Life Sciences Updates

For those who couldn't join us live, we're excited to share the recording of our third SEND webinar! This session focused on Cross-Study Analysis of SEND Datasets using Xbiom, where we covered everything from building a solid study repository to comparing datasets from similar compounds and classes.   What you'll learn: 🔹 Why having a reliable study repository is a game changer (and how to build one) 🔹 How to analyze datasets from the same compound 🔹 Tips for comparing studies within the same class   Catch the full recording here: https://lnkd.in/ggBq5CqN More information here: https://lnkd.in/gM-zh57k

We are thrilled to announce that PointCross Life Sciences and Hexaware Technologies have partnered to launch Clinical Data Automation as a Solution (CDAaaS), powered by PointCross' Xbiom™ platform. This solution is set to revolutionize the way clinical data is managed, reducing costs and timelines by up to 60%. Key Features: • Automated Data Management • Advanced Metadata Repositories and Smart Transformers • Seamless Integration of Wearables and Virtual Monitoring • Onboard Biostatistical Tools & AI Augmentation • Enhanced Patient Insights and Customizable Dashboards With CDAaaS, clinical trials will become more efficient, accurate, and streamlined benefiting both BioPharma and CRO clients. Learn more about how we are transforming clinical data management in Press Release here: https://lnkd.in/gD3p_Duj #PointCrossLifeSciences #ClinicalDataAutomation #LifeSciences #HealthcareInnovation #DigitalTransformation #DataSolution Raja Ramesh Tummala, Suresh Madhavan, Harinarayan Gopichandran (Hari), Rahul Madhavan, Vijaya Iyer, Milan Bhatt, Srini Marimganti, Ghananeel Gondhali

Join Us for the Next Webinar in Our SEND Series! 📅 When: Wednesday, September 25th, 2024 ⏰ Time: 09:00 AM PT / 12:00 PM ET We're excited to continue our SEND webinar series with a deep dive into Cross-Study Analysis of SEND Datasets Using Xbiom. Whether you’re comparing datasets from the same compound, class, or across historical studies, this session will provide practical insights and solutions. What you'll learn: 1) The importance of a strong study repository and how to build one 2) Strategies for analyzing datasets from the same compound 3) Tips on comparing studies within the same class This is the third part of our series, so if you’ve been following along, you know it's going to be packed with valuable takeaways! Register here: https://lnkd.in/geseKvrq Don't miss out—secure your spot today! #SENDWebinar #CrossStudyAnalysis #SENDDatasets #Xbiom #Webinar #LifeSciences

Nonclinical Study Monitoring with Xbiom™ We all know that study reports, while essential, often come too late to influence decisions during the study itself. Imagine having the ability to make real-time adjustments based on ongoing data analysis. That’s exactly what our Interim Nonclinical Study Monitoring Solution offers. Here’s how it works: • Real-Time Data Integration: We pull together data from various sources—whether it’s LIMS, assays, or other platforms—into one cohesive view. • Adaptive Monitoring: Spot early signs of toxicity, tweak protocols, or even consider new trial designs while the study is still running. • Support at Every Step: Our Data Concierge team, made up of data scientists, statisticians, and toxicologists, ensures your data is managed and integrated seamlessly. • Secure and Flexible: All of this happens on a private, encrypted cloud, giving you secure access whenever you need it. Whether you’re a large pharma company or a small biotech, Xbiom™ gives your team the tools to make more informed decisions during your studies, reducing surprises and ensuring consistency in your final data. Want to know more about how Xbiom™ can support your studies? Learn more: https://lnkd.in/g3aphKvB

Webinar Recap: Visualization of SEND Datasets    Last week, PointCross Life Sciences held a webinar on Visualizing your SEND datasets. For those who missed it or want to revisit the webinar, you may access the webinar recording and Q&A below:   Watch the Recording: https://lnkd.in/g2MQtw8S Q&A Session: https://lnkd.in/gkWMTM-u   Webinar Highlights: • How to visualize SEND datasets for QC • Conducting in-depth subject-level reviews • Mastering cross-study comparison and analysis • Understanding the limitations of using only SEND datasets for visualizations • Exploring pre-templated and customized TFLs   You will find this webinar to be particularly valuable if you are a professional in QC, data analysis, or study management.   As part of the industry's leading nonclinical study repository, we are committed to helping you get the most out of your SEND datasets.   Thank you to everyone who joined us and participated. We look forward to seeing you at the next one!   #SEND #DataVisualization #NonclinicalStudies #WebinarRecap #PointCross #DataAnalysis #LifeSciences 

Join Our Upcoming Webinar on "Visualization of SEND Datasets" As a leader in nonclinical study repositories, PointCross is committed to ensuring you extract the maximum value from your SEND datasets. What You’ll Learn: • How to Visualize SEND Datasets for QC Like a Pro • Conducting In-depth Subject-Level Reviews • Mastering Cross-Study Comparison and Analysis • Understanding the Limitations of Using Only SEND Datasets for Visualizations • Exploring Pre-templated and Customized TFLs Register now: https://lnkd.in/gGD7zq7s This session is perfect for anyone in QC, data analysis, or study management. Get ready for some hands-on tips and valuable insights that will elevate your data visualization skills! #DataVisualization #SENDDatasets #NonclinicalStudies #DataAnalysis #QualityControl #StudyManagement #TFLs #Webinar #PointCross #BiomarkerData #LifeSciences #CrossStudyAnalysis #SubjectLevelReview #DataScience #ClinicalResearch

Legumes thrive in low-nitrogen environments by partnering with rhizobia, soil bacteria that convert atmospheric nitrogen into ammonium, a usable form for the plants. These beneficial bacteria are housed in root nodules formed on legume roots. However, the uncontrolled formation of numerous root nodules can impede root function. To prevent this, legumes need to regulate the distribution and number of root nodules, but the precise mechanisms were previously unclear. Recent research on Lotus japonicus, a model leguminous plant, has unveiled that the interaction between legume roots and rhizobia is characterized by periodic gene expression with a six-hour rhythm. This rhythmic gene expression influences the regions of the root susceptible to rhizobial infection and the distribution of nodules. It was also discovered that the plant hormone cytokinin is crucial for maintaining this gene expression rhythm. This groundbreaking study, published in Science, is a collaborative effort conducted by the National Institute for Basic Biology, Nara Institute of Science and Technology, Hokkaido University, Kwansei Gakuin University, RIKEN, and Aichi University of Education. When rhizobia infect legume roots, root epidermal cells form infection threads, membranous tube-like structures guiding the bacteria to the inner root tissue where they can fix nitrogen. Rhizobial infection primarily occurs in a narrow root region just behind the root tip, known as the susceptible region. The continuous cell generation at the root tip perpetually creates new susceptible regions. Ideally, infection threads would be evenly distributed throughout the root. However, closer examination reveals a pattern of densely formed infection threads alternating with sparser regions, suggesting intermittent rather than continuous responses to rhizobia. Detailed studies on the dynamic response of roots to rhizobia over time have been lacking. Using luminescence live-imaging with luciferase as a reporter, the research team observed that NSP1 gene expression, rapidly induced in response to rhizobia and essential for the infection process, exhibited oscillatory patterns at approximately six-hour intervals in the susceptible region. As the root grew, new expression sites appeared apically to the previous oscillation regions. “We noticed that these oscillation regions coincide with areas where infection threads are densely formed, leading us to think that this rhythmic gene expression might be related to the determination of nodule formation sites,” said Dr. Takashi Soyano, Associate Professor of the National Institute for Basic Biology, a member of the research team. Consistent with this notion, a large population of root nodules was formed in the oscillation region, suggesting a link between rhythmic gene expression and nodule formation. Other genes essential for early responses during nodule symbiosis also displayed oscillatory expression patterns, marking the first evidence of periodic

Tokyo, Japan – Researchers from Tokyo Metropolitan University have devised a way to measure both the temperature and velocity profiles of fluid in a convective plume at millimeter length scales in 3D. They combined near-infrared absorption imaging and image processing to separate the motion of tracer particles from snapshots of how light is absorbed, producing both a smooth velocity and temperature map. The technology promises new insights into optimizing the design of micro-heating and cooling devices. Tokyo, Japan – Researchers from Tokyo Metropolitan University have devised a way to measure both the temperature and velocity profiles of fluid in a convective plume at millimeter length scales in 3D. They combined near-infrared absorption imaging and image processing to separate the motion of tracer particles from snapshots of how light is absorbed, producing both a smooth velocity and temperature map. The technology promises new insights into optimizing the design of micro-heating and cooling devices.   Accurate maps of how heat and matter flow at the microscale are vital to the design of micro-heating and cooling devices. A classic example is in liquid-cooled microprocessors, where flow will directly affect how efficiently heat is carried away from chips. Over the years, this has led to a wide range of techniques designed to map flow and temperature; for example, the video tracking of tiny “tracer” particles can yield an accurate flow map. But while methods exist to map different quantities separately, scientists are still looking for the best way to realize the mapping of multiple quantities at once, especially in three dimensions. A team of researchers from Tokyo Metropolitan University led by Professor Naoto Kakuta have been studying the use of near-infrared imaging to capture maps of temperature in bodies of fluid. The absorption by water of light in the near-infrared (NIR) is temperature dependent; by mapping how much is absorbed in different parts of a sample with multiple NIR cameras, they can create an accurate 3D temperature map. In previous work, they had succeeded in applying this to visualize tiny convective plumes, where heating of a microscopic portion of a volume of fluid creates a vertical, circulatory flow. But while temperature could be mapped, it was not possible to map the flow profile at the same time. This is a significant drawback, since convective flows feature a complex coupling between heat transport and flow. But simply adding tracer particles and applying existing methods would require additional illumination by high-power LEDs or lasers. The team had already noticed that tracer particles introduced into the same fluid cast a shadow against the NIR illumination used to create the temperature map. Preliminary work had helped make two-dimensional maps by simply watching how the shadows move. Now, they have succeeded in creating fully 3D maps by using the same two camera system used for their NIR

<!-- Content start --> CARLSBAD, Calif., July 18, 2024. Ionis Pharmaceuticals, Inc. announced today that it has completed enrollment in the pivotal trial of zilganersen (ION373), an investigational RNA-targeted medicine in development for the treatment of children and adults with a rare, progressive and ultimately fatal neurological disorder known as Alexander disease (AxD). The primary endpoint is percent change from baseline in gait speed as assessed by the 10-Meter Walk Test (10MWT). Topline data are anticipated in the second half of 2025. AxD is estimated to occur in an estimated one in one million people in the U.S. and can present throughout life.1-3 The disease is a result of genetic variants in the glial fibrillary acidic protein (GFAP) gene that disrupt the structure and function of astrocytes in the brain. AxD is generally characterized by cognitive dysfunction and progressive neurologic deterioration, including loss of independence and the ability to control muscles for large movements, swallowing and airway protection. Zilganersen is designed to stop the excess GFAP that accumulates because of disease-causing variants in the GFAP gene, with the goal of slowing or stabilizing disease progression in people living with AxD. “Current approaches to disease management for Alexander disease can mitigate some symptoms of AxD but do not address the underlying cause or slow disease progression. Our zilganersen study is the first trial to evaluate an investigational medicine designed to address the underlying cause of Alexander disease,” said Eugene Schneider, M.D., executive vice president and chief clinical development officer at Ionis. “We are grateful for the dedication and support from the patients, families and investigators in the Alexander disease community, whose partnership has made this milestone possible.” About the Zilganersen StudyThe global, multicenter, randomized, double-blind, controlled, multiple-ascending dose (MAD) is a Phase 1-3 study (NCT04849741), which enrolled patients aged two to 65 with Alexander disease (AxD) across 13 sites in eight countries. Participants were randomized in a 2:1 ratio to receive zilganersen or control for a 60-week double-blind treatment period. At 60 weeks, all participants will receive zilganersen for a 180-week open-label treatment period, followed by a 28-week post-treatment follow-up period. The primary endpoint is percent change from baseline in gait speed as assessed by the 10-Meter Walk Test (10MWT) at the end of the double-blind treatment period. Secondary endpoints include change from baseline in patients’ self-identified Most Bothersome Symptom (MBS) Score, Patient Global Impression of Severity (PGIS) Score, Patient Global Impression of Change (PGIC) Score and Clinician Global Impression of Change (CGIC) Score at the end of the double-blind treatment period. The study includes an open-label sub-study in eligible participants under the age of two years with AxD, which

Some species of fish can evolve their egg-laying habits in response to predators in the area in order to survive, according to new research from The University of Texas at Arlington. It has long been observed that organisms modify their traits, including reproductive patterns, in response to changes in their environment. This type of evolutionary plasticity has been observed in many types of animals in different habitats and with varying predators. “We knew that fish who laid their eggs externally often adapted depending on the predators in the area, but we did not know how quickly species could change to these externals pressures,” said biology Professor Matthew Walsh, who recently published a paper on the topic in the journal Proceedings of the Royal Society B. For his research, Dr. Walsh and biology lab technician Christopher Roden studied a small type of fish called the killifish that lives on the island of Trinidad in the Caribbean. Ranging in size from about 2 to 6 inches, the killifish are ideal for evolutionary studies because they are highly adaptable to their surroundings. Some types of killifish are even known to be amphibious, able to live on land to avoid predators. The researchers tested the differences in egg-hatching plasticity among killifish living in sites with and without predators. They then examined the reproductive habits of those two populations by measuring the rates of hatching when eggs were laid submerged in water versus outside water on the surface of moist peat moss. The timing, hatching and offspring growth rates between the two groups of fish were then compared. “Our study found striking differences in egg-hatching plasticity among killifish living in different habitats,” said Walsh. “This research provides new insights into how aquatic organisms adapt and evolve to changes in their environment. These findings may be particularly important in predicting how species are able to adapt to external pressures, such as those caused by climate change.”