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Arbor Strengthens Focus on Therapeutics with Key Additions to Leadership Team – Yahoo Finance

Posted: July 21, 2021 at 2:02 am

- Pam Stetkiewicz, Ph.D., Appointed Chief Operating Officer - Kathryn McCabe, Ph.D., Named SVP, Head of Business Development

CAMBRIDGE, Mass., July 20, 2021 (GLOBE NEWSWIRE) -- Arbor Biotechnologies, an early-stage life sciences company discovering and developing the next generation of genetic medicines, announced today the appointments of Pam Stetkiewicz, Ph.D., as Chief Operating Officer, and Kathryn McCabe, Ph.D., as SVP, Head of Business Development. These appointments further expand Arbors leadership team and strengthen its focus on therapeutics.

Bringing Pam and Katy on at this time represents a significant milestone for Arbor as we drive our genetic medicines portfolio to the clinic and partner with leading companies to bring engineered cell therapies to patients, said Devyn Smith, Ph.D., CEO, Arbor Biotechnologies. Their scientific expertise, business acumen, and extensive experience in cell therapy and gene editing will help us execute on this strategy to develop therapeutics with our tailored library of CRISPR-based genetic editors and modifiers.

Pam Stetkiewicz is joining Arbor from Flagship Pioneering, where she was Senior Vice President, Global Program Leader at Flagship Pioneering Medicines. Dr. Stetkiewicz brings more than 20 years of extensive life-sciences pharmaceutical experience with recent experience at Editas Medicine as Vice President, Program and Alliance Management. At Editas, she led the team that filed the first IND for an in vivo CRISPR therapeutic (EDIT-101 for LCA10). Prior to Editas, Dr. Stetkiewicz worked at Novartis Institute of Biomedical Research for 13 years, in a variety of roles across science, alliance, project and portfolio management. Her last role at Novartis was as Executive Director, in Strategic Alliances which involved early business development and collaborations with external companies. She received her Ph.D. from Johns Hopkins University and a B.S. from the University of Rhode Island.

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Im thrilled to be joining Arbor at this exciting time, said Dr. Stetkiewicz. The company has made significant progress in the discovery and development of innovative therapies, particularly in the genetic medicines space, and I am looking forward to helping fulfill the therapeutic promise of Arbors already impressive discoveries.

Kathryn (Katy) McCabe is joining Arbor from Roche where she was Senior Director of Business Development based in Cambridge, MA. Over the last 20 years, she has combined her scientific knowledge, entrepreneurial spirit, and business experience to help transform novel modalities into new medicines at Roche, Lilly, Baxalta and GSK. Dr. McCabe has focused much of her attention on cell and gene therapy and has closed deals for CAR-T, diabetes cell therapy, in vivo gene editing, and gene therapy as well as led large strategic initiatives in these areas. In addition, she has had close interactions with a number of venture funds as the scientific lead for Lillys limited partnerships. Early in her career, Dr. McCabe led a team of senior scientists to develop stem cells for retina and corneal transplantation. She was a Postdoctoral Fellow in Dr. Marianne Bronners lab at Caltech, received her Ph.D. in Neuroscience and Behavior from the University of Washington, and her B.A from the University of Pennsylvania.

I look forward to finding partners that share our vision of bringing curative therapies to patients, said Dr. McCabe.

About Arbor BiotechnologiesArbor Biotechnologies is an early-stage life sciences company discovering and developing the next generation of genetic medicines. Co-founded by Feng Zhang and David Walt, Arbor uses its proprietary discovery engine to uncover unique CRISPR-based genetic modifiers with differentiated genetic editing and delivery capabilities. Following its strategic partnership with Vertex Pharmaceuticals to accelerate the path to the clinic for Arbors technologies, Arbor recently announced an agreement with Lonza. These partnerships further validate the breadth of applications of Arbors gene editing platform that can be custom tailored to address the underlying pathology of each genetic disease. Arbors pipeline of genetic medicines is focused on bringing curative therapies to all patients with genetic disease.

Media Contact:Kelly Friendlypress@arbor.bio

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Missouri S&T hosts first in series of national critical minerals workshops – Missouri S&T News and Research

Posted: July 21, 2021 at 2:00 am

What are critical minerals, where do we find them, and why are they considered critical? Leading critical-minerals experts from across the country will answer these questions and more during a virtual workshop hosted by Missouri S&T Aug. 2-3. The workshop will provide insight and answers to issues surrounding materials such as cobalt for lithium-ion batteries in electric vehicles, germanium for transistors, tellurium for solar cells and rare earth elements for magnets and electronics.

The term critical minerals describes commodities whose unreliable supply threatens our nations economy and defense, says workshop organizer Dr. Marek Locmelis, assistant professor of geology and geophysics at Missouri S&T. The critical-minerals discussion cuts across a variety of disciplines, from mining and geosciences to public policy to environmental considerations. Important concerns are sustainability, ethical and responsible sourcing, and research for compounds that could replace critical minerals.

Missouri S&T will host eight keynote presenters:

Keynote presentations will address several topics: supply chains, global politics, domestic sourcing and production, recycling, and reprocessing. The workshop will also address the illicit critical-mineral economy, a topic of increasing urgency as critical minerals are sometimes unethically mined for example, using child labor and human trafficking and illegally marketed, similar to issues associated with conflict diamonds.

The workshop will also feature breakout sessions where participants will discuss research needs in areas related to the keynote presentations. The discussions can be used to inform Congress and develop federal funding initiatives.

The workshop is funded through a grant from the National Science Foundation and is the first in a planned series of national conversations about critical minerals. The workshops will bring together representatives from higher education, industry and government to help spur action and disseminate research on critical minerals.

We are grateful for the NSFs support for this crucial topic, says Locmelis. We will continue the discussions during an in-person workshop on the Missouri S&T campus in mid-2022. Because the critical-mineral challenge will stay with us for decades, we look forward to developing the workshop into a regular series of meetings in the future.

In addition to Locmelis, workshop organizers include Dr. Michael Moats, professor and interim chair of materials science and engineering; Dr. Kwame Awuah-Offei, interim director of mining and explosives engineering; Dr. Lana Alagha, associate professor of mining engineering; Dr. Mark Fitch, assistant chair and associate professor of civil, environmental and architectural engineering; Dr. Alanna Krolikowski, assistant professor of history and political science; and Dr. Angela Lueking, associate dean for research in the College of Engineering and Computing at Missouri S&T.

The workshop is open to anyone who is interested in critical minerals. For more information or to register, visit criticalminerals.mst.edu/.

About Missouri University of Science and Technology

Missouri University of Science and Technology (Missouri S&T) is a STEM-focused research university of over 7,600 students and part of the four-campus University of Missouri System. Located in Rolla, Missouri, Missouri S&T offers 101 different degree programs in 40 areas of study and is ranked by CollegeFactual as the best public university to study engineering. For more information about Missouri S&T, visit http://www.mst.edu.

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In Brief This Week: DiaSorin, Cue Health, Avacta, Pandemic Response Lab, TruDiagnostic, and More – 360Dx

Posted: July 21, 2021 at 1:59 am

NEW YORK In a filing with the US Securities and Exchange Commission this week, Luminex said it became a wholly owned, indirect subsidiary of DiaSorin,and the previously announced merger of the companies has been completed.

DiaSorin announced in a separate statement thatit completed the acquisition for a price of $37 per share, or a total equity value of approximately $1.8 billion. The acquisition gives it access to Luminexs multiplexing technology, a portfolio that will strengthen its current offeringand expand its presence in the US, DiaSorin said.

Cue Health said this week that its Cue COVID-19 Test Kit has received regulatory approval from the Central Drugs Standard Control Organisation for professional point-of-care use in India. The molecular test provides results within 20 minutes and connects to smartphones to report results. The test can also detect emerging variants, Cue said in a statement.

Avacta Life Sciences said this week that its diagnostics division has obtained ISO 13485 certification for the quality management system for the manufacture and distribution of its Affimer reagents for use in lateral flow, ELISA, and immunodiagnostic in vitro diagnostic devices. The ISO standard defines the requirements for quality management for a developer and legal manufacturer of diagnostic products and medical devices. Avacta said the certification provides a practical foundation for addressing regulatory requirements and ensures the safety of its products. The certification also means that a CE mark for the AffiDx SARS-CoV-2 antigen lateral flow test can be transferred to Avacta from its partner Mologic, Avacta added.

The Pandemic Response Lab and Brio this week announced they are partnering to offer COVID-19 testing and variant surveillance for the entertainment industry. Brio will provide sample collection services, logistics, reporting, advanced software, and support to entertainment facilities. PRL, operated by Opentrons Labworks, will conduct PCR testing and genome sequencing of positive results to track variants. PRL can provide results from PCR testing in six hours or less, the firms said in a statement. Financial and other terms of the deal were not disclosed.

Ott Scientific said this week it is merging its four legacy organizations into one business called Ethos Biosciences. Ethos will operate four product lines and service brands American Bionostica for lateral flow products; Astral Diagnostics for histology and hematology stains and reagents; Exocell for research and clinical nephrology assays; and Astral Rx for pharmaceutical formulations. Ethos will serve the diagnostics market, including healthcare, biotechnology, veterinary, and food and environmental testing. It will operate in Newtown Square, Pennsylvania, and Logan Township, New Jersey.

The Access to Comprehensive Genomic Profiling Coalition, a group working to expand insurance coverage of broad genomic testing panels for advanced cancer patients, this week announced Strata Oncology as its newest member. Strata offers comprehensive genomic profiling using its StrataNGS panel, and combines patients genomic information with real-world data to provide information doctors can use to make personalized treatment plans. The company also operates a clinical trial platform.

TruDiagnosticsaid this week it has licensed mitotic clock technology from the Van Andel Institute and Cedars-Sinai Medical Center. Developed by epigenetics researchers at those institutions, the mitotic clock examines how many times a cell has undergone replication, and could be useful in clinical research and personalized medicine applications, TruDiagnosticsaid. For instance, the technology may be able to detect cell senescence, a biomarker for aging; unusually high levels of cell division, which may be a biomarker for cancer or other disease; and stem cell depletion. TruDiagnostic said that it will work with researchers at the Van Andel Institute to further develop the technology.

MedMira, a developer and manufacturer of rapid diagnostic tests, said this week that it has closed a C$500,000 ($396,648) equity investment with a Canadian investor to increase its operational capacity. The equity investment, fully diluted, represents less than 1 percent of its total shareholding. Under the terms of the deal, the investor will acquire 2,711,496 equity units at $0.18444 per unit.

ACT Genomics Holdings said this week that its next generation sequencing-focused operation and laboratory at the Hong Kong Science Park has received accreditation from the College of American Pathologists. The new accreditation significantly strengthens the NGS testing services and R&D capacity for the company, which already has CAP-accredited laboratories in Taipei, Taiwan, and Kanagawa, Japan. The 3,500-square-foot Hong Kong laboratory has a dual NGS testing platform from Illumina and Thermo Fisherand is run by a team of eight qualified laboratory technicians, ACT said. Apart from boosting the group's capacity for providing services and support, the three laboratories will continue to pursue research projects, helping ACT develop new products.

In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared on 360Dx.

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In Brief This Week: DiaSorin, Cue Health, Avacta, Pandemic Response Lab, TruDiagnostic, and More - 360Dx

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The University of Vermont: Impactful research, healthier world – Study International News

Posted: July 21, 2021 at 1:56 am

At the University of Vermont, researchers are focusing on what matters. Here, in Burlington, Vermont, surrounded by majestic vistas, some of the brightest minds in the world are harnessing the power of research to achieve no small feat: supporting the health of our environment and our societies. They are striving for sustainable solutions with local, national, and global applications and impact.

Part of UVMs success lies in its cross-disciplinary research and collaboration made possible by a public research university of its size and scale. At the Larner College of Medicine, an innovative research model is shedding light on immune response in dengue infection, with the potential of saving hundreds of millions of lives per year. Another breakthrough is fast-tracking promising discoveries in the fight against cancer.

Over at the College of Education and Social Services (CESS), PhD students are unleashing human potential and in the process of making education accessible to people of all abilities.

To create a better future for all will take the entire might of nations and individuals working together. UVM has the unique strengths to lead this charge. Below are four stories that offer a window on a sliver of the work that UVM is doing to create new knowledge and build new practices to help societies thrive today and for generations to come.

What happens when grit is paired with opportunities

Hans Cabra

Hans Cabra, a Fulbright Scholar from Bogot, Colombia, knows what true courage is. The PhD in Educational Leadership and Policy Studies candidate grew up in a sketchy neighbourhood with a mother who only completed elementary school and a father who barely made it beyond middle school. Where other marginalised children from impoverished backgrounds dont see a way out of the trap, he dared to dream. He applied for a scholarship to Norway and got it.

Education gave me an opportunity to escape poverty and ignited a passion for helping young people to pursue their dreams, he shares. As a PhD scholar at UVM, hes doing just that.

Cabra is pursuing research on after-school programmes and how to cultivate grit and perseverance. I believe that grit is the main ingredient in achieving success, but it has to be paired with the right opportunities, he explains. These opportunities completely changed my life and the lives of my family members. I want to bring this transformative power of education to all the kids in my community and in my country.

Access for all abilities

Sefakor Komabu-Pomeyie grew up in a village in Ghana, marginalised because of her disability and gender. When she was eight years old, she was diagnosed with polio after being administered an expired vaccination. The virus left her unable to walk on her own. Stigma followed.

Sefakor Grateful Komabu-Pomeyie

The power of education helped Komabu-Pomeyie beat the odds of life. In 2011, she was selected as a Ford International Education Fellow, which enabled her to come to Vermont and earn a masters degree in sustainable development, with a concentration in policy analysis and advocacy, from the School for International Training.

Today, Komabu-Pomeyie is taking her education to new heights as she works toward a PhD in Educational Leadership and Policy Studies. She is also building an accessible and inclusive school in Ghana for students of all abilities. The odds may have been stacked against her, but armed with a UVM degree, shes ready to take her seat at the policy table when she returns to Ghana.

Recently, for her work as an education and disabilities advocate, she was honoured with the prestigious International Service Award from the Association of University Centres on Disabilities at a ceremony in Washington, DC.

Its a life-changing moment. Its a huge award. It means the work I have been doing from my village has been recognised internationally, she says, adding her gratitude for UVM professor Maria Mercedes Avila, PhD, for nominating her for the award.

Saving hundreds of millions of lives

The Aedes mosquito-borne dengue virus is a pathogen that plagues the tropical regions of the world. In 2019, it caused a record number of over 400 million cases. Its effects range from asymptomatic to severe diseases many times, it can be fatal.

Vaccines have been hard to develop, as there are four strains to protect equally against. Only one vaccine, Dengvaxia, has been approved for a subset of at-risk individuals in endemic areas.

A study by UVM is offering hope. Led by Associate Professor of Microbiology and Molecular Genetics (MMG) Sean Diehl, PhD, it set out to determine biomarker candidates and predictors for clinical and immunological responses resulting from dengue infection.

Associate Professor of Microbiology and Molecular Genetics Sean Diehl

These data offer new potential biomarkers for characterising dengue virus infection and novel pathways that could be leveraged to combat viral replication, explains Diehl. Our results also gave us some clues about how we might be able to boost protective immune responses, which is the goal of developing effective vaccines.

Diehl adds that for some of the genes identified in this study, little is known about their role in the response against dengue virus. This is very exciting, because it could lead to new ways to fight dengue, so we are now investigating these in the lab, shares Diehl.

A potential target for new cancer treatments

For two decades, UVM Cancer Centre researcher Jason Stumpff, PhD, has studied how cells divide and how mistakes in this process contribute to diseases, such as cancer. Every killer has a weak spot, and Stumpffs latest work has unearthed a vulnerability that could be a potential target for interrupting cancer cell growth.

Stumpffs recent work focuses on the role of a protein called KIF18A in driving cell division. In these new studies, his lab found that cancer cells are more dependent on KIF18A for growth than normal cells. Target KIF18A and its possible to stem or stop cancer.

This promising discovery was made possible by UVMs wide-ranging collaboration with national and international partners. Stumpffs findings mark a milestone in a long research journey that began with support from an American Cancer Society Institutional Research Grant pilot award through the UVM Cancer Centre, and then led to Susan G. Komen and National Institutes of Health (NIH) funding.

The collective impact of this research collaboration exemplifies the importance of sharing data and enhancing rigour of scientific studies to move fundamental science discovery effectively toward important progress in the fight against cancer, says Stumpff.

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Times really up! FDA authority to crack down on regenerative medicines upheld as grace period ends – JD Supra

Posted: July 21, 2021 at 1:54 am

Following the courts decision in US Stem Cell Clinic, CBER Director Peter Marks, M.D., stated in an FDA Voices blog post that the agency will continue cracking down on unapproved products marketed as regenerative medicine therapies, citing how the US Stem Cell decision is a victory for public health and an endorsement of the FDAs work to stop stem cell clinics that place patients at risk by marketing products that violate the law. Dr. Marks also referred to a second injunction case, United States v. Cell Surgical Network et al., which is currently being litigated in the U.S. District Court for the Central District of California, and a third enforcement action pursued by the FDA involving the seizure of vials of Vaccinia Virus Vaccine, Live, which was resolved in March 2018.

Since 2015, FDA has been documenting violations of current Good Manufacturing Practice (cGMP) requirements for tissue products by US Stem Cell Clinic. The agency issued aWarning Letterto the clinic in August 2017, which weanalyzed here. The clinic claimed that FDAs cGMP regulations were not applicable because the treatment falls under FDAs same surgical procedure and 361 HCT/P exceptions to regulation under the Federal Food, Drug, and Cosmetic Act (FDCA) and the Public Health Service Act (PHSA). In June 2019, a Florida district court ruled in favor of FDA, and enjoined the clinic from offering its stem cell therapy to patients.

As we summarized (here), the district courtfoundthat the population of stromal and vascular cells in US Stem Cell Clinics therapy, known as stromal-vascular fraction (SVF), requires FDA approval of a New Drug Application (NDA) or a Biologics License Application (BLA) before it can be commercially marketed. The court also found that the therapy was adulterated and misbranded because of the clinics manufacturing procedures and that its promotion violated statutory requirements.

On appeal with the Eleventh Circuit, US Stem Cell Clinic again argued it is exempt from regulation under the FDCA because the procedure falls into the same surgical procedure exception at 21 C.F.R. 1271.15(b). This provision states that FDAs regulation does not apply if you are an establishment that removes HCT/Ps from an individual and implants such HCT/Ps into the same individual during the same surgical procedure. Arguing before the District Court, FDA had successfullyassertedthat the SVF implanted into the clinics patients does not constitute such HCT/P removed from the patient due to the processing steps applied to the SVF in this case, meaning US Stem Cell Clinic was not covered by this exception.

In prefacing its analysis, the Eleventh Circuit notably explained that it was not merely offering judicial deference to FDA, saying it was giving the agencys view no special weight. The court said that although [t]here was a time when a court faced with a regulation that seemed impenetrable on first read might simply wave the ambiguity flag and defer to the agencys interpretation, this is the case [n]o longer. Rather, the court carefully consider[ed] the text, structure, history, and purpose of [the] regulation, and resolved the apparent ambiguity in FDAs favor.

First, the court considered the clinics argument that cells or tissues can be HCT/Ps only if they are intended for implantation into a patient, and it is the SVF and not the adipose tissue that is intended for implantation. The court rejected this defense, explaining that because adipose tissue contains the SVF, and because HCT/Ps are articles containing or consisting of human cells or tissues that are intended for implantation into a patient, both the adipose tissue and the SVF are HCT/Ps subject to regulation.

Second, US Stem Cell Clinic argued that an HCT/P re-implanted into a patient meets the regulatory definition of such HCT/P if it is like or similar to the HCT/P removed from the patient. The Eleventh Circuit disagreed. Instead, the court adopted FDAs interpretation that such HCT/P refers to the antecedent HCT/P removed from the patient in its original form. The Eleventh Circuit agreed with FDA and the District Court that the SVF procedure does not fall within the same surgical procedure exception because the biological material implanted into the patient is not the same as that removed. The court cited a history of FDA treating such HCT/Ps as meaning HCT/Ps in their original form that have not been subjected to significant processing.

The clinic also argued on appeal that it is exempt from regulation under the FDCA and PHSA because the procedure falls into the 361 HCT/P exception, whereby an HCT/P meeting four criteria (set forth in 21 C.F.R. 1271.10(a)) is deemed a 361 HCT/P, meaning that it is regulated solely under Section 361 of the Public Health Service Act (PHSA) and its implementing regulations in 21 C.F.R. Part 1271. Being deemed a 361 HCT/P subjects a therapy to a lighter regulatory burden. However, the Eleventh Circuit ruled that the 361 HCT/P exception does not apply because the HCT/P in this case is not intended for homologous use only.

Homologous use is the repair, reconstruction, replacement, or supplementation of a recipients cells or tissues with an HCT/P that performs the same basic function or functions in the recipient as in the donor. 21 C.F.R. 1271.3(c). US Stem Cell Clinic argued that SVF meets the homologous use criterion of a 361 HCT/P because SVF was intended to perform the same basic regenerative function both before and after the procedure. However, the District Court determined that the Clinic intended that the SVF treat a litany of illnesses in the recipient, which is not the same basic function that the SVF performed prior to the procedure.

The Eleventh Circuit agreed with the District Court that the clinic intends the stem cells to perform functions after the procedure that are beyond the basic functions the stem cells performed prior to the procedure. The court said that promotion of an HCT/P for an unproven therapeutic use, such as curing cancer, would be a nonhomologous use, and thus the 361 HCT/P exception does not apply in this case. In making this determination, the court said it relied upon the labeling, advertising, and other indications of the manufacturers objective intent. Because the defendants had marketed their SVF therapy to treat an array of diseases, the court found the clinic could not argue the pre-procedure SVF cells were intended to have performed the same function as the re-implanted SVF cells.

In issuing its opinion, the court permanently enjoined US Stem Cell Clinic from offering its adipose stem cell therapy unless and until several conditions were met, including FDA approval of a new drug application or biologics license application for the SVF solution.

In 2017, FDA published a new regenerative medicine policyframeworkconsisting of four guidance documents, which provided for a grace period of risk-based enforcement discretion for certain HCT/Ps, which ended on May 31, 2021. This grace period was meant to give certain manufacturers time to assess whether they need to file an IND or marketing application with FDA, or whether they met the four regulatory criteria for continuing to market their products solely under the authority of section 361 of the PHSA, which does not require pre-market review and approval.

Following up on the governments victory in this legal battle, CBER Director Peter Marks, M.D., published a blog on June 3 warning that FDA will be cracking down on unapproved products marketed as regenerative medicine therapies, citing how the Eleventh Circuit affirmed the lower courts judgment in US Stem Cell as cause for the renewed admonition. Marks wrote that the US Stem Cell decision is a victory for public health and an endorsement of the FDAs work to stop stem cell clinics that place patients at risk by marketing products that violate the law.

More recently, on July 9, CBER added a Q&A page on its website about the end of the HCT/P enforcement discretion period, drawing a clear line in the sand to convey that FDA is serious about the end of enforcement discretion period. Notably, the Q&A page directs physicians not to administer an HCT/P that does not qualify for 361 HCT/P status, until that HCT/P has a BLA, unless that physician is studying the HCT/P as a clinical investigator in a clinical trial under an IND. It also appears to say that there is no grace period for products that were introduced into interstate commerce before May 31, 2021 and are still on the market.

This was the not the first time that CBER has warned of impending enforcement of its regenerative medicine policy framework; in an FDA Voices blog post on April 21, Marks had written that the agency will not again extend the grace period for HCT/P companies to come into compliance with its regenerative medicine policy framework. In both that article and the June 3 publication, Marks emphasized that FDA has taken and will continue to take action regarding unlawfully marketed HCT/Ps. Most recently Marks wrote that, since December 2018, the FDA has issued 400 letters to manufacturers and health care providers who may be offering violative stem cell or related products. In addition, since 2017, FDA has issued 14 Warning Letters and 24 Untitled Letters involving violative HCT/Ps, Marks wrote.

We recently analyzed (online here) the significance that these warnings carry for companies in the regenerative medicine space, and outlined the potential risks of noncompliance. These risks go well beyond FDA enforcement, and include the possibility of FTC action, False Claims Act liability, product liability claims, and susceptibility to private lawsuits.

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How Innovative AI Trends Can Reshape the Biotechnology Industry – CIOReview

Posted: July 21, 2021 at 1:51 am

The biotechnology industry has advanced significantly due to artificial intelligence and other computerized tools.

FREMONT, CA: Biotechnology companies and various health organizations worldwide maintain massive databases. Drug manufacturing, chemical analysis of multiple compounds, RNA and DNA sequencing, enzyme studies, and other similar biological processes require the strong support of computerized tools and applications to increase efficiency and reduce manual errors.

Today, the world is confronted with an unprecedented public health crisis in the form of a Coronavirus pandemic. Economies are collapsing, countries are being placed on lockdown, and all hope is being placed in the biotechnology industry to develop a safe, effective vaccine in the shortest amount of time possible. Artificial intelligence is critical in biotechnology and related applications for managing biological processes, increasing drug production, managing supply chains, and overlooking the industry's data pool.

Increased and improved predictability for both structured and unstructured data enables businesses to plan their operations more efficiently and effectively, resulting in increased productivity and a faster pace of work.

The following are some significant AI trends that will reshape the biotechnology industry.

Advancing Innovations: From the Laboratory to the Market

The demand for drugs, industrial chemicals, food-grade chemicals, and other biochemistry-related raw materials has increased over the last decade. Artificial intelligence in biotechnology is critical for accelerating drug discovery and development (right to the point where it reaches the market). AI-based tools and apps help develop molecule structures based on target markets. It uses machine learning to calculate permutations and combinations of various chemicals to find the best variety without manual experimentation in the lab. Predictive analysis can forecast market demand for a particular drug or chemical using artificial intelligence in biotechnology. AI in biotech can also help manage the intelligent distribution of raw materials required by the biotechnology industry.

Open-Source Artificial Intelligence Platforms: Accelerate Data Analysis

Scientists around the world are researching AI programs that can automate data maintenance and analysis. Using open-source AI programs such as CRISPR libraries and H2O.ai frees lab assistants from repetitive data entry and analysis tasks. Other critical informatics tasks are also systematically analyzed to produce more accurate and timely results. Removing manual functions from healthcare providers and scientists can focus on innovation-driven processes enabled by biotechnology AI.

Expanding Agricultural Biotechnology's Boundaries: Improving Quality and Quantity

Biotechnology is crucial in the development of more and better crops. AI-based tools are required to study crop features, note and compare qualities, and forecast plausible yield. Aside from these tools, the agricultural biotechnology industry uses robotics for packaging, harvesting, and other essential tasks. By combining weather forecasts, farmland data, and the availability of seeds, manure, and pesticides, AI in biotech helps plan future patterns in material movement.

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Within weeks of first COVID-19 outbreak, China’s Qingdao Weida Biotechnology had switched all production capability over to PPE – PRNewswire

Posted: July 21, 2021 at 1:51 am

In April 2020, Weida designed and started producing a highly comfortable protective overall made up of protective clothing, a pair of goggles and a mask after realizing that it was quite inconvenient for medical staff to put on and take off traditional protective gear with poor breathability as well as the separate set of goggles and mask that could easily leave marks on the face. Compared with traditional offerings, the protective overall extends the effective protection time from four hours to eight hours and reduces the number of individual pieces that make up a complete set from 15 to 7 while shortening the time required to suit up and later remove the outfit from 27 minutes to 9. The company has obtained six patents for the protective product based on its advantages, including virus isolation, a high level of air and moisture permeability, the wide window, no facial marks, anti-fog lens and a design that makes it easy to put on and take off.

In March 2020, Weida received approval from the United States Food and Drug Administration and the CE Mark in Europe to export medical masks and isolation gowns to Europe and the US. Notably, the firm's EIDA protective suits, isolation gowns and masks have been exported to 57 countries and regions worldwide, including Canada, France, Italy, Japan, Spain, the UK and the US.

Weida's protective suits, isolation gowns, masks and protective masks have become the preferred choice for the frontline workers at a number of public organizations across China, including the 301 Military Hospital in Beijing, airports in Qingdao and the mobile cabin hospitals in the Xinjiang Uygur Autonomous Region.

SOURCE Information Office of the People's Government of Shandong Province

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Within weeks of first COVID-19 outbreak, China's Qingdao Weida Biotechnology had switched all production capability over to PPE - PRNewswire

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We Think Lixte Biotechnology Holdings (NASDAQ:LIXT) Can Afford To Drive Business Growth – Simply Wall St

Posted: July 21, 2021 at 1:51 am

There's no doubt that money can be made by owning shares of unprofitable businesses. For example, although software-as-a-service business Salesforce.com lost money for years while it grew recurring revenue, if you held shares since 2005, you'd have done very well indeed. Having said that, unprofitable companies are risky because they could potentially burn through all their cash and become distressed.

So should Lixte Biotechnology Holdings (NASDAQ:LIXT) shareholders be worried about its cash burn? In this article, we define cash burn as its annual (negative) free cash flow, which is the amount of money a company spends each year to fund its growth. We'll start by comparing its cash burn with its cash reserves in order to calculate its cash runway.

Check out our latest analysis for Lixte Biotechnology Holdings

A company's cash runway is the amount of time it would take to burn through its cash reserves at its current cash burn rate. When Lixte Biotechnology Holdings last reported its balance sheet in March 2021, it had zero debt and cash worth US$7.7m. Looking at the last year, the company burnt through US$2.7m. That means it had a cash runway of about 2.8 years as of March 2021. That's decent, giving the company a couple years to develop its business. You can see how its cash balance has changed over time in the image below.

Lixte Biotechnology Holdings didn't record any revenue over the last year, indicating that it's an early stage company still developing its business. So while we can't look to sales to understand growth, we can look at how the cash burn is changing to understand how expenditure is trending over time. During the last twelve months, its cash burn actually ramped up 61%. Oftentimes, increased cash burn simply means a company is accelerating its business development, but one should always be mindful that this causes the cash runway to shrink. Lixte Biotechnology Holdings makes us a little nervous due to its lack of substantial operating revenue. We prefer most of the stocks on this list of stocks that analysts expect to grow.

While Lixte Biotechnology Holdings does have a solid cash runway, its cash burn trajectory may have some shareholders thinking ahead to when the company may need to raise more cash. Generally speaking, a listed business can raise new cash through issuing shares or taking on debt. One of the main advantages held by publicly listed companies is that they can sell shares to investors to raise cash and fund growth. By looking at a company's cash burn relative to its market capitalisation, we gain insight on how much shareholders would be diluted if the company needed to raise enough cash to cover another year's cash burn.

Lixte Biotechnology Holdings has a market capitalisation of US$37m and burnt through US$2.7m last year, which is 7.5% of the company's market value. That's a low proportion, so we figure the company would be able to raise more cash to fund growth, with a little dilution, or even to simply borrow some money.

As you can probably tell by now, we're not too worried about Lixte Biotechnology Holdings' cash burn. For example, we think its cash runway suggests that the company is on a good path. Although its increasing cash burn does give us reason for pause, the other metrics we discussed in this article form a positive picture overall. After taking into account the various metrics mentioned in this report, we're pretty comfortable with how the company is spending its cash, as it seems on track to meet its needs over the medium term. Separately, we looked at different risks affecting the company and spotted 3 warning signs for Lixte Biotechnology Holdings (of which 1 is significant!) you should know about.

Of course Lixte Biotechnology Holdings may not be the best stock to buy. So you may wish to see this free collection of companies boasting high return on equity, or this list of stocks that insiders are buying.

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This article by Simply Wall St is general in nature. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. *Interactive Brokers Rated Lowest Cost Broker by StockBrokers.com Annual Online Review 2020

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Vir Biotechnology Initiates Phase 2 Clinical Trial Evaluating the Combination of VIR-2218 and VIR-3434 as a Functional Cure Regimen for Chronic…

Posted: July 21, 2021 at 1:51 am

SAN FRANCISCO, July 15, 2021 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that the first patient has been dosed in the Phase 2 MARCH (Monoclonal Antibody siRNA Combination against Hepatitis B) trial evaluating VIR-2218 together with VIR-3434 for the treatment of patients with chronic hepatitis B virus (HBV) infection a combination designed to achieve a functional cure.

VIR-2218 is an investigational small interfering ribonucleic acid (siRNA) designed to inhibit the production of all HBV proteins (X, polymerase, S and core), which may be acting as immune tolerogens. VIR-3434 is an investigational HBV-neutralizing monoclonal antibody designed to block entry of all 10 genotypes of HBV into hepatocytes, as well as reduce the level of virions and subviral particles in the blood. It has also been Fc engineered to include the XX2 vaccinal mutation, allowing it to potentially function as a therapeutic T cell vaccine against HBV.

HBV infection remains an urgent global public health challenge associated with significant morbidity and mortality, and we believe that a combination approach focused on immune restoration will be critical to achieving a functional cure, said Phil Pang, M.D., Ph.D., Virs chief medical officer. We are excited about the potential of VIR-2218 to serve as the cornerstone of that approach. We believe that combining it with VIR-3434, which has already demonstrated the ability to markedly lower hepatitis B surface antigen at low doses in an ongoing Phase 1 trial, and, most importantly, has the potential to function as a therapeutic T cell vaccine, could be a game changer.

The multi-center, open-label Phase 2 trial is designed to evaluate the safety, tolerability and efficacy of the combination of VIR-2218 and VIR-3434 in approximately 90 adult patients (ages 18 to 65) with chronic HBV infection receiving nucleot(s)ide reverse transcriptase inhibitor therapy. Both VIR-2218 and VIR-3434 will be administered via subcutaneous injection at varying dose levels over the course of the trial for a treatment period ranging from four to 20 weeks, and a follow-up period of up to 116 weeks, depending on the dosing cohort. The primary endpoints of the trial are the proportion of patients with treatment-emergent adverse events and serious adverse events; grading of post-treatment clinical laboratory parameters; and the proportion of patients achieving a functional cure (defined as undetectable HBsAg and sustained suppression of HBV DNA).

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About VIR-2218

VIR-2218 is an investigational subcutaneously administered HBV-targeting siRNA that has the potential to stimulate an effective immune response and have direct antiviral activity against HBV. It is the first siRNA in the clinic to include Enhanced Stabilization Chemistry Plus (ESC+) technology to enhance stability and minimize off-target activity, which potentially can result in an increased therapeutic index. VIR-2218 is the first asset in the companys collaboration with Alnylam Pharmaceuticals, Inc. to enter clinical trials.

About VIR-3434

VIR-3434 is an investigational subcutaneously administered HBV-neutralizing monoclonal antibody designed to block entry of all 10 genotypes of HBV into hepatocytes and reduce the level of virions and subviral particles in the blood. VIR-3434, which has been Fc engineered to potentially function as a T cell vaccine against HBV in infected patients, also incorporates Xencors Xtend in order to have an extended half-life.

About Vir Biotechnology

Vir Biotechnology is a clinical-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases. Vir has assembled four technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. Its current development pipeline consists of product candidates targeting COVID-19, hepatitis B virus, influenza A and human immunodeficiency virus. For more information, please visit http://www.vir.bio.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as may, will, plan, potential, aim, promising and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Virs expectations and assumptions as of the date of this press release. Forward-looking statements contained in this press release include, but are not limited to, statements regarding the ability of VIR-2218 and VIR-3434 (as monotherapies or combination therapies) to treat and/or prevent chronic HBV infection, and the timing, design and enrollment plans for the Phase 2 MARCH trial. Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data observed during preclinical or clinical studies, challenges in the treatment of hospitalized patients, difficulties in collaborating with other companies or government agencies, challenges in accessing manufacturing capacity, successful development and/or commercialization of alternative product candidates by Virs competitors, changes in expected or existing competition, delays in or disruptions to Virs business or clinical trials due to the COVID-19 pandemic, geopolitical changes or other external factors, and unexpected litigation or other disputes. Other factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Virs filings with the U.S. Securities and Exchange Commission, including the section titled Risk Factors contained therein. Except as required by law, Vir assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

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Vir Biotechnology Initiates Phase 2 Clinical Trial Evaluating the Combination of VIR-2218 and VIR-3434 as a Functional Cure Regimen for Chronic...

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Top Biotech Experts to Speak at the 2021 ISPE Biotechnology Virtual Conference & Workshops – Yahoo Finance

Posted: July 21, 2021 at 1:51 am

ISPE announced a world-class line-up of eight leading biotech experts as keynote presenters for the 2021 ISPE Biotechnology Virtual Conference & Workshop. This unparalleled fully interactive virtual event will bring together leading pharmaceutical and biopharmaceutical manufacturers, technology providers, academic scientists, and international regulators to network, share knowledge, and provide an outlook on the evolving landscape and future of biopharmaceutical manufacturing and therapies.

NORTH BETHESDA, Md., July 15, 2021 /PRNewswire-PRWeb/ -- The International Society for Pharmaceutical Engineering (ISPE) announced a world-class line-up of eight leading biotech experts as keynote presenters for the 2021 ISPE Biotechnology Virtual Conference & Workshop. Taking place 22-24 September 2021, this unparalleled fully interactive virtual event will bring together leading pharmaceutical and biopharmaceutical manufacturers, technology providers, academic scientists, and international regulators to network, share knowledge, and provide an outlook on the evolving landscape and future of biopharmaceutical manufacturing and therapies.

"This year, in particular, the industry rallied together to innovate at record speed and partnered in ways that were unprecedented to address not only the public health crisis brought on by the pandemic, but also to ensure patients worldwide would continue to have access to necessary therapies," said Program Co-Chair David Doleski, Head of Global Quality Audit, Sanofi. "This conference will help prepare biopharmaceutical professionals and their organizations for the impact of innovations in biologics that will influence their operations and shape the future."

Keynote presenters will kick off day one of the conference with presentations on industry-critical topics such as regulatory aspects for advanced therapy medicinal products (ATMPs), cell and gene therapies, and COVID-19 therapies and vaccines. Then they will come together for a compelling panel discussion.

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Keynote Presenters:

Matthew JH Davis Senior GMP Inspector Therapeutic Goods Administration

Raj Puri Director, Division of Cellular and Gene Therapies CBER/FDA

Wilson Bryan Director, Office of Tissues and Advanced Therapies CBER/FDA

Francesco Cicirello Director, Quality Assurance Evelo Biosciences

Jessica Beyer Director, Cell Therapy Manufacturing Bristol Myers Squibb

Oliver Henning Senior Vice President Operations BioNTech SE

Rino Rappuoli Chief Scientist GSK

Sandy Douglas Academic Clinician University of Oxford

The ISPE Biotechnology Virtual Conference & Workshop is a leading interdisciplinary forum for all stakeholders of the pharmaceutical and biopharmaceutical value chain to unite and learn about the latest innovations and trends, and openly discuss practical challenges and solutions, from a technical, logistical, and regulatory perspective.

Event exclusives include plant tours featuring state-of-the-art facilities and two in-depth workshops. Workshop participants will be presented with a case study and practice finding solutions with the help of trainers. Topics include control strategy, technology transfer, CMC, computer-based modeling, ATMPs, facility design, and GXP compliance.

"The impact of the evolving regulatory environment and the need to ensure continued innovation and continuity in the supply chain in light of this crisis and assuring preparedness for future crises will be integrated throughout the conference agenda, panel discussions, and accompanying workshops," said Program Co-Chair Prof. Dr. Michelangelo Canzoneri, Global Head of Digital and Data, Healthcare, Merck KGaA, Darmstadt, Germany.

To explore the educational agenda and to register, please visit ISPE.org/Bio21.

About ISPE The International Society for Pharmaceutical Engineering (ISPE) is the world's largest not-for-profit association serving its members through leading scientific, technical, and regulatory advancement across the entire pharmaceutical lifecycle. The 18,500 members of ISPE are building solutions in the development and manufacture of safe, effective pharmaceutical and biologic medicines, and medical delivery devices in more than 90 countries around the world. Founded in 1980, ISPE has its worldwide headquarters and training center in North Bethesda, Maryland USA, and its operations center in Tampa, Florida USA. Visit ISPE.org for more information.

For more information, contact: Amy Henry Marketing Communications Manager International Society for Pharmaceutical Engineering (ISPE) Email: ahenry@ispe.org ISPE.org

Media Contact

Amy Henry, ISPE, 8139602105, AHENRY@ISPE.ORG

SOURCE ISPE

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