Target Health Inc. Attending NORD Rare Disease & Orphan Products Breakthrough Summit

 

As part of our committment to Orphan Drugs, Dr. Jules Mitchel, President of Target Health will participate on a panel entitiled: “The Path to Progress – Rise in Orphan Drug Approvals and Breakthrough Designations,” being held at the NORD Rare Disease & Orphan Products Breakthrough Summit (Wednesday, October 21, 2015. 2-3 pm) in Arlington, VA.

 

Panelists include:

 

Peter Marks, MD, PhD, Deputy Director, CBER, FDA

Jules T. Mitchel, MBA, Ph.D., Co-Founder, Target Health Inc.

Jeff Allen, Executive Director, Friends of Cancer Research

Amit Sachdev, Executive Vice President, Policy, Access and Value, Vertex

 

Moderator:

 

Gayatri R. Rao, MD, JD, Director, Office of Orphan Products Development, FDA

 

This is an hour-long plenary session.  During the first 10 minutes, the moderator will provide context by discussing recent data related to orphan drug designation, approvals, breakthrough designation, etc.  The remainder of the session will be an informal Q/A between and among the moderator, panel members, and the audience.

 

Red-banded Hairstreak (Calycopis cecrops) – James Farley Does it Again

 

From James to the readers of On Target:

 

This is a real macro photo of a real butterfly. The photo was captured outdoors – on Labor Day afternoon – in a beautiful little garden, here in North Carolina. It took me a couple days to figure out what species and subspecies this butterfly is. After narrowing it down and confirming, I found this text on Wikipedia, to give you an idea about the range and size: “The red-banded hairstreak (Calycopis cecrops) is a butterfly native to the southeastern United States. It feeds on fallen leaves of sumac species and other trees. Its size ranges from 0.9-1.25 inches (23-32 mm). It lives near coastal areas.”

 

 

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Red-banded Hairstreak (Calycopis cecrops)

 

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

 

Dental Progress (fill in the blanks)

 

Teeth have always been a problem for humans. The first society to use dental bridges and appliances were the Etruscans, starting around 700 BCE. The image below shows a similar dental bridge created by the Egyptians that uses gold wires to hold the teeth together. This is also the first incarnation of a cosmetic dental practice that would come to be known as “bling“.

 

 

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We’ve come a long way, since the above dentistry, but considering that this bridge was created 2500 years ago, dental progress has been relatively slow. Finally, we have the dental laser, promising a pain-free & stress-free experience at the dentist.

 

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Biolase, Inc. is an international dental equipment and medicine system manufacturer and supplier. It was founded in 1984 and was formerly known as Biolase Technology Inc. In 2013, The company was the winner of the 15th Annual Medical Design Excellence Awards for its design of the product, EPIC 10 diode soft-tissue laser platform. The award is the premier competition for the medicine design industry. The laser products of the company incorporate about 290 patented and patent-pending technologies. The company distributes laser and related medical equipment for dentists, surgeons and other professionals. As of December 31, 2011, it has sold about 8,700 Waterlase systems, which is one of the company’s medicine system products, and over 19,000 laser systems in about 60 countries worldwide. In April 2012, the company acquired159 Waterlase MD Turbo laser systems, which is a part of the company’s dental laser system, from Henry Schein, Inc.

 

Can lasers that cut gum, tooth and bone, really end the rule of the turbine dental drill? Allen Helfer is able to perform root canals on his dental patients without using anesthesia. Instead of boring into teeth with an excruciating turbine-driven 1) ___, the professor of dentistry at Columbia University’s School of Dental & Oral Surgery slices painlessly through gum, tooth and bone with a laser beam. A visit to the oral surgeon will always remain low on the list of pleasant things to do, but the days of throbbing jaws and numbed mouths are drawing to a close. Dentistry is painful because drills are messy and hot. Friction builds up between the drill and the tooth, heating up the enamel and causing nerves to flare. A drill’s vibrations can also weaken the 2) ___ by creating small cracks and fissures in the tooth’s surface. Dental lasers take away all that trouble. They cut by vaporizing the water molecules inside soft, wet 3) ___. An ingenious new laser called Waterlase adds to that the ability to cut through dry teeth and bone by casting a cloud of hot water vapor around the laser’s cutting point, a couple of millimeters from the tooth. The excited water molecules dissipate their energy by bashing against the enamel and bone. Even as the tooth is being cut, it never gets hot, and there is little pain. “It’s basically a microexplosion,“ says Ioana Rizoiu, the head of research and clinical development at Biolase Technology, the San Clemente, Calif. company that created the Waterlase

 

Some 1,500 Waterlase machines have been sold in the U.S. since it won approval from the FDA (4) ___ & ___ ___) in October 1998 for preparing cavities to be filled. Sales have risen steadily since, with Waterlase winning subsequent approvals for root canals in January 2002, bone surgery in February 2002 and root canal complications in February 2003. Biolase’s sales surged 63% to $29 million last year, helping it turn a $2.6 million profit, its first. Chief Executive Jeffrey Jones expects sales to jump at least 40% in following years. There are 140,000 dentists in the U.S.; most of them are general practitioners who work alone and still use anesthesia and 5) ___ drills. Biolase’s competitors include Lumenis, in Israel, and Hoya ConBio, in Fremont, Calif.

 

Some dentists will be reluctant to go vibration-free. The $50,000 price tag on the Waterlase is 33 times that on a high-speed dental drill. But there are compelling reasons to switch. Biolase’s Jones says the Waterlase can generate $1,000 a day as procedures are done more 6) ___, with less delay for anesthesia and fewer complications. Moreover, the laser, which resembles a dental drill in shape, can do things a dentist would never do with a drill, like cut gums. And the laser cuts gums without causing much bleeding. Switching to the laser cuts the price a consumer pays for cosmetic crown-lengthening, used to make teeth look bigger, from $7,000 to $3,000.

 

Jason Doucette, a 30-year-old cosmetic dentist in Reno, Nev., says he occasionally uses anesthesia with his Waterlase and that the laser is useless on silver fillings, which act like mirrors. But most patients are able to get a 7) ___ repaired without a shot to numb them. Another reason the Waterlase and Biolase’s other product, a tooth-whitening laser, appeal to customers is that they sound so high tech. “It’s definitely a huge marketing tool,“ says Doucette. Pain-free chair time can sell even some of the toughest customers’ kids. Barry Jacobson, director of pediatric dentistry at Mount Sinai Hospital in New York, found the “drill“ especially helpful for kids who were allergic to anesthesia or were already on drugs that could interact with painkillers. “Kids love it,“ says Jacobson. “It’s a huge advancement in dentistry for 8) ___, and I don’t think there’s any way you can go back.“ In fact, Jacobson likes the Waterlase so much that he now has two. “Ultimately,“ he says, “Every dentist will have one.“

Source: Forbes, by Matthew Herper; Wikipedia; WebMD.com

 

ANSWERS: 1) drill; 2) tooth; 3) gums; 4) Food & Drug Administration; 5) turbine; 6) quickly; 7) cavity; 8) children

 

Take a look at the Waterlase in action

 

The Crimean War (the first one) & Florence Nightingale

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The Russian destruction of the Turkish fleet at the Battle of Sinop on 30th of November 1853 sparked the Crimean war; painting by Ivan Aivazovsky

 

 

For over 200 years, Russia had been expanding southwards across the sparsely populated “Wild Fields” toward the warm water ports of the Black Sea that did not freeze over like the handful of other ports available in the north. The goal was to promote year-round trade and a year-round navy. Pursuit of this goal brought the emerging Russian state into conflict with the Ukrainian Cossacks and then with the Tatars of the Crimean Khanate and Circassians. When Russia conquered these groups and gained possession of southern Ukraine, known as New Russia during Russian imperial times, the Ottoman Empire lost its buffer zone against Russian expansion, and Russia and the Ottoman Empire fell into direct conflict. The conflict with the Ottoman Empire also presented a religious issue of importance, as Russia saw itself as the protector of Orthodox Christians, many of whom lived under Ottoman control and were treated as second-class citizens.

 

Russia had previously obtained recognition from the Ottoman Empire of the Tsar’s role as special guardian of the Orthodox Christians in Moldavia and Wallachia. Now Russia used the Sultan’s failure to resolve the issue of the protection of the Christian sites in the Holy Land as a pretext for Russian occupation of these Danubian provinces. Nicholas believed that the European powers, especially Austria, would not object strongly to the annexation of a few neighboring Ottoman provinces, especially considering that Russia had assisted Austria’s efforts in suppressing the Hungarian Revolution in 1849.In July 1853, the Tsar sent his troops into the Danubian Principalities. By the way, the term, Tsar, evolved from the title, Caesar, specifically the last part of Cee -zar.

 

The United Kingdom, hoping to maintain the Ottoman Empire as a bulwark against the expansion of Russian power in Asia, sent a fleet to the Dardanelles, where it joined another fleet sent by France. Sultan Abdulmecid I formally declared war on Russia and proceeded to the attack, his armies moving on the Russian army near the Danube later that month. Russia and the Ottoman Empire massed forces on two main fronts, the Caucasus and the Danube. Ottoman leader Omar Pasha managed to achieve some victories on the Danubian front. In the Caucasus, the Ottomans were able to stand ground with the help of Chechen Muslims led by Imam Shamil. The British and French sent in naval task forces to support the Ottomans, as Russia prepared to seize the Principalities. Fewer than half of the 80,000 Russian soldiers who fought in 1853, survived. By far, most of the deaths would result from sickness rather than combat, for the Russian army still suffered from medical services that ranged from bad to none.

 

Into this hellish global chaos, came the intrepid Florence Nightingale.

 

In 1854, under the authorization of Sidney Herbert, the British Secretary of War, Florence Nightingale arrived in Turkey, bringing with her a team of 38 volunteer nurses to care for the British soldiers fighting in the Crimean War, which was intended to limit Russian expansion into Europe. Nightingale and her nurses arrived at the military hospital in Scutari and found soldiers wounded and dying amid horrifying sanitary conditions. Ten times more soldiers were dying of diseases such as typhus, typhoid, cholera, and dysentery than from battle wounds.

 

 

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Florence Nightingale at the hospital in Scutari, by Robert Riggs. Courtesy of the Prints and Photographs Collection, History of Medicine Division, National Library of Medicine, National Institutes of Health.

 

The soldiers were poorly cared for, medicines and other essentials were in short supply, hygiene was neglected, and infections were rampant. Nightingale found there was no clean linen; the clothes of the soldiers were swarming with bugs, lice, and fleas; the floors, walls, and ceilings were filthy; and rats were hiding under the beds.1 There were no towels, basins, or soap, and only 14 baths for approximately 2000 soldiers. The death count was the highest of all hospitals in the region. One of Nightingale’s first purchases was of 200 Turkish towels; she later provided an enormous supply of clean shirts, plenty of soap, and such necessities as plates, knives, and forks, cups and glasses. Nightingale believed the main problems were diet, dirt, and drains?she brought food from England, cleaned up the kitchens, and set her nurses to cleaning up the hospital wards. A Sanitary Commission, sent by the British government, arrived to flush out the sewers and improve ventilation.

Nightingale’s accomplishments during the disastrous years the British army experienced in the Crimea were largely the result of her concern with sanitation and its relation to mortality, as well as her ability to lead, to organize, and to get things done. She fought with those military officers that she considered incompetent; they, in turn, considered her unfeminine and a nuisance. She worked endlessly to care for the soldiers themselves, making her rounds during the night after the medical officers had retired. She thus gained the name of “the Lady with the Lamp,“ and the London Times referred to her as a “ministering angel.“ Her popularity and reputation in Britain grew enormously and even the Queen was impressed.

 

Nightingale’s work brought the field of public health to national attention. She was one of the first in Europe to grasp the principles of the new science of statistics and to apply them to military – and later civilian – hospitals. In 1907, she was the first woman to be awarded the Order of Merit. Nightingale’s image has often been sentimentalized as the epitome of femininity, but she is especially remarkable for her intelligence, determination, and amazing capacity for work.

 

 

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New Gene Therapy for Vision Loss from a Mitochondrial Disease

 

Leber hereditary optic neuropathy (LHON) is an inherited form of vision loss. Although this condition usually begins in a person’s teens or twenties, rare cases may appear in early childhood or later in adulthood. For unknown reasons, males are affected much more often than females. Blurring and clouding of vision are usually the first symptoms of LHON. These vision problems may begin in one eye or simultaneously in both eyes; if vision loss starts in one eye, the other eye is usually affected within several weeks or months. Over time, vision in both eyes worsens with a severe loss of sharpness (visual acuity) and color vision. This condition mainly affects central vision, which is needed for detailed tasks such as reading, driving, and recognizing faces. Vision loss results from the death of cells in the nerve that relays visual information from the eyes to the brain (the optic nerve). Although central vision gradually improves in a small percentage of cases, in most cases the vision loss is profound and permanent. Vision loss is typically the only symptom of LHON; however, some families with additional signs and symptoms have been reported. In these individuals, the condition is described as “LHON plus.“ In addition to vision loss, the features of LHON plus can include movement disorders, tremors, and abnormalities of the electrical signals that control the heartbeat (cardiac conduction defects). Some affected individuals develop features similar to multiple sclerosis, which is a chronic disorder characterized by muscle weakness, poor coordination, numbness, and a variety of other health problems.

 

The global impact of LHON is unknown. In England, the estimated prevalence is about 1 in 30,000.

 

Mitochondria are as complex as any modern manufacturing facility, with specialized machinery for converting nutrients and oxygen into cellular energy. They even have their own DNA, and it is mutations within this mitochondrial DNA (mtDNA) that lead to LHON, as well as a host of other diseases. But the unique nature of mtDNA has presented challenges for developing and testing potential therapies for such diseases.

 

According to an article published in the Proceedings of the National Academy of Sciences (5 October 2015), a novel mouse model had been developed for LHON, and it was found that gene therapy can be used to improve visual function in the mice.

 

The most common mutation behind LHON impairs a mitochondrial gene called ND4. The original research approach, which began about 15 years ago, was to deliver a substitute copy of the gene into mitochondria. In most studies and applications of gene therapy, viruses have now become the preferred vessel for delivering genes into cells. But viruses evolved to invade the body’s cells and penetrate the nucleus, which contains the bulk of our DNA, comprising about 20,000 genes. Most viruses are poor at penetrating mitochondria. To fix that, the authors took advantage of the fact that mitochondria import cellular proteins that they cannot make themselves. By attaching a bit of one such protein to the outer shell of a virus-called an adeno-associated virus – the virus was effectively given a homing signal and entry code into mitochondria. This modified virus has been the key to creating a mouse that replicates LHON and to an investigational gene therapy for LHON that is currently in clinical trials.

 

To create a mouse model for LHON, the authors loaded the virus with a defective copy of the ND4 gene carrying the same mutation that causes about 70% of LHON cases. They also included DNA coding for a red fluorescent protein, as a visible marker for the virus and its payload. Then they injected the virus into fertilized mouse egg cells, and grew the cells to maturity. After breeding the mice through several generations, the authors had their mouse model. The presence of the virally encoded ND4 mutation in the eye was confirmed by essentially doing an eye exam to look for the red fluorescent marker. Over time, the mice showed a loss of retinal ganglion cells, atrophy (shrinkage) of the optic nerve, and a decline in visual responses, as seen in a type of electrical recording from the retina known as an electroretinogram.

 

To develop a gene therapy for LHON, the authors packaged the normal human ND4 gene into the same stealthy virus. This combination, when injected into the eye, led to improved visual function in the LHON mouse model. When injected into normal mice, the virus carrying ND4 did not cause any adverse effects on vision.

 

The mouse research is helping inform an ongoing NEI-supported clinical trial, which is led by the authors and is testing the safety of the same gene therapy approach (without the red fluorescent protein) in people with LHON. The trial is recruiting LHON patients who fit into three categories — those with chronic vision loss in both eyes, with recent-onset vision loss in both eyes, or with recent-onset vision loss in one eye but no signs of abnormal vision in the other eye.

 

Our Brain’s Secrets to Success?

 

Discoveries about how the human brain contributes to our success — both as a species and as individuals — are among the first fruit of projects funded under the National Institutes of Health BRAIN Initiative program as well as the Human Connectome Project. According to a study published in Cell, (24 September 2015), one study may help to explain the mystery of how our primate brain’s outer mantle, or cortex, was able to expand as much as 1000-fold through evolution, compared to other mammals, and another study suggests that the more successful we tend to be –score higher on commonly considered positive personal qualities, such as education and income levels and life satisfaction — the more key parts of our brain tend to talk with each other when we’re not doing anything in particular.

 

The authors found that the human cortex harbors a unique support system for neuron-producing factories during early brain development — in outlying cellular neighborhoods that barely exist in lower animals. The authors also discovered the molecular underpinnings of this unique group of stem cells that churn out thousands of neurons and support cells where their mouse counterparts produce only 10-100. They also discovered that the secret to this prolific output seems to lie in these cells’ ability to carry with them their own self-renewing “niches,“ — support systems that enabled them to thrive in far flung circuit suburbs. The results add to a deeper understanding of the human brain’s parts list and enhance scientists’ ability to perform disease-in-a-dish experiments relevant to uniquely human disorders like autism and schizophrenia, which are difficult to model in rodents.

 

For the study, the authors mined Human Connectome Project data on 461 individuals to find out whether any patterns of brain connectivity are associated with specific sets of correlated demographics and behavior. In addition to images of their resting state structural and functional brain connections, the Project collected data on 280 such subject measures, including psychological factors such as IQ, language performance, rule-breaking behavior and anger. Results showed a set of such measures statistically related to each other emerged as strongly correlated with connectivity between certain brain structures prone to talking with each other during the brain’s default mode, or resting state. This set was mostly composed of positive personal qualities, such as high performance on memory and thinking tasks, life satisfaction, years of education, and income. The set turned out to have a more than three-fold stronger correlation with increased brain connectivity than any of 99 other sets of measures examined. The brain regions associated with the set, which may be related to general intelligence, have been linked to higher-level human thinking – e.g., memory, imagination, sociability, value-guided decision-making and reasoning.

 

First Nucleic Acid-Based Test to Detect Multiple Pathogens from a Single Sample of Cerebrospinal Fluid

 

Meningitis and encephalitis are inflammatory diseases of the membranes that surround the brain and spinal cord and can be caused by bacterial, viral or yeast infections. Such infections can cause brain damage and can be fatal if not treated rapidly.

 

The FDA has cleared for marketing of the first cerebrospinal fluid (CSF) nucleic acid-based test for simultaneous detection of multiple pathogens that can cause central nervous system infections. The FilmArray Meningitis/Encephalitis (ME) Panel uses CSF specimens from patients who have signs and/or symptoms of meningitis or encephalitis and is intended as an aid in the diagnosis of those diseases when used in conjunction with other clinical and laboratory findings. The FilmArray ME Panel is designed to simultaneously test for 14 bacterial, viral and yeast pathogens using a small sample of CSF and can provide results in about an hour, which may enable clinicians to make informed treatment decisions earlier. Currently, testing CSF for multiple organisms is not always possible because it can be difficult to obtain enough fluid from each patient to run multiple tests. Identification of the cause of bacterial central nervous system infections may sometimes take up to three days using current methods. Testing for viral infections may take even longer because many hospital laboratories do not perform such tests and specimens must then be shipped to specialized laboratories for testing.

 

Bacteria and yeast pathogens identified by the FilmArray ME Panel are Escherichia coli K1, Haemophilus influenzae, Listeria monocytogenes, Neisseria meningitidis, Streptococcus agalactiae, Streptococcus pneumoniae and Cryptococcus neoformans/gattii. Viruses identified by the FilmArray ME Panel are Cytomegalovirus, Enterovirus, Herpes simplex virus 1, Herpes simplex virus 2, Human herpesvirus 6, Human parechovirus, and Varicella zoster virus.

 

However, the FilmArray ME Panel does not detect all causes of central nervous system infections or provide information about which antimicrobial drugs may be most effective for treating bacterial infections.  Physicians should continue to perform standard CSF bacterial and fungal cultures in conjunction with the FilmArray ME Panel because false negative and false positive results are possible with the FilmArray ME Panel, and bacterial growth is needed for drug susceptibility testing when results are positive. False negative results could potentially occur when the concentration of organisms in the CSF specimen is below the limit of detection for the FilmArray ME Panel.

 

The FDA reviewed data for the FilmArray ME Panel through the de novo classification process, a regulatory pathway for some low- to moderate-risk devices that are novel and not substantially equivalent to any legally marketed device. The clinical performance of the FilmArray ME Panel was evaluated by a prospective study of CSF samples taken from 1,560 patients with suspected meningitis/encephalitis where results for the FilmArray ME Panel were compared to results from other test methods, including culture. Another study included 150 clinical CSF samples that were previously determined to contain microorganisms, while a third study included 425 CSF samples that were artificially prepared with specific concentrations of bacteria or viruses. Study results demonstrated high agreement between the FilmArray ME Panel, comparator methods and expected results.

 

The FilmArray ME Panel is manufactured by BioFire Diagnostics L.L.C., in Salt Lake City, Utah.

 

Tunisian Tajine with Squash, Chickpeas, Almonds, Yogurt & Couscous

 

Congratulations to Tunisia for winning the 2015 Nobel Peace Prize!

 

In 2014, the Tunisian government adopted a new constitution. The 2015 Nobel Peace Prize went to the Tunisian National Dialogue Quartet, which has been instrumental in guiding the nation toward democracy after the Arab Spring.

 

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I can’t believe it came out so well! ©Joyce Hays, Target Health Inc.

 

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With that long list of ingredients, anything could have gone wrong; but everything went right! ©Joyce Hays, Target Health Inc.

 

 

Ingredients

 

1 Tablespoon unsalted butter (or veggie oil)

1 Tablespoon olive oil

1 onion, small dice

8 fresh garlic cloves, thinly sliced (not squeezed)

1 teaspoon ground cumin

1 teaspoon turmeric (bottled with black pepper)

1 (3-inch) cinnamon stick

Pinch Salt and Pinch black pepper

1 pound butternut squash, cut into 1 inch cubes

3/4 pound red potatoes, large dice

2 cups low-sodium chicken broth or stock

2 cups cooked chickpeas, drained

1 (14-ounce) can Cento diced tomatoes, with juices

2 big pinches of saffron threads

2/3 cup fresh cilantro, well chopped + extra for garnish

2 pinches chili flakes

1/2 preserved lemon, finely chopped (Dean & Deluca or FreshDirect)

1 cup brined green Cerignola olives (Dean & Deluca or FreshDirect)

Steamed couscous, for serving (directions here and elsewhere on the web)

Fresh cilantro leaves, roughly chopped, for garnish

1 cup slivered almonds, toasted, for garnish

Plain Greek (Fage) yogurt, for topping

 

 

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Cutting the butternut squash into cubes. ©Joyce Hays, Target Health Inc.

 

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Save a little time by cutting and/or chopping the onion and garlic on same board, together. ©Joyce Hays, Target Health Inc.

 

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These lovely exotic ingredients add nuance to this dish. The lemon in the photo is a mistake. Try to use preserved lemon (jar on extreme right) and not a fresh lemon. For this recipe, you want a deeper darker lemony flavor and not the bright sparkle of fresh lemon. ©Joyce Hays, Target Health Inc.

 

 

Directions

 

Heat butter and olive oil in a 3- to 4-quart Dutch oven or heavy-bottomed saucepan with a tight fitting lid over medium heat. When oil shimmers, add the garlic and mash it into a paste, with a fork, right in the bottom of the pan. Next, add onion, cumin, and cinnamon, and season with salt and freshly ground black pepper. Cook, stirring occasionally, until spices are aromatic and onions are soft and translucent, about 5 minutes.

 

 

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Squash and potatoes added. ©Joyce Hays, Target Health Inc.

 

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Tomatoes added with saffron, broth and chickpeas. ©Joyce Hays, Target Health Inc.

 

 

Add squash and potatoes, season with salt and black pepper, stir to coat, and cook until just tender, about 3 minutes. Add broth, chickpeas, tomatoes and their juices, and saffron. Bring mixture to a boil then reduce heat to low. Cover and simmer until squash is fork tender, about 10 minutes.

 

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Cilantro and olives added, plus the preserved lemon. ©Joyce Hays, Target Health Inc.

 

 

Remove from heat and stir in preserved lemon, 2/3 cup fresh cilantro and olives. Serve over couscous garnished with cilantro, almonds, and yogurt. With this recipe, the garnishes really make a difference; they definitely enhance and add to the taste.

 

 

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Serve the couscous separately and let people add the Tajine on top or at the side. ©Joyce Hays, Target Health Inc.

 

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Do you see my happy chowhound husband here? He can’t wait to dig into this luscious meatless dish. The reason the dish looks like it’s been in the oven, is because it has. It was made earlier in the day, so I popped it in the oven to heat up, just before we sat down for dinner. ©Joyce Hays, Target Health Inc.

 

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©Joyce Hays, Target Health Inc.

 

We started this meal with a red pinot noir from the vineyards of Paul Hobbs in Napa Valley and a simple antipasto of roasted red peppers, red and green olives, and small chunks of parmesan cheese. Next came the third attempt of the Tunisian Tajine served with couscous and the three garnishes: yogurt, toasted almond slivers, chopped cilantro. Jules gave this dish five plus stars, that’s how good it (finally) was. For some reason, I have been drawn to try the musky earthen flavors of North Africa, and dunno why it took me so long. It’s a real adventure!

 

These spices require a nuanced approach. Too much, which I did on the second try, and you have, for our palates, uneatable leftovers. My first try, was too little, and that meal was bland and uninteresting. After experimenting and tasting as I went, I finally made this recipe, which is amazingly delicious. I continue to develop cooking skills with these (foreign for me) ingredients, so you might get another Tajine next week. We had seconds and thirds and BTW, not only is this a luscious dish, its low calorie.

 

For dessert we tried out a new cake recipe which will take more work before it gets shared.

 

This weekend, we saw A Fool for Love at the Samuel J. Friedland Theater on Broadway. If you like Sam Shepard plays you will love this production, which is ten times better than when we first saw it several years ago, off-Broadway. I love the Friedland Theater because it’s so cozy and intimate. We are patrons of this theater which makes it feel like home, even more. The acting in Fool for Love is excellent. The directing, set design, sound design, lighting are all first rate. Not sure if you would agree, but for me a Sam Shepard play is like a Roy Lichtenstein painting. Fool for Love just opened, so I haven’t had time to read the reviews, but am willing to bet that they’re good. (I usually never read reviews before I see a play, because I like to form my own opinions first). Try to see a performance that has a talk-back afterward. These talk-backs really enhance the theater experience. Ask about it at the box office, before you decide on a date, because they don’t follow each show.

 

 

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Drowning Girl (1963) by Roy Lichtenstein. On display at the Museum of Modern Art, New York

 

From Our Table to Yours!

 

Bon Appetit!