StemCell Therapy

Oct 8th 2020

OCTOBERS FIRST week is a nervous time for scientists with serious accomplishments under their beltsfor this is when the phone might ring from Stockholm. Those who give out the Nobel science prizes (the Karolinska Institute for the physiology or medicine award, and Swedens Royal Academy of Science for the awards in physics and chemistry) are known neither for offering the winners more than an hour or twos notice of the public announcement of their success, nor for respecting time zones. New laureates in North America receive the news in the dead of night. That, though, is normally reckoned a small price to pay for what is still seen as sciences most prestigious honour.

Britain being in a more convenient time zone from the Swedish point of view, Sir Roger Penrose, of Oxford University, was not actually asleep when his own phone rang. But he was, he says, in the shower. He was one of three winners of the physics prize, the others being Andrea Ghez and Reinhard Genzel, of the University of Californias Los Angeles and Berkeley campuses respectively. Their prize was for the theoretical explanation and subsequent discovery of some of the strangest objects in the universe: black holes.

Black holes are, famously, so dense that nothing, not even light, can escape their immense gravitational pull. A black holes centre is thought to be a point of infinite density, called a singularity, where the known laws of physics break down. Though the possibility that they existed was hypothesised a century ago, as a consequence of Einsteins general theory of relativity (which is actually a theory of how gravity shapes the structure and contents of the universe), early work suggested that they could form only from the collapse of perfectly symmetrical stars or gas clouds. That is hardly realistic, and Einstein himself doubted that they actually existed.

They therefore remained a theoretical curiosity until 1965, when an as-yet-unknighted Dr Penrose worked out the specifics of how real matter could collapse in a way that would form one. He showed, using a mathematical concept which he called a trapped surface, that even asymmetric, clumpy stars and dust clouds could become black holes. This work provided the tools needed by observational astronomers to go out hunting for them.

By definition, it is impossible to see a black hole directly. Instead, physicists glean insights into them by studying the effect of their gravity on the motion of their stellar neighbours. Dr Ghez and Dr Genzel used this idea to gather evidence that Sagittarius A*a bright source of radio waves at the centre of the Milky Way, Earths home galaxyis actually a supermassive black hole around which all the stars in the galaxy, the Sun included, orbit.

Dr Ghez and her team employed the Keck Observatory telescope, in Hawaii, with its ten-metre-wide primary mirror, to make their observations. Dr Genzels group used a series of eight-metre-wide telescopes high in the mountains of the Atacama desert, in Chile, for theirs. These instruments were all sensitive enough to peer through the clouds of dust that otherwise obscure the heart of the Milky Way.

Over three decades both sets of researchers, working independently, tracked around 30 of the brightest stars at the galactic centre (see chart). A star called S2, for example, takes 16 years to complete an orbit of Sagittarius A*, and, at its closest approach, comes within 17 light-hours of it. These measurements have permitted astronomers to piece together a picture of Sagittarius A* as a black hole of around 4m solar masses, packed into a region of space that is about the size of the solar system.

April 2019 saw the release of the first-ever image of a black hole (Sagittarius A*s local equivalent at the centre of a galaxy called M87, 53m light-years from Earth). This was taken, in radio frequencies, using the Event Horizon Telescope, a collaboration that links eight existing radio telescopes all around Earth and thus permits far higher resolution than any single instrument could manage. As technology improves, the Event Horizon Telescope could also one day provide a more detailed image of the region around Sagittarius A*.

As is often the way, the chemistry prize went for a discovery that might equally well have been handed out for medicineCRISPR-Cas9 gene editing. The winners were Emmanuelle Charpentier of the Max Planck unit for the science of pathogens, in Berlin, and Jennifer Doudna of the University of California, Berkeley.

CRISPR-Cas9 is derived from a bacterial defence mechanism that snips small sequences of DNA from viral interlopers and copies them into a bacteriums own genome, thus creating a scrapbook by which to recognise such aggressors, should they come again. The laureates prize is not, though, for the mere discovery of a novel bacterial immune system. It is for the adaptation of that discovery into the most important gene-editing tool yet inventedone that is already helping to design disease-resistant crops and new therapies for cancer, and which may, perhaps, end hereditary disease in human beings.

If an organisms collective DNA can be thought of as the book of its life, CRISPR-Cas9 allows for any specific sequence of words within that book to be identified, selected, removed and replaced. This is done by creating a molecule called a guide RNA, which matches a target DNA sequence, and pairing it with an enzyme, Cas9, that is capable of snipping the DNA helix at this point. Then, if so desired, a new piece of DNA can be inserted.

The laureates path to Stockholm began at a caf in Puerto Rico in 2011. That was when Dr Charpentier, who had discovered intriguing and unexplained RNA fragments in a bacterium, engineered a meeting with Dr Doudna, an expert in the DNA-snipping capability of Cas proteins. Since this collaboration bore fruit in 2012, progress has been rapid. By February 2013 Feng Zhang of the Broad Institute in Cambridge, Massachusetts and George Church of Harvard Medical School had independently demonstrated the techniques effectiveness in mouse and human genomes, paving the way for the treatment of human diseases. Clinical trials are now under way to test its power against sickle-cell anaemia and certain cancers, with animal experiments showing promising results in the treatment of muscular dystrophy.

There has also been controversy. In 2018 He Jiankui of the Southern University of Science and Technology, in Shenzhen, China, announced the birth of twin girls whose embryos he had edited with the help of CRISPR-Cas9. Dr Hes stated goal was to induce immunity to HIV, by disabling the gene for a protein which that virus uses to gain admission to cells. This was too much for the authorities. Even ignoring the issues of consent involved when a procedure is carried out on an embryo, making genetic edits so early in life means that they will be incorporated into germ cells, and thus passed down the generations. That raises serious ethical questions, and what Dr He did was declared illegal by the Chinese government. Dr He is now in prison.

Nor is germ-line editing the only controversy surrounding CRISPR-Cas9. A further complication concerns who gets the patents that will monetise it. The University of California and the Broad have been involved for years in a legal battle over the matter. By giving the prize to Dr Doudna and Dr Charpentier the Royal Academy of Science may have put its thumb on the scales. In picking them it has also, for the first time, awarded a Nobel science prize to an all-female group. Dr Charpentier, via a phone link to the room where the announcement was made, said I hope this provides a positive message to young girls. Women in science can also be awarded prizes. But more importantly, women in science can also have an impact.

Regardless of which category it truly fits into, the creation of CRISPR-Cas9 was a high-end piece of technowizardy. The actual prize for medicine, however, went for a piece of old-fashioned medical detective workthe identification of hepatitis C, a virus that causes life-threatening liver infections and is passed on by exposure to contaminated blood. Though other widespread diseases, such as malaria and HIV/AIDS, gain more attention, the World Health Organisation (WHO) reckons that around 70m people are infected with hep C and that it kills 400,000 people a year. Hep C has also, in the past, turned the business of blood transfusion into a lottery, since there was no way to tell whether a particular batch of blood harboured it. That this is no longer the case is, in no small measure, thanks to the work of this years laureatesHarvey Alter, Michael Houghton and Charles Rice.

Dr Alters work came first. In the 1960s he was a colleague of Baruch Blumberg, who discovered the hepatitis B virus (for which he won a Nobel prize in 1976). Hepatitis viruses are labelled, in order of discovery, by letters of the alphabet. A, a waterborne pathogen, causes an acute infection that passes after a few weeks and induces subsequent immunity. The effects of B and C, though, are chronic and may result eventually in cirrhosis and cancer. Blumbergs discovery led him to a vaccine for hep B, and also meant that blood intended for transfusion could be screened. But it became apparent that such screened blood still sometimes caused hepatitis, albeit at lower rates. Since hep A was also being screened for by this time, that suggested a third virus awaited discovery.

In 1978 Dr Alter, then working at Americas National Institutes of Health, proved this was true by injecting into chimpanzees blood from recipients of transfusions screened for the known viruses who had nevertheless developed hepatitis. These animals sometimes then went on to develop the illness. It took until 1989 to clone the new virus. That was done by Dr Houghton, who was then working at Chiron, a Californian biotechnology firm subsequently bought by Novartis, a Swiss pharmaceutical giant.

Dr Houghton amplified viral genetic material drawn randomly from chimpanzees infected with the as-yet-unidentified virus and tested this against antibodies from infected humans. Antibodies are proteins crafted by the immune system to stick specifically to parts of particular pathogens. By looking at which chimpanzee-derived material the antibodies in question attached themselves to, Dr Houghton was able to isolate the virus and identify it as a type of flavivirus, a group that also includes yellow fever and dengue. He also thus provided a way of screening blood intended for transfusion.

Dr Rice, working at Washington University, in St Louis, Missouri, eliminated lingering uncertainties about whether the flavivirus Dr Houghton had identified was the sole cause of hep C. Attempts to use cloned, purified versions of it to infect chimpanzees had not worked, leading to doubts about whether it was acting alone. Dr Rice identified part of the viral genome which looked crucial to the process of infection, but was highly mutable. He suspected that this mutability was hindering successful infection in the laboratory, and was able to eliminate it by genetic engineering. The stabilised virus was, indeed, infectious to chimps.

The consequence of all this is that blood for transfusion can now be screened routinely for hep C, and drugs to treat it have now been developed. Unfortunately, this has not stopped the march of the illness. Those in rich countries have benefited. Deaths in Britain, for example, fell by 16% between 2015 and 2017. But the wider picture is grim. Some countries, such as Egypt, have recently done well. Others, less so.

One reason is that, besides transfusion, hep C is spread by drug users sharing needles. It can also be spread sexually. This stigmatises it in the eyes of some. And unlike HIV/AIDS, which spreads in similar ways but quickly developed a political lobby to find a treatment once it was discovered, no one spoke up at the beginning for those suffering from the effects of hep C.

That is starting to change. In 2016 the WHO published a strategy for the elimination of all forms of hepatitis. The tools are there to do this. Whether the will to use them also exists remains to be seen.

This article appeared in the Science & technology section of the print edition under the headline "They walked in looking like dynamite"

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Who won this years Nobel science prizes? - The Economist

Today the judicial authority may be faced with balancing patent rights and patients rights or right to life. It shall use all the tools at its command and innovate if necessary, but shall rule in favour of life, writes J. PRABHA SRIDEVAN.

THERE cannot be a better moment than now, the year of COVID-19, to place my argument, that the right to health and ergo the right to a life with dignity is way ahead of the right that the patented invention obtains to the owner. An open letter has been addressed by heads of States and others to the World Health Organization (WHO), Our world will only be safer once everyone can benefit from the science and access a vaccine and that is a political challenge.Now is not the time to allow the interests of the wealthiest corporations and governments to be placed before the universal need to save lives, or to leave this massive and moral task to market forces. It is equally a judicial challenge.

I argue that the right to life which logically means the right of access to medicine and the right to health, inheres in every human being and is not bestowed under any grant, and is unlimited by time. But the patent right is one granted by the State to the inventor as a quid pro quo allowing the owner to enforce and protect his right for a period at the end of which the owner shall transfer the technology and the invention comes to the public space.

In a patent litigation between the right of access to medicine and the right to property, the judge must be the sentinel on the qui vive, not just a sentinel on the alert, but literally qui vive Who shall live or Whose side are you on? Whose entitlement is heavier? Today when even the survival of the world as we know it today, depends literally upon who gets the medicine, I say the right to life is heavier.

Public interest is not an either-or factor in (Indias) Patents Act. The General Principles mentioned in the Act as being applicable to working of patented inventions, unmistakably mentions public health. The criteria for granting compulsory license are also grounded in public interest; compulsory licence can be granted in circumstances of national emergency and extreme urgency; and patents can be acquired by the State for a public purpose. Every country has similar provisions and they have been successfully employed both by the North and the South.

By creating a higher bar for determining non-obviousness, India made sure that incremental innovations did not get canonized as patents and its Section 3(d) stands out as a model of how to use the flexibilities in a way that facilitates access to health. The Supreme Court of India said (W)e shall see how the Indian legislature addressed this concern and, while harmonizing the patent law in the country with the provisions of the TRIPS Agreement, strove to balance its obligations under the international treaty and its commitment to protect and promote public health considerations, not only of its own people but in many other parts of the world (particularly in the Developing Countries and the Least Developed Countries). The State contracts with the patentee to enforce and protect the patent rights in return for technology transfer and promotion of technological innovation, for the benefit of not just the owner but also the user, and for the enhancement of social and economic welfare.

The argument of the patent rights holder is that the exclusivity is the reward for the knowledge contributed to the world by their invention. And they must be allowed to recoup it. It is the Money, money, money in Swedish pop group ABBAs words. It is argued that without monetary incentive there will be no innovation. It is argued that the owners have the right to maximise their profits. And since the creators right is a human right too and has been recognised as such, it is not bound to give way to right to health.

Even in the text of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), the social objectives like health needs and access to medicine are inbuilt. But however good a covenant or instrument may be, if those who are implementing it are not good, it will prove to be bad. However bad that covenant or statute may be, if those implementing it are good, it will prove to be good. And it is the wise judge who weighs in these objectives in the balance.

The United Nations Human Rights Council has confirmed the primacy of human rights, such as the right to health over trade, intellectual property rights and other bilateral investment or trade agreements. Resolution 32/L.23 reaffirms the importance of access to medicines for all human beings as one of the fundamental human rights and stresses that improved access could save millions of lives every year.

The Constitution of every country contains implicitly or explicitly an assurance that there is a fundamental right to life. This must be expansively construed. The right to life, we acknowledge, encompasses several rights each one of them being basic and fundamental. The(y) are the right to live with dignity, the right to shelter and the right to health. The State is obligated to ensure that these fundamental rights are not only protected but are enforced and made available to all citizens.

How far can the Court stretch its arm to help? Rejecting the argument that courts can only issue declaratory orders, the South Africa Court said, The nature of the right infringed and the nature of the infringement will provide guidance as to the appropriate relief in a particular case. Where necessary this may include both the issuing of a mandamus and the exercise of supervisory jurisdiction.

It is basic that the power to grant carries with it the power not to grant. But without going to that extreme, the judiciary has enough aids to facilitate access.

The Costa Rica-initiated COVID-19 Technology Access Pool (C-TAP) aims to make vaccines, tests, treatments and other health technologies to fight the virus accessible to all. This indicates the importance of access. If the vaccines and other health technologies are manufactured in developed countries, and made available only to the people there, and even within those countries, only to those groups who have access, it would be inviting disaster of a pandemic proportion.

The Nagoya Protocol can be used as a tool. What has been overlooked in the ongoing discussions on IP issues and COVID is that the Nagoya Protocol and its obligations require sharing of benefits arising from the use of genetic resources. Thus, any commercialisation of COVID- related treatment and/or prevention can be argued to be bound by this protocol and its benefit- sharing provisions.

The judicial authority faced with balancing right to life against right to exclusivity and monetary gains has several tools to employ and to innovate solutions.

It is clear that TRIPS had the pious intent of balancing public health. Even if it had got skewed midway, the course can be corrected now. There is sufficient compass guidance within TRIPS for the judicial authority to rule in favour of access.

It is undeniable that adequate access to affordable medicine or treatment to the stricken cannot be facilitated just by a judicial fiat. It needs executive will, and there are bilateral treaties and other tangential statutes that may come in the way of the TRIPS flexibilities having full play. The initiative and the incentive that a willing generic manufacturer can show is another issue. Even the generics, it is feared, may sing the same song. Sales of drugs will naturally be incentivized to focus on those who can pay more, rather than the vast masses who cannot afford much. This not only unnecessarily raises prices, but reduces the possibility of weak patents being challenged. What effect will the present economic slow-down have on the generic manufacturers? This is, in the words of Prof. Shamnad Basheer a decision that calls into consideration issues of economic and political viability. In other words, the problem of access moves beyond the realm of the purely legal into the realms of economics and politics.

The judicial authority will have to choose life. Forced to choose between protecting the essential right to life an unalienable right assured by the Constitution (Art.5) or over ruling it in favour of secondary or financial interests of the State, I understand, as this dilemma is set out, that judicial ethics dictate to the judge only one possible option: to decide in favour of the undeniable right to life. While intellectual property right (IPR) has been termed as a human right, it is undeniably a granted right, and can be ungranted. The right to life and the right of access to health is a far superior right. It is a right we are born with, like the right to dignity, and we cannot be disrobed of that right.

The time has come to innovate and find an alternative to the present patent system, one which does not rest solely on access-denying exclusivity, but one where innovation and access can co- exist. A monopoly today could literally kill millions. Commenting on the judgment of the Australia High Court in DArcy v. Myriad Genetics, it is observed, This judgment raises the question whether a patent regime should allow quality of life to be the commodity of a monopoly.16

Today that commodity will not be just the quality of life but the very continuance of life. The consequences of a pandemic cannot be geographically limited if supply of the cure is so limited. Even a superficial scan of the demography of the most vulnerable argues the case in favour of access. Therefore, the South should present an alternative where both rights can be harmonised without jeopardising lives or diminishing the quality of lives.

This has happened earlier and the South has resisted such corporate and political hegemony that has facilitated the capitalization of health in various forms, and has been of vital importance and ha(s) won significant victories, but ha(s) not managed to transform or reverse the structural appropriation of health by capital.

The judicial authority must infuse itself with a spirit of constitutionalism that depends upon an interpretive, non-technocratic hermeneutics and has emerged as a democratic counter weight to logics of multinational pharmaceutical capital. It shall weigh in the huge public interest factor when orders of injunction are sought for and cannot ignore it. There are dismal examples of when it should not have been granted. One might convincingly argue that a patent right is predominantly a commercial or market-oriented property interest and is therefore compensable in monetary terms. And commercial interests can never take precedence over saving lives.

There is no acceptable data correlating the expenses incurred in inventing a drug and the price at which the drug is sold. The poser of whether there will be any invention without the rights being enforced and monetized is an arguable one. Assuming without conceding that it is so, it is possible to devise a different model of remuneration than the present one. The exclusive private ownership model lends itself to predatory tactics.

Instead we may have other innovative methods like a patent pool working in cooperation with not just countries and international organizations but also the hundreds of researchers, innovators, companies and universities involved. This will help in combating the crisis and earning collectively. It may be time to think of a pervasive compensatory liability regime. It is not that this tension between the two rights has gone unnoticed. The Sub-Commission on the Promotion and Protection of Human Rights adopted Resolution 2000/7 on Intellectual Property Rights and Human Rights which has an antagonistic approach to TRIPS.

The relationship between the private rights and the public health rights should be spatially expanded in tune with the constitutional aspirations rather than narrowly viewed as a private grasp of the patent owning few. The Court shall explore the various models of rewarding or compensating the inventor, but the Court shall and is bound to defer to the always superior claim of the right to health over right to exclusivity. Today Hamlets question must be answered in favor of life.

(Justice Prabha Sridevan is a former Judge of the Madras High Court and Chair of the Intellectual Property Appellate Board of the Government of India. Views are personal. The article was first published in SouthViews.)

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Patent and Patient Rights in COVID-19: Is the Right to Exclusivity a Hamlet Question? - The Leaflet

On August 19, 2020, the Trump administration made a major announcement that marks the latest development in the ever-evolving saga of the Food and Drug Administrations (FDA) oversight of laboratory-developed tests (LDTs). The administration declared that LDTs, which are a subset of in vitro diagnostic tests (IVDs) developed and used in-house by clinical laboratories, would not be subject to premarket review by the FDA absent formal agency rulemaking. This announcement reversed the position that the FDA staked out in late February 2020, when it issued a guidance document for the industry on the development of IVDs to diagnose COVID-19.

The February guidance set expectations regarding the analytical and clinical validation of IVDs used to address the pandemic and included most complex LDTs intended to diagnose the disease. The FDA published a second policy in March allowing for independent authorization of LDTs by states and expounded on these policies again in May.

The FDAs oversight of LDTs in the context of COVID-19 promulgated with little fanfare given the exigencies of the pandemic represented yet another turn in the agencys mercurial relationship with these controversial diagnostics that dates back more than four decades. Because the administration and the Department of Health and Human Services has now rescinded the FDAs prior guidance, laboratories must decide whether to voluntarily seek an emergency use authorization from the FDA for their LDTs, which would provide the tort protections associated with all such authorized countermeasures, or to proceed without it. Longer term, the future and degree of FDA oversight of LDTs will remain uncertain until either the FDA undertakes a formal rulemaking process or Congress takes legislative action.

IVDs are those reagents, instruments, and systems intended for use in diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae, according to the FDA. Such products are intended for use in the collection, preparation, and examination of specimens taken from the human body. The FDA began regulating them as medical devices when Congress amended the Food, Drug and Cosmetic Act in 1976 to create the comprehensive regulatory scheme providing for the risk-based medical device classification system and premarket review process that exists today. Components of IVDs, such as antibodies, specific receptor proteins, ligands, nucleic acid sequences and other analyte-specific reagents, are also subject to FDA oversight as medical devices. Most of the hundreds of IVDs on the market today have been cleared by the FDA as Class II medical devices, which are sold to laboratories across the country.

The disconnect in this area is that, at the same time the FDA developed a robust regulatory process for premarket review of IVDs, it adopted a decidedly laissez faire approach to regulation of LDTs, a subset of IVDs that are designed, manufactured and used within a single laboratory for clinical use. The FDA perceived LDTs as low risk due to their limited number and primary use in rare disease contexts. Accordingly, LDTs were not subject to the agencys robust premarket evaluations of analytical and clinical validity. Analytical validity focuses on whether a test can accurately and reliably measure what it claims to measure, whereas clinical validity focuses on whether the measurement is predictive of a certain state of health. The result is a bifurcated market, in which IVDs developed for commercial sale are held to rigorous FDA standards while homegrown tests developed for the same uses inside the developers lab are not.

The FDAs oversight of laboratory-developed tests in the context of COVID-19 represented yet another turn in the agencys mercurial relationship with these controversial diagnostics that dates back more than four decades.

Medical and technological advances over the past four decades have driven the development of LDTs to cover a wide range of conditions, including human papillomavirus, Lyme disease, whooping cough, certain cancers and heart disease. The growth of the LDT industry has led to concerns among stakeholders about whether current regulatory oversight of LDTs, led primarily by the Centers for Medicare and Medicaid Services (CMS), is sufficient to ensure their safety and effectiveness. Reports of inaccuracies in cervical cancer testing led to the enactment of the Clinical Laboratory Improvement Amendments of 1988 (CLIA), which extended federal regulations to all laboratories performing testing on human specimens for the purpose of diagnosis or treatment. Under the CLIA, CMS evaluates the analytical but not clinical validity of LDTs during accreditation surveys of laboratories. These surveys are conducted on a biennial basis, so it may take up to two years after an LDT has been offered for clinical use before its analytical validity is confirmed by regulators.

In July 2010, the FDA announced its intent to reconsider its long-standing policy of enforcement discretion with respect to LDTs after identifying issues with several high-risk LDTs and hosted a public workshop to gather feedback from industry stakeholders. Four years later, the FDA issued draft guidance proposing a regulatory framework for LDTs. It followed up a year later with a report on 20 case studies of potential and actual patient harm arising from inaccurate or unreliable LDTs that supported the need for increased LDT oversight. Members of the lab and diagnostic industry pushed back against the FDAs new position, asserting the FDA had no right to regulate LDTs in the first place. They argued LDTs were clinical rather than medical devices and that regulation would constitute an intrusion into the practice of medicine. Industry stakeholders were also concerned that FDA oversight would stifle innovation, raise costs for laboratories and limit patient access to LDTs they deemed vital to public health.

In January 2017, the FDA announced it would not finalize the guidance and invited Congress to address the issue. To advance the discussion, however, the FDA published a position paper synthesizing feedback it received from stakeholders as well as its own views on appropriate oversight that would balance the need for innovation with the need for assuring the safety and effectiveness of LDTs. The FDA proposed an approach in which agency oversight would be phased in over several years based on risk. The proposal would grandfather tests already on the market and exempt from most oversight LDTs that are low risk or intended for rare diseases, forensic use, public health surveillance and so-called traditional tests that use components that are legally marketed for clinical use and whose output is the result of manual interpretation by a qualified laboratory professional, without the use of automated instrumentation or software for intermediate or final interpretation. All other tests, including modified versions of grandfathered tests, would be subject over time to adverse event and malfunction reporting, premarket clearance and approval, and CLIA-based quality requirements. The FDA reserved the right to take action against any LDT, even those exempted from the phased-in requirements, in the event of deceptive promotion or inadequate validation.

Many stakeholders interpreted the FDAs announcement as a retreat to the long-standing position of enforcement discretion while it turned the issue over to Congress to resolve. The reality was less clear, however, as the agency continued to assert its jurisdiction over LDTs in certain circumstances. In October 2018, FDA issued a guidance warning that many genetic tests on the market that claim to predict a patients response to specific medications had not been reviewed by the agency and might not be supported by requisite scientific or clinical evidence. In April 2019, the FDA issued a warning letter to Inova Genomics Laboratory alleging that its genetic tests, which were offered for the same purpose, were adulterated and misbranded, and posed a significant public health concern because they had not been adequately validated. Notably, the FDA rejected Inovas assertions that the company was operating within an LDT Exemption by explaining that no exemption existed and that the agency never created a legal carve out from its premarket review processes for LDTs. The agency also asserted that it retained the discretion to take action against LDTs when appropriate despite its long-standing policy of exercising enforcement discretion. The FDAs unpredictable approach toward LDTs left members of the lab and diagnostic industry unsettled and anxious about federal challenges to the legality of their tests.

Facing the COVID-19 pandemic, the FDA took another step toward more complete oversight when it included LDTs in its polices for other IVDs intended to diagnose the disease. The position was no doubt fueled by the FDAs desire to ensure a measure of analytical and clinical validity for all complex tests used to diagnose the disease, given the obvious exigencies and public health equities at issue. However, the Trump administrations August 19 announcement formally rescinds guidance and other informal statements from the agency concerning premarket review of LDTs. The move frees developers of LDTs to act without FDA pre-review, which offers a measure of clarity for the market but also triggers concern from public health experts who believe now is the time for more oversight, not less.

Against this backdrop, there may be greater pressure than ever on Congress to take up the issue. Lawmakers have made several attempts at determining the future of LDT regulation. A draft bipartisan bill released in March 2017 outlined a regulatory framework for LDTs based in part on a proposal by the Diagnostic Test Working Group, a coalition of industry stakeholders. After feedback from the FDA, lawmakers unveiled a new bill, the Verifying Accurate, Leading-Edge IVCT Development (VALID) Act, in December 2018. On March 5, 2020, lawmakers introduced a revised VALID Act with bipartisan sponsorship.

The VALID Act would create a new regulatory framework to govern the development and use of all in vitro clinical tests (IVCTs), which would include both IVDs and LDTs. The proposal would replace the three-tiered system used to regulate other medical devices with a two-tiered system consisting of low- and high-risk tests (although the legislation would allow the FDA to develop special controls for certain high-risk tests, which could evolve into a third tier of moderate-risk devices). The legislation would require premarket evaluation and compliance with quality system regulations unless an exemption applied. Like the FDAs 2017 proposal, the act would exempt low-risk tests such as those intended to treat rare diseases and some LDTs that are already in use. Current LDTs not eligible for grandfathering under the act would be handled under special transitional provisions. The legislation also includes a precertification program intended to reduce regulatory burdens and provide priority review/breakthrough concepts. The program is modeled after those that exist today for other medical products to support expedited development and review of novel tests or tests intended to treat a life-threatening or irreversibly debilitating human disease or condition.

Whether and when Congress will act on the legislation is unclear. The current controversy surrounding COVID-19 testing is sure to put a spotlight on this issue, and the VALID Act has bipartisan support in committees of jurisdiction in both chambers. But the United States is heading toward another presidential election, and the current Congress has been notably partisan. The Medical Device User Fee Amendments must be renewed in September 2022, and that must-pass legislation is a likely vehicle for enactment of the VALID Act if it is not taken up beforehand. Some form of the legislation certainly could move in the next year, but the window is tight given the election and the other pandemic-related causes, which will take priority.

In the meantime, industry stakeholders should closely monitor developments in the LDT space. LDTs and related genetic tests play a significant role in health care decision-making, and a new regulatory framework will have major implications for the future of these products. But critical questions remain, including whether Congress will take action and whether the FDA will eventually act if Congress does not. Whether the FDA intends to respond to the August 19 announcement by initiating a rulemaking or formally modifying its 2017 position is unclear. The FDA likely will wait for the outcome of the election and take stock of its options then. Regardless of how, if at all, a more defined regulatory framework for LDTs ultimately crystallizes, the latest announcement makes clear that lasting guidance is necessary for all parties to navigate the world of LDTs with some measure of certainty, both during COVID-19 and beyond.

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FDA Oversight of Laboratory-Developed Tests Continues To Evolve - JD Supra

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

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

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

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

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

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

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

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.

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

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

Intersexuality in female moles

Female moles are intersexual and develop masculinizing ovotestes, a distinctive trait among mammals. Real et al. investigated the origin of this trait by sequencing the Iberian mole genome and applying comparative strategies that integrate transcriptomic, epigenetic, and chromatin interaction data. They identified mole-specific genomic rearrangements that alter the three-dimensional regulatory landscape of the androgen-converting gene CYP17A1 and the pro-testicular factor gene FGF9, both of which show distinct expression patterns in mole gonads. The use of transgenic mice confirms the capability of these factors to increase circulating testosterone levels and to induce gonadal masculinization. This study highlights how integrative approaches can reveal the phenotypic impact of genomic variation.

Science, this issue p. 208

Linking genomic variation to phenotypical traits remains a major challenge in evolutionary genetics. In this study, we use phylogenomic strategies to investigate a distinctive trait among mammals: the development of masculinizing ovotestes in female moles. By combining a chromosome-scale genome assembly of the Iberian mole, Talpa occidentalis, with transcriptomic, epigenetic, and chromatin interaction datasets, we identify rearrangements altering the regulatory landscape of genes with distinct gonadal expression patterns. These include a tandem triplication involving CYP17A1, a gene controlling androgen synthesis, and an intrachromosomal inversion involving the pro-testicular growth factor gene FGF9, which is heterochronically expressed in mole ovotestes. Transgenic mice with a knock-in mole CYP17A1 enhancer or overexpressing FGF9 showed phenotypes recapitulating mole sexual features. Our results highlight how integrative genomic approaches can reveal the phenotypic impact of noncoding sequence changes.

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The mole genome reveals regulatory rearrangements associated with adaptive intersexuality - Science Magazine

Fluorescent image shows chromosomes (green) segregating in two developing eggs. In each egg, one chromosome (the largest green one) has too many crossovers and is having problems segregating. The image was taken on a deconvolution fluorescent microscope. Credit: Image courtesy of Diana Libuda

University of Oregon and Northwestern University biologists show that too many crossover events can increase infertility.

The exchange of DNA between chromosomes during the early formation of sperm and egg cells normally is limited to assure fertility.

But when there are too many of these genetic exchanges, called crossover events, the segregation of chromosomes into eggs is flawed, biologists have learned in a project done across three labs at the University of Oregon and Northwestern University.

In a paper published online in September 2020 in the journal PLOS Genetics, researchers documented how the disruptions, as seen in basic research with microscopic roundworms (Caenorhabditis elegans), lead to a range of meiotic defects as the chromosomes are subjected to improper spindle forces.

Inaccurate chromosome segregation in humans is associated with Down syndrome and miscarriages. Such segregation defects as seen in the research can result in increased infertility, said UO biologist Diana E. Libuda, the studys principal investigator.

Over the past century, research has focused on making sure enough crossovers are made during sperm and egg development, said Libuda, a professor in the UOs Department of Biology and Institute of Molecular Biology. It was known that developing sperm and eggs had ways to make sure that not too many crossovers are made, but it was unclear why.

The research team identified two mechanisms that help counteract defects triggered by excess crossover activity in developing eggs and, thus, assist the coordination of the process that helps assure genomic integrity in new generations.

Libuda had reported in the October 9, 2013, issue of Nature the discovery of a mechanism that inhibits the overproduction of crossovers in roundworms. However, Libuda said, it was not possible at that time to study the downstream effects in cases where too many crossovers did occur. Since then, her lab developed a way to generate extra crossovers on a single chromosome.

That ability led to a National Institutes of Health-funded collaboration with Sadie Wignall of Northwestern University, an expert on high-resolution imaging of structures involved in segregation of chromosomes into developing eggs. What Wignall found led Libuda back to Bruce Bowermans UO lab to take a look at chromosome segregation in live developing eggs.

Overall, it was a great joining of scientific strengths to take a multipronged approach to answer this important question, Libuda said.

The research provides fundamental insights that can guide research in other organisms to better understand the mechanisms and, eventually, lead to potential clinical applications.

The same proteins that we are studying in C. elegans are also in humans, Libuda said. In fact, most proteins required for fertility are used across organisms that include yeast, fruit flies, nematodes, zebrafish, mice and humans. Research using these microscopic worms has been shown in numerous contexts to have relevance in human health.

Reference: Excess crossovers impede faithful meiotic chromosome segregation in C. elegans by Jeremy A. Hollis, Marissa L. Glover, Aleesa J. Schlientz, Cori K. Cahoon, Bruce Bowerman, Sarah M. Wignall and Diana E. Libuda, 4 September 2020, PLOS Genetics.DOI: 10.1371/journal.pgen.1009001

Co-authors with Libuda, Bowerman and Wignall on the paper were: Jeremy A. Hollis, a technician in Wignalls lab; former UO biology undergraduate student Marissa L. Glover, now a doctoral student at the University of California, Santa Cruz; Aleesa J. Schlientz, who earned a doctorate from the UO this year; and Cori K. Cahoon, a postdoctoral researcher working in Libudas lab under a fellowship from the Jane Coffin Childs Memorial Fund for Medical Research.

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Over-Exchange of DNA in Sperm and Eggs Results in Chromosome Defects That Can Increase Infertility - SciTechDaily

The Susquehanna Wellness Clinic, a primary care office located in Frenchville, is opening its doors in November of 2020 to begin serving adult patients health and wellness needs.

The clinic is focused on holistic, person-centered approaches to care, aiming to build trusting relationships and provide the personalized care to each individual.

Dr. Baltazar Corcino, M.D. and Jamie Bush, CRNP will be staffing the clinic, and will be supported by a comprehensive team of medical professionals. Both individuals have a long-standing history of providing quality and meaningful care in the Clearfield community.

Corcino has a proud history of caring for the residents of Clearfield County, and is excited to continue this work in the clinic. Hes worked in internal medicine in emergency room, private practice and hospital settings.

Bush, a board-certified nurse practitioner, specializes in family medicine and has additional experience in ICU and ER settings as well as urgent care and neurosurgery settings.

The clinic will serve a variety of needs for adult patients 18 and older. These services include adult medicine, geriatric care, preventative medicine, immunizations, annual wellness visits, health care screenings, laboratory testing, chronic care management and interdisciplinary team planning.

Additionally, the clinic will provide transportation when necessary to seniors 60 and older to clinic appointments, conduct in-home visits to patients physically unable to come into the clinic and Telehealth services to connect virtually when coming in for an appointment isnt an option.

The clinic will be hosting an open house to the public on Oct. 21, from 3 p.m. 5 p.m. The event will include facility tours, meet and greet with staff and light refreshments.

The clinic will officially open its doors on Monday, Nov. 2, 2020 to begin serving patients. Hours of service are Monday Friday, from 8:30 a.m. 3:30 p.m., by appointment.

If you have any questions about the clinic or are interested in becoming a patient, please call 814-765-2695 or e-mail info@susqwell.com. Dont forget to follow the clinic on Facebook for announcements and upcoming events.

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Susquehanna Wellness Clinic to Serve Primary Care Needs of the Area - GANT News

The leader of the free world is now fighting his own battle with a virus that's laid global siege. A concoction of some experimental treatments is helping him do it.

On Monday evening, after spending three nights undergoing treatment for COVID-19 at Walter Reed National Military Medical Center, President Donald Trump returned home to the White House.

Standing on the balcony, Trump removed his mask and gave a double thumbs up to the crowd.

Minutes later, in a produced video released via tweet, Trump claimed his victory over the virus.

"I didn't feel so good," Trump said to camera. "Two days ago I felt great, like better than I have in a long time... better than 20 years ago."

"Now I'm better -- and maybe I'm immune! I don't know. But don't let it dominate your lives. Get out there. Be careful. We have the best medicines in the world, and they're all happened, very shortly, and they're all getting approved."

Trump has been recovering under close watch from a team of physicians administering world-class care and special access to therapeutics. Monday, his personal physician, Dr. Sean Conley, told reporters Trump "has continued to improve" over the past 24 hours, having "met or exceeded all standard hospital discharge criteria."

There is not enough evidence to confirm when, or if, some level of immunity to COVID-19 occurs, and how long it might last. Experts say right now, the president is likely still contagious. The Centers for Disease Control and Prevention says COVID-19 patients should stay isolated for at least 10 days after the start of their symptoms or after receiving a positive test. Trump's doctors said Monday he "may not entirely be out of the woods yet," but they are using what they have called a "multi-pronged approach" in his treatment, which will continue as he recuperates at home.

Trump's diagnosis early Friday morning plunged a nation already in chaos into further crisis, uncertainty and fear for his well-being of urgent concern amid a pandemic that has now claimed the lives of more than 210,000 Americans.

Over the weekend, Trump assured the public he was feeling "much better" since being given a sundry mix of medication, some of it experimental, which he called "miracles coming down from God."

A car with US President Trump drives past supporters in a motorcade outside of Walter Reed Medical Center in Bethesda, Maryland on October 4, 2020.

The full picture of what treatments Trump has received thus far is still evolving, as still-outstanding questions in the public interest are met with more fulsome, forthright detail. Monday, his medical team told reporters they continue to treat him with the intravenous antiviral Remdisivir, and have continued with the steroid Dexamethasone.

Of the combination of medicines and supplements now being deployed to help him recoup, many are not yet definitively known to beat the novel coronavirus, but are thought to help mediate the virus' symptoms and severity in the body. There is, as of now, no drug "approved" by the FDA for COVID-19 treatment, though some have been given emergency authorization.

Some experts have raised questions about the uniquely robust drug regimen now being administered to the president. Dr. Lew Kaplan, president of the Society of Critical Care Medicine and a surgeon at the University of Pennsylvania, said these types of "non-standard processes" can " invite error." This exact combination of medications has not been tested together yet in large-scale studies.

NIH treatment panel guidelines member Dr. Mitchell Levy assured that there is no "miracle" drug yet available.

"If you look at our guidelines, we just don't think there's enough evidence to recommend one way or the other," Levy, chief of pulmonary critical care at Warren Alpert Medical School of Brown University, told ABC News. "So little is proven. It's like the Wild West, and he's the president of the United States, and so you feel like: 'I want to do anything I can to prevent the disease from progressing.' That often drives us to do things outside of the normal standard. And that is never a good idea. There's a standard of care for a reason. With COVID-19, part of the problem is, we're never really sure what the standard of care is."

Other experts are more optimistic

"All of these treatments shift the odds in your favor," Dr. William Schaffner, professor of preventive medicine and infectious diseases at Vanderbilt University Medical Center, told ABC News. "None of them is a magic wand that suddenly makes you feel better," he added, explaining that Trump's treatment plan was made respecting the parameters of available science.

The president's doctors have said he is taking at least eight medicines and supplements. The timeline of Trump's illness remains murky; however, here's what we know about what the president is taking -- and when he started taking it.

Remdesivir

Before Trump was to check out of Walter Reed and head back to the White House Monday evening, his physicians told reporters they planned to administer the fourth dose of the antiviral drug Remdesivir. He has been receiving Remdesivir intravenous infusions since Friday, within 24 hours of revealing his diagnosis. Initially developed for Ebola treatment, it has solid evidence supporting its use in COVID-19 patients, according to the National Institutes of Health, and based on that promising potential, the FDA has issued emergency authorization for its use. Typically given to patients with severe infection, it works by hindering the virus' replication in the body.

Once Trump settles back at the residence, his doctors say, they've made arrangements for the fifth and final dose of his treatment course, Tuesday evening.

In this undated image from video provided by Regeneron Pharmaceuticals on Friday, Oct. 2, 2020, vials are inspected at the company's facilities in New York state, for efforts on an experimental coronavirus antibody drug. Antibodies are proteins the body makes when an infection occurs; they attach to a virus and help the immune system eliminate it.

Regeneron monoclonal antibody "cocktail"

Trump is taking a cocktail of two synthetic, pharmaceutical versions of what occurs naturally in the body to fight off infection. A mix of monoclonal antibodies, this one made by biotech company Regeneron, is thought to be promising, though still in its experimental phase. Late last month, Regeneron published positive, yet preliminary data for its cocktail treatment showing it improved symptoms in patients without severe disease.

While it is not yet FDA-authorized, Trump has been granted access to it under "compassionate use," enabling him to get it outside of a clinical trial. A Regeneron spokesperson confirmed to ABC News that Trump's medical staff reached out to them for permission to use their monoclonal cocktail, and it was cleared with the FDA.

Dexamethasone

Trump's personal physician told reporters Monday afternoon that they continue to treat the president with the steroid Dexamethasone, in response to temporary drops in his oxygen levels.

A corticosteroid used for its anti-inflammatory effects, Dexamethasone has solid evidence supporting its use in COVID-19 patients, according to the National Institutes of Health. In severe cases it's thought steroids can fight the haywire inflammation caused by the virus; however in milder cases, one trial found "no benefit (and the possibility of harm) among patients who did not require oxygen."

When pressed by reporters Monday afternoon, Conley, Trump's personal physician admitted that the president had, in fact, been given supplemental oxygen twice since falling ill. Previously, Conley had said he was not sure if Trump had received it a second time, and would have to check with the nursing staff.

Regarding those two times Trump received supplemental oxygen, Conley said, "it wasn't required."

Schaffner told ABC News that though the press and public have not seen the president's chest X-rays or CAT scans, prescribing the steroid is "a borderline indication within the physicians' prerogative."

Whatever was on those CAT scans, Schaffner said, along with his oxygen levels, seems "undoubtedly what targeted physicians' decision to add dexamethasone," in hopes that it would moderate his immune system response's "collateral damage."

Famotidine

Famotidine, more commonly known by its brand-name Pepcid, is an FDA-approved for heartburn, not COVID-19. Some early, observational studies showed improved survival amongst hospitalized COVID-19 patients. Still, experts caution that observational studies are no substitute for high-quality, randomized trials designed to demonstrate a treatment's true effectiveness. A trial for an intravenous infusion of famotidine is still ongoing.

Zinc

This is not the first time Trump has said he is taking Zinc. In mid-May, Trump told reporters he had been taking both Zinc and Hydroxychloroquine as a "preventative" measure. On Friday, as his doctors listed off the treatments he would now receive for his infection, Zinc again appeared on the list. As an over-the-counter supplement, Zinc is subject to less regulatory oversight. Its virus-fighting properties have shown mixed results in prior studies. Schaffner described Zinc, along with Vitamin D, as "adjunctive therapies, the benefits of which are not known."

"There is some data that Zinc is helpful if you have the common cold," he said. "But not COVID."

Vitamin D

Trump's doctor announced the president is also taking a vitamin D supplement. Studies show an association between vitamin D deficiency and a greater risk of and dying from COVID-19. However, most people get enough vitamin D from their diet. At this point, studies have not demonstrated that taking a vitamin D supplement can help fend off COVID-19 related illness, although there is an ongoing, randomized trial that may offer clarity.

Melatonin

Melatonin is a naturally-occurring hormone with antioxidant, anti-inflammatory properties also helping regulate circadian rhythms. Some researchers have suggested that the supplement might help compliment other COVID-19 treatments. At this point, research showing that this supplement helps COVID-19 patients is limited, but there is at least one small, randomized study ongoing in the U.S.

Aspirin

Available over the counter, aspirin have been taken internationally as concomitant treatment for COVID-19 -- in response to the strange prevalence of clotting and pulmonary embolism doctors have seen crop up in some patients. Aspirin may also help reduce low grade fevers. Saturday, the president's medical team said he no longer had a fever, after less than a day's time. On Monday afternoon, his medical team told reporters Trump "has not been on any fever reducing medications for over 72 hours," but declined to elaborate.

For people for people who don't have increased cardiovascular risks or COVID-19, daily aspirin use is no longer recommended as a way to reduce the risk of heart attacks, because the risks are now believed to outweigh the benefits.

Before taking any medication, people should always check with their doctor, as every patient's situation is different.

This report was featured in the Monday, Oct. 5, 2020, episode of "Start Here," ABC News' daily news podcast.

"Start Here" offers a straightforward look at the day's top stories in 20 minutes. Listen for free every weekday on Apple Podcasts, Google Podcasts, Spotify, the ABC News app or wherever you get your podcasts.

ABC News' Eric Strauss and Ben Gittleson contributed to this report.

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All the president's medicine: How doctors are treating Donald Trump - ABC News

Lexington Appalachian Regional Healthcare (ARH) invites adults across Central Appalachia to participate in a webinar on Preventative Healthcare and How it Saves Lives.

Participants will learn what screenings and immunizations they should have at every age, how living a healthy lifestyle can change your health outcomes andthe importance of maintaining healthcare appointments during a pandemic.

Speakers Dr. Elizabeth Nelson and Dr. Paula Jones will discuss adult preventative screenings by age and gender, beginning at age 18; the importance of regular health check-ups; the importance of a healthy lifestyle; immunizations you should have; COVID safety precautions at hospitals and clinics and the ease of telemedicine.

Elizabeth Thompson Nelson, MD, FHM, practices at Beckley ARH Hospital in Beckley, Wva. Dr. Nelson is board certified in internal medicine, providing care for adults. She diagnoses and treats chronic illness, promotes health and disease prevention and is dedicated to excellence in patient care. Dr. Nelson completed her residency and internship in internal medicine at Georgetown University Hospital in Washington, DC, and her doctor of medicine degree at the Howard University College of Medicine, Washington, DC.

Paula Jones, DO, practices at ARH Medical and Specialty Associates in Harold, Ky. Dr. Jones treats adults and children over 13 years of age, diagnosing and treating both acute and chronic illnesses. She provides routine health screenings and counseling on lifestyle changes in an effort to prevent illnesses before they develop. Dr. Jones completed her doctor of osteopathy from Kentucky College of Osteopathic Medicine in Pikeville, Ky. and is a board-certified Osteopathic Family Physician.

Adults who would like to participate in this webinar can register for the event at the following link: https://zoom.us/webinar/register/WN_vgycht7fQ_uZKOEgKIewTQ

We are making critical coverage of the coronavirus available for free. Please consider subscribing so we can continue to bring you the latest news and information on this developing story.

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ARH webinar on preventative healthcare set for October 5 - Times Tribune of Corbin

GPs tend to talk too much. We give a lot of advice, admits Dr Arash Ahmadi from Brisbanes Racecourse Village Family Practice.

Thats because education is one of the biggest parts of a general practitioners job, Ahmadi explains. A lot of the work they do is around preventative medicine, which means encouraging patients to adopt the lifestyle modifications that will keep them healthy.

So what are the golden rules GPs live by and advise others to follow? To find out, we asked four doctors for the medical advice they think we could all benefit from.

I recommend to everybody to stay away from processed food as much as they can, and to eat as fresh as possible, says Dr Ahmadi.

That means avoiding frozen or pre-prepared foods anything thats ready-made and just needs to be heated up as well as things like sausages.

One of the main issues with processed food is the materials they add to the food to keep it fresh or fresh-looking or fresh-tasting colours, flavours, chemicals, Ahmadi says. He explains that those additives can cause liver damage and high cholesterol.

He advises patients to delete your UberEats app, try to cook as much as you can and look at the nutritional panels on the back of foods in the supermarket. We dont have to be perfect, he says, but weve got to try.

And as for whether Ahmadi follows this advice himself? Absolutely. Nutrition is one of my passions in life.

Something I live by and truly believe in is to do some exercise first thing in the morning, says Dr James Stewart from Southside Medical Practice on the Sunshine Coast. He says the current health guidelines recommend exercising five times a week, for 30-40 minutes per session.

And thats at moderate intensity, Stewart says. So the way I explain that to my patients is that if youre going for a walk, you want to not quite be able to finish your sentences because youre that puffed. Going for a walk where youre comfortable the whole way is good but not great.

He says regular exercise will help with weight control, reduce your cardiovascular risk and do good things for your brain.

The main benefits from exercise, I feel, is to do with mental health. You get a good release of endorphins and serotonin when you exercise and that leads to an improved mood and sense of wellbeing. So if you exercise in the morning, youve got a nice buzz that sets you up for the day.

One piece of advice I tell a lot of patients who are above 65 and at risk of cardiovascular disease is that an aspirin a day keeps the doctor away, says Dr Hany Eldebeiky from Seymour Medical Clinic.

Eldebeiky says a daily aspirin can help to prevent heart attacks and strokes, something that over-65s are at increased risk of. A lot of factors contribute to that, like high cholesterol and high blood pressure, Eldebeiky explains. So when we take an aspirin, this thins the blood a little bit, which improves the blood pressure and prevents clotting or blood coagulation.

He is keen to stress, though, that every individual is different and that it is very important that you consult with your own GP before taking aspirin, or any medication as there are risks as well as benefits. This advice wouldnt apply to a patient with a history of ulcers, or someone at risk of stomach bleeding, for instance, and there are many other people for whom the medication may not be suitable.

But a daily aspirin has worked for him: Im not 65, but I take an aspirin a day and because Im high risk my dad had his first [heart] attack in his 40s, Eldebeiky says. Since I started taking aspirin, I havent had anginal or chest pain again.

Dr Kelly-Anne Garnier, from QV Medical on Elizabeth Street in Melbourne, believes she couldnt live without meditation and mindfulness. Its well known to modulate or reduce the impact of stress, she says. Its something that is evidence-based and effective.

Garnier says that stress is considered to be inflammatory, which can put us at risk of a whole cohort of physical and mental ailments.

All sorts of inflammatory conditions would be worse with stress: skin diseases, auto-immune diseases. Even things like the risk of heart attack and stroke increase with stress, she says. The other impact of stress is sleep disturbance, and we know sleep disturbance is bad for us for all sorts of reasons. And an increased stress level puts us at risk of anxiety, depression and burnout.

As for how to get started with meditation? It is as simple as breathing, becoming aware of ones breath and trying to step outside of oneself and observe oneself, she says. But also, importantly, doing this in a non-judgemental fashion. And thats what takes a little bit of practice the non-judgement. But there really is no right or wrong way [to do it].

This article was amended on 7 October 2020 to stress that individuals must consult with their own general practitioner before taking aspirin.

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An apple a day? Four GPs on the top health advice they give and follow - The Guardian

Love Philly? Sign up for the free Billy Penn email newsletter to get everything you need to know about Philadelphia, every day.

The doctor whos been treating President Donald Trump for the coronavirus has roots in Philadelphia. Its where he trained in medicine.

Dr. Sean Conley, the 40-year-old whos been at the forefront of national health updates lately, has been the presidents physician for two years. He grew up in Doylestown, and graduated from Central Bucks High School East in 1998. His medical degree comes from the Philadelphia College of Osteopathic Medicine.

The Philly higher ed institution is not your average medical school. Turns out Conley doesnt actually have an MD degree.

Instead, hes a DO a doctor of osteopathic medicine. With that certification, Conley can do everything a regular doctor can do, like prescribe medicine and perform surgery in all 50 states.

The training is different in that it takes a more holistic look at the body than traditional medicine. It emphasizes primary care, and practices that encourage the body to heal itself rather than the immediate prescription of medicine or use of surgery to correct problems.

At first, the practice was highly controversial. During the first decade of PCOMs existence, it wasnt even legal in Pennsylvania. Over the next two centuries, debates over osteopathy continued, with traditional physicians critiquing its more controversial practices like the in the late 1800s idea to shake a child to cure scarlet fever.

In recent years, the stigma has mostly dissolved as the training and practice have themselves become more legit. Now, earning a DO degree requires the same training as an MD, plus extra coursework.

Conleys Philly alma mater is considered a pioneer in the field, and helped see it through to the modern day.

The first person to bring osteopathic medicine to Philadelphia was a woman named Clara Martin. In 1899, the city directory listed her as an osteopath, working from an office on 67th Street near the Cobbs Creek Parkway, just south of Mount Moriah Cemetery.

That same year, two physicians named Snyder and Pressly founded what would become PCOM, then called the Philadelphia College and Infirmary of Osteopathy.

Philly was experiencing a general boom in medical institutions right then, notes a published history of the school called To Secure Merit, by Carol Benenson Perloff. Episcopal Hospital, German Hospital (now Lankenau), Jewish Hospital (now Einstein Medical Center) and Presbyterian Hospital were all founded between 1849 and 1882.

PCOM first opened at 12th and Market, filling two rooms inside a 13-story office tower. Within a year, it outgrew that space and relocated to the Witherspoon building at Juniper and Walnut.

Enrollment kept growing. Many students were people inspired by seeing osteopathic doctors step in after traditional medicine had failed.

Alum Arthur Flack, who graduated in 1906, said he got interested when he saw osteopathic medicine helped cure cases of typhoid fever amid an epidemic in his hometown of Butler, Pa.

When I first became a studentmy marvel was as to the intense devotion manifested by the small group of physicians headed by you, Flack said in 1925, according to Perloffs book. Without such sincere devotion, Osteopathy today would be only a memory in Pennsylvania.

Thing is, osteopathy wasnt even legally recognized when PCOM first opened its doors.

The first attempt to legalize it in Pennsylvania passed through the state legislature in 1905, but was vetoed by then-Governor Pennypacker. It wasnt until 1909 that a Governor Stuart signed the bill to allow osteopathic doctors to apply for state licensure, 10 years after the Philadelphia college was first founded.

Licensing made the practice more popular, and PCOM continued to outgrow its facilities. The school moved to Spring Garden Street, then to 33rd and Arch, and eventually to North Broad Street.

Some drama: Before the legalization of osteopathy, the college had raised about $3,000. But the founders continued not to pay faculty with actual money for their teaching they compensated them only with stock in the school.

In 1904, faculty started demanding payment. The founders refused, and there was a theatrical back-and-forth in which the schools deans threatened to resign unless the two founders resigned. Shockingly, both founders did resign, and a board of trustees was established that still exists today.

By 1910, PCOM was considered a pioneer when it became one of the first to adapt to new statewide legalization requirements, and create a four-year program, which it maintains to this day.

After those gazillion relocations and expansions, PCOM landed at its current campus on City Avenue at the Bala Cynwyd border.

The school currently has almost 2,000 students, across areas of study like clinical psychology, biomedical sciences and forensic medicine. Like osteopathic medicine schools nationwide, its really tough to get in. In 2019, nearly 7k students applied for just 441 spots in the program.

Dr. Conley, Trumps doctor, has a degree that takes four years to complete. The first two are spent learning basic and clinical sciences, and the second two doing hands-on work in teaching hospitals.

While enrolled, the Bucks County native likely got plenty of Philly experience, since students spend four months working in city neighborhoods at PCOMs Community Healthcare Centers.

After their four years, some students declare a specialty and spend more time in school. PCOM reports that a majority of its grads end up in family medicine, general internal medicine, OB/GYN or pediatrics.

In general, osteopathic medicine has grown in popularity in recent years seen as a more hands-on version of health care. DOs work to understand how all parts of the body are connected, and take a major focus on preventative and primary care.

An osteopathic medicine student in New York told the New York Times in 2014 she became interested in the practice after a standard MD said shed need surgery to correct her chronic ear infections but then she went to a DO, who corrected the problem by stretching her neck, she said.

The infection happened because of fluid in the ear, said the student, Gabrielle Rozenberg, and the manipulations opened up the ear canal.

The practice has become widespread enough that PCOM has opened two more campuses, both in Georgia. According to the American Association of Colleges of Osteopathic Medicine, about 25% of all medical students today are training at an osteopathic school.

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Trump doctor Conley degree from Philadelphia College of Osteopathic Medicine: What it means - On top of Philly news - Billy Penn

During the COVID-19 pandemic, weve taken restaurant dining outside, replaced international travel with national park road trips and put work meetings that still probably shouldve been emails on Zoom.

But one experience that seems almost impossible to imagine in our new reality is the traditional live music show. While virtual concerts can provide great joy and entertainment, fans have lamented that they dont capture the true feeling of an IRL show.

But when will we get the real deal again? HuffPost asked health experts to share their thoughts on the concert experience in time of coronavirus and their predictions for the future of live music.

Concerts are particularly risky in this pandemic.

While weve figured out relatively safe ways to bring back pre-pandemic activities like restaurant dining, concerts pose many more challenges in the coronavirus era.

Concerts bring together some of the highest-risk behaviors for COVID-19 transmission, said Brian Labus, a professor at the University of Nevada, Las Vegas School of Public Health. We have large groups of people standing in close contact for an extended period of time while singing and cheering. Plus they would need to keep removing their masks to smoke or drink a beer. If we try to change these things, we would really change the entire concert experience.

The social aspect of traditional live music concerts makes it difficult to transition to a scenario where concertgoers are asked to enjoy the music in a socially distanced setting.

- Dr. Kristin Dean, board-certified physician and medical director at Doctor on Demand

As large gatherings, traditional concerts are by nature potential superspreader events. The lack of personal space and constant flow of respiratory droplets as people sing or speak loudly to each other make most music shows a prime location for virus transmission.

Enjoying live music with friends has begun to feel like a remnant of a better time as the impacts of a global pandemic continue to change the way we interact with the world, said Dr. Kristin Dean, a board-certified physician and medical director at the telemedicine service Doctor on Demand. The social aspect of traditional live music concerts makes it difficult to transition to a scenario where concertgoers are asked to enjoy the music in a socially distanced setting.

She noted that attempts to hold live shows with (and without) social distancing, masks and additional precautions have sparked controversy and led to questions around how to move forward while remaining safe.

In August, German researchers conducted an experiment that aimed to answer those questions. To study the spread of the novel coronavirus in a concert setting, they outfitted about 1,500 people with tracking devices and fluorescent hand sanitizer. Participants then attended three simulations of a concert one as if there were no pandemic, one with moderate restrictions and one with more strict safety measures.

While the results have not yet been published, the study has already faced criticism for the risks involved in the experiment and questions about its accuracy given participants were not permitted to drink. Still, the findings could offer helpful insights into the possibilities for live music going forward.

Sean Gallup via Getty Images

Well need to have the virus under control first.

The experts who spoke to HuffPost were in agreement that the virus must be much more under control before we can bring back the concert experience. Most pointed to the need for a very low level of coronavirus transmission in communities, which is best reached through a widely deployed vaccine.

For concerts to be as safe as possible, youd need to have herd immunity established, said Dr. Kim Kilby, a family and preventative medicine physician and senior leader at MVP Health Care. To achieve this, experts have suggested that 75% of the population must either have received the vaccine or survived the infection.

The U.S. is nowhere near the point of herd immunity, and to try to reach that level without a vaccine could cost millions of lives, overwhelm hospitals, further harm the economy and lead to a number of long-term health challenges for those who survive severe cases.

There are multiple vaccine candidates that look promising, but the CDC has said they wont be widely available until mid-2021. Thus, many artists and venues have already moved their concerts to dates next summer, and they may have to push them again as the year unfolds.

No large gatherings such as concerts should be held at least till the middle or end of next year, said Jagdish Khubchandani, a professor of public health at New Mexico State University. Concerts are not essential, and people should find alternate ways of entertainment ... The pandemic wont last forever, but the more we engage in events like concerts, there will be prolonged recovery from the pandemic.

A vaccine will be a big help, but not the total solution.

It is difficult to anticipate when or even if we will return to the traditional live concert setting that we were accustomed to prior to the COVID-19 pandemic, said Dean. Vaccinations, immunity and decreased spread of the virus may result in a safer environment to consider returning to concertgoing as we knew it, but it is too early to tell.

Even if we reach the herd immunity threshold in the next year or so, traditional concerts may still pose a risk to many, as the virus will not simply disappear. As a result, venues will likely need to take precautions to protect concertgoers health, and some music fans may still be hesitant to attend a big show.

It would be a better situation if we had vaccines, but realistically we may have to have a hybrid of recommendations, said Dr. Jake Deutsch, a physician and founder of Cure Urgent Care. He emphasized the need for venue safety measures and rapid testing in addition to greater immunity.

Testing being readily available, accurate, cost-effective, and providing rapid results can also facilitate the return of traditional concerts, noted Dr. Sachin Nagrani, a physician and medical director for the telemedicine and house call provider Heal.

Outdoor concerts will resume before indoor shows.

Outdoor events will return sooner given the lower risk of transmission of the virus when outdoors due to easier ability to distance, naturally high ventilation and sunlight sanitizing outdoor surfaces, said Nagrani.

Indeed, concert organizers have already been testing out new outdoor music experiences amid the pandemic. In August, English artist Sam Fender performed for 2,500 fans at the Virgin Money Unity Arena the U.K.s first socially distanced music venue.

Ian Forsyth via Getty Images

The setup featured spaced-out private platforms, food and drink delivery and strict distancing rules. Six weeks after the venue opened, however, new COVID-19 restrictions to address rising case counts forced it to shut down.

Although outdoor concerts may be a good first step in the return of live music events, changing seasons and everyday weather conditions can be limiting. Keeping people spaced apart is also not necessarily easier outside.

A Hamptons fundraiser concert featuring the Chainsmokers came under fire in July after photos and videos from the event showed egregious social distancing violations.

Masks will be part of the equation for a while.

While the prospect of an effective COVID-19 vaccine looks promising, health experts have made it clear that it wont completely shield everyone from the disease. Therefore, face masks will still be an important part of our lives, especially in high-risk situations like large public gatherings.

People need to understand that even as the vaccine is rolled out, we will need to continue to wear masks and physically distance to prevent spread of coronavirus, said Krutika Kuppalli, an infectious diseases physician and vice chair of the IDSA Global Health Committee.

Mask-wearing will be part of the concert experience of the future, at least for little while, as will other important restrictions, Dean noted.

The same safety measures we recommend for reducing the spread of COVID-19 apply to live music shows, including social distancing, wearing a mask, frequent hand-washing, disinfecting communal surfaces prior to use and remaining home while you are sick or if you have had a known exposure to COVID-19 within the past 14 days, she said.

Expect more checkpoints.

Just as weve seen restaurants do temperature checks before allowing patrons to dine, music venues will likely implement similar measures as concertgoers arrive at shows.

While those checks will not be the only safety installments into the concert experience, we can reasonably expect that temperature checks, questionaries and other protections might be built into concerts in the future, said Kilby.

Concert organizers will have to monitor the spread of the virus in the community and surrounding areas where attendees may travel from. As rapid testing becomes more widely available, venues could also require proof of a negative result.

The reduced capacity will make it difficult, or even impossible, for the bands and promoters to break even.

- Labus

Point-of-care testing to get done in the moment when they arrive would be a game-changer, noted Deutsch.

If there are going to be more checkpoints, however, he believes venues need to rethink the ways they funnel attendees into the space to allow for social distancing. Touchless technological solutions and sanitizer stations at entry and exit points are obvious additions as well.

Organizers will need to reduce crowding.

As in-person concerts resume, organizers will likely have to limit the number of attendees to allow for social distancing. Still, Labus noted, thats not enough to prevent crowding.

Its not just about reduced capacity, we have to reduce the density of the crowds as well, he said. Even if you only allow 10% of the venues capacity, those people will all crowd near the stage unless you have assigned seating that keeps them apart. That means having small crowds spread out in large venues, which would drastically change the concert experience.

Venues with built-in seating may be at an advantage, but other spaces can of course add chairs or other mechanisms to ensure proper spacing.

I do think that outdoor venues will return before indoor ones, Kuppalli said. I would also think smaller venues would be more likely, and places with assigned seating like the Hollywood Bowl would be preferential this way you can have people appropriately distance and wear masks.

Kevin Mazur via Getty Images

Artists and venues will continue to face challenges.

Its no secret the concert industry is struggling in 2020, and a vaccine or gradual resumption of live shows will not cover the financial losses wrought by the pandemic.

The reduced capacity will make it difficult, or even impossible, for the bands and promoters to break even, said Labus. Given the logistical challenges of mounting national tours, I would expect to see smaller acts in smaller venues before we see the return of large arena shows.

In a recent survey of about 1,350 live industry professionals, more than 72% expressed concern about their companys ability to survive COVID-19. A similar number said they do not believe the government has given proper consideration to the plight of the sports and live entertainment industry as compared to other impacted industries such as airlines, hotels, restaurants/retail.

Its important for music fans to support their favorite artists and venues as they navigate this new reality, whether that means donating to relief funds, buying tickets to virtual events or spreading awareness.

There are options to enjoy concerts right now, such as online or drive-in performances, said Nagrani. I highly encourage supporting your favorite artists and venues via the available options given our current constraints.

Virtual concerts and viewings of pre-recorded shows have their own entertainment value, but as Kilby noted, its not quite the same as the powerful live experience.

We can expect that the concert experience will be different going forward, and innovative artists are already trying new ways of engaging fans, she said. Throughout the pandemic, drive-in concerts have gained in popularity as an alternative to traditional concerts, but they are not accessible everywhere. They also dont allow for the same experience or sound quality that a traditional in-person concert would have.

While theres a lot of uncertainty surrounding the concert experience in the age of COVID-19, one thing we know for sure is that its going to take some time for the industry to recover.

As Khubchandani emphasized, We have to be patient.

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When Will Concerts Return? Experts Weigh In. - HuffPost