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Fuelling Innovation in UK Life Sciences

Life science start-ups face several hurdles along the path to success, with many never reaching their potential. A lack of adequate funding and support can limit the development of potentially game-changing technologies. Increasingly, business accelerators especially designed for the life sciences and healthcare, such as Start Codon, are working to help early stage innovative start-up companies become commercially successful businesses, by providing the tools they need to grow. We spoke to Daniel Rooke, Head of Operations and Legal at Start Codon, to learn more about the company and how they can help early stage healthcare and life science businesses in the UK to get off the ground.

Spotlight

ImmunoGen, Inc.

ImmunoGen is a clinical-stage biotechnology company that develops targeted cancer therapeutics using its proprietary antibody-drug conjugate (ADC) technology.

OTHER ARTICLES
MedTech

Better Purification and Recovery in Bioprocessing

Article | July 13, 2022

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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Medical

Nanostructures: Emerging as Effective Carriers for Drug Delivery

Article | August 16, 2022

Natural remedies have been employed in medicine since antiquity. However, a large number of them fail to go past the clinical trial stages. In vivo instability, poor solubility and bioavailability, a lack of target-specific delivery, poor absorption, and side effects of the medication are only a few of the problems caused by the use of large-sized materials in drug administration. Therefore, adopting novel drug delivery systems with targeted medications may be a solution to address these pressing problems. Nanotechnology has received tremendous attention in recent years and has been demonstrated to help blur the boundaries between the biological and physical sciences. With great success, it plays a vital part in enhanced medication formulations, targeted venues, and controlled drug release and delivery. Limitations of Traditional Delivery Trigger the Adoption of Nanoparticles The field of nanotechnology and the creation of drug formulations based on nanoparticles is one that is expanding and showcasing great potential. It has been thoroughly researched in an effort to develop new methods of diagnosis and treatment and to overcome the limitations of several diseases' current therapies. As a result, nanoparticles are being used to improve the therapeutic effectiveness and boost patient adherence to treatment by increasing medication bioavailability, drug accumulation at a particular spot, and reducing drug adverse effects. The nanoparticles could be transformed into intelligent systems housing therapeutic and imaging agents by manipulating their surface properties, size, correct drug load, and release with targeted drug delivery. Nanostructures facilitate the release of combination medications at the prescribed dose since they remain in the blood circulation system for a long time. Therefore, they result in fewer plasma fluctuations with decreased side effects. Due to their nanoscale, these structures can easily enter the tissue system, promote the absorption of drugs by cells, make medication administration more effective, and ensure that the medicine acts at the targeted location. The Way Ahead Nanomedicine and nano-delivery systems are a comparatively new but fast-evolving science in which nanoscale materials are used as diagnostic tools to deliver drug molecules at precisely targeted sites in a controlled manner. It is finding applications for the treatment of diseases such as cardiovascular, neurodegenerative, cancer, ocular, AIDS, and diabetes, among others. With more research and technological advancement, these drug delivery solutions will open up huge opportunities for companies that work with them.

Read More
MedTech

5 Biotech Stocks Winning the Coronavirus Race

Article | September 22, 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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MedTech

Top 3 Biotech Clinical Data Management Trends to Watch in 2022

Article | September 22, 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

Next-Gen Gene Therapy to Counter Complex Diseases

Article | July 13, 2022

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.

Read More
Medical

Laboratory Information Management System for Biotech Labs: Significance & Benefits

Article | August 16, 2022

Natural remedies have been employed in medicine since antiquity. However, a large number of them fail to go past the clinical trial stages. In vivo instability, poor solubility and bioavailability, a lack of target-specific delivery, poor absorption, and side effects of the medication are only a few of the problems caused by the use of large-sized materials in drug administration. Therefore, adopting novel drug delivery systems with targeted medications may be a solution to address these pressing problems. Nanotechnology has received tremendous attention in recent years and has been demonstrated to help blur the boundaries between the biological and physical sciences. With great success, it plays a vital part in enhanced medication formulations, targeted venues, and controlled drug release and delivery. Limitations of Traditional Delivery Trigger the Adoption of Nanoparticles The field of nanotechnology and the creation of drug formulations based on nanoparticles is one that is expanding and showcasing great potential. It has been thoroughly researched in an effort to develop new methods of diagnosis and treatment and to overcome the limitations of several diseases' current therapies. As a result, nanoparticles are being used to improve the therapeutic effectiveness and boost patient adherence to treatment by increasing medication bioavailability, drug accumulation at a particular spot, and reducing drug adverse effects. The nanoparticles could be transformed into intelligent systems housing therapeutic and imaging agents by manipulating their surface properties, size, correct drug load, and release with targeted drug delivery. Nanostructures facilitate the release of combination medications at the prescribed dose since they remain in the blood circulation system for a long time. Therefore, they result in fewer plasma fluctuations with decreased side effects. Due to their nanoscale, these structures can easily enter the tissue system, promote the absorption of drugs by cells, make medication administration more effective, and ensure that the medicine acts at the targeted location. The Way Ahead Nanomedicine and nano-delivery systems are a comparatively new but fast-evolving science in which nanoscale materials are used as diagnostic tools to deliver drug molecules at precisely targeted sites in a controlled manner. It is finding applications for the treatment of diseases such as cardiovascular, neurodegenerative, cancer, ocular, AIDS, and diabetes, among others. With more research and technological advancement, these drug delivery solutions will open up huge opportunities for companies that work with them.

Read More
MedTech

Top 3 Biotech Clinical Data Management Trends to Watch in 2022

Article | September 22, 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.

Read More
MedTech

Top 3 Biotech Clinical Data Management Trends to Watch in 2022

Article | September 22, 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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Spotlight

ImmunoGen, Inc.

ImmunoGen is a clinical-stage biotechnology company that develops targeted cancer therapeutics using its proprietary antibody-drug conjugate (ADC) technology.

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Industrial Impact

The Bracken Organizations Merge to Create a Global Platform to Support Life Science and Digital Health Teams

The Bracken Group | October 11, 2021

Three unique companies with shared origins have now united to better serve their clients in the life sciences industry. The new entity will be known as The Bracken Group (Bracken) with three divisions of the original three companies. The combined companies' mission continues to be supporting the success of companies that improve health, using an integrated network of clients, consultants, and employees across the globe. I am delighted to bring the companies together under the one outstanding leadership team which further improves the services we provide to our clients. The benefits of the synergy that comes from a closer inter-team relationship will be apparent as the cross communication will be immediate. - Dr Colin G. Miller, CEO of The Bracken Group Bracken has been specializing across the life sciences and digital health arenas since inception, This highly regulated life science industry includes high stakes and complex processes. We have created and continue to cultivate an integrated platform to help organizations in this industry succeed. - Elliot Miller, Chief Growth Officer. About Bracken Data Bracken Data was founded in 2016 to improve how the industry can use public clinical trial data. Bracken Data offers a suite of clinical trial dashboard products, and custom data science and analytics services. For more information, please visit BrackenData.com. About Bracken Marketing Bracken Marketing was founded in 2017 to support the success of digital health and life science teams through marketing services, and custom marketing programs. Services include website design, content development, advertising, sales collateral production, and multi-media production. About The Bracken Group The Bracken Group, founded in 2018, provides highly experienced consultative support for the development of products that are designed to improve life, in an ethical manner, underpinned with integrity and quality. Bracken offers biopharmaceutical consulting in the development of drugs, biologics, and medical devices, as well as in the use of medical imaging in clinical trials. Clients leverage The Bracken Group's team of executive consultants across a range of specialties through Virtual C-Suite services and related offerings.

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Research

Synthace Unveils First Life Sciences R&D Cloud Addressing Complexity, Speed & Reproducibility for Scientists

Synthace | August 03, 2021

Synthace, a leading life sciences software company, today announced the first life sciences R&D cloud that includes a no-code software platform addressing the largest barriers to innovation that R&D life scientists currently face. With the release of this new platform, Synthace is also the first vendor to enable scientists to automate experimentation and insight sharing in a unified, global R&D environment. Scientists can now focus on asking the most impactful questions and unlock the true potential of biology. To solve humanity’s hardest problems, such as delivering breakthrough therapies or alternative food sources, the life sciences industry is under tremendous pressure to simultaneously overcome biology’s complexity, accelerate speed to scientific insight, and ensure the reproducibility of experiments. Synthace alleviates these challenges by empowering scientists to improve and accelerate decision-making with more statistically powerful, automated experiments that can minimize human error. Furthermore, Synthace’s cloud platform leverages intelligent, dynamic automation to produce the highest quality data sets that are primed for machine learning (ML) and other advanced analyses to lead to better insights. With Synthace, the life sciences can now benefit from a quantum leap in experimentation capabilities, accelerating development timelines that would have previously been impossible. Customers Accelerate R&D with Synthace Ipsen has been using Synthace to automate the design and construction of therapeutic candidates. With Synthace, Ipsen produced approximately 90 constructs five times faster than previous methods, substantially increasing the number of molecules entering the screening cascade. The platform also achieved a 10-fold reduction in costs associated with DNA synthesis. Karen Bunting, Director of Protein Sciences at Ipsen commented, “Synthace sits very well at the beginning of our drug discovery process. It allows us to explore larger drug design space by simplifying planning and production of multiple molecule variants with combinatorial construct assembly. These throughput improvements help us deliver well-tolerated and effective therapeutic solutions more rapidly to our patients.” Microsoft Research also uses Synthace to automatically generate biological data at a volume that allows its ML algorithms to rapidly improve. As part of reporting on advancements in programming biological systems, a member of its Biocomputation Group noted: “Synthace really comes into its own when we’re performing experiments with complex layouts like combinatorial construct assembly and design of experiments. When we’re building 12 constructs at a time, Synthace automates all the planning that would go into setting up such an experiment and allows it to become routine.” Synthace Life Sciences R&D Cloud The platform provides end-to-end management of the experimental lifecycle, from design through execution to data visualization and knowledge transfer. Synthace adheres to FAIR principles to support interoperability with other major lab informatics platforms to ensure streamlined data management for all of its customers. Only the Synthace Life Sciences R&D Cloud delivers: Complete experimental design, planning and automation, requiring no coding expertise. Scientists can define more informative and impactful experiments that would otherwise be impossible to run and easily implement Quality by Design (QbD) and Design of Experiments (DOE). Seamless, cloud-based data capture, processing, and visualization. R&D teams can deliver deeper and faster insights from fully contextualized, machine learning-ready data sets that are automatically generated from the laboratory. Minimal deployment and onboarding. Customers experience rapid time-to-insight through Synthace’s out-of-the-box platform features and pre-validated protocols for common applications such as ELISA and high-throughput purification, helping them shorten R&D cycles and study more candidates per program. About Synthace Synthace is a life sciences software company enabling life science the way it should be done. Delivering a life sciences R&D cloud to scientists who want to innovate faster, the Synthace platform seamlessly automates experimentation and insight sharing so that scientists can focus on asking the most impactful questions to unlock the true potential of biology. Top global pharmaceuticals, high-growth biotech companies, leading CDMOs, and innovators in artificial intelligence all turn to Synthace to discover solutions to humanity’s hardest problems.

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Medical

Precision NanoSystems is Now a Part of Danaher's Life Sciences Platform

Cytiva, Pall Corporation | June 02, 2021

Danaher Corporation's Life Sciences platform has acquired precision NanoSystems (PNI). PNI is a global leader in technologies and solutions for developing genetic medicines, including mRNA vaccines and therapeutics. PNI will join Danaher's Life Sciences platform and complement other businesses in the forum, including Cytiva and Pall. "PNI has advanced several exciting innovations, and we're thrilled to welcome this talented team," says Emmanuel Ligner, Danaher Group Executive. "As mRNA has matured as a successful technology in some COVID vaccines, we see huge potential for this technology to accelerate other therapies. The work done thus far by the PNI team will also enable our customers at Cytiva and Pall to take a huge step forward in advancing their science to improve the lives of patients." James Taylor, co-founder, and CEO of Precision NanoSystems, says: "Over the last ten years, PNI has been a leading technology company, enabling the development of genetic medicines. Joining Danaher's Life Sciences platform allows our world-class team to accelerate and expand the work we do to support our customers with comprehensive technology platforms and the expertise to manufacture transformative medicines for the benefit of humanity. With the global reach of the Danaher Life Sciences platform and customers who are leaders in biotechnology, this is an incredible opportunity to bring PNI's innovations to market and expand our impact." The overall mRNA therapeutics and vaccines market was growing rapidly and accelerated with the development of COVID-19 mRNA vaccines. It is anticipated that mRNA technology will be used to develop other vaccines and to treat other conditions of high unmet medical need, such as cancer and genetic diseases. At present, most mRNA therapies and other types of genetic medicines in clinical development are designed to be delivered with the help of lipid nanoparticles (LNPs). PNI's Genetic Medicine Toolkit, including its proprietary GenVoyTM LNP delivery platform and NanoAssemblrTM microfluidic-based nanoparticle manufacturing platform, enables the rapid development of genetic medicines. PNI's validated technologies increase the stability, efficacy, yield, and quality of non-viral genetic medication and lower the barrier to develop these essential medicines. PNI is developing a new center of manufacturing excellence in Vancouver, which will proceed as planned. When complete, the biomanufacturing center will further advance Canadian therapeutic and vaccine manufacturing capabilities, broaden the domestic life sciences sector, create new jobs in the region, and foster a new generation of scientific talent. About Pall Pall Corporation may be a filtration, separation, and purification leader providing solutions to meet customers' critical fluid management needs across the broad spectrum of life sciences and industry. Pall works with customers to advance health, safety, and environmentally responsible technologies. The Company's engineered products enable process and product innovation and minimize emissions and waste. Pall Corporation serves customers worldwide. About Cytiva Cytiva is a global life science leader with more than 8,000 associates across 40 countries dedicated to advancing and accelerating therapeutics. As a trusted partner to customers that range in scale and scope, Cytiva brings speed, efficiency, and capacity to research and manufacture workflows, enabling the development, manufacture, and delivery of transformative medicines to patients.

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Industrial Impact

The Bracken Organizations Merge to Create a Global Platform to Support Life Science and Digital Health Teams

The Bracken Group | October 11, 2021

Three unique companies with shared origins have now united to better serve their clients in the life sciences industry. The new entity will be known as The Bracken Group (Bracken) with three divisions of the original three companies. The combined companies' mission continues to be supporting the success of companies that improve health, using an integrated network of clients, consultants, and employees across the globe. I am delighted to bring the companies together under the one outstanding leadership team which further improves the services we provide to our clients. The benefits of the synergy that comes from a closer inter-team relationship will be apparent as the cross communication will be immediate. - Dr Colin G. Miller, CEO of The Bracken Group Bracken has been specializing across the life sciences and digital health arenas since inception, This highly regulated life science industry includes high stakes and complex processes. We have created and continue to cultivate an integrated platform to help organizations in this industry succeed. - Elliot Miller, Chief Growth Officer. About Bracken Data Bracken Data was founded in 2016 to improve how the industry can use public clinical trial data. Bracken Data offers a suite of clinical trial dashboard products, and custom data science and analytics services. For more information, please visit BrackenData.com. About Bracken Marketing Bracken Marketing was founded in 2017 to support the success of digital health and life science teams through marketing services, and custom marketing programs. Services include website design, content development, advertising, sales collateral production, and multi-media production. About The Bracken Group The Bracken Group, founded in 2018, provides highly experienced consultative support for the development of products that are designed to improve life, in an ethical manner, underpinned with integrity and quality. Bracken offers biopharmaceutical consulting in the development of drugs, biologics, and medical devices, as well as in the use of medical imaging in clinical trials. Clients leverage The Bracken Group's team of executive consultants across a range of specialties through Virtual C-Suite services and related offerings.

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Research

Synthace Unveils First Life Sciences R&D Cloud Addressing Complexity, Speed & Reproducibility for Scientists

Synthace | August 03, 2021

Synthace, a leading life sciences software company, today announced the first life sciences R&D cloud that includes a no-code software platform addressing the largest barriers to innovation that R&D life scientists currently face. With the release of this new platform, Synthace is also the first vendor to enable scientists to automate experimentation and insight sharing in a unified, global R&D environment. Scientists can now focus on asking the most impactful questions and unlock the true potential of biology. To solve humanity’s hardest problems, such as delivering breakthrough therapies or alternative food sources, the life sciences industry is under tremendous pressure to simultaneously overcome biology’s complexity, accelerate speed to scientific insight, and ensure the reproducibility of experiments. Synthace alleviates these challenges by empowering scientists to improve and accelerate decision-making with more statistically powerful, automated experiments that can minimize human error. Furthermore, Synthace’s cloud platform leverages intelligent, dynamic automation to produce the highest quality data sets that are primed for machine learning (ML) and other advanced analyses to lead to better insights. With Synthace, the life sciences can now benefit from a quantum leap in experimentation capabilities, accelerating development timelines that would have previously been impossible. Customers Accelerate R&D with Synthace Ipsen has been using Synthace to automate the design and construction of therapeutic candidates. With Synthace, Ipsen produced approximately 90 constructs five times faster than previous methods, substantially increasing the number of molecules entering the screening cascade. The platform also achieved a 10-fold reduction in costs associated with DNA synthesis. Karen Bunting, Director of Protein Sciences at Ipsen commented, “Synthace sits very well at the beginning of our drug discovery process. It allows us to explore larger drug design space by simplifying planning and production of multiple molecule variants with combinatorial construct assembly. These throughput improvements help us deliver well-tolerated and effective therapeutic solutions more rapidly to our patients.” Microsoft Research also uses Synthace to automatically generate biological data at a volume that allows its ML algorithms to rapidly improve. As part of reporting on advancements in programming biological systems, a member of its Biocomputation Group noted: “Synthace really comes into its own when we’re performing experiments with complex layouts like combinatorial construct assembly and design of experiments. When we’re building 12 constructs at a time, Synthace automates all the planning that would go into setting up such an experiment and allows it to become routine.” Synthace Life Sciences R&D Cloud The platform provides end-to-end management of the experimental lifecycle, from design through execution to data visualization and knowledge transfer. Synthace adheres to FAIR principles to support interoperability with other major lab informatics platforms to ensure streamlined data management for all of its customers. Only the Synthace Life Sciences R&D Cloud delivers: Complete experimental design, planning and automation, requiring no coding expertise. Scientists can define more informative and impactful experiments that would otherwise be impossible to run and easily implement Quality by Design (QbD) and Design of Experiments (DOE). Seamless, cloud-based data capture, processing, and visualization. R&D teams can deliver deeper and faster insights from fully contextualized, machine learning-ready data sets that are automatically generated from the laboratory. Minimal deployment and onboarding. Customers experience rapid time-to-insight through Synthace’s out-of-the-box platform features and pre-validated protocols for common applications such as ELISA and high-throughput purification, helping them shorten R&D cycles and study more candidates per program. About Synthace Synthace is a life sciences software company enabling life science the way it should be done. Delivering a life sciences R&D cloud to scientists who want to innovate faster, the Synthace platform seamlessly automates experimentation and insight sharing so that scientists can focus on asking the most impactful questions to unlock the true potential of biology. Top global pharmaceuticals, high-growth biotech companies, leading CDMOs, and innovators in artificial intelligence all turn to Synthace to discover solutions to humanity’s hardest problems.

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Medical

Precision NanoSystems is Now a Part of Danaher's Life Sciences Platform

Cytiva, Pall Corporation | June 02, 2021

Danaher Corporation's Life Sciences platform has acquired precision NanoSystems (PNI). PNI is a global leader in technologies and solutions for developing genetic medicines, including mRNA vaccines and therapeutics. PNI will join Danaher's Life Sciences platform and complement other businesses in the forum, including Cytiva and Pall. "PNI has advanced several exciting innovations, and we're thrilled to welcome this talented team," says Emmanuel Ligner, Danaher Group Executive. "As mRNA has matured as a successful technology in some COVID vaccines, we see huge potential for this technology to accelerate other therapies. The work done thus far by the PNI team will also enable our customers at Cytiva and Pall to take a huge step forward in advancing their science to improve the lives of patients." James Taylor, co-founder, and CEO of Precision NanoSystems, says: "Over the last ten years, PNI has been a leading technology company, enabling the development of genetic medicines. Joining Danaher's Life Sciences platform allows our world-class team to accelerate and expand the work we do to support our customers with comprehensive technology platforms and the expertise to manufacture transformative medicines for the benefit of humanity. With the global reach of the Danaher Life Sciences platform and customers who are leaders in biotechnology, this is an incredible opportunity to bring PNI's innovations to market and expand our impact." The overall mRNA therapeutics and vaccines market was growing rapidly and accelerated with the development of COVID-19 mRNA vaccines. It is anticipated that mRNA technology will be used to develop other vaccines and to treat other conditions of high unmet medical need, such as cancer and genetic diseases. At present, most mRNA therapies and other types of genetic medicines in clinical development are designed to be delivered with the help of lipid nanoparticles (LNPs). PNI's Genetic Medicine Toolkit, including its proprietary GenVoyTM LNP delivery platform and NanoAssemblrTM microfluidic-based nanoparticle manufacturing platform, enables the rapid development of genetic medicines. PNI's validated technologies increase the stability, efficacy, yield, and quality of non-viral genetic medication and lower the barrier to develop these essential medicines. PNI is developing a new center of manufacturing excellence in Vancouver, which will proceed as planned. When complete, the biomanufacturing center will further advance Canadian therapeutic and vaccine manufacturing capabilities, broaden the domestic life sciences sector, create new jobs in the region, and foster a new generation of scientific talent. About Pall Pall Corporation may be a filtration, separation, and purification leader providing solutions to meet customers' critical fluid management needs across the broad spectrum of life sciences and industry. Pall works with customers to advance health, safety, and environmentally responsible technologies. The Company's engineered products enable process and product innovation and minimize emissions and waste. Pall Corporation serves customers worldwide. About Cytiva Cytiva is a global life science leader with more than 8,000 associates across 40 countries dedicated to advancing and accelerating therapeutics. As a trusted partner to customers that range in scale and scope, Cytiva brings speed, efficiency, and capacity to research and manufacture workflows, enabling the development, manufacture, and delivery of transformative medicines to patients.

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Events