Daily Archives: March 5, 2020

For Immediate Release: March 04, 2020

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The U.S. Food and Drug Administration, in collaboration with the U.S. Environmental Protection Agency and the U.S. Department of Agriculture, today launched a new initiative to help consumers better understand foods created through genetic engineering, commonly called GMOs or genetically modified organisms.

The initiative, Feed Your Mind, aims to answer the most common questions that consumers have about GMOs, including what GMOs are, how and why they are made, how they are regulated and to address health and safety questions that consumers may have about these products.

While foods from genetically engineered plants have been available to consumers since the early 1990s and are a common part of todays food supply, there are a lot of misconceptions about them, said FDA Commissioner Stephen M. Hahn, M.D. This initiative is intended to help people better understand what these products are and how they are made. Genetic engineering has created new plants that are resistant to insects and diseases, led to products with improved nutritional profiles, as well as certain produce that dont brown or bruise as easily.

Farmers and ranchers are committed to producing foods in ways that meet or exceed consumer expectations for freshness, nutritional content, safety, sustainability and more. I look forward to partnering with FDA and EPA to ensure that consumers understand the value of tools like genetic engineering in meeting those expectations, said Greg Ibach, Under Secretary for Marketing and Regulatory Programs at USDA.

As EPA celebrates its 50th anniversary, we are proud to partner with FDA and USDA to push agricultural innovation forward so that Americans can continue to enjoy a protected environment and a safe, abundant and affordable food supply, said EPA Office of Chemical Safety and Pollution Prevention Assistant Administrator Alexandra Dapolito Dunn.

The Feed Your Mind initiative is launching in phases. The materials released today include a new website, as well as a selection of fact sheets, infographics and videos. Additional materialsincluding a supplementary science curriculum for high schools, resources for health professionals and additional consumer materialswill be released later in 2020 and 2021.

To guide development of the Feed Your Mind initiative, the three government agencies formed a steering committee and several working groups consisting of agency leaders and subject matter experts; sought input from stakeholders through two public meetings; opened a docket to receive public comments; examined the latest science and research related to consumer understanding of genetically engineered foods; and conducted extensive formative research. Funding for Feed Your Mind was provided by Congress in the Consolidated Appropriations Act of 2017 as the Agricultural Biotechnology Education and Outreach Initiative.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nations food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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03/04/2020

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New 'Feed Your Mind' Initiative Launches to Increase Consumer Understanding of Genetically Engineered Foods - FDA.gov

Space exploration has long been a source of fascination. Since the stars first captured our attention, we have obsessed over that vast curtain of darkness that lies beyond our atmosphere. But to what end? What ultimate goal does mankind strive towards, if not the ability to visit and colonize other worlds?

Before we can take our first steps out into the universe, we have to answer a critical question: Do we have the ability to adapt to other environments very different from what we have on Earth to not only survive, but to thrive? Instead of focusing on how we might terraform other planets to suit us, perhaps we should consider how we might use genetic engineering to alter own bodies to suit those other planets.

As a jumping off point, lets consider the feasibility of using the popular gene-editing tool CRISPR to alter human physiology to tolerate parameters outside of Earths norms. If we take a look at common factors that are significant to human health, gleaned from our experience with space exploration, the most obvious choices for our attention are variations in gravity, atmospheric pressure and gas ratios, and solar radiation levels.

If we consider Mars as our template, because of its relative suitability for colonization, then we must compensate for two-thirds less gravity than Earth. A lack of gravity results in a number of ill effects on human health, including a decrease in bone mass and density over time, particularly in the large bones of the lower extremities, as well as the spine. While we do not have research showing the impact of living on a planet with one-third Earths gravity, we do know that we can expect losses in bone density somewhere under 1-2 percent per month, the amount lost in the microgravity environment of space.

For comparison, the elderly lose 1-1.5 percent per month in Earth gravity. Atmospheric pressure that is either too high or too low also results in complications; low atmospheric pressure results in less oxygen available and causes altitude sickness and possible death. Radiation levels from the sun are another variable that is well known to have upper and lower thresholds for optimal human health, where low levels can lead to vitamin D deficiency and high levels increase cell death and cancer.

It would stand to reason that the human body has a minimum threshold for healthy physiology as regards the environment in which it grows, develops and lives. To colonize other planets successfully, we must consider solutions to overcome these thresholds; for example: prostheses, domed colonies recreating an ideal or near ideal environment, or, as this author suggests, the permanent genetic alteration of humanity as a species. This applies to our four chosen variables of gravitational forces, atmospheric pressure, atmospheric gas ratios, and solar radiation levels. While science fiction might have us consider surgical and biomedical prostheses or the more far-fetched use of animal DNA to change ourselves for this purpose, the key to human adaptation for other planets lies in our own genetics and it may well be CRISPR, the use of the enzyme Cas9 for introduction of altered DNA sequences or CRISPRs to existing cells to change how those cells function, that will make this possible.

Human genetic variation provides a veritable treasure trove of adaptations if one looks at the less common but heritable variations that on Earth may seem irrelevant, nonessential, or even maladaptive, but on another planet could be essential to survival. One example of a gene that, with engineering, could help humanity adapt to higher or lower gravity is the LRP5 gene. Recent research into the LRP5 gene shows that mutations of the gene are responsible for both low bone density and elevated bone density in the case of the later, from increased bone formation. A family of individuals in Nebraska carrying the mutation for elevated bone density have never experienced broken bones even well into old age. A whole colony of such individuals or ones engineered to enhance this mutation further could be expected to fare much better during prolonged space travel in zero gravity as well as in the low gravity environment on a planet like Mars.

While an atmospheric pressure and gas makeup very similar to Earths would be required for humans to survive and thrive outside of a spacesuit, Nepals Sherpas, high altitude dwellers in Ethiopia, and the Collas people in the Central Andes , as well as the deep sea divers of Bajau, may provide a solution to living on planets with differences in atmospheric pressure and oxygen availability. The three groups of high-altitude dwellers appear to have separate adaptations for thriving in low oxygen environments. Recent research indicates that there are genetic mutations in each of these groups. Sherpas mutations allow for more efficient use of available oxygen and resistance to ill effects from hypoxia.

Sherpas experience less of an increase in red blood cells than others and therefore avoid the ill-effects caused, such as edema and brain swelling. Sherpas instead have mitochondria in their cells that make more efficient use of the available oxygen, as well as having more efficient anaerobic metabolism in the absence of oxygen. The Collas show genetic differences in genes that control heart morphology, as well as cerebral vascular flow, as a means to withstand an elevated hematocrit in response to high altitude living. The Amhara people living in high altitudes in Ethiopia unlike the Sherpas do have lower oxygen saturation and higher hemoglobin levels compared to lowland dwellers in the region.

Research has yet to determine what adaptation favors the Amhara, but several genes that may play a role have been isolated. Another group, the Bajau of Thailand, may have complementary genetic variations that help them resist hypoxia and survive the high pressures of deep sea diving. Researchers found them to have 50% larger spleens and also a gene, PDE10A, that controls a thyroid hormone thought to affect spleen size. Capitalizing on any of these genetic features would improve our ability to survive with a lower oxygen content atmosphere, perhaps on a newly terraformed Mars or under domes with oxygen rationing.

While we cannot yet determine how comparable an atmosphere we can create on Mars, it stands to reason that achieving an exact replica atmosphere to Earths could be difficult. An atmosphere that lets in less radiation could impede our production of vitamin D, while a thinner atmosphere would admit an excess of radiation. Vitamin D deficiency could perhaps be handled by supplementation, or instead addressed by increasing our cells response to ultraviolet light to increase vitamin D synthesis. On the other side of the coin, a thinner atmosphere opens us up to higher UVR, which would result in higher rates of skin cancer.

It would stand to reason that, while skin pigmentation has high cultural and historical significance, it could make our species more suitable for colonization of high radiation planets; darker skin with larger melanocytes that react proactively to UVA and UVB radiation through tanning and higher antioxidant and free-radical counteraction would be protective and provide an advantage if we are to branch out into our solar system and beyond. At the same time, this solution poses the problem of vitamin D production.

The answer could lie in isolating and using the genes responsible for East Asian populations lower skin pigmentation coupled with lower skin cancer rates than European populations. A study headed by Pennsylvania university has isolated gene mutations responsible for skin pigmentation differences, SLC24A5, MFSD12, OCA2, and HERC2, by studying African, South Asian Indian, and Australo-Melanesian populations, some of which are associated with vitiligo and a form of albinism common in African populations. These mutations that confer higher vitamin D production to Europeans are not present in East Asians, indicating a different mutation responsible, and, while both populations have higher vitamin D production than African populations, Europeans have a 10-20 percent higher rate of cancer than both Africans and East Asians. Further research into these genes could provide targets for CRISPR to modify the protective factors in our skin without sacrificing vitamin D production of potential colonists.

The question remains: is CRISPR a feasible route to including some of these adaptations to create a new, more suitable colonist? To answer this question we look at the current status of CRISPR research.

While some experiments using CRISPR gene editing were conducted in the technologys infancy, including the controversial creation of twin girls in China designed to be resistant to HIV, we are still quite a bit of research away from using CRISPR with high success rates and full confidence, especially considering the repercussions of rushing into human trials, including the death of trial participants and long-term side-effects of cancer, both of which have occurred in gene-therapy trials.

According to information revealed by the FDA and NIH, 691 trial volunteers died in gene-editing trials prior to the tragic and high-profile death of Jesse Gelsinger in a 1999 trial to treat his OTCD, a rare metabolic disorder. The death was blamed on ethical oversights and a rush to make gene editing pan out before it was ready. The result was a long period of gene-editing fear and oversight but also, in the case of James Wilson, director of the University of Pennsylvanias Institute for Human Gene Therapy responsible for the trials that led to Gelsingers death, greater caution in research methodology. He has put safety at the forefront of his research and asserts that even still the risks of gene editing with CRISPR and other methods brings enough risk to justify human trials only for those diseases that are severe and debilitating enough for patients to accept the risks of gene editing.

What does all this mean for our hypothetical future of using CRISPR to edit the DNA of human colonists for space colonization? Is the technology too far off to serve our purpose or fraught with too much risk? Is it beyond our knowledge and skill to accomplish? The answer to each of these questions is undoubtedly, no.

Weve had too much success in treating complex genetic conditions, like the creation of an immune system for Ashanthi Desilva born with severe combined immunodeficiency (SCVID). Weve unlocked too many keys to making gene therapy safer and more effective to discount the possibility of future use for the advancement of our species into harsher environments. While subsequent uses of gene therapy for SCVID resulted in development of Leukemia years later, further advancements in the research have revealed the need to find the best delivery system for each body system. Adeno-associated viruses, and lentiviruses are being looked at in place of the more aggressive adenovirus or retroviruses for delivery of DNA segments both of which are less likely to provoke an immune response and less likely to trigger cell death by way of the B35 gene in healthy cells, and later cancer.

Regardless of the work ahead and the bumpy road that gene therapy has traveled, vast potential remains at our fingertips whether it is through use of CRISPR or future gene therapy tools. It is a sure eventuality that we will one day have these skills at the ready to spread our species into other worlds, well-equipped to survive and thrive in harsher environments.

Cherrie Newman is a writer and student of human reproduction and biological sciences. She is the author of a science fiction novel series entitled Progeny under the pseudonym CL Fors. Follow her on her blogor on Twitter @clfors

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Building 'better' astronauts through genetic engineering could be key to colonizing other planets - Genetic Literacy Project

When my father, Marc Lapp, died in 2005 at the age of 62 from glioblastoma, he left behind a wife, five children, two stepchildren, and an unfinished manuscript. In the wake of his death, while struggling to make sense of a world without him, I holed up in a writers retreat on the rocky coastline of Provincetown, Massachusetts to see if I could transform his rough ideas into something presentable and publish what would have been his 15th book.

I never succeeded. But the central idea of his book has stayed with me all these years. Drafted at the dawn of the age of genetic engineering long before the development of CRISPR technologies and new ways to alter life as we know it the books message was simple: Weve developed frameworks within and across nation states for protecting environmental integrity for future generations (think the US Endangered Species Act). Now, as we attempt to alter the genetic makeup of living beings, we need new strategies and frameworks for protecting the planets genetic integrity for future generations. He was writing as a scientist, an ethicist and a parent.

I have been reflecting on his insight from so many years ago on the 20th anniversary of The Pacific Declaration, a statement of the ethical principles for this era of genetic engineering that my father and two dozen scientists, ethicists, and authors crafted on another rocky coastline in Bolinas, California and published in October 1999.

The Declaration states: In recognition of the fundamental importance of our planets natural genetic heritage and diversity, and in acknowledgment of the power of genetic engineering to transform this heritage, [we] believe that the proponents and practitioners of genetic technologies must adhere to the principles of prudence, transparency, and accountability.

The document was fundamentally a call to apply the precautionary principle to our collective approach to genetic engineering. The authors noted that the burden of proof must be on those promoting genetic engineering to show that these technologies contribute to the general welfare of consumers, farmers, and society. And that they do so, importantly, without compromising the viability of traditional agricultural practices, including organic farming.

The Declaration was also a call to bring democratic deliberation to decisions about regulation and research priorities: In democratic societies, any decision to deploy powerful new technologies must be made with full public participation and accountability, the Declaration states. And it was a demand for food sovereignty, the concept developed in the 1990s by the global peasant movement, La Via Campesina, that calls for farmer and community power over what food is grown, where, and how.

The month after my father and others gathered to write this Declaration, I found myself getting tear gassed in the streets of Seattle. At the time, I was a graduate student at Columbia University, studying trade policy and globalization. Participating in the global action against the World Trade Organization the so-called Battle of Seattle felt like an appropriate extracurricular activity.

The Seattle action was also intimately tied to the work of my father and his colleagues. For the massive demonstrations in November 1999 against the new global trade regime were also about the future of food and how genetic engineering would affect farmers and eaters all around the world. In the streets, I heard as much from the Teamsters and environmentalists as I heard from Mexican farmers calling for protections of their corn markets in the face of American genetically engineered corn imports.

Since the Pacific Declaration was penned in 1999, commodity agriculture in the US has been remade by genetic engineering. The majority of US corn and soy grown today has been genetically engineered most of it to be resistant to the toxic herbicide Roundup. And the impacts of genetic engineering can now be felt in communities around the world burdened with exposure to toxic pesticides used in concert with these crops, including the tens of thousands suffering from cancers thought to be linked to the weedkiller Roundup with lawsuits pending against its producer, Bayer (which bought Monsanto in 2018). Today, despite the urging of scientists like those who penned the Pacific Declaration, there are no precautionary principles in the US regulatory system for these technologies.

When my dad and his colleagues wrote the Pacific Declaration, it was a call for all of us to ask big questions of this new genetic age: Who benefits? Who is harmed? How do these decisions affect future generations? Twenty years later, these questions are just as pressing.

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The Pacific Declaration: 20 Years Later - Earth Island Journal

Iridescent blue-striped zebrafish dart back and forth in tiny tanks stacked floor-to-ceiling in the basement of the Baylor College of Medicine. The freshwater minnowssome 13,000 strong in their watery studio apartmentsplay an integral role in innovative biomedical research.

They are part of the Gorelick Lab, one of more than 3,250 sites in 100 different countries using zebrafish to advance medicine and better understand human diseases. Led by Daniel Gorelick, Ph.D., assistant professor in the department of cellular and molecular biology at Baylor, the lab studies zebrafish to learn how certain hormones and chemicals affect the development and function of the human heart and brain, as well as other tissues.

Although science and technology are constantly evolving, zebrafish have remained relevant research tools for almost 50 years. Today, scientists are harnessing the power of CRISPR-Cas9 technologywhich can edit segments of the genome by deleting, inserting or altering sections of the DNAto generate specific mutations in zebrafish.

This has been a huge advance because it allows us to create mutant strains of zebrafish that have the same mutations as are found in a human disease, said Gorelick, whose lab is housed in Baylors Center for Precision Environmental Health and is currently undergoing an expansion to accommodate as many as 30,000 fish.

In addition, scientists have long sought to map the cell-by-cell progression of animals, in pursuit of understanding how a single cell develops into trillions of cells that make up an intricate biological system of organs. With single-cell RNA sequencing, a technology named Science magazines 2018 Breakthrough of the Year, scientists are able to track the different, intricate stages of embryo development in unprecedented detail, allowing researchers like Gorelick to study the cascading effects at the cellular level.

Theres just so much evidence now that a lot of the drugs that are effective in humans are also effective in [zebrafish], so people are now starting to use fish to discover drugs, Gorelick said. You want to know, if youre taking a drug or youre exposed to some pollutant, does that cause birth defects? How does that affect the life of humans? We can use [zebrafish] as research tools to understand how the chemicals normally work in a normal embryo.

Regenerative heartZebrafish are named for the colorful horizontal stripes on their bodies, and can grow from 1.5 to 2 inches in length. The tropical fish are native to South Asia.

On the surface, zebrafish appear nothing like humans, but 70 percent of the genes in humans are found in zebrafish and 84 percent of human genes associated with human disease have a zebrafish counterpart, studies show.

George Streisinger, an American molecular biologist and aquarium enthusiast, pioneered the use of zebrafish in biomedicine at the University of Oregon in 1972. His breadth of knowledge about zebrafish laid the groundwork for research methodologies, including developing breeding and care standards and creating tools for genetic engineering and analysis. He performed one of the first genetic screens of zebrafish by using gamma rays to randomly mutate the DNA of certain zebrafish and identify offspring that had notable phenotypes, such as pigmentation defects.

That caused a big explosion in the field and then thats when things really took off, Gorelick said.

Zebrafish are now used as a genetic model for the development of human diseases, including cancer, cardiovascular diseases, infectious diseases and neurodegenerative diseasesto name a few. Housed down the street from Gorelicks lab, John Cooke, M.D., Ph.D., is using zebrafish to study atherosclerosis, the major cause of heart disease in the country. Although zebrafish have only one ventricle to pump blood to the heart, whereas humans have two (a left and a right ventricle), their vasculature is very similar to humans.

The zebrafish can help us in understanding the cardiovascular system, in achieving those basic insights, and in translating those basic insights towards something thats potentially useful for people, said Cooke, director of the Center for Cardiovascular Regeneration at Houston Methodist Research Institute.

Cooke hopes that studying the regenerative capabilities of the zebrafish heart will lead to new discoveries that help human patients.

You can remove 20 percent of their heart, and they can regenerate it, Cooke explained. Why is that? We want to know. There are groups that are studying that amazing regenerative capacity of the [zebrafish] heart, and those insights obtained from that work may lead us to new therapies for people to regenerate the human heart or, at least, improve the healing after a heart attack.

Watching cells migrateAlthough mice are genetically closer to humans than zebrafish, sharing 85 percent of the same genomes, zebrafish have a few key advantages for researchers.

On average, zebrafish produce between 50 to 300 eggs, all at once, every 10 days. Their rapid breeding allows scientists to quickly test the effects of genetic modifications (such as gene knockouts and gene knock-ins) on current fish, as well as ensuing generations.

In addition, zebrafish are fertilized and developed externally, meaning the sperm meets the egg in the water. This allows scientists to access the embryos more easily, as opposed to mouse embryos that develop inside the womb. In one of his research projects, Gorelick simply adds drugs to the water to see how the zebrafish are affected.

Most drugs in the water will get taken up by the embryo, Gorelick said. We add it into the water and it gets taken up the next day when theyre just one day old. All of that discovery happened in zebrafish because you can literally watch it live.

Not only do zebrafish embryos develop quickly, they are also transparent. Within two to four days, a zebrafish will develop all its major organsincluding eyes, heart, liver, stomach, skin and fins.

We can literally watch these cells migrate from different parts of the embryo, form the tube, constrict, form the hourglass, loop on itself, beat regularly and see blood flow all at the same time, Gorelick said. When theres a belly and a uterus, you dont have access. You can use things like ultrasound, like we do with humans, but you cant get down to single-cell resolution like we can with the fish.

Ultimately, zebrafish have proven to be a powerful resource for researchers. Although all zebrafish studies are confirmed in rats and mice, followed by human tissue, they constitute a significant stepping stone.

You wouldnt want to build a house only using a hammer and a screwdriver. I want a power drill and I want a band saw, Gorelick said. Fish are part of that. Theyre not a cure-all. Theyre not the only tool, but theyre an important tool.

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Zebrafish are the tropical minnows advancing genetics and molecular biology - TMC News - Texas Medical Center News

As the world scrambles to monitor and contain the COVID-19 outbreak, drug companies are racing to develop or repurpose treatments to combat the potential pandemic. The death toll continues to climb.

A new survey by Genetic Engineering & Biotechnology News (GEN) reveals 35 active drug development programs in North America, Europe, and China. Those 35 include treatments that have received the greatest public attention in recent days, being developed by companies that range from pharma giants like GlaxoSmithKline and Sanofi, to small and large biotechs such as Moderna and Gilead Sciences. Gileadhas begun clinical trials in Chinaafter peer-reviewed journals showed its antiviral candidate, remdesivir, having positive results ina case involving an American patientandChinese in vitro tests.

Chinas status as the center of the SARS-CoV-2 outbreak is reinforced by a statistic tucked at the bottom of areportpublished February 28 by the state-run Xinhua news agency: Of 234 clinical trials registered with the Chinese Clinical Trial Registry, nearly half (105) focus on treatments for COVID-19.

This list is certain to multiply in coming weeks as global health agencies, governments, and drug developers step up efforts against the SARS-CoV-2 virus.

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35 drugs in the race for a coronavirus treatment - Genetic Literacy Project

A University of Virginia biomedical engineering student is trying to tackle the worlds No. 1 cause of death on a genetic level.

Rita Anane-Wae, from Ghana by way of Glendale, Arizona, and a third-year biomedical engineering student, is using a 2019 Harrison Undergraduate Research grant to seek a genetic solution to atherosclerosis, or the build-up of plaque in ones arteries, which impedes blood flow.

There are cells that will try to fix this problem by covering them and basically pushing the plaque down to allow blood flow, she said. These cells will try to reduce that plaque so that there is correct blood flow. In very serious cases, the plaque can harden and break off. Once it breaks, it can get lodged somewhere and cause a stroke or a heart attack.

Created through a gift from the late David A. Harrison III and his family, the Harrison Undergraduate Research Awards fund outstanding undergraduate research projects. Selected by a faculty review committee, awardees receive as much as $4,000 apiece to pursue their research interests, under the direction of a faculty mentor.

Anane-Wae started working in a laboratory run by Mete Civelek, an assistant professor of biomedical engineering, as a second-year student.

Civelek had already altered her life. Anane-Wae came to UVA to be a chemical engineer. She met Civelek when she signed up as a first-year student for a program that offered faculty mentoring.

At the time I was a chemical engineering major with an interest in biomedical engineering, Anane-Wae said. After talking with him, he was able to assuage my fears about biomedical engineering.

Biomedical engineering is a relatively new field and as such, I did not believe there were many jobs out there, and my parents were worried for the same reason, she said. Mete has a chemical engineering undergrad degree and a masters and Ph.D. in biomedical engineering, so he was the perfect person for me to talk to. He explained the two fields in a unique way, unlike what I had read and seen on YouTube.

Honestly, I love biomedical engineering. When I switched into biomedical engineering, literally in my first class, I though Oh, my God, this is home. I am learning about anatomy, physiology, genes and cells, and it is still all really exciting for me.

Civelek also suggested Anane-Wae participate in the research trip to Uganda through the UVA Minority Health & Health Disparities International Research Training program to perform research on congestive heart failure. While in Uganda, Anane-Wae made rounds with a doctor at a local hospital and met a 17-year-old girl suffering from congestive heart failure.

Her legs were all swollen, Anane-Wae said. She had edema and her stomach was filled with fluid. I was looking at her and thinking, This girl cant lay down because of all the swelling and she cant even be at rest. And I was thinking, She is about my age and I am fortunate enough to be traveling the world and she is here stuck in this hospital bed.

Her encounter with the girl became part inspiration to her and part reminder that congestive heart failure is not just for older patients.

I have a hard time accepting what I am capable of doing, Anane-Wae said. Being here, being in Uganda, working in the lab, it has taught me that I am basically capable of making change. I know what I am supposed to be doing with my time and my future and I know that doing it makes me happy and will make other people better.

In her lab work, Anane-Wae studies a specific gene melanoma inhibitor activity 3, or MIA3 that affects smooth muscle cells.

Smooth muscle cells are able to basically cover the plaque in that disease state, Anane-Wae said. We are running experiments to see how us modulating MIA3 affects the disease.

She said she and members of the research team in the lab also performed experiments knocking out the MIA3 gene from the cells, which led to a more serious disease state.

I think experiments like these are really important because we are not yet at the stage where we can do gene therapy on a person, Anane-Wae said. If you knock out specific genes, it will affect things that we dont understand yet.

Anane-Wae is working on a small section of a large field, but she thinks there is promise in the work she is doing.

The genome-wide association studies show that 161 different genes so far have been associated with coronary artery disease, she said. And we are studying just one. There is so much further that we have to go.

The path is really long, but we are trying to understand the mechanism by which one gene affects the disease and if we actually figure out that mechanism, we can try to apply it to the other genes and maybe understand the bigger picture.

Research can lead her down many blind alleys, which she understands. Anane-Wae is also very conscious of the law of unintended consequences, and how something that solves one problem can create other problems in the process.

We can say that about everything, she said. I think that is the way with all new development. You fix problems and new ones will arise, and then you fix those, too. So we can only do so much. But I think what I have learned is that I have found something about which I am passionate. I have found something that I enjoy and here at UVA, I have found a community of people who will help me develop my skills.

Included in that community, Anane-Wae cited Civelek and Redouane Aherrahrou, an American Heart Association Postdoctoral Fellow with whom she works.

Aherrahrou has known Anane-Wae since she joined the lab in 2018. When she first joined our lab, Rita knew only the fundamental lab skills and methods, he said. After a short amount of training, she learned rapidly and became very familiar with the cell culture techniques and appropriate lab handling. She performed the experiments independently. Her interactions with other lab members are both professional and friendly.

He described Anane-Wae as a diligent researcher, a gifted student, an inspiring person, and enjoyable to be around.

She has a great personality, is open to guidance and responds well to criticism, he said. She wants to apply to Ph.D. programs after she graduates, and I predict a great future in her career as a research scientist.

Civelek said he enjoys having Anane-Wae as part of his team.

She is hard-working, curious and eager to make a scientific impact, he said. I can see the joy in her face when she learns something new. She gets along well with everyone in the lab and is a role model to those who are junior to her. She has a bright future and I am very proud of her accomplishments.

Civelek said Anane-Wae was recently awarded a German Academic Exchange Research Internship in Science and Engineering, which is presented to only 300 students from the U.S. and Canada.

Redouane and Mete both have high standards for me and motivate me to do my very best, Anane-Wae said. They have instilled a confidence in me that I did not have prior to joining the lab, and they continuously push me to achieve great things. I am so fortunate to have these two individuals as mentors, in addition to all of the other members in the laboratory.

A Blue Ridge Scholarship recipient, Anane-Wae is member of the National Society of Black Engineers and the Society of Women Engineers. She also has received a Hugh Bache Scholarship.

Anane-Wae said she is looking at doing big things, such as gene therapy, but realizes that she has to take small steps at first, and that her friends in the lab will help her out when things go wrong.

She has also learned that research is a team effort, not a solo pursuit.

You cant do research by yourself, she said. You wont be able to get anything done. You will have to depend on other people and you have to be able to share what you have learned. You wont get anything done in any amount of time if you dont trust other people and work together.

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First-Year Lab Experience Gave This Student the Confidence to Aim for a Ph.D. - UVA Today

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A microorganism is a microscopic organism, known to be one ofthe earliest life forms on earth. Viruses, fungi, bacteria,archaea, protozoa and algae are the six major forms ofmicroorganisms, exploited expeditiously by the biotechnologists andmicro-biologists for research purposes. From beer brewing, breadmaking to mass production of antibiotics, microorganisms is used inall such processes by the scientists to reach the desired results.Genetic engineering techniques, DNA typing etc., have further pavedway for genetically modified organisms such as the geneticallymodified bacterium, as in the US Supreme court case of Diamond v.Chakrabarty.

The case of Diamond v.Chakrabarty1 in 1980s, opened gates forthe patentability of microorganisms, wherein the claim of aMicro-biologist Dr. Ananda Chakrabarty, for the grant of patent fora live human made & genetically engineered bacterium, capableof breaking the components of crude oil was accepted by the USSupreme Court. In this case, the controller of patents of theUnited States denied the claim for patenting the bacterium per se,stating that, microorganism are product of nature and hence arenon-patentable according to the US patents regime, which wasreversed by the United States Court of Customs and Patent Appeals.Dejected by the decision of the US court of Customs and PatentsAppeal, Sideny A. Diamond, the commissioner of Patents andtrademarks appealed to the US Supreme court2 which againwent in favour of Chakrabarty by establishing that a human made,genetically engineered bacteria was capable of treating oil spillsand thus was an invention accompanied by novelty, usefulness,utility, non-obviousness and industrial applicability3,which a naturally occurring microorganism was incapable of.

Before the US Supreme Court's decision in the case ofDiamond v. Chakrabarty, Patent protection was not granted tomicroorganisms as product claims, but only to the process claims inwhich microorganisms was used as a medium ininventions.4

Article 27(3)(b) of the TRIPS 1994, further established thatmicroorganisms and non-biological and microbiological processes arepatentable by stating that, "Members may also exclude frompatentability, plants and animals other than micro-organisms, andessentially biological processes for the production of plants oranimals other than non-biological and microbiologicalprocesses."

'Microorganisms per' se can be patented, however, itshould be noted that a patent is not granted for a discovery ratherfor an invention which is novel, non-obvious, useful and capable ofindustrial application. Therefore, a patent can only be granted fora micro-organism, when there's a human intervention to create anew, non-obvious and useful microorganism by way of geneticmodification/engineering, cell fusion, gene therapy or othermicro-biological or non-biological techniques.5

Further, since the disclosure of details in written descriptionw.r.t., inventions involving micro-organisms is not possible, theBudapest Treaty provides for a mechanism to deposit microorganismwith any "international Depository Authority" for thepurpose of patent procedure of national patent office of all thecontracting states.

The Indian Patents Act, 1970 added microorganisms under thepurview of patentability through the Patents (Amendment) Act, 2002,in compliance with the TRIPS.

According to Section 3(j) of the Patents Act, 1970, a plant,animal, seeds and biological processes, apart from microorganismsare not patentable. Therefore, section 3(j) of the Indian patentsact, allows patentability of microorganisms.

The landmark judgment of the Calcutta High court in the case ofDimminaco A.G. v. Controller of Patents &Designs on 15th January, 2001, prior tothe 2002 amendment in the patents act, 1970 established a benchmarkin the field of micro-biological research. In this case, an appealwas filed against the Assistant Controller of Patents &Designs, wherein, the process for preparation of infectiousBursitis Vaccine was refused on the grounds that the process ofpreparation of vaccine that contained a living virus cannot beconsidered manufacture and that a vaccine comprising of a livingvirus cannot be considered a substance or inanimate object. Thecourt in this case reversed the decision of the Assistantcontroller and held that, the process of preparing a vendiblecommodity containing a living substance is not excluded from thepurview of the word, 'manufacture' and that the controllererred in denying patent protection to the vaccine just because itcontained a live virus. Furthermore, the end product was novel,capable of industrial application and was useful for protectingpoultry against contagious Bursitis infection, thus making theprocess an invention. The court further allowed the appeal anddirected the petitioner's patent application to be reconsideredwithin two months of the publication/delivery of the judgement.

In the recent Supreme Court's judgment in the case of,Monsanto Technology Pvt. Ltd. v. NuziveeduSeeds6, The plaintiff claimed that theirpatent in the man-made, chemical product called NAS(Nucleotide AcidSequence) containing the gene Bacillus thuringiensis (Bt gene),capable of killing bollworms when inserted in cotton, was not aninfringement under section 3(j) of the patents act, 1970, as heldby the Division bench of the Delhi High Court. Nuziveedu'sclaim was that, NAS was merely a chemical composition in-capable ofreproduction and not a man-made inventive microorganism, capable ofindustrial application7. The Supreme Court in this caseset aside the order of the division bench and restored the order ofthe single bench and reverted back the matter back to the singlebench of the Delhi High Court to be decided on the basis of expertadvice and evidence, who had held that, the claims on NAS wasrightly entertained by the Indian Patent office and that theparties shall remain bound to their sub-lease agreement.

Thus, the current scenario in India w.r.t. patents inmicroorganisms is still at an infancy stage and needsprogression.

The micro-organisms with human interventions, accompanied bynovelty, utility and industrial applicability are patentable. Thetechnological advancements in the field of micro-biology, genetics,etc., have complicated the issues relating to patents inmicroorganisms. Therefore, scientific aspects and legal drafting ofthe invention should be done with due precaution and consideration.Further even though, the issues involved in the Monsanto's casewas highly technical, The Supreme Court missed its opportunity indeciding upon the facts in issue8.

Footnotes

1 447 US 303 (1980)

2 Patenting of microorganisms: Systems and concerns,Ramkumar Balachandra Nair & Pratap Chandran Ramachandranna.Journal of Commercial Biotechnology volume 16, pages337347(2010) access from: https://link.springer.com/article/10.1057/jcb.2010.20

3 Dr. BL Wadehra.Law Relating to Intellectual Property66.(Universal-Lexis Nexis, Fifth Edition, Reprint 2018)

4 Id. at ii.

5 Globalization and Access to Drugs. Perspectives on theWTO/TRIPS Agreement Health Economics and Drugs Series, No.007 (Revised). Essential Medicines and Health Products InformationPortal.A World Health Organization resource. Access from:https://apps.who.int/medicinedocs/en/d/Jwhozip35e/3.4.4.html

6 AIR2019SC559

7 Kluwer Patent Blog.Monsanto v. Nuziveedu: A MissedOpportunity by the Supreme Court?

Access from: http://patentblog.kluweriplaw.com/2020/01/27/monsanto-v-nuziveedu-a-missed-opportunity-by-the-supreme-court/

8 Ibid.

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