AI Helps Unravel Mystery of Neurological Disorders

Neurological disorders are estimated to affect up to 1 billion people around the world—including nearly 100 million Americans—with roughly 7 million people dying of the maladies every year worldwide. The vast spectrum of more than 600 neurological disorders includes Alzheimer’s, Parkinson’s disease, strokes, multiple sclerosis, epilepsy, migraines and brain injuries.

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Top 3 Biotech Clinical Data Management Trends to Watch in 2022

Article | July 20, 2022

Introduction The administration of medical records and data has advanced significantly during the past few decades. Clinical data management, which was once only a small subset of biotech research organizations, has now developed into a mission-critical, specialized unit. In the late 1990s, electronic data capture (EDC) began to alter the traditional function of clinical data management. After that, the data configuration and management of data queries for the EDC system fell under the purview of clinical data management services. Today, clinical data management is not only responsible for managing the clinical data configuration and data queries but also developing and implementing data administration plans, ensuring data accuracy and completeness, and maintaining optimum data security. In recent years, as digital technologies have gained acceptance around the globe, data has become a vital aspect in decision-making across numerous industries, and the life sciences and biotechnology sectors are no exception. Using data has provided granular insights to biotech organizations, assisting them in creating breakthroughs in drug development and medical research and signifying the importance of clinical trial management systems in these medical verticals. The Biggest Biotech Clinical Data Management Trends to Know About Today The future of clinical data management is contingent upon the implementation of systems and regulations. It is imperative for all organizations participating in a medical or life science trial to have transparent rules in place for sharing and retaining patient data. Also, there is a need to have a standardized format for maintaining these records and documents related to trials. This assists biotech organizations in reducing the chances of ambiguity regarding who owns what kind of data or paperwork at any given time. Over the past couple of years, the focus of the life science and biotechnology industries has shifted towards developing more effective medications and therapies, implementing personalized treatment, and finding cures for diseases such as cancer and AIDS. In response to this, a substantial rise in the number of clinical trials is being witnessed globally. As the number of clinical trials continues to accelerate, the spending on these trials rises as well. In response to this, the worldwide cost of conducting clinical trials is anticipated to reach US$ 49.80 billion in 2022. With the transition of the world from traditional to digital, medical professionals and biotech businesses are increasingly shifting towards adopting high-tech and reliable clinical trial management systems for various applications, starting from diagnosis and clinical trials to patient data documentation. But, what are the future trends in biotechnology clinical data management? Let’s discuss. Cloud-Based Clinical Metadata Repositories Automation is emerging as a new frontier in the biotech clinical data management domain, along with other innovative technologies such as artificial intelligence and machine learning. Because of this, life science establishments are witnessing a huge shift from paper-based documentation toward data-based documentation, which is creating mountains of research, compliance, and clinical data. The growing demand for new and more effective medications and drugs is augmenting the need to expedite clinical trials. This is resulting in an increased number of initiatives aimed at optimizing clinical trial processes to prepare and launch successful trials. However, pharmaceutical and biotechnology laboratories are encountering several challenges in collecting, managing, and analyzing metadata due to its complexities. So, what is the best solution to this problem? The answer to this is cloud-based clinical metadata repositories. Clinical research facilities are leveraging advanced, all-in-one, cloud-based clinical metadata repositories to assist them in centralizing and managing metadata; increasing metadata quality, consistency, and accuracy; and speeding up clinical trial management, documentation, and compliance processes. Shift Towards Digital Solutions Electronic Case Report Form Adequate research and accurate data are crucial for a clinical trial to succeed. Whether developing new drugs, medication, or therapies; conducting life science research; or studying the latest clinical trial systems, it is best to use electronic solutions as it reduces the room for mistakes during the transition of clinical data from paper-based format. Realizing this, biotech organizations are shifting towards using electronic case report forms to speed up record retrieval, improve record security, and cut down on operational costs associated with running clinical trials. The electronic case report form assists in lowering the failure rate of the clinical trial, enhancing efficiency, and optimizing security along with improving clinical trial documentation and productivity, further driving its adoption in the medical space. Electronic Clinical Outcome Assessment Electronic clinical outcome assessment is surfacing as one of the fast-growing future trends in biotechnology. It allows clinical trial facilities to automate data entry and improve the reliability of the collected information. The technology enables clinical trial institutions to automatically record patient-provided information about side effects, symptoms, drug timing, and other aspects during the clinical trial for increased precision. It also helps these institutions analyze the results of medication or therapy in clinical trials and lets clinical researchers use medical technologies like biosensor-enabled devices, self-service applications, and medical wearables for evaluation. Hence, biotech clinical facilities are increasingly deploying advanced electronic clinical outcome assessment systems to ensure adherence to protocols and regulations. Clinical Trial Customization The success of a new drug is determined by numerous factors other than its effectiveness, safety, and creativity of its developers, such as a successful clinical trial. Each clinical trial involves a number of decision-making points, and one wrong choice in any of these aspects can jeopardize the success of the entire endeavor. A crucial component of making well-informed decisions is data management, which is a part of clinical study as a whole. Clinical trial customization is emerging as one of the most prominent biotech clinical trial management trends. Every clinical trial is unique and needs a tailored approach to be successful. With the emergence of the trend of personalized treatment around the globe, biotech and pharmaceutical organizations are adopting innovative customized clinical trial management solutions to accelerate the pace of clinical trials and approvals. This is giving clinical researchers innovative ways to come up with new medicines for patients and streamline the clinical data as per the requirements for faster approvals. What Are the Key Clinical Data Management Challenges Faced by Biotech Companies? Groundbreaking medical interventions are of no use without reliable, accurate, and extensive clinical trial data. Without the data, biotech and pharmaceutical companies will not be able to provide the assurance of safety and efficacy required to bring the medication to market. Regulatory bodies such as the Food and Drug Administration (FDA), the Medicines and Healthcare Products Regulatory Agency (MHRA), and others are putting stricter rules in place to ensure the quality of clinical data. In addition, the fast-changing clinical development environment is creating more obstacles for biotech and medical spaces to ensure the accuracy, standard, and completeness of the clinical trial data. Hence, clinical teams are spending valuable time cleaning up data instead of analyzing it. Time spent trying to figure out issues with clinical trial data is detrimental and expensive but also mission-critical. This is because a small issue in the data can lead to numerous consequences, from small delays to calamitous setbacks, making it necessary to rerun clinical trials. This problem will only get more challenging to address as the volume of data and the types of data sources continue to grow. Here are some of the major clinical data management challenges that biotech firms encounter Standardization of Clinical Metadata Stringent Regulatory Compliance Increased Clinical Trial Complexity Mid-Study Changes Why Are Clinical Data Management Systems Garnering Popularity in the Biotech Industry? With the changing regulatory and clinical landscape, biotech and pharmaceutical companies are facing several obstacles in the management of clinical data and clinical trials. In addition, regulatory agencies are moving toward integrated electronic systems, which is making it more and more important for clinical laboratories to change the format of their submissions. Because of this, several biotech clinical labs are focusing on adopting innovative laboratory solutions, such as biotech clinical data management systems, to meet the need for standardized data inputs and replace all manual ways of working with electronic systems. A clinical data management system establishes the framework for error-free data collection and high-quality data submission, resulting in speedier drug discovery and shorter time-to-market. These solutions are gaining huge traction among biotech and pharmaceutical companies, owing to their ability to effectively manage clinical data, accelerate clinical trials, and ensure compliance. Let’s see some of the features of biotech clinical data management software that are most sought after by life-science companies Controlled, standardized data repository. Centralized data analysis and administration. Reduced operational expenditures for clinical data processes. Enhanced process effectiveness. Superior submission quality Compliance with predefined standards. Clinical Data Management Systems: The Future The role of clinical data management systems is evolving at a rapid pace as the life science and medical industries continue to incorporate digital solutions for diverse operations. These systems are being used in a variety of biotech clinical settings, ranging from clinical data compliance to data science and analytics, to help them analyze large and growing volumes of clinical data. Hence, a number of high-tech medical companies are aiming at integrating innovative technologies, such as artificial intelligence and machine learning, into clinical data management software to automate clinical data management tasks, improve clinical data submission, and enhance data quality. These new biotech clinical management technologies are anticipated to help life science laboratories gain a better understanding of diseases and speed up clinical trials in the coming years. FAQ What is a clinical data management system? A clinical data management system (CDMS) is a tool used in clinical research to track, record, and manage clinical trial data across medical establishments such as biotech laboratories. What are the key functions of the biotech clinical data management system? Some of the key functions of biotech clinical data management system are Documentation of Protocols and Regulations Patient Recruitment Real-time Clinical Study Analytics Reporting Investigator Relationship Management Electronic Visit Report Why is a clinical data management system needed for clinical trials today? A clinical data management system helps shorten the time from drug development to marketing by assisting in the collection of high-quality, statistically sound, and accurate data from clinical trials.

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Medical

5 Biotech Stocks Winning the Coronavirus Race

Article | August 16, 2022

There are quite a few companies that have found ways to grow their business during the ongoing COVID-19 pandemic. This is especially true for a number of biotechs now working on developing a potential treatment for, or vaccine against, the virus; shares of such companies have largely surged over the past couple of months. Although many of these treatments and vaccines are still have quite a way to go before they're widely available, it's still worth taking some time to look through what's going on in the COVID-19 space right now. Here are five biotech stocks that are leading the way when it comes to addressing COVID-19. Regeneron Pharmaceuticals (NASDAQ:REGN) wasn't among the initial wave of companies to announce a potential COVID-19 drug. However, investor excitement quickly sent shares surging when the company announced that its rheumatoid arthritis drug, Kevzara, could help treat COVID-19 patients.

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Medical

Wisconsin biotech companies could play key roles in long-term economic recovery from COVID-19 pandemic

Article | July 14, 2022

Whether it’s called a modern “Manhattan Project” or a medical moon shot, the concept of long-term economic recovery rests on how confident people are they won’t risk serious illness by venturing forth in public again. Wisconsin stands to be a significant part of such an undertaking, whatever it’s called. The shorter-term debate is well under way over the gradual lifting of COVID-19 emergency rules, such as the now-extended “safer-at-home” order in Wisconsin. At least a dozen states, including regional coalitions on the East and West coasts, are exploring next steps as they seek to balance responses to the virus with calls for reopening the economy, at least, in part. Wisconsin’s ability to shape longer-term responses will come from private and public resources, which range from companies engaged in production of diagnostics.

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Medical

Better Purification and Recovery in Bioprocessing

Article | August 2, 2021

In the downstream portion of any bioprocess, one must pick through the dross before one can seize the gold the biotherapeutic that the bioprocess was always meant to generate. Unfortunately, the dross is both voluminous and various. And the biotherapeutic gold, unlike real gold, is corruptible. That is, it can suffer structural damage and activity loss. When discarding the dross and collecting the gold, bioprocessors must be efficient and gentle. They must, to the extent possible, eliminate contaminants and organic debris while ensuring that biotherapeutics avoid aggregation-inducing stresses and retain their integrity during purification and recovery. Anything less compromises purity and reduces yield. To purify and recover biotherapeutics efficiently and gently, bioprocessors must avail themselves of the most appropriate tools and techniques. Here, we talk with several experts about which tools and techniques can help bioprocessors overcome persistent challenges. Some of these experts also touch on new approaches that can help bioprocessors address emerging challenges.

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Gilson

Gilson provides high quality, dependable solutions for today's demanding liquid chromatography, solid phase extraction, liquid handling and gel permeation chromatography clean-up requirements. From the legendary PIPETMAN® products to a full range of system solutions, Gilson is the element of purification for your laboratory.

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Using Machine Learning To Reveal How the Brain Encodes Memories

Technology Networks | November 28, 2019

Researchers working in The N.1 Institute for Health at NUS, led by Assistant Professor Camilo Libedinsky from NUS Psychology, and Senior Lecturer Shih-Cheng Yen from the Innovation and Design Programme at NUS Engineering, have discovered that a population of neurons in the brain’s frontal lobe contain stable short-term memory information within dynamically-changing neural activity. This discovery may have far-reaching consequences in understanding how organisms have the ability to perform multiple mental operations simultaneously, such as remembering, paying attention and making a decision, using a brain of limited size. In the human brain, the frontal lobe plays an important role in processing short-term memories. Short-term memory has a low capacity to retain information. “It can usually only hold six to eight items. Think for example about our ability to remember a phone number for a few seconds – that uses short-term memory,” Libendisky explained.

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Electronic Chip Allows Synaptic Connectivity to Be Mapped at High Level

GEN | September 24, 2019

Scientists from Harvard University say they have developed an electronic chip that can perform high-sensitivity intracellular recording from thousands of connected neurons simultaneously. This advance allowed them to map synaptic connectivity at an unprecedented level, identifying hundreds of synaptic connections. “Current electrophysiological or optical techniques cannot reliably perform simultaneous intracellular recordings from more than a few tens of neurons. Here we report a nanoelectrode array that can simultaneously obtain intracellular recordings from thousands of connected mammalian neurons in vitro. The array consists of 4,096 platinum-black electrodes with nanoscale roughness fabricated on top of a silicon chip that monolithically integrates 4,096 microscale amplifiers, configurable into pseudocurrent-clamp mode (for concurrent current injection and voltage recording) or into pseudovoltage-clamp mode (for concurrent voltage application and current recording),” the investigators wrote. “We used the array in pseudovoltage-clamp mode to measure the effects of drugs on ion-channel currents. In pseudocurrent-clamp mode, the array intracellularly recorded action potentials and postsynaptic potentials from thousands of neurons. In addition, we mapped over 300 excitatory and inhibitory synaptic connections from more than 1,700 neurons that were intracellularly recorded for 19 minutes. This high-throughput intracellular-recording technology could benefit functional connectome mapping, electrophysiological screening, and other functional interrogations of neuronal networks.” “Our combination of the sensitivity and parallelism can benefit fundamental and applied neurobiology alike, including functional connectome construction and high-throughput electrophysiological screening,” said Hongkun Park, PhD, the Mark Hyman Jr. professor of chemistry and professor of physics, and co-senior author of the paper.

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Cancer Cells Form Synaptic Connections with Neurons

GEN | September 23, 2019

In aggressive glioblastoma, cancer cells plug into the brain’s neuronal network and receive impulses that appear to stimulate tumor growth. These impulses, which are transmitted via synaptic connections, may explain how brain tumors spread so quickly. They may also be subject to jamming—that is, to interference by drugs. If so, it may be possible to pull the plug on brain cancer. The shocking discovery that cancer tissue, like brain tissue, may be electrically active was reported by scientists from Heidelberg University Hospital and the German Cancer Research Center. In a paper (“Glutamatergic synaptic input to glioma cells drives brain tumor progression”) that appeared in Nature, these scientists noted that previous research had already established that glioblastoma cells connect with one another rather like neurons. This finding has been extended in the new research, which argues that tumor cells not only interconnect like neurons, they also interconnect with neurons. Even more intriguingly, the interconnections are active. “We report a direct communication channel between neurons and glioma cells in different disease models and human tumors: functional bona fide chemical synapses between presynaptic neurons and postsynaptic glioma cells,” the authors of the Nature article wrote. “These neurogliomal synapses show a typical synaptic ultrastructure, are located on tumor microtubes, and produce postsynaptic currents that are mediated by glutamate receptors of the AMPA subtype.”

Read More

Using Machine Learning To Reveal How the Brain Encodes Memories

Technology Networks | November 28, 2019

Researchers working in The N.1 Institute for Health at NUS, led by Assistant Professor Camilo Libedinsky from NUS Psychology, and Senior Lecturer Shih-Cheng Yen from the Innovation and Design Programme at NUS Engineering, have discovered that a population of neurons in the brain’s frontal lobe contain stable short-term memory information within dynamically-changing neural activity. This discovery may have far-reaching consequences in understanding how organisms have the ability to perform multiple mental operations simultaneously, such as remembering, paying attention and making a decision, using a brain of limited size. In the human brain, the frontal lobe plays an important role in processing short-term memories. Short-term memory has a low capacity to retain information. “It can usually only hold six to eight items. Think for example about our ability to remember a phone number for a few seconds – that uses short-term memory,” Libendisky explained.

Read More

Electronic Chip Allows Synaptic Connectivity to Be Mapped at High Level

GEN | September 24, 2019

Scientists from Harvard University say they have developed an electronic chip that can perform high-sensitivity intracellular recording from thousands of connected neurons simultaneously. This advance allowed them to map synaptic connectivity at an unprecedented level, identifying hundreds of synaptic connections. “Current electrophysiological or optical techniques cannot reliably perform simultaneous intracellular recordings from more than a few tens of neurons. Here we report a nanoelectrode array that can simultaneously obtain intracellular recordings from thousands of connected mammalian neurons in vitro. The array consists of 4,096 platinum-black electrodes with nanoscale roughness fabricated on top of a silicon chip that monolithically integrates 4,096 microscale amplifiers, configurable into pseudocurrent-clamp mode (for concurrent current injection and voltage recording) or into pseudovoltage-clamp mode (for concurrent voltage application and current recording),” the investigators wrote. “We used the array in pseudovoltage-clamp mode to measure the effects of drugs on ion-channel currents. In pseudocurrent-clamp mode, the array intracellularly recorded action potentials and postsynaptic potentials from thousands of neurons. In addition, we mapped over 300 excitatory and inhibitory synaptic connections from more than 1,700 neurons that were intracellularly recorded for 19 minutes. This high-throughput intracellular-recording technology could benefit functional connectome mapping, electrophysiological screening, and other functional interrogations of neuronal networks.” “Our combination of the sensitivity and parallelism can benefit fundamental and applied neurobiology alike, including functional connectome construction and high-throughput electrophysiological screening,” said Hongkun Park, PhD, the Mark Hyman Jr. professor of chemistry and professor of physics, and co-senior author of the paper.

Read More

Cancer Cells Form Synaptic Connections with Neurons

GEN | September 23, 2019

In aggressive glioblastoma, cancer cells plug into the brain’s neuronal network and receive impulses that appear to stimulate tumor growth. These impulses, which are transmitted via synaptic connections, may explain how brain tumors spread so quickly. They may also be subject to jamming—that is, to interference by drugs. If so, it may be possible to pull the plug on brain cancer. The shocking discovery that cancer tissue, like brain tissue, may be electrically active was reported by scientists from Heidelberg University Hospital and the German Cancer Research Center. In a paper (“Glutamatergic synaptic input to glioma cells drives brain tumor progression”) that appeared in Nature, these scientists noted that previous research had already established that glioblastoma cells connect with one another rather like neurons. This finding has been extended in the new research, which argues that tumor cells not only interconnect like neurons, they also interconnect with neurons. Even more intriguingly, the interconnections are active. “We report a direct communication channel between neurons and glioma cells in different disease models and human tumors: functional bona fide chemical synapses between presynaptic neurons and postsynaptic glioma cells,” the authors of the Nature article wrote. “These neurogliomal synapses show a typical synaptic ultrastructure, are located on tumor microtubes, and produce postsynaptic currents that are mediated by glutamate receptors of the AMPA subtype.”

Read More

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