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Lilly’s tirzepatide delivered up to 22.5% weight loss in adults with obesity or overweight in SURMOUNT-1 | Eli Lilly and Company – Eli Lilly

Posted: May 2, 2022 at 2:27 am

Participants taking tirzepatide lost up to 52 lb. (24 kg) in this 72-week phase 3 study

63% of participants taking tirzepatide 15 mg achieved at least 20% body weight reductions as a key secondary endpoint

INDIANAPOLIS, April 28, 2022 /PRNewswire/ -- Tirzepatide (5 mg, 10 mg, 15 mg) achieved superior weight loss compared to placebo at 72 weeks of treatment in topline results from Eli Lilly and Company's (NYSE: LLY) SURMOUNT-1 clinical trial, with participants losing up to 22.5% (52 lb. or 24 kg) of their body weight for the efficacy estimandi. This study enrolled 2,539 participants and was the first phase 3 global registration trial evaluating the efficacy and safety of tirzepatide in adults with obesity, or overweight with at least one comorbidity, who do not have diabetes. Tirzepatide met both co-primary endpoints of superior mean percent change in body weight from baseline and greater percentage of participants achieving body weight reductions of at least 5% compared to placebo for both estimandsii. The study also achieved all key secondary endpoints at 72 weeks.

For the efficacy estimand, participants taking tirzepatide achieved average weight reductions of 16.0% (35 lb. or 16 kg on 5 mg), 21.4% (49 lb. or 22 kg on 10 mg) and 22.5% (52 lb. or 24 kg on 15 mg), compared to placebo (2.4%, 5 lb. or 2 kg). Additionally, 89% (5 mg) and 96% (10 mg and 15 mg) of people taking tirzepatide achieved at least 5% body weight reductions compared to 28% of those taking placebo.

In a key secondary endpoint, 55% (10 mg) and 63% (15 mg) of people taking tirzepatide achieved at least 20% body weight reductions compared to 1.3% of those taking placebo. In an additional secondary endpoint not controlled for type 1 error, 32% of participants taking tirzepatide 5 mg achieved at least 20% body weight reductions. The mean baseline body weight of participants was 231 lb. (105 kg).

"Obesity is a chronic disease that often does not receive the same standard of care as other conditions, despite its impact on physical, psychological and metabolic health, which can include increased risk of hypertension, heart disease, cancer and decreased survival," said Louis J. Aronne, MD, FACP, DABOM, director of the Comprehensive Weight Control Center and the Sanford I. Weill Professor of Metabolic Research at Weill Cornell Medicine, obesity expert at NewYork-Presbyterian/Weill Cornell Medical Center and Investigator of SURMOUNT-1. "Tirzepatide delivered impressive body weight reductions in SURMOUNT-1, which could represent an important step forward for helping the patient and physician partnershiptreat this complex disease."

For the treatment-regimen estimandiii, results showed:

The overall safety and tolerability profile of tirzepatide was similar to other incretin-based therapies approved for the treatment of obesity. The most commonly reported adverse events were gastrointestinal-related and generally mild to moderate in severity, usually occurring during the dose escalation period. For those treated with tirzepatide (5 mg, 10 mg and 15 mg, respectively), nausea (24.6%, 33.3%, 31.0%), diarrhea (18.7%, 21.2%, 23.0%), vomiting (8.3%, 10.7%, 12.2%) and constipation (16.8%, 17.1%, 11.7%) were more frequently experienced compared to placebo (9.5% [nausea], 7.3% [diarrhea], 1.7% [vomiting], 5.8% [constipation]).

Treatment discontinuation rates due to adverse events were 4.3% (5 mg), 7.1% (10 mg), 6.2% (15 mg) and 2.6% (placebo). The overall treatment discontinuation rates were 14.3% (5 mg), 16.4% (10 mg), 15.1% (15 mg) and 26.4% (placebo).

Participants who had pre-diabetes at study commencement will remain enrolled in SURMOUNT-1 for an additional 104 weeks of treatment following the initial 72-week completion date to evaluate the impact on body weight and the potential differences in progression to type 2 diabetes at three years of treatment with tirzepatide compared to placebo.

"Tirzepatide is the first investigational medicine to deliver more than 20 percent weight loss on average in a phase 3 study, reinforcing our confidence in its potential to help people living with obesity," said Jeff Emmick, MD, Ph.D., vice president, product development, Lilly. "Obesity is a chronic disease that requires effective treatment options, and Lilly is working relentlessly to support people with obesity and modernize how this disease is approached. We're proud to research and develop potentially innovative treatments like tirzepatide, which helped nearly two thirds of participants on the highest dose reduce their body weight by at least 20 percent in SURMOUNT-1."

Tirzepatide is a novel investigational once-weekly GIP (glucose-dependent insulinotropic polypeptide) receptor and GLP-1 (glucagon-like peptide-1) receptor agonist, representing a new class of medicines being studied for the treatment of obesity. Tirzepatide is a single peptide that activates the body's receptors for GIP and GLP-1, two natural incretin hormones.Obesity is a chronic, progressive disease caused by disruptions in the mechanisms that control body weight, often leading to an increase in food intake and/or a decrease in energy expenditure. These disruptions are multifactorial and can be related to genetic, developmental, behavioral, environmental and social factors. To learn more, visit Lilly.com/obesity.

Lilly will continue to evaluate the SURMOUNT-1 results, which will be presented at an upcoming medical meeting and submitted to a peer-reviewed journal. Additional studies are ongoing for tirzepatide as a potential treatment for obesity or overweight.

About tirzepatide

Tirzepatide is a once-weekly GIP (glucose-dependent insulinotropic polypeptide) receptor and GLP-1 (glucagon-like peptide-1) receptor agonist that integrates the actions of both incretins into a single novel molecule. GIP is a hormone that may complement the effects of GLP-1 receptor agonists. In preclinical models, GIP has been shown to decrease food intake and increase energy expenditure therefore resulting in weight reductions, and when combined with GLP-1 receptor agonism, may result in greater effects on markers of metabolic dysregulation such asbody weight, glucose and lipids. Tirzepatide is in phase 3 development for adults with obesity or overweight with weight-related comorbidity and is currently under regulatory review as a treatment for adults with type 2 diabetes. It is also being studied as a potential treatment for non-alcoholic steatohepatitis (NASH) and heart failure with preserved ejection fraction (HFpEF). Studies of tirzepatide in obstructive sleep apnea (OSA) and in morbidity/mortality in obesity are planned as well.

About SURMOUNT-1 and the SURMOUNT clinical trial program

SURMOUNT-1 (NCT04184622) is a multi-center, randomized, double-blind, parallel, placebo-controlled trial comparing the efficacy and safety of tirzepatide 5 mg, 10 mg and 15 mg to placebo as an adjunct to a reduced-calorie diet and increased physical activity in adults without type 2 diabetes who have obesity, or overweight with at least one of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea or cardiovascular disease. The trial randomized 2,539 participants across the U.S., Argentina, Brazil, China, India, Japan, Mexico, Russia and Taiwan in a 1:1:1:1 ratio to receive either tirzepatide 5 mg, 10 mg or 15 mg or placebo. The co-primary objectives of the study were to demonstrate that tirzepatide 10 mg and/or 15 mg is superior in percentage of body weight reductions from baseline and percentage of participants achieving 5% body weight reduction at 72 weeks compared to placebo. Participants who had pre-diabetes at study commencement will remain enrolled in SURMOUNT-1 for an additional 104 weeks of treatment following the initial 72-week completion date to evaluate the impact on body weight and potential differences in progression to type 2 diabetes at three years of treatment with tirzepatide compared to placebo.

All participants in the tirzepatide treatment arms started the study at a dose of tirzepatide 2.5 mg once-weekly and then increased the dose in a step-wise approach at four-week intervals to their final randomized maintenance dose of 5 mg (via a 2.5 mg step), 10 mg (via steps at 2.5 mg, 5 mg and 7.5 mg) or 15 mg (via steps at 2.5 mg, 5 mg, 7.5 mg, 10 mg and 12.5 mg).

The SURMOUNT phase 3 global clinical development program for tirzepatide began in late 2019 and has enrolled more than 5,000 people with obesity or overweight across six clinical trials, four of which are global studies. Results from SURMOUNT-2, -3, and -4 are anticipated in 2023.

About Lilly

Lilly unites caring with discovery to create medicines that make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help more than 47million people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges, redefining diabetes care, treating obesity and curtailing its most devastating long-term effects, advancing the fight against Alzheimer's disease, providing solutions to some of the most debilitating immune system disorders, and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visitLilly.comandLilly.com/newsroomor follow us onFacebook,Instagram,Twitterand LinkedIn. P-LLY

Lilly Cautionary Statement Regarding Forward-Looking Statements

This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about tirzepatide as a potential treatment for adults with obesity or overweight and the timeline for future readouts, presentations and other milestones relating to tirzepatide and its clinical trials, and reflects Lilly's current belief and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of research development and commercialization. Among other things, there can be no guarantee that the studies will be completed as planned, that future study results will be consistent with the results to date or that tirzepatide will receive regulatory approvals.For further discussion of these and other risks and uncertainties, see Lilly's most recent Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.

Dr. Aronne is co-founder, chief scientific advisor and member of the board of directors for Intellihealth. Dr. Aronne is also a paid scientific advisory board member for Eli Lilly and Company.

iEfficacy estimand represents efficacy prior to discontinuation of study drug.iiTreatment differences for two estimands efficacy and treatment-regimen were evaluated for three tirzepatide doses (5 mg, 10 mg and 15 mg) compared to placebo.iiiTreatment-regimen estimand represents the estimated average treatment effect regardless of treatment discontinuation.

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Lilly's tirzepatide delivered up to 22.5% weight loss in adults with obesity or overweight in SURMOUNT-1 | Eli Lilly and Company - Eli Lilly

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Cautions issued over prenatal genetic tests in IVF and for rare diseases – JD Supra

Posted: May 2, 2022 at 2:26 am

Expectant parents, doctors, and regulators need to reconsider the rising use of gee-whiz genetic testing as doubts emerge about popular blood screenings to detect rare prenatal disorders and a costly test relied on by couples undergoing in-vitro fertilization (IVF) treatment.

This is what the New York Times reported about what researchers have found about preimplantation genetic testing for aneuploidy, or PGT-A. It is an increasingly common screening in IVF and has led potential parents to discard embryos as unfeasible or unacceptable due to abnormalities to carry to term:

PGT-A has, over the last two decades, become a standard add-on to already pricey IVF procedures. But the test, which can cost anywhere from $4,000 to $10,000, has become controversial over the years as studies have cast doubt on whether it increases birthrates from IVF at all. A growing number of scientists have questioned the widespread use of the test, which leads to tens of thousands of discarded embryos per year and causes many women to believe they may not be able to carry biological children. A new study published last week details 50 patients who underwent transfers of abnormal embryos at the Center for Human Reproduction in New York City The study reported eight births after 57 transfer cycles of embryos with abnormal genetic testing results since 2015. Seven of the babies were born healthy. The average age of the women in the study was 41 years old.

The study is a follow-up to a 2015 study also led by the center that first showed that selected abnormal embryos could still be viable. Since then, other fertility clinics worldwide have also started to transfer such embryos. The research was funded by the clinic and by the Foundation for Reproductive Medicine, a nonprofit research organization also based in New York. The new study supports concerns that I and others have had for several years now about the accuracy of these tests, Josephine Johnston, a bioethicist and director of research at the Hastings Center who was not involved in the research, said by email. The study strengthens the argument that PGT-A tests have been prematurely incorporated into fertility medicine and strongly suggests that these tests will have led patients to discard potentially viable embryos.

The newspaper reported this key criticism of the test:

[The problem with PGT-A, the authors of the study argue, is that it provides an incomplete picture that is often interpreted as a very definitive result. The test relies on sampling a handful of cells from the outer shell of the developing embryo and testing to see if each one has 23 pairs of chromosomes [structures, as shown in Harvard single-cell, color photo]. The point of PGT was to select embryos that would give somebody a better chance of achieving pregnancy, said Dr. David Barad, an OB-GYN at the Center for Human Reproduction and a co-author of the study. But doing genetic testing doesnt make embryos better, it just kind of gives us some idea of who they are.

Researchers caution that embryos flagged by the PGT-A test and that prove viable to carry to term have risks of miscarriage or of infants having abnormalities at birth, the newspaper reported. These can be the result, though, of conditions and circumstances such as the mothers age that lead couples into the challenging, costly IVF process.

The PGT-A test, with its results presented without nuance and complete explanation, can derail complex choices about IVF embryos, especially if couples proceed with those now declined due to the PGA-T test, the New York Times reported, quoting experts, including Laura Hercher, director of student research at the Sarah Lawrence College genetic counseling program.

We dont really know what to tell them about the long-term potential consequences to a child thats born. Will there be an increased number of birth defects? Will we find that they have problems down the road? Theres a lot of I dont knows.

The New York Times article, by the way, reports on Anna and Brian Dahlquist, a couple undergoing IVF treatment who declined to implant an embryo due to the PGT-A test but later switched specialists and clinics and went ahead successfully, years later. As she told the newspaper about her healthy son:

I was 39 when I made his embryo. And I was 46 when I became pregnant with him. Thats a long time and a lot of valuable years in both my childs upbringing and my life.

U.S. warns about prenatal blood tests

The federal Food and Drug Administration, meantime, has offered a sharp caution for expectant couples who have experimented with prenatal blood tests to screen fetuses for rare genetic conditions, the New York Times reported, separately. The newspaper quoted a statement from Dr. Jeff Shuren, director of the FDAs Center for Devices and Radiological Health:

While genetic noninvasive prenatal screening tests are widely used today, these tests have not been reviewed by the FDA and may be making claims about their performance and use that are not based on sound science.

The New York Times independently investigated the blood tests with expert assistance recently, reporting:

[A] New York Times examination in January reported on the incidence of false positive results in some of these tests, known as noninvasive prenatal screening tests, or NIPTs. That article quoted women who received false positive screening results for extremely rare conditions; highlighted examples of misleading marketing by companies selling the tests; and described some reports of pregnancies that were terminated based on a screening without a confirmatory test. The agency warned doctors not to diagnose genetic disorders based on these results alone and stressed the need to follow positive screenings with more reliable diagnostic testing. It said it was aware of reports that some women have ended pregnancies based only on the results of these genetic screening tests.

The newspaper had further information about the burgeoning use of these blood tests:

The tests are taken by over a third of pregnant women in the United States. But they fall into a category called lab-developed tests, which are not regulated or approved by the FDA. In its safety notice, the agency said it was working with Congress on legislation to establish a modern regulatory framework for all tests, including the category that covers these screenings. The agencys warning comes after numerous accounts, dating back years, of misinterpretations of the screenings as being definitive. But the criticism has intensified in recent months, with 97 Republican legislators sending a letter to the FDA in January, prompted by the Times article. This is an area that has concerned the agency for a long time, said Alberto Gutierrez, the former director of the FDA office that oversees many medical test The lack of regulation of lab-developed tests has led to many cases where the laboratories have claimed more than they should based on the data that is available, he added. The warning does not come with any consequence for prenatal test manufacturers. But it urged them to submit their products for voluntary approval. A spokeswoman for the agency declined to say whether it was currently working with any manufacturers on this front.

In my practice, I see not onlythe harms that patients suffer while seeking medical services, but also the damage that can be inflicted on them and their loved ones bydefensive and excessive over testing, over diagnosis, misdiagnosis, and over-treatment. Patients struggle too much already to afford needed medical services much less those that are invasive, painful, wasteful, and unnecessary.

Up to a third of medical spending goes for over-treatment and over-testing, withan estimated $200 billion in the U.S. expended on medical services with little benefit to patients. Butgetting doctors and hospitals to stop this excessisnt easy, nor is it a snap to get patients to understand what this problems all about so theyll push their health care providers to do something about it.

With medical tests, like the dubious rare-disease prenatal blood screen promoted by Silicon Valley firms, serious questions must be asked about the dearth of federal oversight. It has been opposed by those who argue that patients benefit best by government staying out of the way of innovation

Caveat emptor, consumers. Patients must insist that their doctors explain fully any test or procedure. This is patientsfundamental right to informed consent. This means they are told clearly and fully all the important facts they need to make an intelligent decision about what treatments to have, where to get them, and from whom. Patients, in turn, must put in the effort to safeguard themselves by improving their knowledge and comprehension about their care a constant learning process that is crucial for those who wish to bring new lives into the world and to nurture them for decades after.

We have much work to do to rein in costly, wasteful, and harmful testing.

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New Immunotherapy Approach Targets a Commonly Mutated Driver Protein Unique to Cancer Cells – On Cancer – Memorial Sloan Kettering

Posted: May 2, 2022 at 2:26 am

Immunotherapy is an increasingly important form of cancer treatment. It encompasses a class of cancer therapies that harness the immune systems natural ability to recognize and eliminate tumor cells. Most immunotherapies work by boosting the power of a type of white blood cell called T cells, so they can better recognize and attack cancer.

Investigators at Memorial Sloan Kettering Cancer Center (MSK) are developing a variety of tactics for creating new immunotherapy treatments. One focus is on finding ways to engineer Tcells to recognize mutated proteins that are unique to cancer cells. A paper reporting a new advance in this area was published in Nature Medicine on April 28, 2022.

The genesis of this project was to try to come up with a new form of cellular immunotherapy that might give an inroad against cancers that are largely unresponsive to current forms of immunotherapy treatment, says physician-scientist Christopher Klebanoff, the papers senior author. Were using a genetic engineering approach to help supercharge T cells in a new way.

Cancer is caused by the accumulation of mutated genes, some of which result in the generation of novel proteins, called neoantigens, that can be perceived by the immune system as foreign. Tcells have a natural ability to recognize neoantigens, and they can be trained to do so even more effectively. The MSK researchers thought that by focusing on neoantigens resulting from recurrent driver mutations (those that actually cause cancer to grow and spread), they could develop an off-the-shelf therapy applicable to many patients. The study was done in collaboration with researchers from the University of Notre Dame.

The driver approach is different from immunotherapies that target neoantigens resulting from patient-specific mutations that are simply along for the ride (called passenger mutations). Therapies targeting neoantigens derived from passenger mutations are only applicable to a single patient because they target mutations unique to that persons cancer.

We're using a genetic engineering approach to help supercharge T cells in a new way.

Dr. Klebanoff and his colleagues decided to focus on a neoantigen created by a common driver mutation in a gene called PIK3CA. Their rationale was that this particular mutation is frequently found in breast cancer, endometrial cancer, and many other types of tumors that could benefit from more effective therapies.

There are already drugs that target this protein, but they cause a lot of side effects, says Smita Chandran, a scientific research lead in Dr. Klebanoffs lab and the Nature Medicine papers first author. We thought that targeting this driver gene with a cell-based immunotherapy might be more effective while at the same time reducing the risks of side effects.

One challenge in immunologically targeting mutant PIK3CA is that its found on the inside of cancer cells, a location that is inaccessible to antibody therapies. Its also unreachable using chimeric antigen receptor (CAR)T therapy, which is a form of cellular immunotherapy that has shown clinical benefit in several types of blood cancers. Antibody and CART therapies can only engage target proteins displayed on the outside of cancer cells. To get around this limitation, the researchers employed a tactic called Tcell receptor (TCR) therapy, which co-opts the T cells unique ability to survey the interior of cells for the presence of abnormal proteins.

We thought that targeting this driver gene with a cell-based immunotherapy might be more effective while at the same time reducing the risks of side effects, says researcher Smita Chandran.

This technology works because both cancer cells and normal cells regularly break down and recycle their proteins. As part of this process, fragments of degraded proteins within a cell are placed in a molecular basket, called a human leukocyte antigen (HLA). The loaded HLA molecule is then shuttled to the cell surface for display to Tcells. The researchers discovered that a common PIK3CA mutation results in a neoantigen that is compatible with an HLA type shared by a large number of patients, creating an elite class of shared tumor-exclusive targets called public neoantigens.

Building on this finding, the investigators went on to demonstrate that Tcells genetically engineered to express a TCR specific to the PIK3CA public neoantigen can attack and eliminate tumor cells while leaving healthy cells that express the normal version of protein unharmed.

TCR-engineered T cells were therapeutically effective against cancer cells in a petri dish and also against patient-derived tumor samples and in laboratory mice implanted with PIK3CA-mutated tumors. Some of the cancer types studied included breast cancer and an aggressive form of endometrial cancer called uterine serous carcinoma. These are cancers for which current immunotherapies have typically not been effective.

In addition to having a large number of side effects, the drugs that are currently approved to target mutant PIK3CA work only for a limited period. Most tumors ultimately develop resistance and begin growing again.

Based on their research in the lab, Drs. Klebanoff and Chandran expect that targeting mutated PIK3CA with immunotherapy rather than targeted therapy will not result in the same degree of resistance.

The researchers plan to work in collaboration with a pharmaceutical company to determine whether this approach could be evaluated in a clinical trial in the future. Its possible that trials could enroll any patient whose tumor carries the PIK3CA public neoantigen, regardless of where in the body the tumors originated. The fact that this therapy targets public neoantigens is the reason this treatment would be considered off-the-shelf, rather than having to be manufactured individually for each patient.

Theres an evolving appreciation that its genetic changes that contribute to cancer formation in the first place, as well as the likelihood a cancer will respond to a given therapy, Dr.Klebanoff says. We want to take the approach of developing treatments that are target-specific but tissue-agnostic and apply this to new immunotherapies, including the PIK3CA public neoantigen described in our paper.

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BioRestorative Therapies Hosts Principal Investigator Meeting for its BRTX-100 Phase 2 Clinical Trial to Treat Chronic Lumbar Disc Disease – BioSpace

Posted: May 2, 2022 at 2:25 am

MELVILLE, N.Y., April 29, 2022 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (the Company or BioRestorative) (NASDAQ: BRTX), a clinical stage biopharmaceutical company focused on stem cell-based therapies, today announced that it is hosting a Principal Investigators Meeting in Uniondale,NY on April 29th - 30th, 2022 for the Companys lead clinical candidate BRTX-100, an autologous bone marrow-derived hypoxic cultured stem cell intended for investigational use in its Phase 2 clinical trial to treat chronic lumbar disc disease.

The meeting will be attended by all principal investigators currently selected across the United States to help coordinate the study, entitled A Phase 2, Double-Blind, Saline-Controlled, Randomized Study to Evaluate the Safety and Preliminary Efficacy of a Single Dose Intradiscal Injection of BRTX-100 for Patients with Chronic Lumbar Disc Disease (cLDD)

Im pleased to announce that we continue to execute our BRTX-100 development plan in accordance with our previously stated timeline objectives, said Lance Alstodt, Chief Executive Officer of BioRestorative Therapies. The Principal Investigator Meeting will be attended in person and will enable a mutual understanding of the studys goals and set best in class procedures to share experiences among the Principal Investigators.

The Company plans to recruit 99 subjects for its Phase 2 trial in 15 leading clinical sites across the United States.

Low back pain (LBP) is a common, often confounding, problem for patients and physicians. In the United States, at least 80% of adults experience at least one episode of LBP during their lifetime. Low back pain is the most common cause of disability among Americans between 45 and 65 years of age. Further, of all musculoskeletal conditions, LBP imposes the highest economic burden on the U.S. healthcare system.

About BioRestorative Therapies, Inc.

BioRestorative Therapies, Inc. (www.biorestorative.com) develops therapeutic products using cell and tissue protocols, primarily involving adult stem cells. Our two core programs, as described below, relate to the treatment of disc/spine disease and metabolic disorders:

Disc/Spine Program (brtxDISC): Our lead cell therapy candidate, BRTX-100, is a product formulated from autologous (or a persons own) cultured mesenchymal stem cells collected from the patients bone marrow. We intend that the product will be used for the non-surgical treatment of painful lumbosacral disc disorders or as a complementary therapeutic to a surgical procedure. The BRTX-100 production process utilizes proprietary technology and involves collecting a patients bone marrow, isolating and culturing stem cells from the bone marrow and cryopreserving the cells. In an outpatient procedure, BRTX-100 is to be injected by a physician into the patients damaged disc. The treatment is intended for patients whose pain has not been alleviated by non-invasive procedures and who potentially face the prospect of surgery. We have received authorization from the Food and Drug Administration to commence a Phase 2 clinical trial using BRTX-100 to treat chronic lower back pain arising from degenerative disc disease.

Metabolic Program (ThermoStem): We are developing a cell-based therapy candidate to target obesity and metabolic disorders using brown adipose (fat) derived stem cells to generate brown adipose tissue (BAT). BAT is intended to mimic naturally occurring brown adipose depots that regulate metabolic homeostasis in humans. Initial preclinical research indicates that increased amounts of brown fat in animals may be responsible for additional caloric burning as well as reduced glucose and lipid levels. Researchers have found that people with higher levels of brown fat may have a reduced risk for obesity and diabetes.

Forward-Looking Statements

This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events or results to differ materially from those projected in the forward-looking statements as a result of various factors and other risks, including, without limitation, those set forth in the Company's latest Form 10-K filed with the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein, and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and the Company undertakes no obligation to update such statements.

CONTACT:Email: ir@biorestorative.com

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BioRestorative Therapies Hosts Principal Investigator Meeting for its BRTX-100 Phase 2 Clinical Trial to Treat Chronic Lumbar Disc Disease - BioSpace

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Transplanted iPS cells in rats offer hope of lumbago cure | The Asahi Shimbun: Breaking News, Japan News and Analysis –

Posted: May 2, 2022 at 2:25 am

Researchers in Japan say a new treatment for lumbago may be in the offing after theyrestored intervertebral disk functions in rats by implanting tissue derived from induced pluripotent stem (iPS) cells.

The team fromOsaka University, working with other researchers, said theywill continue to focus on ways to put their method to deal with the condition linked to lower back pain into practical application.

Our finding can help devise a treatment for lumbago, a painful condition that affects many people, in the future, said Noriyuki Tsumaki, a professor of tissue biochemistry at the university, who is part of the team.

The spinal column in humans has tissue called intervertebral disk between thevertebrae. An estimated13 million people in Japan suffer from lumbago, of whom 20 to 40 percent are believed to suffer from disk degeneration, according to the researchers.

The inner core of the intervertebral disk consists of jelly-like tissue called nucleus pulposus, which acts to absorb impact and helps to give the backbone its flexibility. When thenucleus pulposus becomes damaged or deformed due to aging or pressure, it results in pinched nerves that cause lower back pain.

Once it is compromised,nucleus pulposus does not heal by itself. No therapeutic agents are currently available to treat the problem.

Based on a survey using monkey nucleus pulposus, the team discovered that thejelly-like nucleus pulposus contains cells similar to those in cartilage.

This allowed the team members to developcartilage-like tissue from human iPS cells. The tissue was transplanted into rats whose nucleus pulposus had been removed.

The grafted cells functioned normallyfor at least six months. Rats with transplanted tissue recovered theirnucleus pulposus, which kept their intervertebral disk free from degeneration, though the structure degenerated in the rodents that did not undergo the transplant procedure.

The researchers are looking to test the effectiveness and safety of their technique with larger animals.

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SpaceX capsule returns to Earth with first all-private space station crew Spaceflight Now – Spaceflight Now

Posted: May 2, 2022 at 2:22 am

SpaceXs Dragon Endeavour spacecraft splashes down in the Atlantic Ocean Monday to end Axioms Ax-1 mission. Credit: SpaceX

A SpaceX crew capsule splashed down in the Atlantic Ocean off the coast of Georgia Monday with a retired NASA astronaut and three wealthy businessmen, closing out an extended 17-day mission on the first fully commercial, non-government visit to the International Space Station.

Protected by a thermal shield, the Dragon Endeavour spacecraft plunged back into the atmosphere and withstood a scorching hot re-entry over the southeastern United States. Two drogue parachutes opened up, and then four main chutes unfurled to slow the capsule for a relatively gentle splashdown at 1:06 p.m. EDT (1706 GMT) Monday in rolling seas northeast of Jacksonville, Florida.

The splashdown capped 17 days in orbit for the four-man crew, led by commander Michael Lpez-Alegra, a retired NASA astronaut and now an employee of Axiom Space, the Houston-based company that managed the mission.

Lpez-Alegra was joined on the flight by Larry Connor, an investor and accomplished aerobatic pilot from Ohio, Canadian businessman Mark Pathy, and Israeli entrepreneur Eytan Stibbe, who became the second person from Israel to fly in space. Connor, Pathy, and Stibbe paid for their rides to orbit.

Dragon, SpaceX, we see splashdown and mains (parachutes) cut, radioed Sarah Gillis, SpaceXs crew operations resource engineer, from the companys mission control center in Hawthorne, California.

We concur, repliedLpez-Alegra, who returned from his fifth mission to space, totaling 275 days in orbit. He has now launched on three different types of vehicles NASAs space shuttle, Russias Soyuz spacecraft, and SpaceXs Dragon ferry ship.

On behalf of the entire SpaceX team, welcome back to planet Earth, Gillis said. The Axiom 1 mission marks the beginning of a new paradigm for human spaceflight. We hope you enjoyed the extra few days in space and thanks for choosing to fly SpaceX.

Lpez-Alegra said the crew was feeling well as the capsule bobbed in the Atlantic Ocean. After teams on fast boats secured the parachutes and inspected the Dragon capsule, SpaceXs recovery ship Megan, named for NASA astronaut Megan McArthur, pulled alongside the spacecraft and lifted it from the sea.

The recovery team then opened the hatch and helped each crew member from the spacecraft. All four stood and smiled, flashing a thumbs-up and walking albeit wobbly and with assistance to a medical evaluation room on the recovery ship.

While readjusting to gravity, private astronauts were expected to fly by helicopter back to shore, then travel to Orlando for more medical checks and to meet their families.

Axiom contracted with NASA and SpaceX for the all-private crew mission to the space station. NASA charged Axiom a daily rate for access to the stations life support system, communications network, and other equipment. NASA is paying some of that back to Axiom in exchange for the return of government freezers and experiment specimens on the Dragon spacecraft.

Axiom paid SpaceX for the ride to and from the station on the Dragon spacecraft, and the launch aboard a Falcon 9 rocket from the Kennedy Space Center.

The arrangement is the first of its kind. Previous visits by private astronauts, or space tourists, to the space station occurred on government-led missions on Russian Soyuz spaceships. Before Axioms flight, 11 people had traveled to the space station as paying passengers on Soyuz missions, but they all flew with a government cosmonaut commander.

More Axiom missions are planned to the station in the next few years, leading up to delivery of the companys own commercial module to the orbiting complex. That module will eventually detach from the International Space Station and become the centerpiece for Axioms privately-owned multi-element outpost in low Earth orbit.

Without those two partners, none of this would be possible, said Derek Hassmann, Axioms operations director, referring to NASA And SpaceX. So just an amazing first step thats leading up to our launch and activation of the Axiom station with the first module being planned for 2024.

I would say, overall, this has been just an amazing success, Hassmann told reporters Monday afternoon. The crew performed beyond expectations. The ground teams were tremendous.

The re-entry and splashdown Monday came about 16 hours after SpaceXs Dragon Endeavour spacecraft undocked from the space station. The capsule backed away from the complex at 9:10 p.m. EDT Sunday (0110 GMT Monday).

The Axiom mission, known as Ax-1, was supposed to last 10 days, with the crew spending eight days at the space station. The mission was extended one day because of timing conflict between the planned undocking of the Ax-1 mission and a previously-scheduled Russian spacewalk.

Then persistent high winds in all seven SpaceXs splashdown zones near Florida kept the crew aloft through last week and the weekend. Mission managers were finally satisfied that conditions would be favorable for a return Monday, and they cleared Ax-1 to depart the station Sunday night.

During their time on the International Space Station, the Ax-1 astronauts brought the crew complement on the research lab up to 11 people, including five Americans, three Russians, one German, one Canadian, and one Israeli occupant. The Ax-1 crewspent the bonus time in orbit finishing up experiments and participating in more outreach events that didnt fit into the original flight plan, Hassmann said.

Despite nearly doubling their stay at the space staton, the paying passengers didnt rack up any late checkout fees.

The contact between Axiom and NASA included an equitable balance to cover potential delays in the undocking and return of the Ax-1 mission, said Stephanie Schierholz, a NASA spokesperson.

Knowing that International Space Station mission objectives like the recently conducted Russian spacewalk or weather challenges could result in a delayed undock, NASA negotiated the contract with a strategy that does not require reimbursement for additional undock delays, Schierholz said in a written statement.

There were no additional costs for any parties based on the extension of the mission, Hassmann said.

Axiom has not disclosed the price Connor, Pathy, and Stibbe paid for their flight to the space station. But NASAs inspector general has said a seat on a Dragon mission costs roughly $55 million.

The Ax-1 crew members trained for the mission in Houston and at SpaceXs headquarters in Hawthorne, California.

The first private astronaut mission is a harbinger of a transition from government-led spaceflight operations in low Earth orbit to a future generation of commercial space stations. NASA wants to help steer the space industry through the transition by providing the International Space Station as a testbed for markets that must be developed before companies can take launch and operate a revenue-earning destination in orbit.

A major goal for the U.S. space agency is to rely on commercial industry to develop the next orbiting outpost to replace the International Space Station. The Biden administration recently signaled it will support an extension of station operations though 2030, but by then the research labs oldest elements will have been in space 32 years, more than twice their original design lives.

The fraught relationship between the United States and Russia, the two largest ISS partners, in the wake of Russias invasion of Ukraine has also raised concerns about a replacement for the International Space Station.

Aside from Axiom, several other companies have plans to develop commercial space stations. In December, NASA selected Blue Origin, Nanoracks, and Northrop Grumman to advance their concepts for a commercial habitat and research facility in low Earth orbit.

Those companies are developing concepts for a standalone station, while Axiom will initially focus on a commercial add-on to the ISS.

The Ax-1 mission was a stepping stone toward that goal.

During their time in space, the Ax-1 crew worked with 26 science payloads and technology demonstration experiments, according to Hassmann. They also conducted more than 30 public outreach events in multiple languages.

The experiments on Ax-1 included investigations into self-assembling technology for future satellites and space habitats, the study cancer stem cells, and the test of a new Japanese air purification device. The crew members also served as experiment subjects for scientists to study how spaceflight affects the human body.

Connor partnered with Mayo Clinic and Cleveland Clinic on research looking at heart health and brain and spinal tissue. Pathy worked with the Montreal Childrens Hospital, Canadian research universities, and the Royal Canadian Geographic Society on technology demonstrations, a sleep study and chronic pain experiment, an eye health investigation, and Earth observations.

Stibbe worked with the Israel Space Agency, the Israeli Ministry of Innovation, Science, and Technology, and the Ramon Foundation, an organization established to honor the memory of Ilan Ramon, the first Israeli astronaut who died on the space shuttle Columbia in 2003. He alsocarried with him fragments from Ilan Ramons diary that survived the searing heat of re-entry after the fatal breakup of the shuttle Columbia over Texas in 2003.

The end of the Ax-1 mission clears the way for SpaceX to launch the next crew flight to the space station. Three NASA astronauts and a European Space Agency mission specialist are ready for liftoff from the Kennedy Space Center at 3:52 a.m. EDT (0752 GMT) Wednesday.

The four-person crew will ride a Falcon 9 rocket and SpaceXs Dragon Freedom spacecraft into orbit to begin NASAs Crew-4 mission. The expedition on the space station is scheduled to last approximately five months.

The launch of the Crew-4 mission was delayed to await the return of the Ax-1 mission. The Dragon Endeavour spaceship was docked to the same port needed for arrival of the Dragon Freedom capsule.

SpaceX engineers will analyze data from the Ax-1 mission to ensure there were no issues that might affect the launch of the Crew-4 flight Wednesday. Managers planned to meet for a launch readiness review early Thursday to formally give the go-ahead for liftoff of the Crew-4 mission.

The Ax-1 mission was SpaceXs sixth launch to carry people since a Dragon test flight took off in May 2020 with NASA astronauts Doug Hurley and Bob Behnken, ending a nearly nine-year gap in launching astronauts into orbit from U.S. soil.

NASA invested billions of dollars in helping SpaceX develop the human-rated Dragon spacecraft. SpaceX put up its own private funding in a cost-sharing arrangement with the federal government.

Benji Reed, senior director of SpaceXs human spaceflight programs, said Monday the companys fleet of four Crew Dragon spaceships could accommodate up to six astronaut missions per year.

Half a dozen crew flights per year would be great, or more, Reed said. AndIthink we can get to a place where we can sustain that. If theres a market for it, we can definitely do that.

Each Dragon capsule has four seats.In the long-term, SpaceX wants to retire the Falcon 9 and Dragon fleets in favor of the next-generation fully reusable Starship rocket, which could carry many more passengers into space. When asked Monday, Reed offered no estimate on when the Starship might be ready to fly people.

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Follow Stephen Clark on Twitter: @StephenClark1.

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Perelman School of Medicine 2022 Teaching Awards | University of Pennsylvania Almanac – Almanac

Posted: May 2, 2022 at 2:19 am

Perelman School of Medicine 2022 Teaching Awards Deans Award for Excellence in Clinical Teaching (at an Affiliated Hospital)

The Deans Award for Excellence in Clinical Teaching was established in 1989 to recognize clinical teaching excellence and commitment to medical education by outstanding faculty members from affiliated hospitals. One or more Deans Awards are given annually, the recipients being selected on the advice of a committee composed of faculty and students.

Judd Flesch is an assistant professor of clinical medicine in the department of medicines division of pulmonary, allergy, and critical care. He graduated from the Perelman School of Medicine in 2006 and subsequently completed his internal medicine residency, chief residency, and pulmonary/critical care fellowship at the Hospital of the University of Pennsylvania. During his fellowship, he also served as the Mayock Chief Fellow. He joined Penns faculty in January 2014 and has served as an associate program director of the Internal Medicine Residency Program and site director at Penn Presbyterian Medical Center (PPMC) for the past eight years. In addition to overseeing clinical rotations at PPMC, Dr. Flesch also oversees the mentorship program for residents. He is passionate about clinical teaching, working with residents, fellows, and medical students in both inpatient and outpatient settings. In addition to his educational roles, Dr. Flesch is active in clinical operations leadership at PPMC, serves on the department of medicine Professionalism Committee, and is the co-director of the Penn Medicine Program for LGBTQ Health.

Temitayo Ogunleye is an associate professor of clinical dermatology and the associate director of diversity, equity, and inclusion in the department of dermatology. She received her medical degree from the Perelman School of Medicine, completed her residency training in dermatology at the University of Michigan, and trained at the University of Pennsylvania as a clinician educator fellow to further her interests in medical education and develop her current niches of skin color and hair disorders. Dr. Ogunleye received a masters degree in healthcare innovation from Penn in 2021 and was appointed as medical director of the dermatology clinic at the Perelman Center for Advanced Medicine in January 2022. She plays an active role in medical education, interacting with both medical students and residents in her clinics and on inpatient consultations at Penn Presbyterian Medical Center. She is a member of her departments Clinical Competency Committee and serves as a GME Ombudsperson. She is also a faculty leader of the Faculty Forums committee of the Alliance of Minority Physicians, a resident-led organization comprised of residents, fellows, and attending physicians who are underrepresented in medicine and committed to creating a diverse workforce. A former trainee commented, (she) is simply the best. She is kind, courteous, charismatic. She is a great teacher andI love working with her.

Carla R. Scanzello is an associate professor of medicine in the division of rheumatology at the Perelman School of Medicine, and section chief of rheumatology at the Corporal Michael J. Crescenz VA Medical Center (CMCVAMC) in Philadelphia. Dr. Scanzello received her medical and graduate degrees from Temple University School of Medicine in Philadelphia, completed her residency training at New York-Presbyterian/Weill Cornell Medical Center, and her rheumatology fellowship at the Hospital for Special Surgery in New York. She joined Penn and the CMCVAMC in 2013, where she established a laboratory focused on osteoarthritis therapeutic development within the Translational Musculoskeletal Research Center, which she now co-directs. In addition to her research pursuits, she is dedicated to education of clinical trainees. She regularly supervises rheumatology fellows in their weekly VA clinics and participates as a faculty member in PSOMs Cell & Tissue Biology and Mechanisms of Disease and Therapeutic Interventions courses. She teaches medical students and trainees from multiple specialties and primary care rotating through the rheumatology clinics at the CMCVAMC. This includes bedside teaching within the CMCVAMC Multi-Disciplinary Osteoarthritis Clinic, which she co-established. In partnership with colleagues in endocrinology and radiology, she co-organizes quarterly conferences in metabolic bone disorders for trainees at the CMCVAMC. In all these settings, she encourages trainees to set educational goals for themselves to foster a lifetime of self-directed learning and to collaboratively engage colleagues from other specialties to optimize inter-disciplinary care for patients. As former trainees have commented, Dr. Scanzello is an outstanding teacher. She regularly helps fellows develop learning goals and then revisits these to check in on progress. I appreciate that she takes into account my learning goals and actively incorporates these into her teaching styleShe is a great role model as a rheumatologist.

Nicole Washington is an assistant professor of clinical pediatrics within the department of pediatrics at the Perelman School of Medicine and an attending physician with the division of general pediatrics at the Childrens Hospital of Philadelphia (CHOP). Dr. Washington received her BA in Spanish and her medical doctorate from the University of Virginia. She completed her pediatric residency training at CHOP. After completing her residency, she served as a pediatric chief resident for the hospital and the pediatric residency program. Dr. Washington remains active in the pediatric residency program, serving as one of the associate program directors and an integral member of the Intern Selection Committee; she also is currently the chair of the American Board of Pediatrics Education and Training Committee. Dr. Washington is one of the faculty mentors of the Alliance of Minority Physicians, a resident-led organization at CHOP comprised of residents, fellows, and attending physicians who are underrepresented in medicine and committed to creating a diverse workforce. Dr. Washington has mentored countless residents, medical students, and undergraduate students with a strong dedication to ensuring their personal and professional growth. Dr. Washington is also committed to her own professional growth and improvement, and is currently enrolled in the College of Liberal & Professional Studies Master in Organizational Dynamics Program. She plans to share this new knowledge and growing expertise with her trainees to further their leadership development.

This award was established by the department of anesthesia in 1984. As a pioneer in the specialty of anesthesia and chair of the department from 1943 to 1972, Dr. Dripps was instrumental in the training of more than 300 residents and fellows, many of whom went on to chair other departments. This award is to recognize excellence as an educator of residents and fellows in clinical care, research, teaching, or administration.

David Aizenberg is an associate professor of clinical medicine in the division of general internal medicine. He came to Penn in 2007 as an intern and stayed on to complete his residency and a chief resident year. He then joined the faculty and continued to have an active role within the internal medicine residency. Dr. Aizenberg enjoys optimizing learning environments and has led several educational innovations, including transitioning the program into a block scheduling system and designing and implementing a theme-based ambulatory curriculum. In 2018, Dr. Aizenberg left Penn to lead the Drexel/Hahnemann University Hospital internal medicine residency as its program director. During the unexpected closure of Hahnemann, Dr. Aizenberg advocated on behalf of all the residents and fellows impacted by this crisis and helped them to find receiving programs. Dr. Aizenberg returned to Penn in 2020 and joined the GME leadership team as director of assessment and professional development. In this role, he helps programs improve their assessment systems and coaches struggling housestaff. Dr. Aizenberg continues to be clinically active in outpatient primary care and the inpatient wards at PPMC.

Created in 1987 by the Blockley Section of the Philadelphia College of Physicians, this award is given annually to a member of the faculty at an affiliated hospital for excellence in teaching modern clinical medicine at the bedside in the tradition of William Osler and others who taught at Philadelphia General Hospital.

Sean Harbison is a native Philadelphian, having spent almost his entire education and professional career within blocks of Broad Street. After earning his BA in biology from LaSalle College, Dr. Harbison attended Temple University School of Medicine and completed general surgery training at the Graduate Hospital and at Memorial Sloan Kettering Cancer Center in New York. He has served as a faculty attending surgeon and professor of surgery at Graduate Hospital, Temple University Hospital and, most recently, in the department of surgery at the Perelman School of Medicine, where he focuses on educational roles at each institution. For the past 8 years he has served as an associate clerkship and sub-internship director in the department of surgery, and he recently earned a masters degree in medical education from Penn. He has had his teaching prowess recognized by multiple teaching awards, including induction into AOA Medical Honor Society (2005), three Penn Pearl Awards (1995, 2017, 2021), and the Deans Award for Clinical Teaching (1997). A former student stated, I hope to emulate your style with patients and students when Im a physician: Thank you for making me feel like a valued team-member and [for] an inspired learning experience.

This award was established in 1981 as a memorial to Leonard Berwick by his family and the department of pathology. It recognizes a member of the medical faculty who in his or her teaching effectively fuses basic science and clinical medicine. It is intended that this award recognize persons who are outstanding teachers, particularly among younger faculty.

Katharine Bar is an assistant professor of medicine in the division of infectious diseases and a physician-scientist studying novel approaches to HIV prevention and cure. Her translational research program fuses a virology laboratory studying the basic mechanisms of viral pathogenesis with clinical trials of HIV and SARS-CoV-2 interventions. Dr. Bar is an engaged teacher in both her clinical and research roles at Penn and through her leadership in national scientific organizations. She precepts medical trainees and leads multiple small group sessions for medical students, internal medicine residents, and infectious disease fellows. She is also an active teacher of cell and molecular biology graduate students, for whom she co-directs a journal club format class centered on HIV. Through her laboratory, she serves as a formal mentor for multiple students and an informal mentor to many additional trainees, in particular women pursuing basic and translational research careers. Outside of Penn, she is known as a dynamic speaker who communicates complex concepts in an engaging manner. A physician-scientist trainee mentored by Dr. Bar wrote, Dr. Bar has consistently mentored me through graduate and clinical phases of my development as a physician-scientist, always reminding me of the duality of my training. I have witnessed Dr. Bars tailored mentorship of numerous friends who are graduate students, medical trainees, and budding physician-scientists. She assesses a mentees needs and meets them at their level. Her advice is honest, thoughtful, and based on her wealth of experience as a successful physician-scientist.

This award was established in 2000 by the Penn/VA Center for Studies of Addiction and the department of psychiatry. Scott Mackler is known for his excellence in teaching medical students, residents, post-doctoral fellows, nurses, and other Penn faculty in many different departments in the area of substance abuse.

Subhajit Chakravorty is an assistant professor of psychiatry at the Perelman School of Medicine and a staff physician at the affiliated Corporal Michael J. Crescenz Veterans Affairs Medical Center (CMCVAMC). He completed his medical school training at the University College of Medical Sciences, Delhi, India. He trained in psychiatry at the University of Pittsburgh and completed his sleep medicine training and a master of science in translational research at the University of Pennsylvania. In addition, he completed his addiction research and clinical care fellowship at the affiliated CMCVAMC. He is certified in psychiatry, sleep medicine, and addiction medicine. He attends to patients in sleep medicine at the Hospital of the University of Pennsylvania and addiction psychiatry at CMCVAMC.

His program of research focuses on developing personalized treatment interventions for insomnia comorbid with alcohol use disorder and their underlying mechanisms for change. Additionally, he is interested in understanding how alcohol use interfaces with sleep-related disorders.

The Deans Award for Excellence in Basic Science Teaching was established in 1988 to recognize teaching excellence and commitment to medical student teaching in the basic sciences. One or more Deans Awards are given annually, the recipients being selected on the advice of a committee comprised of faculty and students.

Rahul Kohli is an associate professor of medicine in the division of infectious disease, with a secondary appointment in the department of biochemistry and biophysics. Dr. Kohli obtained his MD and PhD from Harvard Medical School, after which he completed his internal medicine residency at Penn and his post-doctoral fellowship and clinical infectious disease training at Johns Hopkins University. The chief objective of his research group has been to probe DNA modifying enzymes and using approaches rooted in enzymology and chemical biology. The enzymes targeted by his groups studies catalyze the purposeful modification of the genome and are central to host-pathogen interactions or to epigenetics. Dr. Kohlis work has been recognized through support from the Burroughs Wellcome Fund, the Doris Duke Foundation, the Rita Allen Foundation and an NIH Directors New Innovator Award, among others. He has been elected to the American Society for Clinical Investigators (ASCI) and has received the American Chemical Society (ACS) Pfizer Award in Enzyme Chemistry. At Penn, Dr. Kohli is dedicated to the mission of training the next generation of physician-scientists grounded in basic science. Since 2014, he has served as an associate program director of the Penn MD/PhD program. His roles in the program include supporting combined degree students in the Biochemistry and Molecular Biophysics Graduate Group and being the course director for Topics in Molecular Medicine, a course aimed at introducing all first-year combined degree students to cutting edge basic science work with medical implications.

This award was established in 1997 to recognize outstanding teaching by allied health professionals (e.g.; nurses, physicians assistants, emergency medical technicians). The recipient is selected on the advice of a committee composed of faculty and students.

Michelle Jackson has nearly 15 years of experience as a clinician working in the field of individual, couple, and family therapy. She holds a BA in womens studies and philosophy from Temple University and an MSS in clinical social work from the Bryn Mawr College Graduate School of Social Work and Social Research. Currently, Ms. Jackson is an attending faculty member in the Psychiatry Residency Assessment Clinic for third-year residents at Penn. She adds family and systems perspectives to the overall discussion of patients presenting for care and also ensures that residents consider race, gender, sexual orientation, social class, and cultural background for all of their new and on-going patients. Ms. Jackson was on the clinical faculty of the Center for Couples and Adult Families in the department of psychiatry at Penn Medicine until 2019. In that position, she collaborated with the clinical director and other colleagues to provide therapy for a wide variety of family life cycle transitions, adjustment and mood disorders, and relationship concerns. In addition to her work at Penn, Ms. Jackson has been a valued instructor for undergraduate, graduate, and post-graduate students since 2014. She has taught in the department of psychology at Philadelphia University (now part of Thomas Jefferson University), in the Rutgers University School of Social Work, in the Couple and Family Therapy program at Thomas Jefferson University, and in the post-graduate certificate program at Council for Relationships. Known for her enthusiasm and dynamism in the classroom, Ms. Jackson is sought after as a student advisor, professional mentor, and clinical supervisor.

This award was established in 2015 to recognize clinical teaching excellence and commitment to medical education by outstanding housestaff. One award is given annually. The recipient is selected on the advice of a committee composed of faculty and students.

Stphane Vie Guerrier is a senior internal medicine resident at the University of Pennsylvania. She graduated from the Perelman School of Medicine in 2019. After she completes her residency in June of 2022, she will join Penns department of endocrinology as a fellow. She enjoys working alongside Penns hardworking and inquisitive medical students, who teach her unexpected lessons every day.

The Michael P. Nusbaum Graduate Student Mentoring Award was established in 2017 to honor Mikey Nusbaum as he stepped down from his role as Associate Dean for Graduate Education and director of Biomedical Graduate Studies.

Christopher Hunter is the Mindy Halikman Heyer Distinguished Professor of Pathobiology in Penns School of Veterinary Medicine. Dr. Hunter has been a mentor far beyond the borders of his own laboratory, through the T32 grant he leads, the courses he directs, and the regular connection with students across several graduate groups. Dr. Hunters thoughtful advice has guided several generations of biomedical graduate studies (BGS) students through their PhD education and beyond. His dedication to mentoring students and guiding them in reaching their scholarly potential exemplifies the type of scientist and mentor that Mikey Nusbaum represents.

The Jane M. Glick Graduate Student Teaching Award was established in 2009 by the Glick family in remembrance of Jane Glick and her dedication to the Biomedical Graduate Studies (BGS) programs.

Dan Beiting is an assistant professor of pathobiology in Penns School of Veterinary Medicine. Dr. Beitings creation of a new teaching model within Biomedical Graduate Studies through the development of the CAMB 714 DIY Transcriptomics course and his innovative approach to deliver biostatistics training with the BIOM 610 course will have a lasting impact on quantitative training for BGS students for years to come. His dedication to these efforts exemplifies the type of scientist/educator that Jane represented.

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Carrasco elected to American Academy of Arts and Sciences – Vanderbilt University News

Posted: May 2, 2022 at 2:19 am

Nancy Carrasco

The American Academy of Arts and Sciences announced today that Dr. Nancy Carrasco, Joe C. Davis Professor of Biomedical Science and professor and chair of molecular physiology and biophysics, has been elected as one of its new members. Carrasco was elected to the National Academy of Sciences in 2015 and to the National Academy of Medicine in 2020.

Carrasco is an internationally recognized scientist known for her study of membrane transporters. Her pioneering research has had a significant impact on numerous fields, including molecular endocrinology, gene transfer, diagnostic imaging, cancer therapy and public health.

I offer my warmest congratulations to Professor Carrasco on this prestigious and much deserved honor, Chancellor Daniel Diermeier said. In making extraordinary contributions toward the study of membrane transporters and how they affect public health, she has advanced the good of both our university and society as a whole. Vanderbilt is fortunate to have her as an ambassador.

Carrasco was the first to isolate the coding DNA for NIS, the iodide transporter protein that pulls iodide from the bloodstream into the thyroid gland. Iodide (a form of the element iodine) is required for the production of thyroid hormones, which regulate metabolism in almost all tissues and play crucial roles in the development and maturation of the nervous system, skeletal muscles and lungs. Infants who do not have the correct levels of thyroid hormones may have impaired cognitive development and intellectual disability.

Carrascos findings also include key mechanistic details about how the protein works, that it actively transports the pollutant perchlorate, and that it is functionally expressed in lactating breast tissue and in breast cancer. Her studies have suggested that NIS-mediated transport of radioactive iodidea mainstay in the treatment of thyroid cancermight be a useful therapy for breast cancer.

I am delighted that Professor Carrasco has earned this important recognition, said C. Cybele Raver, provost and vice chancellor for academic affairs. Her election attests to our collective excellence as a university and research institution as the number of Vanderbilt faculty in the American Academy of Arts and Sciences continues to grow across disciplines.

Carrasco is among AAA&Ss 261 new members in 2022. She joins 17 current or former Vanderbilt faculty members who have been elected in the past.

Founded in 1780 by John Adams, John Hancock and other leading figures of the American Revolution, AAA&S is one of the countrys oldest and most distinguished honorary societies. In addition to recognizing the scholarly work of its members, it serves as an independent research center, convening leaders from across disciplines to address significant challenges.

This is a great tribute to the impact of Dr. Carrascos research contributions, said Lawrence Marnett, dean of the Vanderbilt University School of Medicine Basic Sciences and Mary Geddes Stahlman Professor of Cancer Research. She not only elucidated how iodine is transported across biological membranes in precise molecular detail, she also discovered that certain environmental pollutants block the transport. Since iodine is critical for thyroid hormone formation, her discoveries have profound physiological and pathophysiological significance. She is a wonderful colleague, and we are very fortunate to have her as a member of our faculty.

Carrasco has received numerous national and international awards, including a Pew Award in the Biomedical Sciences, the Beckman Young Investigators Award from the Arnold and Mabel Beckman Foundation, the Maria Sibylla Merian Prize (Germany), the European Thyroid Associations Merck-Serono Prize, the Noun Shavit Award in Life Sciences (Israel), and a Light of Life Foundation award. She also has served as president of the Society of Latin American Biophysicists.

Carrasco received her M.D. and masters degree in biochemistry from the National Autonomous University of Mexico in her native Mexico City and completed her postdoctoral training at the Roche Institute of Molecular Biology. Before joining Vanderbilt in 2019, she was a member of the faculty at Albert Einstein College of Medicine and Yale School of Medicine.

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Research Assistant in the Division of Science, Biology, Magzoub Research Group job with NEW YORK UNIVERSITY ABU DHABI | 291896 – Times Higher…

Posted: May 2, 2022 at 2:19 am

Description

A research assistant position is available in the Magzoub lab at NYU Abu Dhabi (https://www.magzoub-lab.com). The research will focus on developing novel inhibitors of cancer-associated mutant p53 amyloid aggregation.

We are looking for highly motivated candidates with an interest in working in the areas of biophysics, molecular medicine and chemical biology, and hold a Bachelor of Science (BSc). The ideal candidate will have experience in protein misfolding diseases or amyloid research, and a strong background in developing and testing amyloid inhibitors. Experience inin vivomodels of amyloid diseases is highly desired.

NYU Abu Dhabi offers a stimulating research environment led by a distinguished research community and supported by state-of-the-art research facilities.

The terms of employment are very competitive. Applications will be accepted on a rolling basis and candidates will be considered until the position is filled. To be considered, all applicants must submit in PDF format: a cover letter summarizing research experience and specifying the interests in this position; a curriculum vitae (including a full list of publications); a statement of research interests; and the names and contact details for three references. If you have any questions, please emailmazin.magzoub@nyu.edu

About NYUAD:

NYU Abu Dhabi is a degree-granting research university with a fully integrated liberal arts and science undergraduate program in the Arts, Sciences, Social Sciences, Humanities, and Engineering. NYU Abu Dhabi, NYU New York, and NYU Shanghai, form the backbone of NYUs global network university, an interconnected network of portal campuses and academic centers across six continents that enable seamless international mobility of students and faculty in their pursuit of academic and scholarly activity. This global university represents a transformative shift in higher education, one in which the intellectual and creative endeavors of academia are shaped and examined through an international and multicultural perspective. As a major intellectual hub at the crossroads of the Arab world, NYUAD serves as a center for scholarly thought, advanced research, knowledge creation, and sharing, through its academic, research, and creative activities.

EOE/AA/Minorities/Females/Vet/Disabled/Sexual Orientation/Gender Identity Employer

UAE Nationals are encouraged to apply.

Application Process

This institution is using Interfolio's Faculty Search to conduct this search. Applicants to this position receive a free Dossier account and can send all application materials, including confidential letters of recommendation, free of charge.

Equal Employment Opportunity Statement

For people in the EU, click here for information on your privacy rights under GDPR:www.nyu.edu/it/gdpr

NYU is an equal opportunity employer committed to equity, diversity, and social inclusion.

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Neural pathway key to sensation of pleasant touch identified Washington University School of Medicine in St. Louis – Washington University School of…

Posted: May 2, 2022 at 2:19 am

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Similar to itch, pleasant touch transmitted by specific neuropeptide and neural circuit

Mice engage in grooming behavior, experiencing a phenomenon researchers call pleasant touch. Researchers from the Washington University Center for the Study of Itch and Sensory Disorders have identified a specific neuropeptide and a neural circuit that transmit pleasant touch from the skin to the brain. The findings eventually may help scientists better understand and treat disorders characterized by touch avoidance and impaired social development.

Studying mice, scientists at Washington University School of Medicine in St. Louis have identified a neural circuit and a neuropeptide a chemical messenger that carries signals between nerve cells that transmit the sensation known as pleasant touch from the skin to the brain.

Such touch delivered by hugs, holding hands or caressing, for example triggers a psychological boost known to be important to emotional well-being and healthy development. Identifying the neuropeptide and circuit that direct the sensation of pleasant touch eventually may help scientists better understand and treat disorders characterized by touch avoidance and impaired social development, including autism spectrum disorder.

The study is published April 28 in the journal Science.

Pleasant touch sensation is very important in all mammals, said principal investigator Zhou-Feng Chen, PhD, director of the Center for the Study of Itch & Sensory Disorders at Washington University. A major way babies are nurtured is through touch. Holding the hand of a dying person is a very powerful, comforting force. Animals groom each other. People hug and shake hands. Massage therapy reduces pain and stress and can provide benefits for patients with psychiatric disorders. In these experiments with mice, we have identified a key neuropeptide and a hard-wired neural pathway dedicated to this sensation.

Chens team found that when they bred mice without the neuropeptide, called prokinecticin 2 (PROK2), such mice could not sense pleasant touch signals but continued to react normally to itchy and other stimuli.

This is important because now that we know which neuropeptide and receptor transmit only pleasant touch sensations, it may be possible to enhance pleasant touch signals without interfering with other circuits, which is crucial because pleasant touch boosts several hormones in the brain that are essential for social interactions and mental health, he explained.

Among other findings, Chens team discovered that mice engineered to lack PROK2 or the spinal cord neural circuit expressing its receptor (PROKR2) also avoided activities such as grooming and exhibited signs of stress not seen in normal mice. The researchers also found that mice lacking pleasant touch sensation from birth had more severe stress responses and exhibited greater social avoidance behavior than mice whose pleasant touch response was blocked in adulthood. Chen said that finding underscores the importance of maternal touch in the development of offspring.

Mothers like to lick their pups, and adult mice also groom each other frequently, for good reasons, such as helping emotional bonding, sleep and stress relief, he said. But these mice avoid it. Even when their cagemates try to groom them, they pull away. They dont groom other mice either. They are withdrawn and isolated.

Scientists typically divide the sense of touch into two parts: discriminative touch and affective touch. Discriminative touch allows the one being touched to detect that touch and to identify its location and force. Affective, pleasant or aversive, touch attaches an emotional value to that touch.

Studying pleasant touch in people is easy because a person can tell a researcher how a certain type of touch feels. Mice, on the other hand, cant do that, so the research team had to figure out how to get mice to allow themselves to be touched.

If an animal doesnt know you, it usually pulls away from any sort of touch because it can view it as a threat, said Chen, the Russell D. and Mary B. Shelden Professor in Anesthesiology and a professor of psychiatry, of medicine and of developmental biology. Our difficult task was to design experiments that helped move past the animals instinctual avoidance of touch.

To get the mice to cooperate and to learn whether they experienced touching as pleasant the researchers kept mice apart from cagemates for a time, after which the animals were more amenable to being stroked with a soft brush, similar to pets being petted and groomed. After several days of such brushing, the mice then were placed into an environment with two chambers. In one chamber the animals were brushed. In the other chamber, there was no stimulus of any kind. When given the choice, the mice went to the chamber where they would be brushed.

Next, Chens team began working to identify the neuropeptides that were activated by pleasant brushing. They found that PROK2 in sensory neurons and PROKR2 in the spinal cord transmitted pleasant touch signals to the brain.

In further experiments, they found that the neuropeptide they had homed in on wasnt involved in transmitting other sensory signals, such as itch. Chen, whose laboratory was the first to identify a similar, dedicated pathway for itch, said pleasant touch sensation is transmitted by an entirely different, dedicated network.

Just as we have itch-specific cells and peptides, we now have identified pleasant touch-specific neurons and a peptide to transmit those signals, he said.

Liu B, Qiao L, Liu K, Piccinni-Ash TJ, Chen ZF. Molecular and neural basis of pleasant touch sensation. Science, April 29, 2022. DOI 10.1126/science.abn2749

This work is supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases and the National Institute of Neurological Disorders and Stroke of the National Institutes of Health (NIH). Grant numbers 1R01 AR056318-06 and R01 NS094344.

Washington University School of Medicines 1,700 faculty physicians also are the medical staff of Barnes-Jewish and St. Louis Childrens hospitals. The School of Medicine is a leader in medical research, teaching and patient care, and currently is No. 4 in research funding from the National Institutes of Health (NIH). Through its affiliations with Barnes-Jewish and St. Louis Childrens hospitals, the School of Medicine is linked to BJC HealthCare.

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