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Archive for the ‘Molecular Genetics’ Category

Ask the expert: How vaccines are created – MSUToday

Saturday, October 17th, 2020

As flu season approaches and scientists continue to work on a vaccine for COVID-19, Andrea Amalfitano, dean of the College of Osteopathic Medicine and Osteopathic Heritage Foundation Endowed Professor of Pediatrics, Microbiology and Molecular Genetics, uses his expertise to shed light on how vaccines work and the process for creating new ones. The first of this two-part series addresses general questions about vaccines. The second part will address development of the COVID-19 vaccine.

How do vaccines work?

Vaccines work by introducing specific sub-portions, or antigens, of a desired target, like COVID-19, to the immune system in a manner that is safe and results in a training of the immune system should a vaccine be exposed to COVID-19 naturally.The vaccinated individual will be able to ramp up an immune response that eliminates the COVID-19 much more rapidly than someone who was not vaccinated, thereby minimizing or completely preventing illness.

Our laboratories previously developed, for example, a vaccine platform for use against a variety of targets. This platform was created by genetically engineering a common cold virus to present antigens safely to the immune system. This unique vaccine platform has been safely used in hundreds of clinical trial participants targeting their cancers, and that safety record has allowed researchers to now test the platforms ability to induce beneficial immunity against the COVID-19 virus in human subjects as part of an FDA-approved Phase I clinical trial.

Confirming safety is key, and at this time it is more critical than ever that FDA regulations are maintained and followed, as these will help confirm that an approved vaccine is both effective and safe.Suspending FDA regulations at this crucial time would be the last thing I would recommend, for example, to hasten the approval of any potential COVID-19 vaccine.Suspending FDA oversight would undermine the trust the public would have in any other vaccine, therapeutic, test or other medical device subsequently approved by the FDA.

We hear a lot about the fast-tracking of a coronavirus vaccine. What is the usual time frame for creating a new vaccine?

Andrea Amalfitano, dean of the College of Osteopathic Medicine and Osteopathic Heritage Foundation Endowed Professor of Pediatrics, Microbiology and Molecular Genetics.

In my experience as a clinician/scientist who has developed new vaccine technologies for various purposes, the track typically is multiple years. Fast-tracking is not the typical term applied to vaccines, as the brunt of the time required to get a new vaccine approved is devoted to confirming the vaccine can be scaled up consistently and also has no untoward side-effects, especially when it is planned to be administered to potentially millions of people.

Given that, the annual flu vaccine is what I would consider a fast-tracked vaccine, as it is essentially a novel vaccine every year. The reasons it can be fast-tracked are: 1) the long-standing safety record (decades) of developing and producing flu vaccines using tried and true scale-up methods, 2) long-standing blood tests that consistently measure, and then correlate the amount of anti-flu antibodies generated by each annual flu vaccine with ultimate potential for efficacy.

What are the steps or phases of researching a new vaccine?

Typically, any new drug, vaccine or other form of medical therapeutic or device goes through three phases of clinical trials prior to receiving approval for generalized usage. Phase I studies typically involve dose testing and safety studies in normal human volunteers, as appropriate. Phase II studies involve using optimal doses of the new drug or vaccine in those potentially benefitting from the therapeutic, for example, a new drug to treat high blood pressure being evaluated in patients with high blood pressure. For flu vaccines, this phase would attempt to note how many anti-flu antibodies are produced by the potential new vaccine, and if these antibody levels are above the known thresholds required to have a good vaccine. Phase III studies typically involve testing the new therapeutic in trial subjects as compared to use of currently available therapeutics for the same disease indication to verify it is an improvement.

For flu vaccines, and more specifically COVID-19-specific vaccines, this phase may include asking clinical trial participants to receive a potential COVID-19 vaccine and monitor the rate of COVID-19 infection by these vaccine recipients over time. If the COVID-19 vaccine is good, those who receive the potential vaccine should have a much lower rate of acquiring COVID-19 infection than those trial participants who receive a placebo vaccine.

What are the risks associated with getting a new vaccine?

Vaccines are some of, if not the safest, types of medications doctors can provide to their patients. In fact, if you look back through time, beyond clean water, vaccines have saved more lives and decreased morbidity of the human race more so than any other medicine.

Risks can occur, as with anything administered to a human even excess water consumption can be dangerous to humans. Clinical trials in hundreds or thousands of trial participants serve to identify potential side effects. Furthermore, many times the FDA will also add Phase IV studies, even after a new therapeutic or vaccine is approved, typically to monitor for very low-frequency side effects not identified in prior clinical trials.

Do vaccines have to be kept at a certain temperature to be effective?

This depends on the type of vaccine platform. Some can be dehydrated and/or delivered as an oral pill, while others may require refrigeration at specific temperatures to maintain viability. It is not clear what these viability requirements will be of the several potential COVID-19 vaccines currently being tested.

Obviously, this also has to be a consideration in regard to scalability. For example, if a vaccine can be delivered at room temperature and remain effective as an orally ingestiblepill or tablet, this vaccine will be much more likely to succeed, versus a different vaccine that requires refrigeration until the time of a required administration.

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Q&A: Paul Duprex on the Promise of a COVID-19 Vaccine – UPJ Athletics

Saturday, October 17th, 2020

As the Jonas Salk Chair for Vaccine Research and professor of microbiology and molecular genetics at the University of Pittsburgh, Paul Duprex has been leading the local effort to create candidate vaccines for COVID-19.

In March, he joined an international team of scientists in using the tried and true measles vaccinea weakened form of the virus Duprex has been studying for decadesas the basis for a new candidate vaccine against SARS-CoV-2. Phase 1 testing began in August.

More recently, Duprex joined forces with the massive global vaccine maker Serum Institute of India, which already produces vaccines for two-thirds of the worlds children, to manufacture a similar measles-based SARS-CoV-2 candidate vaccine developed solely at Pitt.

On Oct. 15 from 10 to 11:30 a.m. ET, Duprex will sit on a panel with vaccine experts from March of Dimes, Johns Hopkins, CDC Foundation and Pitt for a discussion about the challenges that lay ahead. The event is free and open to the public.Attendees must register at the Wilson Center website.

UPMC science writer Erin Hare caught up with Duprex in the Center for Vaccine Research, where he serves as director.

Think of a telephone. A telephone is very different in the 1960s compared to the cell phone that you carry in your pocket today. So, just imagine the same analogy and apply that to vaccines.

We can make vaccines in new ways. The toolkit is enormously large now, compared to what it was way back when. That doesn't mean that we don't do the same types of vaccines that were made in the 1960syes, that's part of the portfolio of vaccines, but there are many more vaccines available.

For instance, we can genetically engineer viruses. We can make one virus look like another virus. Or, we can take bits of genetic material and not even introduce proteins, which are normally recognized by the immune system. We can introduce the RNA, which makes the protein, which then is recognized by the immune system.

That's just examples of new ways to think about new vaccines, 65 years on.

One of the advantages is that we have studied coronaviruses for many years. So, we understand a bit about which parts of the coronavirus can be used to make a good immune response.

The other thing which is interesting about coronaviruses is they're really big viruses, and they have the ability to correct mistakes whenever they replicate, so any mutation gets fixed straight away. That's good for us because that means the virus doesn't change much the way some other viruses do.

Like, for example, influenza. Influenza mixes it up all the time. HIV mixes it up all the time. But because SARS-CoV-2 has this drive to keep itself the same, that means the likelihood of changing is less. Plus, the virus just has one genetic segment, so it's not like influenza. So, instead of shuffling a pack of cardsthe genetic material of influenzaSARS-CoV-2 can just play around with one sequence.

So those are all good things for us.

Hard things for us? Well, it's a brand-new virus. So, we still have to understand this relatively young virus. We have to understand a lot more about the biology of it. And, of course, the world is working hard on understanding the biology of SARS-CoV-2.

We need so many because the first vaccine may not always be the best vaccine. It may work, but it might not work as efficiently as some of the other ones, which just take a bit longer to bring through the pipeline of development.

So, it's the same as that old analogy: You shouldn't keep all of your eggs in one basket. It's good to have multiple baskets for your eggs. And it's pretty good to have multiple approaches to deal with a virus that's rather new. The other part of having multiple approaches is we just don't know how long the immune response will last. And therefore we can't assume too much until we have the data.

So, it's all driven by science. Science is creative. People are creative. People come up with many ways to get to the same end point, and that's why we need lots of different sorts of vaccines.

Well, I think one of the things that gives me hope is there are a lot of individuals working on the problem. The world is focusedthe virology community, the immunology community and many other disciplinesare laser focused on solving this problem. People have developed vaccines in the past. So, that gives me hope. But also what we have to remember is vaccines are not easy.

The average time to make a vaccine is 10 and a half years. And if you think about HIV, it pulls that average way up, because 36 years after identifying that virus, we still don't have a vaccine. So therefore vaccines are hard, but vaccines have led to the eradication of infectious diseases, and vaccines have done so much for human health. They consistently deliver, they consistently live up to their expectations, and they have delivered so many people who otherwise would not be here because vaccines actually work.

So, what gives me hope? Vaccines work.

First and foremost, I'm sympathetic to individuals who are trying their best to understand something which is familiar to scientiststhe process of vaccine developmentbut very foreign to the general public. No vaccine has ever been developed under the microscope like these candidate vaccines for SARS-CoV-2.

We also get our news from many different sources. We have social media, we have regular mediawe have this tsunami of information. And that's what makes it really hard for the public to weed through, because not all of that information is equivalent.

So, what's important is to get information from verified, validated, sound sourcesto look at the evidence produced by science. And the evidence says that vaccines work. That does not mean that vaccines work perfectly. Sometimes the influenza vaccine's great, sometimes in one particular year, for whatever reason, it just doesn't work as well. But we don't undermine all the vaccines because we do not get to perfection.

And we do realize that there are side effects, adverse events that happen. And that's why it's really important as we do vaccine development, clinical trials in the here and now, that we use all of the standard approaches in phase 1, phase 2, phase 3 clinical trials, to understand any potential effects, whatever that could be. And we only license safe, efficacious and life-giving vaccines.

What you also have to remember is these companies do much more than make a coronavirus vaccine. Some of them have made vaccines for many years. Some of them have never made a vaccine at all. So, there's an example of why I could be sympathetic and understand the population looking at it and thinking we're going to license something that has never been used before. But remember that these companies have reputations, they have other products, they have history, they have a brand, they are known and it's very unlikely a private company will throw all of that reputation in the air just to be first with unsafe, untested, non-satisfactory coronavirus vaccine.

Vaccines are not just produced and marketed and sold without a lot of care and a lot of attention to how they are made, tested and licensed.

This interview has been edited for length and clarity.

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Iker Jimnez addresses the genetic code in COVID Report – Pledge Times

Saturday, October 17th, 2020

Like every Thursday Iker Jimnez sought answers to the mysteries about the coronavirus in a new installment of COVID Report. In this case, addressed the genetic key to the disease to try to find out if they exist people with more predisposition than others to be infected.

As in previous programs, surrounded himself with prestigious experts They showed their knowledge on the subject. The first to intervene was Paul bastard, pediatrician at the Necker Hospital in Paris and co-author of the latest study on interferons.

15% of patients with severe forms of COVID have a genetic and immunological susceptibility to make a serious form because they cannot defend themselves well because of a defect in interferon. The type I it is the most famous antiviral molecule and it is the first most useful to fight viruses, not only against the coronavirus, but against everyone. When the virus comes into contact with the cells of the body, they recognize it and there is like an alarm signal, which is the one that induces the production of type I interferon and we have found that the patients who have these autoantibodies were older and almost all, 94% were men. That may explain part of why it affects men and older people more, Bastard said.

He subsequently intervened Salvador Macip, specialist in Molecular Genetics and researcher at the University of Leicester, who stated that one of the great mysteries of this virus even now is what type of immunity it provokes: if you get infected, how your body reacts and why some people react better or worse than others. This it depends a lot on genes and factors that we do not know right now, we cant predict. Why are 10% of people going to have such an aggressive response? We have to look for it and understand it, but we do not know the immune reaction. We do not know why there are people who can be reinfected and it seems proven that a certain part of the population can be infected more than once. Why? It is one of the unknowns that must be answered And I dont think well do it anytime soon. It is a very complicated subject and will have to be studied even in years.

Csar Carballo, emergency assistant at the Ramn y Cajal University Hospital, assured that when the pandemic began the vast majority of patients were men. Although sometimes they came some young people who arrived very badly and there was something that we did not explain, which led us to think that there was something we did not know about the disease. You were left wondering what happened to these patients, who were 10-15%.

Carmen Chamber, Secretary General of the Spanish Immunology Society, confirmed that the figures leave no room for doubt. When we see series of mild COVID, there are 28% of men, in the severe it rises to 75% and in the study by Paul Bastard there is talk of 95%. But it is also important for people to know that in 85% of cases, the immune system of people can with the virus. In a wide range of cases it is not known that it has been had.

Miguel Pita, an expert in Genetics and Cell Biology at the Autonomous University of Madrid, stated that genetics always have something to sayeven when we least expect it. Some of them suddenly faced with a disease and make you more or less prepared, and it can even be random. We are detecting more and more elements that they make the prognosis better or worse due to small changes in the genetic material.

It will take time to have the answer, but Nowadays, patients are selected who have had a bad time with those who have not. Those are compared thousands of DNA to see what is different. Results that show that on chromosome 3 there is a region that has genes involved in the matter related to the lung. Now we have to investigate what happens there. You have to be cautious, because they are very early results added the specialist.

Alfredo Corell, Professor of Immunology at the University of Valladolid, member of the board of directors of the Spanish Society of Immunology and scientific disseminator, highlighted the importance of interferon: There are many types and it is so called because interferes so that the virus does not infect so easily. It is produced by cells of the immune system and signals cells with receptors. These signs They help the lung, protect the epithelia, the organism and send signals so that the immune response is lowered. All this together favors the action of interferon.

Although for Camera, interferons explain 10% of severe cases. When there are things that it only justifies a percentage, we are concerned. But its the first step forward we can give .

In a similar vein, Pita expressed himself, emphasizing that it is still early. Lung things, receptor genetics, etc. will be seen. Genetics can explain up to 50% of the variability in the form of prognosis from the patients. These interferon genes are not a single gene: it has been seen people who make anti-interferon antibodies and people who have trouble making interferon. We go really fast but we want to go faster than science allows us .

Pita recalled that it was one of the first results they tried to associate with prognosis of the illness. From the beginning they were very modest, but it could not be stated that it was a determining factor. We are on the verge of seeing more important things. Blood group may influence, but it is less decisive than diabetes or the gender of each person .

Chamber explained that the immune system has two lines defense: a quick and innate first that can beat COVID without leaving a signal in our blood and it is where type I interferon participates; there are a second, which is the adaptive, and its where T lymphocytes, antibodies, etc. go. and leave memory, with which we do the serological tests to know if we have passed the disease or not .

Therefore, Pita emphasized that If you dont have antibodies, it tells you very little. You are not even protected against reinfection, with which deep down it doesnt matter.

Pita gave several brushstrokes on some characteristics of the virus: We are focusing on the cases in which the genetic system goes wrong. But the virus has its own history. Muta pocor. That is good compared to other viruses, and if it were more mutant, it would be more difficult to find a vaccine. But between being not very aggressive and mutating little, we are not in the worst possible situation to be a pandemic. The strength of this virus is that it is very contagious, but many people are asymptomatic or have mild symptoms. If I put you on a bed, it would be less contagious.

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9 innovative Cologne-based healthtech startups to watch out for in 2020 – Silicon Canals

Saturday, October 17th, 2020

Healthcare systems across the world have always been under pressure; the pandemic simply multiplied it. It has also made the pre-existing challenges of healthcare systems visible to everyone. It has come to light that during the tough times, healthcare professionals were under-equipped, underpaid, and overworked.

While these conditions vary from one country to another, this has paved the way for the potential digitalisation of the healthcare services. It wont be an exaggeration to say that the COVID-19 crisis has boosted both the requirement and interest in such innovative solutions. Eventually, there is a high demand than ever before for ehealth or digital health. This has led to a rise in the relevant verticals including telehealth, mhealth, and health analytics.

These are the top global tech PR agencies you should absolutely check out in 2020

As per a report, the global digital health market is estimated to reach $511B (nearly 435B) by 2026, which is an impressive yearly growth rate of 26%. While markets such as the US and China are leading the digitalisation of health systems, other markets have picked up the pace now.

Talking about Germany, it is one of the leading startup scenes and Berlin remains the main focus of the German startup scene. Given that the report cites that the annual public health spending of Germany is $330B (nearly 281B), here we have listed the top healthtech startups in Cologne that are worth your attention right now as sourced from Dealroom.

Founder/s: David HennFounded year: 2016Funding: 25.6M

Cannamedical imports medical cannabis products and sells them to pharmacies and clinical facilities. It ensures medical care for patients and improves their quality of life. The Cannamedical portfolio includes cannabis varieties, medical marijuana grinders, cannabinoid oil, and more to treat ailments such as chronic pain and cancer.

Founder/s: Nicole Faust, Gudrun Schiedner, Wolfgang KintzelFounded year: 2001Funding: 19.4M

CEVEC Pharmaceuticals provides cell technology for the manufacturing of bio-therapeutics from R&D to manufacturing scale. Its product portfolio comprises platform technologies for gene therapy viral sectors, vaccines, and complex recombinant proteins. CEVEC offers a solution for large-scale production of AAV vectors using producer cell lines with all essential components that are integrated into the cell. Recently, the company launched the patent-protected ELEVECTA platform, which is a new and scalable production platform for AAV gene therapy vectors.

Founder/s: Frank Beyer, Gereon LillFounded year: 2016Funding: 2.6M

Fasciotens is a medical tech startup that works on new devices that make it easier to close the abdominal wall and increase the possibility of survival in ill patients. This solution is an external device, which maintains the abdominal wall in a state of tension and increases the intra-abdominal volume. With early abdominal closure, there is decreased mortality, reduced duration of intensive care treatment, and minimised hospital costs.

Founder/s: Hans-Peter DeignerFounded year: 2010Funding: 5.4M

InfanDx develops a new generation of diagnostic tests for the care of neonates. It focuses on the early identification of newborns suffering from critical oxygen supply deficit during birth termed Asphyxia), which is a major cause for brain injury often followed by life long disabilitation. It requires very early application after birth, and currently, theres no test system available to meet this crucial demand. InfanDx closes this diagnostic gap by carrying such a test system through clinical development until it is available for use in the hospital.

Founder/s: Thomas LisowskyFounded year: 2005Funding: 630K

multiBIND biotec develops solutions for disinfection and decontamination. Its technologies bioDECONT and bioCLEAN are not toxic and are free from hazardous chemicals and solvents. The company is involved in the development of technologies, products, and patents related to operations in molecular genetics and biomedicine.

Founder/s: Christoph von Dellingshausen, Donata von Dellingshausen, Nils von DellingshausenFounded year: 2012Funding: NA

BetterDoc operates with the vision to enable patients to get the best possible medical treatment for their health problems. Its data analytics platform aggregates all kinds of quality data from the health system and measures outcomes with patient-reported outcomes (PROs). This way, the company routes patients to the right doctors and getsget the best possible second medical opinion, treatment, or surgery. The BetterDoc service works with leading German health insurance companies for their customers.

Founder/s: Marc Ebinger, Robert HolzFounded year: 2016Funding: NA

Rimasys is a medtech company. The companys mission is to reinvent surgical education and enables medical science, academic, and the healthcare industry to develop and perform better implants, operations, and therapies. It improves patient outcomes at relatively lower costs. Furthermore, Rimasys provides holistic educational concepts for clinics, surgeons, and medtech companies complemented by 3D printing and virtual reality.

Founder/s: Carlos z Martnez, Samuel JellardFounded year: 2019Funding: 90K

Mane Biotech has developed regenerative medicine through stem-cell technology. The company has developed a wearable device for aiding in hair regrowth and delaying hair loss. The device stimulates tissues to accelerate the bodys own mechanism to regenerate hair. The potential of stem-cell driven regeneration is beyond comprehension and Mane Biotech is specialising in this aspect.

Founder/s: Andreas Schmidt, Dieter TrauFounded year: 2010Funding: 11.3M

AYOXXA is a biotech company commercialising innovative technology developed at the National University of Singapore (NUS). AYOXXAs patented technology platform is producing a new generation of biochips, which merges biology with IT. This allows the biochip to accumulate large numbers of applications measuring multiple protein markers for cancer, allergies, cardiovascular, and infectious diseases, in a single test.

Stock photo from S.Borisov/Shutterstock

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Rare Disease Genetic Testing Market To Account To Grow At A CAGR Of 8.30% In The Forecast Period Of 2020 To 2027 | Major Giants Quest Diagnostics,…

Saturday, October 17th, 2020

An influential Rare Disease Genetic Testing Market report carries out an evaluation of the growth rate and the market value of Rare Disease Genetic Testing industry based on market dynamics and growth inducing factors. Thorough market analysis covered in this report by skilled experts gives every bit of knowledge which is imperative to design and align with current market scenarios. This market research report is one-stop archive for in-depth knowledge of market analytics aggregated by a broad rundown of distributors from over the globe. Moreover, for the businesses, it is the most important to get knowhow of consumers demands, preferences, attitudes and their changing tastes about the specific product which can be studied via this winning Rare Disease Genetic Testing Market report.

Rare disease genetic testing market is expected to gain market growth in the forecast period of 2020 to 2027. Data Bridge Market Research analyses the market to account to grow at a CAGR of 8.30% in the above-mentioned forecast period. The increase in the facilities for patients affected by rare diseases has been directly impacting the growth of rare disease genetic testing market.

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Increasing need for an accurate and appropriate diagnosis for rare conditionsis expected to have a significant impact on the rare disease genetic testing market. Other impactful reasons for the market growth are rise in the number of available registries, rising prevalence of rare disorders along with wide-ranging investments in the diagnosis of rare disorders. On the other hand, the growing number of patients undergoingdisease testingand rising government assistance will further boost various new opportunities that will lead to the growth of the rare disease genetic testing market in the forecast period of 2020 to 2027.

Lack of regulatory framework in emerging economies associated with dearth of trained healthcare personnel is acting as major restraints to the growth of the rare disease genetic testing market in the above mentioned forecast period.

This rare disease genetic testing market report provides details of new recent developments, trade regulations, import export analysis, production analysis, value chain optimization, market share, impact of domestic and localized market players, analyses opportunities in terms of emerging revenue pockets, changes in market regulations, strategic market growth analysis, market size, category market growths, application niches and dominance, product approvals, product launches, geographic expansions, technological innovations in the market. To gain more info on rare disease genetic testing market contact Data Bridge Market Research for an Analyst Brief, our team will help you take an informed market decision to achieve market growth.

Rare Disease Genetic Testing Market Country Level Analysis:

The countries covered in the Rare Disease Genetic Testing Market report are U.S., Canada, Mexico in North America, Germany, Poland, Ireland, Italy, U.K., France, Spain, Netherland, Belgium, Switzerland, Turkey, Russia, Rest of Europe in Europe, Japan, China, India, South Korea, New Zealand, Vietnam, Australia, Singapore, Malaysia, Thailand, Indonesia, Philippines, Rest of Asia-Pacific (APAC) in Asia-Pacific (APAC), Brazil, Argentina, Chile, Rest of South America as a part of South America, U.A.E, Saudi Arabia, Egypt, Kuwait, South Africa, Rest of Middle East and Africa (MEA) as a part of Middle East and Africa (MEA).

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Leading Rare Disease Genetic Testing manufacturers/companies operating at both regional and global levels:

Quest Diagnostics, Inc., Centogene N.V., Eurofins Scientific, Strand Life Sciences, Ambry Genetics, PerkinElmer, Inc., Macrogen, Inc., Baylor Genetics, Color, Health Network Laboratories, L.P., Preventiongenetics, Progenity, Inc., Invitae Corporation, 3billion, Inc., Arup Laboratories, Coopersurgical, Inc., Fulgent Genetics, Myriad Genetics, Inc., Laboratory Corporation Of America Holdings and Opko Health, Inc., among other domestic and global players.

GlobalRare Disease Genetic TestingMarket Scope and Market Size

Rare disease genetic testing market is segmented on the basis of disease type, technology, specialty and end use. The growth amongst these segments will help you analyze meager growth segments in the industries, and provide the users with valuable market overview and market insights to help them in making strategic decisions for identification of core market applications.

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U of T’s Medicine by Design invests $1 million to advance new ideas in regenerative medicine – News@UofT

Saturday, October 10th, 2020

Patients with cystic fibrosis experience recurrent lung infections that eventually destroy their airways, shortening their average life expectancy to 50 years in Canada. Current drug treatments, which target a malfunctioning pathway in cells that causes the infections, are costly and have varying effectiveness.

Now, with funding from Medicine by Design, a researcher at the Hospital for Sick Children (SickKids) is combining stem cells, gene editing and computational modelling to try to hijack an alternative cell pathway in the hopes of restoring lung function in these patients.

If successful, our study will be the first to provide proof-of-concept that this alternative approach to treating cystic fibrosis is effective, saysAmy Wong, a scientist working in developmental and stem cell biology at SickKids who is also an assistant professor in the department of laboratory medicine and pathobiology in the University of Torontos Temerty Faculty of Medicine.

Wongs project is one of seven across U of T and its affiliated hospitals that have been awarded 2020New Ideas AwardsandSeed Fundawards from Medicine by Design. Through a $1 million investment, Medicine by Design is supporting research aimed at advancing new concepts expected to be important to regenerative medicine in the coming years. The funded projects will have potential impacts in diseases and conditions such as vision loss, amyotrophic lateral sclerosis (ALS), intestinal disease in premature babies and more.

Supporting novel strategies and approaches is crucial to moving regenerative medicine into the future, saysMichael Sefton, executive director of Medicine by Designand a University Professor at U of Ts Institute of Biomedical Engineeringand thedepartment of chemical engineering & applied chemistry in the Faculty of Applied Science & Engineering.

Our 2020 New Ideas project portfolio integrates mathematical modelling, physics and computational biology with stem cell biology and biomedical engineering, and strengthens engagement with clinicians who are key to translating our research into patient impact. We are particularly delighted this year to support so many outstanding early-career researchers, who will ensure Toronto remains a global leader in regenerative medicine for years to come.

Wong is one of three investigators to receive a 2020 New Ideas Award, which is valued at $100,000 per year for up to two years. Four additional projects were selected for Seed Fund Awards of $100,000 each for one year to further develop their potential.

Medicine by Design selected the funded projects from among 36 short-listed proposals, which were evaluated and ranked through an external peer review process. Applications were submitted by clinicians and researchers at U of T and its affiliated hospitals from a wide range of disciplines including biochemistry, biomedical engineering, developmental and stem cell biology, immunology, neuroscience and surgery.

Medicine by Design builds on decades of made-in-Canada excellence in regenerative medicine dating back to the discovery of stem cells in the early 1960s by Toronto researchers James Till and Ernest McCulloch. Regenerative medicine uses stem cells to replace diseased tissues and organs, creating therapies in which cells are the biological product. It can also mean triggering stem cells that are already present in the human body to repair damaged tissues or to modulate immune responses. Increasingly, regenerative medicine researchers are using a stem cell lens to identify critical interactions or defects that prepare the ground for disease, paving the way for new approaches to preventing disease before it starts. Medicine by Design is made possible thanks in part to a $114-million grant from theCanada First Research Excellence Fund.

Current cystic fibrosis drug treatments target a genetic mutation that causes epithelial cells, which line the airway and act as a barrier against viruses, to function improperly. The mutation affects the function of an important ion channel in cells, called CFTR, which helps to maintain the right balance of fluid in the airways. Poor function causes mucosal obstructions in the airways and prevents clearance of foreign pathogens, which leads to chronic infections and ultimately destroys airway tissue.

In her project, Wong will explore an alternative ion channel in the epithelial cells to determine if it can be hijacked and used to compensate for the lack of function caused by the mutant CFTR. The research will be conducted using a combination of stem cell-derived lung models, gene editing and computational modelling.

Wongs project builds on decades of cystic fibrosis research at SickKids, where the cystic fibrosis gene was first identified 30 years ago.

To date, more than 2,000 mutations in the cystic fibrosis gene have been identified, says Wong. SickKids scientists and U of T researchers have become the epicentre of incredible cystic fibrosis research to understand how this disease works at the genetic and molecular level.

Wong says that, while the idea of targeting an alternative pathway is not necessarily ground-breaking on its own, its the array of tools now available that makes the idea a potential game changer.

We have access to an incredible resource of primary cells and stem cells from more than 100 individuals with cystic fibrosis harbouring various mutations. Wong says.Our lab has developed human lung models from stem cells that can be used to model lung disease such as cystic fibrosis. And with new advanced tools in single-cell genomics and gene-editing, coupled with key collaborations for computational modelling, we are poised to find new therapeutic targets for cystic fibrosis.

Leo Chou, an assistant professor at the Institute of Biomedical Engineering, andHyun Kate Lee, an assistant professor in the department of biochemistry in the Temerty Faculty of Medicineboth Medicine by Design New Investigators are also leading 2020 New Ideas projects.

Chou, along with co-investigatorsJulie Lefebvre, a scientist at SickKids and U of T assistant professor of molecular genetics, andValerie Wallace, a senior scientist at the Krembil Research Institute, University Health Network and a U of T professor of laboratory medicine and pathobiology and ophthalmology, will focus on cell transplantation in the retina, a process that has demonstrated encouraging pre-clinical results such as partial vision restoration in several animal disease models.

Recent research had demonstrated that this restoration is a result of the transfer of proteins complex molecules required for the structure, function and regulation of the bodys tissues between host tissue and donor cells. But the scope of that transfer process is not well understood. Chous project will develop an imaging approach to detect the transfer of mRNA molecules between host and donor cells. The outcomes from this project will inform the future design of cell transplantation therapies and lead to novel methods to deliver therapeutics. This project could improve therapies for retinal diseases and visual impairments, and inform strategies for other degenerative disorders.

Lee and co-investigatorPenney Gilbert,an associate professor at the Institute of Biomedical Engineering, will look at a common but not well-understood structure called the neuromuscular junction (NMJ), which mediates communication between neurons and muscles throughout the body. Defects in NMJ integrity and function underlie fatal diseases such as ALS. NMJ diseases, which affect more than 500,000 people globally, lack effective treatments. This project will use stem cells derived from reprogrammed skin cells of healthy people to develop NMJs in culture. Through high-resolution imaging, the healthy human NMJs will be studied both on their own and along with NMJs built from ALS patient cells. Through this work, the research team aims to identify genes to target to improve the health of NMJs, which could eventually help prevent or delay NMJ degeneration and even promote regeneration.

Michael Garton, an assistant professor at the Institute of Biomedical Engineering, has received a Seed Fund award to tackle the challenge of translating the genetic tools of synthetic biology an area of research that aims to create or redesign biological components using engineering methods into effective medical therapies against a number of diseases.

But they are difficult to translate into human therapies, Garton says, because the bodys T-cells immune cells that detect and destroy cells containing foreign material will identify these tools as foreign and destroy them.

Instead of switching off the T-cells, Gartons goal is to use computational modelling and high-throughput screening to selectively turn off the bodys foreign antigen display system so the immune system will still respond to foreign invaders when necessary, but allow cells containing synthetic tools to survive. If successful, this approach could enable a new generation of synthetic biology-enhanced cell therapies for a range of diseases.

Medicine by Design funding will help to facilitate the integration of synthetic biology and regenerative medicine and aid the development of cell-based therapies that perform better than nature, says Garton.

Other Seed Fund projects will encompass research in repairing the heart after paediatric cardiac surgery, treating an intestinal emergency in premature babies and creating a database for cell lineage paths.

John Parkinson, a senior scientist at SickKids and a U of T professor of biochemistry and molecular genetics, along with co-investigatorsJason Maynes, Wasser Chair in Anesthesia and Pain Medicine at SickKids and a U of Tassociate professor of anesthesiology and biochemistry, andWilliam Navarre, an associate professor in the department of molecular genetics, will investigate manipulating the microbiome, or community of microorganisms in the gut, to improve cardiac repair in post-operative treatment of a congenital heart disorder. Through a process that will identify prebiotics in breast milk that help enhance the production of molecules that research has shown can aid cardiac repair, the team will organize both observational (how disease alters the microbiome) and interventional (how the microbiome alters the disease) multi-site trials, which will provide the opportunity to immediately translate findings into changes in patient care regimens and improve outcomes.

CliniciansAgostino Pierro, a surgeon at the Division of General and Thoracic Surgery at SickKids and a U of T professor of surgery and physiology, and Philip Sherman, a senior scientist and gastroenterologist at the Division of Gastroenterology, Hepatology and Nutrition at SickKids and U of T professor of dentistry, pediatrics and laboratory medicine and pathobiology, have proposed a novel way of enhancing gut repair for a common intestinal emergency in premature babies, called necrotizing enterocolitis (NEC). A leading cause of death for these infants, NEC causes complications such as blindness, intellectual disability, repeat hospitalizations and gut damage even in those that survive. This project will look at whether intestinal organoids organ-like structures grown in the laboratory from stem cells that mimic some of the functions of native intestines can potentially stimulate repair of the gut and recovery from NEC. The project will define how to best transplant organoids, identify how the organoids protect the intestine from injury and assess if organoid transplantation is a valid new treatment for NEC.

Lincoln Stein, who is head of adaptive oncology at the Ontario Institute for Cancer Research and a professor in the department of molecular genetics at U of T, has received seed funding to build a database called Cytomics Reactome, which will be freely available to Canadian and international researchers. The database will build on recent technologies that open the door to the possibility of deciphering cell lineage paths the series of steps that lead a young, undifferentiated cell into a specialized one at single-cell resolution. To accelerate the path from basic research to clinical application, the database will systematically organize pre-existing knowledge of cell lineage paths into a comprehensive, interactive and easily accessible map that can serve as a framework for interpretation and integration of the latest experimental findings.

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Nature Publishes New Research from Vir Biotechnology Demonstrating the Capacity of Enhanced Monoclonal Antibodies to Induce Protective Adaptive…

Saturday, October 10th, 2020

SAN FRANCISCO, Oct. 09, 2020 (GLOBE NEWSWIRE) -- Vir Biotechnology Inc. (Nasdaq: VIR) today announced the publication of preclinical research in an influenza animal model highlighting a new mechanism for enhancing the efficacy of monoclonal antibodies to treat viral infection and induce a protective response. Data demonstrate that selective engagement of an activating Fc receptor on dendritic cells by antiviral monoclonal antibodies induced protective CD8+ T cell adaptive responses. The paper, entitled Fc-optimized antibodies elicit CD8 immunity to viral respiratory infection, was published in the October 8, 2020 online edition of Nature.

In the past several years, we've gained a better understanding of how integral Fc mediated effector functions of monoclonal antibodies are for their therapeutic efficacy in pre-clinical models of neoplastic, infectious and inflammatory diseases, said Jeffrey V. Ravetch, M.D., Ph.D., study senior author and Theresa and Eugene M. Lang Professor and Head of the Leonard Wagner Laboratory of Molecular Genetics and Immunology at The Rockefeller University. These approaches have been successfully applied to anti-tumor therapeutics and have resulted in improved clinical outcomes in a variety of oncologic diseases. Our present studies have uncovered a significant new mechanism by which antibodies, through their Fc region, can not only engage innate immune responses but activate adaptive T cell responses, thereby stimulating protective anti-viral immunity in these models.

The research published in Nature focuses on the role of the Fc domain of monoclonal antibodies, regions with the capacity to bind to other immune cells through a family of receptors (the Fc receptors). By engineering antibodies with modified Fc domains to enhance binding to specific Fc receptors on innate immune cells, investigators observed an enhanced protective immune response. Certain modifications (GAALIE variants) were associated with activation of dendritic cells, as well as antiviral effector T-cells, indicating induction of the adaptive arm of the immune system, which is responsible for long-term immunity. Based on this research, monoclonal antibodies programmed with improved effector function represent a potential new approach in the design of therapeutic antibodies for both the prevention and treatment of infectious diseases.

By observing and learning from our bodys powerful natural defenses, we have discovered how to maximize the capacity of antibodies through the amplification of key characteristics that may enable more effective treatments for viral diseases, said Herbert Skip Virgin, M.D., Ph.D., study co-author and executive vice president, research, and chief scientific officer of Vir. These data may have significant implications across a wide range of infectious diseases, and we look forward to exploring the vaccinal potential of the GAALIE-engineered antibodies we are advancing through clinical development VIR-3434 for chronic hepatitis B and VIR-7832 for SARS-CoV-2.

The preclinical study was conducted by Dr. Ravetch and Stylianos Bournazos, Ph.D., of the Laboratory of Molecular Genetics and Immunology at The Rockefeller University, in collaboration with Dr. Virgin and Davide Corti, Ph.D., senior vice president of antibody research at Virs subsidiary Humabs BioMed SA.

This type of exceptional collaborative partnership between cutting-edge science and clinical application has the potential to significantly improve our ability to address infectious diseases, stated Dr. Virgin.

Vir is currently evaluating several monoclonal antibodies that have been Fc engineered to include the XX2 vaccinal mutation (or GAALIE variant) for which Vir has licensed exclusive rights for all infectious diseases.

About VIR-3434VIR-3434 is a subcutaneously administered HBV-neutralizing monoclonal antibody designed to block entry of all 10 genotypes of HBV into hepatocytes and also to reduce the level of virions and subviral particles in the blood. VIR-3434 has been engineered to have an extended half-life as well as to potentially function as a T cell vaccine against HBV in infected patients.

About VIR-7832VIR-7832 is a monoclonal antibody that has shown the ability to neutralize SARS-CoV-2 live virus in vitro. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (also known as SARS), indicating that the epitope is highly conserved, which may make it more difficult for escape mutants to develop. VIR-7832 has been engineered with the potential to enhance lung bioavailability, have an extended half-life, and function as a therapeutic and/or prophylactic T cell vaccine. VIR-7832 is being developed by Vir and its partner GlaxoSmithKline plc(LSE/NYSE: GSK) as part of their broader collaboration to research and develop solutions for coronaviruses, including SARS-CoV-2.

About Vir BiotechnologyVir Biotechnology is a clinical-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases. Vir has assembled four technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. Its current development pipeline consists of product candidates targeting hepatitis B virus, influenza A, SARS-CoV-2, human immunodeficiency virus and tuberculosis. For more information, please visitwww.vir.bio.

Vir Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as potential, may, will, could, expect, plan, anticipate, believe, estimate, goal, intend, candidate, continuing, developing and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Virs expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include statements regarding the ability of enhanced Fc mediated effector functions in enhancing the efficacy of monoclonal antibodies to treat viral infections and inducing a protective response in animal models, using an oncological therapeutic approach and enhanced effector function in the treatment of infectious diseases, the vaccinal potential of specifically engineered antibodies in the treatment of chronic hepatitis B and SARS-CoV-2, and statements around the companys plans to explore the vaccinal potential of engineered antibodies as it advances through clinical development of VIR-3434 for the treatment of chronic hepatitis B and VIR-7832 for SARS-CoV-2. Many factors may cause differences between current expectations and actual results including unexpected safety or efficacy data observed during preclinical or clinical studies, challenges in treating chronic hepatitis B and neutralizing SARS-CoV-2, difficulty in collaborating with other companies or government agencies, and challenges in accessing manufacturing capacity. Other factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Virs filings with theU.S. Securities and Exchange Commission, including the section titled Risk Factors contained therein. Except as required by law, Vir assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

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SCV News | COVID-19 Testing Facility Coming to SCV – SCVNEWS.com

Saturday, October 10th, 2020

PerkinElmer, the Massachusetts-based diagnostics company that partnered with California to improve COVID-19 testing efficiency and capacity, has signed a lease in Valencia and could open a testing facility in early November, officials confirmed Wednesday.

The company is set to operate at a 134,287-square-foot industrial building that sits on nearly 14 acres of land at 28454 Livingston Ave.

Previous businesses located there have included Stellar Microelectronics, a full-service electronics manufacturing services provider; and NEO Tech, a provider of manufacturing and supply chain technology, which now operates in Chatsworth.

PerkinElmer signed the lease in early September, according to Holly Schroeder, president and CEO of the Santa Clarita Valley Economic Development Corp.

As of Thursday, an estimated 40 job openings, ranging from molecular genetics scientist to customer support, were listed as based in Valencia on PerkinElmers website.

The diagnostics company has not yet provided many other details of their plans, according to Schroeder.

Requests to confirm the companys testing facility location in Valencia and to receive additional information about the lab have not been returned, but officials with the California Health and Human Services Agency have said details would be released in the coming weeks.

As we get closer to the opening of the lab, which is currently slated for early November, well have additional details to share on location, read an emailed statement from the California Department of Public Health.

In late August, the California Hospital Association a member of the states testing task force confirmed in a newsletter the location will be in Valencia with an opening date of Nov. 1.

The testing facility is expected to increase the number of daily COVID-19 tests up to 150,000 by that date, Gov. Gavin Newsom announced in August.

The partnership is also expected to decrease the average turnaround time to 24-48 hours (it now stands at about five to seven days), as well as drive down costs, which now average around $150-$200 per test, the Hospital Association said in a statement, adding that all hospitals will be eligible to use the lab and that it will simultaneously allow for COVID-19 and flu testing.

News of the lease comes as the U.S. National Institutes of Healths Rapid Acceleration of Diagnostics (RADx) initiative has awarded Ellume USA LLC in Valencia $30 million for scale-up and manufacturing of its COVID-19 antigen tests, officials announced Tuesday.

Antigen tests can diagnose a COVID-19 infection, as they can detect certain proteins in the virus, within minutes and are relatively inexpensive, according to the Centers for Disease Control.

Funds are expected to cover Ellumes two unique test cartridges that can return accurate results in 15 minutes or less. One cartridge testing nasal swabs can be read out on two platforms by health care professionals, at the point of care or in laboratory settings for higher throughput. A second cartridge is being developed for home use with a self-administered nasal swab, according to the National Institutes of Health.

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Alumni Spotlight- Procopio brothers and the biology of college life – Knight Crier

Saturday, October 10th, 2020

Submitted Photo

Kyle and Dylan Propcopio, Class of 2020 NPHS grads

The electric buzz backstage before a performance is a feeling known very well to both Dylan and Kyle Procopio.

The dynamic duo reminisce on their time at North Penn with smiles. While at the high school, they were assistants to the Stage Manager in all NPHS theatre productions, cabinet participants in Thespian Troupe, and members of SGS (Stimulation Gaming Society) and National Honors Society. Additionally, they were tremendously involved in Boyscout Troop 51.

Currently studying at Millersville University, the Procopios are both majoring in biology. Kyle, with a concentration in molecular genetics, and Dylan with a double major in secondary education.

Did you have a favorite class you attended while at NP?

Kyle- Definitely Genetics and Embryology with Mr. Christopher! Both Dylan and I enjoyed the curriculum and his teaching style.

Do you plan on being involved in theatre in some aspect during college?

Dylan- Yes! I had a wonderful experience during my involvement with NPHS theatre. I plan on participating in stage crew here at Millersville in any capacity. But, everything is on hold until the pandemic settles down.

What was the transition like from NPHS to Millersville?

Kyle- I was a little nervous about going to Millersville since the coronavirus is still happening. But even with some serious precautions, the transition was pretty smooth. We both found a strong group of friends. And even though the school is a little bigger, it definitely feels like home.

What inspired you to go into biology education?

Dylan- I always loved biology! During boy scouts, I was in charge of instructing some of the newer guys in our troop. I taught them certain nature skills and survival tactics, and I really found it rewarding.

What words of wisdom would you like to give current students at North Penn?

Kyle- Make the most of your time at North Penn! Of course, remember time management is important, but dont forget to make time with friends and activities youre interested in. Those are the memories that will last you a lifetime.

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Alumni Spotlight- Procopio brothers and the biology of college life - Knight Crier

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NVR: 4 UPGRADED Stocks to Ride the Q4 Rally – StockNews.com

Saturday, October 10th, 2020

The market is in an interesting place. We have very strong price action with the market melting up and the Russell 2000 (IWM) leading. This is despite expectations that the market would see some selling due to the upcoming election, failure to reach an agreement on a stimulus package, and rising coronavirus case counts.This type of market action implies that the bad news has already been discounted. Under these conditions, traders and investors should look to buy fundamentally sound stocks. Our POWR Ratings can help you identify these stocks.

Lets take a look at four of the more intriguing POWR Rating upgrades: NVR (NVR), Masimo (MASI), NeoGenomics (NEO), and Workiva (WK).

NVR(NVR)

Building and selling homes, condos, and townhouses are one of the better ways to make money in 2020. This is NVRs business. With homes selling like gangbusters, NVR is raking in the cash. The companys homes are mainly built on a pre-sold basis. NVR also has a mortgage banking service and title service business.

Chances are you have seen NVR operating under the moniker of Ryan Homes, Heartland Homes, and/or NVHomes. The POWR Ratingsshow NVR has A grades in the Buy & Hold and Trade grade components. The stock is ranked 12th of 21 in the Homebuilders space. Home construction in the United States was up more than 22% this summer. Building permit applications are up nearly 20% from June. This is the perfect time to own homebuilder stocks such as NVR.

Masimo(MASI)

Health monitoring systems have quickly advanced, proving capable of accurately measuring everything from pulse rate to blood oxygen saturation levels. MASI makes such systems. The companys systems also monitor blood constituency including total hemoglobin, breathing, and brain activity.

MASI has A grades in each POWR Rating component. The stock is ranked in the top 25 of 140 in the Medical Devices & Equipment category. Of the seven analysts who have studied MASI,five recommend buyingit while two recommend holding and none advises selling.

MASIs quarterly revenue is up more than 30% on a year-over-year basis. MASIs system shipments are also up 174% on a year-over-year basis. The strong demand combined with the aging baby boomer segment of the population should help MASI return to its 52-week high of $258 by years end.

NeoGenomics(NEO)

Genetics diagnostic testing specialists waging war against cancer are at the forefront of medical technology. Such testing is the fastest growing lab industry segment. NEO testing services range from molecular genetic testing to cytogenetics, flow cytometry, anatomic pathology, and fluorescence in-situ hybridization. NEO helps hospital personnel, urologists, pathologists, oncologists, and other medical professionals do their jobs that much better.

NEO is a POWR Ratings beast with A grades in the Buy & Hold and Trade components along with B grades in the remaining components. Furthermore, NEO is ranked in the top 20 of 58 publicly traded companies in the Medical Diagnostics/Research category.

TipRanks shows theaverage analyst price target for NEO is $42.57, indicating it has a 10% upside. Even if NEOs business falters amidst the recession, the companys balance sheet is in tip-top shape with $331 million in cash. Ride NEOs profitable growth wave to new heights and you will be more than happy with your investment.

Workiva(WK)

Cloud platforms that help businesses gather, analyze, and manage important business data in a near-instantaneous manner are becoming that much more important as business shifts to the web. WK provides such solutions. WK clients include those in a wide array of industries ranging from telecom to transportation, consumer goods, real estate, media, financial services, energy, healthcare, and beyond.

WK has A grades in two of the four POWR Components (Buy & Hold and Trade) along with a top 20 rank in the Software Business space. WKs price return year-to-date is 39%. WK had a 2018 price return of 67%. The stocks three-year price return is 164%. The icing on the cake is theanalysts average price target of $65.25, meaning WK is poised to pop another 10%.

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NVR shares were trading at $4,366.20 per share on Friday afternoon, up $17.80 (+0.41%). Year-to-date, NVR has gained 14.65%, versus a 9.38% rise in the benchmark S&P 500 index during the same period.

Patrick Ryan has more than a dozen years of investing experience with a focus on information technology, consumer and entertainment sectors. In addition to working for StockNews, Patrick has also written for Wealth Authority and Fallon Wealth Management. More...

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City of Hope leads novel clinical trial to treat cancer patients with COVID-19 – The Cancer Letter

Saturday, October 10th, 2020

publication date: Oct. 9, 2020

In a new clinical trial, City of Hope is investigating a treatment for cancer patients with COVID-19 by repurposing leflunomide, an anti-inflammatory drug for rheumatoid arthritis, which is inexpensive and has few serious side effects.

Patients treated for cancer in the past two years may also be eligible.

FDA has recently approved the start of a phase I trial. At a later date, a phase II randomized clinical trial may take place if the first trial finds leflunomide to be safe and tolerable for these patients. City of Hope plans to work with other local medical centers who are treating cancer patients for SARS-CoV-2, the virus that causes COVID-19, to enroll them in the trial.

There are currently few effective drugs against COVID-19, and our clinical trial targets a critical high-risk group cancer patients whose immune systems are already weak, Steven T. Rosen, City of Hope provost and chief scientific officer, and the Irell & Manella Cancer Center Directors Distinguished Chair and Morgan & Helen Chu Directors Chair of the Beckman Research Institute, said in a statement. Our hope is that leflunomide will eradicate COVID-19 in cancer patients, providing the medical community with an effective therapy against this devastating virus.

Sanjeet Dadwal, City of Hope chief of the Division of Infectious Diseases, is the principal investigator on the trial.

For the phase I trial, all patients will receive leflunomide and may also be able to simultaneously receive other standard of care treatments for COVID-19. They may receive remdesivir, an antiviral therapy. Patients with acute respiratory distress syndrome may receive the steroid, dexamethasone, and patients with complications of COVID-19 such as cytokine release syndrome, which can lead to multiple organ failure, can receive the antibody tocilizumab.

If the phase I trial is found to be a safe and tolerable treatment, then a phase II randomized, double-blind trial will open at a later date. About half the patients will receive leflunomide with standard of care therapies to treat COVID-19, and the other half will receive a placebo and standard of care drugs as well.

Leflunomide is an oral and generic anti-inflammatory drug approved by FDA to safely treat autoimmune diseases such as rheumatoid arthritis. The therapy has also been used in cancer patients with cytomegalovirus with tolerable side effects.

Laboratory experiments performed at City of Hope and Wuhan, China, indicate that leflunomide has high potential to shut down viral replication by preventing the synthesis of viral RNA, the genetic material. It also downregulates the expression of ACE 2, a receptor for COVID-19 cell entry. A small clinical trial using leflunomide in China also demonstrated the therapy has potential antiviral drug against COVID-19.

In a phase I clinical study, City of Hope treated patients with advanced multiple myeloma with leflunomide. The therapy stabilized their disease with tolerable side effects.

NCI has funded the trial with a P30 grant supplement for COVID-19 research projects. City of Hope is one of a few cancer centers that has received such funding during the pandemic.

City of Hope also received funding from private donors, including The Elias, Genevieve and Georgianna Atol Charitable Trust and The Norman and Sadie Lee Foundation.

Novel CAR T-cell lymphoma therapy developed at MCW advances to phase II study

A novel cancer therapy studied and developed at the Medical College of Wisconsin with promising clinical outcomes is leading to a larger phase II trial to improve on the current standard of care.

Results of phase I of the first-in-the-world double targeted CAR T-cell therapy clinical trial were published in Nature Medicine.

This is a novel, cell-based treatment against cancer targeting two proteins (antigens CD19 and CD20) on the surface of cancer cells. This CAR T-cell therapy trial began in October 2017 and resulted in safe and promising outcomes for patients with relapsed and refractory B cell non-Hodgkin lymphomas which are cancers of the immune system.

MCW researchers collected patient T cells and then used a specially engineered virus to augment their ability to identify and kill cancerous cells and effectively destroy the lymphoma. While phase I focused on safety and feasibility of the treatment, a multi-institutional phase II is being developed to determine the true efficacy and understand how the nuances of the treatment process can result in excellent outcomes for a larger subset of patients.

All patients in the clinical trial had failed prior treatments and their cancer had relapsed. Within 28 days of the CAR-T cell therapy, 82 percent responded positively. Six months later, more than half of the patients cancer remained in remission. A higher dose of the treatment correlated with a prolonged remission, a trend the researchers plan to study further in the trials second phase.

The new treatment genetically alters a persons own immune cells to target cancer cells in a unique and personalized fashion, a significant departure from more routine chemotherapy.

The cell product used for treatment was manufactured using the CliniMACS Prodigy device, which is part of an automated CAR T cell manufacturing platform developed by Miltenyi Biotec.

Housed at the Froedtert & MCW Clinical Cancer Center, the CliniMACS Prodigy device enabled the research team to conduct the CAR T-cell immunotherapy through a self-contained, desktop system, producing new cells ready to be infused back into a patients bloodstream within 14 days. With the device, the entire process was performed locally at Froedtert Hospital.

This research was made possible through philanthropic dollars raised by the Childrens Wisconsin Foundation and the MACC Fund and their support of the Cell Therapy Lab at MCW.

MD Anderson researchers identify characteristics of infused CAR T cells associated with efficacy and toxicity in large B-cell lymphoma

Researchers at MD Anderson Cancer Center have identified molecular and cellular characteristics of anti-CD19 CAR T cell infusion products associated with how patients with large B-cell lymphoma respond to treatment and develop side effects.

The research team also found that early changes in circulating tumor DNA one week after CAR T cell therapy may be predictive of treatment response in a particular patient. The paper was published online in Nature Medicine.

CAR T cell therapy is highly effective against LBCL, corresponding author Michael Green, associate professor of lymphoma and myeloma, said in a statement. However, we experience two main clinical challenges: achieving long-term remission and managing treatment-associated adverse events.

This study suggests that, within the first week of therapy, clinicians may be able to identify a subset of patients who may experience more poor outcomes or adverse treatment reactions, said Green. This would allow the care team to adjust therapy to improve efficacy or to act to mitigate toxicity.

For this study, researchers performed single-cell analysis on CAR T cells to study gene expression profiles in the infused cells. CAR T cells were collected from those remaining in infusion bags following treatment of 24 patients with LBCL. These genetic profiles were compared to treatment responses, determined at three months post-infusion by PET/CT scan.

When we look at the characteristics of the infused CAR T cells, we found that samples from patients who were less responsive to treatment had exhausted T cells, whereas those who experienced complete responses had T cells expressing memory signatures, co-corresponding author Sattva Neelapu, professor of lymphoma and myeloma, said in a statement. Additionally, one cellular signature of T cell exhaustion was more commonly found in patients who exhibited a poor molecular response, and poor molecular response is generally associated with less-positive, long-term outcomes.

Further, the researchers analyzed early molecular responses in the patients by monitoring changes in circulating tumor DNA from treatment to one week post-infusion. The magnitude of change in tumor-associated DNA corresponded with response, suggesting that patients who displayed an early molecular response were more likely to experience a clinical response to treatment.

When we examined the infusion product, we found that a cell population with characteristics similar to myeloid cells, with a monocyte-like transcriptional signature, was associated with development of high-grade neurotoxicity, Green said. Detecting these cells may subsequently lead us to identify patients who would be at higher risk of developing neurotoxicity, allowing us to provide prophylactic treatment with agents that target the specific cellular features.

Further examination may lead to insights into the types and attributes of the cells present within the CAR T infusion product.

This study also tells us that some rare and unexpected cells identified by single-cell analysis could be biologically important, said co-corresponding author Linghua Wang, assistant professor of Genomic Medicine. Going forward, we plan to functionally characterize these monocyte-like cells to better understand their specific biological mechanisms driving these clinical results.

These findings will help researchers develop clinical interventions that can block or target these cells. They also plan to validate the capacity of circulating tumor DNA to accurately predict patients long-term outcomes.

This research was supported in part by the B-cell Lymphoma Moon Shot, part of MD Andersons Moon Shots Program. With support from the Moon Shot and the Cancer Prevention & Research Institute of Texas, the research team plans to utilize PDX models of disease that relapsed following anti-CD19 CAR T cell therapy to preclinically test interventions that could lead to better treatment responses or to prevention of adverse side effects.

Other research support came from the Schweitzer Family Fund, NCI (P30 CA016672) and start-up research funds from MD Anderson. A full list of co-authors and their disclosures can be found here.

MD Anderson researchers: Cancer mutations accumulate in distinct regions based on structure of genome and mutational causes

A study from researchers at MD Anderson Cancer Center indicates that mutations found in cancers do not accumulate randomly, but are found in distinct patterns that vary based on the three-dimensional organization of the genome in the cell as well as the underlying factors causing the mutations.

Mutations caused by external factors, such as ultraviolet light or tobacco smoke, led to mutations in different regions than internal factors, such as defects in DNA damage repair or proofreading machinery. The findings, published in Nature Genetics, are important for understanding what factors may be driving mutations in a given cancer and may point to new therapeutic targets.

DNA is not randomly organized within the nucleus, and we found that this structure is strongly correlated with how cancer cells accumulate mutations, lead author Kadir Akdemir, instructor of genomic medicine, said in a statement. We know there are certain processes causing mutations in cancer cells, but we dont always understand the underlying causes. These findings should give us a clue as to how cancer accumulates mutations, and perhaps we can target and kill cancer cells by leveraging the mutations they accumulate.

Within the nucleus of the cell, DNA is packaged with proteins into chromatin, a highly organized and compacted structure that makes up our chromosomes. Within this structure, genes that are frequently used in the cells are organized together in active domains, which are more readily accessible. Those genes used less often are similarly organized together in inactive domains.

The researchers analyzed whether mutations are distributed more frequently in these active or inactive domains in cancer by studying publicly available whole-genome sequencing data of 3,000 paired samples of normal tissue and tumor tissue across 42 cancer types.

Across every cancer type studied, the inactive domains carried significantly more mutations than the active domains, suggesting that the accumulation of mutations is strongly correlated with the three-dimensional organization of the genome.

As a validation of these findings, the researchers looked specifically at the X chromosome in male and female patients. In females, one of their two X chromosomes is inactivated, so it is essentially itself an inactive domain. When comparing the X chromosome between sexes, females had more mutations than males with a marked distribution difference, largely driven by an abundance of mutations on the inactive chromosome.

Knowing that mutations can be caused by a variety of distinct processes, the researchers also investigated whether external environmental factors resulted in different mutation patterns compared to those caused by internal factors in the cell.

Interestingly, we found that different causes of mutations resulted in distinct accumulation patterns within the cell, senior author Andy Futreal, chair of genomic medicine, said in a statement. Extrinsic factors were associated with an enrichment of mutations in inactive domains, whereas intrinsic factors were correlated with enriched mutations in active domains. This provides us an important foundation going forward to understand the root of cancer mutations when we dont otherwise know the cause.

Knowing the causes and distributions of cancer-related mutations may open up potential therapeutic options, explained Akdemir, such as targeted therapies against a specific signaling pathway or combinations with immunotherapy.

For example, immunotherapy may be able to better recognize a cancer cell if more mutations are present. However, if mutations occur primarily in inactive domains, they would rarely be seen by the immune system. Therapeutic agents that restore activity to these domains, used in combination with immune checkpoint inhibitors, could stimulate a stronger anti-tumor immune response.

This research was supported by the Cancer Prevention & Research Institute of Texas (R1205), The Robert A. Welch Distinguished University Chair in Chemistry, and NIH (P50CA127001, DP5OD023071, Z1AES103266). A full list of authors and their disclosures can be found with the full paper here.

UCSD study: Personalized cancer therapy improves outcomes in advanced disease

Researchers at the University of California San Diego School of Medicine found that patients receiving care for advanced cancer at Moores Cancer Center at UC San Diego Health were more likely to survive or experience a longer period without their disease progressing if they received personalized cancer therapy.

The study was published in Nature Communications.

Led by Razelle Kurzrock, director of the Center for Personalized Cancer Therapy at Moores Cancer Center and senior author of the study, a multidisciplinary molecular tumor board was established to advise treating physicians on course of care using an individual patients molecular tumor makeup to design precision medicine strategies.

Patients who underwent a molecular tumor board-recommended therapy were better matched to genomic alterations in their cancer and had improved outcomes, Kurzrock said in a statement. The three-year survival for patients with the highest degree of matching and who received a personalized cancer therapy was approximately 55% compared to 25% in patients who received therapy that was unmatched or had low degrees of matching.

Of 429 patients evaluated by the molecular tumor board, 62% were matched to at least one drug. Twenty percent of patients matched to all recommended drugs, including combination therapies.

The tumor board acted in an advisory role and treating physicians chose not to use the boards recommended strategy in 38% of cases, opting instead for a standard therapy approach that might have been unmatched to the patients genetic alterations or had a low degree of matching. These patients experienced a lower progression-free survival and overall survival rates.

The use of next-generation sequencing allows for the identification of novel potential targets for patients with cancer to improve outcomes, but there are challenges to using this approach widely, said Shumei Kato, associate professor of medicine at UC San Diego School of Medicine and first author.

One of the hurdles is that every cancer patient appears to be carrying different molecular and genomic patterns despite having the same cancer type, Kato, a Moores Cancer Center medical oncologist specializing in rare and gastrointestinal cancers, said in a statement. This can be challenging since we are customizing therapy based on the unique genomic pattern patients have, and thus it is difficult to predict the response. In addition, this approach requires multidisciplinary expertise as well as access to drugs or clinical trials not always available in smaller practices.

At Moores Cancer Center, the molecular tumor board is composed of experts in basic, transitional and clinical research as well as bioinformatics, genetics, radiology, pathology and physicians in multiple specialties such as medical, surgical and radiation oncology.

This research was funded, in part, by NIH (P30 CA023100) and the Joan and Irwin Jacobs Fund.

Phase III CheckMate-816 trial: Opdivo + chemotherapy demonstrates improvement in pathologic CR in resectable NSCLC

The phase III CheckMate-816 trial met a primary endpoint of pathologic complete response in resectable non-small cell lung cancer.

In the trial, significantly more patients treated with Opdivo (nivolumab) plus chemotherapy before surgery showed no evidence of cancer cells in their resected tissue compared to those treated with chemotherapy alone. CheckMate-816 is the first and only phase III trial to demonstrate a benefit with an immune checkpoint inhibitor in combination with chemotherapy as a neoadjuvant treatment in non-metastatic NSCLC.

Opdivo is sponsored by Bristol Myers Squibb.

Patients in the experimental arm of the trial received up to three doses of Opdivo plus chemotherapy prior to surgery, a standard number of cycles of therapy in the neoadjuvant setting. The safety profile of Opdivo plus chemotherapy was consistent with previously reported studies in NSCLC.

Nivolumab has shown benefit as an adjuvant, or post-surgical, treatment option in other cancer types, and the positive results from CheckMate -816 speak to its potential in the neoadjuvant setting of resectable non-small cell lung cancer, Mark Awad, clinical director of Lowe Center for Thoracic Oncology at Dana-Farber Cancer Institute, said in a statement.

The CheckMate-816 trial is ongoing to assess the other primary endpoint of event-free survival, to which the company remains blinded, as well as key secondary endpoints.

In non-metastatic NSCLC, Bristol Myers Squibb and collaborators are exploring the use of immunotherapy in the neoadjuvant, adjuvant and peri-operative settings, as well as in association with chemoradiation. To date, Opdivo has shown improved efficacy in the neoadjuvant or adjuvant treatment of four tumor types: lung cancer, bladder cancer, esophageal/gastroesophageal junction cancer and melanoma.

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Coronavirus antibodies last at least three months after infection, U of T study finds – News@UofT

Thursday, October 8th, 2020

Coronavirus antibodies can last at least three months after a person becomes infected with the virus that causes COVID-19, according to a study published in Science Immunology.

Researchers from the University of Toronto and the Lunenfeld-Tanenbaum Research Instituteat Sinai Health used both saliva and blood samples from COVID-19 patients to measure and compare antibody levels for over three months post-symptom onset.

They found that antibodies of the IgG class that bind to the SARS-CoV-2 spike protein are detectable for at least 115 days, representing the longest time interval measured. The study is also the first to show these antibodies can also be detected in the saliva.

Our study shows that IgG antibodies against the spike protein of the virus are relatively durable in both blood and saliva, said Jennifer Gommerman, professor of immunology in U of Ts Temerty Faculty of Medicine and leader of the saliva testing effort.

Our study suggests saliva may serve as an alternative for antibody testing. While saliva is not as sensitive as serum, it is easy to collect.

The saliva assay was developed at U of Twhile a team at Lunenfeld-Tanenbaum, led by senior investigator Anne-Claude Gingras, who is also a professor of molecular genetics at U of T, executed the serum assay.

The LTRI platform for detection of antibodies in serum, or blood, is incredibly robust and well suited for assessing the prevalence of infection within the community, said Gingras. This is another tool that can help us better understand and even overcome this virus.

Anne-Claude Gingras, a professor of molecular genetics at U of T, led a team at theLunenfeld-Tanenbaum Research Institute that executed the serum assay for the study (photo courtesy of Mount Sinai Hospital)

Most people who recover from COVID-19 develop immune agents in their blood called antibodies that are specific to the virus. These antibodies are useful in indicating who has been infected, regardless of whether they had symptoms or not.

A large team of scientists collaborated on the study, including Allison McGeer and Mario Ostrowski, who provided access to the paired saliva and serum samples from dozens of patients for the study.

McGeer is a professor of laboratory medicine and pathobiology at U of T, a senior clinician scientistat Lunenfeld-Tanenbaum and principal investigator of the Toronto Invasive Bacterial Diseases Network. Ostrowski is a professor of medicine, immunology, and laboratory medicine and pathobiology at U of Tand a scientist at St. Michaels Hospital, Unity Health Toronto.

The study was co-led by U of T graduate students Baweleta Isho, Kento Abe, Michelle Zuo and Alainna Jamal. James Rini, a professor of biochemistry and molecular genetics at U of T, and Yves Durocher from the National Research Council of Canada, provided key protein reagents for the saliva studies.

The durability of the antibody response to SARS-CoV-2 has been debated in recent months. An earlier study published in Nature Medicine suggested the antibodies can disappear after two months for some individuals who had the virus but did not experience symptoms.

This study led by the Toronto team is in agreement with findings from leading immunologists in the U.S. in describing the antibody response as longer lasting.

While the team admits there is a lot they still dont know about antibody responses to SARS-CoV-2 infection, including how long the antibodies last beyond this period or what protection they afford against re-infection, the research could have broader implications in the development of an effective vaccine.

This study suggests that if a vaccine is properly designed, it has the potential to induce a durable antibody response that can help protect the vaccinated person against the virus that causes COVID-19, Gommerman said.

The researchwas supported by an Ontario Together grant and funding from the Canadian Institutes of Health Research. Funding for the development of the assays in the Gingras lab was provided through donations bythe Royal Bank of Canada, Questcap and the Krembil Foundation.

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Comprehensive Review of Numerical Chromosomal Aberrations in Chromophobe Renal Cell Carcinoma Including its Variant Morphologies. – UroToday

Thursday, October 8th, 2020

Chromophobe renal cell carcinoma (ChRCC) accounts for 5% to 7% of all renal cell carcinomas. It was thought for many years that ChRCC exhibits a hypodiploid genome. Recent studies using advanced molecular genetics techniques have shown more complex and heterogenous pattern with frequent chromosomal gains. Historically, multiple losses of chromosomes 1, 2, 6, 10, 13, 17, and 21 have been considered a genetic hallmark of ChRCC, both for classic and eosinophilic ChRCC variants. In the last 2 decades, multiple chromosomal gains in ChRCCs have also been documented, depicting a considerably broader genetic spectrum than previously thought. Studies of rare morphologic variants including ChRCC with pigmented microcystic adenomatoid/multicystic growth, ChRCC with neuroendocrine differentiation, ChRCC with papillary architecture, and renal oncocytoma-like variants also showed variable chromosomal numerical aberrations, including multiple losses (common), gains (less common), or chromosomal changes overlapping with renal oncocytoma. Although not the focus of the review, The Cancer Genome Atlas (TCGA) data in ChRCC show TP53, PTEN, and CDKN2A to be the most mutated genes. Given the complexity of molecular genetic alterations in ChRCC, this review analyzed the existing published data, aiming to present a comprehensive up-to-date survey of the chromosomal abnormalities in classic ChRCC and its variants. The potential role of chromosomal numerical aberrations in the differential diagnostic evaluation may be limited, potentially owing to its high variability.

Advances in anatomic pathology. 2020 Oct 05 [Epub ahead of print]

Reza Alaghehbandan, Kiril Trpkov, Maria Tretiakova, Ana S Luis, Joanna D Rogala, Ondrej Hes

Department of Pathology, Faculty of Medicine, Royal Columbian Hospital, University of British Columbia, Vancouver, BC., Department of Pathology and Laboratory Medicine, University of Calgary, Calgary, AB, Canada., Department of Pathology, University of Washington, Seattle, WA., Department of Pathology, Portuguese Institute of Oncology of Porto Francisco Gentil, Porto, Portugal., Department of Pathology, Charles University in Prague, Faculty of Medicine and University Hospital in Plzen, Plzen, Czech Republic.

PubMed http://www.ncbi.nlm.nih.gov/pubmed/33021507

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The Microscopic Majesty of Sugars, Salts, and Spices – Atlas Obscura

Thursday, October 8th, 2020

While working on his upcoming cookbook, The Flavor Equation, food writer Nik Sharma packed up an array of salt, sugar, and spices and headed to the University of California, Berkeley. At the Biological Imaging Facility, he trained an AxioImager M1 microscope down at slides covered with brown sugar and kala namak, Indian black salt. With a ZEISS confocal laser scanning microscope, he peered down at bonito flakes and yeast suspended in vinegar.

These powerful microscopes revealed the razor-like ridges of Maldon salt and the fat, gem-like grains of brown sugar. The resulting photos make up a single spread at the end of his 352-page book. Nevertheless, both in his introduction to the book and over the phone, Sharma notes that including the super-zoomed-in photos was his one dream.

Though Sharma has been a food writer and columnist for years (currently with bylines in the New York Times, the Guardian, and Serious Eats), he started out as a molecular biologist, with a background in biochemistry and microbiology and a degree in molecular genetics. The Flavor Equation shows how Sharma has used his education. The book itself is replete with colorful diagrams that wouldnt look out of place in a chemistry textbook and techniques such as one for making oven fries that Sharma adapted from blood collection. (Turns out, citric acid and sodium citrate, via lemon juice and baking soda, can both keep blood from coagulating and improve the texture of your fries.)

While Sharma has pondered a science-themed cookbook for years, from the beginning, he had a clear idea of what he would write: a cookbook that broadens the conception of food science beyond its narrowly Western focus.

As someone who loves science and loves cooking, I have noticed always that theres a very strong emphasis on European foods when it comes to food science, he says. Hed never seen microscope photography of a number of his favorite ingredients.

It was this impulse that led Sharma to take his ingredients to the lab at Berkeley. The resulting photos reveal quite a bit about the qualities of the seasonings, all of which are used in various recipes in the book. Theres an enormous contrast between the defined shape of coarse salt and the fluffy-looking texture of kala namak. Sharma notes that the difference stems from the compounds that make up each. Most table salts are close to pure sodium chloride, while kala namak, mined from the earth and smoked, is made up of numerous other compounds that give it its unique properties. With its sulfuric chemicals, the black salt (which, despite its name, is red and not black) is often used by vegans to give foods a taste reminiscent of eggs.

The same comparison applies to brown sugar and jaggery. Brown sugar is simply white sugar blended with molasses. The result, when viewed under a super-powered microscope, is large, distinct crystals. Jaggery, on the other hand, is much less processed. Boiled down from the juice crushed out of sugarcane, its relative complexity compared to brown sugar is obvious from its varied texture. So its more of an amorphous powder, Sharma says, as the additional compounds inhibit its ability to form a defined crystal structure.

The shapes of seasonings do have an effect on cooking, Sharma says, though in many cases it may be too subtle for many people to notice. One example he gives is kosher salt, specifically the brand Diamond Crystal. If you look under the microscope, its like teeny glass shards. Its so flat and thin. So they dissolve really fast in water at room temperature. Sprinkled on a steak, you have more osmosis taking place with kosher salt because its dissolving faster on the surface. The result, with the salt pulling water towards it quickly, is a better crust on your cooked steak.

Yet only a handful of the otherworldly seasoning pictures made it into Sharmas book. For one thing, he had already gone 200 pages over his publishers limit, and many of the pictures werent quite the right resolution to print. In the end, he satisfied his scientific impulse with the other photos in the book. Sharma, a skilled photographer, took all the photos for The Flavor Equation. For many, he says, he wanted the illusion that he had taken them with a microscope, an effect he accomplished by using a huge homemade light box and glass plates. The cover sports an image of lime slices laid flat, their segments as distinct as panes of stained glass, and a photo of a pool of oil, for a chapter on Richness, is so zoomed in that you can count the bubbles.

While Sharma has dreams of buying a microscope for more food photography, theres a reason he had to go to a special lab for these pictures. (Said scopes are wildly expensive.) So this is the best that I could do, in my own way, he says, to show people the unique geometry of the ingredients they use every day. Its not like science only applies to European food, he states. It also applies to other cultures.

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Neurology Department calls for grant proposals to support Alzheimer’s disease and related research – The South End

Thursday, October 8th, 2020

The Department of Neurology at the Wayne State University School of Medicine, partnered with Department of Psychiatry and Behavioral Sciences, has an endowment from the Albert and Goldye J. Nelson Fund to support scientific research in the detection, pathogenesis, molecular genetics, neurobiology and therapeutic development to cure Alzheimers disease and related disorders. Available funds for the coming fiscal year are between $50,000 and $100,000.

The Neurology Department is accepting proposals for FY 2021.Interested applicants must submit a proposal that consists of:

1. Specific aim (one page)

2. Research plan (six pages)

3. Human subjects if applicable (two pages)

4. Vertebral animals if applicable (two pages)

5. Biosketch (National Institutes of Health format) for all personnel involved in the study

6. Budget with budget justification

7. Resource

8. Support letters

Funds may not be used to cover the principal investigators salary. Proposals are for two to three years. Applicants must have at least a .25 FTE faculty appointment at the School of Medicine.

The deadline for submission is Jan. 31, 2021. The grant will begin Aug. 1, 2021.

Submit proposals to Carla Santiago, research administrator, WSU Department of Neurology - 8D UHC, 4201 St. Antoine, Detroit, MI 48201. E-mail:csantiago@med.wayne.edu.

Please note that the grant submissions must follow grant guidelines. Please click here for the guidelines.

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Researchers receive more than $53 million to study role of white matter lesions in dementia – Newswise

Thursday, October 8th, 2020

Newswise A $53.6 million grant from the National Institutes of Health will aid brain scientists, including a researcher from The University of Texas Health Science Center at Houston (UTHealth), in studying the role of incidental white matter lesions, or WMLs, in dementia among diverse people with cognitive complaints.

The study is led by UC Davis School of Medicine in partnership with UTHealth. It is a new and critical part of the NIHsVascular Contributions to Cognitive Impairment and Dementia(VCID) research program.

Co-principal investigator isMyriam Fornage, PhD, professor of genetics at theBrown Foundation Institute of Molecular Medicine for the Prevention of Human Diseasesat McGovern Medical School at UTHealth. Fornage is a leading researcher on the molecular genetics of cerebrovascular disease.

Our team has been at the forefront of genetic studies of WMLs for two decades, Fornage said. Through the genetic risk profiles we will develop, we will have an opportunity to apply what we have discovered and improve the precision with which we identify patients with a higher prior probability of cognitive impairment and dementia. At the same time, we will be contributing new resources for dementia research everywhere.

The principal investigator isCharles DeCarli, MD, professor of neurology, director of theUC Davis Alzheimers Disease Centerand the nations foremost expert on the role of subcortical cerebrovascular disease in cognitive decline. In the last few years, DeCarli has been awarded national and state research grants exceeding $33 million.

The magnitude of this NIH grant underscores UC Davis Alzheimers Disease Centers national prominence and research leadership, said UC Davis School of Medicine Dean Allison Brashear,MD, a neurologist nationally known for her groundbreaking research in movement disorders. This multiyear research award will enable us to make game-changing advancements in our understanding and treatment of dementia.

WMLs occur when tissue deep in the brain becomes injured, often due to changes in small blood vessels. They are common and often found on brain MRIs of people who have concerns about their brain health.

Why or how WMLs are associated with cognitive decline is not known. Questions surround whether certain WML characteristics, such as size and location, make them greater risk factors for dementia. It also isnt clear how comorbidities additional health conditions such as heart disease or diabetes together with WMLs increase risk for cognitive decline. Defining these connections is essential to improving outcomes for the 5.7 million people in the U.S. affected by cognitive impairment and dementia.

DeCarli and Fornages landmark research is expected to answer these questions and lead to standards for assessing, diagnosing, and treating individuals with WML-related cognitive problems.

This grant gives us the chance to study WMLs from every angle and definitively understand their roles in age- and disease-related cognitive decline and risk for future dementia, DeCarli said. Its the culmination of our three decades of research that has given us great directions, but no final answers yet.

DeCarli and Fornage will conduct a study of patients with WMLs on their MRIs and concerns about cognitive symptoms, but no dementia diagnosis. It will be the first large study of a diverse population on the long-term effects of these lesions on thinking and dementia risk.

Beginning September 2021, study participants will be recruited at UC Davis Health and at least 10 other locations throughout the U.S. They will be from a variety of backgrounds, so the researchers can identify how WML outcomes differ by race, ethnicity, and sex, better representing those at risk for dementia.

Our ultimate goals are to develop a risk profile that identifies the likelihood of WML-related cognitive impairment and dementia over the course of five to 10 years and to identify clear targets for interventional trials, DeCarli said.

Resources to advance all dementia research

Another exciting part of the grant, according to the researchers, is the chance to fund additional studies aimed at refining diagnostic and predictive tools and methods for dementia. The outcomes will enhance dementia research and clinical care worldwide.

Data and samples from these studies will be shared with the wider research community via theNational Alzheimers Coordinating Center at the University of Washingtonand theNational Centralized Repository for Alzheimers Disease and Related Dementias at Indiana University. Images will be shared through theLaboratory of Neuro Imaging at the University of Southern California.

DeCarli and Fornage also participate in theMarkVCID Consortium, supported by the NIHsNational Institute of Neurological Disorders and Stroke. The consortium was established in 2016 to identify biological markers of vascular cognitive impairment and dementia.

This award is co-sponsored by the NIHs National Institute of Neurological Disorders and Stroke andNational Institute on Agingthrough grant 1U19NS120384.

The Brown Foundation Institute of Molecular Medicine (IMM) for the Prevention of Human Diseases is part of McGovern Medical School at The University of Texas Health Science Center at Houston (UTHealth). The IMM is focused on studying and preventing diseases at the genetic, cellular, and molecular levels using DNA and protein technologies and animal models. The IMM is part of the Texas Therapeutics Institute, a multi-institutional collaboration encouraging drug discovery. For more information, visitwww.uth.edu/imm/mission.htm.

The UC Davis Alzheimers Disease Research Center is one of only31 research centers designated and funded by the NIHs National Institute on Aging. The center's goal is to translate research advances into improved diagnosis and treatment for patients while focusing on the long-term goal of finding a way to prevent or cure Alzheimers disease and other dementias. The center also allows researchers to study the effects of the disease on a uniquely diverse population. For more information, visithealth.ucdavis.edu/alzheimers.

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Skyhawk Therapeutics Expands Leadership Team with Chief Medical Officer and Head of Chemistry, and adds to its Scientific Advisory Board – PRNewswire

Thursday, October 8th, 2020

Joseph Duffy PhD brings 20+ years of small molecule discovery chemistry and operations to his role as SVP Chemistry of Skyhawk Therapeutics, Elliot Ehrich MD brings 20+ years of clinical development for novel pharmaceuticals to his role as Chief Medical Officer of Skyhawk Therapeutics,and Rob Hershberg MD-PhD with 25+ years of biotech and pharma experience has joined Skyhawk's Scientific Advisory Board.

WALTHAM, Mass., Oct. 5, 2020 /PRNewswire/ -- Skyhawk Therapeutics today announced that Dr. Elliot Ehrich has joined the Company as Chief Medical Officer and Dr. Joseph Duffy has joined as Senior Vice President of Chemistry. The Company also strengthened its Scientific Advisory Board with the addition of Dr. Rob Hershberg.

"We are delighted that Joe and Elliot have come on board at Skyhawk," said Bill Haney, co-founder and CEO of Skyhawk Therapeutics. "Their combined scientific and clinical accomplishments will be invaluable in shepherding our novel RNA-targeting small molecule drug candidates successfully into the clinic. We are also excited to welcome Rob to our Scientific Advisory Board. His clinical and scientific insight and deep experience as a drug developer will be a tremendous addition to Skyhawk."

Elliot Ehrich, MD most recently served as a Venture Partner at 5AM Ventures and Chief Medical Officer (CMO) at Expansion Therapeutics, a 5AM Ventures portfolio company. Previously, Dr. Ehrich spent 17 years at Alkermes ultimately as Executive Vice President of R&D and CMO. At Alkermes he led the development and successful FDA registration of multiple new medicines. Dr. Ehrich has also worked in clinical pharmacology and clinical research at Merck &Co, Inc..

Dr. Ehrich received a BA in biochemistry from Princeton University and an MD from Columbia University. He completed a residency in internal medicine and a fellowship in immunology and rheumatology at Stanford University Medical School followed by postdoctoral research the Department of Microbiology and Immunology.

Over the past four years, Joseph Duffy PhD, served as Executive Director of Discovery Chemistry atMerckResearch Laboratories in Rahway and Kenilworth, New Jersey, where he oversaw multiple preclinical drug discovery teams. Dr. Duffy's contributions over 24 years at Merck included all phases of drug discovery, from lead identification through clinical phase candidate development. He directed successful lead optimization efforts for multiple indications, resulting in clinical candidates and Investigational New Drug (IND) applications from both internal projects and international collaborative research with biotech organizations. Dr. Duffy received his B.Sc. in Chemistry from Kent State University and his Ph.D. from Harvard University.

Rob Hershberg MD-PhD began his career as an Assistant Professor at Harvard Medical School and an Associate Physician at Brigham and Women's Hospital in Boston. Later, Dr. Hershberg co-founded VentiRx Pharmaceuticals and, as President and Chief Executive Officer, led the company through its transformational partnership with Celgene. Dr. Hershberg joined Celgene in 2014 to lead their efforts in Immuno-Oncology, was promoted to Chief Scientific Officer in 2016, and was subsequently Executive Vice President and Head of Business Development & Global Alliances and served as a member of the Executive Committee until the acquisition of Celgene by Bristol-Myers Squibb in 2019. Rob is currently a Venture Partner on the Frazier Life Sciences team. He completed his undergraduate and medical degrees at the University of California, Los Angeles and received his Ph.D. at the Salk Institute for Biological Studies.

Dr Hershberg joins Skyhawk's distinguished Scientific Advisory Board which includes:

Skyhawk Therapeutics is committed to discovering, developing and commercializing therapies that use its novel SkySTARTM (Skyhawk Small molecule Therapeutics for Alternative splicing of RNA) platform to build small molecule drugs that bring breakthrough treatments to patients.

For more information visit: http://www.skyhawktx.com, https://twitter.com/Skyhawk_Tx, https://www.linkedin.com/company/skyhawk-therapeutics/

SKYHAWK MEDIA CONTACT:Anne Deconinck[emailprotected]

SOURCE Skyhawk Therapeutics

http://www.skyhawktx.com

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Students with disabilities, university accommodations adapt to virtual learning – OSU – The Lantern

Thursday, October 8th, 2020

Ohio State students with disabilities are adjusting to new accommodations for virtual learning. Credit: Mackenzie Shanklin | Assistant Photo Editor

Online classes are decreasing commute times, allowing students to rewatch live lectures and keeping the university community safe from COVID-19; however, for students with disabilities, the technological interface and isolation pose difficulties they dont face in a typical semester.

As a majority of Ohio State courses have moved to distance learning, Scott Lissner, the universitys Americans with Disabilities Act coordinator, said his office is working to provide students with disabilities a comprehensive education while also keeping them safe during the pandemic. For some of those accommodations, online learning is making the process easier.

If everybody is [taking classes] online, it removes a lot of challenges and simplifies things. We know how to integrate captioning in Zoom. We know how to integrate ASL interpreting into Zoom, Lissner said.

CarmenZoom offers captioning of class and lecture recordings, but did not offer live, automated captioning until recently.

Amy Shuman, a professor in the Department of English and former director of disability studies in the department, said although she records all her classes and uploads the videos with transcripts to make them more accessible, she hasnt seen a widespread shift toward the practice.

Ive talked to some of the older faculty who have hearing aids, and theyre frustrated by the lack of the closed captioning, Shuman said.

Lissner said in an email that Zoom tested live, automated captioning over the summer and Ohio State evaluated the system before releasing it Friday. A Friday press release from Ohio States IT department stated that live captioning is a setting Zoom meeting hosts must manually enable for their classes.

Lindsay Rogers, a first-year in molecular genetics who is hearing impaired, said online classes are easier for her than in-person classes because professors can talk directly into her hearing implants via Bluetooth, but shes had difficulty getting accommodations she typically gets each semester.

I requested [note taking assistance] for this semester, and no one contacted me about getting any sort of note taking assistance, Rogers said.

Lissner said students who do not have proper technology for their classes such as small monitors or devices that cannot connect to hearing aids via Bluetooth are sometimes able to borrow devices from the university. The university has screen-reader compatible monitors, for example, and high-quality speakers that can play sound at higher volumes.

Lissner said these loans are offered on a case-by-case basis depending on students specific disabilities. Students with disabilities are encouraged to participate in live class sessions and are provided with the materials necessary to successfully take part, he said.

We work with faculty and students to make sure accessible versions of whatever is being presented on the shared screen are distributed to students who need them prior to class. So they can either open it up in another window or have a dual monitor setup, Lissner said.

Hybrid courses and discussion-based courses can be difficult to replicate for students who require accommodations, but the ADA office tries to make students feel included while working virtually, Lissner said.

For example, if a student needs ADA accommodations in a hybrid class and is unable to attend in-person sessions, monitors can be set up in a circle around the student, with a wide angle camera used in the physical classroom. This creates an environment closer to that of an in-person class.

Isaac Meisner, a second-year in environmental policy and decision making, said having mostly online courses presents challenges with their mental illnesses.

When youre having classes that are completely online, it makes my mental disorders more difficult to handle just because I need that interaction with other people, and Im not really getting it outside of where I live, Meisner said.

Kayden Gill, a third-year in health sciences and co-president of Buckeyes for Accessibility, said as a wheelchair user and someone with a visual impairment, online courses present both positives and negatives. One of the main cons, Gill said, is it is harder to find ways to exercise without traveling across campus.

From a visual disability standpoint, its a lot easier not to have to worry about finding the place in the lecture hall that you can see, or just always having something as large as your screen can make it is nice, Gill said.

Students can register for accommodations on the Student Life Disability Services website.

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Dolly the Sheep: ’90s Media Sensation – Mental Floss

Thursday, October 8th, 2020

It was Saturday, February 22, 1997, and Scottish researchers Ian Wilmut and Keith Campbell were expecting a final moment of calm before the results of their unprecedented scientific experiment were announced to the world.

The team had kept the breakthrough under wraps for seven months while they waited for their paper to be published in the prestigious journal Nature. Confidential press releases had gone out to journalists with the strict instruction not to leak the news before February 27.

But that night, the team was tipped off that journalist Robin McKie was going to break the story the very next day in the British newspaper The Observer.

Wilmut and Campbell raced to the lab at the Roslin Institute on Sunday morning as McKie's story hit the media like a thunderbolt. International news outlets had already started swarming at the institute for access to Wilmut and Campbell's creation: Dolly the sheep, the world's first mammal successfully cloned from a single adult cell. Shielded from the general public, she stuck her nose through the fence and munched calmly on the hay in her pen, unperturbed by the horde of news photographers. Dolly, a woolly, bleating scientific miracle, looked much like other sheep, but with a remarkable genetic difference.

By the end of that Sunday, February 23, nearly every major newspaper in the world carried headlines about Dolly the sheep.

Born on July 5, 1996, Dolly was cloned by Wilmut and Campbell's team at the Roslin Institute, a part of the University of Edinburgh, and Scottish biotechnology company PPL Therapeutics. The scientists cloned Dolly by inserting DNA from a single sheep mammary gland cell into an egg of another sheep, and then implanting it into a surrogate mother sheep. Dolly thus had three mothersone that provided the DNA from the cell, the second that provided the egg, and the third that carried the cloned embryo to term. Technically, though, Dolly was an exact genetic replica of only the sheep from which the cell was taken.

Following the announcement, the Roslin Institute received 3000 phone calls from around the world. Dolly's birth was heralded as one of the most important scientific advances of the decade.

But Dolly wasn't science's first attempt at cloning. Researchers had been exploring the intricacies of cloning for almost a century. In 1902, German embryologists Hans Spemann and Hilda Mangold, his student, successfully grew two salamanders from a single embryo split with a noose made up of a strand of hair. Since then, cloning experiments continued to become more sophisticated and nuanced. Several laboratory animal clones, including frogs and cows, were created before Dolly. But all of them had been cloned from embryos. Dolly was the first mammal to be cloned from a specialized adult cell.

Embryonic stem cells, which form right after fertilization, can turn into any kind of cell in the body. After they modify into specific types of cells, like neurons or blood cells, they're call specialized cells. Since the cell that gave rise to Dolly was already specialized for its role as a mammary gland cell, most scientists thought it would be impossible to clone anything from it but other mammary gland cells. Dolly proved them wrong.

Many scientists in the '90s were flabbergasted. Dollys advent showed that specialized cells could be used to create an exact replica of the animal they came from. It means all science fiction is true, biology professor Lee Silver of Princeton University told The New York Times in 1997.

The Washington Post reported that "Dolly, depending on which commentator you read, is the biggest story of the year, the decade, even the century. Wilmut has seen himself compared with Galileo, with Copernicus, with Einstein, and at least once with Dr. Frankenstein."

Scientists, lawmakers, and the public quickly imagined a future shaped by unethical human cloning. President Bill Clinton called for review of the bioethics of cloning and proposed legislation that would ban cloning meant ''for the purposes of creating a child (it didn't pass). The World Health Organization concluded that human cloning was "ethically unacceptable and contrary to human integrity and morality" [PDF]. A Vatican newspaper editorial urged governments to bar human cloning, saying every human has "the right to be born in a human way and not in a laboratory."

Meanwhile, some scientists remained unconvinced about the authenticity of Wilmut and Campbells experiment. Norton Zinder, a molecular genetics professor at Rockefeller University, called the study published in Nature "a bad paper" because Dolly's genetic ancestry was not conclusive without testing her mitochondriaDNA that is passed down through mothers. That would have confirmed whether Dolly was the daughter of the sheep that gave birth to her. In The New York Times, Zinder called the Scottish pair's work ''just lousy science, incomplete science." But NIH director Harold Varmus toldthe Times that he had no doubt that Dolly was a clone of an adult sheep.

Because she was cloned from a mammary gland cell, Dolly was nameddad joke alertafter buxom country music superstar Dolly Parton. (Parton didnt mind the attribution.) Like her namesake, Dolly the sheep was a bona fide celebrity: She posed for magazines, including People; became the subject of books, journal articles, and editorials; had an opera written about her; starred in commercials; and served as a metaphor in an electoral campaign.

And that wasn't all: New York Times reporter Gina Kolata, one of the first journalists to give readers an in-depth look at Dolly, wroteClone: The Road to Dolly, and the Path Ahead and contrasted the animal's creation with the archetypes in Frankenstein and The Island of Dr. Moreau. American composer Steve Reich was so affected by Dolly's story that he featured it in Three Tales, a video-opera exploring the dangers of technology.

The sheep also became an inadvertent political player when the Scottish National Party used her image on posters to suggest that candidates of other parties were all clones of one another. Appliance manufacturer Zanussi used her likeness for a poster with her name and the provocative caption "The Misappliance of Science" (the poster was later withdrawn after scientists complained). In fact, so widespread was the (mis)use of her name that her makers eventually trademarked it to stop the practice.

Following Dolly, many larger mammals were cloned, including horses and bulls. Roslin Biomed, set up by the Roslin Institute to focus on cloning technology, was later sold to the U.S.-based Geron Corporation, which combined cloning technology with stem cell research. But despite her popularityand widespread fearDolly's birth didn't lead to an explosion in cloning: Human cloning was deemed too dangerous and unethical, while animal cloning was only minimally useful for agricultural purposes. The sheep'sreal legacy is considered to be the advancement in stem cell research.

Dollys existence showed it was possible to change one cells gene expression by swapping its nucleus for another. Stem cell biologist Shinya Yamanaka told Scientific American that Dollys cloning motivated him to successfully develop stem cells from adult cells. He later won a Nobel Prize for his results, called induced pluripotent stem cells (iPS) because they're artificially created and can have a variety of uses. They reduced the need for embryonic stem cells in research, and today, iPS cells form the basis for most stem cell research and therapies, including regenerative medicine.

Dolly had sixoffspring, and led a productive, sociable life with many human fans coming to visit her. In 2003, a veterinary examination showed that Dolly had a progressive lung disease, and she was put down. But four clonescreated from the same cell line in 2007 faced no such health issues and aged normally.

Dolly is still a spectacle, though, nearly 25 years after her creation: Her body was taxidermied and puton display at the National Museum of Scotland in Edinburgh.

See the article here:
Dolly the Sheep: '90s Media Sensation - Mental Floss

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Genetic scissors: a tool for rewriting the code of life – The Hippocratic Post

Thursday, October 8th, 2020

Genetic scissors: a tool for rewriting the code of life: The Nobel Prize in Chemistry 2020

The Royal Swedish Academy of Sciences has decided to award the Nobel Prize in Chemistry 2020 toEmmanuelle CharpentierMax Planck Unit for the Science of Pathogens, Berlin, Germany ANDJennifer A. Doudna University of California, Berkeley, USA

for the development of a method for genome editing

Emmanuelle Charpentier and Jennifer A. Doudna have discovered one of gene technologys sharpest tools: the CRISPR/Cas9 genetic scissors. Using these, researchers can change the DNA of animals, plants and microorganisms with extremely high precision. This technology has had a revolutionary impact on the life sciences, is contributing to new cancer therapies and may make the dream of curing inherited diseases come true.

Researchers need to modify genes in cells if they are to find out about lifes inner workings. This used to be time-consuming, difficult and sometimes impossible work. Using the CRISPR/Cas9 genetic scissors, it is now possible to change the code of life over the course of a few weeks.

There is enormous power in this genetic tool, which affects us all. It has not only revolutionised basic science, but also resulted in innovative crops and will lead to ground-breaking new medical treatments, says Claes Gustafsson, chair of the Nobel Committee for Chemistry.

As so often in science, the discovery of these genetic scissors was unexpected. During Emmanuelle Charpentiers studies of Streptococcus pyogenes, one of the bacteria that cause the most harm to humanity, she discovered a previously unknown molecule, tracrRNA. Her work showed that tracrRNA is part of bacterias ancient immune system, CRISPR/Cas, that disarms viruses by cleaving their DNA.

Charpentier published her discovery in 2011. The same year, she initiated a collaboration with Jennifer Doudna, an experienced biochemist with vast knowledge of RNA. Together, they succeeded in recreating the bacterias genetic scissors in a test tube and simplifying the scissors molecular components so they were easier to use.

In an epoch-making experiment, they then reprogrammed the genetic scissors. In their natural form, the scissors recognise DNA from viruses, but Charpentier and Doudna proved that they could be controlled so that they can cut any DNA molecule at a predetermined site. Where the DNA is cut it is then easy to rewrite the code of life.

Since Charpentier and Doudna discovered the CRISPR/Cas9 genetic scissors in 2012 their use has exploded. This tool has contributed to many important discoveries in basic research, and plant researchers have been able to develop crops that withstand mould, pests and drought. In medicine, clinical trials of new cancer therapies are underway, and the dream of being able to cure inherited diseases is about to come true. These genetic scissors have taken the life sciences into a new epoch and, in many ways, are bringing the greatest benefit to humankind.

Source: https://www.nobelprize.org/prizes/chemistry/2020/press-release/

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Genetic scissors: a tool for rewriting the code of life - The Hippocratic Post

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