Target Health at DIA – San Diego
Dean Gittleman, Sr. Director of Operations, Warren Pearlson, Director of Business Development and Neil Lassalle, Office Manager, will be attending the annual DIA in San Diego this year (Booth 1935). Please contact Warren firstname.lastname@example.org if you will be attending and interested in learning more about us.
Target Health Inc. is Setting Up at DIA
Space Just for Chatting Space for Demos
Storm Clouds Rush Into NYC – on Friday the 13th June 2014 (plus the full moon)
Storm Clouds From the 24th Floor at 261 Madison, Target Health’s Corporate Headquarters – ©Target Health Inc .
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, including the paperless clinical trial, to the pharmaceutical and device industries.
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Joyce Hays, Founder and Editor in Chief of On Target
Jules Mitchel, Editor
Normal breast on left; cancerous breast on right
Breast cancer is a type of cancer originating from breast tissue, most commonly from the inner lining of milk ducts or the lobules that supply the ducts with 1) ___. Cancers originating from ducts are known as ductal carcinomas, while those originating from lobules are known as lobular carcinomas. Breast cancer occurs in humans and other mammals. While the overwhelming majority of human cases are in women, breast cancer can also occur in men. The balance of benefits versus harms of breast cancer screening is controversial.
The characteristics of the cancer determine the treatment, which may include surgery, medications (hormonal therapy and chemotherapy), radiation and/or immunotherapy. 2) ___ provides the single largest benefit, and to increase the likelihood of remission (no further sign of the cancer), several chemotherapy regimens are commonly given in addition. Radiation is used after breast-conserving surgery and substantially improves local relapse rates and in many circumstances also overall survival.
Worldwide, breast cancer accounts for 22.9% of all cancers (excluding non-melanoma skin cancers) in women. In 2008, breast cancer caused 458,503 deaths worldwide (13.7% of cancer deaths in women). Breast cancer is more than 100 times more common in women than in men, although men tend to have poorer outcomes due to delays in 3) ___. Prognosis and survival rates for breast cancer vary greatly depending on the cancer type, stage, treatment, and geographical location of the patient. Survival rates in the 4) ___ world are high; for example, more than 8 out of 10 women (85%) in England diagnosed with breast cancer survive for at least 5 years. In developing countries, however, survival rates are much poorer.
The primary risk factors for breast cancer are female gender and older age. Other potential risk factors include: genetics, lack of childbearing or lack of breastfeeding, higher levels of certain hormones, certain dietary patterns, and obesity. Recent studies have indicated that exposure to light pollution is a risk factor for the development of breast cancer. Smoking tobacco appears to increase the risk of breast cancer, with the greater the amount smoked and the earlier in life that smoking began, the higher the 5) ___. In those who are long-term smokers, the risk is increased 35% to 50%. A lack of physical activity has been linked to ~10% of cases. The association between breast feeding and breast cancer has not been clearly determined; some studies have found support for an association while others have not.
A new pathway that can stop breast cancer cells from spreading has been discovered. Working with human breast cancer cells and a mouse model of breast cancer, scientists identified a new protein that plays a key role in reprogramming cancer cells to migrate and invade other organs. When that protein is removed from cancer cells in mice, the ability of the cells to metastasize to the lung is dramatically 6) ___. The primary cause of death from breast cancer is the spread of tumor cells from the breast to other organs in the body. Northwestern Medicine scientists have discovered a new pathway that can stop breast cancer cells from spreading. The protein, hnRNPM, helps launch a cascade of events that enables breast cancer cells to break away from the original tumor, penetrate the blood stream, invade another part of the body and form a new nodule of that tumor.
Our research suggests that hnRNPM could be an effective target to stop cancer cells from spreading, said Northwestern Medicine scientist Chonghui Cheng, M.D. So far there isn’t a really good target that can cure breast cancer. The more we understand of cancer metastasis and the pathways that control it, the better we will be able to stop breast cancer from 7) ___. Cheng is an assistant professor of medicine in hematology/oncology at Northwestern University Feinberg School of Medicine. She also is a member of the Robert H. Lurie Comprehensive Cancer Center of Northwestern University. The study was published June 1 in the journal Genes & Development.
Cheng and colleagues did experiments using human cells and identified hnRNPM’s role in controlling the processes linked to tumor metastasis. Then they removed the protein in a mouse model of breast cancer and discovered the cancer’s ability to spread was significantly reduced. Collaborating with Kalliopi Siziopikou, M.D., a professor in pathology and director of the breast pathology program at Feinberg, the scientists looked at breast cancer tumor specimens from patients and levels of hnRNPM in those samples. They found aggressive breast tumors, including those that show metastatic traits, expressed higher levels of hnRNPM. This confirmed hnRNPM’s role in the metastasis of human breast cancer, Cheng said. Now we’re investigating how the protein works in order to be able to develop a drug that could prevent tumor metastasis.
The pink ribbon is a symbol to show support for breast cancer awareness
Double mastectomy halves death risk for women with BRCA-related breast cancer. Women with BRCA-related breast cancer who have a double mastectomy are nearly 50% less likely to die of breast cancer within 20 years of diagnosis compared to women who have a single 8) ___, according to a new study led by Toronto, Women’s College Hospital’s Kelly Metcalfe. The findings, published in the British Medical Journal, suggest a double mastectomy may be an effective first-line treatment for women with early-stage breast cancer who carry a BRCA1 or BRCA2 genetic mutation. The BRCA1/2 genes belong to a class of genes that typically act to protect individuals from acquiring cancer, yet women who inherit a mutated form of the genes have a high risk of developing breast and ovarian 9) ___.
Women with a BRCA mutation have a 60-70% chance of developing breast cancer in their lifetime, and once diagnosed, a further 34% chance of developing breast cancer in the opposite breast within 15 years, said Kelly Metcalfe, an adjunct scientist at Women’s College Research Institute and professor at the University of Toronto. For these women, we need to think about treating the first breast cancer, but also about preventing a second breast cancer. To compare the survival rates of women with BRCA-related breast cancers, researchers assessed the medical records of 390 women with stage one or two breast cancer and a BRCA1 or BRCA2 mutation. The women were required to have been initially treated with a single or double mastectomy. The researchers found:
- Women who had a double mastectomy had a 48% greater likelihood of surviving compared to women with a single mastectomy
- For women who developed a new breast cancer in the opposite breast, the risk of dying of breast cancer was doubled
- At twenty years, the survival rate was 88% for women with a double mastectomy and 66% for women with a single mastectomy
Our study’s results provide evidence that in order to improve survival in women with BRCA-associated breast cancer, we need to prevent new breast cancers from developing after an initial diagnosis, said Dr. Steven Narod, a co-author of the study and a senior scientist at Women’s College Research Institute. This study highlights the importance of providing genetic testing for BRCA1 and BRCA2 at the time of breast cancer diagnosis if appropriate. This genetic information could help women make decisions that ultimately may increase their chance of surviving breast cancer.
Last year, Hollywood actress Angelina Jolie, publicly announced her decision to opt for a double mastectomy and breast reconstruction surgery after discovering she had the BRCA1 gene. The then 37 year-old actress said doctors estimated she had a 50% risk of developing ovarian cancer and an 87% risk of breast cancer. While existing research widely supports the benefit of a double mastectomy in preventing breast cancer in women with the gene mutation, the study’s researchers caution more research is necessary to confirm the benefit of a double mastectomy in reducing the risk of death in women diagnosed with BRCA-related 10) ___ cancer.
Women’s College Hospital is a teaching hospital in downtown Toronto, Ontario, Canada. It is located at the north end of Hospital Row, a section of University Avenue where several major hospitals are located. Women’s College Hospital began as Woman’s Medical College in 1883. On June 13, 1883, Dr. Emily Stowe (1831-1903) the first Canadian woman licensed to practice medicine in Canada – led a group of her supporters to a meeting at the Toronto Women’s Suffrage Club, stating that medical education for women is a recognized necessity, and consequently facilities for such instruction should be provided. The motion was seconded adding that the establishment of such a school was a public necessity and in the interests of the community. Less than six months after this meeting, on October 1, 1883, Toronto Mayor A.R. Boswell formally opened Woman’s Medical College.
Sources: Northwestern University: Y. Xu, X. D. Gao, J.-H. Lee, H. Huang, H. Tan, J. Ahn, L. M. Reinke, M. E. Peter, Y. Feng, D. Gius, K. P. Siziopikou, J. Peng, X. Xiao, C. Cheng. Cell type-restricted activity of hnRNPM promotes breast cancer metastasis via regulating alternative splicing. Genes & Development, 2014; 28 (11): 1191 DOI: Women’s College Hospital: K. Metcalfe, S. Gershman, P. Ghadirian, H. T. Lynch, C. Snyder, N. Tung, C. Kim-Sing, A. Eisen, W. D. Foulkes, B. Rosen, P. Sun, S. A. Narod. Contralateral mastectomy and survival after breast cancer in carriers of BRCA1 and BRCA2 mutations: retrospective analysis. BMJ, 2014; 348 (feb11 9): g226 DOI; Wikipedia, ScienceDaily.com; WebMD.com, MedicineNet.com
ANSWERS: 1) milk; 2) Surgery; 3) diagnosis; 4) Western; 5) risk; 6) decreased; 7) spreading; 8) mastectomy; 9) cancers; 10) breast
Frances Burney, Early Mastectomy Patient
Writer, Frances Burney (1752 – 1840)
Because of its visibility, breast cancer was the form of cancer most often described in ancient documents. Because autopsies were rare, cancers of the internal organs were essentially invisible to ancient medicine. Breast cancer, however, could be felt through the skin, and in its advanced state often developed into fungating lesions: the tumor would become necrotic (die from the inside, causing the tumor to appear to break up) and ulcerate through the skin, leaking fetid, dark fluid.
The oldest description of cancer was discovered in Egypt and dates back to approximately 1600 BCE. The Edwin Smith Papyrus describes 8 cases of tumors or ulcers of the breast that were treated by cauterization. The writing says about the disease, There is no treatment. For centuries, physicians described similar cases in their practices, with the same conclusion. Ancient medicine, from the time of the Greeks through the 17th century, was based on humoralism, and thus believed that breast cancer was generally caused by imbalances in the fundamental fluids that controlled the body, especially an excess of black bile. Alternatively, patients often saw it as divine punishment. In the 18th century, a wide variety of medical explanations were proposed, including a lack of sexual activity, too much sexual activity, physical injuries to the breast, curdled breast milk, and various forms of lymphatic blockages, either internal or due to restrictive clothing. In the 19th century, the Scottish surgeon John Rodman said that fear of cancer caused cancer, and that this anxiety, learned by example from the mother, accounted for breast cancer’s tendency to run in families.
Although breast cancer was known in ancient times, it was uncommon until the 19th century, when improvements in sanitation and control of deadly infectious diseases resulted in dramatic increases in lifespan. Previously, most women had died too young to have developed breast cancer. Additionally, early and frequent childbearing and breastfeeding probably reduced the rate of breast cancer development in those women who did survive to middle age. Because ancient medicine believed that the cause was systemic, rather than local, and because surgery carried a high mortality rate, the preferred treatments tended to be pharmacological rather than surgical. Herbal and mineral preparations, especially involving the poison arsenic, were relatively common. Before the 20th century, breast cancer was feared and discussed in hushed tones, as if it were shameful. As little could be safely done with primitive surgical techniques, women tended to suffer silently rather than seeking care.
In 1811, Physician/Surgeon Baron Larrey co-led the surgical team that performed a pre-anesthetic mastectomy on Frances Burney in Paris. Her detailed account of this operation gives insight into early 19th century doctor-patient relationships, and early surgical methods in the home of the patient. Larrey directed the Grande Armee of Napoleon to develop mobile field hospitals, or ambulances volantes (flying ambulances), in addition to a corps of trained and equipped soldiers to aid those on the battlefield. Before Larrey’s initiative in the 1790s, wounded soldiers were either left amid the fighting until the combat ended or their comrades would carry them to the rear line. The practice of triage pioneered by Dominique Jean Larrey during the Napoleonic Wars (1803-1815).
In August 1810, novelist, Frances Burney developed pains in her breast, which her husband suspected could be due to breast cancer. Through her royal network of acquaintances she was eventually treated by several leading physicians and finally, a year later, on 30 September 1811, she underwent a mastectomy performed by 7 men in black, Dr. Larrey, M. Dubois, Dr. Moreau, Dr. Aumont, Dr. Ribe, & a pupil of Dr. Larrey, & another of M. Dubois. The operation was performed in the manner of a battlefield operation under the command of M. Dubois, then accoucheur (midwife or obstetrician) to the Empress Marie Louise, Duchess of Parma, and considered to be the best doctor in France. Burney was later able to describe the operation in detail, since she was conscious through most of it, as it took place before the development of anesthetics.
I mounted, therefore, unbidden, the Bed stead – & M. Dubois placed me upon the Mattress, & spread a cambric handkerchief upon my face. It was transparent, however, & I saw, through it, that the Bed stead was instantly surrounded by the 7 men & my nurse. I refused to be held; but when, Bright through the cambric, I saw the glitter of polished Steel – I closed my Eyes. I would not trust to convulsive fear the sight of the terrible incision. Yet — when the dreadful steel was plunged into the breast – cutting through veins – arteries – flesh – nerves – I needed no injunctions not to restrain my cries. I began a scream that lasted unintermittingly during the whole time of the incision – & I almost marvel that it rings not in my Ears still? so excruciating was the agony. When the wound was made, & the instrument was withdrawn, the pain seemed undiminished, for the air that suddenly rushed into those delicate parts felt like a mass of minute but sharp & forked poniards, that were tearing the edges of the wound. I concluded the operation was over – Oh no! presently the terrible cutting was renewed – & worse than ever, to separate the bottom, the foundation of this dreadful gland from the parts to which it adhered – Again all description would be baffled – yet again all was not over, – Dr. Larrey rested but his own hand, & — Oh heaven! – I then felt the knife (rack)ling against the breast bone – scraping it!
She sent her first-person account of this experience months later to her sister Esther without rereading it, and it remains one of the most compelling early accounts of a mastectomy. It is impossible to know today whether the breast removed was indeed cancerous or whether she suffered from mastopathy. She survived and returned to England in 1812 to visit her ailing father and to avoid her young son, Alexander’s conscription into the French army, while still in recovery from her own illness. She lived to be 88 years old, a long life in the 1800s.
When surgery advanced, and long-term survival rates improved, women began raising awareness of the disease and the possibility of successful treatment. The Women’s Field Army, run by the American Society for the Control of Cancer (later the American Cancer Society) during the 1930s and 1940s was one of the first organized campaigns. In 1952, the first peer-to-peer support group, called Reach to Recovery, began providing post-mastectomy, in-hospital visits from women who had survived breast cancer. The breast cancer movement of the 1980s and 1990s developed out of the larger feminist movements and women’s health movement of the 20th century. This series of political and educational campaigns, partly inspired by the politically and socially effective AIDS awareness campaigns, resulted in the widespread acceptance of second opinions before surgery, less invasive surgical procedures, support groups, and other advances in patient care.
Breast cancer surgical tools in the 18th century
Hormone Treatment Restores Bone Density in Young Women with Spontaneous Primary Ovarian Insufficiency (POI)
Spontaneous primary ovarian insufficiency (POI), which affects 1 in 100 women by age 40, occurs when the ovaries stop producing sufficient estrogen in the absence of a known cause, such as anorexia, chromosome abnormality, or chemotherapy. It is typically characterized by irregular or absent menstrual cycles, hot flashes, and fertility problems. Women with POI have abnormally low levels of reproductive hormones, including estradiol, a type of estrogen produced by the ovary, as well as testosterone, a predominantly male hormone, but also produced by women in smaller amounts. They also have reduced bone mineral density, which can lead to osteoporosis and bone fractures.
According to an article published online in the Journal of Clinical Endocrinology & Metabolism (9 June 2014), it has been observed that hormone replacement therapy in young women with primary ovarian insufficiency (POI) led to increases in their bone mineral density, restoring levels to normal.
Using bone density scans of the hip and lower spine, the authors measured the effects of two hormone replacement regimens on the bone mineral density of women with POI who were between the ages of 18 and 42. For the study, 145 women with POI were randomly assigned to one of two groups: one group received a 100 mcg estradiol patch, progestin pills, and a 150 mcg testosterone patch, and the other group received a 100 mcg estradiol patch, progestin pills, and a placebo patch. For comparison, the scientists also measured bone mineral density in an untreated group of 70 women with normal ovarian function.
Results showed that both hormone treatment regimens led to significant increases in the bone mineral density in the treatment groups. When the study began, women with POI had significantly lower hip and spine bone mineral density levels compared to the control group. By the study’s end, both bone density measures had increased to the same levels as the women without POI. However, the addition of testosterone in the treatment regimen did not prove to be statistically significant in helping increase bone mineral density.
According to the authors, further studies with a greater number of women would be needed to produce statistically valid results as to whether testosterone replacement could benefit women with POI. The authors added that while hormone replacement therapy’s effect on bone mineral density has been studied in postmenopausal women, there is limited research on the effects of this therapy in younger women. What the study did demonstrate is that hormone replacement therapy with an appropriate dose of estradiol delivered via a skin patch combined with oral progestin can improve bone density to normal in women with primary ovarian insufficiency.
Tubular Journey Through Brain Cells – How Science Fiction Becomes Reality
Microtubules are found in all of the body’s cells. They are assembled like building blocks, using a protein called tubulin acetyltransferase (TAT). Microtubules are constantly tagged by proteins in the cell to designate them for specialized functions, in the same way that roads are labeled for fast or slow traffic or for maintenance. Microtubules are constructed first by aligning tubulin building blocks into long strings. Then the strings align themselves side by side to form a sheet. Eventually the sheet grows wide enough that it closes up into a cylinder. TAT then bonds an acetyl group to alpha tubulin, a subunit of the tubulin protein. How the various labels are added to the cellular microtubule network remains a mystery. Recent findings suggested that problems with tagging microtubules may lead to some forms of cancer and nervous system disorders, including Alzheimer’s disease, and have been linked to a rare blinding disorder and Joubert Syndrome, an uncommon brain development disorder.
Some microtubules are short-lived and can rapidly change lengths by adding or removing tubulin pieces along one end, whereas others remain unchanged for longer times. Recognizing the difference may help cells function properly. For example, cells may send cargo along stable microtubules and avoid ones that are being rebuilt. Cells appear to use a variety of chemical labels to describe the stability of microtubules.
According to a study published online in Cell (5 June 2014), scientists at the National Institutes of Health took a molecular-level journey into microtubules. The scientists watched how TAT labels the inside of microtubules. The results answer long-standing questions about how TAT tagging works and offer clues as to why it is important for brain health. According to the authors, the study uncovers how TAT may help cells distinguish between stable microtubules and ones that are under construction, and that since high levels of microtubule tagging are unique to nerve cells, it may be the reason that they have complex shapes allowing them to make elaborate connections in the brain.
To watch TAT at work, high resolution movies were taken of individual TAT molecules interacting with microtubules in real time. In general, tagging reactions work like keys fitting into locks: the better the key fits, the faster the lock can open. Similarly, the rate of the reactions is determined by how well TAT molecules fit around tagging sites. Results showed that TAT surfs through the inside of microtubules and although it can find acetylation sites quickly, the process of adding the tag occurs very slowly. The team investigated this idea by using a technique called X-ray crystallography to look at how atoms on TAT molecules interact with acetylation sites on tubulin molecules. Results suggested that TAT fit poorly around the sites. It looked as though TAT can easily journey through microtubules spotting acetylation sites but may only label those that are stable for longer periods of time. While this may help cells identify the microtubules they need to rapidly change shapes or send cargo to other places, further studies may provide information how microtubule tagging influences nerve cells in health and disease.
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FDA and EPA Issue Draft Updated Advice for Fish Consumption
The U.S. Food and Drug Administration (FDA) and the U.S. Environmental Protection Agency (EPA) have issued draft updated advice on fish consumption. The two agencies have concluded pregnant and breastfeeding women, those who might become pregnant, and young children should eat more fish that is lower in mercury in order to gain important developmental and health benefits. The draft updated advice is consistent with recommendations in the 2010 Dietary Guidelines for Americans.
Previously, the FDA and the EPA recommended maximum amounts of fish that these population groups should consume, but did not promote a minimum amount. Over the past decade, however, emerging science has underscored the importance of appropriate amounts of fish in the diets of pregnant and breastfeeding women, and young children.
An FDA analysis of seafood consumption data from over 1,000 pregnant women in the US found that 21% of them ate no fish in the previous month, and those who ate fish ate far less than the Dietary Guidelines for Americans recommends – with 50% eating fewer than 2 ounces a week, and 75% eating fewer than 4 ounces a week. The draft updated advice recommends pregnant women eat at least 8 ounces and up to 12 ounces (2-3 servings) per week of a variety of fish that are lower in mercury to support fetal growth and development.
The draft updated advice cautions pregnant or breastfeeding women to avoid four types of fish that are associated with high mercury levels: tilefish from the Gulf of Mexico; shark; swordfish; and king mackerel. In addition, the draft updated advice recommends limiting consumption of white (albacore) tuna to 6 ounces a week. Choices lower in mercury include some of the most commonly eaten fish, such as shrimp, pollock, salmon, canned light tuna, tilapia, catfish and cod. When eating fish caught from local streams, rivers and lakes, follow fish advisories from local authorities. If advice isn’t available, limit your total intake of such fish to 6 ounces a week and 1-3 ounces for children.
Before issuing final advice, the agencies will consider public comments, and also intend to seek the advice of the FDA’sRisk Communication Advisory Committee and conduct a series of focus groups. The public can provide comment on the draft advice and the supplemental questions and answers by submitting comments to the Federal Register docket or by participating in any public meetings that may be held. The comment period will be open until 30 days after the last transcript from the advisory committee meeting and any other public meetings becomes available. The dates of any public meetings, as well as when the public comment period will close, will be published in future Federal Register notices at www.federalregister.gov.
Kale/Asparagus/Endive Salad with Tuna Sauce
©Joyce Hays, Target Health Inc.
4 cups kale, washed, dried and cut into ribbons
2 endives, washed, dried, and cut on bias
1 bunch fresh local asparagus, washed, dried, break off tough ends, cut on bias
1 bunch green grapes or red seedless or combo of both
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
Flat leaf parsley, chopped, for garnish
1. Wash and dry all greens. Cut kale into thin ribbons and add to salad bowl
2. Cut or break off tough ends of asparagus. Cut on bias and add to salad bowl
3. Cut endive leaves on bias and add to salad bowl.
4. Wash grapes, dry and add to salad bowl. If grapes are large, cut in half
©Joyce Hays, Target Health Inc.
1. Put the tuna fish in a food processor.
2. Add anchovies, capers, lemon juice, oil. Start the food processor and turn the ingredients into a very fine, smooth paste. If the sauce is too thick, very slowly, add very small amounts of olive oil (or 1 teaspoon) of chicken broth until you get the right consistency.
3. Transfer the mix to a bowl, with spatula (to get every bit of it) and stir in the mayonnaise. Now, mix until obtaining a paste.
4. You can keep the tuna dressing in fridge, until you’re ready to eat. Then add the dressing and toss salad just before serving
©Joyce Hays, Target Health Inc.
©Joyce Hays, Target Health Inc.
If you love the flavor of tuna fish, with the first bite of this salad, your taste buds will exclaim over the combo of tuna and sweet green grapes, all in one mouthful. This particular tuna flavor is so delicious, you might want to try different ingredients that I have experimented with. Pouring the tuna dressing over half of a cut up endive, is a lovely appetizer. Slightly more complex would be to simply add to that endive half, two or three baby spinach leaves, very thin slices of cucumber and or thin radish slices. Top this with some thin slices of a black olive. That’s it.!
On a hot summer evening, you want to eat light, but with nourishment. This salad can be your entire meal. You can make this salad your entire meal. Add some warm 7-grain rolls and an icy white wine or a beer, with fresh fruit for dessert and you’re satisfied with very little effort.
Below is the dessert we had. Strawberries coming from California, are now in season and very sweet. Plump blueberries are also very good right now. I get them both from FreshDirect. The pineapple couldn’t be better from our neighborhood fruit guy. We usually have fresh fruit for dessert all summer long. It’s such a treat to have fruit in peak season. We can’t wait for the peaches.
©Joyce Hays, Target Health Inc.
Nothing says perfection like a flower ©Joyce Hays, Target Health Inc.
From our table to yours.
Bon Appetit !