Health and Fitness: Hip replacement surgery: getting back to what you love – taosnews

More than 300,000 total hip replacement surgeries are performed annually in the United States.

Awhile back, I helped develop a hiking plan for a friend who had hip replacement surgery and wanted to return to hiking gradually as part of her physical therapy. It didn't occur to me that I would need the same type of plan one day.

I have had the opportunity to hike many of the beautiful trails near Taos over the last 30 years. I began to write about hiking for the Taos News in 2011 and wrote the "Taos Hiking Guide" in 2015.

Up until about two years ago, I was hiking 14 miles round trip to places like Las Trampas Lakes near the Truchas Peaks, sometimes backpacking with no problem and little pain. Then that winter, I started to experience a lot of discomfort in my right hip and leg; occasionally my leg would just collapse and refuse to work.

I had seen Dr. Keith Christian, DOM, of Taos Chiropractic Health Center over time whenever I had a little twinge of pain in my knee or hip and for awhile, he was able to straighten out my body and reduce the pain.

But there came a time when no amount of adjusting reduced the pain or improved function. We both realized that something new was going on and Christian suggested that there was some significant deterioration in my hips.

When I got an X-ray at Holy Cross Hospital last summer, it showed that I had worn out all the cartilage in my right hip and had only a bit remaining in my left hip. I made an appointment with Dr. Sean Marvil at Taos Orthopaedic Institute to talk about options for treatment.

It turns out there aren't many options: steroid shots can help with pain for a period of months and stem cell therapy is an emerging approach that has promise for the future, but the proposed solution from Marvil was hip replacement surgery, technically known as total hip arthroplasty, at least for my right hip.

The number of hip replacement surgeries in the U.S. is projected to grow over time. The average age for hip replacement is 67 years old, according to the American Joint Replacement Registry. In addition to improving the quality of life for patients, one study in Sweden showed that hip replacement surgery also may add years to a person's life.

According to the two surgeons I consulted, the reason I needed the procedure is osteoarthritis: a condition that damages the cartilage covering the end of the bones where they come together in the hip socket. This condition arises from a combination of wear and tear and genetics.

Although hip surgery is generally classified as elective surgery, doctors may recommend it if the condition is causing a lot of pain and interfering with the ability to do basic tasks like getting dressed and walking.

Although I had two other friends who have had hip replacement surgery and I was beginning to wonder if my pain was the result of arthritis l, I was still surprised and a little angry at the diagnosis. I had somehow assumed that being active and fit would protect me from needing this kind of surgery. And I am younger than the average age for the surgery by a number of years.

After I had a chance to reflect on the situation a bit, I was relieved that at least there was something that could be done about the pain and dysfunction and that I could again be hiking longer distances. I made the decision to have the surgery and planned for it sometime in the spring of 2020.

Then life intervened. With the coming of the COVID-19 virus, elective surgeries were delayed. My mom who had been diagnosed with ovarian cancer at Christmas passed away in April and during that time all my priorities changed.

Finally in early June, I was able to see a surgeon in Colorado. Due to the requirements of my insurance plan, I had to have the procedure done in Colorado from a preapproved list of doctors in order to have it covered. This was a difficult decision, as I would have been happy to work with Marvil at Taos Orthopaedic Institute.

After reading reviews of all the approved physicians, I chose Dr. Joseph Assini at OrthoOne at Swedish Medical Center in Denver, due to his favorable reviews by past patients.

When asked about the benefits of hip replacement surgery, Assini said, "It is always great to see the amazing pain relief patients get after a total hip replacement. While the path for each patient is variable in terms of time and discomfort, patients will end up happy and generally back to most activities six to 12 weeks from surgery. Being able to help patients get back their quality of life is very rewarding."

Before the surgery in June, I had a variety of exams and tests, including a screening for the COVID virus. All the test results looked good.

Early on the morning of June 24, my sister Brenda Staab picked me up and we went across town to the Rocky Mountain Surgery Center. I had spoken to the anesthesiologist the night before, who advised I have no food for eight hours and no liquids four hours before.

When I arrived, I checked in and was taken back to the preoperative area where an IV was started and I was given some painkillers. Assini stopped by and marked the right hip where the incision would be.

The anesthesiologist discussed the options with me. The two primary options were general anesthetic or a spinal block with additional medication that made sure the patient was asleep for the operation. We agreed on the spinal block as it is less impactful to the body and less likely to cause nausea and other side effects. He explained that he would put some cold gel on my back before giving me the injection. The cold gel was the last thing I remember until waking up a short time later.

What was amazing to me was that the actual hip replacement took under an hour. After demonstrating I could walk with crutches and perform certain other bodily functions to ensure that the spinal block had worn off, I was able to go home later the same day as the procedure.

I came back home to Taos the Sunday after my surgery to settle into the recovery process.

Recovery and physical therapy

Right after the surgery, I had nausea and a fair amount of pain. I was surprised by the extent of the swelling and bruising I experienced, not only in my hip, but also all the way down my leg to my foot, although Assini and staff reassured me that what I was experiencing was in the normal range.

For the first two weeks after surgery, I had to wear compression stockings which were hot and uncomfortable, but reduced the risk of a blood clot, one of the major risks of surgery. I've been taking two aspirin per day as a blood thinner to prevent clots and will need to continue to do so for a total of six weeks.

The pain medication that was prescribed to me was oxycodone - a narcotic drug with many side effects. It carries with it the risk of addiction. For the first few days, I took it every four to six hours and found it made me lightheaded and added to my nausea. Since then, I have been taking only one per day to help me sleep at night and am ready to begin to end that use as well.

In order to get back into shape for hiking and gardening, I have had the pleasure of working with Amryn Ayres of Physical Therapy and Rehab, a program of Holy Cross Hospital. Ayres received her doctorate in physical therapy just over two years ago and has worked at Physical Therapy and Rehab since the beginning of April.

She said, "The goal for physical therapy is to get people back to what they love. Surgery in general has widespread effects on the body in regard to motion, strength and overall function. As physical therapists, we are trained to identify specific impairments and guide you back to feeling better and living your life."

I first saw Ayres five days after surgery. She assessed my mobility and put together a series of exercises for me to do at home. She's also looked at my incision and helped determine it was ready to have the stitches removed.

I have been going to physical therapy one to two times a week since returning home and can feel that my hip and leg are becoming stronger.

After hip replacement on the right side, the patient is not able to drive for several weeks. I found Michelle Chandler, who in addition to being a musician and executive director of the Taos Youth Music School, offers various services to individuals and couples, including ministerial counseling and practical support. Chandler took me to physical therapy and also grocery shopping. Without her assistance, I would not have been able to navigate the first few weeks after surgery.

Also, 10,000 Wags Pet Resort was helpful. They picked up my dog twice a week and took him to play group so he got some exercise when I couldn't walk him.

Although I am not done recovering, I can feel that I'm stronger every day and have been returning to some of my regular activities slowly. I was cleared to drive at about four weeks after surgery and am slowly returning to short hikes with my dog, while continuing my physical therapy appointments and exercises at home.

At five weeks after surgery, I have much better mobility in my hip and the remaining muscle pain from the surgery is gradually decreasing.

Not surprisingly, another thing I observed is having medical insurance is important. The total bill covered by insurance was more than $73,000, with my portion totaling around $3,000.

I may need to have my left hip replaced at some point. But for now, I am going to focus on healing and becoming stronger, so that by the time fall is here, I will be once again hiking high in the mountains around Taos watching the leaves turn to gold.

Read the original:
Health and Fitness: Hip replacement surgery: getting back to what you love - taosnews

How MC Hammer And Other Performing Artists Are Sharing Their Love Of Science – Forbes

If you've been keeping tabs on MC Hammer lately, you may have noticed that he spent the last few weeks enthusiastically talking about science on Twitter. He tweeted about a gene found in neurons, about worm RNA, about slime molds, and much more.

MC Hammer has been sharing his love of science with his Twitter followers in the last few weeks. ... [+] (Pictured here during a Capitol Music Group event on August 8, 2018 in LA. Photo by Rich Polk/Getty Images for Capitol Music Group)

This isn't unprecedented. It's not unusual for MC Hammer to talk about science (he was tweeting about laser-controlled fly brains back in 2014) and it's not unusual for performing artists in general to be vocal supporters of science.

Over the last few years, several other musicians have publicly shared their fascination with various fields of science. A few years ago, singer Charlotte Church revealed that she loves physics. meanwhile, Ben Folds and Rosanne Cash both developed an interest in neuroscience. Folds has spoken with neuroscientist Daniel Levitin about the science behind music, and Cash collaborated with neuroscientist-led band The Amygdaloids on a song. The Wu-Tang Clan's GZA has been focusing on science-themed rap the past decade, creating an as-yet unreleased science album. Bjrk also released a science-inspired album in 2011.

And then there are the scientists with high-profile music careers. Long before he became a TV science presenter and physicist, Brian Cox was keyboard player in '90s band D:Ream. Queen guitarist Brian May quit his astrophysics PhD when the band became too popular to manage both careers, but he picked it back up a few decades later. He now occasionally works on science communication projects with NASA and others. The Offspring's Dexter Holland also paused a PhD during the height of his band's success and returned to USC to finish his PhD in 2017. His thesis on the molecular biology of HIV on got a mention in Rolling Stone.

Some performing artists use their platform to raise attention and money for specific causes. Country singer Willie Nelson is interested in stem cell therapy and has supported the field by raising funds for the University of Texas' Southwestern Medical Center. Meanwhile, actors Michael J Fox and Leonardo DiCaprio both run foundations that support scientific research. Fox launched his foundation in 2000 to provide funding and resources for Parkinson's Disease after he was diagnosed with the condition himself. DiCaprios foundation supports environmental research, and has partly funded a range of research projects, such as a study on kelp forests or research on wildland fires.

The list goes on. For every celebrity that gets unwarranted attention for peddling unproven treatments or gimmicks, you'll find several others being the voice of reason and using their platform to support science. And that public support is something that researchers very much appreciate.

Scientists often have the intention to communicate their work widely, but the constrant struggle to survive beyond their current grant pressures them to focus on getting the research done and published in specialized journals, often without finding the time to share that work with the wider world. However, people are trying to change this through new science communication methods. The field of science communication studies how research is shared and looks for ways to connect people with science. Here, too, we find a celebrity. After presenting the PBS show Scientific American Frontiers, actor Alan Alda founded the Alan Alda Center For Science Communication, which offers advice and training for researchers to help them share their story with others.

In a 2016 interview with the Australian National University, Alda emphasizes that it's important to show the people behind the research. "I think when we see scientists as human beings, the door is open for us a little bit, we can go into their lives. Theyre not the white-coated gurus on the mountaintop."

Showing scientists as human beings is exactly what MC Hammer has been doing with his platform. This week, he has been supporting the #BlackInChem initiative, amplifying the profiles of black chemists and showing his followers some of the people behind the research.

Scientists on Twitter have been understandably excited when MC Hammer retweets them. Not just because of the brief brush with fame, but because researchers are always trying to reach new people with their work.

It can be hard to share science with people beyond the usual science fans. People have to want to attend a science festival, purposely buy a popular science magazine, or deliberately tune in to a science show. Online, our algorithms keep feeding us the same topics we always look at. But by using their platform to share science news and scientist profiles, high-profile performing artists like MC Hammer can break through that bubble and give their audience a glimpse into a world that they might otherwise not seek out themselves.

Link:
How MC Hammer And Other Performing Artists Are Sharing Their Love Of Science - Forbes

Chromosomal Rearrangements Associated with Chemotherapeutic Drug Resistance | McDonnell Boehnen Hulbert & Berghoff LLP – JD Supra

Chemotherapeutic drug resistance is one reason cancer remains an unsolved clinical problem despite the efforts ever since President Nixon declared his "War on Cancer" in 1971. Cancer cells, due in part to the genetic destabilization characteristic of the disease, are capable of expressing genes (normal or aberrant) that permit the cell to avoid the cytotoxic effect of such drugs with the patient providing the situs of selection for and growth of resistant cells. The phenomenon is certain tumor types can have more deleterious consequences than in others, and this is particularly true for glioblastomas (and their non-malignant counterparts, gliomas), cancer of the cells that protect neurons in brain. That organ, confined to the skull, cannot accommodate tumor growth without damaging the brain with which it is confined.

The chemotherapeutic drug of choice for treating glioblastomas is temezolomide (TMZ), an oral alkylating agent that had its chemotherapeutic effect by introducing alkyl groups onto nucleotide bases (preferably at the N-7 and O-6 positions of guanine and N-3 position of adenine) in tumor cell DNA preferentially (due to the greater amount of DNA synthesis occurring in these cells) and disrupting the process leading to cell death (the O-6 methylation having the greatest capacity to induce apoptosis or programmed cell death).O-6-methylguanosnine DNA methyltransferase (MGMT) is the cellular enzyme responsible for repairing alkylated bases in DNA and reduced expression of this gene (e.g., by hypermethylation of the MGMT promoter) is a biomarker for TMZ sensitivity in gliomas and glioblastomas. Recently, a multinational team of researchers* reported genetic rearrangements associated with TMZ resistance, in a paper entitled "MGMT genomic rearrangements contribute to chemotherapy resistance in gliomas" published in Nature Communications. This paper shows a subset of gliomas with rearrangements in the MGMT gene that produce overexpression of the gene and resistance as a result. These authors screened 252 TMZ-treated recurrent gliomas by RNA sequencing and found eight different MGMT genetic fusions (designated BTRC-MGMT,CAPZB-MGMT,GLRX3-MGMT,NFYC-MGMT,RPH3A-MGMT, andSAR1A-MGMTin high-grade gliomas, HGG, andCTBP2-MGMTandFAM175B-MGMT in low-grade gliomas, LGG, in the paper) in seven patients (6 females) with recurrent disease, created by chromosomal rearrangement (see Figure 1c from paper; shown below). These individuals' tumors showed "significantly higher" expression of the rearranged MGMT gene product.

Upon further study, the authors report that five of the eight rearranged genes were located on Chromosome 10 in the vicinity of the MGMT gene itself. The breakpoint in the MGMT was uniformly found at the boundary of exon 2 of the MGMT gene, at a point 12 basepairs upstream of the ATG translation "start" codon. In three of the rearrangements, the breakpoint in the partner gene in the genetic fusion was found in the 5' untranslated region (UTR). All fusions were found to be in-frame (i.e., the reading frame of the MGMT transcript was not disrupted) and the functional regions of the MGMT protein (the methyltransferase domain and DNA-binding domain) were intact. A more fine-structure mapping experiment in the genetic rearrangement resulting in FAM175B-MGMTfound that the fusion was the consequence of a deletion of 4.8 Mb.

The effect of these rearrangements on MGMT expression was elucidated using CRIPSR-Cas9 to produce the BTRC-MGMT, NFYC-MGMT, SAR1A-MGMT, and CTBP2-MGMT rearrangements in cells of two glioblastoma cell lines, U251 and U87. When these cells and their untreated counterparts were challenged by growth in vitro with TMZ, only cells bearing the rearrangements (as confirmed by PCR analysis) were shown to be TMZ resistant. Unlike genetic rearrangements in other cancers that produce fusion proteins (such as the abl-bcr gene produced in chronic myelogenous leukemia bearing the diagnostic Philadelphia chromosome), because most of the rearrangements found involving the MGMT gene were located upstream of the initiation codon of the MGMT gene these authors reasoned that these rearrangements produce increased expression of MGMT leading to TMZ resistance because the cells were better able to repair the methylation injury and replicate functionally. This hypothesis was supported by real-time quantitative PCR analysis of MGMT transcripts in cells bearing the rearrangements, that showed a "striking" increase in expression of MGMT-encoding transcripts (an observation also found in tumors from patients whose gliomas or glioblastomas showed these rearrangements), and Western blot analysis confirmed higher expression levels of the MGMT protein. In two of the rearrangements (BTRC-MGMT and NFYC-MGMT), higher molecular weight fusion proteins were detected as predicted from the genetic data. These results were also replicated in patient tumor-derived stem cells for the BTRC-MGMTandSAR1A-MGMT rearrangements.

These results, and the researchers' conclusion that these rearrangements caused TMZ resistance by overexpression of MGMT, were confirmed by re-establishing TMZ sensitivity in these cells in the presence of O6-benzylguanine (O6-BG), an MGMT inhibitor. These results were further confirmed by detection of double-strand breaks in DNA in these cells in the presence of TMZ and O6-BG.

The relevance of these results to TMZ resistance in vivo was demonstrated using nude mouse xenograft models bearing tumors produced using BTRC-MGMT U251 cells and U251 cells without the rearrangement as control; these cells also contained a recombinant luciferase gene. Mice containing the rearrangement showed no significant prolongation of lifespan in the presence or absence of TMZ, indicating tumor cell resistance, whereas TMZ treatment of nave U251 cells showed improved survival.

While hypomethylation of the native MGMT promoter is the most frequently change associated with TMZ resistance, the results presented in this paper illustrate an alternative mechanism for glioblastomas and gliomas to acquire resistance to TMZ, the only current chemotherapeutic drugs for these maladies. Because these rearrangements were found in patients with recurrent tumors, these authors hypothesize that the rearrangements were selected or by TMZ treatment. A similar rearrangement has also been found in another cancer, medulloblastoma, after TMZ relapse. These authors also suggest that detection of these rearrangements can be used clinically to determine appropriate treatment modalities, particularly for recurrent disease.

* Seve Ballesteros Foundation Brain Tumor Group, Molecular Oncology Programme, Spanish National Cancer Research Center; Division of Life Science, Department of Chemical and Biological Engineering, Center of Systems Biology and Human Health and State Key Laboratory of Molecular Neuroscience, The Hong Kong University of Science and Technology; Beijing Neurosurgical Institute, Capital Medical University; Department of Neurosurgery, Samsung Medical Center, Sungkyunkwan University School of Medicine; Department of Systems Biology, Columbia University; The Jackson Laboratory for Genomic Medicine; and Molecular Cytogenetics Group, Human Cancer Genetics Program, Spanish National Cancer Research Center, CNIO, 28029, Madrid, Spain

See the rest here:
Chromosomal Rearrangements Associated with Chemotherapeutic Drug Resistance | McDonnell Boehnen Hulbert & Berghoff LLP - JD Supra

Chinese Govt-Compensated Experts Plead Guilty to Thieving Investigation From an American Childrens Medi … – 90Xtra

Advertisement

A Chinese researcher pled guilty on July 30 for conspiring to steal proprietary trade insider secrets from a clinic research institute in the United States, and for the wire fraud that accompanied the theft. This was no everyday hospital study facility, possibly. The target was no a lot less than the Nationwide Childrens Hospitals Investigation Institute. The hospital attained a area on the Honor Roll in U.S. Information and Environment Reports most recent rankings of related hospitals in The us.

The FBI referred to as the theft another example of economic malfeasance associated to the Peoples Republic of China. It extra that far from currently being an isolated incident, we see the PRC implicated in around 60 per cent of all trade top secret theft conditions.

The case illustrates one of the worst sides of the Chinese Communist Partys campaign to vacant out the mental assets coffers of not only the United States, but any where in the earth wherever a challenging-gained nugget of scientific or engineering worth may lurk.

The FBI claimed that researcher Li Chen betrayed her employer of 10 yrs by thieving trade strategies from this American institution and transferring them to China immediately after receiving payments from the Chinese federal government.

Chen was a reliable researcher at Nationwide Childrens Clinic, conducting chopping-edge U.S. government-funded exploration, claimed the FBI. With her guilty plea, she admits that she abused this rely on to set up a organization in China for her very own economical attain.

Having fun with this article? Click on right here to subscribe for entire obtain. Just $5 a thirty day period.

The insider secrets at the very least five of them, in accordance to the FBI that Chen admitted she stole relate to exosomes. Exosomes are key mediators of mobile to mobile communication, delivering a distinct cargo of lipids, proteins and nucleic acids that reflects their cell of origin. The exosomes introduced by regenerative cells such as stem cells, for case in point, are powerful motorists of healing and repair, in accordance to Exopharm, an exosome medicine organization. Each Chen and her partner (who is an alleged co-conspirator) worked in Nationwide healthcare labs for 10 years each and every.

The plea settlement claims that Chen begun a enterprise in China to offer exosome isolation kits, and that she admitted to receiving added benefits from the Chinese federal government, which include the Condition Administration of Foreign Qualified Affairs and the Countrywide All-natural Science Basis of China, although also applying for resources from multiple Chinese govt expertise ideas, which China takes advantage of to soak up overseas technological know-how and research for its personal reward.

Broadening the effect of the theft, a NASDAQ-stated American enterprise, Avalon GloboCare, bought Chens Chinese corporation. In accordance to the FBI, Chen agreed to forfeit approximately $1.4 million, 500,000 shares of popular stock of Avalon GloboCare Corp. and 400 shares of widespread stock of GenExosome Systems Inc.

Advertisement

This circumstance, and hundreds of other folks like it, stage to immediate collaboration with CCP-operate expertise attraction and other programs aimed at hoovering up principally STEM-relevant IP from state-of-the-art foreign tutorial, organization, and govt study environments. This situation also points to a amount of formal Chinese cynicism so good that it overrides what is meant to be the key working basic principle of Chinese lifestyle: experience.

CCP talent systems and the chicanery they invite are now perfectly-recognised about the planet. For a state and tradition that purports to function on the price of face supposedly the forex of each individual marriage it should really defy logic that the CCP itself would bait Chinese dwelling abroad to dedicate wholesale thievery in their host nations, and openly enrich them for accomplishing so. The loss of encounter for the Chinese country and people would undoubtedly act as a barrier to such actions.

Seemingly not. In simple fact, nothing at all so evidently illustrates how far the CCP has strayed from common Chinese cultural values than its present development of recruiting well-educated Chinese citizens overseas, and encouraging them to betray their businesses and colleagues by committing felony theft of that extremely employers home, the development of which has usually been funded by overseas taxpayers. In the United States by itself, FBI Director Christopher Wray documented on July 7 that his company is opening a new China-connected counterintelligence scenario about every single 10 hours, and that of the 5,000 these kinds of situations at present on their publications, almost half are associated to China.

By any definition of the term, the CCP is engaged in a conspiracy to steal from The united states, and is doing it in wide daylight. The CCP reads the information, so they know that we know. And due to the fact the theft, in accordance to Wray, is ongoing and presents the FBI induce to open up at least a scenario a working day that is China-facilitated, the only attainable summary is to say that the Chinese Communist Occasion management feels no shame or humiliation in getting been caught purple-handed. In fact, they seem to have been emboldened by their success so far.

N

Get initially-go through access to key article content however to be produced, as nicely as one-way links to believed-provoking commentaries and in-depth articles from our Asia-Pacific correspondents.

Subscribe Newsletter

Not only do the U.S. prosecutions of CCP-facilitated situations of IP theft appear to be of small consequence to Chinese officialdom, the Chinese citizens who are applied as a dragnet to pull in reducing-edge technologies and breakthroughs also appear to be expendable to the CCP, as the chance of currently being caught and convicted is rising. In the United States, the FBI has been exponentially establishing its counterintelligence capabilities, with China as a certain concentrate on.

What smacks almost of desperation to receive technologies at any cost is certainly counterintuitive on the surface area of items. The reputational destruction to China as a nation and to challenging-doing work, trustworthy Chinese by themselves is incalculable.

So what points out Chinas shortsightedness, and its seemingly carefree attitude toward its status without a doubt, towards its face?

Enjoying this posting? Simply click below to subscribe for comprehensive entry. Just $5 a month.

One particular team of human legal rights activists and NGOs thinks it has the reply.

Late past thirty day period, a letter signed by hundreds of U.S. and global religious and human legal rights teams and activists was sent to U.S. Legal professional General William Barr.

The letter urges Barr to declare the Chinese Communist Party a transnational criminal group, or TCO.

Advertisement

Among the other crimes, the letter states that for a long time, the CCP perpetrated and proliferated IP embezzlement and economic espionage on People and U.S. firms, resulting in theft and reduction of huge wealth and prosperity. The extent and breadth of the prison achieve of the CCP is familiar with no bounds.

TCO designation in the United States has been employed teams these as MS-13. If so designated, the CCP and its associates would be slapped with numerous layers of penalties and sanctions anywhere in the entire world that U.S. laws have tooth.

Regardless of whether or not the United States would go so significantly as to officially designate the ruling celebration of China as a criminal firm stays to be witnessed. Even so, just the principle is highly effective. It would certainly go a extended way to detailing why the Chinese Communist Bash is acting as a purchaser of stolen products.

Read the original post:
Chinese Govt-Compensated Experts Plead Guilty to Thieving Investigation From an American Childrens Medi ... - 90Xtra

US government considers ethics of aborted tissue research – Angelus News

A new federal ethics advisory board for fetal tissue research has convened to consider future federally-funded research proposals that involve tissue from aborted babies.

The Human Fetal Tissue Research Ethics Advisory Board of the National Institutes of Health (NIH) met for the first time on July 31, to advise the Health Secretary on the ethics of research proposals involving fetal tissue of aborted babies.

The board was first announced in June of 2019, when the Trump administration decided to halt new research with aborted fetal tissue at NIH facilities, and limited funding of such research conducted outside the NIH.

For the research conducted outside the NIH, or extramural research, the administration announced that an ethics advisory board would be appointed to consider such funding and advise the secretary of Health and Human Services (HHS) on the proposals.

Some researchers have called for the administration to end its moratorium, saying that research with aborted fetal tissue could be vital to developing treatments and a cure for the new coronavirus (SARS-CoV-2).

In February, the HHS announced that it would begin accepting nominations to the board, and during that time period, some researchers at an NIH research laboratory told theWashington Postthat the administrations moratorium on fetal tissue research was hindering possible advances in research on treatments for the coronavirus.

Dr. David Prentice, now a member of the NIH Human Fetal Tissue Research Ethics Advisory Board, told CNA in March that the timing of the comments was peculiar as it could have been related to the consideration of appointments to the board.

Several leading coronavirus vaccine candidates are using cell lines from aborted babies, including some funded by the U.S.; other candidates have been determined to be ethically uncontroversial by the pro-life Charlotte Lozier Institute.

One candidate in particularbeing developed by Moderna and the National Institute of Allergy and Infectious Diseasesis not using fetal cell lines directly in production, but is based on research that involved aborted fetal cell lines. As Moderna was not involved in that research, CLI said that the vaccine candidate is ethically uncontroversial.

The NIH ethics board members are appointed for a duration that lasts as long as the board is convened; the boards charter says that [t]he estimated annual person-years of staff support required is 0.7. Appointments to the board are made by the HHS secretary.

Heading the advisory board is Paige Cunningham, interim president of Taylor University, an evangelical Christian university in Indiana.

Several Catholic bioethicists are on the board, including Fr. Tadeusz Pacholczyk, director of education at the National Catholic Bioethics Center. The co-chair of the Catholic Medical Association (CMA) ethics committee, Greg Burke, is a member, along with CMA member Dr. Ashley Fernandes of the Ohio State University medical school.

The pro-life Charlotte Lozier Institute (CLI) is also represented on the board, with CLI vice president Dr. David Prentice and associate scholars Ingrid Skop and Maureen Condic as members.

Some board members, such as Dr. Lawrence Goldstein of the University of California San Diego, support fetal tissue research; hecalledcell lines from fetal tissue critical in vaccine development, along with stem cell research and the use of humanized mice to develop immune cell-forming tissues.

Two members testified in 2016 before the House select investigative panel of the Energy and Commerce Committee, in a hearing on bioethics and fetal tissue.

Cunningham said at the hearing that [t]he fetus is a human subject entitled to the protections that both traditional and modern codes of medical ethics provide to human subjects.

Kevin Donovan, MD, director of the Pellegrino Center for Clinical Bioethics at Georgetown University Medical Center, also testified, noting the current moral ambiguity in the nations discourse on abortion.

We have decided that we can legally abort the same fetus that might otherwise be a candidate for fetal surgery, even using the same indications as justification for acts that are diametrically opposed, he said. We call it the fetus if it is to be aborted and its tissues and organs transferred to a scientific lab. We call it a baby, even at the same stage of gestation, when someone plans to keep it and bring it into their home.

If we cannot act with moral certainty regarding the appropriate respect and dignity of the fetus, we cannot morally justify its destruction, he said.

During the public portion of the July 31 meeting, board members were introduced and then heard from several researchers who were either in support of or in opposition to research using fetal tissue from elective abortions.

The 2008 Vatican documentDignitatis Personaeaddressed the topic of aborted fetal tissue research, saying that there is a duty to refuse to use such biological material even when there is no close connection between the researcher and the actions of those who performed the artificial fertilization or the abortion, or when there was no prior agreement with the centers in which the artificial fertilization took place.

This duty springs from the necessity to remove oneself, within the area of ones own research, from a gravely unjust legal situation and to affirm with clarity the value of human life, the Congregation for the Doctrine of the Faith document stated.

Read more:
US government considers ethics of aborted tissue research - Angelus News

Mesa Discusses Treating Myelofibrosis and Other MPNs – Targeted Oncology

Ruben Mesa, MD, director, Mays Cancer Center at The University of Texas Health San Antonio, MD Anderson Cancer Center San Antonio, TX, reviewed a case of a 68-year-old woman with a myeloproliferative neoplasm, during a virtual Case Based Peer Perspectives event.

Targeted Oncology: What type of testing would you perform on this patient? Are there certain mutations in particular that you are looking for?

MESA: The NGS [next-generation sequencing] panels are helpful. In myelofibrosis, theyre the most necessary in the potential transplant candidate [who is] of intermediate risk [and for whom] youre uncertain of the [prognosis]. In patients who are high risk, its also useful information. If someone hasoverwhelmingly high-risk disease, theyre not going to be at higher risk [based on these results], but I think its helpful information that we continue to learn about in terms of clonal evolution. Or, if they go to transplant, we know what the clones look like at the onset prior to undertaking [the trans- plant]. Our medical therapies have not resolved these muta- tions, but of course that could change. Its helpful information for us to know.

There are bad actors like ASXL1, EZH1/2, [and] the IDH1 muta- tions. The absence of a bunch of these somatic mutations is somewhat reassuring. Its helpful in combination with the clini- cal data. How are they feeling as far as their spleen, cytopenias, etcetera? There are [many] of these models that have been created, and some of which now have genetic data only. Thats probably incomplete. I can put the stained clone in 2 different patients, but if one is 45 years old and healthy and the other is 70 years old with comorbidities, theres no way those patients are doing the same. I think the clone is important, but the clone always has to live in a person.

Which risk-assessment tool do you use most often?

MIPSS [Mutation-Enhanced International Prognostic Score System] is the most popular, and it has a couple of advantages. One is that it has its own website; you can Google it and book- mark it on your computer. I always tell my trainees, dont bother to memorize any prognostic score in terms of how to calculate it because we have [a] calculator. But have a sense of what...the biological [characteristics are] that make a difference in terms of the prognosis for patients that give you some insight into the behavior of the disease. Have a sense of where and when that [is] useful.

There have been multiple models that have been validated. They help to stratify patients in terms of their outcomes in a range of ways. They are largely surrogates [of transformation to acute myeloid leukemia] as well, although its a different issue. The outcome for the patient with myelofibrosis if they pass away from the diseasewhich is still the majority of patientsis [that] they either die of progressive features of myelofibrosis, which can include progressive debilitation, cytopenias, and a range of complications related to that, or they progress to acute leuke- mia and can pass away from those sets of difficulty.

Why are prognostic models referenced in the National Comprehensive Cancer Network (NCCN) guidelines?

I was involved with the original NCCN guidelines for MPNs [myeloproliferative neoplasms].1 Originally, we had the prog- nostic score, or at that point the DIPSS [Dynamic International Prognostic Scoring System] or the DIPSS-Plus...to help stratify whos lower risk or whos higher risk in terms of therapy to get rid of some of the granularity.

Would you consider transplant in this case?

I have had patients who have done well with transplant. Transplant can be curative, but we can also wait too long, partic- ularly in the setting of myelofibrosis. I think when its being used as salvage therapy in myelofibrosis, the outcomes are less [successful] than we would like. In my estimation, the best time to have a transplant is probably before either the patient or physician really feels the patient needs one. Its during their optimal JAK inhibitor response that they probably do the best. Now, on the flip side, thats the time that they have the most to lose in that their quality of life is good and theyre stable. Its a difficult decision.

Which systemic therapies might you consider in this patient?

In terms of medical therapy, we now have 2 approved ther- apies in the front line, both ruxolitinib [Jakafi] and fedratinib [Inrebic], and many others in development that were discussed at the ASCO [American Society of Clinical Oncology] Annual Meeting and at the 25th Annual Congress of EHA [European Hematology Association].

Ruxolitinib has now been approved for a long time with data from the randomized studiesnow almost historical in nature with the COMFORT studies, both COMFORT-I [NCT00952289] and COMFORT-II [NCT00934544]. It showed for the first time in randomized settings a drug that was effective in myelofibrosis. Ruxolitinib was clearly better than placebo [and best alternative therapy] in the COMFORT-I study that Srdan Verstovsek, MD, PhD, and I led, and which was a European study.2

That was relevant because at the time the standard of care was Hydrea [hydroxyurea]. We recognized in retrospect that hydroxyurea is not as great a therapy for myelofibrosis. Its good therapy for ET [essential thrombocytopenia]. It helps to control platelets reasonably well in many, but its not a perfect drug. In polycythemia vera, its a reasonable frontline therapy, although interferon may have advantages. In myelofibrosis, it might help with leukocytosis but doesnt do much for splenomegaly symp- toms, anemia, fibrosis, or progression toward acute leukemia.

Would you send her for transplant, start ruxolitinib or fedratinib, observation, or something else?

Ill remind [you that] this patient is 68 years old, has a big spleen, has a JAK2 mutation, and leukoerythroblastosis...most physicians would start her on ruxolitinib. That would surely be consistent with our NCCN guidelines.1 Some would refer [her] for stem cell transplant. That would not be incorrect. She has some higher- risk features. She has anemia, 2% [peripheral blood] blasts, and mild thrombocytopenia. In all honesty, some of these things we do in parallel.

I dont typically [rely on transplant], but I do send patients who are potentially eligible to visit with a transplant physician so that that process can start. The patient can learn more about the process. We could see what a potential donor solution would be. We could see what sort of initial response to therapy that they have. Patients who go to transplant would likely start JAK inhibi- tion before they would go [for their transplant]. Even if they found a good sibling match, and the patient wants to go through with that, its probably going to take 3 to 4 months and they can be on JAK inhibition before that. They might have a better outcome with the spleen being smaller and going to transplant better. [Its] a bit of an artificial question in that you might choose to do more than one of these things in parallel.

What are the advantages of JAK inhibition with ruxolitinib?

There are patients from the phase 1 study of ruxolitinib at our centers that are still on the therapy. These are individuals that had expected survival [times] of under 3 years. I think that patients that are having a great response to JAK inhibition have their natural history improved. Splenomegaly symptoms were both clinically meaningful [and measurable according to early ruxolitinib activity].

Every time weve looked at it, there is an indication that ruxoli- tinib improves survival for patients. Now, the studies were not survival studies in their design, and that was for a variety of reasons. It would have been largely unethical and unrealistic to expect patients to stay on placebo forever so that they could do worse on a control arm [to prove] survival advantage. Having been involved with caring for patients with myelofibrosis before JAK inhibitors and after, theres no question that these drugs improve survival. Id say that the rate by which patients passed away...has decreased significantly over the past decade as opposed to my first 15 years of treating myelofibrosis. [Ruxolitinib] does not cure the disease, and its not [successful] in every patient. I dont think we yet truly know why we see that difference.

Why is the spleen response with ruxolitinib so important?

I do not believe...that shrinking the spleen because of its mechan- ical effect leads to an improvement in survival. However, the spleen is a good barometer of the quality of JAK inhibitor response, and responding to JAK inhibitors improves survival. I think tracking this thing is important, not just because it shrinks but because it means that whatever benefit were getting from JAK inhibition is present.

What is the optimal dose of ruxolitinib in this patient population?

Weve learned several things over time, including the issue of dosing, as it relates to efficacy and survival. Patients probably need to be on 10 mg twice a day or more to be getting the optimal benefit. Ideally, [we should be] getting them to 15 mg twice a day, or, if reasonable, 20 mg twice a day. There is contro- versy. My colleague...strongly believes we should start everyone at the higher dose. I think its OK to start lower, but you must accelerate the dose. There are likely too many patients out there on a suboptimal dose of ruxolitinib. Starting with those doses is fine, but rapidly increasing the dose where you truly see a signif- icant reduction in the size of the spleen and improvement in the symptoms [is necessary]. If youre not achieving that, then that is when its important to think about second-line therapy, dose adjustments, or a clinical trial.

What adverse effects (AEs) of ruxolitinib are there that treating physicians should be concerned with?

In terms of toxicities, there are issues of cytopenias. In the phase 1 studies, it was thrombocytopenia that was the dose-limiting toxicity. Anemia is the most functional difficulty in that the throm- bocytopenia is present, but it usually is not the driver in terms of limiting your dose.

When would you choose to use fedratinib?

Since last September, we have the approval of fedratinib as well for these patients.3 It was supported by the phase 3 JAKARTA study [NCT01437787], a randomization between fedratinib at 2 different dose levels versus placebo in patients that had intermediate- or high-risk myelofibrosis. The timing of the trial overlapped with the period before ruxolitinib was approved.

There was a nice response in terms of splenomegaly compared with placebo. There was a 500-mg arm that performed reasonably well in terms of efficacy but had more toxicity, so the approved dose is 400 mg.

In terms of toxicity, there are gastrointestinal toxicities. Typically, patients are [given] prophylaxis with antidiarrheals and antinausea drugs. Id have to say most patients dont tend to have a lot of difficulties with that. They can have cytopenias; there [are] no direct head-to-head data between fedratinib and ruxolitinib in terms of rates of cytopenias, but its not clear that there is necessarily a clear advantage between one or the other.

What does the black box warning say for encephalopathy in patients who receive fedratinib?

It was recognized that there were several cases of individuals who had had some degree of CNS [central nervous system] toxicity in 8 cases out of about the 900 patients that were treated. It was suspected that it was Wernicke encephalopathy. The drug was put on a clinical hold. Those cases were subsequently looked at in great detail by neurologists and others, and what was seen was that there was a rare CNS-confusion episode that did occur. It was only clear that 1 of the patients met the criteria of having Wernicke encephalopathy, but they likely had [that] when they were enrolled in the study. In addition, the Wernickes may have been worsened because this patient, at the 500-mg dose, did have a lot of nausea and vomiting.4

With an abundance of caution the drug was approved, but with a black box warning [cautioning physicians to] measure thiamine, replace thiamine if need be, and monitor for Wernicke [enceph- alopathy]. Having prescribed it after its approval, [I have found that] its not a major limiting factor, but just something to be mindful of and exercise every caution.

References

1. NCCN. Clinical Practice Guidelines in Oncology. Myeloproliferative neoplasms, version 1.2020. Accessed June 29, 2020. https://www.nccn.org/professionals/ physician_gls/pdf/mpn.pdf

2. Mesa RA, Kiladjian JJ, Verstovsek S, et al. Comparison of placebo and best available therapy for the treatment of myelofibrosis in the phase 3 COMFORT studies. Haematologica. 2014;99(2):292-298. doi:10.3324/haematol.2013.087650

3. FDA approves fedratinib for myelofibrosis. FDA. August 16, 2019. Accessed June 29, 2020. https://www.fda.gov/drugs/resources-information-approved-drugs/ fda-approves-fedratinib-myelofibrosis

4. Mullally A, Hood J, Harrison C, Mesa R. Fedratinib in myelofibrosis. Blood Adv. 2020;4(8):1792-1800. doi:10.1182/bloodadvances.2019000954

See original here:
Mesa Discusses Treating Myelofibrosis and Other MPNs - Targeted Oncology

Startup Accelerator: Volumetric Aims to Be the Tissue Bioprinting Farm of the Future – 3DPrint.com

Startup Accelerator is an article series with a focus on new and exciting companies in the 3D printing space, in which 3DPrint.com speaks to startup leadership about their unique technologies and businesses.

At one of the largest medical cities in the world, a startup is pushing the limits of bioprinting technology by harnessing the power and precision of light to structure living tissue. Born as a spin-off out of Rice University, Volumetric has come a long way since being founded in 2018, advancing the creation of biomaterials and a biofabrication platform for cancer research, regenerative medicine, and human organ replacement initiatives worldwide.

Efforts to reproduce the vascular architecture in the body have led Jordan Miller, an assistant professor of bioengineering at Rice University, and one of his bioengineering graduate students, Bagrat Grigoryan, to create Volumetric. The duo has been focusing on innovation that allows scientists to create exquisitely entangled vascular networks that mimic the bodys natural passageways for blood, air, lymph, and other vital fluids. Originally dubbed SLATE, which is short for stereolithography apparatus for tissue engineering, the new open-source bioprinting technology uses additive manufacturing to make soft hydrogels and is the basis for the firms commercially available technology.

While most of the attention in tissue engineering typically goes to the progress being done on cells, Volumetric is playing a key role focusing on the extracellular space, that is, what happens outside cells. If we think about solid organs in the body, like the liver, they are very complex biologically, with an intricate blood vessel structure. What is most apparent in that complexity, is the complexity of the architecture, Miller said to 3DPrint.com. There is a fantastic progress on the cell side as researchers are finding newer and better ways to grow cells, differentiate cells, taking stem cells, and making them into organ-specific functions, however, everything outside of the cell is part of our expert research.

With so much research to back up their development, Miller and Grigoryan were confident that commercializing the technology they developed at the lab was the next step. After licensing, it became the basis for the LumenX bioprinters that are manufactured through a partnership between Volumetric and Cellink one of the worlds leading biotechnology companies.

Designed as an entry-level platform to build vasculature, the LumenX achieves complex branching and tapering of vessels. Moreover, the founders claim that the device photographically cures entire layers at once to crosslink structures 50 times faster than other printing methods. This process is performed with incredible resolution, leveraging more than one million simultaneous points of light to bioprint microscopic features down to 200 microns.

As we were creating this technology at the research lab, we immediately began thinking about its potential in society, suggested Miller. We understood that we wanted to take our basic research out of the lab and into the clinical practice where it would have an impact. So, to translate our technology, we knew that it would have to be commercialized, to stand up as part of a business model that could survive. That is when our research became bigger than just an academic paper. Whereas an academic paper can have an impact on peoples mindsets, a commercialized product can have a big impact directly on peoples lives.

The LumenX by Volumetric and Cellink (Image courtesy of Cellink/Volumetric)

So, the company was born out of huge progress that the team made at the lab, plus, dozens of requests from fellow researchers who wanted to use Volumetrics technology to develop their own projects. Miller and Grigoryan licensed their own intellectual property out of the university and into the company Volumetric, and they have been using it to sell bioinks and bioprinters ever since.

This is a very exciting opportunity, because when there is a scientific finding in a research lab, it is not always obvious how it can translate into a direct impact for society, but commercialization is a way to address this issue.

Creating high-quality biomaterials and 3D biofabrication platforms are part of Volumetrics mission. Aside from LumenX, Volumetric founders also developed the only cell-compatible biomaterials on the market for light-based printing, ideal for creating vascular networks within cell-laden hydrogels or lab-on-a-chip devices. The company is pushing the limits in the field of bioprinting by incorporating the unique ability of its technology to print complex, 3D vascularized living tissue, one of the most advanced and hard to mimic tissues in the field.

Quote request

Are you looking to buy a 3D printer or 3D scanner? We're here to help. Get free expert advice and quotes from trusted suppliers in your area.

Powered by Aniwaa

Multilayer 3D microfluidic plastic chips can be rapidly printed in minutes with the LumenX (Image courtesy of Volumetric/Cellink)

After witnessing successful university spin-off companies emerge around the world, one thing is clear, a major challenge for many startups is related to funding. However, Miller and Grigoryan were able to tap into the National Science Foundation (NSF) and its Innovation Corps program to get most of the funding for their collaboration, and in just two years, the startup has become a strong seller of specialized printers and hydrogel bioinks for printing tissue constructs.

Another great advantage of the company is its location, right at the heart of the Texas Medical Center (TMC), in Houston, working out of Johnson & Johnson Innovation (also known as JLABS), a global network ecosystem that empowers inventors across a broad healthcare spectrum to accelerate the delivery of life-saving, life-enhancing health and wellness solutions to patients around the world. It is by far one of the largest medical centers worldwide and a place where clinicians and surgeons are eager to see bioprinting technology, like Volumetrics, translated from bench to bedside.

Clinicians see first hand the need and urgency for replacement tissues to work. Which led us to craft a clinical strategy for a potential organ we could produce, how we would go about producing it, how we would design the clinical trials, and what early studies need to be complete in order to get there, Miller described. Our work goes beyond just theories, its about actually having surgeons work with our tissue scaffolds, to determine whether the material can be implantable. We need to know if they can put a suture through it and pull without the suture coming right out. We know that our work involves thinking about optimizing the material for the cells, but also for the surgeon.

Although Volumetric still has a lot of work ahead, more than 20 years of experience in bioengineering are helping Miller find a balance for both cells and surgeons to strive.

Jordan Miller and Bagrat Grigoryan in 2018 after founding Volumetric (Image courtesy of Volumetric)

Miller has a very particular vision for Volumetrics future, in part because he considers that the technology is highly scalable. He believes that what lies ahead for bioprinting companies like Volumetric is similar to what happened with the Prague-based open-source 3D printing company Prusa, except that in this case, its for biofabrication.

They [Prusa] are using 3D printers to make the parts that they need, relying on a print farm that is running non-stop, and churning out lots of high-value pieces. That is the perfect analogy of what we see for the future of regenerative medicine, where companies, like Volumetric, will develop large bioprinting farms, scaling out living tissue which could eventually become organ and tissue replacements for people.

The researchers at Volumetric have been working flat-out to provide a blood vessel structure for engineered tissue constructs. This is one of the most difficult feats in the filed, as researchers working towards the biofabrication of artificial vasculature have encountered several challenges to create the functional vessel-like structures that can supply oxygen and nutrients to cells of 3D bioengineered tissues. However, Millers advances at his laboratory at Rice and Volumetric led him to create the first bioprinting technology that addresses the challenges of multivascularization:

Right now, the field of regenerative medicine has the most potential its ever had, we know much more about how cells interact with materials than before, and our technology platform is allowing people to go deeper into biology and develop new materials to move the field forward.

More here:
Startup Accelerator: Volumetric Aims to Be the Tissue Bioprinting Farm of the Future - 3DPrint.com

Cord blood offers hope for rare diseases and ethnic minorities – The Province

A different combination of chemotherapy drugs together with umbilical cord blood may result in a safer, more universal treatment for a variety of genetic disorders. emarys / iStock / Getty Images Plus

Researchers at the University of Pittsburgh Medical Centre may have developed an innovative method of transplanting stem cells, resulting in a safer, universal treatment for a variety of genetic disorders. Through combining this approach with umbilical cord blood, treatment is also more accessible to ethnic minorities, a demographic that historically has had difficulties accessing bone marrow transplants.

The study, published in Blood Advances and the largest of its kind to date, used umbilical cord blood to treat 44 children with varying non-cancerous diseases. Umbilical cord blood is a potent source of hematopoietic stem cells cells that are able to form red and white blood cells in the patients. Due to their ability to develop into different types of cells, this treatment can be used to address many different types of disorders.

We wanted to offer a uniform concept to a wide array of diseases, said Dr. Paul Szabolcs, the Chief of Bone Marrow Transplantation and Cellular Therapies at UPMC Childrens Hospital and principal author of the study. We successfully reduced the intensity of chemotherapy and nevertheless, we were still able to engraft all our patients.

Typically, before receiving a stem cell graft (either umbilical cord blood or bone marrow) patients undergo an intense round of chemotherapy to kill off the patients own immune system and allow the new cells to grow. This method is effective but damaging to the body. For patients who do not have cancer and are pursing this treatment to improve the quality of their life (versus saving their life), the risks may simply be too high.

The approach developed by the team at the Pittsburgh Medical Centre uses a different combination of chemotherapy drugs, which are not as potent to the body. The goal of this approach is not to kill every cell in the patients bone marrow, but to make enough room for the new cells to flourish.

We successfully reduced the intensity of chemotherapy and we were still able to engraft all our patients, says Szabolcs. Using maximum intensity, you might be inadvertently killing patients and causing irreversible organ disease. [We used] use reduced intensity and have excellent survival.

This more moderate procedure is promising for conditions where the standard intensity regime poses a barrier to bone marrow or cord blood transfusions. More than half of the patients in the study had a form of leukodystrophy a genetic disorder that leads to the destruction of the protective coating of the nerves in the brain and spinal cord, according to the National Organization for Rare Disorders.

Three year survival rate after the standard chemotherapy preparation for umbilical cord blood transfusions for individuals with leukodystrophies ranges from 49 per cent to 77 per cent depending on their health at the time of the transfusion. The reduced-intensity approach reported a three year survival rate of 94 per cent.

The stem cells in umbilical cord blood provide a promising treatment as recipients do not have to have a perfect HLA (immune profile) match with the donor.

About 70 per cent of patients who need stem cells or bone marrow transplants have to rely on an unrelated donor to find a match, according to the University of British Columbia Medical Journal. This can create accessibility concerns for ethnic minorities. A 2012 study calculated that match rates for unrelated donors ranges from two per cent for POC to 46 per cent for Caucasians.

Since 2012, Canadian Blood Services has extended campaigns to communities with low match rates to increase the presence of donors. The concern still remains, however. Cord blood offers a hopeful alternative.

Its really applicable for ethnic minorities where the perfect HLA match might be elusive in the living donor population, says Szabolcs. And cord blood is readily available.

emjones@postmedia.com |@jonesyjourn

Dont miss the latest on COVID-19, reopening and life. Subscribe to Healthings daily newsletterComing Out of COVID.

Read more here:
Cord blood offers hope for rare diseases and ethnic minorities - The Province

FDA touts advanced manufacturing to address Covid-19 shortfalls – Endpoints News

Advanced manufacturing techniques can be employed to help address some of the manufacturing and supply chain problems the US has seen during the Covid-19 pandemic, Stephen Hahn, FDA commissioner, and Anand Shah, FDA deputy commissioner for medical and scientific affairs, wrote in a blog post on the FDA website.

The potential public health value of advanced manufacturing is even greater in the context of the ongoing COVID-19 pandemic, which has highlighted the strain on supply chains and the need for adaptive manufacturing systems to accelerate the production of medical countermeasures, Hahn and Shahwrote. The FDA has established a strong regulatory foundation to support the uptake of advanced manufacturing, and COVID-19 provides the unique impetus to spur further advancement of medical manufacturing.

They highlighted key regulations the agency has promulgated in recent years to support advanced manufacturing, specifically:

Additional efforts have been undertaken during the current public health emergency, Hahn and Shah pointed out. A multiyear effort between CDER and the US Biomedical Advanced Research and Development Authority (BARDA) is looking at how continuous manufacturing processes can support the production of medical countermeasures. Further, the FDA Office of the Chief Scientist (OCS) and the Center for Devices and Radiological Health (CDRH) are working with the National Institutes of Health and the Departments of Veterans Affairs to share information on 3D printing standards to increase the stock of essential medical supplies including personal protective equipment and certain medical device parts.

FDA also is working within the International Council for Harmonization to make sure that continuous manufacturing guidances are aligned internationally to support innovators, Hahn and Shah wrote.

Because pandemics by nature are unpredictable, our approach to manufacturing must be adaptable. Advanced manufacturing provides an approach for protecting our supply chain and improving our response capacity during crisis situations, they concluded. By establishing the regulatory foundation, the FDA has created a pathway for industry to continue adopting the needed improvements in manufacturing technology for the benefit of public health.

For a look at all Endpoints News coronavirus stories, check out our special news channel.

RAPS: First published in Regulatory Focus by the Regulatory Affairs Professionals Society, the largest global organization of and for those involved with the regulation of healthcare products. Click here for more information.

Here is the original post:
FDA touts advanced manufacturing to address Covid-19 shortfalls - Endpoints News

Cancer Research Institute Awards $30.2 Million in Grants and Fellowships to Support Basic and Clinical Research in Immunology and Cancer Immunotherapy…

Newswise NEW YORK, August 5, 2020The Cancer Research Institute (CRI), a U.S. nonprofit organization dedicated to the discovery and development of powerful immunotherapies for all cancers, awarded more than $30.2 million in research grants and fellowships in the 2020 fiscal year ending June 30, 2020. In total, CRI gave 94 awards that will advance cancer immunology research at 56 institutions in 8 countries. This also includes an unprecedented six-month extension of funding support for 23 postdoctoral fellows in response to the global COVID-19 pandemic.

While the novel coronavirus has upended all aspects of life across the globe, CRI and our scientists remain committed to fulfilling the promise of cancer immunotherapy, said Jill ODonnell-Tormey, Ph.D., CEO and director of scientific affairs at the Cancer Research Institute. Were proud to support these brilliant scientists and clinicians, especially our young researchers and future leaders, at a critical time in order to bring the benefits of immunotherapy to more cancer patients.

The awards, which are funded entirely by individual, foundation, and corporate donors, include:

The 2020 Cancer Research Institute Lloyd J. Old STARs, or Scientists Taking Risks include:

To help advance immunotherapy for two types of ultra-rare cancer, chordoma and fibrolamellar cancer, which affect the bones of the spine and the liver, respectively, the Cancer Research Institute has partnered with two nonprofits focused on these diseases to fund promising research aimed at improving outcomes for patients with these cancers. These include:

Among this years Technology Impact Award recipients is Neville Sanjana, Ph.D., of the New York Genome Center, who is using massively-parallel genome engineering to comprehensively map all genes that can boost immune responses against pancreatic cancer, which will hopefully enable the development of next-generation T cell therapies for difficult-to-treat cancers.

Finally, included in the Impact Grants is funding for a glioma study carried out by Robert Michael Angelo, M.D., Ph.D., and Sean Bendall, Ph.D., of Stanford University in collaboration with investigators at City of Hope, Stanford, the University of California, Los Angeles, and the University of California, San Francisco, who will use Multiplexed Ion Beam Imaging (MIBI) to image intact, well-annotated glial tumor tissue from pediatric and adult patients in response to vaccine, checkpoint inhibitor, and cellular therapies. This dataset will inform therapeutic strategies based on the presence of tumor targets, expression of immune inhibitory proteins, and the types and functional statuses of T cells and myeloid cells within the context of an intact tumor microenvironment.

To view our full roster of 2020 grant and fellowship award recipients, visit cancerresearch.org/funding. More information about CRIs grants, fellowships, and other programs is available at cancerresearch.org/grants.

About the Cancer Research InstituteThe Cancer Research Institute (CRI), established in 1953, is a highly-rated U.S. nonprofit organization dedicated exclusively to saving more lives by fueling the discovery and development of powerful immunotherapies for all cancers. Guided by a world-renowned Scientific Advisory Council that includes four Nobel laureates and 26 members of the National Academy of Sciences, CRI has invested $445 million in support of research conducted by immunologists and tumor immunologists at the worlds leading medical centers and universities, and has contributed to many of the key scientific advances that demonstrate the potential for immunotherapy to change the face of cancer treatment. To learn more, go to cancerresearch.org.

Here is the original post:
Cancer Research Institute Awards $30.2 Million in Grants and Fellowships to Support Basic and Clinical Research in Immunology and Cancer Immunotherapy...