The Paperless Clinical Trial – New Publication in Applied Clinical Trials

 

On 4 January 2017, Applied Clinical Trials published an online paper, entitled, “Regulatory Considerations when Designing and Running 21st Century Paperless Clinical Trials.“ The paper is coauthored by Jonathan Helfgott, MS, former the Associate Director for Risk Science at FDA CDER OSI and the main author of FDA’s eSource Guidance, and Jules Mitchel, MBA, PhD, President, Target Health Inc. Jonathan is currently the Coordinator of the Regulatory Science Graduate Program at Johns Hopkins University.

 

The following are some excerpts from the paper which is meant to be both informative and evocative.

 

 

Introduction: The regulatory push to the paperless clinical trial has occurred despite a pharmaceutical industry that has been risk-averse in adopting modern-day technology tools that could support clinical trials. This risk aversion is in part due to fear by sites and sponsors of receiving a FDA Form 483. What if the FDA turns down an application if it discovers that, for example, a patient was born in 1982, when in the study database it is recorded as 1983, even when there is no impact on the study results? The clinical sites are also fearful of losing business as a result of any FDA Form 483 finding, however minor.

 

Risk Assessments: A quality by design (QbD) methodology, which includes a risk assessment and risk mitigation strategies, is a critical exercise when building software. Using a Boeing 787 analogy, a plane has several electrical systems that control the engine and the coffee machine. We should not assign the same risk to the coffee machine not delivering hot coffee as we do to the engine failing on takeoff.

 

Discussion and Conclusion: For more than a decade, technologies and processes allowing for the paperless clinical trial have been substantiated and encouraged from both the business and regulatory perspectives. The time is ripe to put away fears of regulatory sanctions when using modern technology, and make changes to modernize and optimize the drug and device development processes that will ultimately, positively, support the regulatory approval process.

 

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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Azithromycin

Azithromycin Structure: Source: By Giorgiogp – Own work, Wikimedia Commons

 

 

Azithromycin is an antibiotic indicated for the treatment of a number of bacterial infections. A team of researchers at the pharmaceutical company Pliva, located in Zagreb, 1) ___, (Gabrijela Kobrehel, Gorjana Radobolja-Lazarevski, and Zrinka Tamburasev, led by Dr. Slobodan Dokic), discovered azithromycin in 1980. It was patented in 1981. In 1986, Pliva and Pfizer signed a licensing agreement, which gave Pfizer exclusive rights for the sale of azithromycin in Western Europe and the United States. Pliva put its azithromycin on the market in Central and Eastern Europe under the brand name Sumamed in 1988. Pfizer launched azithromycin under Pliva’s license in other markets under the brand name Zithromax in 1991. Pfizer’s exclusive rights have since lapsed and Pliva-manufactured azithromycin is also marketed in the United States by generic drug maker Teva Pharmaceuticals (which now owns Pliva).

 

Indications for use of azithromycin include middle ear infections, strep 2) ___, pneumonia, traveler’s diarrhea, and certain other intestinal infections. It may also be used for a number of sexually transmitted infections including chlamydia and gonorrhea infections. Along with other medications, it may also be used for malaria. It can be taken by mouth or intravenously with doses once per day. Common side effects include nausea, vomiting, diarrhea and upset 3) ___. An allergic reaction or a type of diarrhea caused by Clostridium difficile is possible. No harm has been found with its use during pregnancy. Its safety during breastfeeding is not confirmed, but it is likely safe. Azithromycin is an azalide, a type of macrolide antibiotic. It works by decreasing the production of protein, thus stopping bacterial growth.

 

Azithromycin is on the World Health Organization’s List of Essential Medicines, the most important medications needed in a basic 4) ___ system. It is available as a generic medication and is sold under many trade names worldwide. The wholesale cost in the developing world is about 0.18 to 2.98 USD per dose. In the United States it is about 33 USD for a course of treatment.

 

Azithromycin is used to treat many different infections, including:

 

1. Prevention and treatment of acute bacterial exacerbations of chronic obstructive 5) ___ disease due to H. influenzae, M. catarrhalis, or S. pneumoniae. The benefits of long-term prophylaxis must be weighed on a patient-by-patient basis against the risk of cardiovascular and other adverse effects.

2. Acute bacterial sinusitis due to H. influenzae, M. catarrhalis, or S. pneumoniae. Other agents, such as amoxicillin/clavulanate are generally preferred, however.

3. Community-acquired pneumonia’ due to C. pneumoniae, H. influenzae, M. pneumoniae, or S. pneumoniae

4. Acute otitis media caused by H. influenzae, M. catarrhalis or S. pneumoniae. Azithromycin is not, however, a first-line agent for this condition. Amoxicillin or another beta lactam antibiotic is generally preferred.

5. Pharyngitis or tonsillitis caused by S. pyogenes as an alternative to first-line therapy in individuals who cannot use first-line therapy

6. Uncomplicated skin and skin structure infections due to S. aureus, S. pyogenes, or S. agalactiae

7. Urethritis and cervicitis due to C. trachomatis or N. gonorrhoeae

8.Genital ulcer disease (chancroid) in men due to H. ducreyi

9. In combination with ceftriaxone, 6) ___ is part of the United States Centers for Disease Control-recommended regimen for the treatment of gonorrhea. Azithromycin is active as monotherapy in most cases, but the combination with ceftriaxone is recommended based on the relatively low barrier to resistance development in gonococci.

 

Azithromycin has relatively broad but shallow antibacterial activity. It inhibits some Gram-positive bacteria, some Gram-negative 7) ___, and many atypical bacteria. A strain of gonnorhea reported to be highly resistant to azithromycin was found in the population in 2015. Neisseria gonorrhoeae is normally susceptible to azithromycin, but the drug is not widely used as monotherapy due to a low barrier to resistance development.

 

No harm has been found with use during pregnancy. However, there are no adequate well-controlled studies in 8) ___ women. Safety of the medication during breastfeeding is unclear. It has been reported that because only low levels are found in breastmilk and the medication has also been used in young children, it is unlikely that breastfed infants would suffer adverse effects. Nevertheless, it is recommended that the drug be used with caution during breastfeeding.

 

Most common side effects are diarrhea (5%), nausea (3%), abdominal pain (3%), and vomiting. Fewer than 1% of people stop taking the drug due to change in advice comes because to date, no evidence conclusively demonstrates antibiotics (other than rifampicin or rifabutin) affect these contraceptives. Occasionally, patients have developed cholestatic hepatitis or delirium. Accidental intravenous overdose in an infant caused severe heart block, resulting in residual encephalopathy. Clostridium difficile has been reported with use of azithromycin.

 

In 2013 the FDA issued a warning that azithromycin, “can cause abnormal changes in the electrical activity of the heart that may lead to a potentially fatal irregular heart rhythm.“ The FDA noted in the warning a 2012 study that found the drug may increase the risk of 9) ___, especially in those with heart problems, compared with those on other antibiotics such as amoxicillin or no antibiotic. The warning indicated people with preexisting conditions are at particular risk, such as those with QT interval prolongation, low blood levels of potassium or magnesium, a slower than normal heart rate, or those who use certain drugs to treat abnormal heart rhythms.

 

Azithromycin prevents bacteria from growing by interfering with their protein synthesis. It binds to the 50S subunit of the bacterial ribosome, thus inhibiting translation of mRNA. Nucleic acid synthesis is not affected.

 

Azithromycin is an acid-stable antibiotic, so it can be taken orally with no need of protection from gastric acids. It is readily absorbed, but absorption is greater on an empty stomach. Time to peak concentration (Tmax) in adults is 2.1 to 3.2 hours for oral dosage forms. Due to its high concentration in phagocytes, azithromycin is actively transported to the site of infection. During active phagocytosis, large concentrations are released. The concentration of azithromycin in the tissues can be over 50 times higher than in plasma due to ion trapping and its high lipid solubility. Azithromycin’s half-life allows a large single dose to be administered and yet maintain bacteriostatic levels in the infected tissue for several days. Following a single dose of 500 mg, the apparent terminal elimination half-life of azithromycin is 68 hours. Biliary excretion of azithromycin, predominantly unchanged, is a major route of elimination. Over the course of a week, about 6% of the administered dose appears as unchanged drug in urine.

 

After several years, the U.S. Food and Drug Administration approved AzaSite, an ophthalmic formulation of azithromycin, for the treatment of 10) ___ infections. AzaSite is marketed in the U.S. and Canada by Inspire Pharmaceuticals, a wholly owned subsidiary of Merck. Sources: Wikipedia; WebMD

 

ANSWERS: 1) Croatia; 2) throat; 3) stomach; 4) health; 5) pulmonary; 6) azithromycin; 7) bacteria; 8) pregnant; 9) death; 10) eye

 

100 Years Later, Death Theories of Healer, Grigori Rasputin Remain a Mystery

Grigori Rasputin 1869-1916: Photo source: Public Domain, Wikipedia Commons

 

 

Grigori Yefimovich Rasputin was a Russian peasant, an experienced traveler, a mystical faith healer, and trusted friend of the family of Nicholas II, the last Tsar of the Russian Empire. He became an influential figure in Saint Petersburg, especially after August 1915 when Nicholas took command of the army fighting in World War I. Advising his wife, Alexandra Feodorovna, in countless spiritual and political issues, Rasputin became an easy scapegoat for Russian nationalists, liberals and aristocrats. There is uncertainty over much of Rasputin’s life and the degree of influence that he exerted over the extremely shy Tsar and the strong-willed Tsarina. Accounts are often based on dubious memoirs, hearsay, and legend. While his influence and position may have been exaggerated by society gossip and his own drunken boasting his presence played a significant role in the increasing unpopularity of the Imperial couple. It is believed that Rasputin was murdered by monarchists who hoped to save Tsarism by ending his sway over the royal family. The end of December 2016, marked the 100th anniversary of the death of Rasputin, the “mad monk of Russia“, or “lover of the Russian queen.“

 

Grigori Yefimovich Rasputin, a mystic and spiritual healer born in Pokrovskoe in Siberia, wielded huge influence over the Russian royal family, particularly Alexandra, the Tsarina, who looked to the spiritual healer to cure her hemophiliac son, heir, Tsesarevich Alexei.

 

On 13 October 1906, Rasputin paid a visit to the Imperial family and presented an icon. On request of the Tsar, he then visited the next prime minister, Pyotr Stolypin. A few weeks before, 29 people had been killed on Aptekarsky Island in a bomb attack by the Maximalists and two of Stolypin’s children were wounded. Rasputin was invited to pray. On 6 April 1907, Rasputin was invited to Alexander Palace in Tsarskoe Selo, this time to see Tsesarevich Alexei, the heir. The boy had suffered an injury which caused him painful bleeding. By then, it was not known that Alexei had a rare form of hemophilia. The doctors could not supply a cure, and the desperate Tsarina invited Rasputin. He was able to calm the parents and their son, standing at the foot of the bed and praying. From that moment, Alexandra believed Rasputin was Alexei’s savior. Pierre Gilliard, the French historian Helene Carrere d’Encausse, and journalist Diarmuid Jeffreys speculated that Rasputin’s healing practice included halting the administration of aspirin, a pain-relieving analgesic available since 1899. Aspirin is an anticoagulant and has blood-thinning properties; the mechanism of action of aspirin is that it prevents clotting and promotes bleeding, which could have caused the hemarthrosis at the root of Alexei’s joints swelling and pain. On September 1912, the Romanovs were visiting their hunting retreat in the Bialowieza Forest; on 5 September, the careless Tsesarevich jumped into a rowboat and hit one of the oarlocks. A large bruise appeared within minutes. Within a week the hematoma reduced in size. In mid-September, the family moved to Spala (then in Russian Poland). On 2 October, after a drive in the woods, the “juddering of the carriage had caused still healing hematoma in his upper thigh to rupture and start bleeding again.“ Alexei had to be carried out in an almost unconscious state. His temperature rose and his heartbeat dropped, caused by a swelling in the left groin; Alexandra barely left his bedside. A constant record was kept of the boy’s temperature. On 10 October, a medical bulletin appeared in the newspapers, and Alexei received the last sacrament. His condition then improved at once, according to the Tsar. The positive trend continued throughout the next day. According to Nelipa, Robert K. Massie was correct to recommend that psychological factors do play a part.

 

It is not exactly clear on which day, either 9, 10, or 11 October, the Tsarina turned to her lady-in-waiting and best friend, Anna Vyrubova, to secure the help of the peasant healer, who at that time was out of favor. According to his daughter, Rasputin received the telegram on 12 October. If Maria Rasputin was right about the day, the telegram was sent “the longstanding claim that Rasputin had somehow alleviated Alexei’s condition is simply fictitious“, according to Nelipa. The next day he seems to have responded, with a short telegram, including the prophecy: “The little one will not die. Do not allow the doctors [c.q. Eugene Botkin and Vladimir Derevenko] to bother him too much.“ On 19 October, Alexei’s condition was considerably better and the hematoma disappeared, but he had to undergo orthopedic therapy to straighten his left leg. The court physician, Botkin, believed that Rasputin was a charlatan and his apparent healing powers arose from his use of hypnosis, but Rasputin was not interested in this practice before 1913 and his teacher Gerasim Papnadato was expelled from St. Petersburg in 1914. Felix Yusupov, one of Rasputin’s enemies, suggested that he secretly drugged Alexei with Tibetan herbs which he had obtained from a “quack doctor“. For Fuhrmann, these ideas on hypnosis and drugs flourished because the imperial family lived such isolated lives. For Moynahan, “There is no evidence that Rasputin ever summoned up spirits, or felt the need to; he won his admirers through force of personality, not by tricks.“ For Maria Rasputin and Vladimir Sukhomlinov, it was magnetism. For Shelley, the secret of his power lay in the sense of calm, gentle strength, and shining warmth of conviction.

 

What is known about the death of Rasputin, December, 1916, one hundred years ago, is that one evening Rasputin went to the Yusupov Palace in St Petersburg at the invitation of Prince Felix Yusupov. Rasputin’s dead body was recovered from the frozen Neva River days later. No one is completely sure what happened in between these two events. The most well-known account of the events comes from Prince Yusupov himself in his memoirs Lost Splendour. This autobiography reads more like a boy’s own adventure story than a reliable historical document and many doubt the authenticity of what he wrote. According to Yusupov, when Rasputin arrived at the palace he was taken down to the cellar where he was given cake and madeira wine. Upstairs, a gramophone played Yankee Doodle Dandy to fool the monk in to believing there was a party in full swing. Yusupov and his accomplices had planned things carefully. The cakes offered to Rasputin had been laced with enough potassium cyanide to slay a monastery full of monks. But Rasputin just kept eating them. Incredulous at the monk’s survival, Prince Yusupov poured madeira into a cyanide-laced wine glass and handed it to Rasputin. Instead of collapsing into unconsciousness within seconds, as would be expected from a massive dose of cyanide, Rasputin continued to sip the wine like a connoisseur. A second lethal glass disappeared into the monk’s mouth with little apparent effect other than some difficulty swallowing. Asked if he was feeling unwell he replied “Yes, my head is heavy and I’ve a burning sensation in my stomach.“ A third glass of tainted wine only seemed to revive him. Having ingested their whole stock of cyanide, the group of assassins were somewhat at a loss as to what to do next. So they shot him. The bullet appeared to have entered the body near the heart – certain death, or so they thought. But, soon after, Rasputin’s eyes opened and, clearly upset at the turn of events, he attacked Yusupov. There was a ferocious struggle before the prince could free himself and run away up the stairs. Rasputin followed. The group finally emerged into a courtyard, where four more shots were fired into Rasputin’s body before he slumped to the ground. To make sure they wouldn’t be troubled again, the assassins wrapped and tied the body with a piece of heavy linen, bundled it into a car and drove to Petrovski Island, where it was dropped from a bridge into the frozen river below.

 

The whole account sounds fanciful from start to finish, but remarkable things do happen. Human beings have achieved incredible physical feats in spite of horrible injuries. Maybe Rasputin really was still alive after the first shot and capable of a fight. But what about the poison? Surely no one could eat so much cyanide with so little effect? The theories as to why the cyanide didn’t kill Rasputin are almost as numerous as the theories of how he really died. What is surprising is that the theories are scientifically credible. The first theory is that the poisoners were not the supposed strength. Either they didn’t use enough, or the cyanide they had was old stock that had decayed into something far less toxic. Though plausible, a century after the events it is impossible to tell if this is true. The second theory is that Rasputin, aware that someone might be trying to kill him (he had survived at least one assassination attempt already), had decided to protect himself against poison. Perhaps he was inspired by Mithridates, king of Pontus in the first century BCE, who, fearful of poisoners, concocted an antidote or preventative. By ingesting sub-lethal amounts of every known poison he developed an immunity. When Mithridates was under threat from the local populace he tried to kill himself with poison, but the attempt failed and he had to request that a guard kill him with a sword. It is true that the body can develop a natural immunity or tolerance to some very toxic substances by administering very small doses over a period of time. Some of these toxic compounds include snake venom, ricin and opiates, to name but a few. Unfortunately, cyanide isn’t one of those substances. You simply cannot build up a natural tolerance to cyanide by using this method. The third theory is that Rasputin had alcoholic gastritis, which can lead to having less stomach acid. Without acid in the stomach, the potassium cyanide can’t be converted into hydrogen cyanide, and is therefore considerably less toxic. It’s another plausible explanation, but no one really knows if Rasputin suffered from this complaint or not. The fourth theory is that his poisoners unintentionally gave him the antidote along with the poison. Studies have shown that rats fed sugar with cyanide fare a lot better than those fed cyanide without it. The theory, though not proven, is that the sugar binds to the cyanide in a way that allows its excretion before it can be fully absorbed into the body. The assassins therefore may have chosen poorly when they elected to deliver the cyanide in sugary cakes and wine. The final theory is that Yusupov made the whole thing up, and Rasputin was simply shot shortly after he arrived at the palace by a person or persons unknown. This is probably much nearer the truth – but it isn’t nearly as interesting as stories of an “unkillable“ monk.

 

Rasputin was an extraordinary but minor figure. He contributed little to the tragedy that engulfed Russia in the first two decades of the 20th century. Far more important were a grossly incompetent monarch in the shape of Nicholas II, a ruthless revolutionary in the form of Lenin, and a world war that the Russian government was no more able to avert than any other. All combined to bring down a nation that, if left to itself, might perhaps have become what so many Russians have hoped for, a “normal“ and prosperous country. Sources: The Guardian (Kathryn Harkup); Wikipedia

 

Blood Biomarker May Predict Recovery From Concussions

 

Athletes who return to play before full recovery from concussions are at high risk for long-term symptoms like headaches, dizziness, and cognitive deficits with subsequent concussions. About half of college athletes see their post-concussive symptoms resolve within 10 days, but in others, the symptoms become chronic. Despite the millions of sports-related concussions that occur annually in the United States, there is no reliable blood-based test to predict recovery and an athlete’s readiness to return to play. Now, according to an article published online in Neurology (6 January 2017), NIH researchers have identified a blood biomarker that could better identify athletes who need more recovery time before safely returning to play after a sports-related concussion. The new study shows that measuring tau levels could potentially be an unbiased tool to help prevent athletes from returning to action too soon and risking further neurological injury. Tau is also connected to development of Alzheimer’s and Parkinson’s diseases, and is a marker of neuronal injury following severe traumatic brain injuries.

 

The new study evaluated changes in tau following a sports-related concussion in male and female collegiate athletes to determine if higher levels of tau relate to longer recovery durations. To measure tau levels, a group of 632 soccer, football, basketball, hockey, and lacrosse athletes from the University of Rochester first underwent pre-season blood plasma sampling and cognitive testing to establish a baseline. They were then followed during the season for any diagnosis of a concussion, with 43 of them developing concussions during the study. For comparison, a control group of 37 teammate athletes without concussions was also included in the study, as well as a group of 21 healthy non-athletes. Following a sports-related concussion, blood was sampled from both the concussed and control athletes at six hours, 24 hours, 72 hours, and seven days post-concussion.

 

Results showed that concussed athletes who needed a longer amount of recovery time before returning to play, (more than 10 days post-concussion) had higher tau concentrations overall at six, 24, and 72-hours post-concussion compared to athletes who were able to return to play in 10 days or less. These observed changes in tau levels occurred in both male and female athletes, as well as across the various sports studied. According to the authors, these findings indicate that changes in tau measured in as short a time as within six hours of a sports-related concussion may provide objective clinical information to better inform athletes, trainers, and team physicians’ decision-making about predicted recovery times and safe return to play. The authors added that further research will test additional protein biomarkers and examine other post-concussion outcomes.

 

Parental Obesity Linked to Delays in Child Development

 

Research indicates that about 1 in 5 pregnant women in the United States is overweight or obese.

 

According to an article published in Pediatrics (January 2017), children of obese parents may be at risk for developmental delays and were more likely to fail tests of fine motor skill — the ability to control movement of small muscles, such as those in the fingers and hands. Children of obese fathers were more likely to fail measures of social competence, and those born to extremely obese couples also were more likely to fail tests of problem solving ability.

 

For the study, authors reviewed data collected from the Upstate KIDS study, which originally sought to determine if fertility treatments could affect child development from birth through age 3. More than 5,000 women enrolled in the study roughly 4 months after giving birth in New York State (excluding New York City) between 2008 and 2010. To assess development, parents completed the Ages and Stages Questionnaire after performing a series of activities with their children. The test isn’t used to diagnose specific disabilities, but serves as a screen for potential problems, so that children can be referred for further testing. Children in the study were tested at 4 months of age and retested 6 more times through age 3. When they enrolled, mothers also provided information on their health and weight — before and after pregnancy — and the weight of their partners.

 

Results showed that compared to children of normal weight mothers, children of obese mothers were nearly 70% more likely to have failed the test indicator on fine motor skill by age 3. Children of obese fathers were 75% more likely to fail the test’s personal-social domain — an indicator of how well they were able to relate to and interact with others by age 3. Children with two obese parents were nearly 3x more likely to fail the test’s problem solving section by age 3.

 

According to the authors, it is not known why parental obesity might increase children’s risk for developmental delay. The authors note that animal studies indicate that obesity during pregnancy may promote inflammation, which could affect the fetal brain. Less information is available on the potential effects of paternal obesity on child development. The authors added that some studies have indicated that obesity could affect the expression of genes in sperm. If the link between parental obesity and developmental delays is confirmed, the authors wrote, physicians may need to take parental weight into account when screening young children for delays and early interventional services.

 

New NCI Drug Formulary Will Expedite Use of Agents In Clinical Trials

 

The National Cancer Institute (NCI) has launched a new drug formulary (the “NCI Formulary”) that will enable investigators at NCI-designated Cancer Centers to have quicker access to approved and investigational agents for use in preclinical studies and cancer clinical trials. The NCI Formulary could ultimately translate into speeding the availability of more-effective treatment options to patients with cancer.

 

The NCI Formulary is a public-private partnership between NCI and pharmaceutical and biotechnology companies. It is also one of NCI’s efforts in support of the Cancer Moonshot, answering Vice President Biden’s call for greater collaboration and faster development of new therapies for patients. The availability of agents through the NCI Formulary will expedite the start of clinical trials by alleviating the lengthy negotiation process — sometimes up to 18 months — that has been required for investigators to access such agents on their own.

 

The NCI Formulary launched today with 15 targeted agents from six pharmaceutical companies:

 

— Bristol-Myers Squibb

— Eli Lilly and Company

— Genentech

— Kyowa Hakko Kirin

— Loxo Oncology

— Xcovery Holding Company LLC

 

The establishment of the NCI Formulary will enable NCI to act as an intermediary between investigators at NCI-designated Cancer Centers and participating pharmaceutical companies, facilitating and streamlining the arrangements for access to and use of pharmaceutical agents. Following company approval, investigators will be able to obtain agents from the available formulary list and test them in new preclinical or clinical studies, including combination studies of formulary agents from different companies. The NCI Formulary leverages lessons learned through NCI’s Cancer Therapy Evaluation Program (CTEP) and the NCI-MATCH trial, a study in which targeted agents from different companies are being tested alone or in combination in patients with genetic mutations that are targeted by these drugs. As the use of genomic sequencing data becomes more common in selecting cancer therapies, requests for access to multiple targeted agents for the conduct of clinical trials are becoming more common.

 

By the end of 2017, NIH expects to have doubled the number of partnerships and drugs available in the NCI Formulary and CTEP staff continue to discuss the NCI Formulary with pharmaceutical companies to make additional proprietary agents available for studies initiated by investigators at NCI-designated Cancer Centers.

 

The Formulary will complement NIH’s plans for another new public-private partnership in oncology, the Partnership to Accelerate Cancer Therapies (PACT). Through PACT, the NIH, U.S. Food and Drug Administration, biopharmaceutical groups in the private sector, foundations, and cancer advocacy organizations will come together to support new research projects to accelerate progress in cancer research as part of the Cancer Moonshot. PACT research will center on the identification and validation of biomarkers of response and resistance to cancer therapies, with special emphasis on immunotherapies. PACT will also establish a platform for selecting and testing combination therapies. PACT is expected to launch in 2017.

 

Fresh Fruit Dessert Plate with Stuffed Dates and Aril Garnish

Like many relatives, friends and colleagues, we’ve struggled with bouts of serious winter maladies. Weight loss has been the only redeeming feature. In our house, loss of appetite, lead to lethargy regarding creating any food combinations, resulting in new recipes. Luckily, during our “down“ time, we craved fresh fruit. Above, is one of many fruit plates we feasted on, with a low desire for anything else. These ubiquitous plates appeared during breakfast, dinner, snacks and over the past three or four weekends, plus, ever-present at Scrabble. ©Joyce Hays, Target Health Inc.

 

 

Ingredients

 

Cara cara oranges
Blood oranges
Mandarin oranges
Sumo Tangerines
Mangoes
Red seedless grapes
Pomegranate arils
Turkish dates
Tofutti (soy cream cheese)
Grand Marnier

 

Basically, I went onto the fresh fruit page at FreshDirect, and bought a variety of peak oranges, tangerines, pink grapefruit, pomegranate arils, grapes, dates, Tofutti and a bottle of Grand Marnier. Just buy fresh fruit that you and your family like, and create a beautiful plate. ©Joyce Hays, Target Health Inc.

 

 

Directions

 

1. Start by peeling all the fruit. If you feel like marinating some of the fruit in Grand Marnier, do it now. I cut the Cara cara oranges in circles and covered them with this liqueur overnight. The strawberries are on the table, because I was planning to dip them in chocolate to serve with the fruit, but never had the energy to actually do it.

 

Cara cara oranges are at their peak now. Don’t miss this season’s a lovely range of citrus fruit in markets now. I bought these at FreshDirect. ©Joyce Hays, Target Health Inc.

 

Mangoes are very fine in markets right now and as healthy as can be. They can be addictive we found, as we slurped them down. Mmmm super delicious! ©Joyce Hays, Target Health Inc.

 

 

2. Cut your fruit in different shapes: I made some spear shaped mangoes; circles of Cara cara oranges; segments of tangerines; half circles of other oranges. I cut the dates almost in half, spread with Tofutti (soy cream cheese); distributed the grapes and sprinkled the entire plate with the pomegranate arils.

 

Many varieties of grapes are well rated, now. We’ve eaten a lot of these, often with plates of American and European cubed cheeses. ©Joyce Hays, Target Health Inc.

 

One of our favorite soft cheeses, to eat with grapes, is this Italian: Bra Tenero. If you haven’t tried it, you’re in for a treat.  Sometimes, an evening meal of warm crusty bread, robust red wine, your favorite cheeses and lots of grapes, apples and pears, is all you need to feel happy  …oh, and good conversation with plenty of laughs.

 

At one point, we tried some white wine with the fruit, which at any other time would have been just fine; but I found that it did not mix well with my illness and made me feel worse. I had not yet begun taking medication. Jules was okay with it. ©Joyce Hays, Target Health Inc.

 

 

“May Your Days Be Merry and Bright“ (Irving Berlin)

 

 

From Our Table to Yours !

 

Bon Appetit!