CRISPR-Accelerated Gene Drives Pump the Brakes

When a mosquito bite threatens to transmit infection, induce disease, or even contribute to early death, as it often does in malaria-endemic areas of the world, prevention efforts are a critical public health measure. In the last decade, prevention efforts have incorporated innovations such as better insecticides and longer-lasting bed nets, helping prevent hundreds of millions of cases of malaria and saving millions of lives. Although mortality rates have fallen, more than 200 million new malaria cases and almost half a million malaria deaths (mostly in children under 5 years old) still occur each year. Such statistics testify to the limitations in current mosquito prevention methods, as do the illnesses and deaths caused by other mosquito-borne infectious diseases, which include Zika, dengue, yellow fever, and chikungunya.

Spotlight

CIC bioGUNE

CIC bioGUNE (Center for Cooperative Research in Biosciences) is a non-profit biomedical research organization, founded in 2003 at the initiative of the Department of Industry of the Basque Government. We are working to give research in the Basque Country an international focus, incorporating foreign researchers at all levels and strengthening international cooperation since, nowadays, excellence is defined in global terms.

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Research

Biotech in 2022

Article | July 11, 2022

The robust global channel of more than, 800 gene and cell curatives presently in trials will produce clinical readouts in 2022, revealing what lies ahead for advanced curatives. The impact will be felt in 2022, no matter how you slice it. Eventually, how well industry and non-supervisory bodies unite to produce new frameworks for advanced therapies will shape the year 2022 and further. Pacific Northwest talent will continue to contribute to the advancement of gene and cell curatives in both the short and long term, thanks to its deep pool of ground-breaking scientific developers, entrepreneurial directorial leadership, largely skilled translational scientists, and endured bio manufacturing technicians. We may see continued on-life science fund withdrawal from biotech in 2021, but this can be anticipated as a strong comeback in 2022 by biotech industry, backed by deep-pocketed life science investors who are committed to this sector. A similar investment, combined with pharma's cash-heavy coffers, can result in increased junction and acquisition activity, which will be a challenge for some but an occasion for others. Over the last five years, investment interest in Seattle and the Pacific Northwest has grown exponentially, from Vancouver, British Columbia, to Oregon. The region's explosive portfolio of new biotech companies, innovated out of academic centres, demonstrates the region's growing recognition of scientific invention. This created a belief that continued, especially because Seattle's start-ups and biotech enterprises are delivering on their pledge of clinical and patient impact. Talent and staffing will continue to be difficult to find. It's a CEO's market, but many of these funds' return, and are not rising in proportion to the exorbitant prices they're paying to enter deals. This schism has become particularly pronounced in 2021. Hence, everyone in biotech is concerned about reclamation and retention.

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Medical

AI and Biotechnology: The Future of Healthcare Industry

Article | July 14, 2022

Artificial intelligence has grasped the foundation in biotech. It can have the most innovative impact on biotechnology. AI has already established its presence in our day-to-day life. AI has made the existence of self-driving cars possible. Likewise, the benefits and quality that it can contribute to biotech can also be felt. With AI, bio technicians will be able to enhance virtual screening, overlook preliminary datasets from clinics, and decipher an enormous amount of information. It can also help in improving the medication process by gathering and analyzing every bit of information. The Significance of AI in Biotechnology In the past few years, the application of artificial intelligence in the biotechnology industry has shifted from being sci-fi to sci-fact. A vast number of biotech companies like Deep Genomics are adopting AI for making data-driven decisions and use analytics tools to work efficiently. Unlike the AI robots in sci-fi that are ready to take over the world. AI designed for biotech has been designed to solve certain problems or complete a bunch of tasks by using automated algorithms. The aim of AI technology for biotech is to collect insights along with hidden patterns from large amounts of data. All the different industries of biotech including agriculture, animal, medical, industrial, and bioinformatics are gradually being affected by artificial intelligence. Moreover, the biotech industry is realizing that AI enables them some of the important strength to their business, including: Expanding accessibility Cost-effectiveness Critical predictions Efficient decision-making Research centers like PwC have also estimated output of $15.7 trillion by 2030 solely with AI contribution in industries. A survey revealed that about 44% of life science experts are using AI for R&D activities, as well. Use of AI in Biotechnology Altering Biomedical and Clinical Data So far the most developed use of AI is its ability to read voluminous data records and interpret them. It can prove to be a life-save for bio technicians who would have to examine that much data from research publications by themselves for the validation of their hypothesis. With the help of AI, clinical studies of patients will also become easier as all the examination reports and prescriptions will be stored in one place for cross-reference. Furthermore, it will also help in blending and fetching data into usable formats for analysis. Test Result Prediction Through trial and error, AI along with machine learning can help in predicting the response of the patient to certain drugs to provide more effective outcomes. Drug Design & Discovery AI plays a vital role whether it’s designing a new molecule or identifying new biological targets. It helps in identifying and validating drugs. It reduces the cost and time spent on the entire drug trial process and reaches the market. Personalized Medications for Rare Diseases With the combination of body scan results, patients’ body and analytics, AI can also help in detecting dangerous diseases at an early stage. Improving Process of Manufacturing To improve the process of manufacturing in biotechnology, AI offers a wide range of opportunities. It controls quality, reduces wastage, improves useability, and minimizes the designing time. Moving Towards AI-Enhanced Biotech Future Ever since the concept of artificial intelligence has arrived, being curious by nature, humans have started working towards achieving this goal. It has been growing at a fast pace while showing unbelievable growth and achievements at times. In comparison to the traditional methods used in the biotechnology industry, AI-based methods seem more reliable and accurate. In the upcoming years, it will show its success by improving the quality of health people have. You can also develop your AI-based application or know more about it by taking IT consultations.

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MedTech

5 Biotech Stocks Winning the Coronavirus Race

Article | July 13, 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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Spotlight

CIC bioGUNE

CIC bioGUNE (Center for Cooperative Research in Biosciences) is a non-profit biomedical research organization, founded in 2003 at the initiative of the Department of Industry of the Basque Government. We are working to give research in the Basque Country an international focus, incorporating foreign researchers at all levels and strengthening international cooperation since, nowadays, excellence is defined in global terms.

Related News

MedTech

GP-write Partners with DNA Script to Accelerate DNA-Writing Technology and Accessibility

Genome Project-write | October 18, 2021

GP-write’s CAD is a one-stop shop for microbe, plant and animal genome writing and redesign. Its automated workflow allows users to rapidly upload a genome, redesign it and synthesize the new sequence. The tool enables researchers to directly order synthetic DNA or related products and services from GP-write’s affiliated members. DNA Script’s SYNTAX System, a benchtop DNA printer powered by their groundbreaking enzymatic DNA synthesis (EDS) technology, enables users to print sequences designed on GP-write’s CAD tool right in their lab. The first-of-its-kind DNA printer expedites workflows, making DNA writing as simple and efficient as next-generation sequencing. DNA Script will host a roundtable at the GP-write 5.0 conference on October 22 at 12:30 p.m. ET to engage attendees in a discussion centered on biosecurity as it relates to emerging technologies, including GP-write’s new CAD tool and DNA Script’s SYNTAX System. “We’re pleased to join GP-write and their industrial partners to drive innovation on the forefront of DNA printing technologies. Just as NGS, or DNA 'read,' and CRISPR, or DNA 'edit,' have brought significant advances to research and clinical care, we believe the broad accessibility of synthetic DNA printing, or DNA 'write,' offered by our SYNTAX System will be equally transformative and power the next bio-revolution.” Thomas Ybert, co-founder and CEO of DNA Script GP-write President and General Counsel, Amy Cayne Schwartz, notes that the organizations are partnering to work toward realizing “a shared vision of a future where writing genomes is facile, democratized and safely accessible.” Schwartz explains that “this will open up new frontiers for development of novel therapeutics and solutions for environmental health.” About Genome Project-write GP-write, conceived as a sequel to the Human Genome Project, applies lessons learned from HGP to pursue scientific exploration fully integrated with the development of genome engineering technologies. The primary goal of the project is to drive dramatic cost reductions and expedite whole-genome writing and redesign over the next decade, empowering researchers to uncover complex biological behavior and reprogram organisms to address defining global challenges in medicine, biotechnology and environmental health. About DNA Script Founded in 2014, DNA Script is a pioneering life sciences technology company developing a new, faster, more powerful and versatile way to design and manufacture nucleic acids. The company has developed an alternative to traditional DNA synthesis called Enzymatic DNA Synthesis, or EDS, allowing this technology to be accessible to labs with the first benchtop enzymatic synthesis instrument, the SYNTAX System. By putting DNA synthesis back in the lab, DNA Script aims to transform life sciences research through innovative technology that gives researchers unprecedented control and autonomy.

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New Device Permits a Closer Look at Previously Inaccessible Areas of the Genome

Technology Networks | November 25, 2019

Expansions of DNA repeats are very hard to analyze. A method developed by researchers at the Max Planck Institute for Molecular Genetics in Berlin allows for a detailed look at these previously inaccessible regions of the genome. It combines nanopore sequencing, stem cell, and CRISPR-Cas technologies. The method could improve the diagnosis of various congenital diseases and cancers in the future. Large parts of the genome consist of monotonous regions where short sections of the genome repeat hundreds or thousands of times. But expansions of these "DNA repeats" in the wrong places can have dramatic consequences, like in patients with Fragile X syndrome, one of the most commonly identifiable hereditary causes of cognitive disability in humans. However, these repetitive regions are still regarded as an unknown territory that cannot be examined appropriately, even with modern methods. A research team led by Franz-Josef Müller at the Max Planck Institute for Molecular Genetics in Berlin and the University Hospital of Schleswig-Holstein in Kiel recently shed light on this inaccessible region of the genome. Müller's team was the first to successfully determine the length of genomic tandem repeats in patient-derived stem cell cultures. The researchers additionally obtained data on the epigenetic state of the repeats by scanning individual DNA molecules. The method, which is based on nanopore sequencing and CRISPR-Cas technologies, opens the door for research into repetitive genomic regions, and the rapid and accurate diagnosis of a range of diseases.

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Synthego Launches Genome Engineering for iPS Cells

GEN | October 23, 2019

Synthego’s newest offering applies genome engineering in order to address a longtime challenge in research and drug development—the dearth of high-quality, physiologically relevant biological models needed for translational medicine. The provider of genome engineering products and services this week launched a genome engineering service for induced pluripotent stem (iPS) cells—an expansion of automated cell editing capabilities that according to Synthego is designed to achieve extremely high editing efficiency of iPS cells at an industrial scale. Synthego reasons that iPS cells can provide one of the most reliable and accurate models for disease because they allow researchers to create patient-specific variations. Yet iPS cells created through the reprogramming of human adult cells have traditionally been difficult to handle and modify genetically. Synthego’s new offering of iPS cells includes modification by removal of gene function (knockout), single nucleotide variation, protein tagging and other knock-ins, all with the goal of enabling scientists to generate edits at a massive scale to accelerate research and disease modeling.

Read More

MedTech

GP-write Partners with DNA Script to Accelerate DNA-Writing Technology and Accessibility

Genome Project-write | October 18, 2021

GP-write’s CAD is a one-stop shop for microbe, plant and animal genome writing and redesign. Its automated workflow allows users to rapidly upload a genome, redesign it and synthesize the new sequence. The tool enables researchers to directly order synthetic DNA or related products and services from GP-write’s affiliated members. DNA Script’s SYNTAX System, a benchtop DNA printer powered by their groundbreaking enzymatic DNA synthesis (EDS) technology, enables users to print sequences designed on GP-write’s CAD tool right in their lab. The first-of-its-kind DNA printer expedites workflows, making DNA writing as simple and efficient as next-generation sequencing. DNA Script will host a roundtable at the GP-write 5.0 conference on October 22 at 12:30 p.m. ET to engage attendees in a discussion centered on biosecurity as it relates to emerging technologies, including GP-write’s new CAD tool and DNA Script’s SYNTAX System. “We’re pleased to join GP-write and their industrial partners to drive innovation on the forefront of DNA printing technologies. Just as NGS, or DNA 'read,' and CRISPR, or DNA 'edit,' have brought significant advances to research and clinical care, we believe the broad accessibility of synthetic DNA printing, or DNA 'write,' offered by our SYNTAX System will be equally transformative and power the next bio-revolution.” Thomas Ybert, co-founder and CEO of DNA Script GP-write President and General Counsel, Amy Cayne Schwartz, notes that the organizations are partnering to work toward realizing “a shared vision of a future where writing genomes is facile, democratized and safely accessible.” Schwartz explains that “this will open up new frontiers for development of novel therapeutics and solutions for environmental health.” About Genome Project-write GP-write, conceived as a sequel to the Human Genome Project, applies lessons learned from HGP to pursue scientific exploration fully integrated with the development of genome engineering technologies. The primary goal of the project is to drive dramatic cost reductions and expedite whole-genome writing and redesign over the next decade, empowering researchers to uncover complex biological behavior and reprogram organisms to address defining global challenges in medicine, biotechnology and environmental health. About DNA Script Founded in 2014, DNA Script is a pioneering life sciences technology company developing a new, faster, more powerful and versatile way to design and manufacture nucleic acids. The company has developed an alternative to traditional DNA synthesis called Enzymatic DNA Synthesis, or EDS, allowing this technology to be accessible to labs with the first benchtop enzymatic synthesis instrument, the SYNTAX System. By putting DNA synthesis back in the lab, DNA Script aims to transform life sciences research through innovative technology that gives researchers unprecedented control and autonomy.

Read More

New Device Permits a Closer Look at Previously Inaccessible Areas of the Genome

Technology Networks | November 25, 2019

Expansions of DNA repeats are very hard to analyze. A method developed by researchers at the Max Planck Institute for Molecular Genetics in Berlin allows for a detailed look at these previously inaccessible regions of the genome. It combines nanopore sequencing, stem cell, and CRISPR-Cas technologies. The method could improve the diagnosis of various congenital diseases and cancers in the future. Large parts of the genome consist of monotonous regions where short sections of the genome repeat hundreds or thousands of times. But expansions of these "DNA repeats" in the wrong places can have dramatic consequences, like in patients with Fragile X syndrome, one of the most commonly identifiable hereditary causes of cognitive disability in humans. However, these repetitive regions are still regarded as an unknown territory that cannot be examined appropriately, even with modern methods. A research team led by Franz-Josef Müller at the Max Planck Institute for Molecular Genetics in Berlin and the University Hospital of Schleswig-Holstein in Kiel recently shed light on this inaccessible region of the genome. Müller's team was the first to successfully determine the length of genomic tandem repeats in patient-derived stem cell cultures. The researchers additionally obtained data on the epigenetic state of the repeats by scanning individual DNA molecules. The method, which is based on nanopore sequencing and CRISPR-Cas technologies, opens the door for research into repetitive genomic regions, and the rapid and accurate diagnosis of a range of diseases.

Read More

Synthego Launches Genome Engineering for iPS Cells

GEN | October 23, 2019

Synthego’s newest offering applies genome engineering in order to address a longtime challenge in research and drug development—the dearth of high-quality, physiologically relevant biological models needed for translational medicine. The provider of genome engineering products and services this week launched a genome engineering service for induced pluripotent stem (iPS) cells—an expansion of automated cell editing capabilities that according to Synthego is designed to achieve extremely high editing efficiency of iPS cells at an industrial scale. Synthego reasons that iPS cells can provide one of the most reliable and accurate models for disease because they allow researchers to create patient-specific variations. Yet iPS cells created through the reprogramming of human adult cells have traditionally been difficult to handle and modify genetically. Synthego’s new offering of iPS cells includes modification by removal of gene function (knockout), single nucleotide variation, protein tagging and other knock-ins, all with the goal of enabling scientists to generate edits at a massive scale to accelerate research and disease modeling.

Read More

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