UN Panel Discussion on Climate Change and Its Impact on Children’s Health

 

Target Health Inc. is honored that Jules Mitchel, PhD has been invited to speak at a UN Panel Discussion on “Climate Change and Its Impact on Children’s Health.“ His topic will be “The view from FDA and Biotech World.“ Other presenters will include World Health Organization (WHO) staff, pharmaceutical industry experts and representatives of civil society organizations specializing in climate policy issues. The discussion will consider the issue of climate change and its impact on children’s health and will be followed by an interactive Q&A session with the audience.  This is a free event.

 

Date: Thursday, November 17, 2016

Time: 2:00 pm – 5:00 pm

Location: UN Church Center

777 United Nations Plaza, 2nd Floor Conference Room

44th Street between First and Second Avenue, New York, NY, 10017.

Please RSVP before November 15

Aaron Etra, aaron@etra.com

Jules Mitchel, jmitchel@targethealth.com

http://www.unausa.org/membership/council-of-organizations

http://www.globalfoundationdd.org/

 

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 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

 

QUIZ

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Penicillin

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Bacteria that attempt to grow and divide in the presence of penicillin fail to do so, and instead end up shedding their cell walls. Credit: Shudde – Own work, CC BY-SA 3.0, Wikipedia Commons

 

 

Penicillin (PCN or pen) is a group of 1) ___ which include penicillin G (for intravenous use), penicillin V (for oral use), and procaine penicillin and benzathine penicillin (for intramuscular use). Penicillin antibiotics were among the first medications to be effective against many bacterial infections caused by staphylococci and streptococci. Penicillins are still widely used today, though many types of bacteria have developed resistance following extensive use. While 10% of people report that they are allergic to penicillin, realistically, up to 90% of this group may not actually be allergic. Serious allergies only occur in about 0.03% of people.

 

There are several enhanced penicillin families which are effective against additional bacteria; these include the antistaphylococcal penicillins, aminopenicillins and the antipseudomonal penicillins. They are all derived from Penicillium fungi. While the number of penicillin-resistant 2) ___ is increasing, penicillin can still be used to treat a wide range of infections caused by certain susceptible bacteria, including Streptococci, Staphylococci, Clostridium, and Listeria genera. Common adverse drug reactions (> 1% of people) associated with use of the penicillins include diarrhea, hypersensitivity, nausea, rash, neurotoxicity, urticaria, and superinfection (including candidiasis). Infrequent adverse effects (0.1-1% of people) include fever, vomiting, erythema, dermatitis, angioedema, seizures (especially in people with epilepsy), and pseudomembranous colitis.

 

Penicillin is a secondary metabolite of certain species of Penicillium and is produced when growth of the 3) ___ is inhibited by stress. It is not produced during active growth. The Penicillium cells are grown using a technique called fed-batch culture, in which the cells are constantly subject to stress, which is required for induction of penicillin production. The biotechnological method of directed evolution has been applied to produce by mutation a large number of Penicillium strains. These techniques include error-prone PCR, DNA shuffling, ITCHY, and strand-overlap PCR. Semisynthetic penicillins are prepared starting from the penicillin nucleus. The discovery of penicillin, one of the world’s first antibiotics, marks a true turning point in human history – when doctors finally had a tool that could completely cure their patients of deadly infectious 4) ___.

 

Penicillin was discovered in 1928 by Scottish scientist Alexander Fleming. People began using it to treat infections in 1942. As the story goes, Dr. Alexander Fleming, the bacteriologist on duty at St. Mary’s Hospital, returned from a summer vacation in Scotland to find a messy lab bench and a good deal more. Upon examining some colonies of Staphylococcus aureus, Dr. Fleming noted that a mold called Penicillium notatum had contaminated his Petri dishes. After carefully placing the dishes under his microscope, he was amazed to find that the mold prevented the normal growth of the staphylococci. It took Fleming a few more weeks to grow enough of the 5) ___ so that he was able to confirm his findings. There was some factor in the Penicillium mold that not only inhibited the growth of the bacteria but, more importantly, might be harnessed to combat infectious diseases.

 

Fleming: “When I woke up just after dawn on September 28, 1928, I certainly didn’t plan to revolutionize all medicine by discovering the world’s first antibiotic, or bacteria killer. But I guess that was exactly what I did.“

 

Fourteen years later, in March 1942, Anne Miller became the first civilian patient to be successfully treated with 6) ___, lying near death at New Haven Hospital in Connecticut, after miscarrying and developing an infection that led to blood poisoning

.

Actually, Fleming had neither the laboratory resources at St. Mary’s nor the chemistry background to take the next giant steps of isolating the active ingredient of the penicillium mold juice, purifying it, figuring out which germs it was effective against, and how to use it. That task fell to Dr. Howard Florey, a professor of pathology who was director of the Sir William Dunn School of Pathology at 7) ___ University. This landmark work began in 1938 when Florey, who had long been interested in the ways that bacteria and mold naturally kill each other, came across Fleming’s paper on the penicillium mold while leafing through some back issues of The British Journal of Experimental Pathology. Soon after, Florey and his colleagues assembled. They decided to unravel the science beneath what Fleming called penicillium’s “antibacterial action.“ One of Florey’s brightest employees was a biochemist, Dr. Ernst Chain, a Jewish German emmigrant. They produced a series of crude penicillium-mold culture fluid extracts. During the summer of 1940, their experiments centered on a group of 50 mice that they had infected with deadly streptococcus. Half the mice died miserable deaths from overwhelming sepsis. The others, which received penicillin injections, survived. It was at that point that Florey realized that he had enough promising information to test the drug on people. But the problem remained: how to produce enough pure penicillin to treat people. In spite of efforts to increase the yield from the mold cultures, it took 2,000 liters of mold culture fluid to obtain enough pure penicillin to treat a single case of sepsis in a person. Another vital figure in the lab was a biochemist, Dr. Norman Heatley, who used every available container, bottle and bedpan to grow vats of the penicillin mold, suction off the fluid and develop ways to purify the antibiotic. The makeshift mold factory he put together was about as far removed as one could get from the enormous fermentation tanks and sophisticated chemical engineering that characterize modern antibiotic production today.

 

In the summer of 1941, shortly before the United States entered World War II, Florey and Heatley flew to the United States, where they worked with American scientists in Peoria, Ill., to develop a means of mass producing what became known as the wonder 8) ___. Aware that the fungus Penicillium notatum would never yield enough penicillin to treat people reliably, Florey and Heatley searched for a more productive species. One hot summer day, a laboratory assistant, Mary Hunt, arrived with a cantaloupe that she had picked up at the market and that was covered with a “pretty, golden mold.“ Serendipitously, the mold turned out to be the fungus Penicillium chrysogeum, and it yielded 200 times the amount of penicillin as the species that Fleming had described. Yet even that species required enhancing with mutation-causing X-rays and filtration, ultimately producing 1,000 times as much penicillin as the first batches from Penicillium notatum.

 

In the WWII, penicillin proved its high worth. Throughout history, the major killer in wars had been 9) ___ rather than battle injuries. In World War I, the death rate from bacterial pneumonia was 18%; in World War II, it fell, to less than 1%. From January to May in 1942, 400 million units of pure penicillin were manufactured. By the end of the war, American pharmaceutical companies were producing 650 billion units a month. Beginning in 1941, after news reporters began to cover the early trials of the antibiotic on people, Fleming was lionized as the discoverer of penicillin. And much to the quiet consternation of Florey, the Oxford group’s contributions were virtually ignored. That problem was partially corrected in 1945, when Fleming, Florey, and Chain – but not Heatley – were awarded the Nobel Prize in Physiology or Medicine. In his acceptance speech, Fleming presciently warned that the overuse of penicillin might lead to bacterial 10) ___. In 1990, Oxford made up for the Nobel committee’s oversight by awarding Heatley the first honorary doctorate of medicine in its 800-year history. Sources: Wikipedia; Dr. Howard Markel; PBS

 

ANSWERS: 1) antibiotics; 2) bacteria; 3) fungus; 4) diseases; 5) mold; 6) penicillin; 7) Oxford; 8) drug; 9) infection; 10) resistance

 

Veterans Day – Honoring Those Who Served: The Race to Bring Penicillin to the Troops in WWII

 

The following was excerpted from the FDA Blog and authored by John P. Swann, Ph.D., an FDA Historian

 

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Chemical structure of Penicillin G. The sulfur and nitrogen of the five-membered thiazolidine ring are shown in yellow and blue respectively. The image shows that the thiazolidine ring and fused four-membered beta-lactam are not in the same plane. Credit: Public Domain, Wikipedia Commons

 

 

On Veterans Day this year (11 November 2016), we remembered that nearly 75 years ago dozens of American academic, commercial, nonprofit, and governmental institutions – including FDA – joined together in a race to provide penicillin, a promising but complex and unstable medicine to troops fighting in World War II. Knowing that infection is the major killer in wars, not battle injuries, the goal was to help turn a British discovery into a crucial wartime medical contribution and what would become an indispensable therapeutic agent long after that conflict ended.

 

Many people are familiar with the story of Alexander Fleming’s 1928 discovery of a Penicillium mold that had contaminated – and surprisingly destroyed – his cultures of pathogenic organisms. Though Fleming and several others in the next decade studied the mold filtrate, known as penicillin, it was Howard Florey and his colleagues at Oxford who uncovered the drug’s chemotherapeutic potential. Their work began with studies in mice in May 1940 and transitioned to a handful of clinical cases nine months later. However, the drug was difficult to purify. Also, it presented an immense challenge to produce in sufficient quantities for study, and with Britain under siege firms there were too involved in other aspects of the war effort to offer much assistance. So Florey and a colleague came to the U. S. in the summer of 1941 for help.

 

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FDA Voice: A meeting of NRRL staff in the 1940s (courtesy of the American Institute

of the History of Pharmacy).

 

 

Among the first sites they visited was the Department of Agriculture’s Northern Regional Research Laboratory (NRRL) in Illinois, which had extensive experience in fermentation work, and from there they contacted several drug and chemical companies to drum up support. Americans quickly combined forces to tackle the challenge. The federal Office of Scientific Research and Development (OSRD), the federal entity that organized and facilitated investigations to support the war effort, arranged to act as a clearing-house for the latest research on chemical and other studies of penicillin, exchanging data with dozens of organizations in the U.S. and Britain. NRRL developed several production modifications that increased the yield of penicillin by 100 fold.

 

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FDA Voice: An FDA analyst in the 1950s carries out part of the procedure

in testing penicillin for moisture content.

 

 

FDA’s first experience with the potential wonder drug was around September 1942, when the NRRL Director approached FDA about testing the antibacterial effectiveness of a small quantity of penicillin. A year later, enough of the drug had been produced to confirm in 200 patients what the early results at Oxford had suggested, and penicillin was ready to enter the war. First, however, OSRD asked that FDA certify every lot produced by the half-dozen or so manufacturers, a task the agency also performed for insulin under statutory authority that began in 1941. Six FDA technicians certified samples for potency, absence of fever-producing contaminants, toxicity, sterility, and optimum moisture, which can affect the drug’s stability. So scarce was penicillin that companies always reconditioned the occasional rejected lot rather than destroying it.

 

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FDA Voice: The strain of Penicillium notatum that Fleming discovered at St. Mary’s Hospital in London.

 

 

By the end of the war, some of the participating firms had increased purity of the drug from the Oxford group’s one percent to about 85%. Penicillin was not only more potent, it was also more abundant, its production having increased by a factor of 500 from 1943 to 1945. In fact, by 1945 the output of penicillin, formerly under severe restriction outside of military and scientific use, was now available for most civilian needs as well. In a few years the cost of producing penicillin had decreased so much that the glass used to store ampules of the drug cost more than the drug itself. FDA’s wartime work was codified in the Penicillin Amendment of 1945, which mandated FDA’s certification of penicillin and, through subsequent laws, most other antibiotics – a responsibility that continued for nearly four decades, when the need for government testing no longer existed based on industry’s record of production. But it all started with an international effort to provide a lifesaving drug to the armed forces, bringing together all sorts of scientific and medical institutions, including FDA. Like so many others participating in this collaboration on a scale unseen up to that point, FDA played a small but critical role to support our troops at this time of global crisis.

 

This entry was posted in Drugs, Other Topics and tagged Northern Regional Research Laboratory (NRRL), Office of Scientific Research and Development (OSRD), penicillin, Veterans Day, World War II by FDA Voice.

 

Testing of Investigational Inactivated Zika Vaccine in Humans Begins

 

Editor’s note: Ah, the power of governments to do such good in the world.

 

The first of five early stage clinical trials to test the safety and ability of an investigational Zika vaccine candidate called the Zika Purified Inactivated Virus (ZPIV) vaccine to generate an immune system response has begun at the Walter Reed Army Institute of Research (WRAIR) Clinical Trial Center in Silver Spring, Maryland. Scientists with WRAIR, part of the U.S. Department of Defense (DoD), developed the vaccine. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), is co-funding the Phase 1 clinical trial with WRAIR, serving as the regulatory sponsor and providing other support.

 

The experimental ZPIV vaccine is based on the same technology WRAIR used in 2009 to successfully develop a vaccine for another flavivirus called Japanese encephalitis. The ZPIV vaccine contains whole Zika virus particles that have been inactivated, meaning that the virus cannot replicate and cause disease in humans. However, the protein shell of the inactivated virus remains intact so it can be recognized by the immune system and evoke an immune response. NIAID partially supported the preclinical development of the ZPIV vaccine candidate, including safety testing and non-human primate studies that found that the vaccine induced antibodies that neutralized the virus and protected the animals from disease when they were challenged with Zika virus.

 

The new study aims to enroll 75 people ages 18 to 49 years with no prior flavivirus infection. Flaviviruses include Zika virus, yellow fever virus, dengue virus, Japanese encephalitis virus and West Nile virus. Participants will be randomly divided into three groups: the first group (25 participants) will receive two intramuscular injections of the ZPIV test vaccine or a placebo (saline) 28 days apart; the other two groups (25 participants each) will receive a two-dose regimen of a Japanese encephalitis virus vaccine or one dose of a yellow fever vaccine before beginning the two-dose ZPIV vaccine regimen. Investigators chose to administer additional flavivirus vaccines because U.S. service members are often vaccinated against these diseases before deploying to Zika-endemic areas.

 

Additionally, a subgroup of 30 of the participants who receive the two-dose ZPIV regimen will receive a third dose one year later. All participants in the trial will receive the same ZPIV dose at each injection (5 micrograms). A DoD Research Monitor, an independent physician not associated with the protocol, will monitor the conduct of the trial and report any safety issues to the WRAIR Institutional Review Board. Another independent group, the Safety Monitoring Committee, will also monitor participant safety, review data and report any issues to NIAID. As the regulatory sponsor, NIAID ensures the trial follows the study protocol and informs the FDA of any significant adverse events or risks. NIAID also maintains the Investigational New Drug (IND) application for the candidate vaccine. The WRAIR study is expected to be completed by fall 2018.

 

Four additional Phase 1 studies to evaluate the ZPIV investigational vaccine are expected to launch in the coming months. These include

 

1. A trial enrolling 90 adults ages 18-49 years at the Center for Vaccine Development at the Saint Louis University School of Medicine. This site is an NIAID-funded Vaccine and Treatment Evaluation Unit. All participants will receive either two injections of ZPIV or a placebo 28 days apart. Participants will be randomly assigned to receive either a high, moderate or low dose at both injections to evaluate the optimal dose for use in larger future studies.

 

2. A trial enrolling 90 adults ages 21-49 years at the clinical research center CAIMED, part of Ponce Health Sciences University in Puerto Rico. The site is supported by NIAID via a subcontract from the Saint Louis University School of Medicine. This trial will examine the vaccine’s safety and immunogenicity in participants who have already been naturally exposed to dengue virus. Participants will be randomly assigned to receive either a high dose, moderate dose or a placebo.

 

3. NIAID’s Vaccine Research Center (VRC) will test the ZPIV vaccine candidate as a boost vaccination to its DNA Zika vaccine candidate, which entered Phase 1 clinical trials in August. The next part of the study, which will enroll 60 additional participants ages 18-50 years, will take place at the NIH Clinical Center in Bethesda, Maryland, the Center for Vaccine Development at the University of Maryland School of Medicine’s Institute for Global Health in Baltimore, and Emory University in Atlanta. Half of the participants will receive the NIAID Zika virus investigational DNA vaccine followed by a ZPIV vaccine boost four or 12 weeks later. The remaining participants will receive only two doses of ZPIV vaccine four or 12 weeks apart.

 

4. A WRAIR-funded trial enrolling 48 adults ages 18-50 years will be conducted at the Center for Virology and Vaccine Research, part of Beth Israel Deaconess Medical Center and Harvard Medical School in Boston. One group of participants will receive a single dose of the ZPIV vaccine and all other participants will receive two doses of the ZPIV vaccine at varying intervals.

 

BARDA is funding the advanced development of the ZPIV vaccine candidate through a six-year contract with Sanofi Pasteur, which established a collaborative research and development agreement with WRAIR to accelerate further development of the vaccine.

ONCOLOGY

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Dietary Emulsifiers Induce Low-Grade Inflammation in Mice That Could Promote Colon Carcinogenesis

 

Colorectal cancer (CRC) is the fourth leading cause of cancer-related deaths worldwide, resulting in about 700,000 deaths in 2012. There is increasing awareness that the intestinal microbiota, the vast, diverse population of microorganisms that inhabits the human intestines, play a role in driving colorectal cancer. The increased risks conferred by inflammatory bowel disease (IBD) to the development of CRC gave rise to the term “colitis-associated cancer,“ and the concept that inflammation promotes colon tumorigenesis. A condition more common than IBD is low-grade inflammation, which correlates with altered gut microbiota composition and metabolic syndrome, both present in many cases of CRC. Recent findings suggest that low-grade inflammation in the intestine is promoted by consumption of dietary emulsifiers, a ubiquitous component of processed foods which alter the composition of gut microbiota.

 

According to a study published online in Cancer Research (7 November 2016), it was demonstrated in a pre-clinical model of colitis-induced CRC, that regular consumption of dietary emulsifiers carboxymethylcellulose or polysorbate-80 exacerbated tumor development.In this study, the authors fed mice with polysorbate 80 and carboxymethylcellulose, at doses seeking to model the broad consumption of the numerous emulsifiers that are incorporated into the majority of processed foods. Results showed that consuming emulsifiers drastically changed the species composition of the gut microbiota in a manner that made it more pro-inflammatory, thus creating a niche favoring cancer induction and development.  Alterations in bacterial species resulted in bacteria expressing more flagellin and lipopolysaccharide, which activate pro-inflammatory gene expression by the immune system.

 

This study demonstrated that emulsifier-induced alterations in the microbiome were necessary and sufficient to drive alterations in intestinal epithelial cells’ homeostasis, which is thought to govern tumor development. The effects of consuming emulsifiers were eliminated in mice devoid of microbiota (germ-free mice), and transplanting microbiota from emulsifier-treated mice to germ-free mice was sufficient to transfer alterations in intestinal epithelial cells’ homeostasis, suggesting a central role played by the microbiota in tumor development.

 

Overall, these findings support the concept that promoting host-microbiota interactions to cause low-grade gut inflammation can promote colon carcinogenesis. The authors are now investigating which microbiota members are triggering this detrimental effect, as well as the mechanism of altered microbiota-induced cancer promotion.

 

FDA Grants Accelerated Approval to New Treatment for Advanced Soft Tissue Sarcoma

 

Congratulations to our friends and colleagues at Lilly.

 

The National Cancer Institute estimates that 12,310 new cases of soft tissue sarcoma (STS) and nearly 5,000 deaths are likely to occur from the disease in 2016. The most common treatment for STS that cannot be removed by surgery is treatment with doxorubicin alone or with other drugs. STS includes a wide variety of tumors arising in the muscle, fat, blood vessels, nerves, tendons or the lining of the joints.

 

The FDA has granted accelerated approval to Lartruvo (olaratumab) in combinmation with doxorubicin, to treat adults with certain types of STS. Lartruvo is a platelet-derived growth factor (PDGF) receptor-alpha blocking antibody. When stimulated, PDGF receptors cause tumor growth. Lartruvo works by blocking these receptors, which may help slow or stop tumor growth. Lartruvo is approved for use with doxorubicin for the treatment of patients with STS who cannot be cured with radiation or surgery and who have a type of STS for which an anthracycline (chemotherapy) is an appropriate treatment.

 

The safety and efficacy of Lartruvo were studied in a randomized clinical trial involving 133 patients with more than 25 different subtypes of metastatic STS. Patients received either Lartruvo with doxorubicin or doxorubicin alone. The clinical trial measured the length of time patients lived after treatment (overall survival), the length of time tumors did not grow after treatment (progression-free survival) and the percentage of patients who experienced shrinkage of their tumors (overall response rate). Results showed that patients in this trial who received Lartruvo with doxorubicin had a:

 

1.statistically significant improvement in overall survival: the median survival was 26.5 months compared to 14.7 months for patients who received doxorubicin alone.

 

2. median progression-free survival of 8.2 months compared to 4.4 months for patients who received doxorubicin alone.

 

3. tumor shrinkage of 18.2% compared to 7.5% for those who received doxorubicin alone.

 

Lartruvo has serious risks including infusion-related reactions and embryo-fetal harm. Infusion-related reactions include low blood pressure, fever, chills and rash. The most common side effects of treatment with Lartruvo are nausea, fatigue, low levels of white blood cells (neutropenia), musculoskeletal pain, inflammation of the mucous membranes (mucositis), hair loss (alopecia), vomiting, diarrhea, decreased appetite, abdominal pain, nerve damage (neuropathy) and headache.

 

The FDA granted the Lartruvo application fast track designation, breakthrough therapy designation and priority review status because preliminary clinical evidence indicated that it may offer a substantial improvement in effectiveness in the treatment of a serious or life-threatening disease or condition. The FDA is approving Lartruvo under the agency’s accelerated approval program, which allows approval of a drug to treat a serious or life-threatening disease or condition based on clinical data showing the drug has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit. The sponsor is conducting a larger study, which is currently underway, to further explore the effectiveness of Lartruvo across the multiple subtypes of STS. Lartruvo also received orphan drug designation, which provides incentives such as tax credits, user fee waivers and eligibility for exclusivity to assist and encourage the development of drugs intended to treat rare diseases.

 

Lartruvo is marketed by Eli Lilly and Company based in Indianapolis, Indiana.

 

Mango Shrimp with Fresh Corn, Green Grapes, Pine Nuts & Parmesan

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I’ve been experimenting for some time, now, with shrimp and how to make them in a new and interesting way – with or without fruit – and if so, what fruit – which spices – exactly what herbs together, – nuts or not. This recipe is now ready to share with you, in the hopes you will love it as much as Jules and I do – we are four thumbs up! Enjoy! ©Joyce Hays, Target Health Inc.

 

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Oh-h, this is so-o good! You won’t be able to stop eating this delicious recipe, if I do say so myself. ©Joyce Hays, Target Health Inc.

 

Ingredients

 

1.5 pounds fresh shrimp (have your fish monger de-vein & clean them)

1 to 3 cups green grapes, cut in half

1-3 mangos, cut in cubes or pieces

Pinch Kosher or sea salt

12 ounces dry farfalle (bow tie pasta, made in chicken broth)

1 Tablespoon olive oil

3 or 4 Tablespoons truffle oil, (black or white) drizzle before serving

10 scallions, trimmed and thinly sliced (keep the whites and greens separate)

6 garlic cloves, sliced thin

1 cup pine nuts, toasted

5 large or 6 medium ears corn, shucked & kernels removed (approx 4-5 cups kernels)

Pinch black pepper

1 teaspoon turmeric

Pinch chili flakes (no more than 1 pinch)

3 Tablespoons unsalted butter

1/2 cup grated Parmesan cheese, more to taste

1/2 cup fresh cilantro leaves, finely chopped

1/2 cup fresh mint leaves, finely chopped

1/2 cup fresh dill, finely chopped

Handful fresh parsley, finely chopped for garnish

Zest of 1/2 fresh lemon

Juice of 1/2 fresh lemon

 

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Every fresh ingredient here, really adds something special to the flavors of this recipe. ©Joyce Hays, Target Health Inc.

 

 

Directions

 

1. Toast pine nuts, then set aside.

 

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It makes a difference when you toast the pine nuts. Taste one, before and after, that’s how you’ll know. ©Joyce Hays, Target Health Inc.

 

 

2. Cook pasta 1 minute less than usual (according to the package directions). Cook in chicken stock or broth, instead of water.

 

3. When pasta is done, remove it from pot with slotted spoon and put into a separate bowl, to drain. Save all the pasta liquid left in the pot.

 

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Cook your pasta in chicken stock or broth; then drain but save the broth for this recipe and other uses. ©Joyce Hays, Target Health Inc.

 

 

4. Hold your ears of corn at the small end or if more comfortable, at the large end, and with a sharp knife, scrape all of the kernels off and right into a bowl

 

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Shucking the corn. ©Joyce Hays, Target Health Inc.

 

 

5. Do all the chopping, slicing, cutting and grating, you need to do for this recipe, while the pasta is boiling. Chop everything on the same board, and do as much as you can at the same time.

 

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Chopping the dill first. ©Joyce Hays, Target Health Inc.

 

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Cut grapes in half, slice the scallions and grate the parmesan. ©Joyce Hays, Target Health Inc.

 

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Peel the fresh mangoes, then slice and cut into pieces or cubes. I found golden skinned mangoes that are still at their peak. I think some people call them champagne mangoes; they are sweet and delicious and really add a lot to this recipe. ©Joyce Hays, Target Health Inc.

 

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Starting the cooking. ©Joyce Hays, Target Health Inc.

 

 

6. Meanwhile, heat oil in a large oven-proof, pan, (that can also be used for serving on the table) over medium heat. Add garlic cloves sliced, scallions, pinch of salt and cook until soft, 3 minutes. Add 1/4 cup of the pasta liquid (that you saved), and all the corn except for, 1/4 cup corn. Set aside 1/4 cup of corn.

 

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Add most of the corn and stir to combine. Put aside the 1/4 cup of kernels, you saved. ©Joyce Hays, Target Health Inc.

 

 

7. Transfer the sauteed corn mixture, to a blender, or food processor and pur?e mixture until smooth, adding a little extra pasta liquid, if needed, to get a thick but pourable texture. Let it sit, while you do the next step.

 

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From pan to food processor. ©Joyce Hays, Target Health Inc.

 

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Pulse until you puree the contents. ©Joyce Hays, Target Health Inc.

 

 

8. Using the same pan, (over high heat), don’t rinse it out. Add butter and let melt. Add the 1/4 cup corn, that you saved, and cook until tender, 1 minute. (It’s O.K. if the butter browns; that deepens the flavor.)

 

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To the same pan, add butter and the saved corn kernels. ©Joyce Hays, Target Health Inc.

 

 

9. Add the corn puree that you left in the blender, to the white pan with larger pieces of corn. Cook, only, for 30 seconds to heat and combine the flavors.

 

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Add the contents of the blender or food processor, to the whole kernels in the pan. ©Joyce Hays, Target Health Inc.

 

 

10. Reduce heat to medium. Add all the pasta that was draining in a bowl. Add the lemon zest and stir it in, then add the lemon juice and stir it in.

 

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Here, I’m adding the cooked, drained pasta to the pan and the lemon zest. ©Joyce Hays, Target Health Inc.

 

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After stirring the pasta in, I’m adding all the chopped herbs. ©Joyce Hays, Target Health Inc.

 

 

11. Add half (not all) the pasta liquid still left, to the pan with corn. Toss everything to coat all the pasta. Cook for 1 minute. If you think the mixture is too thick, add a little more of the left-over pasta liquid. If not too thick and just right, go to the next step.

12. Stir in 1/4 cup of the scallion greens, the Parmesan, the herbs, the chili flakes and the toasted pine nuts.

 

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Add the toasted pine nuts and stir in. ©Joyce Hays, Target Health Inc.

 

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Finally, add some parmesan and the chili flakes. Stir well and toss to combine everything well. ©Joyce Hays, Target Health Inc.

 

 

13. For the final few minutes, before serving, dust with more freshly grated parmesan, and drizzle over the parmesan, the 2 Tablespoons of truffle oil and with a cover on, warm for a few more minutes.

14. Also, consider, putting this in a preheated 400 degree oven for 10 minutes, so the parmesan melts. No cover, if you put in the oven.

 

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About to cook the shrimp in another pan, so I’m covering the pasta mixture, while I cook the shrimp. ©Joyce Hays, Target Health Inc.

 

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In another pan, over high heat, add olive oil and freshly sliced garlic cloves, sautee them for a minute, then add the shrimp. Cook batches of shrimp at a time, so there’s only one layer. Cook for 1 to 2 minutes on each side. Using cooking tongs, turn each shrimp over. Remove each shrimp when loses its grayish color and turns pink and white. Remove each piece, the second the turned shrimp turns pink and white or it will be overdone and rubbery. Remove to a plate covered with paper towel to drain. ©Joyce Hays, Target Health Inc.

 

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Just before serving, add the grape and mango pieces, plus the cooked shrimp, to the pasta pan. Toss well. If you want to reheat the whole dish, preheat the oven to 400 degrees, and warm up the covered dish for 5 to 10 minutes. Serve right away. ©Joyce Hays, Target Health Inc.

 

This dish is so delicious, you might want this recipe to serve as a one dish meal. We did start with white wine and cruditees, but I had no salad or other side dish. You could warm up in the oven some French or Italian bread and/or rolls and dip them in olive oil, to go along with this fabulous shrimp mango entr?e.

 

This weekend we saw the best theater, so far this year. Heisenberg, at the Samuel Friedman Theater. Everything in this production, by Manhattan Theater Club (where we are patrons) is perfect. I will go out on a limb and predict that Mary Louise Parker will win the Tony for best actress. Heisenberg should win a Tony for best play. Run, don’t walk to get tickets for this extremely stimulating theatrical experience. They don’t come along that often, so try not to miss this production.

 

Following a sold-out, world-premiere run at Manhattan Theatre Club Stage II Off-Broadway space last year, Simon Stephens’ acclaimed two-hander has returned to the New York stage with Denis Arndt and Mary-Louise Parker reprising their roles. The show began previews at the Samuel J. Friedman Theatre September 20 and opened October 13. It had been scheduled to run through December 3, but will now continue through December 11.

 

The new play, by The Curious Incident of the Dog in the Night-Time Tony winner Stephens with direction by Mark Brokaw, sees two beguiling strangers quickly embark on a life-changing journey. “Amidst the bustle of a crowded London train station, Georgie spots Alex, a much older man, and plants a kiss on his neck,“ state production notes. “This electric encounter thrusts these two strangers into a fascinating and life-changing game. Directed by Drama Desk Award winner Mark Brokaw (How I Learned to Drive), Heisenberg brings to blazing, theatrical life the uncertain and often comical sparring match that is human connection.“ The creative team includes Mark Wendland (scenic design), Michael Krass (costume design), Donald Holder (lighting design) and David Van Tieghem (sound design).Denis Arndt and Mary-Louise Parker (Joan Marcus)

 

Tickets to Heisenberg can also be purchased by visiting ManhattanTheatreClub.com. The Samuel J. Friedman Theatre is located at 261 West 47th St.

 

Heisenberg brings to blazing, theatrical life the uncertain and often comical sparring match that is human connection.

 

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This was the perfect complimenting wine for the Shrimp Mango dish. We recommend it it highly.

©Joyce Hays, Target Health Inc.

 

 

From Our Table to Yours !

 

Bon Appetit!