Study Suggests MDMA Could Help People With PTSD, Autism

April 22, 2019 | 43 views

Drugs like ketamine or MDMA (the active ingredient in ecstasy) have thus far been regarded as party drugs, and have spent several decades under legal restrictions because of the perception. However, recent studies have shown that these mind-altering substances might actually be useful for doing exactly that altering how the brain functions. While ketamine has been shown to provide relief from drug-resistant forms of depression, a study conducted earlier this month with MDMA shows promising results for a wider array of beneficiaries, from patients with mental health issues like post-traumatic stress disorder, to people with conditions characterized by difficulty interpreting social cues, like autism. The study was led by researchers from Johns Hopkins University and the Massachusetts Institute of Technology, who tested mice with a single dose of MDMA, finding that they were able to re-trigger a part of the brain that made positive connections with social interactions. Think of the brain as a soft, pliable thing  as we grow into adulthood, our brains are less moldable and less likely to react differently to situations. While we’re young, there exists what researchers refer to as a ‘critical period,’ where social behaviors are learned. During this window or period, which happens during adolescence, our brains are wired to perceive social interactions as more rewarding  they make us feel good. As we age, this window closes and we might display a diminishing desire for social interaction. As it happens, this is the case for mice, too.

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Amplycell

Ever had a promising cell line which just did not perform ? A cell line which does not produce enough, or long enough? Amplycell is a biotech service company of which mission is to optimize recombinant protein and monoclonal antibody productions for Diagnostic and Pharmaceutical firms.

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How to Choose a Reliable Biotech Clinical Trial Management System?

Article | July 13, 2022

Introduction The medical and life-science industries are experiencing a robust transformation with the increasing prevalence of various types of diseases, including infectious diseases, chronic disorders, and acute conditions around the world. As a result, a significant rise in demand for more effective therapeutic drugs and bionics is being witnessed, leading to a swift increase in the number of clinical trials. For a successful trial, it is important for biotech companies to ensure the data submitted to regulatory bodies regarding clinical trials is accurate, reliable, and definitive from an ethical point of view. A reliable clinical trial management system plays a vital role in collecting, monitoring, and managing clinical data. The availability of high-quality clinical data also helps clinical research institutions make efficient treatment decisions and provide proper patient care. Hence, a number of biotech companies and research organizations are focusing on leveraging innovative clinical trial management solutions to handle a large amount of data, particularly in multi-center trials, and generate reliable, high-quality, and statistically sound data from clinical trials. However, selecting the most appropriate and reliable clinical trial management system is vital for the clinical trial's success. Let's see some of the steps that will assist these firms in choosing the right CTMS. Key Steps for Selecting Right Biotech Clinical Trial Management System Prioritize Study Needs Considering and prioritizing study needs is a crucial step in choosing the most reliable clinical trial management system for biotech companies. Prioritizing helps them to identify a solution that improves the study's quality and removes uncertainty for researchers when faced with difficult choices. Hence, biotech and life-science organizations should choose a clinical trial system that is simple to use, well-organized, and suitably designed to minimize the number of clicks required to complete a task. Select CTMS with Multiple Integrations Integrated clinical trial management systems provide the best value for the companies’ funds as they guarantee the smooth functioning of research protocols. In addition, integrations are necessary to fully understand the importance and advantages of clinical trial management software for ensuring smooth transitions between site management and data collection. Biotech and clinical research should look for CTMS platforms that can integrate with electronic medical record (EMR) platforms and clinical research process content (CRPC) billing grids. This will allow them to use the same billing designations and ensure compliance while minimizing the need for duplicate processes. Ensure System Compliance and Security Clinical research organizations need to adhere to a plethora of complex regulations in order to ensure compliance with one of the most challenging environments of principles, which is information security and privacy. Security and system compliance are vital aspects of choosing the right CTMS solutions for biotech firms as they assist in building trust and form a part of the system’s duties. While selecting CTMS systems, it is essential for companies engaged in clinical research to ensure that these platforms are able to configure both, group and individual permissions, along with having a data backup and recovery plan for hosted systems. This will allow companies to assess the privacy and security implications of research and anticipate complications that may arise in each phase of the project. Assess the Scalability Choosing a scalable CTMS that can accommodate various types of fluctuations and expansions enables biotech and clinical firms to quickly adapt to fast-changing trends and demand spikes while reducing maintenance costs and enhancing user agility. As scalability also means secure and expanded data storage, these businesses should instead use SaaS solutions than manually manage an ever-growing collection of hard drives. The right CTMS ensures accommodating the firm’s availability requirements without incurring the capital costs associated with expanding a physical infrastructure. The Closing Thought A well-executed and successful clinical trial involves multiple stages and processes. Several quality controls and stringent adherence to regulations are essential for the steps, along with efficient cross-departmental processes and procedures. Incorporating the right CTMS paves the way for paperless data collection, regulatory filing, and fiscal management tools for biotech researchers and administrative personnel.

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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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Top 10 biotech IPOs in 2019

Article | July 12, 2022

The big question at the start of 2019 was whether the IPO window would stay open for biotech companies, particularly those seeking to pull off ever-larger IPOs at increasingly earlier stages of development. The short answer is yes—kind of. Here’s the long answer: In the words of Renaissance Capital, the IPO market had “a mostly good year.” The total number of deals fell to 159 from 192 the year before, but technology and healthcare companies were standout performers. The latter—which include biotech, medtech and diagnostics companies—led the pack, making up 43% of all IPOs in 2019. By Renaissance’s count, seven companies went public at valuations exceeding $1 billion, up from five the year before

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Cell Out? Lysate-Based Expression an Option for Personalized Meds

Article | February 18, 2020

Cell-free expression (CFE) is the practice of making a protein without using a living cell. In contrast with cell line-based methods, production is achieved using a fluid containing biological components extracted from a cell, i.e., a lysate. CFE offers potential advantages for biopharma according to Philip Probert, PhD, a senior scientist at the Centre for Process Innovation in the U.K.

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Spotlight

Amplycell

Ever had a promising cell line which just did not perform ? A cell line which does not produce enough, or long enough? Amplycell is a biotech service company of which mission is to optimize recombinant protein and monoclonal antibody productions for Diagnostic and Pharmaceutical firms.

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Neurocrine Biosciences and Xenon Launch Up-to-$1.7B Epilepsy, Neuroscience Collaboration

GEN | December 02, 2019

Neurocrine Biosciences has agreed to exclusively license and co-develop Xenon Pharmaceuticals’ Phase I epilepsy candidate XEN901 as a treatment for children—as well as develop three preclinical compounds, the companies said today—through a collaboration that could generate up to $1.7 billion for Xenon. XEN901 is designed as a highly selective Nav1.6 sodium channel inhibitor being developed to treat children with SCN8A developmental and epileptic encephalopathy (SCN8A-DEE) and other potential indications, including adult focal epilepsy. Xenon has completed a Phase I trial of a powder-in-capsule formulation of XEN901 in healthy adults. However, Xenon has also developed a pediatric-specific, granule formulation of XEN901, and has completed juvenile toxicology studies intended to support pediatric development of the drug candidate. “With its proven expertise in developing and commercializing treatments for neurological disorders, we believe Neurocrine Biosciences is an ideal partner to maximize the potential value of XEN901 for patients,” Xenon CEO Simon Pimstone, MD, PhD, FRCPC, said in a statement.

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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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Researchers Uncovered a New Mechanism of Neurodegeneration

Technology Networks | November 22, 2019

Charcot-Marie-Tooth disease (CMT) is an inherited neurodegenerative condition that affects 1 in 2500 individuals. Currently, however, it is still lacking effective treatment options. New research has demonstrated that a class of cytoplasmic enzymes called tRNA synthetases can cause CMT by interfering with the gene transcription in the nucleus. This breakthrough is the result of an international academic collaboration, where scientists from the VIB-UAntwerp Center for Molecular Neurology and the Scripps Research Institute were the driving force. The study was published in the leading journal Nature Communications. Charcot-Marie-Tooth disease (CMT) is a condition that affects the peripheral nervous system. It leads to progressive muscle weakness and loss of sensation in the lower and - later on - upper limbs. It is the most commonly inheritable neuromuscular disorder and, at the moment, remains incurable. The first symptoms can appear both in early childhood or during adult life. Over 90 genes are implicated in the pathology so far and these are involved in a variety of processes. This complexity makes it a difficult condition to study and find a treatment for.

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Neurocrine Biosciences and Xenon Launch Up-to-$1.7B Epilepsy, Neuroscience Collaboration

GEN | December 02, 2019

Neurocrine Biosciences has agreed to exclusively license and co-develop Xenon Pharmaceuticals’ Phase I epilepsy candidate XEN901 as a treatment for children—as well as develop three preclinical compounds, the companies said today—through a collaboration that could generate up to $1.7 billion for Xenon. XEN901 is designed as a highly selective Nav1.6 sodium channel inhibitor being developed to treat children with SCN8A developmental and epileptic encephalopathy (SCN8A-DEE) and other potential indications, including adult focal epilepsy. Xenon has completed a Phase I trial of a powder-in-capsule formulation of XEN901 in healthy adults. However, Xenon has also developed a pediatric-specific, granule formulation of XEN901, and has completed juvenile toxicology studies intended to support pediatric development of the drug candidate. “With its proven expertise in developing and commercializing treatments for neurological disorders, we believe Neurocrine Biosciences is an ideal partner to maximize the potential value of XEN901 for patients,” Xenon CEO Simon Pimstone, MD, PhD, FRCPC, said in a statement.

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

Researchers Uncovered a New Mechanism of Neurodegeneration

Technology Networks | November 22, 2019

Charcot-Marie-Tooth disease (CMT) is an inherited neurodegenerative condition that affects 1 in 2500 individuals. Currently, however, it is still lacking effective treatment options. New research has demonstrated that a class of cytoplasmic enzymes called tRNA synthetases can cause CMT by interfering with the gene transcription in the nucleus. This breakthrough is the result of an international academic collaboration, where scientists from the VIB-UAntwerp Center for Molecular Neurology and the Scripps Research Institute were the driving force. The study was published in the leading journal Nature Communications. Charcot-Marie-Tooth disease (CMT) is a condition that affects the peripheral nervous system. It leads to progressive muscle weakness and loss of sensation in the lower and - later on - upper limbs. It is the most commonly inheritable neuromuscular disorder and, at the moment, remains incurable. The first symptoms can appear both in early childhood or during adult life. Over 90 genes are implicated in the pathology so far and these are involved in a variety of processes. This complexity makes it a difficult condition to study and find a treatment for.

Read More

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