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Hebrew U. researchers show which foods prevent, promote...
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"We do it for the sake of knowledge."But sometimes results come anyway. For example, the center — not Mizrahi personally — has made splashy headlines for therapies such as deep brain stimulation, a treatment for Parkinson’s disease.In 2009, Mizrahi won the Sir Zelman Cowen Universities Fund Prize for Discovery in Medical Research, which goes to a scientist under 45 at Hebrew University or the University of Sydney, in alternate years. The award honored Mizrahi for his work on new approaches that are “essential steps towards therapies which will allow the regeneration of brain structures from stem cell technology,” according to the prize website.Hebrew University’s brain sciences center was founded in 2009 with $20 million in funding from the Edmond J. Safra Foundation. In 2015 this was increased by another $30 million, a hefty chunk of the center’s $150 million initial budget. Next year, the center will move into a new 156,000-square-foot home, the Goodman Brain Sciences building. (The new building will be the largest neuroscience center in Israel and one of the most ambitious in the world, according to Hebrew University.)Until then, Mizrahi says his time as a visiting professor at Stanford, where he can focus on studying and learning about techniques like revolutions in RNA sequencing, is a gift and a privilege. But he is also looking to the future, including to students he and others are training back at the Center for Brain Sciences.He said it’s those “the scientists of tomorrow” who are growing up within the interdisciplinary approach, who will be able to take research even further with their intuitive understanding of how to approach the brain from many points of view. But once they become scientists, they’ll find it’s a hard but rewarding road, where being ready to fail again and again is a prerequisite for the job.“Science is not for everyone,” Mizrahi said, even if he’s sure that it’s definitely for him.Read the source article at jweekly.com
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HU Bioengineering: Building a Better Tomorrow
Bioengineering is a multidisciplinary field that weaves together knowledge of biology, physics, chemistry, and computer science, aiming to create tangible applications in life sciences and medicine.
The Alexander Grass Center for Bioengineering educates a new generation of multidisciplinary innovators and entrepreneurs at the cutting edge of biotechnology and medical science. The Grass Center for Bioengineering aims to bring together researchers at the Hebrew University of Jerusalem who work on the development of transformative technology. Projects include nanotechnology-based diagnostic devices, innovative medical devices advanced computational models, and microchip alternatives for animal and human testing. Read more about the Grass Center here.
BioDesign: Medical Innovation
Biodesign is a multi-disciplinary, team-based approach to medical innovation, created by the Hebrew University of Jerusalem and Hadassah Medical Center in partnership with Stanford University. The program takes outstanding medical fellows, bioengineering and business graduate students and tutors them in the science and practice of bringing a medical innovation to the market.
BioDesign is a one-year academic course taught by Hebrew University faculty, clinical experts, medical device entrepreneurs, corporate executives, intellectual property attorneys and venture capitalists. It provides a unique opportunity to gain real-world experience in an academic environment growing a new generation of entrepreneurs.
Since starting 2012, the BioDesign program has developed innovations such as:‘Liver-on-a-chip,’ functional liver cells that detect real-time changes in metabolism and viability and drastically reduces using animal testing in research Digital holography reducing dentures procedure• Headphones to help detect ear infection and lung disease in infants• Pressure-sensing socks feel the pain of diabetic patients• Robotic intubation prototype crawls to the lungs in difficult situations• Curvy plastic tube protects against obesityBioDesign Medical innovations have been featured in MedGadget, FoxNews, MSNBC, Times of Israel, and the Jerusalem Post and more
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While the FDA has approved three drugs containing synthetic cannabinoids (Marinol, Syndros and Cesamet, which treat symptoms of AIDS and chemotherapy), it has never approved a product derived from botanical marijuana. According to the agency's guidelines, "Study of marijuana in clinical trial settings is needed to assess the safety and effectiveness of marijuana for medical use." Yet initiating clinical trials on U.S. soil is difficult to the point of being nearly impossible. So, American companies are increasingly taking a shortcut: beginning phases 1 and 2 of their clinical trials in Israel, after which they will complete phase 3 in the U.S., speeding up the process through which they can apply for FDA approval of the botanical cannabis drugs they are developing.
Though this level of American R&D in Israel is new, Israel's impact on the American cannabis industry is not. The very fact that medical marijuana is now legal in 29 U.S. states and counting, is a direct result of Israeli research, which essentially legitimized the study of cannabis in the international scientific community that had long stigmatized it. Without this research, "We wouldn't have the scientific interest we have now around the world," says Paul Armentano, deputy director of the D.C.-based National Organization for the Reform of Marijuana Laws (NORML). "That really opened the door to making the study of cannabis and cannabinoids a legitimate avenue for more conventional scientists and researchers.""The seriousness with which the Israeli scientific community approaches this is incomparable," says Charles Pollack, director of the Lambert Center for the Study of Medicinal Cannabis at Thomas Jefferson University in Philadelphia. "Israel is a hotbed of quality cannabis research, because they have a much more favorable regulatory climate for doing serious scientific research on medical cannabis."
Israel is becoming the offshore greenhouse for American cannabis companies seeking to overcome the federal roadblocks.
The Lambert Center is one of several American institutions that have partnered with BOL, collaborating on at least one of the more than 50 clinical trials the Israeli company will begin once its new facility is fully operational in late September. Of the 15 international companies that have already signed up to conduct their R&D at BOL's facility, at least six are American, and Gedo is in talks with more.
BOL isn't the only Israeli cannabis company benefitting from international interest. A growing number of American investors are getting on the Israeli cannabis wagon, which they see as the best vehicle for transforming the medical cannabis field, still in its infancy, into a pharmaceutical-level industry.
According to Saul Kaye, the founder of iCAN, an Israeli cannabis R&D firm, 2016 saw the investment of more than $250 million in Israeli cannabis companies and startups – half of that investment came from North America. Kaye predicts that investment will grow ten-fold over the next two years, reaching $1 billion. At least 50 American cannabis companies – and counting – have established R&D operations in Israel.
Israel's journey to the forefront of the medical cannabis field began with 86-year-old Israeli chemist Raphael Mechoulam, known in the field as the Grandfather of Medical Marijuana. In 1963, as a young researcher, Mechoulam secured 11 pounds of Lebanese hashish, which had been confiscated by his friend at a police station in Tel Aviv. He used that hash to identify, isolate and synthesize THC, the psychoactive compound in cannabis, for the first time in history, and study its medical uses. He was also the first to decode the structure of CBD, the plant's primary non-psychoactive ingredient. But Mechoulam's most groundbreaking discovery came in 1992, when he and his team at Hebrew University in Jerusalem discovered the physical reason humans can get high.
"It turned out that the cannabinoids in the plant actually mimic the compounds that we form in our brain," says Mechoulam, a professor and researcher at Hebrew University who works with several American cannabis companies. He and his team discovered that THC triggers the human body's largest receptor system, now known as the endocannabinoid system, and that the human brain produces its own cannabinoids – compounds that stimulate the body almost exactly the way THC does.
While Mechoulam's research is what first placed Israel on the medical marijuana map, the country's progressive attitudes toward cannabis, coupled with the Israeli government's liberal regulatory policies and the nation's technological leadership, are what have maintained Israel's status as the capital of medical marijuana research and development. It might also help that Israel has the world's highest ratio of marijuana users, according to Israel's Anti-Drug Authority, with 27 percent of the population aged 18-65 having used marijuana in the last year. That rate is followed by Iceland and the U.S., at 18 and 16 percent respectively.
While the Israeli government invests millions of dollars in medical cannabis research, the U.S. government makes the same research nearly impossible.
"There are onerous restrictions on conducting this research in the U.S. that don't exist in Israel," says one expert.Despite the fact that 95 percent of the U.S. population lives in states where cannabis is legal in some form, marijuana remains federally illegal. This policy makes conducting research into the medical benefits of marijuana notoriously difficult on U.S. soil. Researchers who wish to do so must go through the DEA, the FDA and the National Institute on Drug Abuse (NIDA). Even when American researchers are given approval, they have only one source for their material: a cannabis farm at the University of Mississippi, operated by NIDA. The process, if successful, can take years.
At least 15 American cannabis companies have set up their entire R&D operations on Israeli soil.Cannabics, a Maryland-based, publicly-traded company, is conducting a clinical trial at an Israeli hospital in order to develop a capsule for cancer treatment. In 2015, One World Cannabis Pharmaceuticals, a public company based in Delaware, established an Israeli subsidiary overseen by Yehuda Baruch, the first head of the Israeli government's medical cannabis program, established in 2007. They are now beginning phase 1 of a clinical trial to test the benefits of a topical cannabis cream to treat psoriasis. Their next trial will study the efficacy of a soluble pill for the treatment of chronic pain. They eventually plan to conduct clinical trials on patients with multiple myeloma.Some Israeli companies have partnered with American companies to establish a presence in the U.S., where they sell products that were developed in Israel. For example, Tikun Olam, Israel's first medical cannabis distributor, opened an American subsidiary in 2016. It now sells its proprietary medical-grade plant strains at 10 dispensaries in Delaware and Nevada and will soon be available at dispensaries in Oregon and California. Their most popular strain is Avidekel, a non-psychoactive CBD blend used to help children with seizures.Some American researchers have even moved to Israel all together. Alan Shackelford, a Harvard-trained physician, was among the first American doctors to prescribe cannabis to a child. His eight-year-old epileptic patient Charlotte Figi sparked national interest in CBD after her miraculous story aired on CNN's Weed documentary in 2013.Yet after years of failed attempts to conduct clinical trials in the U.S., Shackelford recently established his own research entity in Israel because of his frustration with the American government's stonewalling."The U.S. government has funded $1.4 billion in marijuana research since 2008," says Schackelford. "Yet $1.1 billion of that went to studying addiction, withdrawal and drug abuse," problems that barely exist with cannabis when compared to the effects of other legal medications, like prescription painkillers, which killed more than 17,000 Americans in 2016.His research subjects in Israel will include the development of new delivery methods, he says, "because to date, most medical cannabis products no matter where you look in the world, are pot-culture derived. They're things like brownies, cookies, candy and smoking. Even with advances to these things being much more consistent, they're still not medically appropriate."While the U.S. government restricts American cannabis companies on U.S. soil, it does not prevent them from or penalize them for conducting their work in Israel. According to Robert Farrell, president of Kalytera, "The FDA has no problem with this work being done in Israel. When you file with the FDA, in the application you say, 'Look we've done the previous studies in Israel, gave the drug to this many patients, the drug is safe, it works, now we want to conduct a larger study with patients in the U.S.' If the FDA is satisfied with the data, they'll say, 'Go ahead, try it in the U.S.'"
The FDA will never get behind cannabis the plant as medicine, since it can't be controlled as a consistent drug.Even the National Institutes of Health (NIH) has funded cannabis research in Israel. Indeed, much of Professor Mechoulam's groundbreaking research was funded by the American government. The NIH provided him with grants to the tune of $100,000 a year for over four decades, says Mechoulam.There is also nothing preventing Israeli companies from receiving FDA approval for their cannabis-based drugs, as long as they meet FDA requirements. In order to do so, they will need to develop the kind of products that are more in line with pharmaceutical standards, such as the kinds of capsules and inhalers BOL is developing.While that goal is feasible, Gedo and others admit that it will take time, perhaps several years, to achieve. The process of getting FDA approval is an arduous one, especially for a drug that has long been viewed with skepticism by the medical establishment. Yet it is these clinical trials that are taking place at a record pace in Israel, along with the advancement of pharmaceutical grade cannabinoid drugs, that will enable Israeli companies to eventually receive FDA approval for their drugs, or for the drugs that they are helping American companies to develop.As Gedo notes, the FDA will never get behind cannabis the plant as medicine, since it can't be controlled as a consistent drug that has the same effect day in and day out. After all, there are 140 active compounds in cannabis, and the composition of the flowers plucked from one branch can fluctuate wildly, by up to 300 percent. "The experience of a user will vary a lot with the same strain," says Gedo. "So even if you have the best-grown product, it will never become a scientific pharmaceutical product."This is precisely why the FDA has never approved a botanical marijuana drug, a larger problem than scheduling when it comes to drug approval. According to Senate testimony by the FDA's Douglas Throckmorton in 2016, who was citing a report from the Institute of Medicine, in order to obtain FDA approval, drug manufacturers "must demonstrate that they are able to consistently manufacture a high-quality drug product. This is an essential part of drug development and presents special challenges when the drug is derived from a botanical source, such as marijuana…. If there is any future for marijuana as a medicine, it lies in its isolated components, the cannabinoids and their synthetic derivatives."BOL and other Israeli companies are working to meet that challenge by developing cannabis-based drugs – the capsules, inhalers, creams and oils composed of isolated, controlled and consistent cannabinoids. Going this route, they could eventually receive FDA approval.While Gedo is optimistic, he's also realistic, knowing the complexity of the FDA's drug approval process, and the skepticism that remains among many in the medical establishment.Still, asked when Israeli companies might be exporting their cannabis medicine to the U.S., Michael Dor, of the Israeli Health Ministry says, "I believe it's not far."Read the source article at Rolling Stone
Israeli scientist develops early diagnostic test for...
The exciting news coming out of Israel, that a scientist has developed a groundbreaking test to categorically detect Parkinson’s disease, is giving the medical and science worlds hope for the future. Suaad Abd-Elhadi, a PhD student at the Institute for Medical Research Israel-Canada in the Hebrew University of Jerusalem Faculty of Medicine, has developed the lipid ELISA diagnostic tool. She won the Kaye Innovation Award for 2017 for the breakthrough invention of this highly sensitive kit that may lead to earlier detection of Parkinson’s disease, along with better tracking of the disease’s progression and a patient’s response to therapy. Parkinson’s disease is the second most common neurodegenerative disorder in humans, after Alzheimer’s disease. It is typically characterized by changes in motor control such as tremors and shaking, but can also include non-motor symptoms, from the cognitive to the behavioral. An estimated seven to 10 million people worldwide are living with Parkinson’s disease, with medication costing approximately $2,500 a year, and therapeutic surgery costing up to $100,000 per patient. Making an accurate diagnosis of Parkinson’s, particularly in early stages and mild cases, is difficult, and there are currently no standard diagnostic tests other than clinical information provided by the patient and the findings of a neurological exam. Once Parkinson’s is revealed, the disease is usually already progressing. “Earlier diagnosis can help by seeing how a given drug affects the progress of the disease, for example,” Abd-Elhadi told Haaretz. “A big problem is that early PD looks just like other neurodegenerative diseases, which hinders appropriate care,” she explained. “A great deal of effort is presently being put into delaying the progress of PD, for which purpose one needs to know that one has it.” The global medical field has long noted that one of the best hopes for improving diagnosis is to develop a reliable test for identifying a biomarker — a substance whose presence would indicate the presence of the disease. In the case of the lipid ELISA, the cellular secretion of interest is a specific protein called alpha-synuclein. ELISA stands for “enzyme-linked immunosorbent assay.” An assay is a procedure used in laboratory settings to assess the presence, amount and activity of a target entity, such as a drug, cell or biochemical substance. ELISA is a common assay technique that involves targeting cellular secretions. The alpha-synuclein protein serves as a convenient biomarker that is closely associated with the tissues where Parkinson’s disease can be detected, along with the neurological pathways the disease travels along, causing its characteristic symptoms. As a simple and highly sensitive diagnostic tool that can detect Parkinson’s biomarkers, the lipid ELISA could lead to a minimally invasive and cost-effective way to improve the lives of Parkinson’s patients, according to a Hebrew University statement. Abd-Elhadi has already demonstrated a proof of concept and is now in the process of analyzing a large cohort of samples, including moderate and severe Parkinson’s and control cases, as part of a clinical study. Through Yissum, its technology transfer company, the Hebrew University holds granted patents on the technology, and has signed an agreement with Integra Holdings for further development and commercialization. Abd-Elhadi is earning her doctorate in biochemistry and molecular biology. Under the supervision of Ronit Sharon, she conducts research that has been published in Scientific Reports and Analytical and Bioanalytical Chemistry.Read the source article at ISRAEL21c