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Antibiotics disrupt gut bacteria, impact bone health

January 28, 2019 | 53 views

A new study about the side effects of antibiotic treatment reveals that it may dysregulate postpubertal skeletal development by interfering with gut bacteria. The trillions of bacteria living in our bodies are crucial for our health. They support the gastrointestinal and immune systems. They also help the body absorb nutrients from foods and supplements.

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Alpha Biologics Sdn Bhd

Alpha Biologics is a contract bio-manufacturing organisation offering process development and FDA/EMEA cGMP compliant services to the worldwide pharmaceutical and biotechnology industry.

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How to Choose a Reliable Biotech Clinical Trial Management System?

Article | July 12, 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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MEDTECH

Top 3 Biotech Clinical Data Management Trends to Watch in 2022

Article | July 16, 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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MEDTECH

Top 10 biotech IPOs in 2019

Article | September 22, 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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MEDTECH

Expansion of BioPharma: Opportunities and Investments

Article | July 12, 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.

Read More
MEDTECH

Immunology: A New Frontier in Medical Science

Article | July 16, 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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MEDTECH

Top 3 Biotech Clinical Data Management Trends to Watch in 2022

Article | September 22, 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

Read More

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.

Read More
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Spotlight

Alpha Biologics Sdn Bhd

Alpha Biologics is a contract bio-manufacturing organisation offering process development and FDA/EMEA cGMP compliant services to the worldwide pharmaceutical and biotechnology industry.

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MEDICAL

Cajal Neuroscience Launches with $96 Million to Transform Target and Drug Discovery in Neurodegeneration

Cajal Neuroscience | November 30, 2022

Cajal Neuroscience, a biotechnology company integrating human genetics, functional genomics and advanced microscopy to discover novel targets and therapeutics for neurodegeneration, launched today with the completion of a $96 million Series A financing. Cajal is uniquely focused on the mechanistic, spatial and temporal complexity of neurodegeneration, integrating deep expertise in neuroscience, neuroanatomy and computational biology with state-of-the-art technologies for high-throughput functional validation. The financing was led by The Column Group and Lux Capital, with additional participation from Two Sigma Ventures, Bristol Myers Squibb, Evotec, Alexandria Venture Investments, Dolby Family Ventures and other investors. “We’ve all seen the challenges that face drug discovery in neurodegeneration. Cajal was founded to meet those challenges head-on by convening some of the best minds in the field and integrating a suite of cutting-edge technologies to identify and advance therapies for neurodegeneration in a completely new way. I truly believe our approach can revolutionize neurodegeneration drug discovery by understanding disease mechanisms with spatial and temporal resolution at unprecedented scale,” Ignacio Muñoz-Sanjuán, Ph.D., Chief Executive Officer at Cajal “We want to get to the ground truth of neurodegenerative diseases. Cajal was started from grassroots, bringing together an incredible team of scientists, advisors and investors who share the long-term vision of building foundational systems to explore new pathways and targets and making a difference for patients suffering from neurodegeneration,” said Rob Hershberg, M.D., Ph.D., Co-founder and Executive Chairman of the Board at Cajal. Inspired by the pioneering work of Santiago Ramón y Cajal, whose discoveries on the structural and functional organization of the brain became the foundation of modern neuroscience, Cajal seeks to transform the field of neurodegeneration by revealing the complex and dynamic mechanisms driving disease. Cajal’s platform combines state-of-the-art approaches and technologies, including integrative human genetics and multi-omics, highly multiplexed functional genomics and industrialized whole brain imaging. Through this approach, Cajal is systematically validating the thousands of targets implicated in diseases such as Parkinson’s and Alzheimer’s and creating a comprehensive understanding of neurodegeneration that reveals how, where and when different mechanisms contribute to disease. “The legendary neuroscientist Santiago Ramón y Cajal said that all outstanding work, in art as well as science, results from immense zeal applied to a great idea. That’s precisely why we raced to fund this team,” said Josh Wolfe, Co-founder and Managing Partner at Lux Capital. “When you get the rare combination of the leading scientific minds in neuroscience teaming up to work with cutting-edge visualization, sequencing and computational techniques, and to apply a never-before taken approach to discovering targets and drugs for neurodegenerative disease, you don’t walk slowly toward it -- you sprint for your life.” Cajal’s leadership team includes world-class scientists and experienced biotechnology entrepreneurs who bring scientific rigor, drug development expertise and commitment to advancing therapies for neurodegenerative diseases. About Cajal Neuroscience Cajal Neuroscience is a biotechnology company committed to discovering novel therapeutics for neurodegeneration by leveraging a powerful platform designed to reveal the mechanistic, spatial and temporal complexity of disease at unprecedented scale. Cajal combines a suite of state-of-the-art approaches and technologies, including integrative human genetics and multi-omics, high-throughput functional genomics and advanced microscopy, to accelerate neurodegeneration target and drug discovery. Cajal is headquartered in Seattle, WA.

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RESEARCH, INDUSTRY OUTLOOK

BigHat Biosciences Announces Research Collaboration with Merck

BigHat Biosciences, Inc. | November 30, 2022

BigHat Biosciences, Inc., a biotechnology company with a machine learning-guided antibody discovery and development platform, announced a collaboration with Merck, known as MSD outside of the United States and Canada, to apply the company’s technology to design candidates for up to three drug discovery programs. BigHat’s design platform, Milliner, integrates a high-speed characterization with ML technologies to engineer antibodies with more complex functions and better biophysical properties. This approach could help reduce the difficulty of optimizing antibodies and other therapeutic proteins. Under the collaboration, BigHat and Merck will collaborate to optimize up to three proteins by leveraging BigHat’s platform to synthesize, express, purify, and characterize molecules. Mark DePristo, co-founder and CEO of BigHat, continued, "We are thrilled to be collaborating with Merck's world-class drug development teams to design safer, more effective antibodies for these important therapeutic programs.” The teams have initiated work on the first program and are looking forward to using the power of the complementary skills sets within each research team to generate high-quality lead antibodies. “We are excited to begin this collaboration to advance next-generation antibody therapeutics to patients,” said Elizabeth Schwarzbach, BigHat’s Chief Business Officer. "This agreement with Merck brings us a major step closer to our goal of 3-5 deep collaborations with leading biopharmas to complement our internal therapeutic pipeline." “This agreement with BigHat expands Merck’s strategy of applying AI/ML across our drug discovery capabilities. We look forward to working with the team to leverage BigHat’s technology and expertise in enabling molecular design of novel biologic candidates.” Juan Alvarez, vice president of Biologics Discovery, Merck Research Laboratories About BigHat Biosciences, Inc. BigHat Biosciences is designing safer, more effective antibody therapies for patients using machine learning and synthetic biology. BigHat integrates a wet lab for high-speed characterization with machine learning technologies to guide the search for better antibodies. They apply these design capabilities to develop new generations of safer and more effective treatments for patients suffering from today’s most challenging diseases. BigHat is a Series B biotech outside San Francisco with a team-oriented, inclusive, and family-friendly culture. BigHat’s broad pipeline of wholly-owned and partnered therapeutic programs span many disparate indications with high unmet need, such as cancer, inflammation, and infectious disease. BigHat has raised over $100M from top investors, including Section 32, a16z, and 8VC.

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CELL AND GENE THERAPY

Cimeio Therapeutics Announces Issuance of Key Patent Covering Cell Therapy Platform

Cimeio | November 29, 2022

Cimeio Therapeutics, a biotechnology company developing a novel approach to cell therapies, today announced the U.S. Patent Office has issued a key patent covering the company’s Shielded-Cell & Immunotherapy Pairs platform. U.S. Patent No. 11,499,168 covers a method for in vivo selective depletion of edited primary hematopoietic cells or non-edited primary hematopoietic cells. This method was first discovered and developed in the lab of company founder Lukas Jeker, M.D., Ph.D., at the University of Basel, and is exclusively licensed to Cimeio. “This comprehensive intellectual property provides broad protection for our platform. We believe this patent, along with those we’ve filed for our target antigen and immunotherapy portfolio, cements us as a leader in the emerging field of cell shielding and will enable the broad development of our SCIP platform.” Cimeio CEO Thomas Fuchs Cimeio uses genome editing to insert novel protein variants into hematopoietic stem cells or other types of cells, allowing the cells to maintain their function while making them resistant to paired immunotherapy depletion. Cimeio’s platform has effectively shielded cells from depletion mediated by antibodies, T-cell engagers, ADCs, and CAR-T cells in preclinical studies. The company is advancing its first programs towards clinical development for genetic and malignant hematologic diseases. As previously disclosed, two posters for the company’s pipeline programs will be presented at the American Society of Hematology meeting in December 2022 in New Orleans. About Cimeio Cimeio is an applied gene editing and immunotherapy company developing a portfolio of Shielded-Cell & Immunotherapy Pairs® which has the potential to transform hematopoietic stem cell transplant. Cimeio’s technology platform is based on the design and expression of modified variants of naturally occurring cell surface proteins in HSCs. These novel variants maintain their function but are resistant to depletion when targeted by a paired immunotherapy which has high affinity for the wild-type version of these proteins. This technology has significant therapeutic potential, which Cimeio is using to develop curative treatments for patients with genetic diseases, hematologic malignancies, and severe autoimmune disorders.

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MEDICAL

Cajal Neuroscience Launches with $96 Million to Transform Target and Drug Discovery in Neurodegeneration

Cajal Neuroscience | November 30, 2022

Cajal Neuroscience, a biotechnology company integrating human genetics, functional genomics and advanced microscopy to discover novel targets and therapeutics for neurodegeneration, launched today with the completion of a $96 million Series A financing. Cajal is uniquely focused on the mechanistic, spatial and temporal complexity of neurodegeneration, integrating deep expertise in neuroscience, neuroanatomy and computational biology with state-of-the-art technologies for high-throughput functional validation. The financing was led by The Column Group and Lux Capital, with additional participation from Two Sigma Ventures, Bristol Myers Squibb, Evotec, Alexandria Venture Investments, Dolby Family Ventures and other investors. “We’ve all seen the challenges that face drug discovery in neurodegeneration. Cajal was founded to meet those challenges head-on by convening some of the best minds in the field and integrating a suite of cutting-edge technologies to identify and advance therapies for neurodegeneration in a completely new way. I truly believe our approach can revolutionize neurodegeneration drug discovery by understanding disease mechanisms with spatial and temporal resolution at unprecedented scale,” Ignacio Muñoz-Sanjuán, Ph.D., Chief Executive Officer at Cajal “We want to get to the ground truth of neurodegenerative diseases. Cajal was started from grassroots, bringing together an incredible team of scientists, advisors and investors who share the long-term vision of building foundational systems to explore new pathways and targets and making a difference for patients suffering from neurodegeneration,” said Rob Hershberg, M.D., Ph.D., Co-founder and Executive Chairman of the Board at Cajal. Inspired by the pioneering work of Santiago Ramón y Cajal, whose discoveries on the structural and functional organization of the brain became the foundation of modern neuroscience, Cajal seeks to transform the field of neurodegeneration by revealing the complex and dynamic mechanisms driving disease. Cajal’s platform combines state-of-the-art approaches and technologies, including integrative human genetics and multi-omics, highly multiplexed functional genomics and industrialized whole brain imaging. Through this approach, Cajal is systematically validating the thousands of targets implicated in diseases such as Parkinson’s and Alzheimer’s and creating a comprehensive understanding of neurodegeneration that reveals how, where and when different mechanisms contribute to disease. “The legendary neuroscientist Santiago Ramón y Cajal said that all outstanding work, in art as well as science, results from immense zeal applied to a great idea. That’s precisely why we raced to fund this team,” said Josh Wolfe, Co-founder and Managing Partner at Lux Capital. “When you get the rare combination of the leading scientific minds in neuroscience teaming up to work with cutting-edge visualization, sequencing and computational techniques, and to apply a never-before taken approach to discovering targets and drugs for neurodegenerative disease, you don’t walk slowly toward it -- you sprint for your life.” Cajal’s leadership team includes world-class scientists and experienced biotechnology entrepreneurs who bring scientific rigor, drug development expertise and commitment to advancing therapies for neurodegenerative diseases. About Cajal Neuroscience Cajal Neuroscience is a biotechnology company committed to discovering novel therapeutics for neurodegeneration by leveraging a powerful platform designed to reveal the mechanistic, spatial and temporal complexity of disease at unprecedented scale. Cajal combines a suite of state-of-the-art approaches and technologies, including integrative human genetics and multi-omics, high-throughput functional genomics and advanced microscopy, to accelerate neurodegeneration target and drug discovery. Cajal is headquartered in Seattle, WA.

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RESEARCH, INDUSTRY OUTLOOK

BigHat Biosciences Announces Research Collaboration with Merck

BigHat Biosciences, Inc. | November 30, 2022

BigHat Biosciences, Inc., a biotechnology company with a machine learning-guided antibody discovery and development platform, announced a collaboration with Merck, known as MSD outside of the United States and Canada, to apply the company’s technology to design candidates for up to three drug discovery programs. BigHat’s design platform, Milliner, integrates a high-speed characterization with ML technologies to engineer antibodies with more complex functions and better biophysical properties. This approach could help reduce the difficulty of optimizing antibodies and other therapeutic proteins. Under the collaboration, BigHat and Merck will collaborate to optimize up to three proteins by leveraging BigHat’s platform to synthesize, express, purify, and characterize molecules. Mark DePristo, co-founder and CEO of BigHat, continued, "We are thrilled to be collaborating with Merck's world-class drug development teams to design safer, more effective antibodies for these important therapeutic programs.” The teams have initiated work on the first program and are looking forward to using the power of the complementary skills sets within each research team to generate high-quality lead antibodies. “We are excited to begin this collaboration to advance next-generation antibody therapeutics to patients,” said Elizabeth Schwarzbach, BigHat’s Chief Business Officer. "This agreement with Merck brings us a major step closer to our goal of 3-5 deep collaborations with leading biopharmas to complement our internal therapeutic pipeline." “This agreement with BigHat expands Merck’s strategy of applying AI/ML across our drug discovery capabilities. We look forward to working with the team to leverage BigHat’s technology and expertise in enabling molecular design of novel biologic candidates.” Juan Alvarez, vice president of Biologics Discovery, Merck Research Laboratories About BigHat Biosciences, Inc. BigHat Biosciences is designing safer, more effective antibody therapies for patients using machine learning and synthetic biology. BigHat integrates a wet lab for high-speed characterization with machine learning technologies to guide the search for better antibodies. They apply these design capabilities to develop new generations of safer and more effective treatments for patients suffering from today’s most challenging diseases. BigHat is a Series B biotech outside San Francisco with a team-oriented, inclusive, and family-friendly culture. BigHat’s broad pipeline of wholly-owned and partnered therapeutic programs span many disparate indications with high unmet need, such as cancer, inflammation, and infectious disease. BigHat has raised over $100M from top investors, including Section 32, a16z, and 8VC.

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CELL AND GENE THERAPY

Cimeio Therapeutics Announces Issuance of Key Patent Covering Cell Therapy Platform

Cimeio | November 29, 2022

Cimeio Therapeutics, a biotechnology company developing a novel approach to cell therapies, today announced the U.S. Patent Office has issued a key patent covering the company’s Shielded-Cell & Immunotherapy Pairs platform. U.S. Patent No. 11,499,168 covers a method for in vivo selective depletion of edited primary hematopoietic cells or non-edited primary hematopoietic cells. This method was first discovered and developed in the lab of company founder Lukas Jeker, M.D., Ph.D., at the University of Basel, and is exclusively licensed to Cimeio. “This comprehensive intellectual property provides broad protection for our platform. We believe this patent, along with those we’ve filed for our target antigen and immunotherapy portfolio, cements us as a leader in the emerging field of cell shielding and will enable the broad development of our SCIP platform.” Cimeio CEO Thomas Fuchs Cimeio uses genome editing to insert novel protein variants into hematopoietic stem cells or other types of cells, allowing the cells to maintain their function while making them resistant to paired immunotherapy depletion. Cimeio’s platform has effectively shielded cells from depletion mediated by antibodies, T-cell engagers, ADCs, and CAR-T cells in preclinical studies. The company is advancing its first programs towards clinical development for genetic and malignant hematologic diseases. As previously disclosed, two posters for the company’s pipeline programs will be presented at the American Society of Hematology meeting in December 2022 in New Orleans. About Cimeio Cimeio is an applied gene editing and immunotherapy company developing a portfolio of Shielded-Cell & Immunotherapy Pairs® which has the potential to transform hematopoietic stem cell transplant. Cimeio’s technology platform is based on the design and expression of modified variants of naturally occurring cell surface proteins in HSCs. These novel variants maintain their function but are resistant to depletion when targeted by a paired immunotherapy which has high affinity for the wild-type version of these proteins. This technology has significant therapeutic potential, which Cimeio is using to develop curative treatments for patients with genetic diseases, hematologic malignancies, and severe autoimmune disorders.

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