. They assessed a group of NIH patients who had their DNA sequenced for reasons unrelated to tryptase, as well as a group of healthy unrelated volunteers from the ClinSeq study, — 172 people in total. To the authors’ surprise, all those with high blood levels of tryptase also had duplications of the alpha tryptase gene. Many people with the duplicate gene reported experiencing symptoms similar to those seen in the original group of severely affected families, including irritable bowel syndrome, skin flushing and itching. According to the authors, the families they originally studied may be among the more severely affected on a spectrum of disease, while some people with alpha tryptase gene duplications experience few or mild symptoms. Additionally, it’s important to note that many people with normal tryptase levels also suffer from these problems.

 

Although more research is needed to understand how elevated tryptase contributes to this constellation of symptoms, this study helps set the stage for future advances in diagnosis and treatment. For example, further development of the laboratory test to detect alpha tryptase gene copies eventually could lead to a diagnostic test that could be used clinically to identify people with this genetic change. The authors also are planning to develop strategies to block alpha tryptase, which potentially could ease the health problems associated with additional copies of the gene.

 

Guillain-Barre Syndrome Associated with Zika Virus Infection in Colombia

 

Zika virus (ZIKV) infection has been linked to the Guillain-Barre syndrome. From November 2015 through March 2016, clusters of cases of the Guillain-Barre syndrome were observed during the outbreak of ZIKV infection in Colombia. As a result, a study published in the New England Journal of Medicine (2016; 375:1513-1523), attempted to characterized the clinical features of cases of Guillain-Barre syndrome in the context of this ZIKV infection outbreak, and investigated their relationship with ZIKV infection.

 

For the study, a total of 68 patients with the Guillain-Barre syndrome at six Colombian hospitals were evaluated clinically, and virologic studies were completed for 42 of the patients. Reverse-transcriptase-polymerase-chain-reaction (RT-PCR) assays were performed for ZIKV in blood, cerebrospinal fluid, and urine, as well as antiflavivirus antibody assays.

 

A total of 66 patients (97%) had symptoms compatible with ZIKV infection before the onset of the Guillain-Barre syndrome. The median period between the onset of symptoms of ZIKV infection and symptoms of the Guillain-Barre syndrome was 7 days (interquartile range, 3 to 10). Among the 68 patients with the Guillain-Barre syndrome, 50% were found to have bilateral facial paralysis on examination. Among 46 patients in whom nerve-conduction studies and electromyography were performed, the results in 36 patients (78%) were consistent with the acute inflammatory demyelinating polyneuropathy subtype of the Guillain-Barre syndrome. Among the 42 patients who had samples tested for ZIKV by RT-PCR, the results were positive in 17 patients (40%). Most of the positive RT-PCR results were in urine samples (in 16 of the 17 patients with positive RT-PCR results), although 3 samples of cerebrospinal fluid were also positive. In 18 of 42 patients (43%) with the Guillain-Barre syndrome who underwent laboratory testing, the presence of ZIKV infection was supported by clinical and immunologic findings. In 20 of these 42 patients (48%), the Guillain-Barre syndrome had a parainfectious onset. All patients tested were negative for dengue virus infection as assessed by RT-PCR.

 

According to the authors, the evidence of ZIKV infection documented by RT-PCR among patients with the Guillain-Barre syndrome during the outbreak of ZIKV infection in Colombia lends support to the role of the infection in the development of the Guillain-Barre syndrome.

 

FDA/EMA Initiate Rare Diseases and Patient Engagement Clusters

 

Dr. Jules Mitchel, President of Target Health, had the honor to be on a panel with Dr. Jonathan Goldsmith at the annual NORD meeting this past week.

 

The following was posted on October 18, 2016 by FDA Voice and authored by Jonathan Goldsmith, M.D., FACP, and Sandy Kweder, M.D., RADM (Ret.) US Public Health Service:

 

Drug development and approval happens across the globe and FDA strives to collaborate with other countries and international regulatory agencies to ensure public health. One of FDA’s most valuable collaborators is the European Medicines Agency (EMA) – its counterpart agency for drug regulation in Europe that coordinates a network of 4,500 scientists and evaluates and supervises medicines for more than 500 million people in 31 countries.

 

For more than a decade, FDA and EMA scientists have collaborated to help solve some of our biggest challenges. FDA works with them in groups called “clusters.“ The first cluster was initiated in 2004. Since then clusters have been formed to focus on treatments for children; establish effective measures for the development and use of biosimilar medications as cost effective alternatives to brand name biologic drugs; evaluate new treatments for patients with cancer; set standards to help develop medicines personalized to a patient’s genetic makeup, and much more. Both agencies have benefited from this joint work. The EMA summarizes these and our other clusters on its website.

 

Just last month FA and EMA established a cluster that will work to advance treatments for patients with rare diseases. This cluster’s primary goal is for FDA and EMA scientists to share valuable information about their work and to collaborate on certain review aspects of rare disease drug development programs. FDA’s core members of the cluster include experts from FDA’s Center for Drug Evaluation and Research’s Rare Diseases Program, the Office of Pediatric Therapeutics, the Center for Biologics Evaluation and Research’s director’s office, and the Office of Orphan Products Development, but other experts will be engaged on specific topic areas as the cluster evolves. Among many other important activities, our agencies will collaborate on:

 

1. Identification and validation of trial end points;

2. Potential trial designs when only small populations of patients are available for testing the safety and effectiveness of prospective new therapies;

3. Ways to apply flexibility in evaluation of drug development programs;

4. Expediting the review and approval of drugs to treat rare diseases to bring new drugs to patients in need as soon as possible.

 

FDA and EMA’s work also builds on another exciting and recent development – a patient engagement cluster formed in June 2016 to incorporate the patient’s involvement and viewpoint in the drug development process. FDA and EMA are interested in understanding patient’s experiences and gaining input on their tolerance for risk and uncertainty, on current therapy and its benefits or shortcomings and on the benefits that patients seek. This cluster, among other valuable efforts, will:

 

1. Help each agency learn how the other involves patients in their work, and to develop common goals of expanding future engagement activities with patients;

2. Discuss ways for finding patients that can serve as spokespersons for their community;

3. Explore ideas to help train selected patients and advocates to effectively participate in agency activities, and;

4. Develop strategies for reporting the significant impact of patient involvement.

 

Given the focus of both of these new clusters, FDA expects that they will address new areas of interest and also draw on expertise from all of the other clusters, such as oncology, pediatrics, and orphan diseases, contributing to more advanced and robust collaborations across both of our organizations. Focusing on patients with rare diseases and working to advance patient input enhances the value of the cluster activities. And finally, it is hoped that with their colleagues at the EMA, each can accomplish more together than what could be done individually.

 

Jonathan C. Goldsmith, M.D., FACP, FDA’s Associate Director, Rare Diseases Program, Center for Drug Evaluation and Research, Office of New Drugs

Sandra Kweder, M.D., Rear Admiral (Ret.) US Public Health Service, FDA’s Deputy Director, Europe Office, and Liaison to European Medicines Agency

 

Torta di Spinaci con Formaggio, uva e Mandorle Tostate

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This is not risotto; however, there is one similarity.  To make risotto, the rice is always cooked in a broth.  In this recipe, the rice is cooked in chicken stock or broth, but there are many more ingredients than you would find in a risotto.  This dish is not better than risotto, just different.  ©Joyce Hays, Target Health Inc.

 

 

Ingredients

 

2 pounds fresh spinach (about 3 bunches), washed three times

1 cup red seedless grapes, washed well and cut in half

1 red onion

10 fresh garlic cloves, sliced

1 1/2 cups Carnaroli or Arborio rice

Pinch Salt and pepper

Pinch chili flakes

1 teaspoon turmeric

2 Tablespoons butter, plus more to butter the baking dish

1 cup freshly grated Parmesan

1 cup slivered almonds

1 heaping Tablespoon black mustard seeds

1 cup ricotta

1 cup freshly grated Gruyere

1/4 cup currants

1/4 cup dried cranberries

Pinch of grated nutmeg

1 teaspoon grated lemon zest

1 teaspoon fresh lemon juice

1 teaspoon fresh parsley, well chopped

1 teaspoon fresh thyme, well chopped

1 teaspoon fresh sage, well chopped

 

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Directions

 

1. Spinach is grown in a sandy soil, so fresh spinach (even if It comes in a plastic bag or box) needs to be rinsed well two or three times, or you take the chance of ruining all your cooking, when you (and hopefully not guests) start to eat. There’s nothing worse than taking a first bite, and feeling your teeth crunch down on grains of sand, or grit. So, first step is to wash all the spinach leaves well at least two times, if not three.

2. Use a large pot and add chicken stock or broth. Bring to a boil. Add spinach and wilt it by cooking for 30 seconds, no longer. Remove with a wire mesh spider or tongs and rinse in a colander with cold water. Squeeze dry, first with your hands, and then with paper towel. Chop roughly, not in small pieces.

 

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Cook the fresh (washed 3 times first) spinach in chicken stock or broth. ©Joyce Hays, Target Health Inc.

 

 

3. In the same pot, boil the rice for 10 minutes, keeping it slightly underdone. Drain and spread on a baking sheet to cool, then transfer to a large bowl.

 

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After spinach has wilted and you’ve removed it from the pot, add the rice, as you see above. ©Joyce Hays, Target Health Inc.

 

 

4. While rice is cooking, do all your cutting, chopping and grating.

 

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Chopping onion and garlic. ©Joyce Hays, Target Health Inc.

 

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Rinse, dry and cut the grapes. ©Joyce Hays, Target Health Inc.

 

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Chop all your fresh herbs at the same time. ©Joyce Hays, Target Health Inc.

 

 

5. Heat oven to 375 degrees. Butter a 2-quart souffl? dish (or other baking dish) and dust with about 2 Tablespoons grated Parmesan.

6. Melt 2 Tablespoons butter in a small skillet over medium heat. Cook the onion and garlic, until it’s transparent. When done, add to the bowl with rice.

 

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Cooking the onion & garlic in butter. ©Joyce Hays, Target Health Inc.

 

 

7. Use the same small pan you cooked the onions & garlic in, and add almonds and the mustard seeds and cook, stirring, until golden, about 2 minutes. Watch out for mustard seeds popping out of the pan or in your eye. You can cover the pan, however, you still have to stir constantly. Season lightly with salt and add contents of skillet to the bowl with rice. Scrape everything out with a spatula.

 

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Adding almond slivers & black mustard seeds to cook with the onions & garlic. ©Joyce Hays, Target Health Inc.

 

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Adding cooked contents of skillet (look at the golden brown almonds) to the bowl with the cooked rice. Stir to combine. ©Joyce Hays, Target Health Inc.

 

 

8. Add remaining Parmesan to rice, along with the ricotta, Gruyere, dried cranberries, currants, red grapes, nutmeg, turmeric, chili flakes, fresh lemon juice, lemon zest, thyme, parsley and sage. Season lightly with salt and add pepper to taste.

 

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Adding the fruit to the bowl. Stir to combine. ©Joyce Hays, Target Health Inc.

 

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First added all spices, herbs, lemon, etc.; then added all the cheese. Stir to combine. ©Joyce Hays, Target Health Inc.

 

 

9. Add chopped spinach and gently toss rice to distribute ingredients evenly. Transfer mixture to prepared baking dish.

 

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Finally, add the cooked spinach and stir to combine all ingredients well. ©Joyce Hays, Target Health Inc.

 

 

10. Cover and bake for 30 minutes.

11. Finally, dust the top with a little more freshly grated Parmesan, keep uncovered and bake 10 minutes more, until top is browned.

 

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A perfect lunch, brunch, simple supper, or tasty side dish with fish or poultry. ©Joyce Hays, Target Health Inc.

 

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A very affordable French red Bordeaux. Fine for the spinach/rice recipe, but could have been a little less dry, for my taste, and not the best for the duck.  ©Joyce Hays, Target Health Inc.

 

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Because we had duck (an experiment, not bad, but not yet ready to share) with the spinach-cheese pie, we decided to have a nice Bordeaux. ©Joyce Hays, Target Health Inc.

 

The Big Apple is beautiful this time of year, with cool crisp days and nights. We went to the MetOpera this weekend and saw an adequate production of Don Giovanni.  The voices were fine, of course, the music was gorgeous, the set designs were terrible.

 

Take a listen below of two of the magnificent arias from this opera.

 

Luciano Pavarotti, the greatest tenor that ever lived, singing:- Dalla sua Pace – Don Giovanni

 

Placido Domingo – Il mio tesoro (Don Giovanni)

 

 

From Our Table to Yours !

 

Bon Appetit!