Symposium on Risk-based Monitoring and eSource – DIA Meeting, 2015

 

On June 16, 2015, at the DIA Annual Meeting in Washington, DC, between 3:30- 5:00, Dr. Jules T. Mitchel, PhD, MBA, President of Target Health Inc., will be chairing a symposium on How Risk-Based Monitoring and eSource Methodologies Are Impacting Clinical Sites, Patients, Regulators and Sponsors. This symposium will show how risk-based monitoring and eSource methodologies are impacting the way clinical trials are being conducted and managed. Specific topics include:

 

The Time Is Now for Risk-Based Monitoring: Frances E. Nolan, Medidata Solutions Worldwide,

Overcoming Clinical Trial Data Collection Challenges with eSource Solutions and Leveraging Mobile Technologies: Avik Kumar Pal, CliniOps

Using eSource to Maximize Clinical Development Productivity and Efficiency: Edward Stephen Seguine, Clinical Ink

Please let us know if you will be attending.

 

View From the Triboro Bridge at 6 am (NYC)

 

The Triboro Bridge, now officially known as the Robert F. Kennedy Bridge since 2008, connects Manhattan, Queens and The Bronx. Here is the view from the bridge, when Dr. Mitchel landed at 5 am at JFK, after returning from a conference and meetings with clients in Israel.The bridge you are looking at is the one you use when taking Amtrak to Boston. By the way, “real New Yorkers“ still call it the TriboroBridge.

 

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View from the Triboro Bridge at 6am ©Target Health Inc. 2015

 

ON TARGET is the newsletter of Target Health Inc., a NYC-based, full-service, contract research organization (eCRO), providing strategic planning, regulatory affairs, clinical research, data management, biostatistics, medical writing and software services to the pharmaceutical and device industries, including the paperless clinical trial.

 

For more information about Target Health contact Warren Pearlson (212-681-2100 ext. 104). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel or Ms. Joyce Hays. The Target Health software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website.

 

Joyce Hays, Founder and Editor in Chief of On Target

Jules Mitchel, Editor

 

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Preventative Medicine

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Asclepius, the god of medicine and healing in Greek mythology. Depictions of the serpent-entwined rod of Asclepius are frequently used to represent medicine.

 

Preventive medicine or healthcare consists of measures taken for disease prevention, as opposed to disease 1) ___. Disease and disability are affected by environmental factors, genetic predisposition, disease agents, and lifestyle choices. Health, disease, and disability are dynamic processes which begin before individuals realize they are affected. Disease prevention relies on anticipatory actions that can be categorized as primary, secondary, and tertiary prevention. Each year, millions of people die preventable deaths. Studies show that about half of all 2) ___ in the United States are due to preventable behaviors and exposures. Leading causes included cardiovascular disease, chronic respiratory disease, unintentional injuries like falls especially in older people, diabetes, and certain infectious diseases. One study estimates that 400,000 people die each year in the United States due to poor diet and a sedentary lifestyle. According to estimates made by the World Health Organization (WHO), about 55 million people died worldwide in 2011, two thirds of this group from non-communicable diseases, including cancer, diabetes, and chronic cardiovascular and lung diseases.

 

A 2010 study reported that in the United States, vaccinating children, cessation of smoking, daily prophylactic use of aspirin, and screening of breast and colorectal cancers had the most potential to prevent premature death. Preventive health measures that resulted in savings included vaccinating children and adults, smoking cessation, daily use of aspirin, and screening for issues with alcoholism, obesity, and vision failure. There are many methods for prevention of disease. It is recommended that adults and children aim to visit their doctor for regular check-ups, even if they feel 3) ___, to perform disease screening, identify risk factors for disease, discuss tips for a healthy and balanced lifestyle, stay up to date with immunizations and boosters, and maintain a good relationship with a healthcare provider. Some common disease screenings include checking for hypertension (high blood pressure), hyperglycemia (high blood sugar, a risk factor for diabetes mellitus), hypercholesterolemia (high blood cholesterol), screening for colon cancer, depression, HIV and other common types of sexually transmitted disease such as chlamydia, syphilis, and gonorrhea, mammography, colorectal cancer screening, a pap test (to check for cervical cancer), and screening for osteoporosis. Genetic testing can also be performed to screen for mutations that cause genetic disorders or predisposition to certain diseases such as breast or ovarian cancer. However, these measures are not affordable for every individual and the cost effectiveness of preventive healthcare is still a topic of debate.

 

Primary prevention consists of “health promotion“ and “specific protection.“ Health promotion activities are non-clinical life choices, for example, eating nutritious meals and exercising daily, that both prevent disease and create a sense of overall well-being. Preventing disease and creating overall well-being, prolongs our 4) ___ expectancy. Health-promotional activities do not target a specific disease or condition but rather promote health and well-being on a very general level. On the other hand, specific protection targets a type or group of diseases and complements the goals of health promotion. In the case of a sexually transmitted disease such as syphilis health promotion activities would include avoiding microorganisms by maintaining personal hygiene, routine check-up appointments with the doctor, general sex education, etc. whereas specific protective measures would be using prophylactics (such as 5) ___) during sex and avoiding sexual promiscuity.

 

Food is very much the most basic tool in preventive health care. The 2011 National Health Interview Survey performed by the Centers for Disease Control was the first national survey to include questions about ability to pay for food. Difficulty with paying for food, medicine, or both is a problem facing 1 out of 3 Americans. If better food options were available through food banks, soup kitchens, and other resources for low-income people, obesity and the chronic conditions that come along with it would be better controlled. A “food 6) ___“ is an area with restricted access to healthy foods due to a lack of supermarkets within a reasonable distance. These are often low-income neighborhoods with the majority of residents lacking transportation. There have been several grassroots movements in the past 20 years to encourage urban gardening, such as the GreenThumb organization in New York City and the Brooklyn Grange. Urban gardening uses vacant lots to grow food for a neighborhood and is cultivated by the local residents. Brooklyn Grange grows crops on rooftops. Mobile fresh markets are another resource for residents in a “food desert“, which are specially outfitted buses bringing affordable fresh fruits and vegetables to low-income neighborhoods. These programs often hold educational events as well such as cooking and nutrition guidance. Programs such as these are helping to provide healthy, affordable foods to the people who need them the most.

 

Scientific advancements in genetics have significantly contributed to the knowledge of hereditary diseases and have facilitated great progress in specific protective measures in individuals who are carriers of a disease gene or have an increased predisposition to a specific disease. Genetic testing has allowed physicians to make quicker and more accurate diagnoses and has allowed for tailored treatments or personalized 7) ___. Personalized medicine will be an important part of the future of preventive healthcare. Each individual will be required to obtain a greater knowledge of healthcare, and to maintain knowledge with ongoing self-education. Humans in the 21stCentury are going to have to be much better educated about everything. Similarly, specific protective measures such as water purification, sewage treatment, and the development of personal hygienic routines (such as regular hand-washing) became mainstream upon the discovery of infectious disease agents such as bacteria. These discoveries have been instrumental in decreasing the rates of communicable diseases that are often spread in unsanitary conditions.

 

Finally, a separate category of health promotion has been propounded, based on the ?new knowledge’ in molecular biology – in particular epigenetics – which points to how much physical as well as affective environments during fetal and newborn life may determine 8) ___health. This is commonly called primal prevention. It involves providing future parents with pertinent, unbiased information on primal health and supporting them during their child’s primal life (i.e., “from conception to first anniversary“). This includes adequate parental leave – ideally for both parents – with kin care-giving and financial help if needed.

 

Colorectal cancer (also called bowel cancer, colon cancer, or rectal cancer) is globally the second most common cancer in women and the third-most common in men, and the fourth most common cause of cancer death after lung, stomach, and liver cancer. It is also highly preventable; about 80 percent of colorectal cancers begin as benign growths, commonly called 9) ___, which can be easily detected and removed during a colonoscopy. Other methods of screening for polyps and cancers include fecal occult blood testing. Lifestyle changes that may reduce the risk of colorectal cancer include increasing consumption of whole grains, fruits and vegetables, and reducing consumption of red meat. Given that high quality screening and follow-up care has been shown to reduce cervical cancer rates by up to 80%, most developed countries now encourage sexually active women to undergo a pap test every 3-5 years.

 

Skin cancer is the most common cancer in the United States. The most lethal form of skin cancer, melanoma, leads to over 50,000 annual deaths in the United States. Childhood prevention is particularly important because a significant portion of ultraviolet radiation exposure from the sun occurs during childhood and adolescence and can subsequently lead to skin cancer in adulthood. Furthermore, childhood prevention can lead to the development of healthy habits that continue to prevent cancer for a lifetime. The Centers for Disease Control and Prevention (CDC) recommends several primary prevention methods including: limiting sun exposure between 10 AM and 4 PM, when the sun is strongest. 10) ___ cancer is very preventable.

 

ANSWERS: 1) treatment; 2) deaths; 3) healthy; 4) life; 5) condoms; 6) desert; 7) medicine; 8) adult; 9) polyps; 10) Skin

 

The Tragic Death of Dave Goldberg (1967-2015)

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Dave Goldberg in the offices of SurveyMonkey, where he was chief executive, in 2013. Credit Jim Wilson/The New York Times

 

David Goldberg Silicon Valley executive, who was CEO of SurveyMonkey, died of severe head trauma in an exercise accident at a resort in Punta Mita near Puerto Vallarta on Mexico’s Pacific coast. David Goldberg, husband of Facebook executive Sheryl Sandberg, was found lying next to a treadmill. It was reported that he left his room at about 4pm to exercise, and family members went to look for him after he didn’t return. He was found at about 6:30pm in a gymnasium lying by a treadmill in a pool of blood, with a blow to the lower back of his head. He apparently had slipped on the treadmill and hit the machine.

 

Goldberg was born in Minneapolis, Minnesota on October 2, 1967. His mother Paula Goldberg is co-founder and executive director of the Pacer Center and his father, Mel Goldberg (1942-1998) was associate dean and professor at the William Mitchell College of Law. He interned at the Minneapolis Star Tribune newspaper while in high school. He graduated from Blake School in Minneapolis in 1985, and graduated magna cum laude from Harvard University in 1989, majoring in history and government. Goldberg worked for Bain & Company for two years after graduating from college. He had planned to attend law school but instead joined Capitol Records, where he served as director of marketing strategy and new business development. He founded LAUNCH Media in 1994, and led it through its acquisition by Yahoo Inc. in 2001. He quit Yahoo in 2007 and joined Benchmark Capital. He then joined SurveyMonkey in 2009.

 

Goldberg married Cheryl Sandberg in 2004, and they had two children. They met when both worked for Yahoo. David was a Silicon Valley executive whose company runs an online polling and questionnaire service. In the early 1990s he maxed out his credit cards to fund his first Internet venture, and then went on to work at other tech companies including Yahoo. Under Goldberg’s leadership, SurveyMonkey grew from 14 to 500 employees, with a 2014 market cap of $2 billion and 25 million customers.

 

Sports medicine retired physician, Gabe Mirkin MD says in an article on his website that it is very unlikely that he died just from falling off the treadmill and banging his head. Mirkin says that “the only thing I know about his medical history is that he reportedly had high blood pressure. The most common cause of high blood pressure is high blood sugar, and from looking at his pictures I am almost certain that he was diabetic or pre-diabetic. Almost all people with a fat belly and relatively small buttocks have excess fat stored in the liver, which increases risk for a heart attack and sudden death.“ According to Mirkin, newspaper reports claim that his death was caused by loss of a huge amount of blood from the cut on his head, which is almost impossible. When most people cut themselves, they form clots and bleed only a little. However, people with a large belly and high blood pressure are usually told to take aspirin or other anti-clotting medications that can cause massive bleeding into the brain after a head injury, which can stop breathing and cause death. People who store fat primarily in their bellies store excess fat in their livers, and excess liver fat can lead to diabetes. A high rise in blood sugar damages every cell in your body. To prevent your blood sugar level from rising too high after you eat, your pancreas releases insulin that drives sugar from the bloodstream into your liver. However, if your liver is full of fat, it will not accept the sugar from blood. Instead your liver releases its stored sugar into the bloodstream to drive your blood sugar level even higher. If you have a large belly and small hips, the odds are overwhelming that you are already diabetic and are headed for a heart attack. Furthermore, if you have diabetes or other heart attack risk factors, your doctor is most likely to put you on aspirin and other anti-clotting medications that will increase your chances of bleeding into your brain with any trauma to your head. Mirkin advises that if you and your doctor agree that you should take medication and/or supplements, make sure you are aware of their potential side effects. People who take aspirin or other anti-clotting medications would be wise to have another person present when they exercise or do anything that has a risk of falling.

 

Here at Target Health Inc., we feel that no matter what the sport or exercise is, you should do it with a partner. Who knows, perhaps Dave Goldberg’s life could have been saved if he had not exercised alone. We are truly sorry for the loss of this wonderful person. Sources: The New York Times; Gabe Mirkin MD; Wikipedia

 

NIH Study Solves the Mystery of the Tubulin Code

 

Microtubules are cylindrical structures that provide shape to cells and act as conveyor belts, ferrying molecular cargo throughout cells. Although all microtubules have the same basic appearance, they are marked on their outside surface with a variety of chemical groups. These markers impact a cell’s activity by changing the stability of microtubules, thus affecting cell shape, or by repositioning molecular cargo traveling on the microtubules. The microtubule markers are constantly being added and removed, depending on the local needs of the cell. Think about a highway system where street signs are constantly changing and roads are quickly built or torn apart.

 

Driving down the highway, you encounter ever-changing signs — speed limits, exits, food and gas options. Seeing these roadside markers may cause you to slow down, change lanes or start thinking about lunch. In a similar way, cellular structures called microtubules are tagged with a variety of chemical markers that can influence cell functions. The pattern of these markers makes up the “tubulin code“ and according to a paper published online in Cell, May 7, 2015, the mechanism behind one of the main writers of this code is tubulin tyrosine ligase-7 (TTLL7). According to the authors, understanding the structural characteristics of this specific molecule opens the door to learning how elaborate patterns of chemical markers are laid down on microtubules. In addition, deciphering the tubulin code could reveal how the markers affect normal cellular function as well as what happens when they are damaged, leading to neurodegenerative disorders.

 

TTLL7 is a protein that adds glutamate tags onto microtubules. Using a number of advanced imaging and biochemical techniques, the authors have revealed the 3-D structure of TTLL7 bound to the microtubule. There are nine proteins that make up the TTLL family, but TTLL7 is the most abundant in the brain and one of the main tubulin code writers. These results represent the first atomic structure of any member of the TTLL family. The findings define how TTLL7 interacts with microtubules and how members of the TTLL family use common strategies to mark microtubules with glutamate tags. The authors were able to see how TTLL7 positions itself on the microtubule by grabbing onto the microtubule tails.

 

The most common microtubule marker in the brain is glutamate. The addition of glutamate markers to microtubules plays important roles in brain development and brain cell repair following injury. For example, one of the signatures of damaged cells in cancer or blunt trauma is a change in the pattern of these microtubule markers. In addition, mutations in TTLL genes have been linked with several neurodegenerative disorders. The authors plan to extend their research by investigating interactions between members of this family of proteins. They want to mix and match the TTLL proteins to see how they can control patterns of microtubule tagging. From that, it may be possible to learn how the cell is making those patterns and what happens during cellular damage, as in cancers or neurodegeneration, when these patterns are disrupted.

 

Ease of Weight Loss Influenced by Individual Biology

 

More than one-third of American adults are obese. Complications from obesity can include heart disease, type 2 diabetes and certain types of cancer, some of the leading causes of preventable death. Successful weight loss is variable for reasons not fully elucidated. Whether effective weight loss results from smaller reductions in energy expenditure during caloric restriction is also not known.

 

According to an article published online in Diabetes (11 May 2015), evidence has been found supporting the commonly held belief that people with certain physiologies lose less weight than others when limiting calories. A study, performed at the Phoenix Epidemiology and Clinical Research Branch (PECRB), evaluated 12 men and women with obesity in the facility’s metabolic unit, using a whole-room indirect calorimeter, which allows energy expenditure to be calculated based on air samples.

 

The study was designed to take baseline measurements of the participants’ energy expenditure in response to a day of fasting, followed by a six-week inpatient phase of 50% calorie reduction. After accounting for age, gender, race and baseline weight, it was found that the people who lost the least weight during the calorie-reduced period were those whose metabolism decreased the most during fasting. Those people have what the researchers call a “thrifty“ metabolism, compared to a “spendthrift“ metabolism in those who lost the most weight and whose metabolism decreased the least.

 

According to the authors, when people who are obese decrease the amount of food they eat, metabolic responses vary greatly, with a ‘thrifty’ metabolism possibly contributing to less weight lost. The authors added that while behavioral factors such as adherence to diet affect weight loss to an extent, the study suggests one should consider a larger picture that includes individual physiology, and that weight loss is one situation where being thrifty doesn’t pay.“ It is not known whether the biological differences are innate or develop over time. Further research is needed to determine whether individual responses to calorie reduction can be used to prevent weight gain.

 

Biosimilars: New Guidance to Help Manufacturers Develop More Treatment Options

 

Many of our most important, but also expensive, drugs are biological products. These products are used to treat patients who have a variety of serious and life-threatening medical conditions including rheumatoid arthritis, psoriasis, diabetes, and cancer. According to FDA, having more approved biosimilars is good for public health and it looks forward to continuing to help manufacturers develop these important products. Biosimilars are highly similar to, and have no clinically meaningful differences from, an already approved biological product. Biosimilars can provide more treatment options for patients, and possibly lower treatment costs. In early March, FDA approved the first biosimilar, Zarxio (filgrastim-sndz), a biosimilar to Neupogen (filgrastim), used to help stimulate growth of white blood cells in patients with cancer and help them fight infection.

 

According to FDA, manufacturers are now working hard to develop more biosimilars for the U.S. market. By nature, biologic products are highly complex molecules, so developing biosimilar versions of these products is challenging. Over the past few weeks, FDA released four guidances for industry – useful tools to help manufacturers navigate the new terrain of biosimilar development.

 

One Guidanc assists companies in demonstrating that a proposed product is indeed biosimilar to an existing biologic product, and is intended to provide clarity to manufacturers about the expectations for a biosimilar development program.

 

A second focuses on the analytical studies that demonstrate that the product is “highly similar“ to an existing biological product, which supports the demonstration of biosimilarity.

 

A third guidance answers common questions about the biosimilar development and application process and contains information intended to provide a better understanding of the law that allows biosimilars development.

 

A fourth, still in draft form — which means FDA is accepting public comment, — answers a variety of additional questions that have arisen regarding the biosimilars development process.

 

Broccoli/Cheddar Stuffed Potato Skins with Avocado Cream Topping

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Truly delicious! Pick up and eat out of your hand. Dinner, lunch, brunch, snack, barbecue, any time of day or night ©Joyce Hays, Target Health Inc.

 

Ingredients

 

8 small Idaho potatoes, scrubbed and dried

4 teaspoons olive oil

Pinch salt, pinch black pepper (optional), pinch chili flakes

2 garlic cloves, minced

5 cups broccoli florets (2 bunches), coarsely chopped

Olive oil cooking spray

Pieces of artificial bacon (garnish option)

1 cup extra sharp cheddar cheese, grated

 

Avocado Cream Topping (recipe below)

 

1 ripe avocado

2 Tablespoons sour cream

1 handful fresh cilantro, chopped well

1 clove fresh garlic, squeezed

Pinch black pepper (optional)

 

 

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At my market, avocados are very good now. Get them firm, but with a little give, when you squeeze them. ©Joyce Hays, Target Health Inc.

 

Directions – Bake the Potatoes

 

1. Preheat oven to 450 degrees to bake the potatoes until done.

2. Pierce potatoes with fork a couple of times and wrap in paper towel.

3. Turn to high and microwave these potatoes for about 15 minutes.

4. Take out and allow to cool down or bake in oven until done.

5. Slice your baked potatoes after they’ve cooled, in half the long way.

6. Then using a spoon, remove the flesh, but leave enough on the skins to support them with the filling. Leave about 1/8“ of skin with flesh.

7. Don’t damage the skin when scraping. You can use the insides of the potatoes for another recipe, like potato pancakes, or just whipped garlic potatoes.

 

 

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Brushed with olive oil and about to go into the oven ©Joyce Hays, Target Health Inc.

 

Brush all the potato skins with olive oil, place on baking sheet, skin side down, and bake for about 20-30 minutes, until the skins are crisp with toasty brown edges. Then remove from oven and set aside.

 

 

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Make the avocado cream sauce. Food processers make cooking so much easier. ©Joyce Hays

 

Topping

 

While the skins are in the oven, prepare the avocado cream topping and the filling.

 

To make the avocado cream, get out your food processor and add the avocado, sour cream, cilantro, pinch salt, the juice of one squeezed fresh garlic clove and set it on high, and process until the topping is smooth. This should take no more than one minute or less. With a small spatula, get all of this good topping out of the food processor and into a medium to small serving bowl. Put this on your dining table for people to add themselves.

 

 

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While the potato skins are in the oven getting crispy, sautee the garlic and add the steamed broccoli with a pinch of salt. Stir for 2-3 minutes. ©Joyce Hays, Target Health Inc.

 

Next, steam the broccoli florets for about 3 to 4 minutes. Drain and set aside.

 

Spray a pan with olive oil spray and sautee the minced garlic for 1 or 2 minutes. Then add the broccoli florets and stir the two veggies for about 3 or 4 minutes, over medium high flame. Add a pinch of salt and pepper, if you wish, or omit the salt.

 

With a spatula get all of the broccoli florets and little pieces of garlic out of the pan and into a large bowl.

 

Stir in the cup of freshly grated cheese and a few of the artificial bacon bits (they come in a small jar and I bought mine on Amazon). You could also stir in a little of the chopped cilantro.

 

 

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Here, the skins are baked, then filled with the broccoli/cheese mixture and ready to go back into the oven for about 5 more minutes or until the broccoli gets a bit softer and the cheese melts. ©Joyce Hays, Target Health Inc.

 

Next, lower oven to 400 degrees or lower, like 350 degrees.

 

With a tablespoon, fill the potato skins with the broccoli/cheese mixture (divide it evenly). Wait until you’re ready to serve the meal. Then bake the filled skins for 5 minutes, or until you see that the cheese has melted and looks yummy and gooey.

 

Now, carefully with a tablespoon, add the stuffed potatoes to a serving platter and serve while warm. Sprinkle with some of the bacon bits.

 

 

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Here’s the avocado cream sauce, ready to serve over the baked broccoli/cheese potatoes. ©Joyce Hays, Target Health Inc.

 

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©Joyce Hays, Target Health Inc.

 

Topped with the Avocado sauce, this is actually a balanced meal in itself, especially if you double the recipe. Add some chilled white wine (or red) and you’re all set. This recipe is very versatile . . . good with fish, steak, poultry. These stuffed potatoes are great out of doors, because they’re easy to pick up and eat right out of your hand.

 

Jules returned home after a week out of the country seeing clients and attending a conference. Exhausted after a 12 hour flight, he tried to stay awake, to resume the NY time zone. These stuffed potato skins were perfect and he loved them.

 

We started with Le Volte a high rated Tuscany blend of merlot and cabernet sauvignon, and one of our favorite salads (lush ripe tomatoes, avocado, green olives, cucumbers, sliced endive, in a simple refreshing dressing of fresh lemon juice, olive oil and 1 minced fresh garlic clove.) Then the warm stuffed broccoli/cheese potatoes with delicious topping, and finally turkey meatballs with pasta. Dessert was cut up fresh mandarin orange segments.

 

We purposely made no weekend plans. We will sleep and eat and drink and nap all weekend until the jet lag is no more.

 

 

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We’re drinking a delicious Tuscany blend of merlot and cabernet sauvignon. You can almost smell the Mediterranean and feel the breezes. Leave it to the languishing Italians to create this liquid silk. Tenuta dell’Ornellaia, le Volte IGT, 2011

 

From Our Table to Yours!

 

Bon Appetit!