NSPRI advocates agric trust fund to fast-track development

As part of solutions to the challenges in agriculture, and to fast-track agro-economic development and diversify sustainably, a dedicated trust fund to finance agricultural research, which, in turn, will prop up new technologies and products, should be emplaced by the Federal Government.

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BluTest Laboratories Ltd

Microbiology Contract Research Organization specializing in microbiology outsourcing, virus screening, antimicrobial product development, biocide efficacy testing, bacteria, mycobacteria, bacterial endospores, virology, biofilms, disinfection, clean room and environmental monitoring.

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MedTech

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

Article | July 13, 2022

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

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MedTech

Nanostructures: Emerging as Effective Carriers for Drug Delivery

Article | July 20, 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.

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MedTech

Next-Gen Genetics Cancer Therapies Creating Investment Prospects

Article | October 7, 2022

Genetic therapeutics such as genetic engineering and gene therapy are increasingly emerging as one of the most influential and transformed biotechnological solutions around the globe in recent times. These genetic solutions are being assessed across various medical domains, including cancer treatment, neurology, oncology, and ophthalmology. Citing the trend, the genetics industry is estimated to experience a tsunami of approvals, with over 1,000 cell and gene therapy clinical trials currently underway and over 900 companies worldwide focusing on these cutting-edge therapies. Growing Cancer Encourages Advancements in Genetic Technologies With the surging cases of cancers such as leukemias, carcinomas, lymphomas, and others, patients worldwide are increasing their spending on adopting novel therapeutic solutions for non-recurring treatment of the disease, such as gene therapy, genetic engineering, T-cell therapy, and gene editing. As per a study by the Fight Cancer Organization, spending on the treatment of cancer increased to $200.7 billion, and the amount is anticipated to exceed $245 billion by the end of 2030. Growing revenue prospects are encouraging biotechnology and biopharmaceutical companies to develop novel genetic solutions for cancer treatment. For instance, Bristol-Myers Squibb K.K., a Japanese pharmaceutical company, introduced a B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy, Abecma, for the treatment of relapsed or refractory (R/R) multiple myeloma in 2022. Amid a New Market: Genetics Will Attract Massive Investments Despite several developments and technological advancements, genetics is still considered to be in a nascent stage, providing significant prospects for growth to the companies that are already operating in the domain. Genetics solutions such as gene therapies, gene editing, and T-cell immunotherapy are emerging as highly active treatments across various medical fields, resulting in increasing research and development activities across the domain, drawing significant attention from investors. Given the potential of genetic treatments and the focus on finding new ways to treat cancer and other related diseases, it's easy to understand why companies are investing in the domain. For instance, Pfizer has recently announced an investment of around $800 million to construct development facilities supporting gene therapy manufacturing from initial preclinical research through final commercial-scale production. Due to these advancements, cell and gene therapies are forecast to grow from $4 billion annually to more than $45 billion, exhibiting growth at a 63% CAGR. The Future of Genetics Though there is a significant rise in advancement in genetic technologies and developments, the number of approved genetic treatments remains extremely small. However, with gene transfer and CRISPR solutions emerging as new modalities for cancer treatment, the start-up companies will attract a growing amount and proportion of private and public investments. This is expected present a tremendous opportunity for biopharma and biotechnology investors to help fund and benefit from the medical industry's shift from traditional treatments to cutting-edge genetic therapeutics in the coming years.

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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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BluTest Laboratories Ltd

Microbiology Contract Research Organization specializing in microbiology outsourcing, virus screening, antimicrobial product development, biocide efficacy testing, bacteria, mycobacteria, bacterial endospores, virology, biofilms, disinfection, clean room and environmental monitoring.

Related News

Oxitec Signs New Multi-year Development Agreement to Apply 2nd Generation Technology to Control Soybean Looper

Prnewswire | April 16, 2019

a UK-based biotechnology company that pioneered the use of biologically-engineered insects to control disease-spreading mosquitoes and crop-destroying agricultural pests and a wholly-owned subsidiary of Intrexon (NASDAQ: XON), has announced the signing of a new multi-year development agreement with a collaborator to develop a self-limiting soybean looper (Chrysodeixis includens) to suppress this damaging agricultural pest that is found throughout the Americas. Soybean looper threatens a variety of crops, primarily soybeans as well as cotton, sweet potatoes, peanuts, lettuce, herbs, tomato, tobacco, and others. It has been historically difficult to control due to growing insecticide resistance. Additionally, individual adult females can lay up to 700 eggs each in their lifetime, allowing a small number of insects to exponentially grow in a very short time span. Oxitec's self-limiting soybean looper will leverage the advantages and benefits of Oxitec's 2nd generation technology as part of their commitment to advancing a new global standard for targeted, safe pest management using self-limiting insects. "Soybean looper threatens crops in the Americas, especially in Brazil and the US, where current control tools are under pressure. It is necessary to rapidly deploy new, safe and targeted technologies," said Grey Frandsen, Chief Executive Officer at Oxitec. "Our targeted biologically-based approach offers the opportunity to suppress this major agricultural pest, prevent widespread crop losses and, perhaps most importantly, complement the newest generations of other valuable pest control methods." As the need for agricultural productivity increases, so does the need for novel pest management solutions. Oxitec's approach has the potential to counter against insects developing resistance to both new and existing methods of insect control.

Read More

Scientists develop artificial chemical receptor to assist viral transduction for T cell engineering

Phys.org | April 15, 2019

Engineered T cell immunotherapy, such as chimeric antigen receptor T cell (CAR-T) and T cell receptor T cell (TCR-T) therapy, has emerged as a potent therapeutic strategy for treating tumors. However, the genetic manipulation of primary T cells remains inefficient, especially during the clinical manufacturing process. There's an urgent need to develop a reliable method for the preparation of engineered T cells. A research team led by Prof. Cai Lintao at the Shenzhen Institutes of Advanced Technology (SIAT) of the Chinese Academy of Sciences and other collaborators developed a "safe, efficient and universal" technique based on bioorthogonal chemistry and glycol-metabolic labeling for viral-mediated engineered T cell manufacturing. Their findings were published in Advanced Functional Materials. In this strategy, the functional azide motifs were anchored on T cell surfaces via the intrinsic glycometabolism of exogenous azide-glucose, thus serving as an artificial ligand for viral binding. The complementary functional moiety dibenzocyclooctyne (DBCO)/-conjugated PEI1.8K (PEI-DBCO) was coated on the lentiviral surface, which strengthened the virus-T cell interaction through DBCO/azide bioorthogonal chemistry.

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Engineering Accuracy in CRISPR

Technologynetworks | April 16, 2019

Biomedical engineers at Duke University have developed a method for improving the accuracy of the CRISPR genome editing technology by an average of 50-fold. They believe it can be easily translated to any of the editing technology's continually expanding formats. The approach adds a short tail to the guide RNA which is used to identify a sequence of DNA for editing. This added tail folds back and binds onto itself, creating a "lock" that can only be undone by the targeted DNA sequence. The study appears online on April 15 in the journal Nature Biotechnology. "CRISPR is generally incredibly accurate, but there are examples that have shown off-target activity, so there's been broad interest across the field in increasing specificity," said Charles Gersbach, the Rooney Family Associate Professor of Biomedical Engineering at Duke. "But the solutions proposed thus far cannot be easily translated between different CRISPR systems." CRISPR/Cas9 is a defense system that bacteria use to target and cleave the DNA of invading viruses. While the first version of CRISPR technology engineered to work in human cells originated from a bacteria called Streptococcus pyogenes, many more bacteria species carry other versions. Scientists in the field have spent years looking for new CRISPR systems with desirable properties and are constantly adding to the CRISPR arsenal. For example, some systems are smaller and better able to fit inside of a viral vector to deliver to human cells for gene therapy. But no matter their individual abilities, all have produced unwanted genetic edits at times.

Read More

Oxitec Signs New Multi-year Development Agreement to Apply 2nd Generation Technology to Control Soybean Looper

Prnewswire | April 16, 2019

a UK-based biotechnology company that pioneered the use of biologically-engineered insects to control disease-spreading mosquitoes and crop-destroying agricultural pests and a wholly-owned subsidiary of Intrexon (NASDAQ: XON), has announced the signing of a new multi-year development agreement with a collaborator to develop a self-limiting soybean looper (Chrysodeixis includens) to suppress this damaging agricultural pest that is found throughout the Americas. Soybean looper threatens a variety of crops, primarily soybeans as well as cotton, sweet potatoes, peanuts, lettuce, herbs, tomato, tobacco, and others. It has been historically difficult to control due to growing insecticide resistance. Additionally, individual adult females can lay up to 700 eggs each in their lifetime, allowing a small number of insects to exponentially grow in a very short time span. Oxitec's self-limiting soybean looper will leverage the advantages and benefits of Oxitec's 2nd generation technology as part of their commitment to advancing a new global standard for targeted, safe pest management using self-limiting insects. "Soybean looper threatens crops in the Americas, especially in Brazil and the US, where current control tools are under pressure. It is necessary to rapidly deploy new, safe and targeted technologies," said Grey Frandsen, Chief Executive Officer at Oxitec. "Our targeted biologically-based approach offers the opportunity to suppress this major agricultural pest, prevent widespread crop losses and, perhaps most importantly, complement the newest generations of other valuable pest control methods." As the need for agricultural productivity increases, so does the need for novel pest management solutions. Oxitec's approach has the potential to counter against insects developing resistance to both new and existing methods of insect control.

Read More

Scientists develop artificial chemical receptor to assist viral transduction for T cell engineering

Phys.org | April 15, 2019

Engineered T cell immunotherapy, such as chimeric antigen receptor T cell (CAR-T) and T cell receptor T cell (TCR-T) therapy, has emerged as a potent therapeutic strategy for treating tumors. However, the genetic manipulation of primary T cells remains inefficient, especially during the clinical manufacturing process. There's an urgent need to develop a reliable method for the preparation of engineered T cells. A research team led by Prof. Cai Lintao at the Shenzhen Institutes of Advanced Technology (SIAT) of the Chinese Academy of Sciences and other collaborators developed a "safe, efficient and universal" technique based on bioorthogonal chemistry and glycol-metabolic labeling for viral-mediated engineered T cell manufacturing. Their findings were published in Advanced Functional Materials. In this strategy, the functional azide motifs were anchored on T cell surfaces via the intrinsic glycometabolism of exogenous azide-glucose, thus serving as an artificial ligand for viral binding. The complementary functional moiety dibenzocyclooctyne (DBCO)/-conjugated PEI1.8K (PEI-DBCO) was coated on the lentiviral surface, which strengthened the virus-T cell interaction through DBCO/azide bioorthogonal chemistry.

Read More

Engineering Accuracy in CRISPR

Technologynetworks | April 16, 2019

Biomedical engineers at Duke University have developed a method for improving the accuracy of the CRISPR genome editing technology by an average of 50-fold. They believe it can be easily translated to any of the editing technology's continually expanding formats. The approach adds a short tail to the guide RNA which is used to identify a sequence of DNA for editing. This added tail folds back and binds onto itself, creating a "lock" that can only be undone by the targeted DNA sequence. The study appears online on April 15 in the journal Nature Biotechnology. "CRISPR is generally incredibly accurate, but there are examples that have shown off-target activity, so there's been broad interest across the field in increasing specificity," said Charles Gersbach, the Rooney Family Associate Professor of Biomedical Engineering at Duke. "But the solutions proposed thus far cannot be easily translated between different CRISPR systems." CRISPR/Cas9 is a defense system that bacteria use to target and cleave the DNA of invading viruses. While the first version of CRISPR technology engineered to work in human cells originated from a bacteria called Streptococcus pyogenes, many more bacteria species carry other versions. Scientists in the field have spent years looking for new CRISPR systems with desirable properties and are constantly adding to the CRISPR arsenal. For example, some systems are smaller and better able to fit inside of a viral vector to deliver to human cells for gene therapy. But no matter their individual abilities, all have produced unwanted genetic edits at times.

Read More

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