June 18, 2018

University of New Hampshire

Scientists have been able to prove the existence of small black holes and those that are super-massive but the existence of an elusive type of black hole, known as intermediate-mass black holes (IMBHs) is hotly debated. New research shows the strongest evidence to date that this middle-of-the-road black hole exists, by serendipitously capturing one in action devouring an encountering star.


This image shows data from NASA/ESA’s Hubble Space Telescope (yellow-white) and NASA’s Chandra X-ray Observatory (purple). The purple-white source in the lower left shows X-ray emission from the remains of a star that was ripped apart as it fell towards an intermediate mass black hole. The host galaxy of the black hole is located in the middle of the image.
Credit: X-ray: NASA/CXC/UNH/D.Lin et al, Optical: NASA/ESA/STScI



Scientists have been able to prove the existence of small black holes and those that are super-massive but the existence of an elusive type of black hole, known as intermediate-mass black holes (IMBHs) is hotly debated. New research coming out of the Space Science Center at the University of New Hampshire shows the strongest evidence to date that this middle-of-the-road black hole exists, by serendipitously capturing one in action devouring an encountering star.

“We feel very lucky to have spotted this object with a significant amount of high quality data, which helps pinpoint the mass of the black hole and understand the nature of this spectacular event,” says Dacheng Lin, a research assistant professor at UNH’s Space Science Center and the study’s lead author. “Earlier research, including our own work, saw similar events, but they were either caught too late or were too far away.”

In their study, published in Nature Astronomy, researchers used satellite imaging to detect for the first time this significant telltale sign of activity. They found an enormous multiwavelength radiation flare from the outskirts of a distant galaxy. The brightness of the flare decayed over time exactly as expected by a star disrupting, or being devoured, by the black hole. In this case, the star was disrupted in October 2003 and the radiation it created decayed over the next decade. The distribution of emitted photons over the energy depends on the size of the black hole. This data provides one of the very few robust ways to weight, or determine the size of, the black hole.

Researchers used data from a trio of orbiting X-ray telescopes, NASA’s Chandra X-ray Observatory and Swift Satellite as well as ESA’s XMM-Newton, to find the multiwavelength radiation flares that helped identify the otherwise uncommon IMBHs. The characteristic of a long flare offers evidence of a star being torn apart and is known as a tidal disruption event (TDE). Tidal forces, due to the intense gravity from the black hole, can destroy an object — such as a star — that wanders too close. During a TDE, some of the stellar debris is flung outward at high speeds, while the rest falls toward the black hole. As it travels inward, and is ingested by the black hole, the material heats up to millions of degrees and generates a distinct X-ray flare. According to the researchers, these types of flares, can easily reach the maximum luminosity and are one of the most effective way to detect IMBHs.

“From the theory of galaxy formation, we expect a lot of wandering intermediate-mass black holes in star clusters,” said Lin. “But there are very, very few that we know of, because they are normally unbelievably quiet and very hard to detect and energy bursts from encountering stars being shredded happen so rarely.”

Because of the very low occurrence rate of such star-triggered outbursts for an IMBH, the scientists believe that their discovery implies that there could be many IMBHs lurking in a dormant state in galaxy peripheries across the local universe.

Story Source:

Materials provided by University of New HampshireNote: Content may be edited for style and length.

Journal Reference:

  1. Dacheng Lin, Jay Strader, Eleazar R. Carrasco, Dany Page, Aaron J. Romanowsky, Jeroen Homan, Jimmy A. Irwin, Ronald A. Remillard, Olivier Godet, Natalie A. Webb, Holger Baumgardt, Rudy Wijnands, Didier Barret, Pierre-Alain Duc, Jean P. Brodie, Stephen D. J. Gwyn. A luminous X-ray outburst from an intermediate-mass black hole in an off-centre star clusterNature Astronomy, 2018; DOI: 10.1038/s41550-018-0493-1


Source: University of New Hampshire. “Best evidence of rare black hole captured.” ScienceDaily. ScienceDaily, 18 June 2018. <>.

2018 DIA Meeting in Boston


Let us know if you are attending, and if yes, visit us at Booth 2337.

This year we will feature:


1. CRO services: Reg Affairs, Clinical Research, Biostats, Data Management and Medical Writing

2. Our paperless clinical trial operation

3. Target e*CRF® fully integrated with Target e*CTR®, our patented web-based direct data entry solution

4. Target eICF™ fully integrated with Target e*CRF®

5. A glimpse into our next software version which will be EDC for All


For more information about Target Health contact Warren Pearlson (212-681-2100 ext. 165). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel. The Target Health software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website.


Joyce Hays, Founder and Editor in Chief of On Target

Jules Mitchel, Editor



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Side-view of the human eye, viewed approximately 90o temporal, illustrating how the iris and pupil appear rotated towards the viewer due to the optical properties of the cornea and the aqueous humor. Photo credit: Paul Savage –, CC BY 2.0,



The human eye is an organ which reacts to 1) ___ and pressure. As a sense organ, the mammalian eye allows vision. Human eyes help to provide a three dimensional, moving image, normally colored in daylight. Rod and cone cells in the retina allow conscious light perception and vision including color differentiation and the perception of depth. The human eye can differentiate between about 10 million colors and is possibly capable of detecting a single photon. Similar to the eyes of other mammals, the human eye’s non-image-forming photosensitive ganglion cells in the retina receive light signals which affect adjustment of the size of the 2) ___, regulation and suppression of the hormone melatonin and entrainment of the body clock.


The eye is not shaped like a perfect sphere, rather it is a fused two-piece unit, composed of the anterior segment and the posterior segment. The anterior segment is made up of the cornea, iris and lens. The cornea is transparent and more curved, and is linked to the larger posterior segment, composed of the vitreous, retina, choroid and the outer white shell called the sclera. The cornea is typically about 11.5 mm (0.3 in) in diameter, and 1/2 mm (500 um) in thickness near its center. The posterior chamber constitutes the remaining five-sixths; its diameter is typically about 24 mm. The cornea and sclera are connected by an area termed the limbus. The 3) ___ is the pigmented circular structure concentrically surrounding the center of the eye, the pupil, which appears to be black. The size of the pupil, which controls the amount of light entering the eye, is adjusted by the iris’ dilator and sphincter muscles.


Light energy enters the eye through the cornea, through the pupil and then through the lens. The lens shape is changed for near focus (accommodation) and is controlled by the ciliary muscle. Photons of light falling on the light-sensitive cells of the retina (photoreceptor cones and rods) are converted into electrical signals that are transmitted to the brain by the optic 4) ___ and interpreted as sight and vision. Dimensions typically differ among adults by only one or two millimeters, remarkably consistent across different ethnicities. The vertical measure, generally less than the horizontal, is about 24 mm. The transverse size of a human adult eye is approximately 24.2 mm and the sagittal size is ?23.7 mm with no significant difference between genders and age groups. The typical adult eye has an anterior to posterior diameter of 24 millimeters, a volume of six cubic centimeters (0.4 cu. in.) and a mass of 7.5 grams (weight of 0.25 oz.).


The eyeball grows rapidly, increasing from about 16-17 millimeters (about 0.65 inch) at birth to 22.5-23 mm (approx. 0.89 in) by three years of age. By age 13, the eye attains its full 5) ___.


The eye is made up of three coats, or layers, enclosing various anatomical structures. The outermost layer, known as the fibrous tunic, is composed of the cornea and sclera. The middle layer, known as the vascular tunic or uvea, consists of the choroid, ciliary body, pigmented epithelium and iris. The innermost is the retina, which gets its oxygenation from the 6) ___ vessels of the choroid (posteriorly) as well as the retinal vessels (anteriorly). The spaces of the eye are filled with the aqueous humor anteriorly, between the cornea and lens, and the vitreous body, a jelly-like substance, behind the lens, filling the entire posterior cavity. The aqueous humor is a clear watery fluid that is contained in two areas: the anterior chamber between the cornea and the iris, and the posterior chamber between the iris and the lens. The lens is suspended to the ciliary body by the suspensory ligament (Zonule of Zinn), made up of hundreds of fine transparent fibers which transmit muscular forces to change the shape of the lens for 7) ___(accommodation). The vitreous body is a clear substance composed of water and proteins, which give it a jelly-like and sticky composition.


The Greek roots of the word ophthalmology are (ophthalmos, “eye”) and (logia, “study, discourse”) i.e., “the study of eyes”. The discipline applies to all animal eyes, whether human or not, since the practice and procedures are quite similar with respect to disease processes, while differences in anatomy or disease prevalence, whether subtle or substantial, may differentiate the two. Ophthalmology is a branch of medicine and surgery (both methods are used) that deals with the anatomy, physiology and diseases of the 8) ___ and orbit. An ophthalmologist is a specialist in medical and surgical eye disease. Their credentials include a doctorate degree in medicine, followed by an additional four years of Ophthalmology residency training. They may or may not receive residency training in internal medicine, pediatrics, or general surgery before the ophthalmology residency. Additional training may be sought through a fellowship in a particular specialty of eye pathology. Ophthalmologists are allowed to medically treat eye disease, prescribe glasses or contact lenses, implement laser therapy, and perform surgery when needed. Ophthalmologists may participate in academic research on the diagnosis and treatment for eye disorders.


Ophthalmologists are physicians (MD/MS after MBBS or D.O./DOMS/ DNB, not OD or BOptom) who have completed a college degree, medical school, and residency in ophthalmology. Ophthalmology training equips eye specialists to provide the full spectrum of eye care, including the prescription of glasses and contact lenses, medical treatment, and complex microsurgery. In many countries, ophthalmologists also undergo additional specialized training in one of the many subspecialties. Ophthalmology was the first branch of 9) ___ to offer board certification, now a standard practice among all specialties. In the United States, ophthalmologists must complete four years of undergraduate studies, four years of medical school, one year general surgical residency, three years of ophthalmology residency and optional one to two years of speciality training. Physicians must complete the requirements of continuing medical education to maintain licensure and for recertification. Professional bodies like the American Academy of Ophthalmology and American Society of Cataract and Refractive Surgery organize conferences, help physician members through continuing medical 10) ___ programs for maintaining board certification, and provide political advocacy and peer support.


ANSWERS: 1) light; 2) pupil; 3) iris; 4) nerve; 5) size; 6) blood; 7) focusing; 8) eyeball; 9) medicine; 10) education


Patricia Bath MD, Inventor (1942 to Present)

Patricia Bath MD – Inventor of Laserphaco Probe – Photo credit: National Library of Medicine;; Public Domain, Wikipedia Commons


Patricia Era Bath is an American ophthalmologist, inventor, and academic. She broke ground for women and African Americans in a number of areas. Bath was the first African American to serve as a resident in ophthalmology at New York University. She is also the first African American woman to serve on staff as a surgeon at the UCLA Medical Center. And finally, Bath is the first African-American woman physician to receive a patent for a medical purpose. The holder of four patents, she also founded the non-profit American Institute for the Prevention of Blindness in Washington, D.C.


Dr. Bath was born on November 4, 1942, in Harlem, Manhattan. Her father, an immigrant from Trinidad, was newspaper columnist, a merchant seaman and the first African American to work for the New York City Subway as a motorman. Her father inspired her love for culture and encouraged Bath to explore different cultures. Her mother descended from African slaves. It was evident by Bath’s teachers that she was a gifted student and pushed her to explore her strengths in school in science. With the help of a microscope set she was given as a young child, Bath knew she had a love for math and science. Bath attended Charles Evans Hughes High School where she excelled at such a rapid pace that she obtained her diploma in just two and a half years.


Inspired by Albert Schweitzer’s work in medicine, Bath applied for and won a National Science Foundation Scholarship while attending high school; this led her to a research project at Yeshiva University and Harlem Hospital Center on connection between cancer, nutrition and stress which helped her interest in science shift to medicine. The head of the researched program realized the significance to her findings during the research and published them in a scientific paper that he later presented. In 1960, still a teenager, Bath won the “Merit Award” of Mademoiselle magazine for her contribution to the project. Bath received her Bachelor of Arts in chemistry from Manhattan’s Hunter College in 1964 and relocated to Washington, D.C. to attend Howard University College of Medicine where she received her doctoral degree in 1968. During her time at Howard, she was President of the Student National Medical Association and received fellowships from the National Institutes of Health and the National Institute of Mental Health.


Bath interned at Harlem Hospital Center, subsequently serving as a fellow at Columbia University. Bath traveled to Yugoslavia in 1967 to study children’s health which caused her to become aware that the practice of eye care was uneven among racial minorities and poor populations, with much higher incidence of blindness among her African American and poor patients. She determined that, as a physician, she would help address this issue. It was also not easy for her to go to medical school since her family did not have the funds for it. She persuaded her professors from Columbia to operate on blind patients at Harlem Hospital Center, which had not previously offered eye surgery, at no cost. Bath pioneered the worldwide discipline of “community ophthalmology”, a volunteer-based outreach to bring necessary eye care to underserved populations.


After completing her education, Bath served briefly as an assistant professor at Jules Stein Eye Institute at UCLA and Charles R. Drew University of Medicine and Science before becoming the first woman on faculty at the Eye Institute. In 1978, Bath co-founded the American Institute for the Prevention of Blindness, for which she served as president. In 1983, she became the head of a residency in her field at Charles R. Drew, the first woman ever to head such a department. In 1993, she retired from UCLA, which subsequently elected her the first woman on its honorary staff. She served as a professor of Ophthalmology at Howard University’s School of Medicine and as a professor of Telemedicine and Ophthalmology at St. Georges University. She was among the co-founders of the King-Drew Medical Center ophthalmology training program.


In 1981, she conceived the Laserphaco Probe, a medical device that improves on the use of lasers to remove cataracts, and “for ablating and removing cataract lenses”. The device was completed in 1986 after Bath conducted research on lasers in Berlin and patented in 1988, making her the first African-American woman to receive a patent for a medical purpose. The device, which quickly and nearly painlessly dissolves the cataract with a laser, irrigates and cleans the eye and permits the easy insertion of a new lens, is used internationally to treat the disease. Bath has continued to improve the device and has successfully restored vision to people who have been unable to see for decades. Three of Bath’s four patents relate to the Laserphaco Probe. In 2000, she was granted a patent for a method she devised for using ultrasound technology to treat cataracts. Bath has been honored by two of her universities. Hunter College placed her in its “hall of fame” in 1988 and Howard University declared her a “Howard University Pioneer in Academic Medicine” in 1993. A children’s picture book on her life and science work, The Doctor with an Eye for Eyes: The Story of Dr. Patricia Bath (The Innovation Press, ISBN 9781943147311) was published in 2017, and was cited by both the National Science Teachers Association and the Chicago Public Library’s list of best kids books of the year.



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TAILORX Trial Finds Most Women With Early Breast Cancer Do Not Benefit From Chemotherapy


Editor’s note: This is government sponsored research at its best, and for the believers, bless the NIH for doing what no one else would do!!!


According to new data released at the American Society of Clinical Oncology (ASCO) annual meeting in Chicago last week, findings from the Trial Assigning Individualized Options for Treatment (Rx), or TAILORx trial, show no benefit from chemotherapy for 70% of women with the most common type of breast cancer. The study found that for women with hormone receptor (HR)-positive, HER2-negative, axillary lymph node – negative breast cancer, treatment with chemotherapy and hormone therapy after surgery is not more beneficial than treatment with hormone therapy alone. The trial was supported by the National Cancer Institute (NCI), part of the National Institutes of Health, and designed and led by the ECOG-ACRIN Cancer Research Group. Findings from the study will be published in The New England Journal of Medicine.


TAILORx, a phase 3 clinical trial, was opened in 2006 and was designed to provide an evidence to the question of whether hormone therapy alone is not inferior to hormone therapy plus chemotherapy. The trial used a molecular test (Oncotype DX Breast Recurrence Score) that assesses the expression of 21 genes associated with breast cancer recurrence to assign women with early-stage, HR-positive, HER2-negative, axillary lymph node — negative breast cancer to the most appropriate and effective post-operative treatment. The trial enrolled 10,273 women with this type of breast cancer at 1,182 sites in the United States, Australia, Canada, Ireland, New Zealand, and Peru. When patients enrolled in the trial, their tumors were analyzed using the 21-gene expression test and assigned a risk score (on a scale of 0 to 100) for cancer recurrence. Based on evidence from earlier trials, women in the trial who had a score in the low-risk range (0 to 10) received hormone therapy only, and those who had a score in the high-risk range (26 and above) were treated with hormone therapy and chemotherapy. Women in the trial who had a score in the intermediate range (11 to 25) were randomly assigned to receive hormone therapy alone or hormone therapy with adjuvant chemotherapy. The goal was to assess whether women who received hormone therapy alone had outcomes that were as good as those among women who received chemotherapy in addition to hormone therapy.


The study found that the primary endpoint of the trial, invasive disease-free survival — the proportion of women who had not died or developed a recurrence or a second primary cancer — was very similar in both groups. Five years after treatment, the rate of invasive disease-free survival was 92.8% for those who had hormone therapy alone and 93.1% for those who also had chemotherapy. At nine years, the rate was 83.3% for those with hormone therapy alone and 84.3% for the group that had both therapies. None of these differences were considered statistically significant. The rates of overall survival were also very similar in the two groups. At five years, the overall survival rate was 98.0% for those who received hormone therapy alone and 98.1% for those who received both therapies, and at nine years the respective overall survival rates were 93.9% and 93.8%. The investigators also found that women with a score of 0-10 had very low recurrence rates with hormone therapy alone at nine years (3%). This confirmed similar findings from earlier studies. In addition, they found that women with a score of 26-100 had a distant recurrence rate of 13% despite receiving both chemotherapy and hormone therapy. This finding indicates the need to develop more effective therapies for women at high risk of recurrence.


According to the authors, the new findings suggest that chemotherapy may be avoided in about 70% of women with HR-positive, HER2-negative, node-negative breast cancer:


– older than 50 and with a recurrence score of 11-25 (45%)

– any age with a recurrence score of 0-10 (16%)

– 50 years old or younger with a recurrence score of 11-15 (8%)


The findings suggest that chemotherapy may be considered for the remaining 30% of women with HR-positive, HER2-negative, node-negative breast cancer:


– any age with a recurrence score of 26-100 (17%)

– 50 years old or younger with a recurrence score of 16-25 (14%)


The new results demonstrated that chemotherapy is not beneficial for most women in the intermediate-risk group. This data adds to findings from a TAILORx analysis published in 2015 that provided prospective evidence that the gene expression test could identify women with a low risk of recurrence who could be spared chemotherapy.


There is however, one caveat to the new findings. When the study analyzed premenopausal women and those younger than 50 years old at the higher end of the intermediate-risk range (16-25) separately, the results showed there may be a small benefit from chemotherapy, and thus these women should consider chemotherapy with their doctor. However, it is unclear if this benefit is due to the effect of chemotherapy or to endocrine suppression caused by chemotherapy-induced menopause. According to the authors, before TAILORx, there was uncertainty about the best treatment for women with a mid-range score of 11-25 on the Oncotype DX Breast Recurrence Score test. The authors added that now we know that any woman with early-stage breast cancer age 75 or younger should have the 21-gene expression test and discuss the results with her doctor to guide her decision to the right therapy.


In addition to the NIH, the study was supported in part by the Breast Cancer Research Foundation, Komen Foundation, and the Breast Cancer Research Stamp. The stamp funding provided more than $5 million to the trial. Since 1998, when the charity stamp was authorized by Congress and first issued by the United States Postal Service, more than $86 million has been raised for breast cancer research. The net proceeds from sales of the stamp are transferred to NIH and the Medical Research Program of the Department of Defense to fund breast cancer research.


The genomic assay used in the trial was the Oncotype DX Breast Recurrence Score test from Genomic Health, Inc., Redwood City, California.



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


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


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


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


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


Innovation at FDA


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


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


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


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


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


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


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


Our actions will focus on three key areas:


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


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


Blue Wave Brownies

These brownies are so healthy and delicious, I had one with my coffee Sunday morning. ©Joyce Hays, Target Health Inc.


If we shared some with you, and asked whether you liked the chocolate, you would give a positive reply, not in the least bit cognizant that two of the ingredients are black beans and avocado. ©Joyce Hays, Target Health Inc.


These brownies are one of the healthiest desserts I have ever made. Think about it: dark chocolate, avocado, black beans, walnuts: all heart healthy foods. Easy to make and because they’re so healthy, you’ll be making them all the time now; hopefully! ©Joyce Hays, Target Health Inc.



1/2 cup unsweetened Belgian cocoa powder

1 teaspoon of your best vanilla extract

1/4 cup coconut oil

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

3 large eggs

1/2 cup dark brown sugar

1/2 cup coconut sugar

1 pinch Kosher salt

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

1 large ripe avocado

1 teaspoon baking powder

1 cup walnuts


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




1. Preheat oven to 350 degrees

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


About to toast the walnuts. ©Joyce Hays, Target Health Inc.


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


3. Measure the chocolate chips, then set aside


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


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

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


My food processor makes my recipe world possible; without it, most of my recipes would take much too long. We’re so lucky to have it. This whole recipe, pretty much depends on this precious piece of equipment, since all but two of the ingredients, simply get tossed in the processor, pulsed, blended and that’s it! ©Joyce Hays, Target Health Inc.


Growing up, I cooked in the kitchen with my mother, and really enjoyed it. My father thought I should go to the Cornell School of Home Economics (now gone & I went to Columbia University instead). My specialty in those days was creating salads and the dressing for roast turkey and chicken. My mother’s sense of whimsey made preparing food fun. A banana cut in half, sliced, with skin left, became a banana boat with men in the boat. A hot cooked cereal called wheatina, became tiger cereal when raisins were added. You get the picture, the kitchen was a fun place for me. ©Joyce Hays, Target Health Inc.


The unbelievable becomes believable, homemade brownies made with avocado. ©Joyce Hays, Target Health Inc.


And, the chocolate batter is done. ©Joyce Hays, Target Health Inc.


This chocolate batter is as finger-lickin’ good as it was in the kitchen of my childhood. ©Joyce Hays, Target Health Inc.


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

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


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


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


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


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


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


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

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

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


This is the piece I had with my coffee, Sunday morning. ©Joyce Hays, Target Health Inc.


One of the best Pinot Noirs around, Paul Hobbs, Napa Valley. ©Joyce Hays, Target Health Inc.


We started with the Paul Hobbs Pinot Noir, baked zucchini sticks and a salad. Then curried cauliflower over saffron rice. Finally, dessert, the unbelievably (low calorie, and healthy) delicious brownies with cool whip on top. ©Joyce Hays, Target Health Inc.


Have a great week everyone!


Bon Appetit!


June 14, 2018

University of Adelaide

Storm-driven ocean swells have triggered the catastrophic disintegration of Antarctic ice shelves in recent decades, according to new research published in Nature today.


This is ice calving off an ice shelf in the Antarctic.
Credit: Ian Phillips, Australian Antarctic Division



Storm-driven ocean swells have triggered the catastrophic disintegration of Antarctic ice shelves in recent decades, according to new research published in Nature today.

Lead author Dr Rob Massom, of the Australian Antarctic Division and the Antarctic Climate and Ecosystems Cooperative Research Centre, said that reduced sea ice coverage since the late 1980s led to increased exposure of ice shelves on the Antarctic Peninsula to ocean swells, causing them to flex and break.

“Sea ice acts as a protective buffer to ice shelves, by dampening destructive ocean swells before they reach the ice shelf edge,” Dr Massom said.

“But where there is loss of sea ice, storm-generated ocean swells can easily reach the exposed ice shelf, causing the first few kilometres of its outer margin to flex.”

“Over time, this flexing enlarges pre-existing fractures until long thin ‘sliver’ icebergs break away or ‘calve’ from the shelf front.”

“This is like the ‘straw that broke the camel’s back’, triggering the runaway collapse of large areas of ice shelves weakened by pre-existing fracturing and decades of surface flooding.”

Study co-author Dr Luke Bennetts, from the University of Adelaide’s School of Mathematical Sciences, said the finding highlights the need for sea ice and ocean waves to be included in ice sheet modelling.

This will allow scientists to more accurately forecast the fate of the remaining ice shelves and better predict the contribution of Antarctica’s ice sheet to sea level rise, as climate changes.

“The contribution of the Antarctic Ice Sheet is currently the greatest source of uncertainty in projections of global mean sea level rise,” Dr Bennetts said.

“Ice shelves fringe about three quarters of the Antarctic coast and they play a crucially important role in moderating sea level rise by buttressing and slowing the movement of glacial ice from the interior of the continent to the ocean.”

“While ice shelf disintegration doesn’t directly raise sea level because they are already floating, the resulting acceleration of the tributary glaciers behind the ice shelf, into the Southern Ocean, does.”

Study co-author, Dr Phil Reid, from the Australian Bureau of Meteorology, said the research identifies a previously under-appreciated link between sea ice loss and ice shelf stability.

“Our study underlines the importance of understanding the mechanisms driving these sea ice trends, particularly in regions where sea ice acts as a protective buffer against ocean processes,” he said.

The discovery comes after the international research team, from Australia, the United States and New Zealand, combined satellite images and surface and ocean wave data with modelling, to analyse five major ice shelf disintegrations, between 1995 and 2009.

These included the abrupt and rapid losses of 1600 square kilometres of ice from the Larsen A Ice Shelf in 1995, 3320 square kilometres from the Larsen B Ice Shelf in 2002, and 1450 square kilometres from the Wilkins Ice Shelf in 2009.

Each disintegration event occurred during periods when sea ice was significantly reduced or absent, and when ocean waves were large.

In only a matter of days, the collapse of the Larsen B Ice Shelf in 2002 removed an area of ice shelf that had been in place for the previous 11,500 years. Removal of the ice shelf buttressing effect also caused a 3- to 8-fold increase in the discharge of glacial ice, behind the shelf, into the ocean, in the year following disintegration.


An ice sheet forms through the accumulation of snowfall, in this case on the Antarctic continent, when annual snowfall exceeds annual snowmelt. Over thousands of years the layers of snow build up and compact, forming a sheet of ice up to thousands of metres thick and thousands of kilometres across. As the ice thickens, the increasing height of snow and ice causes the ice sheet to flow.

The Antarctic Ice Sheet covers an area of about 14 million square kilometres; by comparison, the area of Australia is about 7.7 million square kilometres, and that of the USA is about 9.8 million square kilometres. It contains more than 90% of the world’s ice — enough to potentially raise global mean sea level by about 57 metres.

Grounded ice is that part of the ice sheet that is land-based and not floating on the ocean. Melting of grounded ice above sea level contributes to sea level rise.

Ice shelves are thick plates of ice, up to several hundred metres thick and fed by tributary glaciers. They are floating seaward extensions of the grounded ice sheet.

Sea ice is ice that originates from the freezing of seawater (unlike ice sheets, glaciers, icebergs and ice shelves). Sea ice typically forms a thin and highly-dynamic veneer up to a few metres thick that covers between about 3 million square kilometres (in winter) to 19-20 million square kilometres (in summer) of the Southern Ocean surrounding Antarctica. By comparison, the areas of the Antarctic continent, Australia and the USA are about 14, 7.7 and 9.8 million square kilometres, respectively.

Ocean swell is defined as regular long-period waves that are generated by distant storms and are no longer growing or being sustained by the wind (as opposed to locally-generated wind waves).

The Antarctic Peninsula forms a mountainous 1300 km northward extension of Antarctica towards the southern tip of South America. It forms the northernmost part of mainland Antarctica.

Story Source:

Materials provided by University of AdelaideNote: Content may be edited for style and length.

Journal Reference:

  1. Robert A. Massom, Theodore A. Scambos, Luke G. Bennetts, Phillip Reid, Vernon A. Squire, Sharon E. Stammerjohn. Antarctic ice shelf disintegration triggered by sea ice loss and ocean swellNature, 2018; DOI: 10.1038/s41586-018-0212-1


Source: University of Adelaide. “Ocean waves following sea ice loss trigger Antarctic ice shelf collapse.” ScienceDaily. ScienceDaily, 14 June 2018. <>.

Method created in Brazil combines mass spectrometry analysis of blood serum with an algorithm that recognizes patterns associated with viral diseases as well as diseases of bacterial, fungal and even genetic origin.

June 13, 2018

Fundação de Amparo à Pesquisa do Estado de São Paulo

Method created in Brazil combines mass spectrometry analysis of blood serum with an algorithm that recognizes patterns associated with diseases from various origins. Adoption of machine learning technique allows the program to adapt itself to possible viral mutations.



A platform that can diagnose several diseases with a high degree of precision using metabolic markers found in patients’ blood has been developed by scientists at the University of Campinas (UNICAMP) in Brazil.

The method combines mass spectrometry, which can identify tens of thousands of molecules present in blood serum, with an artificial intelligence algorithm capable of finding patterns associated with diseases of viral, bacterial, fungal and even genetic origin.

The research was supported by the São Paulo Research Foundation — FAPESP and conducted as part of Carlos Fernando Odir Rodrigues Melo’s PhD. The results have been published in Frontiers in Bioengineering and Biotechnology.

“We used infection by Zika virus as a model to develop the platform and showed that in this case, diagnostic accuracy exceeded 95%. One of the main advantages is that the method doesn’t lose sensitivity even if the virus mutates,” said Melo’s supervisor Rodrigo Ramos Catharino, principal investigator for the project. Catharino is a professor at UNICAMP’s School of Pharmaceutical Sciences (FCF) and head of its Innovare Biomarker Laboratory.

Another strength of the platform, he added, is the capacity to identify positive cases of Zika even in blood serum analyzed 30 days after the start of infection, when the acute phase of the disease is over.

“None of the currently available diagnostic kits has the sensitivity to detect infection by Zika after the end of the acute phase. The method we developed could be useful to analyze transfusion blood bags, for example,” Catharino said.

Machine learning

Development and validation of the platform involved analysis of blood samples from 203 patients treated at UNICAMP’s general and teaching hospital. Of these, 82 were diagnosed with Zika by the method currently considered the gold standard in this field: real-time polymerase chain reaction (RT-PCR), which detects viral RNA in body fluids during the acute phase of the infection.

The other 121 patients were the control group. Approximately half had the same symptoms as the group that tested positive for Zika, such as fever, joint pain, conjunctivitis and rash, but had negative RT-PCR results for Zika. The rest had no symptoms and also tested negative or were diagnosed with dengue.

All collected samples were analyzed in a mass spectrometer, a device that acts as a kind of molecular weighing scale, sorting molecules according to their mass.

“We identified some 10,000 different molecules in the patients’ serum, including lipids, peptides, and fragments of DNA and RNA. Among these metabolites, there were particles produced both by Zika and by the patient’s immune system in response to the infection,” said the FAPESP scholarship supervisor.

All the data obtained in the spectrometry analysis of both the group that tested positive for Zika and the control group were then fed into a computer program running a random-forest machine learning algorithm. This type of artificial intelligence tool is capable of analyzing a large amount of data by specific statistical methods in search of patterns that can be used as a basis for classification, prediction, decision making, modeling and so on.

“The algorithm separates samples randomly, determines which one will be the training group and the blind group, and then carries out testing and validation. At the end, it tells us whether with that number of samples it was possible to obtain a set of metabolic markers capable of identifying patients infected by Zika,” Catharino explained.

Each new set of patient data fed into the program enhances its learning capacity and makes it more sensitive, he went on. In the case of Zika, the FAPESP-funded study established a panel of 42 biomarkers as a specific key to identifying the virus. Twelve of these were found by the algorithm to be highly prevalent in the blood of patients who tested positive for the disease.

“In this platform, it isn’t important to know a lot individually about each of the molecules that serve as markers of the infection. It’s the set that matters and that will tell us with a high level of accuracy whether we’re looking at Zika. Moreover, even if the virus mutates, the program adapts and changes too. It’s not a static methodology,” Catharino said.

The UNICAMP group is currently performing tests to evaluate the platform’s capacity to diagnose systemic diseases caused by fungi. They also plan to test how well it detects bacterial and genetic diseases. Anderson de Rezende Rocha, a professor at the same university’s Institute of Computing (IC-UNICAMP), is collaborating on the research.

In the cloud

In theory, any laboratory equipped with a mass spectrometer could use the new diagnostic platform developed at UNICAMP. Mass spectrometers are routinely used in procedures such as measuring vitamin D and screening blood spots from newborns to detect metabolic diseases via the heel prick test.

“Our proposal is to make the platform available in the cloud, so that it can be downloaded to any mass spectrometer anywhere in the world. Data analysis can be performed online. Whether it would be free or paid is yet to be defined,” Catharino said.

Story Source:

Materials provided by Fundação de Amparo à Pesquisa do Estado de São PauloNote: Content may be edited for style and length.

Journal Reference:

  1. Carlos Fernando Odir Rodrigues Melo, Luiz Claudio Navarro, Diogo Noin de Oliveira, Tatiane Melina Guerreiro, Estela de Oliveira Lima, Jeany Delafiori, Mohamed Ziad Dabaja, Marta da Silva Ribeiro, Maico de Menezes, Rafael Gustavo Martins Rodrigues, Karen Noda Morishita, Cibele Zanardi Esteves, Aline Lopes Lucas de Amorim, Caroline Tiemi Aoyagui, Pierina Lorencini Parise, Guilherme Paier Milanez, Gabriela Mansano do Nascimento, André Ricardo Ribas Freitas, Rodrigo Angerami, Fábio Trindade Maranhão Costa, Clarice Weis Arns, Mariangela Ribeiro Resende, Eliana Amaral, Renato Passini Junior, Carolina C. Ribeiro-do-Valle, Helaine Milanez, Maria Luiza Moretti, Jose Luiz Proenca-Modena, Sandra Avila, Anderson Rocha, Rodrigo Ramos Catharino. A Machine Learning Application Based in Random Forest for Integrating Mass Spectrometry-Based Metabolomic Data: A Simple Screening Method for Patients With Zika VirusFrontiers in Bioengineering and Biotechnology, 2018; 6 DOI: 10.3389/fbioe.2018.00031


Source: Fundação de Amparo à Pesquisa do Estado de São Paulo. “Platform uses artificial intelligence to diagnose Zika and other pathogens: Method created in Brazil combines mass spectrometry analysis of blood serum with an algorithm that recognizes patterns associated with viral diseases as well as diseases of bacterial, fungal and even genetic origin..” ScienceDaily. ScienceDaily, 13 June 2018. <>.

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