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FDA Moves to Modernize Drug Review Process

Under a new “knowledge management” approach for the Center for Drug Evaluation and Research (CDER), sponsors will submit applications that present data in a structured format so that it can be transmitted to teams of experts from multiple disciplines able to assess applications for new drugs and biologics in a timely and efficient manner. The aim is to shift sponsors away from long, narrative documents filed in PDF format that are repetitive and obscure important issues. Instead, CDER assessment teams composed of medical reviewers, pharmacologists, statisticians, pharmacists and other specialists as needed will examine the data to answer specific questions relevant to the product under review. CDER director Janet Woodcock is finalizing this process for assessing and approving new drugs in order to be able to handle a surge in submissions that reflects important advances in biopharmaceutical science, as well as the digital revolution that has expanded exponentially the data and information supporting biomedical research. 

Spotlight

Taconic Biosciences

Taconic is a global provider of genetically modified mouse and rat models and services. As a full-service industry leader, founded in 1952, Taconic helps clients acquire, test, develop, breed, cryopreserve, prepare, and distribute highly relevant research lines worldwide. Whether you require custom genetically engineered, precision mouse models, or traditional study-ready models, Taconic's scientists will partner with you to rapidly and efficiently obtain the high quality models needed for your discovery or preclinical programs.

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MedTech

Advancement in Genomics Accelerating its Penetration into Precision Health

Article | October 7, 2022

Genomics is an interdisciplinary field of biology emphasizing the structure, editing, evolution, function, and mapping of genomes. It is creating deeper inroads across the precision health domain with the increasing introduction of advanced technologies such as quantum simulation, next-generation sequencing (NGS), and precise genome manipulation. As precision health focuses on providing the proper intervention to the right patient at the right time, genomics increasingly finds applications in human and pathogen genome sequencing in clinical and research spaces. Rising Hereditary Diseases Burden Paving the Way for Genomics in Precision Health In the last few years, a significant surge in the prevalence of diseases and ailments such as diabetes, obesity, baldness, and others has been witnessed across the globe. A history of family members with chronic diseases, such as cancer, diabetes, high blood pressure, hearing issues, and heart disease, can sometimes continue into the next generation. Hence, the study of genes is extensively being conducted for predicting health risks and early treatment of these diseases. It also finds use in CRISPR-based diagnostics and the preparation of precision medication for the individual. In addition, ongoing advancements in genomics are making it possible to identify different genetic traits that persuade people to more widespread diseases and health problems. The Emergence of Genomics Improves Disease Understanding Genomics refers to the study of the complete genetic makeup of a cell or organism. Increasing scientific research in the area substantially contributes to increasing knowledge about the human genome and assists in improving the ability to understand disease etiology, risk, diagnosis, treatment, and prevention. On account of these improvements, innovative genomic technologies and tools are being developed to enable better precision health not only for the individual but for various regional populations as well. The Way Forward With growing preference for personalized medicine and an increasing need for more accurate pathogen detection and diagnostics, genomics is gaining huge popularity across the precision health domain. Also, increasing research activities for developing novel high-precision therapeutics and rising importance of gene study in the prevention, diagnosis, and management of infectious and genetic diseases will further pave the way for genomics in the forthcoming years.

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MedTech

Laboratory Information Management System for Biotech Labs: Significance & Benefits

Article | July 16, 2022

If you have ever visited the testing laboratory of a large biotechnology company, you will be aware that managing the laboratory's operations single-handedly is no easy task. The greater the size of a lab, the more research and testing activities it must accommodate. A variety of diagnostic tests are prescribed for patients in order to detect various diseases. For example, it may include blood glucose testing for diabetics, lipid panel, or liver panel tests for evaluating cardiac risk and liver function, cultures for diagnosing infections, thyroid function tests, and others. Laboratory management solutions such as laboratory information management systems (LIMS) and other software play a significant role in managing various operational data at biotech laboratories. It is one of the important types of software developed to address thedata management and regulatory challenges of laboratories. The software enhances the operational efficiency of biotech labs by streamlining workflows, proper record-keeping, and eradicating the need for manually maintaining data. What Are the Benefits of Laboratory Information Management Software in Biotechnology? As the trends of digitization and technology continue to create deeper inroads into the biotechnology sector, a significant rise in the adoption of innovative medical software solutions, such as LIMS, is being witnessed for managing research data, testing reports, and post-research results globally. Here are a few reasons that are encouraging biotech facilities to adopt LIMS solutions Real-Time Data Collection and Tracking Previously, collecting and transporting samples was a tedious and time-consuming task. However, the adoption of LIMS with innovative tracking modules has made the job easier. The real-time sample tracking feature of LIMS has made it possible for personnel to collect the research data in real-time and manage and control the workflow with a few mouse clicks on the screen. Increase Revenue LIMS makes it possible to test workflows while giving users complete control over the testing process. A laboratory is able to collect data, schedule equipment maintenance or upgrades, enhance operational efficiency, and maintain a lower overhead with the help of the LIMS, thereby increasing revenue. Streamlined Workflow With its completion monitoring, LIMS speeds up laboratory workflows and keeps track of information. It assigns tasks to the specialist along with keeping a real-time track of the status and completion of each task. LIMS is integrated into the laboratory using lab information, which ultimately speeds up internal processes and streamlines the workflow. Automatic Data Exchange LIMS solutions store data in a centralized database. Automated transfer of data between departments and organizations is one of the major features of LIMS. Through its automated information exchange feature, LIMS improves internal operations, decreases the reporting time for data sharing, and assists in faster decision-making. Final Thoughts As the healthcare sector continues to ride the wave of digital transformation, biotech laboratories are emphasizing adopting newer technologies to keep up with the changes. Citing this trend, laboratory information management systems are becoming crucial for biotech and medical organizations for maintaining research data, instant reporting, and managing confidential, inventory, and financial data with centralized data storage.

Read More
Medical

Immunology: A New Frontier in Medical Science

Article | August 16, 2022

Introduction Recent developments in the bioengineering of monoclonal antibodies (mAbs) have revolutionized the treatment of numerous rheumatic and immunological disorders. Currently, several immunological disorders are successfully being targeted and treated using innovative medical techniques such as immunotherapy. Leading companies are increasingly investing in research activities to expand the usage and application of immunology for the treatment of various infectious diseases, including multiple sclerosis, inflammatory bowel disorders, lupus, and psoriasis, leading companies are increasingly investing in research activities. Today, the efforts of researchers in immunology, with a long history of study and research, have borne fruit, as bioengineered mAbs are now being employed in clinical practices. Accelerating Investments: Paving the Way for Immunology The increasing prevalence of infectious diseases, cancer, and immune-mediated inflammatory disorders (IMIDs) is raising the need for more precise classification and an in-depth understanding of the pathology underlying these ailments. Numerous leaders in the biotechnology domain are thus focusing on undertaking numerous strategies, such as new facility launches and collaborations, to address the need by finding deeper inroads into immunology and its use in disease treatments. For instance, in 2022, the University of Texas MD Anderson Cancer Center announced the launch of a visionary research and innovation hub, the James P. Allison Institute, to find new roads in immunotherapy, develop new treatments, and foster groundbreaking science. These developments will result in better diagnosis through the use of selective biomarkers, and early detection of fatal diseases and their treatment, which will prevent complications from happening. Also, the identification of high-risk populations through a deeper understanding of genetic and environmental factors can assist in the prevention of disease through immunotherapy. The Way Forward Immunology has led to the development of biotechnology, making it possible to develop novel drugs and vaccines, as well as diagnostic tests, that can be used to prevent, diagnose, and treat a wide range of autoimmune, infectious, and cancerous diseases. With the rapid advancement in technology and the integration of artificial intelligence, immunology is finding its way into an array of domains and industries, encompassing several research areas including medicine, pharmaceuticals, agriculture, and space. Today, not only researchers but also leading biotech and pharmaceutical companies have recognized that conventional therapies with pharmaceutical and chemical products are being replaced by products derived from immunology. This is because they work well for health problems, are environmentally friendly, and are also emerging as a wealth-generating business in the medical field.

Read More
MedTech

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.

Read More
MedTech

How to Choose a Reliable Biotech Clinical Trial Management System?

Article | October 7, 2022

Genomics is an interdisciplinary field of biology emphasizing the structure, editing, evolution, function, and mapping of genomes. It is creating deeper inroads across the precision health domain with the increasing introduction of advanced technologies such as quantum simulation, next-generation sequencing (NGS), and precise genome manipulation. As precision health focuses on providing the proper intervention to the right patient at the right time, genomics increasingly finds applications in human and pathogen genome sequencing in clinical and research spaces. Rising Hereditary Diseases Burden Paving the Way for Genomics in Precision Health In the last few years, a significant surge in the prevalence of diseases and ailments such as diabetes, obesity, baldness, and others has been witnessed across the globe. A history of family members with chronic diseases, such as cancer, diabetes, high blood pressure, hearing issues, and heart disease, can sometimes continue into the next generation. Hence, the study of genes is extensively being conducted for predicting health risks and early treatment of these diseases. It also finds use in CRISPR-based diagnostics and the preparation of precision medication for the individual. In addition, ongoing advancements in genomics are making it possible to identify different genetic traits that persuade people to more widespread diseases and health problems. The Emergence of Genomics Improves Disease Understanding Genomics refers to the study of the complete genetic makeup of a cell or organism. Increasing scientific research in the area substantially contributes to increasing knowledge about the human genome and assists in improving the ability to understand disease etiology, risk, diagnosis, treatment, and prevention. On account of these improvements, innovative genomic technologies and tools are being developed to enable better precision health not only for the individual but for various regional populations as well. The Way Forward With growing preference for personalized medicine and an increasing need for more accurate pathogen detection and diagnostics, genomics is gaining huge popularity across the precision health domain. Also, increasing research activities for developing novel high-precision therapeutics and rising importance of gene study in the prevention, diagnosis, and management of infectious and genetic diseases will further pave the way for genomics in the forthcoming years.

Read More
MedTech

Immunology: A New Frontier in Medical Science

Article | July 16, 2022

If you have ever visited the testing laboratory of a large biotechnology company, you will be aware that managing the laboratory's operations single-handedly is no easy task. The greater the size of a lab, the more research and testing activities it must accommodate. A variety of diagnostic tests are prescribed for patients in order to detect various diseases. For example, it may include blood glucose testing for diabetics, lipid panel, or liver panel tests for evaluating cardiac risk and liver function, cultures for diagnosing infections, thyroid function tests, and others. Laboratory management solutions such as laboratory information management systems (LIMS) and other software play a significant role in managing various operational data at biotech laboratories. It is one of the important types of software developed to address thedata management and regulatory challenges of laboratories. The software enhances the operational efficiency of biotech labs by streamlining workflows, proper record-keeping, and eradicating the need for manually maintaining data. What Are the Benefits of Laboratory Information Management Software in Biotechnology? As the trends of digitization and technology continue to create deeper inroads into the biotechnology sector, a significant rise in the adoption of innovative medical software solutions, such as LIMS, is being witnessed for managing research data, testing reports, and post-research results globally. Here are a few reasons that are encouraging biotech facilities to adopt LIMS solutions Real-Time Data Collection and Tracking Previously, collecting and transporting samples was a tedious and time-consuming task. However, the adoption of LIMS with innovative tracking modules has made the job easier. The real-time sample tracking feature of LIMS has made it possible for personnel to collect the research data in real-time and manage and control the workflow with a few mouse clicks on the screen. Increase Revenue LIMS makes it possible to test workflows while giving users complete control over the testing process. A laboratory is able to collect data, schedule equipment maintenance or upgrades, enhance operational efficiency, and maintain a lower overhead with the help of the LIMS, thereby increasing revenue. Streamlined Workflow With its completion monitoring, LIMS speeds up laboratory workflows and keeps track of information. It assigns tasks to the specialist along with keeping a real-time track of the status and completion of each task. LIMS is integrated into the laboratory using lab information, which ultimately speeds up internal processes and streamlines the workflow. Automatic Data Exchange LIMS solutions store data in a centralized database. Automated transfer of data between departments and organizations is one of the major features of LIMS. Through its automated information exchange feature, LIMS improves internal operations, decreases the reporting time for data sharing, and assists in faster decision-making. Final Thoughts As the healthcare sector continues to ride the wave of digital transformation, biotech laboratories are emphasizing adopting newer technologies to keep up with the changes. Citing this trend, laboratory information management systems are becoming crucial for biotech and medical organizations for maintaining research data, instant reporting, and managing confidential, inventory, and financial data with centralized data storage.

Read More
Medical

Laboratory Information Management System for Biotech Labs: Significance & Benefits

Article | August 16, 2022

Introduction Recent developments in the bioengineering of monoclonal antibodies (mAbs) have revolutionized the treatment of numerous rheumatic and immunological disorders. Currently, several immunological disorders are successfully being targeted and treated using innovative medical techniques such as immunotherapy. Leading companies are increasingly investing in research activities to expand the usage and application of immunology for the treatment of various infectious diseases, including multiple sclerosis, inflammatory bowel disorders, lupus, and psoriasis, leading companies are increasingly investing in research activities. Today, the efforts of researchers in immunology, with a long history of study and research, have borne fruit, as bioengineered mAbs are now being employed in clinical practices. Accelerating Investments: Paving the Way for Immunology The increasing prevalence of infectious diseases, cancer, and immune-mediated inflammatory disorders (IMIDs) is raising the need for more precise classification and an in-depth understanding of the pathology underlying these ailments. Numerous leaders in the biotechnology domain are thus focusing on undertaking numerous strategies, such as new facility launches and collaborations, to address the need by finding deeper inroads into immunology and its use in disease treatments. For instance, in 2022, the University of Texas MD Anderson Cancer Center announced the launch of a visionary research and innovation hub, the James P. Allison Institute, to find new roads in immunotherapy, develop new treatments, and foster groundbreaking science. These developments will result in better diagnosis through the use of selective biomarkers, and early detection of fatal diseases and their treatment, which will prevent complications from happening. Also, the identification of high-risk populations through a deeper understanding of genetic and environmental factors can assist in the prevention of disease through immunotherapy. The Way Forward Immunology has led to the development of biotechnology, making it possible to develop novel drugs and vaccines, as well as diagnostic tests, that can be used to prevent, diagnose, and treat a wide range of autoimmune, infectious, and cancerous diseases. With the rapid advancement in technology and the integration of artificial intelligence, immunology is finding its way into an array of domains and industries, encompassing several research areas including medicine, pharmaceuticals, agriculture, and space. Today, not only researchers but also leading biotech and pharmaceutical companies have recognized that conventional therapies with pharmaceutical and chemical products are being replaced by products derived from immunology. This is because they work well for health problems, are environmentally friendly, and are also emerging as a wealth-generating business in the medical field.

Read More
MedTech

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.

Read More
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Spotlight

Taconic Biosciences

Taconic is a global provider of genetically modified mouse and rat models and services. As a full-service industry leader, founded in 1952, Taconic helps clients acquire, test, develop, breed, cryopreserve, prepare, and distribute highly relevant research lines worldwide. Whether you require custom genetically engineered, precision mouse models, or traditional study-ready models, Taconic's scientists will partner with you to rapidly and efficiently obtain the high quality models needed for your discovery or preclinical programs.

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Medical

NiKang Therapeutics Completes $200 Million Series C Financing to Advance Highly Differentiated Small Molecules Addressing Difficult-to-Drug Targets

NiKang Therapeutics | May 31, 2021

NiKang Therapeutics Inc., a clinical-stage biotech company focused on developing innovative small molecule oncology medicines to assist patients with unmet medical needs; today announced the completion of an oversubscribed $200 million Series C financing led by Cormorant Asset Management, HBM Healthcare Investments, and Octagon Capital Advisors with participation from a premier syndicate of funds, including new investors EcoR1 Capital, Perceptive Advisors, Wellington Management, Ally Bridge Group, Pavilion Capital, funds and accounts managed by BlackRock, RA Capital Management, Surveyor Capital (a Citadel company), Samsara BioCapital, PFM Health Sciences, Invus, Janus Henderson Investors and Logos Capital. All existing investors, including CBC Group, RTW Investments, LP, Lilly Asia Ventures, Matrix Partners China, and Casdin Capital, participated in the financing. About the funding, Bing Yao, Ph.D., former CEO and chairman of Viela Bio, and Ting Jia, Ph.D., founder and chief investment officer of Octagon Capital Advisors, will join NiKang’s Board of Directors. “We are thrilled to have such an outstanding group of investors as our shareholders,” said Zhenhai Gao, Ph.D., co-founder, president, and chief executive officer of NiKang. “Their support of our vision allows us to build the world’s leading precision oncology company. We are now well-positioned to rapidly advance our pipeline into the clinic, including our differentiated HIF-2 alpha inhibitor, and to bring our company to the next level of growth.” “This financing is a testament to the quality of our science and team,” Kelsey Chen, Ph.D., MBA, chief financial officer, added. “Since joining NiKang, I have witnessed the passion and dedication of a group of talented scientists who are devoting their lives to advancing treatments for patients. We are grateful to be recognized by such a high-caliber group of investors.” “NiKang has made remarkable progress over the last eight months since our initial investment,” said Ting Jia, Ph.D., a chief investment officer of Octagon. “We are impressed by the team’s accomplishment. We believe NiKang’s unique approach to attacking difficult-to-drug targets offers promising opportunities to develop breakthrough treatments for cancer patients. We are excited to co-lead the series C financing and partner with the NiKang team to accelerate its growth.” “We are proud of what NiKang has achieved since its inception,” said Sean Cao, executive chairman of NiKang and managing director of CBC Group, which incubated the company. “The strength of this group of investors validates NiKang’s achievements and demonstrates their confidence in NiKang’s potential to grow into a leading innovative drug company.” Proceeds will be used to advance the company’s lead drug candidates into the clinic, expand the pipeline, and fund internal drug discovery programs. About NiKang Therapeutics NiKang Therapeutics is a clinical-stage biotech company focused on discovering and developing innovative small molecule oncology medicines to assist patients with unmet medical needs. Our target selection is driven by deep insights into disease biology and molecular pathways. Our discovery approach is informed by target structure biology and capitalizes on structure-based drug design. The successful implementation of our strategy enables us to rapidly and efficiently discover and advance proprietary drug candidates with the most desirable pharmacological features into clinical studies. We strive to bring transformative medicines to patients in need.

Read More

Medical

TeselaGen Biotechnology Announced the Launch of a New Protein Optimization Toolkit for Automated Biotherapeutic Drug Design and Development

TeselaGen Biotechnology | May 21, 2021

TeselaGen Biotechnology today announced the launch of a new protein optimization toolkit for biotherapeutic drug design and development, introducing significant enhancements to the company’s flagship TeselaGen® OS to form designing and developing pharmaceuticals and biotherapeutics faster and fewer expensive. The new capabilities, easily accessible via the cloud-based platform, simplify the planning of highly complex combinatorial protein libraries and support AI models for optimizing new peptides and proteins. New application programming interfaces (APIs) and integration tools have also been extended to further enhance users’ access to the new capabilities. TeselaGen integrates the facility of AI with one end-to-end platform for design, construction, data gathering, and analysis of bioproduct performance, from pharmaceuticals to food and fabrics, significantly accelerating time to plug and reducing costs. The platform’s DESIGN, BUILD, TEST, and find out modules enable researchers to effectively collaborate across an organization's development pipeline to style and build experiments, standardize and share data, and learn and preserve project results by embedding them during a machine learning model. TeselaGen’s DESIGN is an intuitive, user-interface-driven module that permits scientists to style highly complex combinatorial libraries. With this new release, the planning now supports aminoalkanoic acid parts which will be efficiently mapped to DNA. TeselaGen can then automatically generate biology protocols for efficiently synthesizing and assembling the corresponding DNA libraries. TeselaGen’s DISCOVER now supports AI models which will recommend new peptides and proteins supported by the training of supervised and unsupervised learning models. The platform also supports the modeling of unnatural amino acids and multicriteria optimization of proteins. R&D groups can utilize the TeselaGen OS to hurry the invention process. Datasets are uploaded and arranged within the platform and immediately useful for model building within TeselaGen’s DISCOVER module. TeselaGen has demonstrated that it can increase the planning and build speed of biological products and reduce the prices related to research & development by an order of magnitude. Current partnering companies are using the new capabilities for designing antibodies and optimizing their binding affinity, titer, specific productivity, immunogenicity, or other phenotypic variables of interest. Researchers also are looking to TeselaGen for rapidly engineering new vaccines - using methods like virus-like particles (VLPs), DNA, and RNA vaccines - opening the door to attacking rapidly mutating RNA and retroviruses like influenza, HCV, HIV, or coronaviruses. About TeselaGen Biotechnology TeselaGen Biotechnology has developed the primary artificial intelligence-enabled OS for biotechnology, enabling the event and commercialization of high-performance bioproducts – from pharmaceuticals to food to fabrics – faster and easier than ever. TeselaGen® connects biologists, lab technicians, and bioinformaticians so that they will collaboratively design and build experiments, organize and standardize data then test and continually learn from the info. TeselaGen has been deployed by Fortune 50 companies and emerging innovators in biopharmaceuticals, agriculture, and specialty chemicals. the corporate is privately held and based in San Francisco, California.

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AI

Iktos Partners with Kadmon to Use AI for New Drug Design

Iktos, Kadmon | May 19, 2021

Iktos, a company specializing in Artificial Intelligence for new drug design, announced today that it has signed a Research Collaboration Agreement with Kadmon, a clinical-stage biopharmaceutical company based in New York, USA, under which Iktos' generative modeling artificial intelligence (AI) technology will be used to allow the rapid and cost-effective design of novel drug candidates. Iktos will use its de novo structure-based generative modeling technologies to find novel compounds that meet a pre-defined target product profile as part of the deal, to speed up Kadmon's early-stage discovery efforts. Kadmon discovers, develops, and delivers small molecules and biologics for the treatment of human diseases. Intending to identify and develop new product candidates for significant unmet medical needs, Kadmon is expanding and incorporating novel drug discovery platforms. The AI technology developed by Iktos, which is focused on deep generative models, aids in the speed and efficiency of the drug discovery process. Iktos' technology creates virtual novel molecules that have all of the properties of a successful drug molecule automatically. This approach, which has been validated by Iktos' other collaborations, is an innovative approach to one of the most difficult problems in drug design: finding molecules that meet several important drug criteria at the same time, such as potency, selectivity, safety, and project-specific properties. Iktos' technology enables the creation of new hits with optimal protein-ligand interactions in early-stage discovery projects, as predicted by molecular modeling technology. This technique allows for a one-of-a-kind discovery of chemical space, as well as the development of innovative molecule designs with greater Freedom to Operate. Furthermore, allowing multi-parametric in silico optimization from the start of a project greatly reduces the hit finding and hit-to-lead optimization phases. About Iktos Iktos, a French start-up founded in October 2016, specializes in the development of artificial intelligence technologies for chemical research, especially medicinal chemistry, and new drug design. Iktos is working on a proprietary and innovative approach focused on deep learning generative models that allow users to build molecules in silico that follow all of the performance criteria of a small molecule discovery project using existing evidence. Iktos technology allows for significant efficiency gains in upstream pharmaceutical R&D. Iktos' software is utilized as both professional services and a SaaS software platform, Makya. Spaya, a synthesis planning software built on Iktos' proprietary AI technology for retrosynthesis, is also in the works.

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Medical

NiKang Therapeutics Completes $200 Million Series C Financing to Advance Highly Differentiated Small Molecules Addressing Difficult-to-Drug Targets

NiKang Therapeutics | May 31, 2021

NiKang Therapeutics Inc., a clinical-stage biotech company focused on developing innovative small molecule oncology medicines to assist patients with unmet medical needs; today announced the completion of an oversubscribed $200 million Series C financing led by Cormorant Asset Management, HBM Healthcare Investments, and Octagon Capital Advisors with participation from a premier syndicate of funds, including new investors EcoR1 Capital, Perceptive Advisors, Wellington Management, Ally Bridge Group, Pavilion Capital, funds and accounts managed by BlackRock, RA Capital Management, Surveyor Capital (a Citadel company), Samsara BioCapital, PFM Health Sciences, Invus, Janus Henderson Investors and Logos Capital. All existing investors, including CBC Group, RTW Investments, LP, Lilly Asia Ventures, Matrix Partners China, and Casdin Capital, participated in the financing. About the funding, Bing Yao, Ph.D., former CEO and chairman of Viela Bio, and Ting Jia, Ph.D., founder and chief investment officer of Octagon Capital Advisors, will join NiKang’s Board of Directors. “We are thrilled to have such an outstanding group of investors as our shareholders,” said Zhenhai Gao, Ph.D., co-founder, president, and chief executive officer of NiKang. “Their support of our vision allows us to build the world’s leading precision oncology company. We are now well-positioned to rapidly advance our pipeline into the clinic, including our differentiated HIF-2 alpha inhibitor, and to bring our company to the next level of growth.” “This financing is a testament to the quality of our science and team,” Kelsey Chen, Ph.D., MBA, chief financial officer, added. “Since joining NiKang, I have witnessed the passion and dedication of a group of talented scientists who are devoting their lives to advancing treatments for patients. We are grateful to be recognized by such a high-caliber group of investors.” “NiKang has made remarkable progress over the last eight months since our initial investment,” said Ting Jia, Ph.D., a chief investment officer of Octagon. “We are impressed by the team’s accomplishment. We believe NiKang’s unique approach to attacking difficult-to-drug targets offers promising opportunities to develop breakthrough treatments for cancer patients. We are excited to co-lead the series C financing and partner with the NiKang team to accelerate its growth.” “We are proud of what NiKang has achieved since its inception,” said Sean Cao, executive chairman of NiKang and managing director of CBC Group, which incubated the company. “The strength of this group of investors validates NiKang’s achievements and demonstrates their confidence in NiKang’s potential to grow into a leading innovative drug company.” Proceeds will be used to advance the company’s lead drug candidates into the clinic, expand the pipeline, and fund internal drug discovery programs. About NiKang Therapeutics NiKang Therapeutics is a clinical-stage biotech company focused on discovering and developing innovative small molecule oncology medicines to assist patients with unmet medical needs. Our target selection is driven by deep insights into disease biology and molecular pathways. Our discovery approach is informed by target structure biology and capitalizes on structure-based drug design. The successful implementation of our strategy enables us to rapidly and efficiently discover and advance proprietary drug candidates with the most desirable pharmacological features into clinical studies. We strive to bring transformative medicines to patients in need.

Read More

Medical

TeselaGen Biotechnology Announced the Launch of a New Protein Optimization Toolkit for Automated Biotherapeutic Drug Design and Development

TeselaGen Biotechnology | May 21, 2021

TeselaGen Biotechnology today announced the launch of a new protein optimization toolkit for biotherapeutic drug design and development, introducing significant enhancements to the company’s flagship TeselaGen® OS to form designing and developing pharmaceuticals and biotherapeutics faster and fewer expensive. The new capabilities, easily accessible via the cloud-based platform, simplify the planning of highly complex combinatorial protein libraries and support AI models for optimizing new peptides and proteins. New application programming interfaces (APIs) and integration tools have also been extended to further enhance users’ access to the new capabilities. TeselaGen integrates the facility of AI with one end-to-end platform for design, construction, data gathering, and analysis of bioproduct performance, from pharmaceuticals to food and fabrics, significantly accelerating time to plug and reducing costs. The platform’s DESIGN, BUILD, TEST, and find out modules enable researchers to effectively collaborate across an organization's development pipeline to style and build experiments, standardize and share data, and learn and preserve project results by embedding them during a machine learning model. TeselaGen’s DESIGN is an intuitive, user-interface-driven module that permits scientists to style highly complex combinatorial libraries. With this new release, the planning now supports aminoalkanoic acid parts which will be efficiently mapped to DNA. TeselaGen can then automatically generate biology protocols for efficiently synthesizing and assembling the corresponding DNA libraries. TeselaGen’s DISCOVER now supports AI models which will recommend new peptides and proteins supported by the training of supervised and unsupervised learning models. The platform also supports the modeling of unnatural amino acids and multicriteria optimization of proteins. R&D groups can utilize the TeselaGen OS to hurry the invention process. Datasets are uploaded and arranged within the platform and immediately useful for model building within TeselaGen’s DISCOVER module. TeselaGen has demonstrated that it can increase the planning and build speed of biological products and reduce the prices related to research & development by an order of magnitude. Current partnering companies are using the new capabilities for designing antibodies and optimizing their binding affinity, titer, specific productivity, immunogenicity, or other phenotypic variables of interest. Researchers also are looking to TeselaGen for rapidly engineering new vaccines - using methods like virus-like particles (VLPs), DNA, and RNA vaccines - opening the door to attacking rapidly mutating RNA and retroviruses like influenza, HCV, HIV, or coronaviruses. About TeselaGen Biotechnology TeselaGen Biotechnology has developed the primary artificial intelligence-enabled OS for biotechnology, enabling the event and commercialization of high-performance bioproducts – from pharmaceuticals to food to fabrics – faster and easier than ever. TeselaGen® connects biologists, lab technicians, and bioinformaticians so that they will collaboratively design and build experiments, organize and standardize data then test and continually learn from the info. TeselaGen has been deployed by Fortune 50 companies and emerging innovators in biopharmaceuticals, agriculture, and specialty chemicals. the corporate is privately held and based in San Francisco, California.

Read More

AI

Iktos Partners with Kadmon to Use AI for New Drug Design

Iktos, Kadmon | May 19, 2021

Iktos, a company specializing in Artificial Intelligence for new drug design, announced today that it has signed a Research Collaboration Agreement with Kadmon, a clinical-stage biopharmaceutical company based in New York, USA, under which Iktos' generative modeling artificial intelligence (AI) technology will be used to allow the rapid and cost-effective design of novel drug candidates. Iktos will use its de novo structure-based generative modeling technologies to find novel compounds that meet a pre-defined target product profile as part of the deal, to speed up Kadmon's early-stage discovery efforts. Kadmon discovers, develops, and delivers small molecules and biologics for the treatment of human diseases. Intending to identify and develop new product candidates for significant unmet medical needs, Kadmon is expanding and incorporating novel drug discovery platforms. The AI technology developed by Iktos, which is focused on deep generative models, aids in the speed and efficiency of the drug discovery process. Iktos' technology creates virtual novel molecules that have all of the properties of a successful drug molecule automatically. This approach, which has been validated by Iktos' other collaborations, is an innovative approach to one of the most difficult problems in drug design: finding molecules that meet several important drug criteria at the same time, such as potency, selectivity, safety, and project-specific properties. Iktos' technology enables the creation of new hits with optimal protein-ligand interactions in early-stage discovery projects, as predicted by molecular modeling technology. This technique allows for a one-of-a-kind discovery of chemical space, as well as the development of innovative molecule designs with greater Freedom to Operate. Furthermore, allowing multi-parametric in silico optimization from the start of a project greatly reduces the hit finding and hit-to-lead optimization phases. About Iktos Iktos, a French start-up founded in October 2016, specializes in the development of artificial intelligence technologies for chemical research, especially medicinal chemistry, and new drug design. Iktos is working on a proprietary and innovative approach focused on deep learning generative models that allow users to build molecules in silico that follow all of the performance criteria of a small molecule discovery project using existing evidence. Iktos technology allows for significant efficiency gains in upstream pharmaceutical R&D. Iktos' software is utilized as both professional services and a SaaS software platform, Makya. Spaya, a synthesis planning software built on Iktos' proprietary AI technology for retrosynthesis, is also in the works.

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