Academy Fellows in Changing of the Guard at Schools of Optometry
On October 2, 2013, two highly regarded schools of Optometry announced that beginning in June 2014, they would see their highly regarded deans step down after about a decade of leadership at the heads of their optometry institutions. At University of California at Berkeley, the campus administration gratefully thanked and highlighted the accomplishments of current Dean Dennis M. Levi, OD, PhD, FAAO, during the past 12 years. At The Ohio State University, the campus congratulated Melvin Shipp, OD, MPH, PhD, FAAO, for his decade-long leadership at the OSU College of Optometry. Both of our Academy colleagues are well known to the optometry, ophthalmology, and vision science communities.
In highlighting the achievements of Dennis Levi, the UCB Executive Vice Chancellor and Provost noted, “Levi’s signature achievement has been to create a culture of collegiality and collaboration within the school, especially between the clinical and research faculty. He opened new paths for faculty, students, and staff to contribute to the school’s decision-making processes. He has helped the school attain greater diversity in all its endeavors.”
Provost Breslauer went on to point out, “Ten talented tenure-track faculty were hired during his deanship, rejuvenating the faculty, increasing its diversity, fostering innovation in research and teaching, and expanding the school’s affiliations and working relationships with other academic departments and groups on campus. Similarly, the clinical faculty made great strides, attaining a greater voice in the school’s affairs and with a higher proportion of them now dedicated full time to Optometry’s academic programs. Student services have been vastly improved and extended. As an expression of their gratitude, the last seven graduating classes have made substantial gifts to the school, including a record-setting gift by the UC Optometry Student Association of $250,000 that was matched by the Chancellor as part of the campus campaign. Alumni and development units were restarted and reinvigorated. Optometry’s Continuing Professional Education programs have flourished. Berkeley Optometry’s worldwide reputation for excellence in its Vision Science research and programs remain top rated. The school’s extramurally funded research portfolio, now almost $56 million, is at an all-time high. The National Institutes of Health training grant in Vision Science, already the oldest and most successful in the United States, was recently reapproved for continuation, extending its 35-year history. The goal of developing a cadre of clinical researchers to ultimately populate the faculties of optometry schools around the world was launched through a K-12 training grant and continues with NIH support.
During his academic career, Dennis Levi’s research focus shifted from investigations into the etiology of amblyopia to the recovery of function. Most of his efforts have been in behavioral studies or psychophysics. He found that a surprising amount can be learned, with the right kind of training, to correct some amblyopia, even after the previously assumed critical period of 6 to 8 years of age.
Dean Levi has accumulated many awards and honors during his distinguished career. He twice received the Garland Clay Award (1982, 1983) as well as the Glenn Fry Award (1987) from the American Academy of Optometry. He was elected Fellow of the Optical Society of America (1995) and received an Honorary Doctor of Science from the State University of New York (1998). He served as chair of the Board and editor in chief of the journal Vision Research and is currently editor in chief of the open-access Journal of Vision. Particularly notable is the highest honor given by the American Academy of Optometry, the Charles F. Prentice Medal and Lecture (2011).
At the Ohio State University, the campus administration also had glowing words of praise for Melvin Shipp. The Executive Vice President and Provost announced on October 2, 2013, “I want you to be among the first to know that Melvin D. Shipp, dean of the College of Optometry since 2004, has advised me that he will both step down as dean at the end of his second term in May 2014 and retire from the university at the end of June 2014. As one of the premier colleges of optometry in the nation, the college has continued to flourish and accelerate that trajectory under Mel’s leadership.”
Provost Steinmetz continued, “He led the completion and implementation of its strategic plan, further advancing the college’s mission. In that regard, strategies tied directly to the overall plan include a net increase of faculty and, in the past year alone, the college hired four tenure-track faculty members and one research-track faculty member. In addition, the college has enriched, diversified, and restructured the clinical care experience, including modification to the curriculum to further enhance students’ mastery of clinical skills and clinical decision making. Furthermore, the college’s professional training program and graduate program have educated students who excel on National Board Examinations.
The college has a myriad of research, teaching, and clinical collaborations with colleges across the university and in the central Ohio community. In addition, the college has many professional affiliations such as the American Academy of Optometry, the American Public Health Association, the National Board of Examiners of Optometry, and the Ohio Optometric Association. Furthermore, renovations in Fry Hall to address environmental issues, as well as the renovation of preclinic training and anatomy laboratory spaces, have improved research and clinic spaces until Starling Loving Hall and Fry Hall can be replaced.
A national leader, he is a Fellow of the American Academy of Optometry, a diplomate, and a former chair of its Public Health and Environmental Optometry Section, among many other elected honors and other awards. At Ohio State, Mel’s research interests have included the evaluation of the impact of vision-related public policy and traffic safety, the reduction of racial and ethnic eye and vision health disparities, and relationships between blood homocysteine levels and premature presbyopia.
Dean Shipp earned his OD from Indiana University, an MPH from Harvard University, and a DrPH from the University of Michigan. He is only the second optometrist to receive the DrPH degree and the first to do so through the highly competitive Pew Health Policy Doctoral Fellowship Program at the University of Michigan.”
High-Flying Incoming Deans at UCB and OSU Optometry Schools
At the same time that the provosts at UCB and OSU were appreciating the fine service of our Academy fellows for leadership as deans in Optometry on their campuses for more than a decade, they used the occasion to announce incoming deans for June 2014. Both have been leaders in our American Academy of Optometry, and both have an outstanding reputation in both education and research for their history of leadership. At UCB School of Optometry, John Flanagan, MCOptom, PhD, FAAO, will take the helm, and at OSU, they will welcome the first female dean at their College of Optometry, Karla Zadnik, OD, PhD, FAAO.
John Flanagan is currently a professor at the School of Optometry and Vision Science, University of Waterloo, and the Department of Ophthalmology and Vision Sciences, University of Toronto. He is director of the Glaucoma Research Unit, Toronto Western Research Institute, and a senior scientist at the Toronto Western Hospital, University Health Network.
In announcing John’s 2014 appointment, Dean Dennis Levi noted, “He has held continuous federal research funding for more than 25 years from the Canadian Institutes of Health Research, with additional research funding from the American Health Assistance Foundation and the Glaucoma Research Society of Canada. He has supervised 42 graduate students and has authored more than 145 peer-reviewed publications. In addition, he has published 10 book chapters and three books and has given numerous invited lectures around the world. His research interests include basic mechanisms of human glaucoma (glial cell activation, proteomics, and neuroprotection), ocular imaging, clinical psychophysics, 24-hour intraocular pressure, ocular blood flow, and studies of vascular reactivity.
Awards include Certificate of Merit for Research Excellence, Glaucoma Research Society of Canada; Claire Bobier Lecture, University of Waterloo; Springer Lecture, University of Alabama; the Glenn A. Fry Award from the American Academy of Optometry; Outstanding Performance Award, University of Waterloo, 2008 and 2013; the 2011 Institute of Medical Science Mel Silverman Mentorship Award, Faculty of Medicine, University of Toronto; and Dario Lorenzetti Lecture, Department of Ophthalmology, McGill University, 2013. He was a founding member of the Optometric Glaucoma Society, was the program chair from 2002 to 2007, OGS president from 2007 to 2012, and is currently the OGS executive vice president. In 2008, he was appointed chair of the Clinical Research Ethics Committee at the University of Waterloo. He has also served as a governor and senator at the University of Waterloo and was a member of the Senate Executive Committee. He is currently a member of the Eye Health Council of Ontario.
UCB Provost Breslauer, in his welcome noted, “We are proud to welcome John Flanagan as our eighth Dean of the School of Optometry. He combines the intellectual stature, administrative acumen, and interpersonal skills required to serve with distinction as dean. Campus leaders very much look forward to working with John in his new role.
The College of Optometry at OSU will welcome the Academy’s immediate past president, Karla Zadnik, OD, PhD, FAAO, as the new dean in 2014. Karla is no stranger to the Academy nor to the broader optometric community and vision/ophthalmology community.
As The Ohio State University College of Optometry prepares to celebrate its centennial in 2014, Dr. Zadnik, the College’s Glenn A. Fry Professor in Optometry and Physiological Optics, and associate dean, will become its first female dean on June 1. Karla received her academic degrees from the University of California, Berkeley School of Optometry. Her education and early professional experiences were “all UC—all the time,” with undergraduate education at the University of California, Santa Barbara, and 14 years as a faculty member at the University of California, Davis, in the Department of Ophthalmology.
The National Institutes of Health/National Eye Institute has invested heavily in Dr. Zadnik, first as a trainee during graduate school and then as a principal investigator and study chairman on two large multicenter cohort studies, the Collaborative Longitudinal Evaluation of Keratoconus (CLEK) Study and the Collaborative Longitudinal Evaluation of Ethnicity and Refractive Error (CLEERE) Study. These two studies launched and developed many of her collaborators’ careers. She served on the National Eye Institute’s National Advisory Eye Council from 2000 to 2004.
Dr. Zadnik has served the profession of optometry well. She is the immediate past president of the American Academy of Optometry (AAO), having served a decade as its Research Committee chair in the 1990s. She is a diplomate and past chairman of the Academy’s Section on Cornea, Contact Lenses, and Refractive Technology (CCLRT). She has chaired the American Optometric Association’s (AOA) Council on Research since 2000 and has overseen the AOA/AAO-sponsored Summer Invitational Research Institute for many years, mentoring countless young faculty members from around the country over lobster served in her backyard.
Her many honors and recognitions include the American Optometric Foundation’s 1995 Glenn A. Fry Award, the 2009 Warren G. and Ruth P. Morris Optometrist of the Year Award from the Ohio Optometric Association, the CCLRT’s Max Schapero Memorial Lecturer Award, the AOA’s Contact Lens and Cornea Section’s Donald R. Korb Award for Excellence, both in 2009, an Honorary Doctor of Science degree from the Illinois College of Optometry in 2005, and the Alumnus of the Year Award from the University of California, Berkeley, in 2006. In 2010, Ohio State University selected her as a Distinguished Scholar, the first faculty member from the College of Optometry to receive that award.
Karla notes that her own career “has been highlighted by a series of mentors that include Mark Mannis, now chair of the Department of Ophthalmology and Visual Science at UC Davis; the late Mert Flom; Israel Goldberg of Health Research Associates; Tony Adams, dean emeritus of the UC Berkeley School of Optometry, past AAO president, and editor of Optometry and Vision Science; and retiring Ohio State College of Optometry Dean Mel Shipp.”
Building on their legacies and their guidance of her, this “native daughter” of Ohio and granddaughter of Stow, Ohio, optometrist, William J. Henry, is excited about the opportunity to lead Ohio State Optometry into its second 100 years.
More 2013 Academy Photography Contest Winners
Last month, OVS News highlighted the Grand Prize images in the Academy Photo Contest and also announced the runners-up and those with honorable mention.
Here we show the images that earned them those other awards in the contest. Recall that the 2013 Primary Care Section Annual Academy Ocular Photography Contest received 128 submissions from 86 different optometrists. The submissions were divided into anterior and posterior segment categories that received 70 and 58 submissions, respectively. Grand prizes were awarded for the anterior and posterior segments (images in November 2013 OVS News), followed by runners-up (two) and honorable mentions (five) from the combined submissions.
1st Runner-up: John B. Lewis, OD, FAAO
Manatee County Rural Health Services, Bradenton, FL
Image system used: Cannon CR-4 45NM
2nd Runner-up: Matt Kauffman, OD
University of Missouri, St. Louis College of Optometry, St. Louis, MO
Image system used: Nikon D100 DSLR
Honorable Mention 1: Patrick Simard, OD, MSc, MBA, FAAO
Clinique d’Optométrie Bélanger, Montréal, Québec, Canada
Hemorrhagic retinal detachment 24 hours after knocking head against a shelf
Image system used: Cannon CR-DGi
Honorable Mention 2: Mohammad R. Rafieetary, OD, FAAO
Charles Retina Institute, Memphis, TN
Ampiginous Choroiditis/Acute Posterior Multifocal Placoid Pigment Epitheliopathy (APMPPE)
Image system used: Color Photograph: Zeiss Visucam
FA and ICG: Heidelberg Retinal Angiography
Honorable Mention 3: Amy C. Nau, OD
University of Pittsburgh, Pittsburg, PA
Boston keratoprosthesis with contact lens and fungal infiltrate
Image system used: Zeiss anterior segment camera
Honorable Mention 4: Phillip L. Carney, Jr., OD, FAAO
Wallace Eye Associates, Alexandria, LA
Persistent Primary Hyaloid Vasculature
Image system used: Nidek AFC-230
Honorable Mention 5: Aimee Lam Haswell, OD
Oasis Eye Care, Garner, NC
Insect (ant) conjunctival foreign body located in the caruncle
Image system used: Cannon SD camera with slit lamp attachment
Academy Fellow and OVS Board Member Honored with TFOS Lifetime Achievement Award
Optometry and Vision Science (OVS) has learned that Kelly K. Nichols, OD, MPH, PhD, FAAO, and Diplomate of Public Health and Environmental Vision Section of the Academy, was recently given this Award. The announcement, from the Tear Film and Ocular Surface Society (TFOS), noted, “Congratulations to Kelly K. Nichols and Gary N. Foulks for being awarded TFOS Lifetime Achievement Awards at the TFOS Business Meeting. Both of these individuals have performed extraordinary services for TFOS. Each of them has served as Steering Committee members and Subcommittee chairs of the TFOS Dry Eye WorkShop and the TFOS Workshops on Meibomian Gland Dysfunction (MGD) and Contact Lens Discomfort (CLD). Kelly also chaired and Gary was vice chair of the MGD Workshop. In addition, Gary, as editor in chief of The Ocular Surface (TOS) for many years, has facilitated communication and promoted a stronger relationship between TOS and TFOS. They have both played an outstanding role in the growth of TFOS. Accordingly, as one of its last official duties, the TFOS Governing Board recognized Kelly’s and Gary’s exceptional energy and tireless commitment with Lifetime Achievement Awards.”
In fact, both Kelly and Gary were part of the OVS Guest Editor Team that published the OVS Feature Issue “Dry Eye: Clinical and Research Challenges” in August 2008.
ORGANIZATION AND INSTITUTION NEWS
New Head of Department at University of Melbourne Optometry
Recently, the Head of Department at the highly renowned Department of Optometry and Vision Sciences at the University of Melbourne Australia announced that, in 2014 (April), Associate Professor Allison McKendrick, MScOptom, PhD, will assume a 3-year term in leadership of that department. In making the announcement, Professor Algis Vingrys, PhD, FARVO, noted, “Allison McKendrick is currently associate professor and deputy head at the Department of Optometry and Vision Sciences. She is a therapeutically qualified clinician with more than 15 years of experience and a special interest in glaucoma detection and management and visual perception and aging. Apart from being deputy head, she also coordinates the Research Higher Degree Program and is an active researcher in our department.
Allison completed her PhD under the supervision of David Badcock and myself in 1998 in the topic of ‘The Nature of the Visual Deficit in Migraine’ and has made an international reputation by researching in this area. She has held competitive research funding for more than 15 years from The Australian Research Council and the NHMRC, with additional research funding from industry partners. She has supervised graduate students and has authored more than 65 peer-reviewed publications. In addition, she has published two book chapters, with her most notable being a chapter on flicker perception in the seminal text Adlers Physiology of the Eye. Allison has given numerous invited lectures around the world.” He continues, “We are proud to welcome Allison as our fifth Head of the Department of Optometry and Vision Sciences and our first female to hold this role. She brings a sense of enthusiasm and intellectual rigor to the Department that will sustain our research, teaching, and clinical arms.”
Smartphones a Boon to Blind and Low-Vision Patients
A recent article in NY Times (September 29, 2013; Nick Bilton) highlighted the way in which smartphones have become a boon to those with low vision and who are blind. In addition to the obvious advantage of being able to adjust brightness, contrast, and size of text, there are now many Apps that turn voice commands into text or provide voice answers to questions related to time, location, and directions. Perhaps the best known is the Siri feature of the newer iPhones and iPads. But many smartphones have similar features that allow access to the world that might normally be provided by vision.
Bilton notes, “Smartphones and tablets, with their flat glass touch screens and nary a texture anywhere, may not seem like the best technological innovation for people who cannot see. But advocates for the blind say that the devices could be the biggest assistive aid to come along since Braille was invented in the 1820s.” He continues, “Among Apple’s features are ones that help people with vision problems take pictures. In assistive mode, for example, the phone can say how many heads are in a picture and where they are in the frame, so someone who is blind knows if the family photo she is about to take includes everyone.
All this has come as a delightful shock to most people with vision problems.
‘We were sort of conditioned to believe that you can’t use a touch screen because you can’t see it,’ said Dorrie Rush, the marketing director of accessible technology at Lighthouse International, a nonprofit vision education and rehabilitation center. ‘The belief was the tools for the visually impaired must have a tactile screen, which, it turns out, is completely untrue.’ Ms. Rush, who has a retinal disorder, said that, before the smartphone, people who were visually impaired could use a flip-phone to make calls, but they could not read on the tiny 2-inch screens. While the first version of the iPhone allowed people who were losing their vision to enlarge text, it wasn’t until 2009, when the company introduced accessibility features that the device became a benefit to blind people. Apple’s assistive technologies also include VoiceOver, which the company says is the world’s first gesture-based screen reader and lets blind people interact with their devices using multitouch gestures on the screen. For example, if you slide a finger around the phone’s surface, the iPhone will read aloud the name of each application.
In a reading app, like one for a newspaper, swiping two fingers down the screen will prompt the phone to read the text aloud. Taking two fingers and holding them an inch apart, then turning them in a circle like opening a padlock calls a slew of menus, including ones with the ability to change VoiceOver’s rate of speech or language.
The iPhone also supports more than 40 different Braille Bluetooth keyboards.”
Nobel Prize in Medicine 2013: Vesicle Trafficking Trio Wins
On October 7, 2013, the Nobel Prize in medicine for 2013 was announced, and three US researchers shared the prize for major contributions to understanding the organization of how vesicle contents are discharged at the cell membrane. Each contributed in different ways in revealing the machinery that regulates the transport and secretion of proteins in our cells.
As Lawrence Altman (NY Times, October 7, 2013) noted, “The Karolinska Institute in Stockholm announced the winners: James E. Rothman of Yale University; Randy W. Schekman of the University of California, Berkeley; and Dr. Thomas C. Sudhof of Stanford University.
Their research solved the mystery of how cells organize their transport system, the Karolinska committee said. Dr. Schekman discovered a set of genes that were required for vesicle traffic. Dr. Rothman unraveled protein machinery that allows vesicles to fuse with their targets to permit transfer of cargo. Dr. Sudhof revealed how signals instruct vesicles to release their cargo with precision.
The tiny vesicles, which have a covering known as membranes, shuttle the cargo between different compartments or fuse with the membrane. The transport system activates nerves. It also controls the release of hormones. Disturbances in this exquisitely precise control system cause serious damage that, in turn, can contribute to conditions like neurological diseases, diabetes, and immunological disorders.”
At UC Berkeley, a press release commented, “In what some thought was a foolish decision, Schekman decided in 1976, when he first joined the College of Letters and Science at UC Berkeley, to explore this system in yeast. In the ensuing years, he mapped out the machinery by which yeast cells sort, package, and deliver proteins via membrane bubbles to the cell surface, secreting proteins important in yeast communication and mating. Yeast also uses the process to deliver receptors to the surface, the cell’s main way of controlling activities such as the intake of nutrients like glucose.
In the 1980s and 1990s, these findings enabled the biotechnology industry to exploit the secretion system in yeast to create and release pharmaceutical products and industrial enzymes. Today, one-third of the insulin used worldwide by diabetics is produced by yeast, and the entire world’s supply of the hepatitis B vaccine is from yeast. Both systems were developed by Chiron Corporation of Emeryville, CA, now part of Novartis International AG, during the 20 years Schekman consulted for the company.”
World Council of Optometry Curricular Support Document
The World Council of Optometry (WCO) has published its first-ever curriculum support document that is now available on the WCO Web site. “Curricular support elements for an optometry program” has been produced by the WCO education committee to help schools, colleges, and universities intending to start or upgrade an optometry program and can be used as a basis for designing their curriculum. Fifteen elements of practice are covered in the guide, including patient examination, patient management, general health assessment, specialized care, and professional responsibilities. Essentially, the document covers all the competencies an optometrist needs to qualify at the highest level of international standards.
World Council of Optometry Education Committee Chair Gerald Lowther said, “This exciting initiative was started a few years ago by former education committee chair Maurice Yap with the help of the Hong Kong Polytechnic University staff.” It is now available for the profession to use at: www.worldoptometry.org/en/publications/curricular-support-elements-for-an-optometry-programme.cfm.
Making a Lacrimal Gland for Tears?
On October 1, 2013, Medicine News noted the documentation of proof of concept of a fully functional bioengineered lacrimal gland. The report, titled “Researchers regenerate fully functional bioengineered saliva and tear glands” noted, “Organ replacement regenerative therapy has been proposed as having the potential to enable the replacement of organs that have been damaged by disease, injury, or aging. A research group led by Professor Takashi Tsuji (professor in the Research Institute for Science and Technology, Tokyo University of Science, and director of Organ Technologies Inc.) has provided a proof of concept for bioengineered organ replacement as the next step for regenerative therapy.
Dr. Tsuji’s research group (Hirayama et al.) reports the successful orthotopic transplantation of a bioengineered lacrimal gland germ into an adult extraorbital lacrimal gland defect model mouse, which mimics the corneal epithelial damage caused by lacrimal gland dysfunction. The bioengineered lacrimal gland germ and harderian gland germ both developed in vivo and achieved sufficient physiological functionality, including tear production in response to nervous stimulation and ocular surface protection. This study demonstrates the potential for bioengineered organ replacement to functionally restore the lacrimal gland.”
History of Genetics: Enter the Fruit Fly
The tiny fruit fly plays an outsized role in the history of genetics. Dan Cossins (The Scientist, September 1, 2013) tells a very interesting story that places the fruit fly center stage. He notes, “In 1904, developmental biologist Thomas Hunt Morgan was appointed professor of Experimental Zoology at Columbia University in New York City, where he began to explore heredity as the key to development. A few years later, he turned to the suitably fecund fruit fly, Drosophila melanogaster, to search for mutations—the spontaneous heritable changes that had already been observed in plant—and set up a dedicated laboratory in Schermerhorn Hall’s Room 613. Here, hundreds of fly-filled milk bottles cluttered a cramped space that became known as the Fly Room, where Morgan and his students made seminal discoveries about genes and chromosomes that paved the way for modern genetics and transformed biology into an experimental science.
‘Morgan’s discoveries made it possible to address a series of questions regarding the function and structure of genes,’ wrote neurobiologist Eric Kandel in a 2002 essay in Columbia’s alumni magazine. ‘Some answers came from Morgan and his protégés; others came from the scientists they influenced,’ added Kandel. ‘In every case, the discoveries made by these pioneering researchers set the agenda for biology in the 20th century.’
Cossins continues, ‘The first couple of years in the Fly Room were frustrating. Despite subjecting roughly 60 generations of flies to extreme temperatures and exposing them to salts, sugars, acids, alkalis, x-rays, and radium, Morgan and his colleagues failed to detect any visibly mutated flies. Then, in April 1910, they finally spotted one: a fly with white eyes rather than the usual red. With a series of crossbreeding experiments, Morgan determined that the white-eye mutation was recessive and linked to sex. More observations revealed that the allele for eye color lies on the X chromosome—the first time a trait had been linked with a specific chromosome.’
The findings, published in Science in 1910 and 1911, confirmed the chromosomal theory of inheritance—an idea derived from Gregor Mendel’s work and one that Morgan had previously doubted. Subsequent work carried out in the Fly Room demonstrated that some genes are grouped together on the same chromosome and almost always inherited together. But the researchers also showed that such linked genes can be separated when two paired chromosomes cross over and exchange material. By 1913, Alfred Sturtevant, one of Morgan’s students, had created the first physical map of genes on a chromosome, work that was continued through the 1930s by another Morgan disciple, Calvin Bridges.
For such achievements, Morgan was awarded the 1933 Nobel Prize in Physiology or Medicine. (Although he was the sole laureate, he shared the prize money with Sturtevant and Bridges.) But Morgan’s legacy reached even further: the egalitarian atmosphere he cultivated in the Fly Room—where he encouraged students to develop ideas and execute experiments—became the blueprint for modern American research culture.
‘The idea that students could do the research was new,’ says Stuart Firestein, a biologist at Columbia who plays Morgan in a forthcoming movie set in the Fly Room. ‘That’s how we all operate now, of course. So not only did Morgan introduce fly genetics, he also introduced a new kind of laboratory culture to science.’”
Some Wisdom on Science Teaching
Among a number of wonderful quotes about science, the authors in The Scientist (October 11, 2013. October 2013’s selection of notable quotes) came up with some excellent selections. One I particularly related to was by Nobel Laureate Elizabeth Blackburn on how to improve science teaching in the United States. It was first reported in the NY Times on September 3, 2013.
“The way we teach [science] now, with an hour of instruction here and a laboratory class there, it doesn’t allow for what has been my experience: that immersion is the essence of scientific discovery.
Medtronic’s Artificial Pancreas Approved for US Diabetics
On September 27, 2013, Medtronic Inc., maker of heart-rhythm devices, won US regulatory approval for the first artificial pancreas that shuts itself off when a patient’s blood sugar levels get dangerously low.
The device, called the MiniMed 530G, combines an insulin pump with a sensor that halts insulin delivery for 2 hours if a patient’s blood sugar falls below preset levels. It’s a step toward a fully automatic artificial pancreas that adjusts insulin delivery continuously as glucose levels change.
The pancreas produces the hormone insulin, which converts blood sugar to energy. Type 1 diabetes occurs when insulin-releasing beta cells in the pancreas are destroyed. Patients repeatedly test their glucose levels throughout the day and then inject insulin to control blood sugar. The Medtronic system is an advance over existing machines that sound an alarm to wake sleeping patients when their blood sugar gets too low.
The approval came about 6 months earlier than investors expected. The machine is approved in the United States for patients who are at least 16 years old. The company plans more tests in children as a young as 2 years. Medtronic will conduct a postapproval study to track the device’s performance and communicate directly with patients to monitor their experience.
Alphaeon Cataract Device License Deal
On October 9, 2013, Alphaeon, a wholly owned subsidiary of Strathspey Crown Holdings LLC, announced that it has acquired an exclusive US license from Visiometrics, SL, to market the HD Analyzer. The HD Analyzer provides eye doctors with an assessment of light scatter inside the eye for early detection of the existence of a cataract. The HD Analyzer’s Optical Scatter Index (OSI) assists in the tracking of cataract progression and is said to be a measurement of what a patient actually sees. The device, a Class I product registered with the FDA, is currently manufactured in Irvine, CA, and will be commercialized by Alphaeon beginning in January 2014.
NICE Recommends Iluvien for Blinding Eye Disease
On September 3, 2013, Alimera Sciences reported that UK’s NICE recommended Iluvien for the treatment of a blinding diabetic eye disease, diabetic macular edema. When the final guidance is published, people in England and Wales who have DME and have already undergone cataract surgery can receive Iluvien from the National Health Service. Iluvien is a sustained-release intravitreal microimplant insert that is placed in the back of the eye where it slowly releases a corticosteroid for up to 3 years. Iluvien has received marketing authorization in the United Kingdom, Austria, Portugal, Germany, France, and Spain and is pending in Italy. Iluvien is currently commercially available in the United Kingdom and Germany. The final draft guidance reverses the published guidance issued by NICE on January 23, 2013, and takes into consideration a simple patient access scheme submitted by Alimera is expected to be published in November 2013.
In a separate news release on October 21, 2013, in The Australian, there is a report that “in its third complete response (rejection) letter (CRL), the FDA told pSivida’s licensing partner Alimera that it couldn’t green light Iluvien—a single-dose treatment for diabetic macular edema—because the benefits didn’t outweigh the risks. The FDA was concerned mainly about the higher incidence of cataracts among patients treated with Iluvien during the 2-year 1000-patient clinical trial. In its first CRL in late 2010, the FDA told Alimera to deliver a third year of trial data. Alimera did so, but in November 2011, the FDA ordered two more trials. However, the regulator then accepted a reapplication for the use of Iluvien for “chronic”’ situations, which means the patient has suffered the disease for at least 3 years. But there’s a glimmer of hope in that the FDA has convened a meeting of its advisory committee for January 27 next year. In other words, the regulator itself still believes there’s a way to move the drug to approval.” The Australian continues, “One option is to confine the drug to patients who have already had cataract surgery, which means that their lenses have been replaced with a synthetic polymer and they can’t suffer further cataracts, which only grow on the natural material. Voila! Risk removed—and it’s still a sizable submarket. Not for the first time, the FDA’s stance is at odds with that of European drug regulators in that Iluvien is approved for use in most of the European nations that count. Just as importantly, it’s also expected to be eligible for government subsidies in the United Kingdom and France.”