Target Health Launches 2 Major EDC eSource Programs

 

While eSource is revolutionizing the clinical trial business, no marketing application has occurred utilizing Target e*CTR or any other eSource solution. Therefore, to “put our money where our mouth is,“ and to receive regulatory imprimatur, a PMA (device) submission is planned for Q4 2014 and an NDA in Q2 2015.

 

Last week was quite busy as 2 large clinical programs were launched utilizing Target e*CRF® (EDC), fully integrated with Target e*CTR® (eClinical Trial Record). A Phase 3 study will include up to 22 clinical sites and a Phase 2 study will include up to 45 clinical sites. The former program is being monitored by Target Health while the latter program is being monitored by a large global CRO.

 

Basically, there are 2 types of eSource systems out there; web-based and tablet-based, the latter requiring a dedicated device(s) distributed to each site. Many years ago we assessed the advantages and disadvantages of a “thick client“ where there is a requirement for a dedicated device with embedded software for data collection. We concluded that in today’s world of connectivity and with the issues of the cost of devices and the costs of device distribution and maintenance, as well as the many factors associated with management of the multiple changes that occur during a clinical trial, that fully web-based is the way to go. Time has proven us correct as connectivity is rarely an issue and a backup computer belonging to staff member is always somewhere in the office. And yes, in many ways we are similar to an electronic medical record (EMR) for clinical trials, where a clinician logs in and simply enters data. However in contrast to many EMRs, we provide a user-friendly experience.

 

The following summarizes the features of Target e*CTR vs. Tablet Systems in a head-to-head comparison:

 

Comparison of Target e*CTR vs. Tablet Systems as eSource Solutions
  Target e*CTR Tablet Systems
REGULATORY ISSUES    
  1. Part 11-Compliant eSource System
Yes Yes
  1. Ongoing clinical trials
Yes Yes
  1. Compliant with FDA and EMA compliance guidances
Yes Yes
     
TECHNICAL ISSUES    
  1. Web access
Yes Yes
  1. eSignatures
Yes Yes
  1. Minimizes SDV
Yes Yes
  1. Works on any computer
Yes No
  1. Has coding module
Yes No
  1. Has a randomization module
Yes No
  1. Has an IMP management module
Yes No
  1. Has monitoring reports
Yes No
  1. Generates SAE reports
Yes No
  1. Can seamlessly interact with any EDC system
Yes No
  1. Can work offline (thick client)
No Yes
  1. Can interact with the electronic health record
Ongoing Development Program No
 
OTHER SERVICES
  1. CRO Service Provider
Full Service No
  1. Fully integrated Risk-based Monitoring Reports
Yes No
  1. eTMF
Yes No

 

LET FREEDOM RING

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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, and if you like the weekly newsletter, ON TARGET, you’ll love the Blog.

 

Joyce Hays, Founder and Editor in Chief of On Target

Jules Mitchel, Editor

Test Your Knowledge of Shistosomiasis

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Skin blisters on the forearm, created by the entrance of Schistosoma parasite.

 

Schistosomiasis, (also known as bilharzia, snail fever, and Katayama fever) is a disease caused by 1) ___ of the Schistosoma type. It may infect the urinary tract or intestines. Symptoms may include abdominal pain, diarrhea, bloody stool, or blood in the urine. In those who have been infected a long time, liver damage, kidney failure, infertility, or bladder cancer may occur. In children it may cause poor growth and learning difficulty. The disease is spread by contact with water that contains the parasites. These parasites are released from freshwater snails that have been infected. The disease is especially common among children in developing countries as they are more likely to play in infected 2) ___. Other high risk groups include farmers, fishermen, and people using infected water for their daily chores. Diagnosis is by finding the eggs of the parasite in a person’s urine or stool. It can also be confirmed by finding antibodies against the disease in the blood.

 

Methods to prevent the disease include improving access to clean water and reducing the number of 3) ___. In areas where the disease is common entire groups may be treated all at once and yearly with the medication praziquantel. This is done to decrease the number of people infected and therefore decrease the spread of the disease. Praziquantel is also the treatment recommended by the World Health Organization for those who are known to be infected.

 

Schistosomiasis affects almost 210 million people worldwide, and an estimated 12,000 to 200,000 people die from it a year. The disease is most commonly found in Africa, Asia and South America. Around 700 million people, in more than 70 countries, live in areas where the disease is common. Schistosomiasis is second only to 4) ___, as a parasitic disease with the greatest economic impact. Above all, schistosomiasis is a chronic disease. Many infections are subclinically symptomatic, with mild anemia and malnutrition being common in endemic areas. Acute schistosomiasis may occur weeks after the initial infection. Symptoms include: abdominal pain, cough, diarrhea, eosinophilia, fever, fatigue, hepatosplenomegaly (enlargement of both the liver and the spleen), genital sores, mild itching.

 

 

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Calcification of the bladder wall on a plain x-ray image of the pelvis, in a 44 year old sub-Saharan man. This is due to urinary schistosomiasis.

 

Bladder cancer diagnosis and mortality are generally elevated in affected areas.

 

Schistosomes have a typical trematode vertebrate-invertebrate lifecycle, with 5) ___ being the definitive host. The life cycles of all five human schistosomes are broadly similar: parasite eggs are released into the environment from infected individuals, hatching on contact with fresh water to release the free-swimming miracidium. Miracidia, then infect freshwater snails by penetrating the snail’s 6) ___. After infection, close to the site of penetration, the miracidium transforms into a primary (mother) sporocyst. Germ cells within the primary sporocyst will then begin dividing to produce secondary (daughter) sporocysts, which migrate to the snail’s hepatopancreas. Once at the hepatopancreas, germ cells within the secondary sporocyst begin to divide again, this time producing thousands of new parasites, known as cercariae, which are the larvae capable of infecting mammals.

 

The most common way of getting schistosomiasis in developing countries is by wading or swimming in lakes, ponds and other bodies of water that are infested with the snails that are the natural reservoirs of the Schistosoma pathogen. A few countries have eradicated the disease, and many more are working toward it. The World Health Organization is promoting these efforts. In some cases, urbanization, pollution, and/or consequent destruction of snail habitat has reduced exposure, with a subsequent decrease in new infections. Prevention is best accomplished by eliminating the water-dwelling snails that are the natural reservoir of the disease. Acrolein, copper sulfate, and niclosamide can be used for this purpose. Recent studies have suggested that snail populations can be controlled by the introduction of, or augmentation of existing, crayfish populations.

 

Schistosomiasis is readily treated using a single oral dose of the drug praziquantel annually. As with other major parasitic diseases, there is ongoing and extensive research into developing a schistosomiasis 7) ____ that will prevent the parasite from completing its life cycle in humans. In 2009,Eurogentec Biologics developed a vaccine against bilharziosis in partnership with INSERM and researchers from the Pasteur Institute. The World Health Organization has developed guidelines for community treatment of schistosomiasis based on the impact the disease has on children in endemic villages.

 

The Bill & Melinda Gates Foundation has recently funded an operational research program — the Schistosomiasis Consortium for Operational Research and Evaluation (SCORE) to answer strategic questions about how to move forward with schistosomiasis control and elimination. The focus of SCORE is on development of tools and evaluation of strategies for use in mass drug administration campaigns.

 

Antimony has been used in the past to treat the disease. In low doses, this toxicmetalloid bonds to sulfur atoms in enzymes used by the parasite and kills it without harming the host. This treatment is not referred to in present-day peer-review scholarship; praziquantel is universally used. Outside of the U.S., there is a drug available exclusively for treating Schistosoma mansoni (oxamniquine) and one exclusively for treating S.hematobium (metrifonate).

 

20 million have severe consequences from the disease. In many areas, schistosomiasis infects a large proportion of children under 14 years of age.

 

Schistosomiasis is endemic in Egypt, exacerbated by the country’s dam and irrigation projects along the 8) ___. From the late 1950s through the early 1980s, infected villagers were treated with repeated injections of tartar emetic. Epidemiological evidence suggests that this campaign unintentionally contributed to the spread of hepatitis C via unclean 9) ___. Egypt has the world’s highest hepatitis C infection rate, and the infection rates in various regions of the country closely track the timing and intensity of the anti-schistosomiasis campaign.

 

Schistosomiasis, known as bilharzia or bilharziosis in many countries, was named after German physician Theodor Bilharz, who first described the cause of urinary schistosomiasis in 1851. The first doctor who described the entire disease cycle was Brazilian parasitologist Piraja da Silva in 1908. The first known case of infection was discovered in 2014, it belongs to a child who lived 6,200 years ago. It was a common cause of 10) ___ for Ancient Egyptians in the Greco-Roman Period

 

ANSWERS: 1) worms; 2) water; 3) snails; 4) malaria; 5) humans; 6) foot; 7) vaccine; 8) Nile; 9) needles; 10) death

 

Oldest Ever Schistosomiasis Egg Found in June 2014, May Be First Proof of Early Human Technology Exacerbating Disease Burden

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Schistosoma life cycle. Source: CDC

 

Schistosomiasis is a disease caused by several species of flatworm parasites that live in the blood vessels of the bladder and intestines. Infection can result in anemia, kidney failure, and bladder cancer. The parasite spends part of its life cycle in snails that live in warm fresh water, before leaving the snail to burrow through the skin of people wading or swimming in the water. Schistosoma mansoni and its close relatives affect millions worldwide and kill an estimated 250,000 people a year.

 

According to an article published in The Lancet Infectious Diseases (DOI: 10.1016/S1473-3099(14)70794-7), the discovery of a schistosomiasis parasite egg in a 6,200-year-old grave at a prehistoric town by the Euphrates river in Syria may be the first evidence that agricultural irrigation systems in the Middle East contributed to disease burden. The study results showed that schistosomiasis may have been spread by the introduction of crop irrigation in ancient Mesopotamia, the region along the Tigris-Euphrates river system that covers parts of modern-day Iraq, Iran, Kuwait, Syria, and Turkey.

 

According to one of the authors Dr Piers Mitchell, at the University of Cambridge, UK, the discovery might be among the oldest evidence of human-made technology inadvertently causing disease outbreaks. “The individual who contracted the parasite might have done so through the use of irrigation systems that were starting to be introduced in Mesopotamia around 7,500 years ago. These irrigation systems distributed water to crops and may have triggered the beginning of the enormous disease burden that schistosomiasis has caused over the past 6,000 years.“

 

The discovery at Tell Zeidan in Syria was made by an international team of archaeologists and biological anthropologists working at Cambridge (UK), The Cyprus Institute (Cyprus), and the University of Chicago’s Oriental Institute (USA). It shows that the parasite infected humans there at least a thousand years earlier than has been found in Egypt. The oldest Schistosomiasis egg found previously was in Egyptian mummies from 5,200 years ago.

 

The egg was found in the pelvic area of the human burial where the intestines and bladder would have been during life. Control soil samples from the head and foot areas of the grave contained no parasitic eggs, suggesting that the gravesite was not contaminated with the parasite more recently.

 

“Schistosomiasis has become progressively more common over time so that it causes a huge burden across the world today, with over 200 million people infected. It causes anemia which significantly decreases physical productivity in infected people, and may also cause bladder cancer. We would expect these consequences in ancient peoples to have had a significant impact upon early civilizations in the region,“ says Dr Mitchell.

 

How Serotonin Makes the Schistosome Parasites Move

 

January 16, 2014

Public Library of Science

 

A study published on January 16 in PLOS Pathogens (2014; 10 (1): e1003878 DOI: 10.1371/journal.ppat.1003878) has identified a new part of the molecular pathway that controls parasite movement. Because coordinated movement is essential for the schistosome life cycle in its human host, this protein is a promising new drug target.

 

“We know that many anti-parasitic drugs act on the worm’s nervous system,“ says Paula Ribeiro from McGill University in Montreal, Canada, the lead author of the new study, “and have known for over 40 years that the neurotransmitter serotonin controls schistosome movement. As schistosomes are becoming resistant to the only effective drug we have, it was time to go after their serotonin receptor.“

 

Serotonin is a signaling molecule that is used across species, including man, mouse, and worm. It exerts its function through specific serotonin receptors that span the membranes of nerve cells. When these receptors pick-up serotonin the nerve cells become activated. In some cases, this activation in turn activates muscle cells, eventually resulting in movement.

 

As nobody had discovered a schistosome serotonin receptor yet, Ribeiro and colleagues started by a computer (or “in silico“) search for DNA sequences from S. mansoni that looked similar to known serotonin receptor genes. They found a candidate and verified that the corresponding protein, which they called Schistosoma mansoni 5HTR, or Sm5HTR, is indeed a serotonin receptor. When cells that have the protein embedded in their membrane get exposed to serotonin on the outside, the scientists could measure a typical response inside these cells.

 

The scientists then went on to examine where in the parasite Sm5HTR is present, and report that the receptor is found widely on nerve cells in both larvae and adult worms. When they used various ways to interfere with receptor function, they found that larval and adult schistosomes were greatly inhibited in their movement. For example, when schistosome larvae are bathed in serotonin, they become twitchy and hyperactive. Larvae which have many fewer receptors don’t show that response. And adult worms with fewer receptors move much less than those with normal numbers.

 

These studies suggest that even if schistosomes have additional serotonin receptors (and the in silico analysis suggests that there is at least one other), Sm5HTR is a major mediator of serotonin-controlled worm movement. The authors concluded that “We know from previous studies that locomotion is critical for survival of the parasite and that drug-induced paralysis is an effective way of clearing worm infections. Having identified Sm5HTR allows us to begin searching for selective receptor inhibitors that cause paralysis of the worm and may be suitable for therapeutic use.“ Sources: The Lancet, PLoS, Wikipedia, ScienceDaily.com

Adults Stop Anti-Rejection Drugs After Partial Stem-Cell Transplant Reverses Sickle Cell Disease

 

In the United States, more than 90,000 people have sickle cell disease (SCD), a genetic disorder found mainly in people of African ancestry. Worldwide, millions of people have the disease. In SCD, sickle-shaped cells block blood flow which can cause severe pain, organ damage and stroke. The only cure is a blood stem-cell, or bone marrow, transplant. Immunosuppressant medication reduces immune system strength and can cause serious side effects such as infection and joint swelling.

 

Myeloablative allogeneic hematopoietic stem cell transplantation (HSCT) has been shown to be curative for children with severe SCD, but toxicity may be prohibitive for adults. Nonmyeloablative transplantation has been attempted with degrees of preparative regimen intensity, but graft rejection and graft-vs-host disease remain significant.

 

As a result, a study published in the Journal of the American Medical Association (2014;312:48-56), was performed to determine the efficacy, safety, and outcome on end-organ function with this low-intensity regimen for sickle cell phenotype with or without thalassemia (blood disorder passed down through families  in which the body makes an abnormal form of hemoglobin. The disorder results in excessive destruction of red blood cells, which leads to anemia.

 

For the study, from July 16, 2004, to October 25, 2013, 30 patients aged 16-65 years with severe disease enrolled in this nonmyeloablative transplant study, consisting of alemtuzumab (1 mg/kg in divided doses), total-body irradiation (300 cGy), sirolimus, and infusion of unmanipulated filgrastim mobilized peripheral blood stem cells (5.5-31.7?x?106 cells/kg) from human leukocyte antigen-matched siblings. The primary end point was treatment success at 1 year after the transplant, defined as a full donor-type hemoglobin for patients with sickle cell disease and transfusion independence for patients with thalassemia. The secondary end points were the level of donor leukocyte chimerism; incidence of acute and chronic graft-vs-host disease; and sickle cell-thalassemia disease-free survival, immunologic recovery, and changes in organ function, assessed by annual brain imaging, pulmonary function, echocardiographic image, and laboratory testing.

 

Results showed that 29/30 patients survived a median 3.4 years (range, 1-8.6), with no nonrelapse mortality. One patient died from intracranial bleeding after relapse. As of October 25, 2013, 26 patients (87%) had long-term stable donor engraftment without acute or chronic graft-vs-host disease. The mean donor T-cell level was 48%; the myeloid chimerism levels, 86%. Fifteen engrafted patients discontinued immunosuppression medication with continued stable donor chimerism and no graft-vs-host disease. The normalized hemoglobin and resolution of hemolysis among engrafted patients were accompanied by stabilization in brain imaging, a reduction of echocardiographic estimates of pulmonary pressure, and allowed for phlebotomy to reduce hepatic iron. The mean annual hospitalization rate was 3.23 the year before, 0.63 the first year after, 0.19 the second year after, and 0.11 the third year after transplant.

 

For patients taking long-term narcotics, the mean use per week was 639 mg of intravenous morphine-equivalent dose the week of their transplants and 140 mg 6 months after transplant. There were 38 serious adverse events: pain and related management, infections, abdominal events, and sirolimus related toxic effects.

 

According to the authors, among 30 patients with sickle cell phenotype with or without thalassemia who underwent nonmyeloablative allogeneic HSCT, the rate of stable mixed-donor chimerism was high and allowed for complete replacement with circulating donor red blood cells among engrafted participants. The authors added that further accrual and follow-up are required to assess longer-term clinical outcomes, adverse events, and transplant tolerance.

 

People with sickle cell disease interested in joining NIH blood stem-cell transplant studies may call 1-800-411-1222 for more information.

Telemedicine, Using Non-Physicians, Catches Blinding Disease in Premature Babies

 

About 450,000 (12%) of the 3.9 million babies born each year in the United States are premature. The number of preterm infants who survive has surged in middle income countries in Latin America, Asia, and Eastern Europe. In these parts of the world, rates of childhood blindness from retinopathy of prematurity (ROP) are estimated at 15 to 30%, compared to 13% in the United States.

 

Some degree of ROP appears in more than half of all infants born at 30 weeks pregnancy or younger, but only about 5-8% of cases become severe enough to require treatment. A full-term pregnancy is 40 weeks. In ROP, blood vessels in the tissue in the back of the eye called the retina begin to grow abnormally, which can lead to scarring and detachment of the retina. Treatment involves destroying the abnormal blood vessels with lasers or freezing them using a technique called cryoablation. Early diagnosis and prompt treatment is the best prevention for vision loss from ROP, which is why the American Academy of Ophthalmology recommends routine screening for all babies who are born at gestational age 30 weeks or younger or who weigh less than 3.3 pounds at birth.

 

According to a study published in JAMA Ophthalmology (26June 2014), telemedicine is an effective strategy to screen for ROP. According to the authors, if the adopted is adopted broadly, it could help ease the strain on hospitals with limited access to ophthalmologists and lead to better care for infants in underserved areas of the country.

 

The telemedicine strategy consists of electronically sending photos of babies’ eyes to a distant image reading center for evaluation. Staff at the image reading center, who are trained to recognize signs of severe ROP, identified whether infants should be referred to an ophthalmologist for evaluation and potential treatment. The study tested how accurately the telemedicine approach reproduced the conclusions of ophthalmologists who actually examined the babies.

 

The study evaluated ROP screening during the usual care of 1,257 premature infants who were born, on average, 13 weeks early. About every nine days, each infant underwent screening by an ophthalmologist, who assessed whether referral for treatment was warranted. Those who were referred were designated as having referral-warranted ROP (RW-ROP). Either immediately before or after the exam, a non-physician staff member in the neonatal intensive care unit (NICU) took images of the infant’s retinas and uploaded them to a secure server at the University of Oklahoma, Oklahoma City. Trained non-physician image readers at the University of Pennsylvania, Philadelphia, then downloaded the photos, independently evaluated them following a standard protocol, and reported the presence or absence of RW-ROP.

 

Through the telemedicine approach, non-physician image readers correctly identified 90% of the infants deemed to have RW-ROP based on examination by an ophthalmologist; they were also correct 87% of the time when presented with images from infants who lacked RW-ROP. The examining ophthalmologists documented 244 infants with RW-ROP on examination. After referral, 162 infants were treated. Of these, non-physician image readers identified RW-ROP in all but three infants (98%).

 

In a separate analysis, the study evaluated the ability of non-physicians and physicians in assessing photos for RW-ROP. Three physicians evaluated image sets from a random sample of 200 babies (100 with RW-ROP based on the eye exam findings; 100 without) using the standard grading protocol. On average, the physicians correctly identified about 86% of RW-ROP cases; the non-physicians were correct 91% of the time. The physicians correctly identified about 57% of babies without RW-ROP; non-physicians were correct 73% of the time. 

 

According to the authors, weekly ROP screening — or even more frequently for high-risk babies — is a realistic goal for telemedicine and could help catch all cases needing treatment. While in the study, imaging was restricted to occasions when an ophthalmologist examined the baby, in practice, hospital staff could implement an imaging schedule based on the baby’s weight, age at birth, and other risk factors.

 

Telemedicine for evaluating ROP offers several other advantages.

 

1) Telemedicine may help detect RW-ROP earlier. In the study, about 43% of advanced ROP cases were identified by telemedicine before they were detected by an ophthalmologist — on average, about 15 days earlier.

 

2) Telemedicine could save babies and their families the hardship and hazards of being unnecessarily transferred to larger nurseries with greater resources and more on-site ophthalmologists.

 

3) Telemedicine might also bring down the costs of routine ROP screening by reducing the demands on ophthalmologists, whose time is better allocated to babies who need their attention and expertise.

 

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

 

FDA Issues Draft Guidances for Industry on Social Media and Internet Communications About Medical Products: Designed with Patients in Mind

 

The following was extracted from FDA Voice (June 17, 2014)

 

Ongoing changes in technology both transform medical products as well as in the ways both patients and health care providers learn about those products. In today’s world, in addition to traditional sources of medical product information, patients and health care providers regularly get information about FDA-regulated medical products through social media and other Internet sources. But regardless of the Internet source used to communicate about medical products, the public health is best served by clear, accurate, truthful and non-misleading information about them.

 

That’s why the agency has proposed two draft guidances for industry with recommendations to help manufacturers and their representatives accurately communicate online about prescription drugs and medical devices. These documents strive to ensure that the information provided by drug and device companies is accurate and will help patients to make well-informed decisions in consultation with their health care providers.

 

The first guidance provides recommendations for the presentation of risk and benefit information for prescription drugs or medical devices using Internet/social media sources with character space limitations, such as Twitter and the paid search results links on Google and Yahoo. These recommendations address the presentation of both benefit information and risk information in this setting. However, no matter what Internet source is used, benefit claims in product promotions should be balanced with risk information. And companies should provide a way for consumers to gain direct access to a more complete discussion of risks associated with their products.

 

The second guidance provides recommendations to companies that choose to correct third-party information related to their own prescription drugs and medical devices. This draft guidance provides FDA’s recommendations on the correction of misinformation from independent third parties on the Internet and through social media sites. For example, FDA recommends that any corrections should address all misinformation in a clearly defined portion of a forum on the Internet or social media, whether the misinformation is positive or negative.

 

FDA developed these new guidances, in part, to respond to requests for best practices from companies and other stakeholders with the understanding that technology continues to evolve. As a result, FDA worked across FDA Centers and Offices to develop best practices that can be applied to existing online Internet sites as well as those that have yet to be developed.

 

These draft guidances are the latest in a series, and the agency is very interested in receiving comments from interested parties. There is additional information about the new draft guidances on FDA’s social media guidances webpage, and FDA would like interested parties to share comments and suggestions.

 

FDA sees social media as an important resource for industry and is committed to developing additional guidance for drug and device manufacturers that outline the agency’s current thinking. All of this work is being done with the best interest of patients in mind.

Baked Stuffed Cheezy Tomatoes with Tuna

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Just out of the oven                            ©Joyce Hays, Target Health Inc.

 

Tuna Puree Ingredients (takes 5 minutes)

Put all of these ingredients into a food processor, blend and set aside

2 cans (7 oz) tuna fish in oil

2 Tablespoons anchovy paste

2 Tablespoon capers

4 Tablespoons fresh lemon, juice

1/2 cup extra-virgin olive oil

4 Tablespoons Kraft mayonnaise

Pinch black pepper

 

 

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Get all your ingredients lined up                       ©Joyce Hays, Target Health Inc.

 

Ingredients For Stuffing

2 eggs

1 cup grated soy cheese (save some for garnish)

1 cup quinoa

2 cups tuna puree

1 zucchini

1/2 cup olive oil, divided

1 large shallot, minced

6 to 8 garlic cloves, sliced

1/2 teaspoon crushed red pepper flakes

1 teaspoon cumin

1 teaspoon turmeric

1 teaspoon cardamom

6 large tomatoes

2 large Portobello mushrooms, cleaned, and finely chopped in a food processor)

Kosher salt and freshly ground pepper, to taste

1 1/2 cups Panko

1/2 cup mashed cooked yam, more if needed. Bake 3 yams.

Flat leaf parsley, chopped, for garnish

 

 

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Ready to be stuffed                             ©Joyce Hays, Target Health Inc.

 

Directions

Preheat oven to 350 degrees

  • Wash the 6 tomatoes and slice the top off each tomato.  Save the top for later.  Scoop out the insides of each tomato, but don’t scrape too close to the skin. You want the outside to stay firm in order to hold the stuffing, when baking
  • Cook the quinoa. Rinse the grains well. Bring the water to a boil and add the quinoa, cooking until it is translucent and tender, and the germ has spiraled out from the grain, 12 to 15 minutes, careful not to overcook. Drain, measure 2 cups and set aside. This makes about 2 1/2 cups cooked quinoa, more than is needed for the rest of the recipe; the remainder can be eaten by itself or added to soups or salads.
  • While the quinoa is cooking, coarsely grate the zucchini. Spread the grated zucchini out on a kitchen towel, then roll up the towel and wring it to squeeze out as much moisture as possible. Set aside.
  • In a large saute pan, heat the olive oil over low heat and add the minced shallot, sliced garlic and red pepper flakes, and all the seasonings. Cook until the shallots are soft, about 3 minutes.
  • To the pan, add the mushroom pureed and zucchini, and cook for 3 more minutes to soften, stirring often.
  • Place the mixture in a large bowl and add the quinoa, then add salt and pepper to taste. Set aside to cool.
  • Now, add the Panko and mashed yam to the large bowl.
  • Add the 2 eggs and the tuna puree to the mixture
  • Add most of the freshly grated soy cheese and mix into the rest of the ingredients
  • With your hands, knead the mixture to fully incorporate the eggs and tuna puree.
  • Rub olive oil all over each of the 6 tomatoes
  • Oil the baking dish
  • Now, with a teaspoon, carefully pack the stuffing into each hollowed out tomato, and place the 6 stuffed tomatoes into a shallow baking dish, deep enough to catch any drippings

 

 

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Ready to bake after sprinkling grated soy cheese on top ©Joyce Hays, Target Health Inc.

 

1. Add the top slice of tomato to the stuffing and sprinkle the freshly grated soy cheese on top.

2. Bake in oven for 30 to 40 minutes.

3. Garnish with some chopped fresh parsley and serve with a green veggie like saut?ed broccoli or kale or just some cole slaw.  (We had home made cole slaw and some sweet green baby peas)

4. Sliced fresh fruit for dessert (We had cut up, and mixed together, fresh strawberries, fresh pineapple, fresh blueberries, fresh raspberries, topped with vanilla Activa yogurt)

 

 

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Left-overs for Sunday  ©Joyce Hays, Target Health Inc.

 

Here’s another fun time I had experimenting with ingredients like quinoa, tuna, soy cheese and interesting spices. I am finding that spices that Jules usually doesn’t like, now, he loves if other flavors balance out the spicy-ness. I added the tuna puree to get some depth from the quinoa and mushrooms.  You don’t even know you’re eating tuna. Isn’t the presentation pretty? I served it with jasmine rice, sweet green baby peas and home-made cole slaw. For dessert we had cut up fresh fruit topped with vanilla Activa yogurt.

 

We both loved this recipe and toasted my cooking with icy Orvieto.

 

 

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Dessert: Sweet, Healthy, Delicious    ©Joyce Hays, Target Health Inc.

 

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We celebrated American Independence Day this weekend, which always touches us. We know that parts of the world still ache for individual freedom.  Let us hope that the rest of the planet finds their own path towards, liberty and freedom for all!

 

From our table to yours

 

Bon Appetit !