StemCell Therapy

Blood sugar - the main type of sugar you get from eating food - supplies the body's cells with energy. However, consistently high levels can unleash destruction on the body. If you have type 2 diabetes, you are prone to high blood sugar levels because the main regulating force - insulin production - is impaired.

The effects of high blood sugar levels often constitute the first perceptible warning signs of type 2 diabetes.

Some of the most acute symptoms stem from autonomic neuropathy - damage to nerves that control your internal organs.

As the National Institute of Diabetes and Digestive and Kidney Diseases (NIH), high blood sugar in the blood from diabetes can damage your nerves and the small blood vessels that nourish your nerves, leading to autonomic neuropathy.

Struggling to adjust your eyes in a dark room is a warning sign of autonomic neuropathy.

READ MORE:Diabetes type 2 symptoms: The alternating toilet habits that signal high blood sugar

NIH explains: "Damage to the nerves in your pupils may make them slow to respond to changes in light and darkness."

The health body adds: "Your eyes may take longer to adjust when you enter a dark room. You may have trouble seeing the lights of other cars when driving at night."

This is otherwise known as 'dark adaptation', which refers to how the eye recovers its sensitivity in the dark after exposure to bright lights

Other signs of autonomic neuropathy include problems with:

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According to the NHS, you should see a GP if you have any of the symptoms of type 2 diabetes or you're worried you may have a higher risk of getting type 2 diabetes.

"You'll need a blood test, which you may have to go to your local health centre for if it cannot be done at your GP surgery."

The earlier diabetes is diagnosed and treatment started, the better.

As the NHS explains, early treatment reduces your risk of other health problems.

Lifestyle changes are usually recommended to bring blood sugar levels down to keep the risks of diabetes at bay.

There are two key components to blood sugar control - eating a healthy, balanced diet and regular exercise.

A common misconception about type 2 diabetes is that you need to avoid eating certain foods.

There's technically nothing you cannot eat if you have type 2 diabetes, but you'll have to limit certain foods.

The worst offenders are carbohydrates because carbs are brown down into glucose relatively quickly - this causes spikes in blood sugar.

There are some general dietary principles that can help you to manage type 2 diabetes.

According to the NHS, you should:

Physical exercise helps lower your blood sugar level - you should aim for 2.5 hours of activity a week, advises the health body.

"You can be active anywhere as long as what you're doing gets you out of breath," it adds.

Originally posted here:
Type 2 diabetes symptoms: Do you experience 'dark adaption'? It could be a warning sign - Express

The changes brought by the COVID-19 pandemic have had an impact across society, and courts and IP offices are no exception. As part of our series of articles looking at what to expect in 2021, Kilburn & Strode attorneys discuss some of the legal developments on the horizon.

Its not just business meetings, webinars and Christmas quizzes that are suited to Zoom; court and IP office hearings are increasingly conducted virtually too.

At the EPO, oral proceedings in examination and oppositions will be heldonlineunless there are exceptional circumstances until September 2021 (at least). Board of Appeal hearings are heading the same way. While some practitioners have been sceptical about these changes, at Kilburn & Strode we see video conferencing as a hugely powerful and accessible medium for getting to a good decision quickly.

This is good news for SMEs, who may now be able to afford to fight cases they couldnt otherwise, says associate Rosie Carrie. But, she adds, the long-term implications are hard to predict: Will parties be more likely to be confrontational when not seeing each other in person? Will they pursue arguments more strongly? Will the opportunity to resolve issues in an informal setting be missed?

At the EUIPO, there may be changes too. Areformin 2019 overlooked by many people at the time means that the CJEU now accepts appeals from the EU General Court only where they raise an issue that is significant with respect to the unity, consistency or development of EU law. In practice, this means the General Court is now the final arbiter for most cases involving EU trade marks and registered Community designs. That may lead to the EUIPO Boards of Appeal holding more oral hearings between parties, something that until now has been extremely rare.

Patent priorities

With normal routines disrupted and the opportunity to reflect, the pandemic has led many people to consider their values and priorities getting fit, learning new hobbies or their social and political values. Policy debates about the balance between competition and innovation, between access and reward; or between control and free speech have always been part of IP. In this new environment, will we see them become even more prominent?

In patents, for example, partnerNick Bassilsays he increasingly sees morality issues being raised regarding patents for stem cells, gene therapy etc, arising from the ordre public (public policy) and morality exception in Article 53(a) of the EPC: This will become more and more relevant with genetic medicine. More generally, debates about access to medicine, the role of patents, pricing mechanisms and sourcing of drugs are gaining attention as the pandemic increases awareness (if not understanding) of the role of medicine (see our separate article on political and social trends).

On your marks

In trade marks, meanwhile, debates are continuing about the proper scope of protection and whether making broad and/or multiple related trade mark applications should be discouraged (including on the grounds of bad faith). These issues were not fully resolved in last yearsSkyKickdecision from the CJEU, but should be addressed further in the MONOPOLY case pending before the EU General Court.

Trade mark partnerIain Stewartsays: These debates reflect wider concerns about the cluttering of trade mark registers. One view is that unlike in the US where there are strict use requirements, in Europe there are too many marks that are registered but not used. It means clearance searches in the EU are becoming a nightmare. Sometimes the results run to dozens of pages, explains Iain. As well as being a practical challenge for those seeking to apply for trade marks, particularly internationally, cluttering raises questions about the accessibility of the trade mark system and its ability to serve all users, especially SMEs.

UPC or not UPC?

The end of 2020 saw Germany take important steps towards ratifying the Unified Patent Court (UPC) Agreement, raising the possibility that it could theoretically come into effect, though significant legal challenges remain (meaning ratification by Germany and implementation in 2021 is unlikely).Gwilym Robertssays: The UPC was always a lofty ideal and the simplification it offers remains attractive. But with the continuing legal challenges it faces one wonders if its time to look at alternative multilateral arrangements bringing the same benefits.Whatever comes out Kilburn & Strode will continue to be a part of it as we continue to expand our European presence.

Read article three here

See the article here:
How the law will change in 2021 - Lexology

In addition to carving out a distinguished medical career, Dr Cliff Bacchus has built a reputation as a novelist unafraid to tackle challenging social issues, most recently the practice of intermarriage between cousins.

By the time they reach their sixties, most people would be looking forward to retiring and taking things easier. For medical doctor Dr Cliff Bacchus, however, it marked the launch of a second career as a novelist.

Now aged 78, Dr Bacchus has published three critically-acclaimed novels within the last 15 years, with the latest gripping psychological thriller Curses of Cousins just released.

For the Bahamas-based author, who also runs two busy pain management clinics in the country, writing is a much-needed creative escape from the pressures of the day job.

Since 1974, he has served the medical needs of the Bahamian island that has been his adopted home since he left his native Guyana to study medicine in what was then Communist Russia.

During all that time, he has consulted the rich, the famous, and the less fortunate with equal attention, and care for all, initially as a senior medial officer working for the government before going into private practice in the early 2000s.

His standing as a physician also led him to be cast as a doctor in 2007 Bahamas-set Hollywood film Bad Girl Island after he conducted the medical examinations for the director, Stewart Raffill, and crew.

Perhaps somewhat unsurprisingly, Dr Bacchus draws heavily upon his training and experiences for his novels also including his literary debut, 2007s A Doctor and a Gentleman and 2011s Do No Harm in the sense that they are all fundamentally driven forward by a thought-provoking consideration of contemporary medical issues or ethics.

In the case of Curses of Cousins, the narrative is wrapped around an exploration of intermarriage between cousins.

It is a practice that goes on not only in certain communities within the Bahamas but around the world, including the UK. While perfectly legal, it is a semi-taboo subject within society, hardly spoken of.

The problem is that this practice also carries with it a serious risk of genetic defects in any resulting offspring. Indeed, it is believed that two children born from such unions die in the UK from resultant genetic abnormalities every single week.

In the novel, the protagonist, teacher Brooklyn Watts, sets out to find out why her family, and many other families on the fictional Bahamian island of Sigatoo, suffer chronic, incurable illnesses.

In her case, it is alopecia and multiple sclerosis (MS), and, as she quickly comes to learn, her and others ill-health, previously attributed to a curse, is in fact a direct result of the traditional island practice of cousin marriage.

Despite the pain she suffers daily from her debilitating condition, she sets out on a quest to educate the population about the risks that such marriages carry to the next generation.

For Dr Bacchus, who was named Physician of the Year by the Government of the Bahamas in 2000, it is a vitally-important health issue to address.

I got the idea for Curses of Cousins as I have had several patients with genetic-based conditions that resulted from intermarriage between cousins, he says.

Im not calling for the practice to be banned outright, but there needs to be an open acknowledgment that children of such marriages run a significant risk of inheriting genetic defects that could impact their quality of life.

With this awareness then, at least, those who still wish to enter into such relationships can understand the importance of carrying out genetic counselling and blood tests to ensure a healthy progeny.

The novel is also notable for another battle that Brooklyn must face while trying to confront ignorance, superstition, and traditionalism within her society: a war between the literal forces of good and evil for control of her mind.

I always include a metaphysical aspect to my novels, explains Dr Bacchus who, in additional to a medical degree and membership of the American Association of Family Physicians and the American Association of Anti-Aging Medicine, holds a degree in metaphysical science and is the Worshipful Master of his islands Masonic lodge.

I do believe that beyond the physical we are all attuned to a higher, cosmic consciousness.

In Curses of Cousins this war between the personifications of good and evil adds a deeper level to the readers understanding of Brooklyn, and also another perspective on the obstacles she must overcome from certain parts of society in bringing about positive change.

As well as praising his latest novel for its originality and daring to broach the pressing issue of cousin marriage, reviewers have also highlighted Dr Bacchuss realistic depiction of a female lead a rare achievement for a male author.

This, however, is something that he attributes as much to his environment as his writing skills.

He says: All my life Ive been in the company of women. My children were all girls and in all my years of practice I have worked alongside female nurses.

Its given me a better understanding of the female mind than most men, I think, and it is wonderful that readers and reviewers concur.

Brooklyn was a fascinating character to create, being independently-minded, courageous and determined to protect future generations so that they wouldnt suffer in the same way that she does.

Some readers have called her inspirational, and that makes the whole writing process more than worthwhile.

I always intended to highlight the issue of intermarriage through fiction because it stands a much better chance of reaching the widest audience, compared to a dusty old academic paper that will never be read by anyone save other doctors.

But a novel stands or falls on whether the central character engages with readers, so it looks like all those years in almost exclusively female company has paid off.

As to the future, Dr Bacchus is already working on his next novel, which will be focused on another global issue world poverty.

Writing keeps my young, he adds. Its far more relaxing the medicine while also providing the opportunity to communicate with the world.

Curses of Cousins by Cliff Bacchus is out now on Amazon , priced 9.07 in paperback and 3.02 as an eBook.

EXCLUSIVE INTERVIEW WITH DR CLIFF BACCHUS

Dr Cliff Bacchus discusses his new novel, psychological thriller Curses of Cousins, and what motivates him as an author.

Q. What was your motivation for becoming an author?

A. To expand my outreach to people around the world.

Q. Your latest novel deals with a very grave subject: the risk of genetic abnormalities from intermarriage. Why did you feel it better to cover this subject through fiction than nonfiction?

A. Through fiction, I can reach more people, and generate more interest through theme, plot structure, unique characterisation, and suspense.

Q. What do you hope readers get from reading your new novel, Curses of Cousins?

A. I want them to grasp the theme: that cousins marrying cousins may not be the best for the children you give birth to. However, this is not a concrete rule. There are many who intermarry because of custom and religion, but it is time to reflect on the subject. If it works for you, fine! It is my point of view, based on experience as a medical doctor for nearly five decades.

Q. How did you get the idea for your latest novel?

A. From my medical experience over many decades.

Q. Describe a typical day in your life

A. I rise early, write for two hours until clinic time, 8 am to 11 am. Then its clinic again from 3 pm to 5 pm, followed by a walk and watching BBC news, CNN and talk shows, or a spot of painting on canvas. Bedtime is by 12 midnight.

Who are your literary inspirations, and why?

A. Shakespeare, Jane Austin, and Sidney Sheldon. Inspirational!

Q. All your novels include a metaphysical element. Can you explain why you feel it important to weave this into your stories?

A. Metaphysics deals with abstract concepts such as being, knowing, identity, time, and space. My novels are just about that. My novels must have meaning!

Q. If you could offer one piece of advice to somebody wanting to become an author, what would it be?

A. Be prepare to work hard and love it. Be prepared to accept the lonely life and love it. Be prepared to do research and love it.

Q. What satisfaction does writing bring you?

A. Knowing that I can communicate the truth and hope for the acceptance of it.

What can readers expect next from you?

A. Another work of fiction as I hone the craft for better and better.

Read this article:
Writing is the best medicine - The London Economic

For the better part of five years, a coalition of environmental groups and tort lawyers (aided by the mainstream press) has relentlessly asserted that the weedkiller glyphosate poses a serious cancer risk. A team of respected epidemiologists poured gasoline on this already raging fire in 2018, when they published a meta-analysis (which Ill refer to as the Zhang paper after the first author) that found a significant association between glyphosate exposure and the risk of non-Hodgkins lymphoma (NHL).

In part one of this series, I detailed how the authors of what appeared to be an important paper made some highly questionable decisions in order to reach their conclusion, namely selecting certain data points and excluding others from the studies they considered. Despite the serious defects that I and a few other scientists pointed out soon after the paper appeared online, the papers conclusion that relatively heavy exposure to glyphosate was associated with a 41 percent increased risk of NHL ensured that it would get widespread publicity.

But there were still other indications of bias in the paper that provide insight into the authors thinking. In this follow-up piece, I want to examine some of the other instances of bias, then address three crucial questions. How could this paper, flawed as it is, have passed peer review and largely escaped serious criticism in the two years following publication? What does the Zhang paper reveal about the authors mindset, and about standards of scholarship in the field of environmental epidemiology? And, finally, what are the implications for efforts to produce reliable science that can guide policy makers and consumers?

Well before I got to the heart of the Zhang paper, I picked up signals that put my critical antennae on guard. On page three, the authors stated, GBHs [glyphosate-based herbicides] have recently undergone a number of regional, national, and international evaluations for carcinogenicity in humans [20-23], resulting in considerable controversy regarding glyphosate and GBHs overall carcinogenic potential.

In order to support their claim of considerable controversy, the authors provided two references to agencies that found that glyphosate is not a health concern (US Environmental Protection Agency, EPA; Joint FAO/WHO Meeting on Pesticide Residues, JMPR) and two that found it to be a probable carcinogen (The International Agency for Research on Cancer, IARC; and Californias Office of Environmental Health Hazard Assessment, OEHHA), thus implying that opinion is evenly divided and balanced.

In fact, roughly a dozen national and international agencies have found glyphosate to be safe and non-carcinogenic (EPA, Health Canada, the European Food Safety Authority, the European Chemicals Authority, the UNs Food and Agriculture Organization, and the health agencies of France, Germany, Australia, New Zealand, Japan, and Brazil). The fact is that IARC is the only major agency that has found glyphosate to be problematic, and its analysis has been deemed defective by many independent experts. As for OEHHA, it mechanically follows IARC in its designation of carcinogens under Californias Proposition 65, a byzantine law approved by voters in 1986 that has led the Golden State to list garlic bread and, for a time, coffee as possible carcinogens.

Whatever controversy over glyphosate there is, then, is the product of political and legal considerations, not evidence that the weedkiller causes cancer. However, the assertion that there is considerable controversy is important to the Zhang authors because, in their telling, it is what motivated their meta-analysis, as the following sentence makes clear: Hence, addressing the question of whether or not GBHs are associated with NHL has become even more critical (emphasis mine).

Throughout the paper, there are other similarly one-sided characterizations of the evidence on specific topics.

First, in their introduction, the authors emphasized the amount of glyphosate used in the past decade and noted that it has been detected in various foods and baby formula, concluding that glyphosate may be considered ubiquitous in the environment. However, they omitted that glyphosate has relatively low acute and chronic toxicity compared to other pesticides and that the levels detected in foods are well below the level at which any adverse effects would be expected.

They observed that use of glyphosate increased roughly 16-fold between 1992 and 2009, but they failed to note that the incidence of NHL has remained unchanged over the past thirty years.

Second, they articulated criticisms of the Agricultural Health Study (AHS) at length based on secondary considerations, but failed to note its strengths. The AHS is, in fact, the best epidemiological investigation of glyphosates cancer-causing potential, and it poses a significant challenge to Zhangs conclusion. It is striking that the authors failed to note the much more serious problems with the case-control studies they inappropriately combined with the AHS (Read part one for a full analysis of this issue).

Third, to supplement the results of the meta-analysis of human studies, Zhang et al. summarized the results of studies of lymphomas in mice following the administration of glyphosate, which they interpreted as providing additional evidence of the carcinogenicity of glyphosate. However, the evidence appears mixed and, where increasing trends were seen in the tumor yield with increasing doses of glyphosate, they were modest. Researchers have evaluated glyphosate rodent studies for all tumor sites and found more instances of tumor decreases with increasing glyphosate exposure levels than tumor increases.

Finally, the authors pointed to a number of biological mechanisms that may play a role in the development NHL in humans and of lymphoma in animals. While such mechanisms are worthy of study, it is generally recognized that the results of laboratory studies are less directly relevant to risk assessment than epidemiologic studies and, secondarily, animal experiments.

Thus, there is a pattern throughout the Zhang paper of what I call motivated reasoning. Rather than evaluating the evidence on its merits, the authors constructed a narrative designed to support their a priori hypothesis. In other words, their critical faculties served to imprison them in their motivated thinking, always a danger in science thatphysicist Richard Feynman addressed in his 1974 commencement address at Caltech titled Cargo Cult Science. Feynman emphasized that when you formulate a hypothesis, you must list all the observations and facts that support it, but you must also list all of the observations and facts that do not agree with it. This is the only way not to fool yourselfand, Feynman added, you are the easiest person to fool.

Given the Zhang papers unjustified assumptions and methodological flaws, how did it survive peer review? Peer review is a lottery, by which I mean the quality of the review depends very much on the individuals who perform the review, as well as the editor who oversees the review. Some reviewers are tough minded and the study author senses they miss nothing in evaluating a paper.

At the other extreme, reviewers who are less alert or less methodologically astute may feel that the authors have made a convincing case. I would argue that Zhang et al. wrote their paper with an emphasis on justifying their choices and judgments rhetorically, if not scientifically. One almost feels snowed by their arguments. And their style of argumentation appears to have been very effective. What is clear is that neither the editors nor the reviewers noticed the pattern of motivated reasoning, selective attention to facts, and unsupported assumptions that I have described.

The fact that the Zhang paper was published in Mutation Research, a publication with a broad focus on genetic toxicology, rather than in an epidemiology journal may have increased the likelihood of an inadequate review of a paper reporting on a meta-analysis of observational epidemiology studies.

The authors response to substantive criticism has been revealing. Rather than acknowledging criticism and presenting valid arguments to support their position or modifying it, they doubled down on their hypothesis and tried to divert attention from the key issues, while asserting the transparency and quality of their work. In addition, they implied that their critics must have some conflict of interest.

I will give just one example among many. In her February 2020 Forbes piece, responding after a full year to my critique published in February 2019, Lianne Sheppard, the Zhang papers senior author, wrote that cherry-picking of data to achieve particular results is never acceptable scientific practice, and in the case of our meta-analysis, this claim is not true. But, based on her a priori hypothesis, she defended her selection of the one relative risk out of five from the AHS (relative risk 1.12) that ensured a statistically significant result.

This was not the main analysis presented by the AHS researchers in their paper that was the unlagged relative risk of 0.87. And, as I made clear in part one, there are two glaring facts that should have motivated Sheppard to reconsider her choice. First, the AHS, by far the largest and most careful study, showed no support for her a priori hypothesis that the highest exposure group would show the strongest association and demonstrated this point in all five analyses! Second, as the Zhang authors themselves acknowledged, the latency period for NHL to develop is uncertain, and could be as short as two years, although their conclusion is based on the assumption that it is 20 years. Recognition of both these facts should have made the authors reconsider the justification for their analysis.

After this evasion of the science, Sheppard went on to raise further diversions, arguing that publications in the popular media are not appropriate for the serious business of evaluating risks scientifically. Only the sacred precincts of academic journalswhere my colleagues and I have recently published a thorough critique of the Zhang paper are suitable venues for such discussion. Sheppard seems unaware of the flourishing, real-time discussions of critical issues in science and medicine by the likes of Eric Topol, Peter Hotez, Vinay Prasad, and many others on Twittter. True scientists are happy to engage with an interested audience, whatever the forum.

I have devoted time to examining this paper because I believe it is symptomatic of a state of mind that is prevalent in environmental and lifestyle epidemiology. This area is challenging due to the difficulty of measuring human exposure to low-level environmental agentsoften measured at a single point in timeand gauging their long-term health effects against the background of exposures that are often orders of magnitude stronger (smoking, alcohol consumption, diet, body mass index, postmenopausal hormones, etc). Nevertheless, numerous papers continue to be published examining the association of self-reported exposures to trace levels of chemicals in urine or blood with risk of some chronic disease.

There are those working in this area who appear to feel that, in spite of the limitations of the studiesor, perhaps, because of these limitationsone has to take seriously results that are suggestive of an association. In a sense, because of the difficulty of documenting low-level exposures, scientists may feel that they have to give them the benefit of the doubt. Given the limitations of the data, the findings of such studies need to be interpreted with an allowance for the fact that the studies cant tell us what we want to know.

The science policy scholar Daniel Sarewitz has used the term trans-science to refer to the study of complex questions that cant be answered by present-day science. In the absence of definitive data, what seems to be most important to these people is their interest in the question regarding the effects of a particular chemical agent. This is how results from weak studies that appear to point to a risk can be seized on, and this is what appears to have happened in the Zhang paper. What is lacking in high-quality evidence is compensated for by ideological and moral zeal.

Researchers are keenly aware that the media, the public, and even journal editors and reviewers are sensitive to findings that appear to implicate a common exposure in chronic disease. Where strong data are lacking but the issue is one that will resonate with the public and the media, scientists know that their message will get picked up and get traction. Weve seen many examples of this in research on electromagnetic fields, endocrine disrupting chemicals and BPA, DDT and other pesticides, e-cigarettes, and many other issues.

A number of agencies and institutions have been associated with this type of motivated sciencethe International Agency for Research on Cancer (IARC) regarding glyphosate, cell phones, and other exposures; the National Institute for Environmental Health Sciences (NIEHS) regarding BPA; and the Endocrine Society regarding endocrine-disrupting chemicals generally.

In contrast to the kind of science exemplified by the Zhang paper, there are examples of sober and careful work by scientists who are trying to advance knowledge in their field by building on firm results and framing new hypotheses. This work, however, is unlikely to attract media attention.

A recent paper by Moubadder et al. has reviewed environmental exposures in relation to NHL. With regard to environmental exposures, they noted that several infectious agents have been causally linked to NHL. However, with regard to chemical exposures, they concluded that numerous studies have attempted to link NHL risk to chemical exposures, but in spite of many reported associations, causality has not been established.

Commenting on the Zhang meta-analysis, they had this to say:

A recent meta-analysis that included the 2018 Agricultural Health Study (AHS), a cohort of pesticide applicators that have been followed prospectively, and five casecontrol studies found the relative risk of NHL to increase by 41% among those highly exposed to glyphosate-based herbicides [meta-risk ratio (RR) = 1.41; 95% CI, 1.131.75; ref. 20]. However, studies on the AHS population alone, which includes 515 incident NHL cases, have consistently observed no association between reported glyphosate exposure and NHL risk, regardless of the latency period (i.e., 5-, 10-, 15-, and 20-year lag times; refs. 21, 22).

Taking a broad view of the role of environmental exposures in the etiology of NHL, Moubadder considered glyphosate specifically, but still came to the conclusion that causality has not been shown for any chemical.

In contemplating the contrast between the Moubadder paper and the Zhang paper, I was reminded of interviewing the reproductive expert Richard Sharpe about the huge amount of fruitless research that had been devoted to BPA as a cause of adverse reproductive events. In the early 1990s Sharpe had been one of the originators of the so-called environmental estrogen hypothesis and had seen it grow into a huge academic bandwagon, which he dissociated himself from. Sharpe shifted his attention to studying the effects of pharmaceuticals taken by pregnant women on the fetus and the developing child, as well as other exposures. The shift away from studying trace exposures to BPA to more significant exposures has already led to evidence of real effects.

Explaining why he went his own way, he said, I was lucky that the question that drove me was what causes these disorders? not how do EDCs [endocrine disrupting chemicals] cause these disorders? Such a simple difference, but it takes your thought processes in a very different direction.

Geoffrey Kabat is a cancer epidemiologist and the author ofGetting Risk Right: Understanding the Science of Elusive Health Risks. Find Geoffrey on Twitter@GeoKabat

Link:
Misleading glyphosate-cancer study Part 2: 'Symptom of a widespread problem'Concerns about ideological activism in science research and communications...

Shelby County Judge William Bostick III on Monday ordered 47-year-old Jeff West to serve 16 years in prison for the death of his wife, Kat West.

In November, Jeff West was convicted of reckless manslaughter in the death of 42-year-old Kat West, a Calera mother and online exhibitionist.

Kat West died from a blow to the head from a Lucid Absinthe bottle wielded by her husband, a jury deemed. He has maintained his innocence for more than three years, contending she died as the result of a drunken, accident fall.

Jeff West addressed the court before sentencing. He talked of all hes missed while jailed over the past three years. He never mentioned his wife by name or her death, only saying I lost my best friend.

Bostick said he took into consideration Kat Wests familys pleas of leniency. He said he gave less weight to the testimony of Nancy Martins request, however. Martin, Kat Wests mother, has supported her son-in-law throughout the entire criminal process. The judge said, In my opinion, shes ignored the evidence in this case.

He said he also considered Jeff Wests military history, his lack of criminal record and his strong ties to the community.

We dont drag people into courts of law and try them for who they are. We drag people into courts of law and try them for what they did,' Bostick said. Our laws designed to punish people not for who they are but for what they do. In this case the the jury found you to be responsible for your wifes death. They imposed that responsibility on you. You were afforded the opportunity to accept responsibility for causing your wifes death. You have, for your own reasons, taken the position that you dont intend to do that. So the jury had to do that for you.

I know there were some versions of the evidence that may say Kat was responsible for her own death, or her drinking. She contributed to her demise, but I dont consider that mitigating at all in this case,' the judge said. Domestic violence always follows according to a pattern. Kats death was foreseeable I dont believe you woke up the morning that this offense occurred and decided todays the day Im going to kill her. I dont believe the happened. But I do believe this could have been avoided, I do believe it was foreseeable and I do believe with the jury that it is your reckless acts that caused her death.

West will receive credit for the nearly three years hes already served. He will appeal.

The case was prosecuted by assistant district attorneys Daniel McBrayer and Ben Fuller. Joined by District Attorney Jill Lee, they spoke following Mondays sentencing. Obviously we would have preferred a 20-year sentence just as we would have preferred a murder verdict,' McBrayer said. We respect the judges sentence and the jurys verdict. We are glad he will see the inside of a prison for this killing. We think thats important.

Prior to the start of last years trial, Jeff West was offered a plea deal that would have allowed him to be released immediately for time served. He turned down that deal. That is our standard practice. Here in this case we did make an offer that was within the voluntary guidelines but that was premised on the defendant accepting responsibility for this crime and he didnt,' McBrayer said. So thats why you see a difference in what we offered in the case and the ultimate sentence we asked for.

McBrayer was asked for his reaction to Jeff Wests statement in which he only barely mentioned his wife. It struck me that he mentioned very little other than himself,' he said.

McBrayer described Jeff West as calculating. I think he was very thoughtful and deliberative about every action and every word that he said in this case,' he said. The jury found this was a reckless act but it was backed up by intentional actions, whether it was moving the body , what he said to police, and when he said it.

Fuller said Jeff West has refused to accept any responsibility. Its been consistent throughout the trial. That was our point he bears responsibility from start to finish and he just refuses to accept that,' he said.

Jeff Wests attorney, John Robbins, said he was expecting a 20-year sentence. I appreciate we didnt get the full maximum sentence. My position has been that even though he was convicted of manslaughter,' he said, I think this was a case that probation would have been appropriate, especially after serving almost three years on this so far.

He said he asked Jeff West if he was sorry he did not take the plea deal. He still satisfied with that position that hes taken since Day 1,' Robbins said. Im not at liberty to tell you exactly what he said, but you can read between the lines.

Im sorry the prosecution wants him to come out and say I did this. Since Day 1 he has denied it and thats his position. It wasnt going to change,' he said. He had an opportunity to take that position and go home. He refused to admit to something that he didnt do. You have to respect the person for that.

Robbins talked about how much weight is given to a victims family and their wishes in criminal cases. Usually, the victims family does not take the side of the defendant which is what happened in this case.

Still, Robbins said, the same amount of equity should be given to the wishes of Kat Wests family. You cant take into consideration only when its convenient for you,' Robbins said. Thats what the prosecution did. Its convenient when the family wants to jump up and down and want vengeance. On the other hand, when the family wants leniency and mercy, we want to ignore that.

Here is full coverage of the death of Kat West

Kat West was killed Friday, Jan. 12, 2018.

Her body was found about 5 a.m. the following day by a 19-year-old neighbor who was on her way to work at a fast-food restaurant. The victim was wearing only a sports bra. A cell phone was nearby with a green bottle on top of it, which witnesses said appeared staged.

Kat West touted herself on social media as a stay-at-home mom but also had a subscription-only website, where she went by the name Kitty Kat West. Her Twitter and Instagram accounts, also under the name of Kitty Kat West, featured revealing photos of West, and directed viewers to her paid adult website, which cost $15.99 per subscription.

Jeff West, a former Birmingham Southern College campus security officer and U.S. Army veteran, has been held in the Shelby County Jail since his arrest three years ago. The couple had a daughter, Logan, who also goes by Lola, who is a teen.

During Mondays sentencing hearing, the couples 15-year-old daughter, a student at Calera High School, testified on behalf of her father, asking a judge to release him. She said she grew up in a loving home. Her father, she said, never spanked her nor was he ever loud or abusive. Instead, she described him as always calm.

He has always been my shield against the world,' Logan told the judge. Please give me my father back as soon as possible.

During a recess, Logan hugged her father for nearly two minutes.

Both Jeff Wests mother, Sue West, and mother-in-law, Nancy Martin, also testified on his behalf. The two families have presented a united front since the 2018 death and Jeff Wests arrest.

Martin, the only witnesses for the defense at last years trial, said she was shocked that he was convicted in the death of her daughter. He has always been a kind and caring person,' Martin said. He is a good man.

The Martins have custody of Logan but share the responsibility with Jeff Wests parents. We are a family,' she said.

Sue West, speaking for herself and her husband, Jerry West, broke down while talking about her son. He has always been empathetic and kind,' she said. He tries to see the good in everyone and every situation. He is the most forgiving person I know.

I need my child back,' Sue West said. Logan needs her dad back. This has been an absolute nightmare.

Jeff West (Shelby County Jail)

Also in Mondays sentencing hearing, McBrayer and Fuller again presented a photo of Kat West as she was found that Saturday morning, face down, bloodied and wearing only a pink bra.

They also played audio of a portion of his interview with police during which Jeff West was asked if the couple had arguments. He said it was nothing out of the ordinary but that they argued over her drinking. I dont like her drinking,' he told them.

Asked why they bought liquor that night, he said, I love her and she said she could control it.

In closing arguments, McBrayer said that Jeff West is a trained crime scene investigator who clearly knew what he was doing that night. He said even as recently as last week, Jeff West refused to take responsibility for the crime. He is what he always was, calculating,' McBrayer said.

He said Jeff West is a trained crime scene investigator who knew what he was doing when he staged the Lucid Absinthe bottle on top of the cell phone. Those two things, her drinking and her social media use, were what drove Jeff West to kill her, he said. He said evidence also showed that Jeff West moved his wifes body after he killed her to make it look like she had been hit by a vehicle.

The killing, and the consequences, merit a tougher sentence than the minimum guidelines call for. McBrayer asked that Jeff West get 20 years in prison.

Robbins, in his sentencing closing statements, said its been a difficult case on everyone involved. Not every person is the same, not every crime is the same and he said the judge should consider that when imposing Jeff Wests sentence, especially his 21 years of service in the U.S. Army during which he saw combat. He has no criminal record, and strong family times to the community.

He was not convicted of an intentional act,' Robbins said.

Robbins asked for no more than time served plus one additional year. He asked that the judge consider the familys feelings. Theyre pleading for mercy,' Robbin said.

The week-long trial took place in November 2020 at which time prosecutors said they believed Jeff West was motivated to kill his wife over her excessive drinking and frequent use of social media to promote her adult website.

In the hours leading up to the killing, the couple had shared a date night dinner and drinks out and a stop at a liquor store after where they bought Jameson whiskey and the bottle of Absinthe.

They both drank a lot and then Jeff West took two photos of his wife, who posed in a pink bra, pink multi-colored panties and pink stiletto shoes.

At some point, prosecutor Daniel McBrayer said, an argument erupted. He is tired and fed up with this Instagram stuff, McBrayer said. He grabs her phone and chunks it out the front door where it lands in the street. Prior testimony showed that Kat Wests phone was cracked.

Kat West went outside to retrieve her phone. She was wearing only the pink bra no pants or panties or shoes. McBrayer has said he believes Jeff West grabbed the liquor bottle, followed her outside and, holding the bottle in an inverted position, delivered the fatal blow to her head.

This marriage was not in a good place, McBrayer said during last years trial. This (was) a relationship on the rocks.

Jeff West carefully placed the Absinthe bottle on top of her cell phone and went back inside, leaving the front door open, McBrayer said. Jeff West then waited for somebody to find his wifes dead body in the street.

Shes dead. He doesnt know what to do because hes got a body outside of his (home) McBrayer said.

Crime scene photos and autopsy photos shown to the jury throughout the trial showed her head and upper body lying in the gutter and asphalt while her legs were in a neighbors grass. A couple of feet from her body was a large pool of blood and a blood trail flowing downhill.

A crime analyst testified that Jeff Wests left thumb and left ring finger fingerprints were found on the Lucid Absinthe bottle in an inverted position. In other words, the prints indicated the bottle was held upside down and by the bottles throat rather than its base.

Jeff Wests attorney, however, said he didnt believe Kat West was killed. She fell and hit her head, Robbins said. Theres no murder here.

A state medical examiner called by the prosecution testified that the wound to Kat Wests skull was so significant that it was not likely to have been caused by a fall.

Alabama Department of Forensic Sciences pathologist Dr. Stephen Boudreau said the laceration to Kat Wests skull was two inches long with the skin split open and contusions surrounding the wound.

The force of the blow and subsequent brain bleed, Boudreau said, pushed the brain down to the stem with deadly results.

It was a considerable amount of force to cause an injury like that, the doctor said. Kat West would likely have lost consciousness immediately, he said. Scalp wounds bleed like mad...its (the brain) a very vascular structure.

Asked if it was possibly to get that type of injury from a fall, Boudreau said it wasnt likely, especially at her height of 5-feet, 2-inches. The doctor said Kat West died from blunt force trauma. Whatever it was had an edge, but it wasnt sharp, he said of the object he believes caused her death.

Boudreau also testified that Kat Wests blood alcohol content was .23, nearly three times the legal limit to drive, and said urine and eye fluid toxicology testing indicated that at some point that night her alcohol levels would have been significantly higher.

Kat West had some bruises on her right leg in varying stages of healing that werent likely due to whatever incident caused her death, Boudreau testified. She also had a fresh injury to her toe that probably happened in the same time frame of the fatal head injury.

Home of Jeff and Kat West on Greenwood Circle in Calera.

Robbins said while the couple had arguments, like most married couples do, there was no discord or threat of violence in the marriage -- especially not that night.

Both sides discussed frequent text messages between the two. While the prosecution pointed out frequent arguments via text mostly one-sided with Kat West being the verbal aggressor Jeff Wests attorney also tried to use them to his advantage.

In December, about three weeks before Kat Wests death, she accused her husband via text of throwing away 14 years of marriage. Another text read, Im never doing this holiday again with you.

But text messages exchanged between the two on the day of the killing showed them making plans for that night and using terms of endearment with one another. The couple had matching tattoos on their wrists that read 4Life and often ended their texts with 12345 meaning I love you for life or 123, meaning I love you.

Jurors also heard testimony about forensics found on Kat Wests phone, which included the phones Health App, showing the number of steps she took, or where her phone was, the night authorities believe she was killed. The last time her phone moved, according to the data, was at 1054 p.m. and recorded 87 steps.

Data from the ADT alarm system showed the front door to the West home opened at 10:53:01 p.m. on Jan 12, 2018 and closed at 10:53:11 p.m. It opened again at 1:51:46 a.m. and remained open until 5:12:45 a.m., at which time it closed.

Jeff West had told investigators he fell asleep about 10:30 p.m. and didnt wake up again until 5:15 a.m. when he was awakened by his dogs barking at the fleet of police vehicles outside of his home. Though he said he went to bed at 10:30 p.m., testimony from his Health App phone data showed he took 18 steps from 11:03 p.m. until 11:10 p.m.

Robbins pointed out that that no blood or DNA was found on Jeff Wests clothes or his hands. And, Robbins said, no hair or scalp or brain tissue was found on the Lucid Absinthe bottle. Theres no suggestion of a struggle or fight in the house, Robbins said.

Jeff West, the attorney said, cooperated with police throughout the entire interrogation, voluntarily giving them permission to search the couples phones. He addressed the observation that Jeff West showed little to no emotion in the lengthy videotaped interview with police.

People deal with stressful situations, trauma, in different ways,' Robbins said. Not everybody stands there and cries. Hes a trained soldier. Soldiers are trained to keep their emotions in check.

Jeff West initially was expected to take the stand in his defense. However, he later spoke with his family and told the judge he would instead stay silent.

Go here to read the rest:
Kat Wests husband, Jeff West, sentenced to 16 years in wifes death - AL.com

Excitement took wing in the scientific community in the early 1990s, when the first gene therapy trial showed significant success, only to crash at the end of the decade with a patients tragic death.

Twenty years later, the excitement is back and greater than before. Although safety remains a concern, investigators are breaking ground in cell and gene therapy, and many believe that ultimately, a string of cured cancers will follow.

In 2017, the excitement over these therapies returned in spades when the FDA signed off on a cell-therapy drug for the first time, approving the chimeric antigen receptor (CAR) T-cell treatment tisagenlecleucel (Kymriah; Novartis) for patients with B-cell precursor acute lymphoblastic leukemia. At last, scientists had devised a way to reprogram a persons own T cells to attack tumor cells.

Were entering a new frontier, said Scott Gottlieb, MD, then-FDA commissioner, in announcing the groundbreaking approval.

Gottlieb was not exaggerating. The growth in CAR T-cell research is exploding. Although only a handful of cell and gene therapies are on the market, the FDA predicted in 2019 that it will receive more than 200 investigational new drug applications per year for cell and gene therapies, and that by 2025, it expects to have accelerated to 10 to 20 cell and gene therapy approvals per year.

We can absolutely cut the number of cancer deaths down so that one day in our lifetimes it can be a rare thing for people to die of cancer, said Patrick Hwu, MD, president and CEO of Moffitt Cancer Center in Florida and among gene therapys pioneers. It still may happen here and there, but itll be kind of like people dying of pneumonia. Its like, He died of pneumonia? Thats kind of weird. I think cancer can be the same way.

Essentially, you can kill any cancer cell that has an antigen that is recognized by the immune cell, Hwu said. The key to curing every single cancer, which is our goal, is to have receptors that can recognize the tumor but dont recognize the normal cells.

Community oncologists will need to be increasingly familiar about the various products, including their immediate and longer-term risks, Bo Wang, MD, and Deepu Madduri, MD, recently wrote in OncologyLive.1 It is key to understand the optimal time for referring these patients to an academic institution, as well as how to manage the requisite post CAR T-cell therapy in the community setting. Madduri is an assistant professor of medicine, hematology and medical oncology, as well as associate director of cellular therapy service, and director of clinical operations with the Center of Excellence for Multiple Myeloma at The Tisch Cancer Institute and the Icahn School of Medicine at Mount Sinai in New York, New York. Wang is a third-year clinical fellow in hematology/oncology at Mount Sinai.

Early referral to academic centers and hospitals equipped to deliver therapies is crucial for patients eligible for therapy. However, as advances continue in the field, community practices may be called upon to administer therapies in their clinic.

The Community Oncology Alliance (COA) envisions a broader role for the settings in which CAR T-cell therapies can be administered. When the Centers for Medicare & Medicaid Services (CMS) was considering coverage for CAR T-cell therapies in 2019, COA officials argued against limiting approvals to hospitals.

It is important to understand that there are state-of-the-art community oncology practices that have significant experience and capabilities in administering highly complex treatments, COA officials wrote in a letter to CMS. For example, stem cell transplants, which are similar in complexity to CAR T therapy, are performed successfully in the community oncology practice setting.2

Broader use of gene therapies depends on several factors, including navigating the logistics of gene therapies, addressing the high costs, and managing toxicities.3

Autologous CAR T-cell therapies involve a manufacturing process that requires coordination between the treating facility and the processing facility. Following leukapheresis, patients may require maintenance therapy to control disease progression during the manufacturing time, which can take 3 to 5 weeks.

In terms of cost, gene and cell therapies can cost from $375,000 to $475,000 per dose and they may face coverage restrictions from payers. Approvals could take weeks to obtain.3,4

Because of cytokine release syndrome and neurotoxicities associated with CAR T-cell therapy, the FDA mandates risk evaluation and mitigation strategy training for centers.

Further, providers may find that real-world experiences with gene therapies are different from those seen in the clinical trial setting, according to Ankit J. Kansagra, MD.

In a presentation at the 2020 American Society of Clinical Oncology Virtual Education Program, Kansagra, an assistant professor of medicine and Eugene P. Frenkel, MD, Scholar in Clinical Medicine at Harold C. Simmons Comprehensive Cancer Center in Dallas, Texas, said that in practice patients may be older and have more aggressive disease, with double- and triple-hit lymphomas.4

Specifically, Kansagra noted that medications such as steroids and/or tocilizumab (Actemra) to prevent or treat cytokine release syndrome or other toxicities were more frequently used in the real-world setting than what had been seen in clinical trials.

As it stands now, only a fraction of eligible patients are receiving CAR T-cell therapies, Kansagra said. Potentially, 9750 patients a year may be eligible for CAR T-cell therapies in approved and upcoming hematologic indications. From 2016 to 2019, a total of 2058 patients received CAR T-cell infusion.4

Next steps for transplanting these novel therapies to clinical practice will require changes in key areas, Kansagra said, such as supply chain management, patient support, and financial systems (Figure).4

Figure. Next Steps for Effective Delivery of Gene and Cell Therapies4

Meanwhile, multiple myeloma experts advise providers to be ready for change. As commercially available myeloma CAR T-cell therapies are approved, it will be even more important for community oncologists to better understand these therapies so they can offer them to their patients, Wang and Madduri wrote.1

Cell therapy involves cultivating or modifying immune cells outside the body before injecting them into the patient. Cells may be autologous (self-provided) or allogeneic (donor-provided); they include hematopoietic stem cells and adult and embryonic stem cells. Gene therapy modifies or manipulates cell expression. There is considerable overlap between the 2 disciplines.

Juliette Hordeaux, PhD, senior director of translational research for the University of Pennsylvanias gene therapy program, is cautious about the FDAs predictions, saying shed be thrilled with 5 cell and/or gene therapy approvals annually.

For monogenic diseases, there are only a certain number of mutations, and then well plateau until we reach a stage where we can go after more common diseases, Hordeaux said.

Safety has been the main brake around adeno-associated virus vector [AAV] gene therapy, added Hordeaux, whose hospitals program has the institutional memory of both Jesse Gelsingers tragic death during a 1999 gene therapy trial as well as breakthroughs by 2015 Giants of Cancer Care winner in immuno-oncology Carl H. June, MD, and others in CAR T-cell therapy. Sometimes there are unexpected toxicity [events] in trials.I think figuring out ways to make gene therapy safer is going to be the next goal for the field before we can even envision many more drugs approved.

In total, 3 CAR T-cell therapies are now on the market, all targeting the CD19 antigen. Tisagenlecleucel was the first. Gilead Sciences received approval in October 2017 for axicabtagene ciloleucel (axi-cel; Yescarta), a CAR T-cell therapy for adults with large B-cell non-Hodgkin lymphoma. Kite Pharma, a subsidiary of Gilead, received an accelerated approval in July 2020 for brexucabtagene autoleucel (Tecartus) for adults with relapsed/ refractory mantle cell lymphoma.

Another CD19-directed therapy under FDA review for relapsed/refractory large B-cell lymphoma, is lisocabtagene maraleucel (liso-cel; JCAR017; Bristol Myers Squibb). Idecabtagene vicleucel (ide-cel; bb2121; Bristol Myers Squibb) is under priority FDA review, with a decision expected by March 31, 2021. The biologics license application for ide-cel seeks approval for the B-cell maturation antigendirected CAR therapy to treat adult patients with multiple myeloma who have received at least 3 prior therapies.5

The number of clinical trials evaluating CAR T-cell therapies has risen sharply since 2015, when investigators counted a total of 78 studies registered on the ClinicalTrials. gov website. In June 2020, the site listed 671 trials, including 357 registered in China, 256 in the United States, and 58 in other countries.6 Natural killer (NK) cells are the research focus of Dean A. Lee, MD, PhD, a physician in the Division of Hematology and Oncology at Nationwide Childrens Hospital in Columbus, Ohio. He developed a method for consistent, robust expansion of highly active clinical-grade NK cells that enables repeated delivery of large cell doses for improved efficacy. This finding led to several first-in-human clinical trials evaluating adoptive immunotherapy with expanded NK cells under an FDA investigational new drug application. Lee is developing both genetic and nongenetic methods to improve tumor targeting and tissue homing of NK cells. His efforts are geared toward pediatric sarcomas.

The biggest emphasis over the past 20 to 25 years has been cell therapy for cancer, talking about trying to transfer a specific part of the immune system for cells, said Lee, who is also director of the Cellular Therapy and Cancer Immunology Program at Nationwide Childrens Hospital, at The Ohio State University Comprehensive Cancer Center Arthur G. James Cancer Hospital, and at the Richard J. Solove Research Institute.

However, Lee said, NKs have wider potential. This is kind of a natural swing back. Now that we know we can grow them, we can reengineer them against infectious disease targets and use them in that [space], he said.

Lee is part of a coronavirus disease 2019 (COVID-19) clinical trial, partnering with Kiadis, for off-the-shelf K-NK cells using Kiadis proprietary platforms. Such treatment would be a postexposure preemptive therapy for treating COVID-19. Lee said the pivot toward treating COVID19 with cell therapy was because some of the very early reports on immune responses to coronavirus, both original [SARS-CoV-2] and the new [mutation], seem to implicate that those who did poorly [overall] had poorly functioning NK cells.

The revolutionary gene editing tool CRISPR is making its initial impact in clinical trials outside the cancer area. Its developers, Jennifer Doudna, PhD, and Emmanuelle Charpentier, PhD, won the Nobel Prize in Chemistry 2020.

For patients with sickle cell disease (SCD), CRISPR was used to reengineer bone marrow cells to produce fetal hemoglobin, with the hope that the protein would turn deformed red blood cells into healthy ones. National Public Radio (NPR) did a story on one patient who, so far, thanks to CRISPR, has been liberated from the attacks of SCD that typically have sent her to the hospital, as well from the need for blood transfusions.7

Its a miracle, you know? the patient, Victoria Gray of Forest, Mississippi, told NPR.

She was among 10 patients with SCD or transfusion-dependent beta-thalassemia treated with promising results, as reported by the New England Journal of Medicine.8

Stephen Gottschalk, MD, chair of the department of bone marrow transplantation and cellular therapy at St Jude Childrens Research Hospital, said, Theres a lot of activity to really explore these therapies with diseases that are much more common than cancer.

Animal models use T cells to reverse cardiac fibrosis, for instance, Gottschalk said. Using T cells to reverse pathologies associated with senescence, such as conditions associated with inflammatory clots, are also being studied.

CAR T, I think, will become part of the standard of care, Gottschalk said. The question is how to best get that accomplished. To address the tribulations of some autologous products, a lot of groups are working with off-the-shelf products to get around some of the manufacturing bottlenecks. I believe those issues will be solved in the long run.

See the article here:
Harnessing the Potential of Cell and Gene Therapy - OncLive

Ibram X. Kendi: What I learned from cancer

This is where I find myself, at the threshold between an old familiar state and an unknown future. Cancer no longer lives in my blood, but it lives on in other ways, dominating my identity, my relationships, my work, and my thoughts. Im done with chemo but I still have my port, which my doctors are waiting to remove until Im further out of the woods. Im left with the question of how to repatriate myself to the kingdom of the well, and whether I ever fully can. No treatment protocols or discharge instructions can guide this part of my trajectory. The way forward is going to have to be my own.

My first foray into this new selfhood is learning how to drive. As I get more comfortable behind the wheel, a hazy idea begins to crystallize into a grand plan. I need to leave the familiar, to trust that I can navigate the world alone. I need to become my own caregiver. It took me a while to say I was a cancer patient. Its time for me to figure out who I am now. By the time I finally pass my drivers test, the next step is obvious: Im going to embark on a solo cross-country road trip.

Over the next few weeks, I pack all of my belongings into boxes, put the boxes into storage, and sublet my apartment. I cant afford to buy my own car but my friend Gideon generously offers the use of his old Subaru. Between the extra income from renting out my apartment and the $4,000 in my savings account, I should be able to make do. I plan to camp and crash on couches as often as possible, staying in only the occasional motel room. I scour Craigslist for secondhand camping gear and buy a portable propane gas stove, a subzero sleeping bag, a foam bedroll, and a tent. I pack all this, along with a crate of books, a first-aid kit, a camera, and a sack of kibble for my scruffy terrier mutt, Oscar, into the car. Before leaving, I go in for a last checkup with my oncologist.

My road trip will take me 15,000 miles across 33 states. It will last 100 days, the maximum amount of time my medical team has agreed to until my next follow-up appointment. As I turn the keys in the ignition and drive away from New York City, I realize that this is a rite of passage that I hope will bridge the distance between no longer and not yet.

Either my GPS is a liar or I am an erratic driver, but I always seem to take nearly twice as long as it predicts to get to where Im going. Take a right turn inrecalculating its robotic voice says condescendingly when I miss yet another exit. My next destination, Columbus, Ohio, will entail my longest drive yet. The GPS predicts that, if I follow its barrage of orders exactly as told, I will arrive in nine hours and 21 minutes. Unlikely.

Since hitting the road, Im on no ones clock but my own.

Two weeks earlier, when I first left home, I was so tense that I regularly had to remind myself to breathe. Each minute behind the wheel presented new and overwhelming scenarios: Do I have the right of way? What does a blinking red light mean? Was that an Egyptian hieroglyph on the traffic sign? Lane changes and merging onto the freeway had proved especially stressfulan existential guessing game of will I live or will I not. But with each day, I am feeling more confident, and it has been at least 72 hours since another driver has honked at me in anger or bewilderment.

Originally posted here:
I Survived Cancer, and Then I Needed to Remember How to Live - The Atlantic

Introduction

Chronic myeloid leukemia (CML) is a myeloproliferative disorder characterized by a reciprocal chromosomal translocation which forms the abnormal BCR-ABL1 fusion gene because of an acquired reciprocal t (9; 22) (q34; q11) translocation. The disease is traditionally described as manifesting in one of the three distinct clinical phases: chronic phase (CP), accelerated phase (AP), and blast crisis (BC).1 The introduction of tyrosine kinase inhibitors (TKIs) dramatically improved the outcomes of patients with CML. At present, patients with chronic phase CML (CML-CP) can attain long-term survival.2,3 The Sokal, Hasford, and European Treatment and Outcome Study (EUTOS) scores are used to determine the prognosis of CML patients. However, there are still some patients in which the treatment failed and their CML-CP transformed to CML-AP or CML-BC.46 Hoffmann VS et als team reported that 3.114% of CML patients had progressive clinical features at diagnosis or during long-term follow-up.7 In previous studies, clinical workers usually focused on the effect of treating CML-CP patients with TKIs.8,9 Although the prognosis of patients with CML-CP is accurate, the characteristics and markers for determining the prognosis of the advanced phase of CML are still not clear. The BCR-ABL1 transcript and somatic variants in epigenetic modifiers were confirmed, and these can be used to predict the response to imatinib.10,11 Lauseker M et als study determined that blast counts, age, chromosomal aberrations, and hemoglobin are the prognostic factors for patients with advanced phase.12 In another study, the results showed that many factors such as myeloid immunophenotype, treatment with TKIs before transformation to CML-BC, patients' age, and platelet counts <102109/L could predict poor survival rates in CML-BC patients.13 Studies have discovered various prognostic factors that are related to chronic or advanced phase of CML. However, for patients diagnosed with CML the factors that can be used to determine their prognosis and survival outcomes are still not clear.

During follow-up periods, a complete Blood Count (CBC) is used to assess the effect of treating CML patients with TKIs.14 The red blood cell distribution width (RDW) is a simple parameter that is part of the standard full blood count and measures of the heterogeneity in the size of a circulating patients erythrocytes. The RDW is provided by automated hematology analyzers and it reflects the distribution of the red blood cell (RBC) volume.15 There is increasing evidence that an elevated RDW is associated with a poor prognosis for people in the general population,16,17 as well as in patients with coronary artery disease,1820 metabolic syndrome,21 and heart failure.22,23 Traditionally, RDW has been used in the investigation of the etiology of anemia.24 The previous study only used the upper limit of the normal RDW range (RDW value 15.0%) to predict the prognosis and the response of CML-CP patients to treatment.25 However, it may not be suitable for determining the prognosis of CML patients when they are diagnosed at their first admission. Yuta Baba et als team identified a new RDW cutoff using different clinical outcomes of patients with myelodysplastic syndrome.26 Therefore, the hypothesis that different RDW values indicate the occurrence and the different phases of CML is proposed. In addition, it is suggested that assessing patients RDW is more favorable for assessing their treatment and for their follow-up evaluations.

The present study found that RDW was temporarily elevated when the CML-CP of patients transformed to the advance phase. The present study used X-tile software and data from a training and validation cohort established the most suitable RDW cutoff value based on the different phases of CML. In addition, univariate and multivariate analyses were used to determine which factors are associated with the advanced phase of CML in all patients. Based on the records of the patients, the role of RDW as a predictor of the prognosis and survival outcomes of the patients was also confirmed in the present study.

Our study retrospectively reviewed 153 CML patients from January 2009 to December 2019 at the Second Affiliated Hospital & Yuying Childrens Hospital of Wenzhou Medical University. The patients were all over 18 years of age and were treated with TKIs and their outcome was followed up for at least 12 months. CML-CP and CML-AP/BC were diagnosed according to the European Leukemia Net (ELN2013) criteria.27

The criteria for excluding patients from the present study were: patients age <18 years (n = 19); patients data were not completed (n = 11); patients without follow-up data (n = 7); patients initially treated with interferon- (n = 8); patients treated with any chemotherapeutic agent prior to or in combination with TKI treatment (n = 6); patients that received a blood transfusion prior to TKI treatment (n = 9); patients that received a hematopoietic stem cell transplant during follow-up (n = 8); and patients who had an NYHA grade of III/IV (n = 3). The framework and criteria used to select patients for inclusion in the present study are described in Figure 1.

Figure 1 Flow chart of the criteria used to select the patients for inclusion in the present study.

The clinical characteristics of the patients that were recorded included their age, gender, history of smoking, Splenomegaly, history of cardiovascular system diseases, and with what they were initially treated. We defined a patient as a nonsmoker if they had never smoked or had smoked less than 100 cigarettes in their lifetime. All others were classified as smokers. The detailed clinical information of the patients is summarized in Table 1. The definitions of a partial cytogenetic response (PCyR), a major molecular response (MMR), and a complete cytogenetic response (CCyR) were in accordance with the recommendations of the ELN 2013. The categories of response to treatment with TKIs included optimal, warning, and failure responses, and were defined according to the ELN 2013 recommendations.27

Table 1 Clinical Characteristics of the CML Patients

The overall survival (OS) of a patient was defined as the length of time from diagnosis to death or the last follow-up. Event-free survival (EFS) was defined as the time period from the date of diagnosis to the date of the first event or the last follow-up. Events were defined as either two consecutive confirmations of a loss of CCyR, the transformation of CML-CP to CML-AP/BC, or any cause of death. Transformation-free survival (TFS) was defined as the period from the date of the diagnosis when the patients CML-CP transformed to CML-AP/BC or the last follow-up. All of the patients consented to participate in the present study by signing an informed consent form. The present study was approved by the Research Ethics Board of The Second Affiliated Hospital & Yuying Childrens Hospital of Wenzhou Medical University (Number: LCKY2020-430) and it was conducted in accordance with the Declaration of Helsinki.

In our study, the CBC was obtained from patients peripheral venous blood using a Sysmex XI5000, Japan. The RDW values at diagnosis were obtained prior to treatment. Accordingly, the range 11.6~15.0% was considered normal.

To avoid overfitting and to analyze the interobserver reproducibility of the RDW values, the CML patients were randomly assigned to training cohort (n = 106; 70%) and validation cohort (n = 47; 30%) using R software version 3.0.1 (http://www.R-project.org). The distribution of the p value of the RDW cutoff value was determined using X-tile software, version 3.6.1 (Yale University School of Medicine, New Haven, Conn) and also confirmed using the training cohort, which included patients with advanced phase.

The statistical analyses were performed using the software SPSS V. 26.0 (SPSS; Chicago, IL, USA). Categorical data were compared between groups using Fishers exact test or the chi-square test. Continuous data were compared using the t-test. The relationship between the clinical features and the advanced phase of CML were analyzed using univariate and multivariate analyses. The KaplanMeier method was used to analyze OS, EFS, TFS, and the CML-associated deaths. The Log rank test was used to compare OS, EFS, TFS, and CML-associated deaths between groups of patients with low and high RDW values. A p value less than 0.05 was considered statistically significant.

The 153 CML patients included in the present study consisted of 137 and 16 newly diagnosed CML-CP and CML-AP/BC patients, respectively. During follow-up examinations, the CML-CP of 11 patients was determined to have transformed to CML-AP/BC. One-hundred and eighteen of the 137 patients with CML-CP had RDW values higher (86.13%; range 13.3~22.9%) than the normal range. The 16 patients diagnosed with CML-AP/BC when diagnosed all had RDW values (100%; range 15.2~19.9%) that were higher than the normal range.

The patients in the high RDW group had higher WBC counts (p < 0.001), lower hemoglobin levels (p < 0.001), lower RBC counts (p < 0.001), higher RDW when diagnosed (p < 0.001), a higher probability of splenomegaly, and higher probabilities of blast and eosinophils in the peripheral blood (p < 0.05) compared to patients in the low RDW group and in the training cohort, whereas, when comparing patients in the high and low RDW groups, no differences were observed in their ages, gender, platelet count, history of smoking, or diseases of their cardiovascular systems (Table 1). Furthermore, based on patients in the validation cohort, differences in the WBC count, hemoglobin level, RBC count, and RDW when diagnosed were also found for patients in the low and high RDW groups in the validation cohort (p < 0.05). No statistical differences were observed in any of the other clinical features (Table 1). Our study also additionally analyzed the differences in patients with CP between low and high RDW groups in patients with CP (Supplement Table 1).

There were 137 newly diagnosed CML-CP patients, 16 newly diagnosed CML-AP/BC patients, and 11 patients developed to CML-AP/BC during the followed period. Besides, our study also collected 168 healthy peoples RDW value, who did not have tumors and other diseases (age; range 18~68 years). There were significant differences in RDW value among Normal and CML-CP groups (p < 0.001; Figure 1A), Normal and CML-AP/BC groups (p < 0.0001; Figure 2A), CML-CP and CML-AP/BC groups (p = 0.0003; Figure 2A).

Figure 2 (A) Differences in the RDW values between healthy people (normal, n = 168) and patients with CML-CP (n = 137) and CML-AP/BC (n = 27). (B) The distribution of the p values of the different RDW cutoff values of the patients (n = 106) in the training cohort (***p<0.001).

Application of the X-tile software to the training cohort (n = 106, 90%) determined that an RDW value of 16.8% distinguished between patients with CML-CP and CML-AP/BC (p = 0.0069, Figure 2B). Application of the KaplanMeier method to the training (p = 0.0028, Figure 3A) and validation cohort (p = 0.0221, Figure 3B) showed that patients in both cohorts with higher RDW values have significantly shorter OS than patients with low RDW values. Furthermore, the distribution of patients in the training (Figure 3C) and validation (Figure 3C) cohorts with advanced phase CML in the high and low RDW groups are also shown.

Figure 3 The overall survival of patients in the training (A) and validation (B) cohorts. The distribution of patients in the training (C) and validation (D) cohorts with advanced phase CML and in the high and low RDW groups which were based on the RDW cutoff value.

To further prove the practicality of using this RDW cutoff value to predict the CML phase, Spearmans rank correlation coefficient was used to determine if there is a correlation between RDW values and blast cells in the bone marrow when diagnosed. The result showed that the RDW value is a better factor for predicting patients with the advanced phase (p = 0.011; r = 0.543) than patients with CML-CP.

Our study investigated the extent to which the RDW value could predict CML patients response to treatment as measured using the recommendations of the ELN 2013. Compared to the CML patients in the low RDW group, the CML patients in the high RDW group were associated with a significantly poorer response to treatment after 3, 6, and 12 months after the commencement of treatment (Table 2).

Table 2 Associations Between RDW and the Responses Treatment with TKIs

The OS (p = 0.0008; Figure 4A) and EFS (p = 0.0221; Figure 4B) of patients in the high RDW group were significantly less than that of the patients in the low RWS group, respectively. Furthermore, the CML-associated deaths were significantly higher in patients with advanced CML (83.3%) compared to patients with CML-CP and with high (14.5%) and low (2.4%) RDW values (p < 0.001; Figure 4D). The RDW values could not be used to predict TFS (p = 0.0821; Figure 4C).

Figure 4 The relationship between CML-CP patients with low and high RDW values and their (A) OS, (B) EFS, and (C) TFS. (D) The death rates of patients with CML-CP in the low and high RDW groups, and those with advanced phase CML, respectively.

To evaluate the correlation between the RDW values and the therapeutic effect of TKIs, the dynamic changes in the RDW values of CML patients following treatment over time with TKIs were analyzed. The RDW value was initially elevated at 1 month (median 16.6% when diagnosed and 17.6% after 1 month of treatment; p = 0.001, Figure 5A) but declined significantly after 3 months (median 15.7% at 3 months; p = 0.001 Figure 4A) of treatment with TKIs. Furthermore, compared with the RDW values of the CML patients at diagnosis, the RDW values were significantly lower after 6 months of treatment with TKIs treatment (median14.5%; p < 0.001, Figure 5A).

Figure 5 (A) Changes in the RDW value of patients with CML that were treated over time with TKIs. (B) Changes in the RDW values in the different groups of CML patients that were treated over time with TKIs. (**p<0.01; ***p<0.001).

To compare the longitudinal changes of the RDW values between patients in the low and high RDW groups, the patients with CML-CP were compared with patients with CML-CP and advanced CML, ie, all-CML. The RDW values of the patients in all CML and low RDW groups at diagnosis returned to the normal range after 6 months of treatment with TKIs (Figure 5B).It took 2 years for the patients in, while the high RDW group patients tend to return to the normal range in 2 years (Figure 5B).

The univariate analysis showed that ages (OR, 1.063; 95% CI, 1.029~91.098; p < 0.001), WBC counts (OR, 0.214; p < 0.001), RBC count (OR, 0.594; 95% CI, 0.356~0.992; p < 0.001), hemoglobin level (OR, 0.970; 95% CI, 0.952~0.989; p = 0.047), RDW value when diagnosed (OR, 1.264; 95% CI, 1.024~1.559; p = 0.029), platelet count (OR, 0.997; 95% CI, 0.996~0.999; p = 0.006), eosinophil in PB (OR, 0.214; p < 0.001), basophil in PB (OR, <0.001; 95% CI, 1.029~91.098; p < 0.001), history of cardiovascular system disease (OR, 1.648; 95% CI, 1.103~2.463; p = 0.001) were all significantly associated with advanced phase (Table 3). However, gender, history of smoking, and splenomegaly were not associated with the advanced phase (Table 3).

Table 3 Univariate and Multivariate Analyses of Factors for the Advanced Phase in All Patients

The multivariate analysis showed that age (OR,1.081; 95CI% 1.039~1.125; p < 0.001), being a female (OR,0.332; 95CI% 0.119~0.926; p = 0.035), platelet count (OR,0.997; 95CI% 0.994~0.999; p=0.001), RDW value when diagnosed (OR,1.469; 95CI% 1.121~1.925; p=0.005) were correlated with advanced phase, but while not any of the other variables (Table 3).

CML is a neoplastic disease, and its genetic and cytogenetic changes play important roles in the prognosis and treatment process of patients. Our study demonstrated that higher RDW values are an adverse prognostic and survival outcomes biomarker for CML-CP patients. The multivariate analysis demonstrated that age, platelet count, and RDW at diagnosis were related to the advanced phase. Consequently, the dynamic changes of the RDW values of CML patients could help clinical workers manage the follow-up treatment of the patients. In agreement with the significance of responses to early treatment, the RDW value at diagnosis also predicted the outcomes, because it reflected an early response at 3 months, to treatment.28 The vast majority of CML patients are diagnosed with CML-CP. However, some patients present with features of advanced phase at diagnosis. Most studies analyzing prognostic factors and survival outcomes for CML-AP/BC refer to patients that developed this advanced phase of CML from an initial diagnosis of CML-CP.29,30 The results of these studies indicate that despite the availability of TKIs, the treatment options and the outcome for these patients are still poor. After transformation from CML-CP to CML-BC, the median survival time in a German CML-study IV was 7.9 months.13 Therefore, there is still a need for more markers to predict the advanced phase and for the prognosing patients with CML-CP. Detection of the BCR-ABL1 transcript level is the gold standard method for monitoring CML minimal residual disease and the optimal management of CML patients.31 Although there are many emerging technologies, such as digital PCR, to detect the transcription level of BCR-ABL1,3234 RDW detection is a widely available and inexpensive test that is performed as part of the complete blood count. It is important to point out that the average lifespan of RBCs is 120 days; thus, RDW could be used as an indicator during the long-term follow-up of patients with CML.

Our study showed that RDW plays an important role in determining the prognosis and the effect of treatment with TKIs. What follows is a description of the reasons why RDW plays a key prognostic role in CML. It is well established that the RDW value is elevated when the destruction of RBCs increases or there is an increase in the production of infective defective RBCs.15 CML is a specific disease in which the CML stem cells have to differentiate towards the erythroid cell lineage, resulting in the involvement of malignant clone-derived erythropoiesis.35 Some studies have recently revealed that patients harboring IDH1/2 and ASXL1 mutations had significantly higher RDW values than those without these mutations.36,37 Furthermore, these mutations are often present in CML cells and are associated with the status of the disease in CML patients.37 Although baseline prognostic factors for the efficacy of treatment with second TKIs have not yet been determined, the multiple predictors for the efficacy of treatment with imatinib have already been reported. A recent study showed that the Sokal low and medium/high groups responded equally to dasatinib treatment.38 Another study proved that Treatment-Free Remission after second-line nilotinib treatment in patients with CML-CP was greatly improved and none had CML progression to AP or BC.39 However, in our study, only 14 patients chose to be treated with the second TKIs treatment. We did not make a distinction between patients treated with first and second TKIs in our study, we analyzed the change in RDW values of patients treated with TKIs as a whole.

We were aware of some limitations in our study. Our study split the 153 patients into a training and validation cohort for the internal validation. However, the sample size of the CML patients that enrolled in the study was not large and the results of single-center retrospective cohort studies are not generalizable to other populations.

The stratification of CML patients according to their RDW value can be used to determine their prognosis, survival outcomes, and advanced phase. This stratification is beneficial to subsequent treatment. To avoid CML-CP transforming to advanced phase, patients whose RDW 16.8% when diagnosed need more time for follow-up. In the future, we will validate these findings in a larger population, which may provide new insights into CML therapy and follow-up treatment.

This work was supported by the Natural Science Foundation of Zhejiang Province, China [No. LY18H200006], Science and Technology Planning Project of Wenzhou, Zhejiang, China (No. Y20180108), Basic Public Welfare Technology Research Project of Zhejiang Province [LGF20H200005], and the Lin Hes New Medicine and Clinical Translation Academician Workstation Research Fund [18331203].

The authors report no conflicts of interest in this work.

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[Full text] Higher Red Blood Cell Distribution Width is a Poor Prognostic Factor f | CMAR - Dove Medical Press

The new health guidelines have allowed private dental clinics to start functioningNew Delhi : Observably, the Covid-19 pandemic hit a pause button on many of our routine activities, including regular visits to the dentist. When the pandemic peaked, health authorities put restrictions in place for dental care, and dental clinics saw only emergency cases and advised patients to wait when it came to non-essential or non-urgent procedures including regular check-ups, cleaning, fillings, etc., which resulted in a substantial drop in the preventive dental care visits of oral patients across India.

Lt Gen. Dr Vimal Arora, Chief Clinical Officer, Clove Dental said, Oral Health data in India says that 8 out of 10 Indians suffer from some or the other kind of dental diseases which clearly reflects that Oral & Dental Health has always been deprioritized even in pre-Coovid times. However, with this pandemic people have further delayed their dental visits for past 10 months, the result of which is that the oral health conditions which could have been handled with simple cavity filling, now need RCT & Crowning and even extraction in some cases leading to loss of tooth. Ministry of Health and Family Welfare estimates that currently (2019), about 60% of Indias adult population and 70% of its school-going children are affected by dental caries (cavities) or tooth decay. And, periodontal disease infections of the tissue around the teeth has ended up affecting at least 85% of the population. The country is also considered the world capital for oral cancer. Of the total body cancers, Oral cancers accounts for over 30% of all body cancers.

Drop in Dental Care

Dr Anirudh Singh, General Manager, Clove Dental, South West India said, Traditionally, check-ups are recommended every six months. But people often ignore this, which leads to the severity of the dental problems demanding expensive treatments and care. According to the draft National Oral Health Policy, the proportion of untreated caries of permanent teeth and severe periodontitis is the maximum compared to other oral disorders. Yet, only 12.4% of adults have ever had their mouth examined by a dentist. Routine check-ups are the part of preventive treatments. However, due to COVID, preventive treatments have gone down by 63.7%, as the patient visits have declined. As COVID has prompted the delay in treatments, we see the need for more restorative treatments now. Therefore, prioritising dental care is as important as any other healthcare problems.

A fundamentally different approach is required to effectively tackle the global burden of oral diseases. The public health problems associated with oral diseases are a serious burden in every nation around the globe. What is lacking is the awareness to the disease and the information as to what all poor oral health can create in the body. Excellent dental health is the gateway for the overall body health; is the true slogan.

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Fear of Covid keeps patients away from dental clinics resulting in an increased need of treatment. - ETHealthworld.com

3d printing human body. 3d printed implants on white background.

Back in the 1970s, there was a television show called The Six-Million-Dollar Man about a fictional astronaut severely injured in a test crash, and then having several body parts replaced by robotics. The shows opening narration promised that he would be better than he was before. Better. Faster. Stronger.

Life is now imitating art, and then some. 3D printers are currently being used to construct not only customized prosthetics for patients in need, but a wide variety of other medical items foremost among them tissues and organoids, as well as surgical models and tools. It is estimated that 13 percent of 3D printing revenue comes courtesy of the medical field, and that some $3.19 billion will be spent on technology in that sector by 2025. Thats over $2 billion more than in 2018 ($1.13 billion), a compound annual growth rate (CAGR) of 15.89 percent.

There are many reasons for this uptick, not the least of which are that these items can be produced quickly and inexpensively. But there is none bigger than the ever-increasing demand for prosthetics. Some 30 million people around the world, including 1.9 million in the U.S., are in need of such devices, and as of 2018 only 20 percent of them had been provided for.

Factor in other devices and an aging population with a consequent increase in demand for personalized treatment as noted by Tim Deng, Principal Medical Devices Analyst at GlobalData, in a report on the website Express Healthcare and the overwhelming need becomes that much clearer.

So too are the benefits of meeting that need. Better, faster, stronger? Well, that part might be a bit of a stretch, at least for now. But certainly it appears that 3D printers are making it possible for patients to be as good, as fast and as strong as they were before illness or injury left them a shell of their former selves.

Serendipity helped galvanize the 3D prosthetics industry. In 2011 an artist named Ivan Owen developed a puppet hand for a steampunk event i.e., an event where modern technology melds with elements of Victorian-era history and fashion. He circulated a video of his creation, which was seen by Richard Van As, a South African carpenter who, having just lost four fingers in an accident, was looking for a prosthetic hand that would enable him to return to work. The two of them collaborated to construct just such a device, then used a 3D printer to develop another for a five-year-old boy who was born without fingers.

Owen, instead of patenting his invention, elected to open-source it. That led in 2013 to the formation of the nonprofit organization e-NABLE, an online community enabling people to collaborate on the design of 3D prosthetic limbs. Another nonprofit, Limbitless Solutions, came along a year later, with the mission of providing 3D-printed arms for children.

Then there is the startup Unlimited Tomorrow. In 2020, some six years after its founding, the Rhinebeck, N.Y.-based company also rolled out a prosthetic arm courtesy of a 3D printer, while emphasizing its affordability (as low as $7,995.) compared to prosthetics produced by other means (over $50,000).

3D printers are getting ever closer to being able to produce organs, and progress is being made on other fronts as well. In 2018, researchers at the University of Utah became the first to produce ligaments and tendons in that fashion, by extracting stem cells from a patients body fat, printing them onto a layer of hydrogel, allowing time for the cells to form the required connective tissue outside the body and then implanting it where needed.

This is a particularly important breakthrough, since injuries to tendons and ligaments had in the past proven to be difficult to treat. Most commonly, tissue from cadavers was used, but there was the risk of rejection, or that the connective tissue wouldnt perform as expected.

In 2019, there was another promising development when a team at Rice University made promising strides toward producing cardiovascular networks and lung-like air sacs through the use of bioprinting technology called stereolithography apparatus for tissue engineering, or SLATE. The team hopes to commercialize that technology in the future, which could have obvious benefits for those suffering from heart or lung disease.

Truly there seem to be no bounds to what 3D printers might mean for healthcare. The possibility exists of dental professionals using the technology to create customized dental implants, prosthetics and braces that printing could be done in-office without long wait times. Once the patients teeth have been scanned, their dental treatment will be printed in-office. This allows for a better fit and even time for immediate troubleshooting. Compared to taking a mold and relying on an outside source, this is more convenient for both patients and professionals.

On the other side of the equation, a 3D printer can be used to create customized instruments for use in complex surgeries and the process can be done far more quickly than is the case by other means. It is also possible to create three-dimensional models of patients internal systems before surgical procedures, giving doctors a clear understanding of the challenges they face.

Also of interest is the production of customized medication via 3D printer, a process begun in 2015 to counter the trend toward producing dosages best-suited for white adult men, meaning women and children were receiving more than was necessary. Customizing the dosage, Multiply Labs CEO Fred Paretti told the website 3D Natives, goes a long way toward highlighting the individuality of each patient, since the error in dosage of certain active ingredients can even lead to the malfunctioning of some treatments.

The bottom line is that 3D printers will be making an even greater impact on the medical field in the years ahead, as evidenced by the fact that the number of U.S. hospitals featuring the technology grew from three in 2010 to over 100 in 2019. The need is there, and the evolution will certainly only continue. And someday, maybe there really will be a Six-Million-Dollar Man.

Photo: belekekin, Getty Images

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3D medical printing making strides, and helping patients do the same - MedCity News

REHOVOT, Israel, Feb. 9, 2021 /PRNewswire/ --Aleph Farms Ltd. (the Company)and its research partner at the Faculty of Biomedical Engineering at the Technion Israel Institute of Technology, have successfully cultivated the world's first slaughter-free ribeye steak, using three-dimensional (3D) bioprinting technology and natural building blocks of meat real cow cells, without genetic engineering and immortalization. With this proprietary technology developed just two short years after it unveiled the world's first cultivated thin-cut steak in 2018 which did not utilize 3D bioprinting, the Company now has the ability to produce any type of steak and plans to expand its portfolio of quality meat products.

Unlike 3D printing technology, Aleph Farms' 3D bioprinting technology is the printing of actual living cells that are then incubated to grow, differentiate, and interact, in order to acquire the texture and qualities of a real steak. A proprietary system, similar to the vascularization that occurs naturally in tissues, enables the perfusion of nutrients across the thicker tissue and grants the steak with the similar shape and structure of its native form as found in livestock before and during cooking.

"This breakthrough reflects an artistic expression of the scientific expertise of our team," enthuses Didier Toubia, Co-Founder and CEO of Aleph Farms. "I am blessed to work with some of the greatest people in this industry. We recognize some consumers will crave thicker and fattier cuts of meat. This accomplishment represents our commitment to meeting our consumer's unique preferences and taste buds, and we will continue to progressively diversify our offerings," adds Toubia. "Additional meat designs will drive a larger impact in the mid and long term. This milestone for me marks a major leap in fulfilling our vision of leading a global food system transition toward a more sustainable, equitable and secure world."

The cultivated ribeye steak is a thicker cut than the company's first product a thin-cut steak. It incorporates muscle and fat similar to its slaughtered counterpart and boasts the same organoleptic attributes of a delicious tender, juicy ribeye steak you'd buy from the butcher. "With the realization of this milestone, we have broken the barriers to introducing new levels of variety into the cultivated meat cuts we can now produce. As we look into the future of 3D bioprinting, the opportunities are endless," says Technion Professor Shulamit Levenberg, Aleph's Co-Founder, Chief Scientific Advisor and a major brainpower behind the company's IP. Levenberg is considered a global leader in tissue engineering and has amassed over two decades of research in the field at the Massachusetts Institute of Technology (MIT), in the United States and at the Technion, in Israel. Levenberg is also the former Dean of the Biomedical Engineering Faculty at the Technion.

Aleph Farms' zealous plans to diversify its offering align with its mission to create a global platform for local production, leveraging a highly scalable technology to create culinary experiences that can be adapted for the different food cultures around the world.

About the Technion Israel Institute of Technology and the Faculty of Biomedical Engineering:

Technion Israel Institute of Technology, consistently ranked among the world's top science and technology research universities, is Israel's first university. Since its founding in 1912, the institute has educated generations of engineers, architects, and scientists who have played a key role in laying the State of Israel's infrastructure and establishing its crucial high-tech industries.

The Faculty of Biomedical Engineering at the Technion offers undergraduate and graduate programs for students interested in integrating research, development and engineering methods in all areas of medicine. The Faculty's state-of-the-art research labs enable the acquisition of skills and practical experience in diverse fields which are at the forefront of contemporary science.

About Aleph Farms:

Aleph Farms is a food company that is paving a new way forward as a leader of the global sustainable food ecosystem, working passionately to grow delicious beef steaks from non-genetically engineered cells, isolated from a cow, using a fraction of the resources required for raising an entire animal for meat, without antibiotics and without the use of Fetal Bovine Serum (FBS). Aleph Farms was co-founded with The Kitchen Hub of the Strauss Group and with ProfessorShulamit Levenberg, former Dean of the Biomedical Engineering faculty of the Technion - Israel Institute of Technology. Aleph Farms is backed by some of the world's most innovative food producers, such as Cargill, Migros, and the Strauss Group.

The company has recently received top accolades for its contribution to the global sustainability movement from the World Economic Forum, UNESCO, Netexplo Forum, FAO and EIT Food.

Twitter/LinkedIn/Facebook/Instagram/YouTube/Medium: @AlephFarms

For further information, please contact:

SOURCE Aleph Farms

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Aleph Farms and The Technion Reveal World's First Cultivated Ribeye Steak - PRNewswire

09 Feb 2021 --- Scientists in China and Japan have developed a method to increase paddy field-grown rice yield by over 30 percent while sequestering more CO2 and using less fertilizer than traditional varieties.

Researchers at Nagoya University in Japan and Nanjing Agricultural University in China achieved this functionality by increasing the expression of the plasma membrane proton pump gene OSA1 in the rice plant, which was previously found to influence stomatal opening.

CO2 intake in plants occurs exclusively through the stomata, which are holes on the leaves' surface.

By increasing nutrient uptake and stomatal opening, the researchers were able to increase the rate of photosynthesis thereby speeding up growth and yield with less resources.

This new genetics-based approach detailed in Nature could improve crop efficiency for more types of plants to increase the food supply while mitigating the overproduction of CO2.

Click to EnlargeRice with the overexpressed OSA1 gene had a 25 percent increase in its CO2 storage capacity compared to wild rice.New functionalityThe group of scientists found the proton pump overexpressed rice, when compared to a wild strain, took up over 20 percent more mineral nutrients through its roots and opened its stomata over 25 percent wider when exposed to light.

On further analysis, they found that its carbon dioxide storage capacity (the indicator of photosynthesis activity) increased by over 25 percent. Its dry weight (biomass) increased by 18 to 33 percent in hydroponic laboratory growth.

Testing rice in the fieldWith this determined, the researchers set out to find if the results could be replicated under realistic growing conditions.

They conducted yield measurement exercises at four separate rice farms over the course of two years, finding that the rice with the overexpressed OSA1 gene had a yield over 30 percent higher than that of the wild strain.

They also discovered that even if the level of nitrogen fertilizer was reduced by half, it still produced a greater yield than the wild strain did with normal levels of nitrogen.

Capturing more CO2As they take in mineral nutrients such as nitrogen, phosphorus and potassium through their roots, plants simultaneously absorb carbon dioxide through the stomata on their leaves and grow through photosynthesis.

Photosynthesis enables, not only the farming of plants for food, but the exchange of carbon dioxide and management of the earths environment.

While these early-stage models have been created through genetic modification (GM), the researchers anticipate that future generations will use genome editing or chemical engineering instead.

Edited by Missy Green

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Researchers create rice that captures more CO2 with 30 percent more yield - FoodIngredientsFirst

In Australia, scientists collect buckets of coral sperm, mixing one species with another in an attempt to create a new super coral that can withstand rising temperatures and acidifying seas. In Nevada, scientists nurse a tiny colony of one-inch long Devils Hole pupfish in an uncomfortably hot, Styrofoam-molded pool. And in Massachusetts, Harvard University scientists research injecting chemicals into the atmosphere to dim the suns light and slow down the runaway pace of global warming.

These are some of the scenes from Elizabeth Kolberts new book, Under a White Sky, a global exploration of the ways that humanity is attempting to engineer, fix, or reroute the course of nature in a climate-changed world. (The title refers to one of the consequences of engineering the Earth to better reflect sunlight: Our usual blue sky could turn a pale white.)

Kolbert, a New Yorker staff writer, has been covering the environment for decades: Her first book, Field Notes from a Catastrophe, traced the scientific evidence for global warming from Greenland to Alaska; her second, The Sixth Extinction, followed the growing pace of animal extinctions.

Under a White Sky covers slightly different ground. Humanity is now, Kolbert explains, in the midst of the Anthropocene a geologic era in which we are the dominant force shaping earth, sea, and sky. Faced with that reality, humans have gotten more creative at using technology to fix the problems that we unwittingly spawned: Stamping out Australias cane toad invasion with genetic engineering, for example, or using giant air conditioners to suck carbon dioxide out of air and turn it into rock. As Kolbert notes, tongue-in-cheek: What could possibly go wrong?

This interview has been condensed and lightly edited for clarity.

Q.Under a White Sky is about a lot of things rivers, solar geoengineering, coral reefs but its also about what nature means in our current world. What got you interested in that topic?

A.All books have complicated births, as it were. But about four years ago, I went to Hawaii to report on a project that had been nicknamed the super coral project. And it was run by a very charismatic scientist named Ruth Gates, who very sadly passed away about two years ago. We have very radically altered the oceans by pouring hundreds of billions of tons of CO2 into the air and we cant get that heat out of the oceans in any foreseeable timescale. We cant change the chemistry back. And if we want coral reefs in the future, were going to have to counter what weve done to the oceans by remaking reefs so they can withstand warmer temperatures. The aim of the project was to see if you could hybridize or crossbreed corals to get more vigorous varieties.

This idea that we have to counteract one form of intervention in the natural world (climate change) with another form of intervention (trying to recreate reefs) just struck me as a very interesting new chapter in our long and very complicated relationship with nature. And once I started to think about it that way, I started to see that as a pretty widespread pattern. Thats really what prompted the book.

Q.Some of these human interventions to save nature seem hopeful and positive and others go wrong in pretty epic ways. How do you balance those two types of stories?

A.The book starts with examples that probably will strike many Grist readers as OK, that makes sense. That makes sense. But it goes from regional engineering solutions through biotechnology, through gene editing, and all the way up to solar geoengineering. So it kind of leads you down what we might call a slippery slope. And one of the interesting things about these cases is that they will divide up people differently. Even people who consider themselves environmentalists will come down on different sides of some of these technologies. The bind were in is so profound that theres no right answer.

Q.So someone who accepts what were doing to save the Devils Hole pupfish might not necessarily accept gene-editing mosquitos or dimming the sun through solar geoengineering.

A.Exactly. And I think sometimes those lines seem clearer than they are once you start to think about it.

Q.At one point in the book, theres a quote that is (apocryphally) attributed to Einstein: We cannot solve our problems with the same thinking we used when we created them. But you dont say whether you agree with that sentiment or not. Is that on purpose?

A.Yeah, you can read the book and say, Im really glad people are doing these things, and I feel better. Or you can read the book and say, as one scientific quote does, This is a broad highway to hell. And both of those are very valid reactions.

Q.When you write about geoengineering, you point out that many scientists conclude that its necessary to avoid catastrophic levels of warming, but that it could also be a really bad idea. Do you think that in 15 or 20 years youll be writing about a geoengineering experiment gone wrong, much as youre writing now about failed attempts to protect Louisiana from flooding?

A.I might argue about the timescales. Im not sure Ill be reporting on it in 15 years, but I think you might be reporting on it in 30 years.

At the moment, its still the realm of sci-fi, and Im not claiming to have any particular insight into how people are going to respond in the future. But the case thats made in the book by some very smart scientists is that we dont have very many tools in our toolbox for dealing with climate change quickly, because the system has so much inertia. Its like turning around a supertanker: It takes literally decades, even if we do everything absolutely right.

Q.Youve reported on climate change for a long time. How does it feel to see geoengineering being explored as a more valuable and potentially necessary option?

A.Well, one thing I learned in the course of reporting the book was that what we now refer to as geoengineering was actually the very first thing that people started to think about when they realized we were warming the climate. The very first report about climate change that was handed to Lyndon Johnson in 1965 wasnt about how we should stop emitting it was: Maybe we should find some reflective stuff to throw into the ocean to bounce more sunlight back into space!

Its odd, its kind of almost freakish, and I cant explain it, except to say that it sort of fits the pattern of the book.

Q.Theres been a longstanding fight in environmentalism between a technology-will-save-us philosophy and a return-to-nature philosophy. Based on the reporting in this book, do you think that the technology camp has won?

A.I think the book is an attempt to take on both of those schools of thought. On some level, technology has won even people who would say dont do geoengineering still want to put up solar panels and build huge arrays of batteries, and those are technologies! But where does that leave us? It goes back to Ruth Gates and the super coral project. There was a big fight among coral biologists about whether a project like that should even be pursued. The Great Barrier Reef is the size of Italy even if you have some replacement coral, how are you going to get them out on the reef? But Gatess point was, were not returning. Even if we stopped emitting CO2 tomorrow, youre not getting the Great Barrier Reef back as it was in a foreseeable timeframe.

My impulse as an old-school environmentalist is to say Well, lets just leave things alone. But the sad fact is that weve intervened so much at this point that even not intervening is itself an intervention.

Q.Now that we have a U.S. president who takes climate change seriously, do you think we could actually start cutting carbon emissions quickly?

A.I really do want to applaud the first steps that the Biden administration has taken. I think they show a pretty profound understanding of the problem. But the question, and its a big one, is What are the limits? Will Congress do anything? What will happen in the Supreme Court? The U.S. is no longer the biggest emitter on an annual basis, but on a cumulative basis were still the biggest. And we still dont have resolution on how much CO2 we can put up there to avoid 1.5 or 2 degrees Celsius of warming. Those are questions with big error bars. If were lucky, I think we can avoid disastrous climate change. But if were not lucky, were already in deep trouble.

Q.Is there anything else you want to say about the book?

A.It sounds kind of weird after our conversation, but the book was actually a lot of fun to write. It sounds odd when youre talking about a book where the subject is so immensely serious.

Q.You mean like when the undergraduates in Australia are tossing each other buckets of coral sperm?

A.Yes! There is always humor in all these situations. I hope that sense of fun comes through.

Will Biden deliver on climate? Get weekly analysis of federal climate policy action in the first months of Bidens term.

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Interview: Elizabeth Kolbert on why well never stop messing with nature - Grist

In Borneo, the balmy forests of the Malay Archipelago are home to some of the richest biodiversity on Earth. The ecosystems of this island nation, the third-largest in the world, and the largest in Asia, support more than 15,000 plant species and 1,400 amphibians, birds, fish, mammals, reptiles and insects. But since 2000, Borneo's wildlife has faced critical endangerment. Because in just the last two decades, the island has experienced a forest loss that rounds out to at least 39%.

The culprit? Palm oil, a productive vegetable oil derived from the tropic-friendly oil palm tree. The edible oil is a cost-effective alternative to more production-heavy vegetable oils like coconut or olive, and so has become a staple ingredient across food products, detergents and biofuel, as well as in cosmetics. Yet its insatiable demand has quickly outgrown supply: Oil palm plantations now cover more than 66 million acres of the Earth's surface, according to environmental advocacy group Rainforest Rescue, depleting crucial ecosystems and displacing Indigenous peoples in the process. Today, the United Nations reports that only half of Borneo's original forest cover remains.

While palm oil is a particularly devastating case study, it's far from the only example of humans taking undue advantage of the planet's natural resources for industrial gain. In the beauty industry alone, crops, animal byproducts and oils yes, including palm are big for business; palm oil, for one, produces moisturizing fatty acids and texturizing alcohols, an A-plus skin-care combo.

So what if we could safely and sustainably recreate the world's most threatened ingredients, while also making them even more effective? That's a question scientists have been asking since the '60s, when biotechnology first began cropping up to study genetic engineering. Today, biotechnology can be defined as an area of applied science that harnesses living organisms and their derivatives to produce better products and processes. And the beauty industry is leading the charge.

"Biotechnology is essentially technology that's used in the lab to recreate endangered ingredients that ultimately improve people's lives or in the case of beauty, skin or to help solve an old problem," says Catherine Gore, president of vegan skin-care brandBiossance. "There are only a certain number of resources available to us, and biotechnology provides that perfect answer to still build brands through incredible ingredients and not make a negative imprint on the planet, or on your skin, for that matter."

A palm oil plantation and factory encroaches on a wildlife reserve in Malaysia, inhabited by both endangered animals and around 1,200 Indigenous peoples who live in riverbank communities.

Photo: Giles Clarke/Getty Images

Biossance launched in 2017 with squalane as its "hero ingredient." Developed via biotechnology, the brand's 100% plant-based, shelf-stable version of the moisturizer is touted as a more eco-friendly substitute for squalene, an organic compound primarily obtained from shark liver oil. Biossance derives its squalane from small-batch renewable Brazilian sugarcane that's then bio-fermented using its own yeast.

"Biotechnology uses bacteria and yeast as nano factories to produce active ingredients, minimizing the impact on the environment," says Dr. Hadley King, a board-certified dermatologist in New York City. "By using only tiny amounts of botanicals, biotechnology is a highly sustainable process. Active ingredients derived from plants and animals are sometimes criticized for the amount of land, water and energy they require, and with animal-derived ingredients, there are also issues of not being cruelty-free."

Squalene was first described and identified in 1916, and though shark harvesting more euphemistically known as "squalene fishing" has since fallen out of favor, sharks have taken a hit nonetheless. In 2006, the European Union banned targeted fisheries, noting a steep decline in certain shark populations, but according to global non-profit coalition Shark Allies, 2.7 million sharks are still harvested each year for their livers. According to Gore, Biossance's squalane isn't only a more ethical alternative to the shark-based substance, but chemically, it also reportedly works better, too.

"If you look at squalene in a vial, you'll see it's pretty cloudy and compromised in terms of quality, so it tends to oxidize on the skin," she says. Compare that to "totally clear and weightless" squalane, which also causes no oxidation science speak for "going bad" after having been exposed to air. "It's an identical counterpart, and we can make as much as the world needs without having a single negative imprint on the planet," claims Gore.

Ingredients formulated through biotechnology can also be far less expensive to manufacture than so-called "naturally derived" ones. While it takes a pretty penny to develop a new biotechnology product (roughly $1.2 billion, to be exact, according to the Tufts Center for the Study of Drug Development), companies may see a drastic dip in long-term operational costs. And with open sourcing, beauty brands can even work together to share technological breakthroughs across the industry at a rate more affordable than it may take for a company to develop its own technology. It's why Biossance sells its squalane to other prestige cosmetics brands.

Fishermen remove caught sharks from a boat in the Mexican state of Baja California Sur.

Photo: Federico Vespignani/Bloomberg via Getty Images

Beauty (skin care, especially) is so reliant on pioneering formulations that biotechnology is kind of a no-brainer. In 2019, Swiss fragrance company Givaudan developed a biotechnologically-produced version of ambroxide, an organic chemical and one of the key constituents responsible for the woody scent of ambergris. Ambroxie is naturally produced in the digestive system of sperm whales, but Givaudan's renewable version, Ambrofix, is made from fermenting sustainably-sourced sugar cane.

Elsewhere in Switzerland, cosmetic supplier Mibelle uses IceAwake, a trademarked ingredient that helps "rejuvenate" aging, sleep-deprived skin. Mibelle developed its technology from just a few samples of glacial ice melt from the Swiss Alps, taking advantage of the nearby water's high levels of microbial content.

As for palm oil? New York City-based C16 Bioscience has developed its own lab-grown alternative to the ingredient via a fermentation process that uses microbes to brew palm oil like beer and to do it to scale. The biotechnology firm closed a $20 million Series A round last March led by Breakthrough Energy Ventures, a $1 billion fund led by Bill Gates to accelerate innovations in sustainable energy.

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With almost no environmental impact in the product formulation itself, it's understandable that biotechnology alternatives can be considered the most "sustainable" option for eco-conscious consumers. But unlike the food sector that offers a number of third-party certification programs, beauty is less stringent, at least as far as governmental agencies are concerned.

The Food and Drug Administration regulates cosmetics, sure, but the term "organic" is not actually defined in any of its standards. Neither is "sustainable," or "clean," or even "natural," and there's no assurance that products that fall into those buckets are necessarily better for your skin overall. (Which is why it's so problematic that these products are also rarely accessible to those with lower incomes, a disproportionate number of whom are people of color.) And all that continues to mislead shoppers, now tasked with pilfering through ingredient lists and research findings on their own time.

"There's the potential for greenwashing [in biotechnology]," says Dr. King. "We need transparency and helpful labeling standards to help us understand and navigate the options. And ultimately, we need excellent safety and efficacy data to be able to evaluate these ingredients."

Biossance's proprietary squalane oilboth hydrates while locking in moisture.

Photo: Courtesy of Biossance

At Biossance, Gore assures that her team is committed to educating curious shoppers not just about biotechnology, but the company's internal processes as a whole. ("The word biotechnology can be rather abstract," she says. "So it naturally leads to more questions, and potentially more confusion, and that's what has to be targeted.") Transparency may be the most effective solution, then, at least until industry-wide accreditation services become available for beauty brands and their customers. Biotechnology is not waiting around, though.

"We're going to see new types of biotechnology ingredients emerge that are beyond just identical to their natural counterpart, but exceed them in quality and performance," says cosmetic chemist Ron Robinson, founder and CEO of BeautyStat, a beauty-influencer agency and blog that launched its own skin-care line in 2019. Robinson hints that BeautyStat is working on "something big" in the biotechnology world, but can't disclose details just yet.

The possibilities are endless, and not limited to the planet's most endangered flora and fauna, though they certainly take precedence. Gore suggests that consumers look out for biotechnologically-developed sandalwood, an officially "vulnerable" plant species that supplies an oil now frequently used in aromatherapy and perfumery. Biossance's parent corporationAmyris, a synthetic chemical company headquartered outside Oakland, recreated sandalwood using yeast fermentation.

If biotechnology feels rather futuristic, like something out of a flashy, 1960s sci-fi movie, that's because, well, it kind of is. As cross-industry climate action becomes increasingly necessary, Gore is hopeful that scientific innovation will, hopefully, only continue to rise to the occasion.

"The ultimate goal is to ask the questions across the board," she says. "How are ingredients being processed and harvested now? And is there a better solution?"

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Is Biotechnology the Answer to a More Sustainable Beauty Industry? - Fashionista

By Al Nigrin

Here is my interview with Joey Skaggs: Satire and Art Activism 1960s to the Present and Beyond Director Judy Drosd and Joey Skaggs.

Nigrin: The 2017 documentary filmArt of the PrankDirected by Andrea Marini, seems like a primer or greatest hits on Joeys life as a performance artist. The four oral histories that are part ofJoey Skaggs: Satire and Art Activism 1960s to the Present and Beyondseem to go deeper into his career. Was this what you were hoping to achieve?

Drosd: Andrea Marinis film, Art of the Prank, touches on many of Joeys performances and media satires, but he also wanted to follow Joey working on a new media hoax to show in real time what goes on behind the scenes. So, we get to watch Joey in the act of creating a fake documentary film, Pandoras Hope, which hes making to bring attention to the controversial issue of genetic modification and engineering. There are always limitations to how much material you can cover in a documentary. Any filmmaker will tell you about the heartbreaking and sometimes brutal cuts you have to make to keep the material focused and riveting. Choices have to be made in service of the story, and Andrea was knee deep in Joeys archival material he wanted to use but couldnt. Joeys work is provocative, confrontational and frequently outrageous so it has attracted a lot of media coverage over the decades. His performances are ephemeral, happening in plain sight in everyday life. He collected documentation of his performances as well as the news coverage because otherwise there would be no evidence that these things occurred. Consequently, he has a large collection of film, video, audio and print materials in addition to the physical art works he created to execute the concepts. Now that Art of the Prank has been launched into the world, Joey and I decided to dig deeper into the archive and create these new, more detailed and nuanced oral histories using material not included in the film. We dont have the same limitations Andrea had to deal with. Were approaching this as an open-ended non-linear project. Each piece is (and future pieces will be) as long as they need to be to tell a compelling story.

Nigrin: How did this oral history project come about? You mention in your press packet that you are working with NYU. How are they helping?

Skaggs: As I get older, Im thinking about what to do with my vast collection, which not only includes coverage of my work, but also sheds light on the times, illuminating what was going on that provoked and inspired me. Does it all go into a dumpster when Im gone? Is it picked apart by people who dont necessarily understand the work? So, Ive been seeking a way to preserve it and share it with the public. This is a dilemma all artists face.

Drosd: We reached out to NYU Professor Howard Besser, PhD., who founded the Moving Image Archiving and Preservation Department in the Tisch School of the Arts. Howard is a supporter of Joeys work and became a champion in helping us shape the collection for eventual transference to an institution that can care for it in perpetuity. He arranged for us to have an NYU graduate student intern this past summer to start the process, but when the Covid-19 pandemic hit, we had to segue from hands-on to an online-only experience. Our intern, David Griess, created a detailed Collection Assessment of Joeys archival materials as a first step, and also, at Joeys suggestion, began researching the ins and outs of doing oral histories to accompany the collection. We filmed a couple of tests with David, which became the first and second episodes in the Joey Skaggs Satire and Art Activism, 1960s to the Present and Beyond film. Joey and I then shot many more stories and I began editing this oral history project. NYUs involvement and support will continue as we move forward. Thanks to the New Jersey Film Festival, the first four episodes will be screened together as a single film on February 12, 2020.

Nigrin: You mentioned in the Video Q+A you did for the New Jersey Film Festival that there are more than 50 of these oral histories. Do you plan to release those as well? What periods are these focused on? Are they focused on particular performances?

Drosd: We are creating oral histories on a wide spectrum of Joeys lifes work and experiences. Its hard to say how many episodes there will be. However, each one transports you back in time to a different era and you get a sense of Joeys challenges and the imaginative and frequently hilarious work that he created over the years, all of which remains amazingly relevant today.

Nigrin: The music in these short films seems a bit twee at times. Other times quite serious. Can you elaborate on the use of the music in your films?

Drosd: The stories are nostalgic and music is critical to the narrative. It heightens the mood and helps pull the viewer into the time and place of the story. We tried to be truthful to the soundtrack of Joeys life, and we added a little cheekiness, just to underscore the absurdity of some of the stories. Since we cant afford the rights to songs by the Doors, or Deep Purple, or other iconic musical artists of the times, we did the next best thing. We found royalty free music that could, by association, set that tone. Also, we are fortunate to have a good friend, Daniel Pemberton, who is a world renowned movie composer (Steve Jobs, King Arthur: Legend of the Sword, Mollys Game, Oceans 8, Spider-Man: Into the Spider-Verse, Yesterday, Birds of Prey, The Trial of the Chicago 7 and many more), and he has given us access to music to which he owns full rights.

Nigrin: Are there any memorable stories while you made this film or any other info about your film you would like to relay to us?

Skaggs: Everything I do depends on the talent and generosity of a lot of other people. So far, in this series, Im so grateful to graphic designer Kaboom J. Schneider, and motion graphics animator Claudio Castillo, both of whom contributed to the titles. And then, there are all the people who appear in the episodes. I want to recognize all of them because I couldnt be successful without them.

Drosd: Working on these oral histories has been a trip down memory lane for both Joey and me. Because of the pandemic, weve been confined to one location. But this project has temporarily transported us out of todays divisive political reality and put us back in touch with the incredibly divisive realities of previous eras that inspired so much of Joeys activism and satire.

Skaggs: It seems there is always hype, hypocrisy, the mis-use of power, greed, racial injustice, and endless war. We have to continuously resist, preferably in a creative way and where possible with humor. If people get just one thing from this film series, I hope it is the inspiration to use their voices and stand up against social injustice and oppression.

Here is more info on this screening:

Joey Skaggs: Satire and Art Activism 1960s to the Present and Beyond - Judy Drosd (New York, New York) Joey Skaggs is a satirist, performance artist, and activist who for decades pioneered the use of the media as an integral part of his artwork. Skaggs art is both timely and timelessly relevant in that he tackles far ranging cultural, political and social issues, producing works that question and challenge authority and examine societal beliefs in a profound and humorous way. These four short documentaries are the first in a series of Joey Skaggs oral histories produced with technical support from NYUs Moving Image Archiving and Preservation program in the Tisch School of the Arts. In Joey Skaggs:The Early Years, 1940s to 1960s,Joey looks back at some of the earliest influences that led him away from the art establishment and into the streets.In Joey Skaggs: Art as Activism, 1960s and 1970s,Joey talks about the roots of his activism and his earliest renegade and inflammatory performance art in the streets of New York City. We see the spark that ignites his life-long controversial relationship with the news media. In Joey Skaggs: The Bad Guys Talent Management Agency,using historical archival footage, Joey tells the hilarious story of this 1984 media performance piece in which he helps his friend Verne fulfill his life-long ambition to become an actor. And in Joey Skaggs: The Fat Squad, Joey enlists his stable of eager actors and unleashes them as Fat Squad commandos, tough guys you can hire to use force to keep you on your diet. With extraordinary archival footage, Joey shows how he hooked the global news media, always hungry for salacious stories, into covering businesses that were definitely too good to be true. Joey Skaggs' work is also the subject of Andrea Marini's award-winning feature documentaryArt of the Prank, which won the Best Documentary prize at the New Jersey Film Festival back in 2017.2020; 52min.

Friday, February 12, 2021 - $12=General

Film will be available on VOD (Video On Demand) for 24 hours on its showdate.

To buy tickets for this screening go here:

https://watch.eventive.org/newjerseyfilmfestival2021/play/5faa91d9cbe29a0a49aefc78

Information:

https://newjerseyfilmfestival2021.eventive.org/welcome

https://newjerseyfilmfestival2021.eventive.org/schedule

(848) 932-8482; http://www.njfilmfest.com

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REHOVOT, Israel, Feb. 8, 2021 /PRNewswire/ -- CollPlant Biotechnologies (NASDAQ: CLGN) today announced it has entered into a worldwide exclusive development and commercialization agreement for dermal and soft tissue filler products with Allergan Aesthetics, an AbbVie company.

CollPlanthasgrantedAllergan Aesthetics worldwide exclusivity to use itsplant-derived recombinant human collagen (rhCollagen)in combination with Allergan Aesthetics' proprietary technologies, for the production and commercialization of dermal and soft tissue fillers. In addition, Allergan Aesthetics has the right of first negotiation for CollPlant's technology in two future additional products.

CollPlant will receive an upfront payment of $14 million and is entitled to receive up to an additional $89 million in milestone payments. In addition, CollPlant is eligible to receive royalty payments and a fee for the manufacture and supply of rhCollagen to Allergan Aesthetics.

Yehiel Tal, Chief Executive Officer of CollPlant, stated, "We are very pleased to formalize this collaboration with Allergan Aesthetics, the worldwide leader in dermal and soft tissue fillers. We believe that combining technologies from Allergan Aesthetics and CollPlant will create a paradigm shift in the medical aesthetics field. CollPlant's rhCollagen is non-immunogenic and non-allergenic, and offers better tissue regeneration performance over animal-derived collagen which is currently used in medical aesthetics. This agreement further validates CollPlant's technology as the gold standard collagen for regenerative and aesthetic medicine. We look forward to a highly productive partnership."

Roger J. Pomerantz, MD, FACP, Chairman of the Board of Directors at CollPlant, said, "Our company is extremely excited to expand our work in medical aesthetics towards commercialization in the dermal filler market, which is projected to reach $10 billion by 2026. This collaboration is a major step forward, firmly placing CollPlant at the next level in applying our regenerative medicine technology to tackle new areas in biomedicine."

About CollPlant

CollPlant is a regenerative and aesthetic medicine company focused on 3D bioprinting of tissues and organs, and medical aesthetics. CollPlant's products are based on its rhCollagen (recombinant human collagen) that is produced with CollPlant's proprietary plant based genetic engineering technology.

CollPlant's products address indications for the diverse fields of tissue repair, aesthetics and organ manufacturing, and are ushering in a new era in regenerative and aesthetic medicine.

CollPlant's flagship rhCollagen BioInk product line is ideal for 3D bioprinting of tissues and organs. In 2018, CollPlant entered into a licensing agreement with United Therapeutics, whereby United Therapeutics is using CollPlant's BioInks in the manufacture of 3D bioprinted lungs for transplant in humans.

For more information, visithttp://www.collplant.com.

Contacts at CollPlant:

Eran RotemDeputy CEO & Chief Financial OfficerTel: + 972-73-2325600/631Email:[emailprotected]

Safe Harbor for Forward-Looking Statements

This press release may include forward-looking statements. Forward-looking statements may include, but are not limited to, statements relating to CollPlant's objectives, plans and strategies, as well as statements, other than historical facts, that address activities, events or developments that CollPlant intends, expects, projects, believes or anticipates will or may occur in the future. These statements are often characterized by terminology such as "believes," "hopes," "may," "anticipates," "should," "intends," "plans," "will," "expects," "estimates," "projects," "positioned," "strategy" and similar expressions and are based on assumptions and assessments made in light of management's experience and perception of historical trends, current conditions, expected future developments and other factors believed to be appropriate. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Many factors could cause CollPlant's actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including, but not limited to, the following: CollPlant's history of significant losses and its need to raise additional capital and its inability to obtain additional capital on acceptable terms, or at all; CollPlant's expectations regarding the timing and cost of commencing clinical trials with respect to products which are based on CollPlant's rhCollagen; CollPlant's ability to obtain favorable pre-clinical and clinical trial results; regulatory action with respect to the products, including but not limited to acceptance of an application for marketing authorization, review and approval of such application, and, if approved, the scope of the approved indication and labeling; commercial success and market acceptance of the products; CollPlant's ability to establish sales and marketing capabilities or enter into agreements with third parties and its reliance on third-party distributors and resellers; CollPlant's ability to establish and maintain strategic partnerships and other corporate collaborations; CollPlant's reliance on third parties to conduct some aspects of its product manufacturing; the scope of protection CollPlant is able to establish and maintain for intellectual property rights and the companies' ability to operate their business without infringing the intellectual property rights of others; the overall global economic environment; the impact of competition and new technologies; general market, political, and economic conditions in the countries in which the companies operate; projected capital expenditures and liquidity; changes in the companies' strategy; and litigation and regulatory proceedings. More detailed information about the risks and uncertainties affecting CollPlant is contained under the heading "Risk Factors" included in CollPlant's most recent annual report on Form 20-F, respectively, filed with the SEC, and in other filings that CollPlant has made and may make with the SEC in the future. The forward-looking statements contained in this press release are made as of the date of this press release and reflect CollPlant's current views with respect to future events, and neither company undertakes, and each company specifically disclaims, any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

SOURCE CollPlant

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CollPlant Announces Development and Global Commercialization Agreement with Allergan Aesthetics, an AbbVie company, for rhCollagen in Dermal and Soft...

Researchers from the Antimicrobial Resistance (AMR) Interdisciplinary Research Group (IRG) at Singapore-MIT Alliance for Research and Technology (SMART), MITs research enterprise in Singapore, and Nanyang Technological University (NTU) have developed a tool using CRISPRi technology that can help understand and prevent biofilm development, drug resistance, and other physiological behaviors of bacteria such as Enterococcus faecalis.

E. faecalis, which is found in the human gut, is one of the most prevalent causes of hospital-associated infections and can lead to a variety of multidrug-resistant, life-threatening infections including bacteremia (bloodstream infection), endocarditis (infection of the heart), catheter-associated urinary tract infection, and wound infections.

However, current methods for understanding and preventing E. faecalis biofilm formation and development are labor-intensive and time-consuming. The SMART AMR research team designed an easily modifiable genetic technique that allows rapid and efficient silencing of bacteria genes to prevent infections.

In a paper published in the journal mBio, the researchers explain the scalable dual-vector nisin-inducible CRISPRi system, which can identify genes that allow bacteria like E. faecalis to form biofilms, cause infections, acquire antibiotic resistance, and evade the host immune system. The team combined CRISPRi technology with rapid DNA assembly under controllable promoters, which enables rapid silencing of single or multiple genes, to investigate nearly any aspect of enterococcal biology.

Infections caused by E. faecalis are usually antibiotic-tolerant and more difficult to treat, rendering them a significant public health threat, says Irina Afonina, postdoc at SMART AMR and lead author of the paper. Identifying the genes that are involved in these bacterial processes can help us discover new drug targets or propose antimicrobial strategies to effectively treat such infections and overcome antimicrobial resistance.

The team believes their new tool will be valuable in rapid and efficient investigation of a wide range of aspects of enterococcal biology and pathogenesis, host-bacterium interactions, and interspecies communication. The method can be scaled up to simultaneously silence multiple bacterial genes or perform full-genome studies.

Bacterial biofilms are clusters of bacteria that are enclosed in a protective, self-produced matrix, says SMART AMR principal investigator and NTU Associate Professor Kimberly Kline, also the corresponding author of the paper. The system we designed enables us to easily interrogate various stages during the biofilm developmental cycle of E. faecalis. By selectively silencing certain genes in preformed, mature biofilms, we can erode the biofilm and force it to disperse.

The scalable CRISPRi system uses high-throughput screens that can allow for rapid identification of gene combinations to be simultaneously targeted for novel and efficient antimicrobial combinatorial therapies.

The idea behind SMARTs inducible CRISPRi system was conceived by Kline and SMART AMR principal investigator Professor Timothy Lu, an associate professor in the MIT departments of Electrical Engineering and Computer Science and Biological Engineering, while Afonina developed and delivered the genetic tool.

The research is carried out by SMART and supported by the National Research Foundation (NRF) Singapore under its Campus for Research Excellence And Technological Enterprise (CREATE) program.

SMART was established by MIT in partnership with the NRF Singapore in 2007. SMART is the first entity in CREATE developed by NRF. SMART serves as an intellectual and innovation hub for research interactions between MIT and Singapore, undertaking cutting-edge research projects in areas of interest to both Singapore and MIT. SMART currently comprises an Innovation Center and five IRGs: AMR, Critical Analytics for Manufacturing Personalized-Medicine, Disruptive and Sustainable Technologies for Agricultural Precision, Future Urban Mobility, and Low Energy Electronic Systems.

The AMR IRG is a translational research and entrepreneurship program that tackles the growing threat of antimicrobial resistance. By leveraging talent and convergent technologies across Singapore and MIT, they tackle AMR head-on by developing multiple innovative and disruptive approaches to identify, respond to, and treat drug-resistant microbial infections. Through strong scientific and clinical collaborations, they provide transformative, holistic solutions for Singapore and the world.

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A new tool to investigate bacteria behind hospital infections - MIT News

DALLAS--(BUSINESS WIRE)--Taysha Gene Therapies, Inc. (Nasdaq: TSHA), a patient-centric, clinical-stage gene therapy company focused on developing and commercializing AAV-based gene therapies for the treatment of monogenic diseases of the central nervous system (CNS) in both rare and large patient populations, today announced multi-year collaborations with Cleveland Clinic and UT Southwestern Gene Therapy Program (UTSW) to advance next-generation mini-gene payloads for AAV gene therapies for the treatment of genetic epilepsies and additional CNS disorders. Taysha will have an exclusive option on new payloads, constructs and intellectual property associated with, and arising from, the research conducted under this agreement.

A team of researchers from Cleveland Clinic Lerner Research Institute will create mini-gene payloads designed to address some of the long-standing limitations in AAV gene therapy. UTSW will create and evaluate vector constructs in in vivo and in vitro efficacy models of genetic epilepsies and additional CNS disorders.

By pushing the boundaries of AAV vector engineering, we may be able to overcome some of the challenges inherent with gene therapy and potentially expand the range of treatable genetic CNS diseases with gene therapies. We appreciate the support from Taysha and UTSW in this work, said Dennis Lal, Ph.D., Assistant Staff at Cleveland Clinic Genomic Medicine Institute and Neurological Institute. We believe that our proprietary approach to overcoming current limitations of packaging capacity and our access to data on thousands of protein structures associated with a whole host of monogenic CNS disorders has the potential to enable a deep pipeline of functioning mini-genes.

Cleveland Clinic and UTSW are two of the worlds preeminent leaders in gene therapy innovation, and this collaboration is designed to leverage our capabilities and synergies with these institutions to pioneer novel approaches to address vector capacity, which is a common limitation when treating genetic disorders associated with large proteins, said Suyash Prasad, MBBS, M.SC., MRCP, MRCPCH, FFPM, Chief Medical Officer and Head of Research and Development of Taysha. We look forward to a productive collaboration with the goal of developing treatments with promising benefits to patients with debilitating genetic epilepsies.

About Taysha Gene Therapies

Taysha Gene Therapies (Nasdaq: TSHA) is on a mission to eradicate monogenic CNS disease. With a singular focus on developing curative medicines, we aim to rapidly translate our treatments from bench to bedside. We have combined our teams proven experience in gene therapy drug development and commercialization with the world-class UT Southwestern Gene Therapy Program to build an extensive, AAV gene therapy pipeline focused on both rare and large-market indications. Together, we leverage our fully integrated platforman engine for potential new cureswith a goal of dramatically improving patients lives. More information is available at http://www.tayshagtx.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as anticipates, believes, expects, intends, projects, and future or similar expressions are intended to identify forward-looking statements. Forward-looking statements include statements concerning or implying the potential of our collaboration with the Cleveland Clinic and UTSW, the potential of our product candidates to positively impact quality of life and alter the course of disease in the patients we seek to treat, our research, development and regulatory plans for our product candidates, the potential benefits of rare pediatric disease designation and orphan drug designation to our product candidates, the potential for these product candidates to receive regulatory approval from the FDA or equivalent foreign regulatory agencies, and whether, if approved, these product candidates will be successfully distributed and marketed. Forward-looking statements are based on managements current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks regarding our business are described in detail in our Securities and Exchange Commission (SEC) filings, including in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, which is available on the SECs website at http://www.sec.gov. Additional information will be made available in other filings that we make from time to time with the SEC. Such risks may be amplified by the impacts of the COVID-19 pandemic. These forward-looking statements speak only as of the date hereof, and we disclaim any obligation to update these statements except as may be required by law.

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Taysha Gene Therapies Announces Collaborations to Advance Next-Generation Mini-Gene Payloads for AAV Gene Therapies for the Treatment of Genetic...

Dublin, Feb. 08, 2021 (GLOBE NEWSWIRE) -- The "Global CRISPR Gene Editing Market: Focus on Products, Applications, End Users, Country Data (16 Countries), and Competitive Landscape - Analysis and Forecast, 2020-2030" report has been added to ResearchAndMarkets.com's offering.

The global CRISPR gene editing market was valued at $846.2 million in 2019 and is expected to reach $10,825.1 million by 2030, registering a CAGR of 26.86% during the forecast.

The development of genome engineering with potential applications proved to reflect a remarkable impact on the future of the healthcare and life science industry. The high efficiency of the CRISPR-Cas9 system has been demonstrated in various studies for genome editing, which resulted in significant investments within the field of genome engineering. However, there are several limitations, which need consideration before clinical applications. Further, many researchers are working on the limitations of CRISPR gene editing technology for better results. The potential of CRISPR gene editing to alter the human genome and modify the disease conditions is incredible but exists with ethical and social concerns.

The growth is attributed to the increasing demand in the food industry for better products with improved quality and nutrient enrichment and the pharmaceutical industry for targeted treatment for various diseases. Further, the continued significant investments by healthcare companies to meet the industry demand and growing prominence for the gene therapy procedures with less turnaround time are the prominent factors propelling the growth of the global CRISPR gene editing market.

Research organizations, pharmaceutical and biotechnology industries, and institutes are looking for more efficient genome editing technologies to increase the specificity and cost-effectiveness, also to reduce turnaround time and human errors. Further, the evolution of genome editing technologies has enabled wide range of applications in various fields, such as industrial biotech and agricultural research. These advanced methods are simple, super-efficient, cost-effective, provide multiplexing, and high throughput capabilities. The increase in the geriatric population and increasing number of cancer cases, and genetic disorders across the globe are expected to translate into significantly higher demand for CRISPR gene editing market.

Furthermore, the companies are investing huge amounts in the research and development of CRISPR gene editing products, and gene therapies. The clinical trial landscape of various genetic and chronic diseases has been on the rise in recent years, and this will fuel the CRISPR gene editing market in the future.

Within the research report, the market is segmented based on product type, application, end-user, and region. Each of these segments covers the snapshot of the market over the projected years, the inclination of the market revenue, underlying patterns, and trends by using analytics on the primary and secondary data obtained.

Key Companies Profiled

Abcam, Inc., Applied StemCell, Inc., Agilent Technologies, Inc., Cellecta, Inc., CRISPR Therapeutics AG, Thermo Fisher Scientific, Inc., GeneCopoeia, Inc., GeneScript Biotech Corporation, Horizon Discovery Group PLC, Integrated DNA Technologies, Inc., Merck KGaA, New England Biolabs, Inc., Origene Technologies, Inc., Rockland Immunochemicals, Inc., Synthego Corporation, System Biosciences LLC, ToolGen, Inc., Takara Bio

Key Questions Answered in this Report:

Key Topics Covered:

1 Technology Definition

2 Research Scope

3 Research Methodology

4 Market Overview4.1 Introduction4.2 CRISPR Gene Editing Market Approach4.3 Milestones in CRISPR Gene Editing4.4 CRISPR Gene Editing: Delivery Systems4.5 CRISPR Technology: A Potential Tool for Gene Editing4.6 CRISPR Gene Editing Current Scenario4.7 CRISPR Gene Editing Market: Future Potential Application Areas

5 Global CRISPR Gene Editing Market, $Million, 2020-20305.1 Pipeline Analysis5.2 CRISPR Gene Editing Market and Growth Potential, 2020-20305.3 Impact of COVID-19 on CRISPR Gene Editing Market5.3.1 Impact of COVID-19 on Global CRISPR Gene Editing Market Growth Rate5.3.1. Impact on CRISPR Gene Editing Companies5.3.2 Clinical Trial Disruptions and Resumptions5.3.3 Application of CRISPR Gene Editing in COVID-19

6 Market Dynamics6.1 Impact Analysis6.2 Market Drivers6.2.1 Prevalence of Genetic Disorders and Use of Genome Editing6.2.2 Government and Private Funding6.2.3 Technology Advancement in CRISPR Gene Editing6.3 Market Restraints6.3.1 CRISPR Gene Editing: Off Target Effects and Delivery6.3.2 Ethical Concerns and Implications With Respect to Human Genome Editing6.4 Market Opportunities6.4.1 Expanding Gene and Cell Therapy Area6.4.2 CRISPR Gene Editing Scope in Agriculture

7 Industry Insights7.1 Introduction7.2 Funding Scenario7.3 Regulatory Scenario of CRISPR Gene Editing Market7.4 Pricing of CRISPR Gene Editing7.5 Reimbursement of CRISPR Gene Editing7.5.1 CRISPR Gene Editing: Insurance Coverage in the U.S.

8 CRISPR Gene Editing Patent Landscape8.1 Overview8.2 CRISPR Gene Editing Market Patent Landscape: By Application8.3 CRISPR Gene Editing Market Patent Landscape: By Region8.4 CRISPR Gene Editing Market Patent Landscape: By Year

9 Global CRISPR Gene Editing Market (by Product Type), $Million9.1 Overview9.2 CRISPR Products9.2.1 Kits and Enzymes9.2.1.1 Vector-Based Cas99.2.1.2 DNA-Free Cas99.2.2 Libraries9.2.3 Design Tools9.2.4 Antibodies9.2.5 Other Products9.3 CRISPR Services9.3.1 gRNA Design and Vector Construction9.3.2 Cell Line and Engineering9.3.3 Screening Services9.3.4 Other Services

10 CRISPR Gene Editing Market (by Application), $Million10.1 Overview10.2 Agriculture10.3 Biomedical10.3.1 Gene Therapy10.3.2 Drug Discovery10.3.3 Diagnostics10.4 Industrial10.5 Other Applications

11 Global CRISPR Gene Editing Market (by End User)11.1 Academic Institutions and Research Centers11.2 Biotechnology Companies11.3 Contract Research Organizations (CROs)11.4 Pharmaceutical and Biopharmaceutical Companies

12 Global CRISPR Gene Editing Market (by Region)12.1 Introduction12.2 North America12.3 Europe12.4 Asia-Pacific12.5 Latin America

13 Competitive Landscape13.1 Key Developments and Strategies13.1.1 Overview13.1.1.1 Regulatory and Legal Developments13.1.1.2 Synergistic Activities13.1.1.3 M&A Activities13.1.1.4 Funding Activities13.2 Market Share Analysis13.3 Growth Share Analysis

14 Company Profiles14.1 Overview14.2 Abcam, Inc.14.2.1 Company Overview14.2.2 Role of Abcam, Inc. in the Global CRISPR Gene Editing Market14.2.3 Financials14.2.4 SWOT Analysis14.3 Applied StemCell, Inc.14.3.1 Company Overview14.3.2 Role of Applied StemCell, Inc. in the Global CRISPR Gene Editing Market14.3.3 SWOT Analysis14.4 Agilent Technologies, Inc.14.4.1 Company Overview14.4.2 Role of Agilent Technologies, Inc. in the Global CRISPR Gene Editing Market14.4.3 Financials14.4.4 R&D Expenditure, 2017-201914.4.5 SWOT Analysis14.5 Cellecta, Inc.14.5.1 Company Overview14.5.2 Role of Cellecta, Inc. in the Global CRISPR Gene Editing Market14.5.3 SWOT Analysis14.6 CRISPR Therapeutics AG14.6.1 Company Overview14.6.2 Role of CRISPR Therapeutics AG in the Global CRISPR Gene Editing Market14.6.3 Financials14.6.4 R&D Expenditure, 2017-201914.6.5 SWOT Analysis14.7 Thermo Fisher Scientific, Inc. INC14.7.1 Company Overview14.7.2 Role of Thermo Fisher Scientific, Inc. in the Global CRISPR Gene Editing Market14.7.3 Financials14.7.4 R&D Expenditure, 2017-201914.7.5 SWOT Analysis14.8 GeneCopoeia, Inc.14.8.1 Company Overview14.8.2 Role of GeneCopoeia, Inc. in the Global CRISPR Gene Editing Market14.8.3 SWOT Analysis14.9 GeneScript Biotech Corporation14.9.1 Company Overview14.9.2 Role of GenScript Biotech in the Global CRISPR Gene Editing Market14.9.3 Financials14.9.4 SWOT Analysis14.1 Horizon Discovery Group PLC14.10.1 Company Overview14.10.2 Role of Horizon Discovery Group PLC in the Global CRISPR Gene Editing Market14.10.3 Financials14.10.4 SWOT Analysis14.11 Integrated DNA Technologies, Inc.14.11.1 Company Overview14.11.2 Role of Integrated DNA Technologies, Inc. in the Global CRISPR Gene Editing Market14.11.3 SWOT Analysis14.12 Merck KGaA14.12.1 Company Overview14.12.2 Role of Merck KGaA in the Global CRISPR Gene Editing Market14.12.3 Financials14.12.4 SWOT Analysis14.13 New England Biolabs, Inc.14.13.1 Company Overview14.13.2 Role of Integrated DNA Technologies, Inc. in the Global CRISPR Gene Editing Market14.13.3 SWOT Analysis14.14 Origene Technologies, Inc.14.14.1 Company Overview14.14.2 Role of Origene Technologies, Inc. in the Global CRISPR Gene Editing Market14.14.3 SWOT Analysis14.15 Rockland Immunochemicals, Inc.14.15.1 Company Overview14.15.2 Role of Rockland Immunochemicals, Inc. in the Global CRISPR Gene Editing Market14.15.3 SWOT Analysis14.16 Synthego Corporation14.16.1 Company Overview14.16.2 Role of Synthego Corporation in the Global CRISPR Gene Editing Market14.16.3 SWOT Analysis14.17 System Biosciences LLC14.17.1 Company Overview14.17.2 Role of System Biosciences LLC in the Global CRISPR Gene Editing Market14.17.3 SWOT Analysis14.18 ToolGen, Inc.14.18.1 Company Overview14.18.2 Role of ToolGen, Inc. in the Global CRISPR Gene Editing Market14.18.3 SWOT Analysis14.19 Takara Bio14.19.1 Company Overview14.19.2 Role of Takara Bio in the Global CRISPR Gene Editing Market14.19.3 Financials14.19.4 SWOT Analysis

For more information about this report visit https://www.researchandmarkets.com/r/c7om7t

Originally posted here:
Outlook on the CRISPR Gene Editing Global Market to 2030 - Analysis and Forecasts - GlobeNewswire

GAITHERSBURG, Md., Feb. 04, 2021 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the start of the rolling review process for authorization of NVX-CoV2373, its COVID-19 vaccine, by multiple regulatory agencies. The reviews will continue while the company completes its pivotal Phase 3 trials in the United Kingdom (U.K.) and United States (U.S.) and through initial authorization for emergency use granted under country-specific regulations.

The rolling review of our submission by regulatory authorities of non-clinical data and early clinical studies will help expedite the review process and bring us that much closer to delivering a safe and effective vaccine worldwide, said Gregory M. Glenn, MD, President of Research and Development, Novavax. We appreciate the agencies confidence in Novavax based on our early data and the collective sense of urgency to ensure speedier access to much-needed COVID-19 vaccination.

To date, Novavax has begun the rolling review process with several regulatory agencies worldwide, including the European Medicines Agency (EMA), U.S. Food and Drug Administration (FDA), U.K. Medicines and Healthcare products Regulatory Agency (MHRA), and Health Canada. As part of the rolling review, the company will continue to submit additional information, including clinical and manufacturing data.

Novavax recombinant protein-based vaccine candidate is currently in Phase 3 clinical development in both the U.K. and U.S. for the prevention of COVID-19. It was the first vaccine to demonstrate clinical efficacy against the original strain of COVID-19 and both of the rapidly emerging variants in the United Kingdom and South Africa.

About NVX-CoV2373

NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is adjuvanted with Novavax patented saponin-based Matrix-M to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19. In preclinical studies, NVX-CoV2373 induced antibodies that block binding of spike protein to cellular receptors and provided protection from infection and disease. It was generally well-tolerated and elicited robust antibody response numerically superior to that seen in human convalescent sera in Phase 1/2 clinical testing. NVX-CoV2373 is currently being evaluated in two pivotal Phase 3 trials: a trial in the U.K that demonstrated 89.3 percent overall efficacy and 95.6 percent against the original strain in a post-hoc analysis, and the PREVENT-19 trial in the U.S. and Mexico that began in December. It is also being tested in two ongoing Phase 2 studies that began in August: A Phase 2b trial in South Africa that demonstrated up to 60 percent efficacy against newly emerging escape variants, and a Phase 1/2 continuation in the U.S. and Australia.

About Matrix-MNovavax patented saponin-based Matrix-M adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

About NovavaxNovavax, Inc.(Nasdaq: NVAX) is a biotechnology company that promotes improved health globally through the discovery, development and commercialization of innovative vaccines to prevent serious infectious diseases. The companys proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. Novavaxis conducting late-stage clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults and will be advanced for regulatory submission. Both vaccine candidates incorporate Novavax proprietary saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.

For more information, visit http://www.novavax.com and connect with us on Twitter and LinkedIn.

Novavax Forward Looking Statements

Statements herein relating to the future ofNovavaxand the ongoing development of its vaccine and adjuvant products are forward-looking statements.Novavaxcautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading Risk Factors in the Novavax Annual Report on Form 10-K for the year endedDecember 31, 2019, and Quarterly Report on Form10-Qfor the period endedSeptember 30, 2020, as filed with theSecurities and Exchange Commission(SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with theSEC, available atsec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

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Novavax Announces Start of Rolling Review by Multiple Regulatory Authorities for COVID-19 Vaccine Authorization - GlobeNewswire