Target Health Blog

Discover all the latest about our products, technology, and Target Health culture on our official blog.

Jackson Pollack Salad

June 25, 2018

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Target Healthy Eating

This week. ©Joyce Hays, Target Health Inc.
Two weeks ago. ©Joyce Hays, Target Health Inc.
Three weeks ago. ©Joyce Hays, Target Health Inc. 
Four weeks ago. ©Joyce Hays, Target Health Inc. 
Yummy salad; we ate this all weekend. ©Joyce Hays, Target Health Inc.

Ingredients 

1/2 head red cabbage, shredded with mandolin

1/4 head green cabbage, shredded with mandolin

1 and 1/2 carrots, grated

2 heaping Tablespoons parsley, chopped

3 heaping Tablespoons dill, chopped

1 large shallot, chopped

3 large garlic cloves, pressed

1 pinch salt

1 pinch black pepper

1 pinch chili flakes (optional)

1/2 teaspoon agave

1/4 teaspoon Dijon mustard

4 Tablespoons apple cider vinegar

1/2 cup buttermilk

2 Tablespoons sour cream

4 Tablespoons Kraft mayonnaise

This salad has been evolving for ten years and will continue. The next time I make it, I will add 3 mashed anchovy fillets (mashed with the garlic cloves), instead of any salt. As well as being salty, the anchovies add that umami flavor. However, I promise you, that this iteration of the Jackson Pollock salad, will be filled with awesome flavors. ©Joyce Hays, Target Health Inc.

Directions

1. Do all cutting, shredding, slicing, chopping so everything is ready to add when needed.

Chopping the dill, parsley and shallot, at the same time. ©Joyce Hays, Target Health Inc.
I wouldn't have the patience to do this salad without the mandolin, which I got at Williams-Sonoma. The cutting board under the mandolin is specially tempered clear glass. ©Joyce Hays, Target Health Inc.
I graduated from art school, before I went to Columbia Univ (grad & undergrad) and always wondered how I would combine my psychology credentials with the art degree. As the founder of THI and also of the ON TARGET newsletter, I guess that's the combo. Anyway, I digress. I really love color, so when I had the chance to paint with veggies, as in this salad, I couldn't resist the homage to Jackson Pollock, a wild genius, if there ever was one. I know he would've liked the idea and loved this salad. ©Joyce Hays, Target Health Inc.

2. Put the first five ingredients in a large salad serving bowl and toss well.

3. Put the next eleven ingredients in a smaller bowl, starting with the chopped shallot, and mix well

I added all the dressing ingredients to my large measuring cup. ©Joyce Hays, Target Health Inc.
Added the dressing and ready for 3 minutes of tossing all ingredients so well combined. ©Joyce Hays, Target Health Inc.

4. Having tossed well, refrigerate this salad for about 2 hours before serving, so all of the diverse flavors have a chance to mingle.

Oh, how good this combo was: very fresh shrimp (Whole Foods) sauteed in a little oil and garlic, with the Jackson Pollock salad; Yum! ©Joyce Hays, Target Health Inc.
This chardonnay was perfect for the seafood and JP salad at lunch and another meal of saut?ed chicken thighs & pears, with JP Salad. ©Joyce Hays, Target Health Inc.

Have a great week everyone! 

Bon Appetit!

FDA Approves Automated Insulin Delivery and Monitoring System for Use in Younger Pediatric Patients

June 25, 2018

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Regulatory

The human pancreas naturally supplies a low, continuous rate of insulin, known as basal or background insulin. In patients with diabetes, the body's ability to produce or respond to insulin is impaired. Because the pancreas does not make insulin in people with type 1 diabetes, patients must consistently monitor their glucose levels throughout the day and inject insulin with a syringe, pen or pump to avoid becoming hyperglycemic (high glucose levels). In addition, management of type 1 diabetes includes following a healthy eating plan and physical activity. Type 1 diabetes, also known as juvenile diabetes, is typically diagnosed in children and young adults.

The FDA has expanded the approval of the MiniMed 670G hybrid closed looped system, a diabetes management device that is intended to automatically monitor glucose (sugar) and provide appropriate basal insulin doses with little or no input from the user, to include individuals aged 7 to 13 with type 1 diabetes. The FDA originally approved this device in September 2017 for use in patients 14 years of age and older with type 1 diabetes.

The MiniMed 670G hybrid closed looped system works by measuring glucose levels in the body every five minutes and automatically adjusting insulin delivery by either administering or withholding insulin. The system includes: a sensor that attaches to the body to measure glucose levels under the skin; an insulin pump strapped to the body; and an infusion patch connected to the pump with a catheter that delivers insulin. While the device automatically adjusts insulin levels, users need to manually request insulin doses to counter carbohydrate consumption at mealtime. 

The FDA evaluated data from a clinical trial of the MiniMed 670G hybrid closed looped system that included 105 individuals aged 7 to 11 years old. Study participants wore the device for approximately 3.5 months and participated in three phases of the study to evaluate both at-home use as well as remote use. The study found no serious adverse events associated with use of the MiniMed 670G and that the device is safe for use in people age 7 to 13 years with type 1 diabetes. Risks associated with use of the system may include hypoglycemia, hyperglycemia, as well as skin irritation or redness around the device's infusion patch. As part of this approval, the FDA is requiring the product developer to conduct a post-market study to evaluate device performance in real-world settings in children between the ages of 7 and 13. This device is not approved for use in children 6 years of age or younger and in individuals who require less than eight units of insulin per day.

The expanded approval of MiniMed 670G hybrid closed looped system was granted to Medtronic.

PCIT-ED Shows Promise for Treating Depression in Preschool-Aged Children

June 25, 2018

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Children as young as 3-years-old can be diagnosed with clinical depression, and although preschool-aged children are sometimes prescribed antidepressants, a psychotherapeutic intervention is greatly needed. According to a study published online in the American Journal of Psychiatry (20 June 208), it was shown that a therapy-based treatment for disruptive behavioral disorders can be adapted and used as an effective treatment option for early childhood depression. The authors adapted Parent-Child Interaction Therapy (PCIT), which has been shown to be an effective way to treat disruptive behavioral disorders in young children. In standard PCIT treatment, parents are taught techniques for successfully interacting with their children. They then practice these techniques in controlled situations while being coached by a clinician. 

In order to target the therapy for childhood depression, the authors adapted this standard intervention by adding a new emotional development (ED) module to the treatment. This extra material used the basic techniques of PCIT to train parents to be more effective at helping their children regulate emotions and to be better emotion coaches for their children. The training was designed to help enhance the children's emotional competence and emotion regulation abilities. For the study, children ages 3-6 who met criteria for early childhood depression and their parents were randomly assigned to PCIT-ED treatment or a waitlist group. Children in the PCIT-ED group completed standard PCIT modules for a maximum of 12 treatment sessions, followed by an emotional development module lasting eight sessions. There are currently no empirically tested treatments that are widely used to treat early childhood depression; therefore, children in the waitlist group were monitored but received no active intervention. Children and their parents in the waitlist group were offered PCIT-ED treatment after completion of the study. The authors assessed before and after treatment or the waiting period (depending on group assignment), children's psychiatric symptoms, their emotional self-regulation abilities, their level of impairment and functioning, and their tendency to experience guilt. Parents were assessed for depression severity, coping styles, and strategies they used in response to their child's negative emotions, and for stress within the parent-child relationship. 

Results showed that at the completion of treatment, children in the PCIT-ED group were less likely to meet criteria for depression, more likely to have achieved remission, and were more likely to score lower on depression severity than children in the waitlist group. Children in the PCIT-ED treatment group had improved functioning, fewer comorbid disorders, and were rated as having greater emotional regulation skills and greater “guilt reparation“ (e.g., spontaneously saying ''sorry'' after having done something wrong, appropriate empathy with others, etc.) compared with children in the waitlist group. Parents in the PCIT-ED group also benefited. They were found to have decreased symptoms of depression, lower levels of parenting stress, and reported employing more parenting techniques that focused on emotion reflection and processing than parents in the waitlist group. Parents also overwhelmingly reported positive impressions of the therapeutic program.

According to the authors, the study provides very promising evidence that an early and brief psychotherapeutic intervention that focuses on the parent-child relationship and on enhancing emotion development may be a powerful and low-risk approach to the treatment of depression,“ and that it will be very important to determine if gains made in this early treatment are sustained over time and whether early intervention can change the course of the disorder.

New Evidence that Viruses May Play a Role in Alzheimer's Disease

June 25, 2018

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Neurology

Alzheimer's disease (AD) is an irreversible, progressive brain disorder that slowly destroys memory and thinking skills and, eventually, the ability to carry out simple tasks. More evidence is accumulating to indicate that this loss of cognitive functioning is a mix of many different disease processes in the brain, rather than just one, such as buildup of amyloid or tau proteins. Identifying links to viruses may help researchers learn more about the complicated biological interactions involved in AD, and potentially lead to new treatment strategies. 

National Institute on Aging (NIA) study finds new evidence that viruses may play a role in AD.

According to an article published online in the journal Neuron Analysis (21 June 2018), large data sets from post-mortem brain samples of people with and without AD has revealed new evidence that viral species, particularly herpesviruses, may have a role in AD biology. The study harnessed data from brain banks and cohort studies participating in the Accelerating Medicines Partnership - Alzheimer's Disease (AMP-AD) consortium. The authors emphasized that while their findings do not prove that the viruses cause the onset or progression of AD, the findings do show that viral DNA sequences and activation of biological networks -- the interrelated systems of DNA, RNA, proteins and metabolites -- may interact with molecular, genetic and clinical aspects of AD. 

The authors originally set out to find whether drugs used to treat other diseases can be repurposed for treating AD, and designed the study to map and compare biological networks underlying AD. What they found is that AD biology is likely impacted by a complex constellation of viral and host genetic factors, adding that there are specific testable pathways and biological networks. The authors used multiple layers of genomic and proteomic data from several NIA-supported brain banks and cohort studies. They began their direct investigation of viral sequences using data from the Mount Sinai Brain Bank and were able to verify their initial observations using datasets from the Religious Orders Study, the Memory and Aging Project and the Mayo Clinic Brain Bank. They were then able to incorporate additional data from the Emory Alzheimer's Disease Research Center to understand viral impacts on protein abundance. Through the application of sophisticated computational modeling the authors made several key findings, including: 

Human herpesvirus 6A and 7 were more abundant in Alzheimer's disease samples than non-Alzheimer's.

There are multiple points of overlap between virus-host interactions and genes associated with Alzheimer's risk.

Multiple viruses impact the biology of Alzheimer's disease across domains such as DNA, RNA and proteins.

Important roles for microbes and viruses in Alzheimer's disease have been suggested and studied for decades. Since the 1980s, hundreds of reports have associated AD with bacteria and viruses. These studies combined suggest a viral contribution but have not explained how the connection works. While the current findings are more specific, they do not provide evidence to change how risk and susceptibility are assessed, nor the diagnosis and treatment of AD. Rather, the research gives scientists reason to revisit the old pathogen hypothesis and will be the basis for further work that will test whether herpes virus activity is one of the causes of AD. 

More on this research is available in announcements from the Icahn School of Medicine at Mount SinaiArizona State University and Cell Press, the publisher of Neuron.

Oskar Hertwig, Developmental Biologist

June 25, 2018

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History of Medicine

Oskar Hertwig: Photo credit: Erik Nordenskiold, The history of biology: a survey. Knopf, New York, 1935, S. 594. Online: archive.org, Public Domain, https://commons.wikimedia.org/w/index.php?curid=1020140

Oscar Hertwig (21 April 1849 - 25 October 1922) was a German zoologist and professor, who also wrote about the theory of evolution circa 1916, over 55 years after Charles Darwin's book The Origin of Species. He was the elder brother of zoologist-professor Richard Hertwig (1850-1937). The Hertwig brothers were the most eminent scholars of Ernst Haeckel (and Carl Gegenbaur) from the University of Jena. They were independent of Haeckel's philosophical speculations but took his ideas in a positive way to widen their concepts in zoology. Initially, between 1879-1883, they performed embryological studies, especially on the theory of the coelom (1881), the fluid-filled body cavity. These problems were based on the phylogenetic theorems of Haeckel, i.e. the biogenic theory (German = biogenetisches Grundgesetz), and the "gastraea theory".

Within 10 years, the two brothers moved apart to the north and south of Germany. Oscar Hertwig later became a professor of anatomy in 1888 in Berlin; however, Richard Hertwig had moved 3 years prior, becoming a professor of zoology in Munich from 1885-1925, at Ludwig Maximilians Universitat, where he served the last 40 years of his 50-year career as a professor at 4 universities. Richard's research focused on protists (the relationship between the nucleus and the plasm = "Kern-Plasma-Relation"), as well as on developmental physiological studies on sea urchins and frogs. He also wrote a leading Zoology textbook. He also discovered mitosis and meiosis. 

Oscar Hertwig was a leader in the field of comparative and causal animal-developmental history. He also wrote a leading textbook. By studying sea urchins he proved that fertilization occurs due to the fusion of a sperm and egg cell. He recognized the role of the cell nucleus during inheritance and chromosome reduction during meiosis: in 1876, he published his findings that fertilization includes the penetration of a spermatozoon into an egg cell. Oscar Hertwig experiments with frog eggs revealed the 'long axis rule', or Hertwig rule. According to this rule cell divides along its long axis (1884). In 1885 Oscar wrote that nuclein (later called nucleic acid) is the substance responsible not only for fertilization but also for the transmission of hereditary characteristics. This early suggestion was proven correct much later in 1944 by the Avery - MacLeod - McCarty experiment which showed that this is indeed the role of the nucleic acid DNA. While Oscar was interested in developmental biology, he was opposed to chance as assumed in Charles Darwin?s theory. His most important theoretical book was: "Das Werden der Organismen, eine Widerlegung der Darwinschen Zufallslehre" (Jena, 1916) (translation: "The Origin of Organisms - a Refutation of Darwin's Theory of Chance").

Hertwig was elected a member of the Royal Swedish Academy of Sciences in 1903. Oscar Hertwig is known as Oscar Hedwig in the book "Who discovered what when" by David Ellyard. A history of the discovery of fertilization for mammals including scientists like Hertwig and other workers is given by the book "The Mammalian Egg" by Austin.

Epithelial Cells

June 25, 2018

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Quiz

Illustration of the dividing epithelium cell surrounded by epithelium tissue. Spindle apparatus rotates inside the cell. The rotation is a result of astral microtubules pulling towards tri-cellular-junctions (TCJ), signaling centers localized at the regions where three cells meet. Graphic credit: Margo. raichman - Own work, CC BY-SA 4.0,https://commons.wikimedia.org/w/index.php?curid=52087985

Epithelium is one of the four basic types of animal tissue, along with connective tissue, muscle tissue and nervous tissue. Epithelial tissues line the outer surfaces of organs and blood vessels throughout the body, as well as the inner surfaces of cavities in many internal organs. An example is the epidermis, the outermost layer of the 1) ___. There are three principal shapes of epithelial cell: squamous, columnar, and cuboidal. These can be arranged in a single layer of cells as simple epithelium, either squamous, columnar, cuboidal, pseudo-stratified columnar or in layers of two or more cells deep as stratified (layered), either squamous, columnar or cuboidal. All glands are made up of epithelial 2) ___. Functions of epithelial cells include secretion, selective absorption, protection, transcellular transport, and sensing.

Epithelial layers contain no blood 3) ___, so they must receive nourishment via diffusion of substances from the underlying connective tissue, through the basement membrane. Cell junctions are well-employed in epithelial tissues. Epithelial tissues have as their primary functions:

1. Protect the tissues that lie beneath from radiation, desiccation, toxins, invasion by pathogens, and physical trauma

2. Regulation and exchange of chemicals between the underlying tissues and a body cavity

3. Secretion of hormones into the circulatory system, as well as the secretion of sweat, mucus, enzymes, and other products that are delivered by ducts

4. Provide sensation

Cells of epithelial tissue are tightly packed and form a continuous sheet. They have almost no intercellular spaces. All epithelia is usually separated from underlying tissues by an extracellular fibrous basement membrane. The lining of the mouth, lung alveoli and kidney tubules all are made of epithelial 4) ___. The lining of the blood and lymphatic vessels are of a specialized form of epithelium called endothelium. Epithelium lines both the outside (skin) and the inside cavities and lumina of bodies. The outermost layer of human skin is composed of dead stratified squamous, keratinized epithelial cells. Tissues that line the inside of the mouth, the esophagus, the vagina, and part of the rectum are composed of nonkeratinized stratified squamous epithelium. Other surfaces that separate body cavities from the outside environment are lined by simple squamous, columnar, or pseudostratified epithelial cells. Other 5) ___ cells line the insides of the lungs, the gastrointestinal tract, the reproductive and urinary tracts, and make up the exocrine and endocrine glands. The outer surface of the cornea is covered with fast-growing, easily regenerated epithelial cells. A specialized form of epithelium - endothelium forms the inner lining of blood vessels and the heart, and is known as vascular endothelium, and lining lymphatic vessels as lymphatic endothelium. Another type, mesothelium, forms the walls of the pericardium, pleurae, and peritoneum.

In arthropods, the integument, or external "skin", consists of a single layer of epithelial ectoderm from which arises the cuticle, an outer covering of chitin the rigidity of which varies as per its chemical composition.

Epithelial tissue rests on a basement membrane, which acts as a scaffolding on which epithelium can grow and regenerate after injuries. Epithelial tissue has a nerve supply, but no 6) ___ supply and must be nourished by substances diffusing from the blood vessels in the underlying tissue. The basement membrane acts as a selectively permeable membrane that determines which substances will be able to enter the epithelium. It is known that some corneal diseases and degenerations have a significant heritable background. Because the density of the corneal endothelial cells is strongly 7) ___, this knowledge should stimulate future genetic studies to identify genes and pathways that are involved in determining corneal endothelial cell density (ECD) which might in turn lead to future treatments to prevent epithelial cell (EC) loss.

There is evidence that a major pressure driving evolution of CNS blood-tissue barriers was the selective advantage given by fine control (homeostasis) of the brain ionic microenvironment. The blood-brain barrier (BBB) is a diffusion barrier, which impedes influx of most compounds from blood to brain. Three cellular elements of the brain microvasculature compose the BBB-endothelial cells, astrocyte end-feet, and pericytes (PCs). Tight junctions (TJs), present between the cerebral endothelial cells, form a diffusion barrier, which selectively excludes most blood-borne substances from entering the 8) ___. At the blood brain 9) ___, the endothelial cells do not act alone, but function within a well organized 'neurovascular unit' (NVU), a modular structure integrating the local neuronal population and its associated astrocytic glia with the cells forming the microvascular tube providing blood flow, the endothelium and pericytes, and in arterioles also smooth muscle. Microglia, the resident immune cells of the CNS, are associated with the NVU, in quiescent state in normal physiology, but becoming activated in pathology.

When researchers today refer to HERS, they are including the studies, done over a century ago, of Oskar Hertwig. HERS stands for: Hertwig's Epithelial Root Sheath. Today, NIH clinical reports in tandem with developmental and evolutionary studies re-introduce HERS as the ultimate governor of the periodontal ligament, the regulator of its width and homeostasis and the shield against resorption and ankylosis. From an evolutionary 10) ___ perspective, HERS appears to have evolved first to provide elastic anchorage for and mediate eruption of amphibian teeth and then may have evolved to facilitate the formation of a non-mineralized periodontal ligament in crocodiles and mammals and maintain its functional integrity. During development, HERS fenestration allows mesenchymal cells from the dental follicle to penetrate the epithelial barrier and deposit cementum. A part of this function may be related to the induction of acellular cementogenesis, and future studies will provide definitive answers to address this important issue.

ANSWERS: 1) skin; 2) cells; 3) vessels; 4) tissue; 5) epithelial; 6) blood; 7) heritable; 8) brain; 9) barrier; 10) biology

Sources: NIH.gov; /www.frontiersin.org; Wikipedia

The Talented Mr. Farley

June 25, 2018

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What's New

James Farley, photographer extraordinaire, friend and colleague, sent us some recent photos. Hard to choose, but we all agreed that one below was exceptional.

Here are the specs:

The camera perspective (on a tall tripod) was above the head. That's how high-up the flowers were. They were at the height of my eyes, as I stood.
RShot on Canon 5D Mark IV with Canon 17mm Tilt-shift lens using Lee Filters 0.6 standard filter. 
Rhododendrons at Sunset on Roan Mountain, North Carolina, June 14, 2018. Jane Bald and Round Bald in view. © Copyright Advanced Fine Art 2018 / All Rights Reserved

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.

Joyce Hays, Founder and Editor in Chief of On Target

Jules Mitchel, Editor

Blue Wave Brownies

June 18, 2018

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Target Healthy Eating

These brownies are so healthy and delicious, I had one with my coffee Sunday morning. ©Joyce Hays, Target Health Inc.
If we shared some with you, and asked whether you liked the chocolate, you would give a positive reply, not in the least bit cognizant that two of the ingredients are black beans and avocado. ©Joyce Hays, Target Health Inc.
These brownies are one of the healthiest desserts I have ever made. Think about it: dark chocolate, avocado, black beans, walnuts: all heart healthy foods. Easy to make and because they're so healthy, you'll be making them all the time now; hopefully! ©Joyce Hays, Target Health Inc.

Ingredients

1/2 cup unsweetened Belgian cocoa powder

1 teaspoon of your best vanilla extract

1/4 cup coconut oil

1 can black beans, rinsed very well and drained, then lightly paper toweled

3 large eggs

1/2 cup dark brown sugar

1/2 cup coconut sugar

1 pinch Kosher salt

1 cup dark Belgian chocolate chips, measure them out and set aside

1 large ripe avocado

1 teaspoon baking powder

1 cup walnuts

Easy ingredients to find. ©Joyce Hays, Target Health Inc.

Directions

1. Preheat oven to 350 degrees

2. Toast the walnuts then chop them coarsely and set aside.

About to toast the walnuts. ©Joyce Hays, Target Health Inc.
After toasting the walnuts, chopping them. ©Joyce Hays, Target Health Inc.

3. Measure the chocolate chips, then set aside

Starting to measure out the chocolate chips. ©Joyce Hays, Target Health Inc.

4. With coconut oil, oil a square baking dish, about 8x8, or a small rectangular dish

5. Into a food processor, add all the ingredients, except for the two above, the walnuts and the chocolate chips. Set the nuts and the chips aside

My food processor makes my recipe world possible; without it, most of my recipes would take much too long. We're so lucky to have it. This whole recipe, pretty much depends on this precious piece of equipment, since all but two of the ingredients, simply get tossed in the processor, pulsed, blended and that's it! ©Joyce Hays, Target Health Inc.
Growing up, I cooked in the kitchen with my mother, and really enjoyed it. My father thought I should go to the Cornell School of Home Economics (now gone & I went to Columbia University instead). My specialty in those days was creating salads and the dressing for roast turkey and chicken. My mother's sense of whimsey made preparing food fun. A banana cut in half, sliced, with skin left, became a banana boat with men in the boat. A hot cooked cereal called wheatina, became tiger cereal when raisins were added. You get the picture, the kitchen was a fun place for me. ©Joyce Hays, Target Health Inc.
The unbelievable becomes believable, homemade brownies made with avocado. ©Joyce Hays, Target Health Inc.
And, the chocolate batter is done. ©Joyce Hays, Target Health Inc.
This chocolate batter is as finger-lickin' good as it was in the kitchen of my childhood. ©Joyce Hays, Target Health Inc.

6. Pulse all the ingredients until you get a nice smooth chocolate batter

7. With a spatula, scrape and pour the chocolate batter out of the food processor and into the buttered baking dish.

Adding the chocolate chips. ©Joyce Hays, Target Health Inc.

8. Add the chocolate chips to the batter and with the spatula, mix the chips into the batter. Sort of swirl them around.

Sprinkle the chopped walnuts over the top of the batter and bake, watching carefully that nothing burns. Each oven is different. ©Joyce Hays, Target Health Inc.

9. Over the top of the batter, sprinkle the chopped walnuts that you have toasted.

Good around the clock: dessert, snack, breakfast with coffee, take to school or to the office. ©Joyce Hays, Target Health Inc.

10. Bake, uncovered for 25 minutes, and check with a toothpick to see if they're done. If toothpick doesn't come out smoothly and clean, bake for another 10 minutes and test again. If not ready, bake for another 5 minutes, or until toothpick comes out with no batter sticking to it.

11. When you take the brownies out of the oven, don't serve them right away. Let them sit in the baking dish, on top of the stove, to cool down for about 30 minutes.

12. Serve plain or with ice cream, whipped cream, low calorie cool whip, etc.

This is the piece I had with my coffee, Sunday morning. ©Joyce Hays, Target Health Inc.
One of the best Pinot Noirs around, Paul Hobbs, Napa Valley. ©Joyce Hays, Target Health Inc.
We started with the Paul Hobbs Pinot Noir, baked zucchini sticks and a salad. Then curried cauliflower over saffron rice. Finally, dessert, the unbelievably (low calorie, and healthy) delicious brownies with cool whip on top. ©Joyce Hays, Target Health Inc.

Have a great week everyone!

Bon Appetit!

Innovation at FDA

June 18, 2018

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Regulatory

The following was taken from a posting on June 6, 2018 by FDA Voice, authored by Scott Gottlieb, M.D., and Anna Abram

Scientific advances in biotechnology, such as genome editing and synthetic biology, hold enormous potential to improve human and animal health, animal welfare, and food security. And researchers and companies based in the United States helped pioneer these technologies. To advance this progress, it's key that the FDA adopt a regulatory approach to these technologies that's as innovative and nimble as the opportunities that FDA is being tasked with evaluating. FDA is committed to helping ensure the safety of biotechnology products, while also facilitating innovation by applying a risk-based regulatory approach that provides developers with regulatory clarity and predictability and maintains public confidence in the regulatory system.

FDA is taking some new steps to approve products enabled by new techniques of biotechnology that have the potential to significantly enhance public health. For instance, new methods can be used to alter animals to minimize or prevent their ability to spread human disease. Genome editing in animals and plants also can be used to produce human drugs, devices, or biologics, including tissues or organs for xenotransplantation. Scientists are also exploring editing the genomes of animals with the goal of improving the health and welfare of food producing animals and public health, for example by reducing their susceptibility to diseases like novel influenzas and resistance to zoonotic or foreign animal diseases. Similar and equally beneficial applications of genome editing are currently being explored in food crops. These include the ability to develop disease-resistant plants and plants with increased resistance to environmental stress. Such advances can have many advantages to consumers, including better yields, more product variety, and healthier nutrient profiles. 

FDA believes that it is uniquely committed and positioned - with the expertise, experience, credibility and trusted scientific framework - to advance innovation and support the development of products with immense potential for public benefit, since the breadth of FDA's statutory authorities and regulatory framework allows it to comprehensively review the potential impacts of products on both human and animal health. For example, for genetically engineered animals, FDA evaluates not only the safety of food or drug products derived from that animal, but also the effect of the genetic alteration on the health of the animal. FDA has decades of experience successfully evaluating products of complex technologies, such as recombinant DNA-derived plant foods, medicines made with nanotechnology, and cellular and gene therapy products.

Moreover, because of the wide spectrum of products that FDA regulates, and the in-depth scientific and policy engagement that the agency has with innovators and counterpart regulatory agencies around the world, FDA can help facilitate the progression of research and development. For example, FDA is focused on the timely transition of technologies from animal research models to products intended for use in humans. As knowledge of genome editing applications increases over different product areas, FDA expect to build on those even greater synergies and increase its understanding to help with assessments of risks to human and animal health.

FDA will continue to apply a risk-based framework grounded in sound science to evaluate products of plant and animal biotechnology, and our framework will continue to evolve as science advances and experience with these technologies grows. FDA is looking forward to working with stakeholders to help understand current scientific information and describe challenges and gaps in regulatory science that are important for regulatory decision-making. FDA is also going to take new steps to help developers understand their responsibility to ensure product safety and we'll identify ways to help reduce unnecessary regulatory burden and undue barriers to bring potential beneficial products to commercialization while ensuring their safety.

Protecting and promoting public health is FDA's mission at the same time FDA wants to support innovation and sustaining public confidence. To help advance these goals, in early May, FDA formed a new Biotech Working Group. This Working Group is comprised of representatives from multiple FDA centers and offices. In the coming months, FDA will release an Action Plan that lays out the steps it intends to take to ensure that FDA will have a flexible regulatory framework for evaluating the safety of products that also supports plant and animal biotechnology innovation.

Our actions will focus on three key areas:

First, advancing and protecting public and animal health by promoting innovation through an efficient and predictable science- and risk-based regulatory framework; second, strengthening public outreach and communication through strong, effective and transparent engagement with stakeholders; and third, increasing engagement with domestic and international partners through coordinated and collaborative actions to support regulatory alignment and efficiency.

FDA is taking concrete and proactive steps to help ensure the safety of plant and animal biotechnology products, while promoting innovation and enhancing public and market confidence in FDA's regulation of these products at home and abroad. FDA recognizes the tremendous opportunities offered by this new technology and is committed to developing a framework that allows these innovations to safely advance and fulfill the potential envisioned by those who are pioneering these approaches, as well as inspire public confidence in these methods. Clearly, the advance of these technologies holds significant public health promise and unlocking their full potential and competitiveness depends on the trust FDA builds now and in the years to come.

New Approach to Immunotherapy Leads to Complete Response in Breast Cancer Patient Unresponsive to Other Treatments

June 18, 2018

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Oncology

According to an article published online in Nature Medicine (4 June 2018), a novel approach to immunotherapy, developed at the National Cancer Institute (NCI), has led to the complete regression of breast cancer in a patient who was unresponsive to all other treatments. The new immunotherapy approach is a modified form of adoptive cell transfer (ACT). ACT has been effective in treating melanoma, which has high levels of somatic, or acquired, mutations. However, it has been less effective with some common epithelial cancers, or cancers that start in the lining of organs, that have lower levels of mutations, such as stomach, esophageal, ovarian, and breast cancers. 

In an ongoing phase 2 clinical trial, the investigators are developing a form of ACT that uses tumor-infiltrating lymphocytes (TILs) that specifically target tumor cell mutations to see if they can shrink tumors in patients with these common epithelial cancers. As with other forms of ACT, the selected TILs are grown to large numbers in the laboratory and are then infused back into the patient (who has in the meantime undergone treatment to deplete remaining lymphocytes) to create a stronger immune response against the tumor.

A patient with metastatic breast cancer came to the trial after receiving multiple treatments, including several chemotherapy and hormonal treatments, that had not stopped her cancer from progressing. To treat her, the authors sequenced DNA and RNA from one of her tumors, as well as normal tissue to see which mutations were unique to her cancer, and identified 62 different mutations in her tumor cells.  The authors then tested different TILs from the patient to find those that recognized one or more of these mutated proteins. TILs recognized four of the mutant proteins, and the TILs then were expanded and infused back into the patient. She was also given the checkpoint inhibitor pembrolizumab to prevent the possible inactivation of the infused T cells by factors in the tumor microenvironment. After the treatment, all of this patient's cancer disappeared and has not returned more than 22 months later. According to the authors, this is an illustrative case report that highlights, once again, the power of immunotherapy, and if confirmed in a larger study, it promises to further extend the reach of this T-cell therapy to a broader spectrum of cancers."

The investigators have seen similar results using mutation-targeted TIL treatment for patients in the same trial with other epithelial cancers, including liver cancer and added that results like this in patients with solid epithelial tumors are important because ACT has not been as successful with these kinds of cancers as with other types that have more mutations.

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