Monthly Archives: December 2021

Embryology

RMA of New York Opens State-of-the-Art IVF Laboratory in Brooklyn, expanding access to fertility care to New York’s most populous county – PRNewswire

For the past 10 years, RMA of New York had served the Brooklyn community at a satellite office in downtown Brooklyn. The opening of this new, full-service center, enhanced with an onsite state-of-the-art IVF laboratory, allows Brooklyn residents to meet all of their fertility needs in one location. Accessibility is a key component to positive patient experiences and successful outcomes, since fertility treatment often involves frequent or even daily visits to the office.

RMA of New York founding partner Dr. Alan Copperman commented, "We are committed to providing exceptional, accessible, and inclusive fertility care to communities in Brooklyn and the surrounding area. By practicing personalized and precise reproductive medicine, I am confident that we will replicate the high success rates we have achieved for two decades at our Manhattan location, and that we will be able to help an entire community of people access care locally and fulfill their family building dreams."

RMA of New York consistently delivers high IVF success rates and is globally recognized as a leader in the field of reproductive medicine and assisted reproductive technology. Personalized, precision medicine and clinical excellence have been hallmark characteristics of RMA of New York for the past 20 years.

Medical Director Dr. Jovana Lekovich, alongside reproductive endocrinology and infertility specialists Dr. Tia Jackson-Bey and Dr. Jenna Friedenthal, will care for patients at the Brooklyn location. With decades of experience among them, they will offer patients a personalized reproductive treatment plan that will meet individualized family-building goals.

Dr. Lekovich emphasized, "We are opening our doors to individuals and couples who come from a wide range of backgrounds, ethnicity, sexual orientations, and cultures, but who share a dream of parenthood.We will combine scientific excellence and compassionate care and do everything in our power to make those dreams come true."

This team of top fertility experts will provide patients with a full range of on-site fertility care from low-tech treatments, such as intrauterine insemination (IUI), to the latest advanced assisted reproductive techniques, such as in vitro fertilization (IVF) and preimplantation genetic testing (PGT). Fertility preservation treatment programs will now be more accessible with the new state-of-the-art lab that will also provide on-site egg and sperm freezing, and long term storage.

With four offices in Manhattan, three in the Hudson Valley at RMANY at CareMount, and six on Long Island at RMALIIVF, RMA of New York's new Brooklyn location demonstrates a sustained commitment of the organization to provide fertility care to the region. RMA of New York, in partnership with the Department of Obstetrics, Gynecology, and Reproductive Medicine at The Icahn School of Medicine at Mount Sinai, is committed to using genomic medicine, big data, and multi-scale biology to personalize care and improve patient outcomes.

About Reproductive Medicine Associates of New York (RMA of New York)

RMA of New York is widely recognized as a global leader in state-of-the-art reproductive medicine, and serves as the Division of Reproductive Endocrinology and Infertility at the Icahn School of Medicine at Mount Sinai. Led by an integrated team of physicians and scientists with extensive reproductive endocrinology, infertility, and embryology training, RMA of New York is renowned for its pioneering research in the field and for delivering high IVF success rates. For the past 20 years, the physicians of RMA of New York have consistently been distinguished as "Top Doctors" by Castle Connolly and New York Magazine, as well as Super Doctors. Headquartered in midtownManhattan, RMA ofNew Yorkhas fertility clinic locations throughoutManhattan, Brooklyn,Westchester, Long Island, and abroad inMexico City. For more information, please visitwww.rmany.com.

Contact: Pamela Pearlman 212-756-5777 [emailprotected]

SOURCE Reproductive Medicine Associates of New York

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RMA of New York Opens State-of-the-Art IVF Laboratory in Brooklyn, expanding access to fertility care to New York's most populous county - PRNewswire

Embryology

Argentine bishops want people to hear the pope, not about the pope – Crux Now

ROME Even though the papacy isnt a popularity contest, a popes influence in his home country is one way to measure how hes doing. Alas, when it comes to Pope Franciss Argentina, things are a bit more complicated: According to the local bishops, Argentines hear about the pope, but they dont actually hear him.

According to a 2020 poll by the National Scientific and Technical Research Council (CONICET), nine in ten Argentines affirm that their religiosity did not increase after the election of historys first pope from the global south. Furthermore, 40 percent of Argentines are completely indifferent to the pope, and within this number, 32 percent of those who answered identify as Catholic. And 27 percent of the people think hes too involved in politics instead of spiritual affairs.

Seeing these numbers, it comes as no surprise that the head of the Argentine bishops conference, Bishop Oscar Ojea of San Isidro, believes that two of the six challenges the local church faces for the coming years involve Pope Francis and his magisterium:

Speaking about the Synod, which includes a two-year consultation process at a parish, diocesan, national and regional levels before the actual Synod of Bishops on synodality, to be held in Rome in Oct. 2023, Ojea said that with it, The Church goes out to listen in a world of deaf ears, in which each group listens to its own discourse. Before the proposal of the Synod there are different reactions and fears.

As president of the Argentine bishops, he said, I have clearly seen sectors of a secularized mentality, very entrenched in some media outlets, that do not hesitate to use disinformation, slander and defamation to attack the Church, seeking to expel it from the public space.

On the other hand, he argued, there is a religious fundamentalism that does not respect the freedom of others and feeds forms of intolerance and violence, longing for a church that imposes power.

These two sectors, according to Ojea, have much economic and media power, and in Argentina, they have joined together, like Pharisees and Sadducees, to systematically denigrate the church through the figure of Pope Francis, who has deserved the respect and consideration of most of the peoples of the world, near or far from the church, over these nine years of his pontificate.

In his own country, the bishop pointed out, these groups have become a major obstacle for Pope Francis to be read directly and thus his teachings reach the faithful. Instead, our people have heard more opinions and qualifications about him than what he expresses through his words and writings.

We must continually unmask these two extremes, without allowing ourselves to be defeated by a secularism that worldlyizes the church or by a fundamentalism that prevents it from enculturating itself and properly reading the signs of the times, Ojea said.

On the matter of clerical sexual abuse, the president of the Argentine bishops said: We must not give in to any kind of cover-up. We have to be very firm in this determination. We bishops, in these situations, carry a real cross. We must first of all protect the victims, recognize that although there are some false allegations, the vast majority of the allegations are true and this should concern us, occupy us and invite us to deepen in a reorganization of the ecclesial structure.

He pointed out that protecting children, preventing abuse, and helping survivors is a task for the entire Church, called to confront the weight of a culture impregnated with clericalism inherited from its history.

Ojea also spoke of the need to fight all forms of abuse, including those of power, financial nature and conscience.

Speaking about gender ideology, the prelate said that on this matter, it is important for the laity to be formed, because in a certain sense, we have found ourselves surprised in the mist of a very fast cultural change.

It is possible to distinguish without separating, the biological sex from the sociocultural role of sex, Ojea said. Gender ideology instead distinguishes sex and gender by separating them and thus preventing a harmonious relationship of all aspects of the human person.

Pope Francis has referred to this issue in several opportunities throughout his pontificate, calling it a global war against the family. Last year, speaking about where he sees evil in a book about Pope John Paul II, he said that one place is gender theory. Right away I want to clarify that I am not referring to people with a homosexual orientation. The Catechism of the Catholic Church invites us to accompany them and provide pastoral care to these brothers and sisters of ours.

Gender theory, he said, has a dangerous cultural aim of erasing all distinctions between men and women, male and female, which would destroy at its roots Gods most basic plan for human beings: Diversity, distinction. It would make everything homogenous, neutral. It is an attack on difference, on the creativity of God and on men and women.

RELATED: He was a great, Pope Francis says of St. John Paul II

Francis said he did not want to discriminate against anyone, but was convinced that human peace and well-being had to be based on the reality that God created people with differences and that accepting not ignoring those differences is what brings people together.

When it comes to the Argentine bishops, Ojea said that we prefer to adopt a gender perspective. Gender ideology instead thinks of gender as a fluid and self-constructed reality independent of biology so that ones identity could be designed according to the autonomous desire of each person.

The prelate also said that all persons must be treated according to their equal dignity, and on this regard, we cannot deny that our history bears traces of a patriarchal history in which the equal dignity of males and females has not been recognized in practice and we see that here a profound change is necessary.

Ojea said the bishops conference sees the imposition of gender ideology on all educational projects, ignoring the freedom of parents and educational institutions, is also part of the sixth challenge they foresee for upcoming years.

On the fourth challenge, the defense of life, Ojea said that sometimes, the Catholic Church is accused of being anti-rights and that by being against abortion and same-sex marriage, the Church is putting these in the same bag with violence against women.

We must make it clear that we are not anti-rights because in the first place we defend the right of every mother and every unborn child, that is, the right of all, without excluding anyone, he said. We must always strongly affirm our most resounding rejection of all types of violence, especially that which is exercised against the most vulnerable, women and children.

Abortion on demand in the first 14 weeks of gestation was legalized in Argentina in December. In the videos, Ojea says he spoke about the matter with Pope Francis back in January, when the two met at the Vatican. During that conversation, the pontiff urged the bishop to find creative ways to continue underlining the importance of life, and the fact that it is science and embryology books that prove that life begins at conception.

On the first challenge, that of being a missionary Church, he said it comes directly from Francis programmatic letter, Evangelii Gaudium, published in 2013, where he wrote: I dream of a missionary option capable of transforming everything.

The immediate context of the pandemic has left deep traces of anger, sadness, disillusionment and fear, Ojea said. All these shards left by the pandemic cannot be evaluated conveniently because of the proximity in time. This missionary outreach of our Church faces this reality and this context.

Follow Ins San Martn on Twitter:@inesanma

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Argentine bishops want people to hear the pope, not about the pope - Crux Now

Embryology

The ethical pitfalls of company-sponsored egg freezing – UCAN

In recent years, elective egg freezing by single women to preserve their fertility without medical reason commonly referred to as social egg freezing has gained much popularity worldwide. To date, this procedure is banned in only a handful of countries such as Singapore and China, where there is much ongoing debate to permit it.

The high costs of the procedure make it inaccessible to many younger single women with fewer savings, but with optimal egg quality for successful freezing. Hence some big corporations have stepped in to provide egg freezing benefits to their female employees for example, tech giants such as Apple, Facebook and Google.

Nevertheless, corporate sponsorship of egg freezing may be a violation of good medical ethics, in particular with regards to patient autonomy. This is in fact a key foundational cornerstone of biomedical ethics and can be broadly defined as the right of patients to make key medical decisions involving themselves, in accordance with one's own values, reasons, and motives, without undue influence and coercive pressure from another person or organization.

This is of particular significance for elective medical procedures involving substantial risks to patients, such as social egg freezing. Although unnecessary for the sustenance of either life or health, patients are exposed to substantial risks during egg freezing. For example, besides invasive surgery for egg extraction, patients can also potentially develop ovarian hyperstimulation syndrome (OHS), a medical condition where the body overreacts to injected hormones, the severe form of which may be life-threatening.

It can be argued that company sponsorship of egg freezing is unethical because it interferes with the patients autonomous decision-making process to undergo elective egg freezing without a valid medical reason while incurring substantial risks to herself. This is completely unlike employee medical benefits for the treatment of life or health-threatening conditions, which is involuntary and not the result of personal choice.

In a recent post that was published on Womens Forum Australia, it was stated that by normalizing and incorporating the practice as an employee benefit into workplace culture, it is not unreasonable to expect that this could create a more subtle pressure on women to take up the offer.

Added to such concerns is the fact that employers have a conflict of interest in delaying women from having children, as it keeps them in the workforce and is arguably more economically viable than other family-friendly work policies.

Worryingly, there may be an unwritten rule that if egg freezing benefits are available, then female employees are expected to utilize them to delay childbearing, rather than take maternity leave; or else they will not be promoted or be the first to be laid off if the opportunity arises.

A company offering to sponsor elective egg freezing for their female employees is akin to enticing and abetting them to undergo this risky procedure without a valid medical reason, thereby exerting some degree of undue influence on their decision-making process.

Moreover, the act of sponsoring egg freezing may be tantamount to encouraging and abetting false hope of future motherhood with this elective procedure, due to its low success rates. The American Society of Reproductive Medicine (ASRM) reported that the pregnancy success rate is relatively low, at around two percent to 12 percent per frozen egg.

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Similarly, the Human Fertilisation and Embryology Authority of the United Kingdom reported that only about one in five IVF treatment cycles were successful with a patients own frozen eggs. The uncertainty of future conception with social egg freezing may be further aggravated by the late age at which the majority of career women freeze their eggs, typically in their mid-thirties to early forties.

In future, if female employees are unable to conceive with their frozen eggs, could their employers be held accountable for encouraging and abetting them to freeze their eggs via company fringe benefits?

Indeed, as bioethics professor Heidi Mertes wrote: Egg freezing is often misleadingly portrayed as an insurance policy instead of a last resort. Each frozen egg cell represents a small chance of a healthy live birth, and those chances decline fast after a womans 35th birthday. Rather than an insurance policy, women are instead buying lottery tickets. If they buy a lot of tickets (that is, if they are able to bank a large number of good quality egg cells), they have a reasonable chance of success, but uncertainty is a fundamental feature of the system. Facebook and Apple are therefore investing in a false sense of security. They are certain to get a return on that investment, but are their employees?

Mertes also stated that company-sponsored egg freezing created a situation whereby women "owe" their employers. For example, a single woman who freezes her eggs at age 30 and bumps into Mr. Right the next day may want to embark on parenthood the year after. Will she be free from outside pressure to go ahead, or will the frozen eggs be regarded by both parties (employer and employee) as an addendum to the employment contract in which the employee has promised not to get pregnant in the first few years to follow? Also, what happens when she changes jobs?

Lawyer Lauren Geisser postulated that instead of refashioning the corporate norms of female employees sacrificing their youth and peak childbearing years for their employers, companies may find it in their best interest to offer egg freezing sponsorship at the expense of finding a long-term solution to sustaining long-term work-life balance and equality in the workplace.

Hence, corporate sponsorship of social egg freezing would implicitly assume that women will continue to bear the brunt of childcare and that the workplace will continue to be incompatible with pregnancy and motherhood, thus providing an empty solution of deferring childbirth via egg freezing.

Similar views were voiced by the journalist Nitasha Tiku, who wrote that women may feel pressured to use the egg freezing benefit to delay childbearing, just like everyone feels pressured to always be on call to the office, always check email, always have a smartphone in hand. If such coercive pressure exists, then this would be a clear violation of the patients autonomous decision-making process.

As such, company sponsorship of egg freezing should be viewed as a trespass on a patients autonomous decision-making process, thus contravening good medical ethics, and should therefore be strictly regulated or even prohibited by health authorities worldwide.

Dr. Alexis Heng Boon Chin is an associate professor of biomedical science at Peking University, China. He previously worked in the field of human clinical assisted reproduction research in Singapore and has authored 50 international journal publications on ethical and legal issues relating to new reproductive technologies in addition to publishing more than 250 scientific journal articles. The views in this article are those of the author and do not necessarily reflect the official editorial position of UCANews.

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Cell Biology

Outlook on the Cell Isolation Global Market to 2026 – by Technique, Cell Type, Product, Application, End-use and Region – ResearchAndMarkets.com -…

DUBLIN--(BUSINESS WIRE)--The "Cell Isolation Market: Global Industry Trends, Share, Size, Growth, Opportunity and Forecast 2021-2026" report has been added to ResearchAndMarkets.com's offering.

The global cell isolation market exhibited strong growth during 2015-2020. Looking forward, the publisher expects the market to grow at a CAGR of around 17% during 2021-2026.

Companies Mentioned

Keeping in mind the uncertainties of COVID-19, we are continuously tracking and evaluating the direct as well as the indirect influence of the pandemic on different end-use sectors. These insights are included in the report as a major market contributor.

Cell isolation, or separation, refers to the process of identifying and removing one or more specific cells from a heterogeneous mixture of cell population. The targeted cells are identified, isolated and separated according to their type. Some commonly used methods for cell isolation include magnet-activated cell separation, filtration, centrifugation and flow cytometry. Cell isolation is also used to diagnose diseases, cellular research and therapies by analyzing the ribonucleic acid (RNA) expressions. It aids in minimizing experimental complexity while analyzing the cells and reducing the interference from other cell types within the sample. As a result, it finds extensive application in cancer research, stem cell biology, immunology and neurology.

Significant growth in the medical and pharmaceutical industries is one of the key factors creating a positive outlook for the market. Furthermore, increasing emphasis on cell-based research is providing a thrust to the market growth. Researchers actively utilize isolated cells to develop novel cell therapies and cell-based treatments for various chronic medical ailments. Pharmaceutical manufacturers are also widely using cell isolation technologies to improve drug discovery and develop drugs with enhanced efficacies. In line with this, the increasing requirement for personalized medicines is also contributing to the growth of the market.

Additionally, the development of advanced separation tools for proteins, nucleic acids, chromatin and other complex cells for subsequent analysis is also contributing to the growth of the market. Other factors, including extensive research and development (R&D) activities in the field of biotechnology, along with the implementation of favorable government policies, are anticipated to drive the market toward growth.

Competitive Landscape:

The competitive landscape of the industry has also been examined along with the profiles of the key players being Alfa Laval AB, Becton Dickinson and Company, Beckman Coulter Inc. (Danaher Corporation), Bio-Rad Laboratories Inc., General Electric Company, Merck KGaA, Miltenyi Biotec B.V. & Co. KG, pluriSelect Life Science UG (haftungsbeschrankt) & Co. KG, Roche Holding AG, STEMCELL Technologies Inc., Terumo Corporation and Thermo Fisher Scientific Inc.

Key Questions Answered in This Report:

Key Topics Covered:

1 Preface

2 Scope and Methodology

3 Executive Summary

4 Introduction

4.1 Overview

4.2 Key Industry Trends

5 Global Cell Isolation Market

5.1 Market Overview

5.2 Market Performance

5.3 Impact of COVID-19

5.4 Market Forecast

6 Market Breakup by Technique

7 Market Breakup by Cell Type

8 Market Breakup by Product

9 Market Breakup by Application

10 Market Breakup by End Use

11 Market Breakup by Region

12 SWOT Analysis

13 Value Chain Analysis

14 Porters Five Forces Analysis

15 Price Analysis

16 Competitive Landscape

16.1 Market Structure

16.2 Key Players

16.3 Profiles of Key Players

For more information about this report visit https://www.researchandmarkets.com/r/b2ndjc

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Outlook on the Cell Isolation Global Market to 2026 - by Technique, Cell Type, Product, Application, End-use and Region - ResearchAndMarkets.com -...

Cell Biology

Colorectal Cancer Patients May Have More Drug Options With Systems Approach to Biomarker Identification – Genetic Engineering & Biotechnology News

Some patients are not eligible for targeted treatments for colorectal cancer because they have cancer-promoting mutations that are believed to cause resistance to these drugs. Now, researchers combined mathematical modeling with experimental cancer cell biology to determine why KRAS G13D is a biomarker for sensitivity to epidermal growth factor receptor (EGFR)-targeted therapies. This finding suggests that personalized medicine may benefit from using biomarkers based on biophysically defined subsets of mutations instead of gene-based and allele-based biomarker strategies.

The findings were published inCell Reports in the paper, Identification of RAS mutant biomarkers for EGFR inhibitor sensitivity using a systems biochemical approach.

Colorectal cancer patients who have tried all of the standard treatment options but still seen their cancer progress are in need of new options. Our study suggests that one already available targeted therapy could benefit up to 12,000 additional colon cancer patients every year, said Edward Stites, MD, PhD, assistant professor, integrative biology laboratory at the Salk Institute for Biological Sciences. Our findings are preclinical, and we hope this research will motivate clinicians to develop clinical trials that further examine our results.

Cetuximab was the first drug to gain FDA approval to block EGFR activity in colorectal cancer. Since then, other drugs that target EGFR also have received approval. But from the early development of these drugs, doctors believed that patients with a mutation in any one of the RAS proteins would not respond to EGFR drugs. Therefore, whenever molecular testing of a patients tumor revealed a RAS mutation, the patient was not offered these targeted therapies.

However, not all RAS mutations are the same. The critical mechanistic difference, the authors noted, between KRAS G13D and the other most common KRAS mutants is impaired binding to tumor suppressor Neurofibromin (NF1). The team hypothesized that impaired binding to NF1 is a biophysical biomarker that defines other RAS mutations that retain therapeutic sensitivity to EGFR inhibition.

The researchers combined computational and experimental approaches to find more RAS mutations that should not cause resistance to the EGFR drugs. Using cells from cancers that were identical except for specific RAS mutations allowed them to compare how each specific mutation influenced the response to EGFR-inhibiting drugs. They found that some RAS mutations did not prevent the drugs from working. These experiments also allowed them to validate their computational studies, which helps establish how new computational methods could contribute to improving treatment options for cancer patients.

The investigators also examined how well different RAS mutants bound to NF1. Stites previous mathematical models hinted that NF1 could play a key role in the cells response to targeted drugs. In their new studies, the researchers revealed that the RAS mutants that do not bind NF1 well retain sensitivity to EGFR drugs, while the RAS mutants that bind NF1 well are resistant to EGFR drugs. This relationship to EGFR drugs was not originally apparent, but the computational modeling was able to uncover it from within the available and varied data.

Ultimately, the investigators identified 10 distinct RAS mutations that do not preclude the use of EGFR inhibitors. Many of the drugs that would work for these mutations are already approved by the FDA for other uses, which means that doctors could start prescribing them for their patients off label even before clinical trials are conducted.

Stites stresses that this study also helps to validate the mathematical and computational methods developed by his team. Models can solve scientific problems that traditional methods cannot, he said. We hope that future clinical trials will help identify the magnitude of benefit as well as whether all the RAS mutations we identified are equally sensitive to the EGFR-inhibiting drugs and how other mutations in addition to RAS may influence the strength of the response.

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Colorectal Cancer Patients May Have More Drug Options With Systems Approach to Biomarker Identification - Genetic Engineering & Biotechnology News

Cell Biology

Chemistry professor researching genetic causes of schizophrenia: News at IU: Indiana University – IU Newsroom

The genetic causes of schizophrenia have remained elusive to researchers, but Indiana University Bloomington chemistry professor Yan Yu is taking on that challenge as part of a collaborative effort involving three institutions.

Yu and her team of graduate students at IU will collaborate with labs at the University of California San Diego and University of North Carolina Chapel Hill on a one-year pilot program to identify the genes that cause schizophrenia.

The severe neuropsychiatric disorder affects 1 in 100 people worldwide -- more than 21 million people -- and affects daily functioning by causing people to interpret reality abnormally. Symptoms can include hallucinations, delusions and confused thinking, and schizophrenia increases the risk of premature death. Treatment is needed to control the disorder, and the researchers hope to aid those efforts with their discoveries.

"Once genes associated with schizophrenia are identified, drugs can then be developed to specifically target the receptors and signaling pathways that are encoded by those genes," said Yu, an associate professor in the Department of Chemistry in the College of Arts and Sciences.

Identifying the genes is challenging because many genetic variations are involved, and studies have identified 145 genomic regions where variation is associated with schizophrenia risk. Thus, understanding how combinations of schizophrenia-related mutations alter neuronal function is a big challenge, Yu said.

The pilot program is supported by a $165,000 award from the Gordon and Betty Moore Foundation and administered by Research Corporation for Science Advancement. The award will be split evenly among the three labs. The funding is seed money to help the labs get preliminary results, Yu said, so they can compete for larger grants.

"The project is very ambitious as it brings together three labs in completely different fields," Yu said.

The multidisciplinary team will combine biosensors and advanced imaging from IU, precision genome editing from UC San Diego, and neuron cell biology from North Carolina. Yu has expertise in quantitative live-cell imaging and will determine how the schizophrenia-associated variations affect endosomal trafficking and degradation in neuronal cells. A Janus particle biosensor technique developed by Yu's lab is the foundation and centerpiece for the collaborative project, she said.

Alexis Komor, assistant professor of chemistry at UC San Diego, and Stephanie Gupton, associate professor of cell biology and physiology at North Carolina, are the other lead researchers on the project.

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Chemistry professor researching genetic causes of schizophrenia: News at IU: Indiana University - IU Newsroom

Cell Biology

Lyell Immunopharma Announces cGMP Qualification of LyFE Manufacturing Center in Advance of Initiating Clinical Programs – Yahoo Finance

Lyells cGMP-compliant manufacturing facility, is designed to produce cell products at scale for upcoming clinical trials across its CAR, TIL and TCR programs

LyFE Manufacturing Center integrates digital data analytics into processes for real-time production monitoring and optimization

SOUTH SAN FRANCISCO, Calif., Dec. 15, 2021 (GLOBE NEWSWIRE) -- Lyell Immunopharma, Inc. (Lyell), (Nasdaq: LYEL), a T-cell reprogramming company dedicated to the mastery of T cells to cure patients with solid tumors, announced today that its LyFE Manufacturing Center in Bothell, Washington has been commissioned and qualified in compliance with the U.S. Food and Drug Administrations (FDAs) Current Good Manufacturing Practices (cGMP).

The cGMP qualification confirms Lyell has the proper design, monitoring and control of its manufacturing facility. Since becoming operational in April 2021, the LyFE Center has completed successful engineering runs at scale in support of the Companys planned upcoming clinical trials.

We are advantageously positioned with qualified manufacturing infrastructure that we own and control to support consistent and reliable manufacture of cell products for our upcoming clinical trials, said Liz Homans, Chief Executive Officer of Lyell. We believe that combining cGMP manufacturing with our deep understanding of T-cell biology will help us achieve our vision of curing patients with solid tumors.

With 70,000 square feet of space, the LyFE Manufacturing Center provides several key capabilities for cell therapy manufacturing. The facility utilizes electronic systems with advanced data and analytics for real-time feedback, batch monitoring and process optimization. To support its digital manufacturing capabilities, Lyell collaborates with Amazon Web Services (AWS). The LyFE Manufacturing Center is one of the first cell therapy manufacturing facilities to benefit from AWS's extensive experience with cloud computing, Internet of Things (IoT) and advanced analytics.

Story continues

Lyell is dedicated to developing safe and effective cell therapies for patients by investing in innovative operations and technology, including our LyFE Manufacturing Center that is designed to support a broad pipeline and is now qualified to support cGMP manufacturing standards, said Stephen Hill, Chief Operating Officer of Lyell. Integrating digital systems into our manufacturing operations means quicker access to data, leading to faster recognition and implementation of process improvements.

About Lyell Immunopharma, Inc.

Lyell is a T-cell reprogramming company dedicated to the mastery of T cells to cure patients with solid tumors. The Company focuses on addressing what it believes are the primary barriers that limit consistent, reliable, and curative responses to adoptive T-cell therapy: T-cell exhaustion and lack of durable stemness, which includes proliferative capacity, ability to self-renew and ability to differentiate and eliminate solid tumors. Lyell is applying its proprietary ex vivo genetic and epigenetic reprogramming technology platforms, Gen-R and Epi-R, to address these barriers in order to develop new medicines with improved, durable, and potentially curative clinical outcomes. Lyell is based in South San Francisco, California and Seattle and Bothell, Washington. To learn more, please visit http://www.Lyell.com.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements expressed or implied in this press release include, but are not limited to, statements regarding: Lyells ability to produce cell products at scale for upcoming clinical trials across the Companys CAR, TIL and TCR programs; the integration of digital systems into our manufacturing operations and whether such integration will result in quicker access to data and faster recognition and implementation of process improvements; Lyells ownership and control of manufacturing infrastructure to support consistent and reliable manufacture of cell products for upcoming clinical trials; Lyells vision of curing patients with solid tumors; the therapeutic potential of Lyells product candidates; and other statements that are not historical fact. These statements are based on Lyells current plans, objectives, estimates, expectations and intentions, are not guarantees of future performance and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, but are not limited to, risks and uncertainties related to: the effects of the evolving COVID-19 pandemic; Lyells ability to submit planned INDs on the anticipated timing or at all; initiation of planned clinical trials and enrollment of patients in its future clinical trials; Lyells ability to manufacture and supply its product candidates for its future clinical trials; the preclinical profiles of Lyells product candidates not translating in clinical trials; the potential for results from clinical trials to differ from preclinical, early clinical, preliminary or expected results; significant adverse events, toxicities or other undesirable side effects associated with Lyells product candidates; the significant uncertainty associated with Lyells product candidates ever receiving any regulatory approvals; Lyells ability to obtain, maintain, or protect intellectual property rights related to its product candidates; implementation of Lyells strategic plans for its business and product candidates; the sufficiency of Lyells capital resources and need for additional capital to achieve its goals; and other risks, including those described under the heading Risk Factors in Lyells Quarterly Report on Form 10-Q for the quarter ended September 30, 2021 and Lyells future reports to be filed with the SEC. Forward-looking statements contained in this press release are made as of this date, and Lyell undertakes no duty to update such information except as required under applicable law.

Contact:Ellen RoseVice President, Communications and Investor Relationserose@lyell.com

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Lyell Immunopharma Announces cGMP Qualification of LyFE Manufacturing Center in Advance of Initiating Clinical Programs - Yahoo Finance

Cell Biology

Q&A: Dr. Thomas Rando on preventing age-related diseases and turning discoveries into cures – UCLA Newsroom

For Dr. Thomas Rando, the path to becoming a physician-scientist began with something that he didnt learn in high school biology.

After one class that touched on the connections between neurons and muscle fibers, Rando took it upon to himself to find all the information he could about how cells communicate through electrical signals. Soon, he began pursuing that interest at Harvard University, where he completed his undergraduate work, a doctorate in cell and developmental biology and his medical degree.

Rando joined the neurology faculty at the Stanford University School of Medicine in 1995. There, he founded a clinic to treat patients with Duchenne muscular dystrophy a muscle-wasting disease that affects approximately 1 in 5,000 boys in the U.S. and established a research program focused on muscular dystrophies, tissue repair and stem cell biology. For more than two decades, Randos lab also has studied the biology of aging. His work in that area was inspired by the patients he treated during his tenure as chief of neurology at the Veterans Affairs Palo Alto Health Care System.

Rando joined UCLA in October as director of the Eli and Edythe Broad Center ofRegenerative Medicine and Stem Cell Research. In this interview, he addresses the future of his field, the importance of state support for stem cell research and what he might be doing if he had to choose another career. Answers have been edited for brevity and clarity.

What are your predictions for the future of aging research?

From my labs work and the work of others, it appears to be possible whether through diet or drugs or new technologies to restore youthful properties to old cells. And that gives us great hope that were on to something in terms of understanding the fundamental biological changes of aging that lead us to be susceptible to diseases like cancer, heart disease and dementia.

The No. 1 risk factor for all of these conditions is not the genes that you carry; its your age. And I think were close to understanding the biology of aging to the point where we can modify it to reduce an individuals susceptibility to these diseases.

Today, when we test the blood of seemingly healthy people and find they have high cholesterol, we offer them statins to reduce their risk of a future stroke or heart attack. I can see a day when a blood test can tell us a persons risk of developing Alzheimers disease, lung cancer, diabetes or any of the other age-related diseases, and then we can prescribe the right drugs to reduce their susceptibility.

And if we can achieve that, the goal will be to reduce their risk factors for age-related diseases so they can live a healthier, long life as opposed to just a longer life. So thats the focus of our research: Can we increase peoples healthspan so that as they get into their 70s, 80s, 90s, even their 100s, theyre still physically fit and mentally sharp?

In 2020, California voters passed Proposition 14, which allocated $5.5 billion to stem cell research. How will that help shape the field?

It will do two things. It will move the field forward at the right pace and lead to many more clinical trials of stem cell therapies. At the same time, it will advance basic science research, which will help us better understand the fundamental properties of stem cells and what they are capable of. I mean, stem cell research is still a relatively new field, and although weve learned a great deal in the past several decades, theres still so much we have yet to discover.

Were lucky to live in California, where voters agreed it was an important initiative, and I think it will turn out to be a financial boon for the state. There will be companies formed and diagnostics and therapeutics developed that will benefit the state enormously and, by extension, the country and the world.

What has surprised you about the research enterprise at UCLA?

When I was being recruited, many people touted UCLAs collaborative culture. Honestly, I had heard that before from a lot of places; thats a common thing for people to say. But I have never seen it more true than here at UCLA.

Ive seen the collaborations that have been established, and Ive seen the shared spaces and equipment these are things that really inspire and energize people. Thats the way science is moving anyway away from the individual investigator to cross-disciplinary team science. I shouldnt have been surprised because UCLA is known for this, but I was duly impressed. I couldnt ask for a better environment for a highly collaborative program like the Broad Stem Cell Research Center.

Why is collaboration so important in stem cell research?

We dont just do great research here; we turn discoveries into first-in-human therapies. My role as director, and the role of the center as a whole, is to identify disease areas in which UCLA has expertise and bring all of the relevant experts together to form a pipeline from basic science research to clinical application. And there are so many disciplines that intersect with stem cell biology: medicine, life and physical sciences, engineering and dentistry are just a few.

What excites you about living and working in Los Angeles?

Making sure the university is active in the Los Angeles community is written into the genome of people at UCLA. The university is and considers itself to be a real part of the fabric of L.A., and the city views it that way, too. Im really looking forward to expanding the stem cell centers outreach to local high schools and health organizations.

If you had to choose a career other than your own, what would you be doing?

Woodworking is the kind of craft that I think I could have easily turned into profession and I would have loved it. When I was a young scientist, I could spend hours and hours at the lab bench, forget what time it was and forget to eat. The only other place Ive ever experienced that is in a woodshop, where I could spend 12 hours working and be sorry that the day was over. I havent pursued that interest for a long time, but Ive always thought I would get back to it one day.

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Q&A: Dr. Thomas Rando on preventing age-related diseases and turning discoveries into cures - UCLA Newsroom

Cell Biology

A potential protector against a mild heart attack’s aftereffects on metabolism – The Ohio State University News

A new study in mice shows transplanted brown fat can reduce type 2 diabetes risk factors after a heart attack, an encouraging finding for scientists who hope to apply the so-called good fats beneficial properties to drugs that can help prevent health problems.

In the study, transplanting brown fat tissue into the abdomens of obese mice protected the animals from developing glucose intolerance, a hallmark of type 2 diabetes, after a mild heart attack.

Gene activation linked to negative effects after the heart attack was dampened in the transplanted mice, suggesting that brown fat or adipose tissue talks to other tissue in the body in ways that affect a variety of metabolism-related processes. The research team is continuing to tease out the substances and mechanisms behind that cross talk and how it affects whole-body physiology.

In this study, the mice transplanted with brown adipose tissue were still obese but more metabolically healthy. The heart attack-induced glucose intolerance was negated by brown adipose tissue. The findings make a pretty powerful statement, said senior study author Kristin Stanford, associate professor of physiology and cell biology in The Ohio State University College of Medicine.

We think brown fat is secreting something, and if we can identify whats being released we can target that as a therapeutic.

The research is published online in the International Journal of Obesity.

Clinical research has shown that after a mild heart attack, people are more likely to develop insulin resistance and glucose intolerance, and are consequently more susceptible to having a second heart attack. Stanford said that what remains unclear is the cause for those increased risks: Does the first cardiac event itself make people more insulin resistant, or does the condition develop because people tend to be more sedentary after a heart attack?

Our primary thought process was, if we could improve glucose metabolism and reduce insulin resistance, would that have a protective effect later? said Stanford, whose lab is based in Ohio States Davis Heart and Lung Research Institute.

All mice in the study were fed a high-fat diet for eight weeks before being divided into experimental or control groups. Researchers transplanted brown fat from donor mice into the abdomens of the experimental group. Sixteen weeks later, half of all of the mice underwent a surgery in which one coronary artery was obstructed, inducing a mild heart attack.

The mice, all males, were kept on the high-fat diet and monitored for 24 weeks after the heart attack. At this point, the mice that had a heart attack but did not receive brown adipose tissue transplants had developed type 2 diabetes. The mice that had received brown adipose tissue transplants, while still obese, maintained normal glucose tolerance.

These results showed brown adipose tissue was protective against glucose intolerance even throughout the duration of the heart attack and the massive high-fat diet these mice were on for 40 or so weeks, Stanford said.

The transplanted tissue had additional long-term protective effects against problems seen in other mice after the heart attack, staving off an increase in the size of the hearts left ventricular chamber a sign of scarring that can lead to heart failure and preventing a drop in exercise tolerance.

Brown fat is known for its heat-generating properties it helps keep babies warm, for example but is hard to come by in the adult human body, with small amounts interspersed between the shoulder blades.

Stanfords lab had previously shown that exercise can drive up a beneficial lipid that comes from brown fat, a finding that helped explain how exercise boosts metabolism at the cellular level.

We didnt know whether brown adipose tissue would increase duration of exercise, and it did, suggesting that it improves whole-body health, which is an important marker, she said. We still need to figure out whether the protection comes from something secreted from the brown fat or from just increasing its mass.

The transplantation method could help the researchers in their pursuit of the tissue cross talk theory. Brown fat tissue was lodged in the animals abdomens among folds of visceral white adipose tissue the far more abundant type of fat in mammals bodies.

The team analyzed post-heart attack changes in expression of almost 100 genes linked to inflammation, scarring, insulin signaling, glucose metabolism and specific cell functions in the brown and white fat, the liver, heart and muscles of all of the mice. The increased presence of brown fat negated a host of damaging post-heart attack gene activations, leading the researchers to suggest that brown fat could be a key to preventing metabolic changes that harm the health of obese patients with cardiovascular disease.

Our hope is that we could eventually translate that to see how increasing brown adipose tissue could be a potential therapeutic in humans to protect them against insulin resistance or subsequent heart attacks, Stanford said.

Our data show that brown fat is affecting other tissues were just not exactly sure how. There could be several subtle changes working together as opposed to one direct tissue being modified, she said. Brown fat is such a small tissue, but it is so active.

This work was supported by grants from the National Institutes of Health and the American Heart Association.

Co-authors, all from Ohio State, include Carmem Peres Valgas da Silva, Vikram Shettigar, Lisa Baer, Eaman Abay, Kendra Madaris, Mikayla Mehling, Diego Hernandez-Saavedra, Kelsey Pinckard, Nickolai Seculov and Mark Ziolo.

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A potential protector against a mild heart attack's aftereffects on metabolism - The Ohio State University News

Cell Biology

Ethical issues cloud case report of unproven stem cell therapy for autism – Spectrum

Cell service: Parent reports suggest that a stem cell therapy eased their childrens autism traits, but experts remain skeptical.

Cavan Images / Getty Images

Undisclosed financial conflicts of interest and a lack of proper clearance mar a new study that injected four autistic children with stem cells from their own bone marrow, bioethicists say.

The study, which was published in October in Frontiers in Pediatrics, did not undergo ethical review and approval by an institutional review board (IRB), a critical step for research involving human participants.

While Im not familiar with their local or institutional regulations, in my view international standards would require prior institutional review and approval for this kind of experimental intervention, says Paul Knoepfler, professor of cell biology and human anatomy at the University of California, Davis, who has blogged critically about stem cell treatments for autism. Theres also no good rationale for the experimental treatment they used, which would have been something that an IRB also discussed, Knoepfler says.

Whats more, the study investigators did not disclose their ties to an Austrian clinic that sells the unproven therapy, nor did they disclose that the four childrens families paid to receive the injections possible financial conflicts of interest. An unrelated 2019 study of an unproven stem cell therapy for autism was retracted last week after similarly failing to disclose that its participants had paid to receive the treatment.

The new studys lead investigator Georg Kobinia, director of the Austrian Society for Regenerative Medicine, does not dispute that the participants families paid for his stem cell procedures. In response to emailed questions from Spectrum, Kobinia confirmed that the participants families had paid to receive the injections, but he did not answer questions about how much the procedure cost.

The treatments were ethically justifiable, he told Spectrum, because they were performed only after other autism therapies had failed to produce changes in the childrens behavior and co-occurring physical conditions.

Still, the largest placebo-controlled clinical trial of a stem cell treatment for autism to date showed no meaningful benefits, which raises questions about the rationale for Kobinias teams approach.

The children in the new study, who ranged from 3 to 14 years old, received the stem cell injections at Kobinias medical office, Stem Cell Therapy-Vienna, in Austria. While the children were sedated, Kobinia and his team extracted bone marrow from each childs hip bone, separated out the stem cells and then administered them back to each child via both a spinal tap and an intravenous infusion.

Before the treatment and at three-month intervals during the following year, the researchers asked the childrens parents to fill out the Autism Treatment Evaluation Checklist, a questionnaire that asks about changes in a childs autism-related behaviors. None of the childrens parents reported outcomes at all five time points.

All four childrens scores decreased after treatment, suggesting a reduction in autism traits and the severity of co-occurring physical issues. For instance, parents of one child reported improvement in their sons digestive issues, which autistic people experience at higher rates than their non-autistic peers do.

The team describes its work as promising. But the case series does not compare the four treated children with placebo or treatment-as-usual controls, so it is not clear how they can say that or draw any firm conclusions, Knoepfler says. Theres still a long way to go before the field gets to the point where people are convinced that this is an effective treatment.

Whats more, parent-reported outcomes can be unreliable, introducing several types of bias into a study, says Kristen Bottema-Beutel, associate professor of teaching, curriculum and society at Boston College in Massachusetts. Parents are invested in seeing their child gain from an intervention and may change the way they interact with their child, which can lead to positive changes a form of bias called placebo-by-proxy, she says. And parents so want their children to benefit from an intervention that, even in the absence of real improvements, they can subconsciously provide higher ratings on post-intervention reports, an issue known as detection bias. Bottema-Beutel studiesconflicts of interest in autism researchand is sometimes paid to speak on the topic.

Kobinia says that the stem cell injection he and his colleagues used does not constitute an experimental therapy and therefore does not require approval by an IRB. He also says that the retrospective nature of the case report precludes these procedures being classified as trials.

But for the case series to be retrospective, the children would have had to receive the stem cells with ethical approval for a different condition, Knoepfler says. Then, Kobinia and his team would have had to dig into the data after the fact to find out whether the procedure had inadvertently improved their autism-related behavioral traits.

Otherwise, anyone could do human experiments without IRB approval and then just claim that since reporting about it in a manuscript came later, that no IRB approval was needed, he says.

Additionally, despite conducting the treatments in a medical office that sells stem cell therapies for various conditions, and even though families paid for the procedure, Kobinia and his colleagues reported in their study that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. In response to Spectrums questions about this, Kobinia says there was no conflict, as a doctors office is not a company or clinic.

But the conflict-of-interest issue is not addressed by claiming a doctors office location, says Arthur Caplan, director of medical ethics at New York University in New York City. That is laughable.

Cite this article: https://doi.org/10.53053/ARWI8127

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Ethical issues cloud case report of unproven stem cell therapy for autism - Spectrum