Sunset in New York City

 

As the holiday season approaches, and the days are shorter, the sunsets in NYC are breath-taking. Fortunately, the corner offices on the 24th floor faces SW, so the views are beyond spectacular.

Words cannot describe this gorgeous view from the 24th Floor.  ©Target Health Inc.

 

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. 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

Filed Under News | Leave a Comment

FDA Approves Pill With Sensor That Digitally Tracks if Patients Have Ingested Their Medication

FDA.gov

 

 

Last week, the U.S. Food and Drug Administration approved the first drug in the U.S. with a digital ingestion tracking system. Abilify MyCite, are aripiprazole tablets with sensor. Abilify has an ingestible 1) ___ embedded in the pill that records that the medication was taken. The product is approved for the treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder and for use as an add-on treatment for depression in adults. The system works by sending a message from the pill’s sensor to a wearable patch. The patch transmits the information to a mobile application so that patients can track the ingestion of the medication on their smart 2) ___. Patients can also permit their caregivers and physician to access the information through a web-based portal.

 

“Being able to track ingestion of medications prescribed for mental illness may be useful for some patients,“ said Mitchell Mathis, M.D., director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research. “The FDA supports the development and use of new technology in prescription 3) ___ and is committed to working with companies to understand how technology might benefit patients and prescribers.“

 

It is important to note that Abilify MyCite’s prescribing information (labeling or package 4) ___) notes that the ability of the product to improve patient compliance with their treatment regimen has not been shown. Abilify MyCite should not be used to track drug ingestion in “real-time“ or during an emergency because detection may be delayed or may not occur.

 

Schizophrenia is a chronic, severe and disabling brain disorder. About 1% of Americans have this illness. Typically, symptoms are first seen in adults younger than 30 years of age. Symptoms of those with schizophrenia include hearing 5) ___, believing other people are reading their minds or controlling their thoughts, and being suspicious or withdrawn. Bipolar disorder, also known as 6) ___-depressive illness, is another brain disorder that causes unusual shifts in mood, energy, activity levels and the ability to carry out day-to-day tasks. The symptoms of bipolar disorder include alternating periods of depression and high or irritable mood, increased activity and restlessness, racing thoughts, talking fast, impulsive behavior and a decreased need for sleep.

 

Abilify MyCite contains a Boxed Warning alerting health care professionals that elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of 7) ___. Abilify MyCite is not approved to treat patients with dementia-related psychosis. The Boxed Warning also warns about an increased risk of suicidal thinking and behavior in children, adolescents and young adults taking antidepressants. The safety and effectiveness of Abilify MyCite has not been established in pediatric patients. Patients should be monitored for worsening and emergence of suicidal thoughts and behaviors. Abilify MyCite must be dispensed with a patient Medication Guide that describes important information about the drug’s uses and 8) ___.

 

In the clinical trials for Abilify, the most common side effects reported by adults taking Abilify were nausea, vomiting, constipation, headache, dizziness, uncontrollable limb and body movements (akathisia), anxiety, insomnia, and restlessness. Skin irritation at the site of the MyCite patch placement may occur in some patients. Prior to initial patient use of the product, the patient’s health care professional should facilitate use of the drug, patch and app to ensure the patient is capable and willing to use the system.

 

Abilify was first approved by the FDA or 9) ___ and ___ ___, in 2002 to treat schizophrenia. The ingestible sensor used in Abilify MyCite was first permitted for marketing by the FDA in 2012. The FDA granted the approval of Abilify MyCite to Otsuka Pharmaceutical Co., Ltd. The sensor technology and patch are made by Proteus Digital Health.

 

The FDA, an agency within the U.S. Department of Health and 10) ___ Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

 

ANSWERS: 1) sensor; 2) phone; 3) drugs; 4) insert; 5) voices; 6) manic; 7) death; 8) risks; 9) Food and Drug Administration; 10) Human

 

A Short History of Pills

An old Cadmach rotary tablet press

Photo credit: Slashme at the English language Wikipedia, CC BY-SA 3.0, https://commons.wikimedia.org/w/index.php?curid=21895660

 

 

Pills date back to roughly 1500 BCE. They were presumably invented so that measured amounts of a medicinal substance could be delivered to a patient. A long time ago, around 4,000 years or so, medicines were generally liquid preparations. An inscription on an Assyrian clay tablet instructs the user to pulverize various seeds, plant resins and leaves together–then dissolve them in beer. Pills are first referenced in ancient Egyptian. One famous set of papyruses is filled with medical remedies, including pills made from bread dough, honey or grease. Medicinal plants would be reduced to powders, and other active ingredients, and would then be mixed with these substances–then little balls, or pills, would be formed with the fingers. Early ingredients of pills included saffron, myrrh, cinnamon, tree resins and many other botanicals. Pills came in various sizes as well as flat and round, and other assorted shapes. As far back as 500 BCE, some were even trademarked with special indentations in the pills.

 

Hippocrates, knew about the curative powers of willow bark. And in ancient Greece, the round balls or other shapes were called katapotia (meaning “something to be swallowed“). It was the Roman scholar Pliny (23-79 CE–who first coined the word “pilula.“

 

Some early pills still exist in museums, such as a famous one dating from 500 BCE. that was known as Terra Sigillata–consisting of clay from a particular island that was mixed with goat’s blood then shaped into pills. Terra Sigillata was supposedly good for practically every ailment, including dysentery, ulcers and gonorrhea. A pill was originally defined as a small, round, solid pharmaceutical oral dosage form of medication. The oldest known pills were made of the zinc carbonates hydrozincite and smithsonite. The pills were used for sore eyes, and were found aboard a Roman ship Relitto del Pozzino which wrecked in 140 BCE. Today, pills include tablets, capsules, and variants thereof like caplets ? essentially any solid form of medication, colloquially falls into the pill category. There are pieces of ancient Roman pill-making equipment, such as a carved stone in the British Museum. The stone has long flat grooves into which the pill maker would press clay or other substances to make long, snaky strings. Then the pill maker would pry the strings out and cut them into discs to form pills–much the way one cuts dough for cookies.

 

During the Middle medieval times, people would coat their pills with slimy plant substances and other materials so they were easier to swallow and tasted less bitter. Some pills were rolled in spices, and later pills began to be coated with gold and silver. Silver, unfortunately, rendered the pills pretty inert, since they’d pass right through the digestive tract without releasing any of their medicinal compounds. Gilding of pills, continued well into the 19th century. Medicines in pill form were popular in 17th century England and thereafter. Pill manufacturers were granted special patent rights from the king for their top-secret formulas. One famous patented product from the 18th century: “Hooper’s Female Pills,“ which were guaranteed to contain “the best purging and anti-hysterik ingredients.“ And pills, of course, made their way over to the still-new United States–which had its own set of patent-protected preparations, courtesy of the U.S. Patent office–including Chase’s Kidney-Liver Pills, Cheeseman’s Female Regulating Pills and Williams’ Pink Pills for Pale People.

 

The old-fashioned, roll-and-cut kinds of pills had a drawback: Their preparation required moisture. Early researchers, (doctors) were learning that this moisture could de-activate the drugs contained. In the 1800s, innovators began sugar-coating and gelatin-coating pills. At this time gelatin capsules were invented, as well as the ability to compress tablets. In 1843, English scientist, William Brockedon invented a different pill form. Powder was placed in a tube and then compressed with a mallet, until it solidified. Eventually, this invention became popular. Holloway’s Pills were perhaps the most famous of the patent medicines, and were popular enough to make Thomas Holloway a wealthy man. Testimonials to the value of the pills can be found at this time, in newspapers all over the British Empire, including Indian, Australia and the North American colonies. The range of diseases the pills claimed to cure is astonishing. Along with Holloway’s Ointment, Holloway’s Pills could treat almost anything. Analysis of the pills showed that they contained aloe, myrrh, and saffron. While probably not harmful, these pills would be unlikely to have the claimed affects. The Holloway advertising changed from time to time, listing a variety of dangers that the pills could prevent. An example, for “Children’s Complaints“:

 

“It is not generally known, but such is the fact that children require medicine oftener than their parents. Three-fourths of the children die before they attain the age of eight years. Let their

mothers, then, be wise, and give to their children small doses of these invaluable pills once or twice every week… The gross humors that are constantly floating about in the blood of children, the forerunners of so many complaints, will thus be expelled, and the lives of thousands saved and preserved to their parents.“

 

Pills have always been difficult to swallow and efforts long have been made to make them go down easier. In medieval times, people coated pills with slippery plant substances. Another approach, used as recently as the 19th century, was to gild them in gold and silver, although this often meant that they would pass through the digestive tract with no effect. In the 1800s sugar-coating and gelatin-coating was invented, as were gelatin capsules. In 1843, the British painter and inventor William Brockedon was granted a patent for a machine capable of “Shaping Pills, Lozenges and Black Lead by Pressure in Dies“. The device was capable of compressing powder into a tablet without use of an adhesive. In the tablet-pressing process, it is important that all ingredients be fairly dry, powdered or granular, somewhat uniform in particle size, and freely flowing. Mixed particle sized powders segregate during manufacturing operations due to different densities, which can result in tablets with poor drug or active pharmaceutical ingredient (API) content uniformity but granulation should prevent this. Content uniformity ensures that the same API dose is delivered with each tablet. Some APIs may be tableted as pure substances, but this is rarely the case; most formulations include excipients. Normally, a pharmacologically inactive ingredient (excipient) termed a binder is added to help hold the tablet together and give it strength. A wide variety of binders may be used, some common ones including lactose, dibasic calcium phosphate, sucrose, corn (maize) starch, microcrystalline cellulose, povidone polyvinylpyrrolidone and modified cellulose (for example hydroxypropyl methylcellulose and hydroxyethylcellulose).

 

Often, an ingredient is also needed to act as a disintegrant to aid tablet dispersion once swallowed, releasing the API for absorption. Some binders, such as starch and cellulose, are also excellent disintegrants. Tablets are simple and convenient to use. They provide an accurately measured dosage of the active ingredient in a convenient portable package, and can be designed to protect unstable medications or disguise unpalatable ingredients. Colored coatings, embossed markings and printing can be used to aid tablet recognition. Manufacturing processes and techniques can provide tablets with special properties, for example, sustained release or fast dissolving formulations. Some drugs may be unsuitable for administration by the oral route. For example, protein drugs such as insulin may be denatured by stomach acids. Such drugs cannot be made into tablets. Some drugs may be deactivated by the liver when they are carried there from the gastrointestinal tract by the hepatic portal vein (the “first pass effect“), making them unsuitable for oral use. Drugs which can be taken sublingually are absorbed through the oral mucosa, so that they bypass the liver and are less susceptible to the first pass effect. The oral bioavailability of some drugs may be low due to poor absorption from the gastrointestinal tract. Such drugs may need to be given in very high doses or by injection. For drugs that need to have rapid onset, or that have severe side effects, the oral route may not be suitable. For example, salbutamol, used to treat problems in the respiratory system, can have effects on the heart and circulation if taken orally; these effects are greatly reduced by inhaling smaller doses direct to the required site of action. A proportion of the population have difficulties swallowing tablets either because they just don’t like taking them or because their medical condition makes it difficult for them (dysphagia, vomiting). In such instances it may be better to consider alternative dosage form or administration route.

 

Tablets can be made in virtually any shape, although requirements of patients and tableting machines mean that most are round, oval or capsule shaped. More unusual shapes have been manufactured but patients find these harder to swallow, and they are more vulnerable to chipping or manufacturing problems. Tablet diameter and shape are determined by the machine tooling used to produce them – a die plus an upper and a lower punch are required. This is called a station of tooling. The thickness is determined by the amount of tablet material and the position of the punches in relation to each other during compression. Once this is done, we can measure the corresponding pressure applied during compression. The shorter the distance between the punches, thickness, the greater the pressure applied during compression, and sometimes the harder the tablet. Tablets need to be hard enough that they don’t break up in the bottle, yet friable enough that they disintegrate in the gastric tract. Tablets need to be strong enough to resist the stresses of packaging, shipping and handling by the pharmacist and patient. The mechanical strength of tablets is assessed using a combination of (i) simple failure and erosion tests, and (ii) more sophisticated engineering tests. The simpler tests are often used for quality control purposes, whereas the more complex tests are used during the design of the formulation and manufacturing process in the research and development phase. Standards for tablet properties are published in the various international pharmacopeias (USP/NF, EP, JP, etc.). The hardness of tablets is the principle measure of mechanical strength. Hardness is tested using a tablet hardness tester. The units for hardness have evolved since the 1930s, but are commonly measured in kilograms per square centimeter. Models of tester include the Monsanto (or Stokes) Hardness Tester from 1930, the Pfizer Hardness Tester from 1950, the Strong Cob Hardness Tester and the Heberlain (or Schleeniger) Hardness Tester.

 

Lubricants prevent ingredients from clumping together and from sticking to the tablet punches or capsule filling machine. Lubricants also ensure that tablet formation and ejection can occur with low friction between the solid and die wall, as well as between granules, which helps in uniform filling of the die. Common minerals like talc or silica, and fats, e.g. vegetable stearin, magnesium stearate or stearic acid are the most frequently used lubricants in tablets or hard gelatin capsules. In the tablet pressing process, the main guideline is to ensure that the appropriate amount of active ingredient is in each tablet. Hence, all the ingredients should be well-mixed. If a sufficiently homogenous mix of the components cannot be obtained with simple blending processes, the ingredients must be granulated prior to compression to assure an even distribution of the active compound in the final tablet. Two basic techniques are used to granulate powders for compression into a tablet: wet granulation and dry granulation. Powders that can be mixed well do not require granulation and can be compressed into tablets through direct compression.

 

Combined oral contraceptive pills were nicknamed “the pill“ in the 1960s

__________________________________________________________________

 

https://www.pinterest.com/nanherriman/19th-century-medicine/

 

ONCOLOGY

Filed Under News | Leave a Comment

Study Identifies Essential Genes for Cancer Immunotherapy

 

According to a study published online in Nature (7 August 2017), genes have been identified that are necessary in cancer cells for immunotherapy to work. These results address the problem of why some tumors don’t respond to immunotherapy or respond initially but then stop as tumor cells develop resistance to immunotherapy.

 

Cancer immunotherapy relies on T cells, a type of cell in the immune system, to destroy tumors. The authors have previously shown that the infusion of large numbers of T cells can trigger complete regression of cancer in patients, and that T cells can directly recognize and kill tumor cells. However, some tumor cells are resistant to the destruction unleashed by T cells.

 

To investigate the basis for this resistance, the authors sought to identify the genes in cancer cells that are necessary for them to be killed by T cells. Working with a melanoma tumor cell line, the authors used a gene editing technology called CRISPR that “knocks out,“ or stops the expression, of individual genes in cancer cells. By knocking out every known protein-encoding gene in the human genome and then testing the ability of the gene-modified melanoma cells to respond to T cells, the authors identified more than 100 genes that may play a role in facilitating tumor destruction by T cells. Once the authors identified these “candidate“ genes, they sought additional evidence that these genes play a role in susceptibility to T cell-mediated killing. To this end, they examined data on “cytolytic activity,“ or a genetic profile that shows cancer cells are responding to T cells, in more than 11,000 patient tumors from The Cancer Genome Atlas, a collaboration between NCI and the National Human Genome Research Institute, also part of NIH. Results showed that a number of the genes identified in the CRISPR screen as being necessary for tumor cells to respond to T cells were indeed associated with tumor cytolytic activity in patient samples. One such gene is called APLNR. The product of this gene is a protein called the apelin receptor. Although it had been suspected to contribute to the development of some cancers, this was the first indication of a role in the response to T cells. Further investigation of tumors from patients resistant to immunotherapies showed that the apelin receptor protein was nonfunctional in some of them, indicating that the loss of this protein may limit the response to immunotherapy treatment.

 

According to the authors, the results show that many more genes than were originally expected play a vital role in dictating the success of cancer immunotherapies. The authors also noted that this gene list could serve as a blueprint to study the emergence of tumor resistance to T cell-based cancer therapies, and that if this set of genes is validated in clinical trials, then this data could eventually lead to more effective treatments for patients.

 

Obesity During Pregnancy May Lead to Fetal Overgrowth

 

Macrosomia, or large body size at birth, is common among children born to obese women, particularly those who have gestational diabetes (high blood sugar during pregnancy). Macrosomia also increases the risk that an infant will experience bone fracture during delivery, as well as the likelihood that the infant will need to be delivered by cesarean section. Having a large infant also increases a mother’s risk for postpartum hemorrhage, or excessive bleeding at birth.

 

According to an article published in JAMA Pediatrics (13 November 2017), obesity during pregnancy — independent of its health consequences such as diabetes — may account for the higher risk of giving birth to an atypically large infant.

 

In the current study, researchers analyzed ultrasound scans taken throughout pregnancy of more than 2,800 pregnant women: 443 obese women with no accompanying health conditions, such as diabetes, and more than 2300 non-obese women. The researchers categorized the women’s weight according to their body mass index (BMI) score. Women with a BMI ranging from 30 to 44.9 were classified as obese, while those with a BMI of <29.9 were considered non-obese.

 

Results showed that beginning in the 21st week of pregnancy, ultrasound scans revealed that for fetuses of obese women, the femur (thigh bone) and humerus (upper arm bone) were longer than those of the fetuses of non-obese women. The differences between fetuses of obese and non-obese women continued through the 38th week of pregnancy. For fetuses in the obese group, the average femur length was 0.8 millimeters longer (about 0.03 inches), compared to the non-obese group, and humerus length was about 1.1 millimeters longer (about 0.04 inches), compared to the non-obese group. Average birth weight was about 100 grams (about 0.2 pounds) heavier in the obese group. Moreover, infants born to obese women were more likely to be classified as large for gestational age (birth weight above the 90th percentile), compared to infants born to non-obese women.

 

The study could not determine exactly why the fetuses of obese women were larger and heavier than fetuses in the non-obese group. The authors theorized that because obese women are more likely to have insulin resistance (difficulty using insulin to lower blood sugar), higher blood sugar levels could have promoted overgrowth in their fetuses. The authors also pointed out that earlier studies have indicated that the higher risk of overgrowth seen in newborns of obese women may predispose these infants to obesity and cardiovascular disease later in life. They called for additional studies to follow the children born to obese women to determine what health issues they may face.

 

FDA Launches Comprehensive Regenerative Medicine Policy Framework

 

The FDA has announced a comprehensive policy framework for the development and oversight of regenerative medicine products, including novel cellular therapies. The framework, which is outlined in a suite of four guidance documents, builds upon the FDA’s existing risk-based regulatory approach to more clearly describe what products are regulated as drugs, devices, and/or biological products. Further, two of the guidance documents propose an efficient, science-based process for helping to ensure the safety and effectiveness of these therapies, while supporting development in this area. The suite of guidance documents also defines a risk-based framework for how the FDA intends to focus its enforcement actions against those products that raise potential significant safety concerns. This proposed framework is intended to balance the agency’s commitment to safety with mechanisms to drive further advances in regenerative medicine so innovators can bring new, effective therapies to patients as quickly and safely as possible. The policy also delivers on important provisions of the 21st Century Cures Act.

 

The framework includes two final guidance documents and two draft guidance documents.

 

New Final Guidance Documents

 

The two final guidance documents clarify the FDA’s interpretation of the risk-based criteria manufacturers use to determine whether a product is subject to the FDA’s premarket review. The first guidance provides greater clarity around when cell and tissue-based products would be excepted from the established regulations if they are removed from and implanted into the same individual within the same surgical procedure and remain in their original form. The second final guidance helps stakeholders better understand how existing regulatory criteria apply to their products by clarifying how the agency interprets the existing regulatory definitions “minimal manipulation“ and “homologous use.“

 

As this field advances, the FDA has noted that there are a growing number of regenerative medicine products subject to FDA premarket authorization. These guidance documents will help explain how the FDA will provide a risk-based framework for its oversight. The policy framework defines how we intend to take action against unsafe products while facilitating continued innovation of promising technologies. To accomplish this goal, the guidance document has clarified the FDA’s view of “minimal manipulation“ and “homologous use.“ These are two concepts that are defined in current regulation to establish the legal threshold for when a product is subject to the FDA’s premarket approval requirements. By further clarifying these terms in the final guidance, the FDA is applying a modern framework for its oversight. Under the new policy, in order to allow manufacturers of products time to comply with the requirements, for the first 36 months following issuance of the final guidance document the FDA intends to exercise enforcement discretion for certain products that are subject to the FDA’s premarket review under the existing regulations, but are not currently meeting these requirements. The FDA does not intend to exercise such enforcement discretion for those products that pose a potential significant safety concern. Going forward, the FDA will apply a risk-based approach to enforcement, taking into account how products are being administered as well as the diseases and conditions for which they are being used. This risk-based approach allows product manufacturers time to engage with the FDA, as to determine if they need to submit a marketing authorization application and, if so, submit their application to the FDA for approval.

 

New Draft Guidance Documents

 

The two draft guidances provide important information to help spur development and access to innovative regenerative therapies. The first draft guidance, which builds off the regenerative medicine provisions in the 21st Century Cures Act, addresses how the FDA intends to simplify and streamline its application of the regulatory requirements for devices used in the recovery, isolation, and delivery of regenerative medicine advanced therapies (RMATs), including combination products. The guidance specifies that devices intended for use with a specific RMAT may, together with the RMAT, be considered to comprise a combination product.

 

The second draft guidance describes the expedited programs that may be available to sponsors of regenerative medicine therapies, including the new Regenerative Medicine Advanced Therapy (RMAT) designation created by the 21st Century Cures Act, Priority Review, and Accelerated Approval. In addition, the guidance describes the regenerative medicine therapies that may be eligible for RMAT designation – including cell therapies, therapeutic tissue engineering products, human cell and tissue products, and combination products using any such therapies or products, as well as gene therapies that lead to a durable modification of cells or tissues (including genetically modified cells).

 

Both draft guidance documents will have 90-day comment periods.

 

Adaptation of Lebanese Fattoush Salad with Grilled Haloumi

After adapting this Lebanese salad to available produce, and adjusted to our taste, I have come up with one of the most delicious and refreshing salads, we have had in a long time. Easy to make and beautiful to serve. ©Joyce Hays, Target Health Inc.

 

Most of these ingredients are easy to find, if not, I’ve given substitutes. The haloumi cheese is available at Amazon and Zabar’s. ©Joyce Hays, Target Health Inc. 

 

Fattoush (also fattush, fatush, fattoosh, and fattouche) is a Levantine bread salad made from toasted or fried pieces of Arabic flat bread combined with mixed greens and other vegetables, such as radishes and tomatoes. Fattush belongs to the family of dishes known as fattat (plural of fatteh), which use stale flatbread as a base.

 

Fattoush includes vegetables and herbs according to season and taste. The vegetables are cut into relatively large pieces compared to tabbouleh which requires ingredients to be finely chopped. Staghorn sumac is usually used to give fattoush its sour taste.

 

I decided not to make croutons out of the pita or flat bread. Instead, I served warm pita at the table, with garlic hummus. Although I like to use ground sumac in other dishes, I didn’t want a sour taste in this salad, so omitted the sumac.

 

Ingredients

1 large green capsicum (pepper) or avocado, cut in cubes

1 Lebanese, or long English cucumber, finely chopped

2 ripe truss or vine tomatoes, finely chopped

1/2 red onion, finely chopped

1/2 bunch fresh parsley, leaves chopped

1/2 bunch fresh coriander, leaves chopped

2 pita bread toasted, then make small croutons in food processor

1/4 to 1/2 pound haloumi cheese, cubed (or muenster)

Zest of 1/2 lemon

Juice of 1/2 lemon

 

Dressing 

1/4 cup extra virgin olive oil

1 pinch chili flakes

2 Tablespoons lemon juice

3 small garlic cloves, crushed or squeezed

1/2 teaspoon caster sugar

 

Using a garlic press, you can squeeze the garlic right into a small bowl with the other dressing ingredients. ©Joyce Hays, Target Health Inc.

  

Directions

1. Rinse all of your raw veggies well. You don’t know where they’ve come from or who has handled them. Also, there could be residue from pesticides, even though the claim is organic. Why take a chance, when it only takes a few minutes.

2. Do all of your chopping, cutting slicing, squeezing, peeling etc.

3. Make the dressing first. Simply combine all the ingredients into a small bowl, as you see above.

 

Something so-o refreshing about the smell of chopped cucumbers. ©Joyce Hays, Target Health Inc.

 

Do all of your chopping first. ©Joyce Hays, Target Health Inc.

 

4. If you plan to toast pita or flat bread, do that now. Then, either cut the toasted bread into cubes, or put into food processor and pulse, until you get the size of crouton you want to put into the salad. I have no photos to show re: bread, because decided not to have bread in this kind of salad.

5. In a large salad bowl, that you plan to use for serving, add all of the salad (veggies plus herbs) ingredients, in no special order, and toss them.

 

Making this salad made me feel really healthy; eating it was even better and such a pleasure. You’re going to love this salad. ©Joyce Hays, Target Health Inc.

 

Not a chore; rather, time well spent! ©Joyce Hays, Target Health Inc.

 

You decide if you want to fry the cheese or simply add the cheese cubes to the salad. Do this step last, add the cheese cubes to the salad and give one last toss. I didn’t fry the cheese. ©Joyce Hays, Target Health Inc.

 

I added the dressing last, after adding the cheese cubes. Then several good tosses. ©Joyce Hays, Target Health Inc.

 

6. After tossing the fresh ingredients, add the toasted pita to the salad, if you want to.

7. If you decide to fry the cheese, heat a non-stick frying pan over medium-high heat. Cook the haloumi or muenster, turning, for 2 minutes or until golden. Arrange over the salad. Serve drizzled with a little extra lemon juice.

 

©Joyce Hays, Target Health Inc.

 

We had this salad with warm pita, hummus and well chilled white wine. Then a new recipe I’m working on, curried quinoa with chicken thighs, toasted pistachios, golden raisins. Just about ready to share with you

For dessert, a simple fresh berry combo, photo below.

 

Fresh berry combo for dessert. ©Joyce Hays, Target Health Inc.

 

Varieties of Arab salad: Arab salad, Fattoush, Palestinian salad, Matbucha, Tabbouleh and Raheb. Source: Wikipedia Commons.

 

Pouilly-Fuisse has become our default white wine, taking the place of sauvignon blanc and pinot grigio.

 

We have been following the work of Rajiv Joseph for many years. This weekend we saw his latest play, Describe the Night, produced by one of the theaters we are proud to be patrons of, The Atlantic Theater Company on West 20th Street, here in Manhattan. YOU CANNOT MISS THIS WONDERFUL PRODUCTION WHICH IS RAJIV JOSEPH’S BEST! This is an epic drama based on the life and writings of the great Russian-Jewish, playwright and author, Isaak Babel (1894-1940), who was executed by Stalin’s secret police in 1940. His work was not published in its original versions again, until the 1990s. Babel’s diary becomes a focal point, around which this drama unfolds and weaves around, going, very affectively, back and forth in time. This play is so well acted and directed, that it catches the audience’s attention, immediately, and doesn’t let it go until the final scene. During the two intermissions, we all said agreed (members of audience) that we couldn’t wait to see what would happen next. Certain years of Soviet and Russian history are well integrated into this amazing play.

The sets are excellent and so is the sound design. Be prepared for one of the best theatrical experiences of the year, as Rajiv Joseph expertly traces the stories of seven men and women connected by history, myth and conspiracy theories.

 

Playwright, Rajiv Joseph

Photo credit: Jessica Johnston – Nefariouschafe, CC BY 3.0, https://en.wikipedia.org/w/index.php?curid=17945095

 

Isaak Babel

More about Isaak Babel

Hope you had a great week!

 

From Our Table to Yours

Bon Appetit!