How to prepare for bone marrow transplant

A bone marrow transplant is a medical procedure performed to replace bone marrow that has been damaged or destroyed by disease, infection, or chemotherapy, also called a stem cell transplant, this is a treatment for some types of cancer. For example, leukemia, multiple myeloma, or some types of lymphoma. Doctors also treat some blood diseases with stem cell transplants. The stem cell transplant procedure involves several steps involved in this transplant, so one must know completely about what he/she is going to go through. But first, let’s get to know what bone marrow is.

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Premier Healthcare Germany

Premier Healthcare Germany, with its head office in Germany ( Hamburg), specializes in organizing medical treatment and diagnostics in Europe. The expert case managers facilitate international patients’ access to high-quality medical care in many parts of Europe. The multilingual team has the necessary expertise to communicate with European doctors and international patients alike.

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MedTech

Better Purification and Recovery in Bioprocessing

Article | July 16, 2022

In the downstream portion of any bioprocess, one must pick through the dross before one can seize the gold the biotherapeutic that the bioprocess was always meant to generate. Unfortunately, the dross is both voluminous and various. And the biotherapeutic gold, unlike real gold, is corruptible. That is, it can suffer structural damage and activity loss. When discarding the dross and collecting the gold, bioprocessors must be efficient and gentle. They must, to the extent possible, eliminate contaminants and organic debris while ensuring that biotherapeutics avoid aggregation-inducing stresses and retain their integrity during purification and recovery. Anything less compromises purity and reduces yield. To purify and recover biotherapeutics efficiently and gently, bioprocessors must avail themselves of the most appropriate tools and techniques. Here, we talk with several experts about which tools and techniques can help bioprocessors overcome persistent challenges. Some of these experts also touch on new approaches that can help bioprocessors address emerging challenges.

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MedTech

Laboratory Information Management System for Biotech Labs: Significance & Benefits

Article | July 20, 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.

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Medical

Top 3 Biotech Clinical Data Management Trends to Watch in 2022

Article | August 16, 2022

Introduction The administration of medical records and data has advanced significantly during the past few decades. Clinical data management, which was once only a small subset of biotech research organizations, has now developed into a mission-critical, specialized unit. In the late 1990s, electronic data capture (EDC) began to alter the traditional function of clinical data management. After that, the data configuration and management of data queries for the EDC system fell under the purview of clinical data management services. Today, clinical data management is not only responsible for managing the clinical data configuration and data queries but also developing and implementing data administration plans, ensuring data accuracy and completeness, and maintaining optimum data security. In recent years, as digital technologies have gained acceptance around the globe, data has become a vital aspect in decision-making across numerous industries, and the life sciences and biotechnology sectors are no exception. Using data has provided granular insights to biotech organizations, assisting them in creating breakthroughs in drug development and medical research and signifying the importance of clinical trial management systems in these medical verticals. The Biggest Biotech Clinical Data Management Trends to Know About Today The future of clinical data management is contingent upon the implementation of systems and regulations. It is imperative for all organizations participating in a medical or life science trial to have transparent rules in place for sharing and retaining patient data. Also, there is a need to have a standardized format for maintaining these records and documents related to trials. This assists biotech organizations in reducing the chances of ambiguity regarding who owns what kind of data or paperwork at any given time. Over the past couple of years, the focus of the life science and biotechnology industries has shifted towards developing more effective medications and therapies, implementing personalized treatment, and finding cures for diseases such as cancer and AIDS. In response to this, a substantial rise in the number of clinical trials is being witnessed globally. As the number of clinical trials continues to accelerate, the spending on these trials rises as well. In response to this, the worldwide cost of conducting clinical trials is anticipated to reach US$ 49.80 billion in 2022. With the transition of the world from traditional to digital, medical professionals and biotech businesses are increasingly shifting towards adopting high-tech and reliable clinical trial management systems for various applications, starting from diagnosis and clinical trials to patient data documentation. But, what are the future trends in biotechnology clinical data management? Let’s discuss. Cloud-Based Clinical Metadata Repositories Automation is emerging as a new frontier in the biotech clinical data management domain, along with other innovative technologies such as artificial intelligence and machine learning. Because of this, life science establishments are witnessing a huge shift from paper-based documentation toward data-based documentation, which is creating mountains of research, compliance, and clinical data. The growing demand for new and more effective medications and drugs is augmenting the need to expedite clinical trials. This is resulting in an increased number of initiatives aimed at optimizing clinical trial processes to prepare and launch successful trials. However, pharmaceutical and biotechnology laboratories are encountering several challenges in collecting, managing, and analyzing metadata due to its complexities. So, what is the best solution to this problem? The answer to this is cloud-based clinical metadata repositories. Clinical research facilities are leveraging advanced, all-in-one, cloud-based clinical metadata repositories to assist them in centralizing and managing metadata; increasing metadata quality, consistency, and accuracy; and speeding up clinical trial management, documentation, and compliance processes. Shift Towards Digital Solutions Electronic Case Report Form Adequate research and accurate data are crucial for a clinical trial to succeed. Whether developing new drugs, medication, or therapies; conducting life science research; or studying the latest clinical trial systems, it is best to use electronic solutions as it reduces the room for mistakes during the transition of clinical data from paper-based format. Realizing this, biotech organizations are shifting towards using electronic case report forms to speed up record retrieval, improve record security, and cut down on operational costs associated with running clinical trials. The electronic case report form assists in lowering the failure rate of the clinical trial, enhancing efficiency, and optimizing security along with improving clinical trial documentation and productivity, further driving its adoption in the medical space. Electronic Clinical Outcome Assessment Electronic clinical outcome assessment is surfacing as one of the fast-growing future trends in biotechnology. It allows clinical trial facilities to automate data entry and improve the reliability of the collected information. The technology enables clinical trial institutions to automatically record patient-provided information about side effects, symptoms, drug timing, and other aspects during the clinical trial for increased precision. It also helps these institutions analyze the results of medication or therapy in clinical trials and lets clinical researchers use medical technologies like biosensor-enabled devices, self-service applications, and medical wearables for evaluation. Hence, biotech clinical facilities are increasingly deploying advanced electronic clinical outcome assessment systems to ensure adherence to protocols and regulations. Clinical Trial Customization The success of a new drug is determined by numerous factors other than its effectiveness, safety, and creativity of its developers, such as a successful clinical trial. Each clinical trial involves a number of decision-making points, and one wrong choice in any of these aspects can jeopardize the success of the entire endeavor. A crucial component of making well-informed decisions is data management, which is a part of clinical study as a whole. Clinical trial customization is emerging as one of the most prominent biotech clinical trial management trends. Every clinical trial is unique and needs a tailored approach to be successful. With the emergence of the trend of personalized treatment around the globe, biotech and pharmaceutical organizations are adopting innovative customized clinical trial management solutions to accelerate the pace of clinical trials and approvals. This is giving clinical researchers innovative ways to come up with new medicines for patients and streamline the clinical data as per the requirements for faster approvals. What Are the Key Clinical Data Management Challenges Faced by Biotech Companies? Groundbreaking medical interventions are of no use without reliable, accurate, and extensive clinical trial data. Without the data, biotech and pharmaceutical companies will not be able to provide the assurance of safety and efficacy required to bring the medication to market. Regulatory bodies such as the Food and Drug Administration (FDA), the Medicines and Healthcare Products Regulatory Agency (MHRA), and others are putting stricter rules in place to ensure the quality of clinical data. In addition, the fast-changing clinical development environment is creating more obstacles for biotech and medical spaces to ensure the accuracy, standard, and completeness of the clinical trial data. Hence, clinical teams are spending valuable time cleaning up data instead of analyzing it. Time spent trying to figure out issues with clinical trial data is detrimental and expensive but also mission-critical. This is because a small issue in the data can lead to numerous consequences, from small delays to calamitous setbacks, making it necessary to rerun clinical trials. This problem will only get more challenging to address as the volume of data and the types of data sources continue to grow. Here are some of the major clinical data management challenges that biotech firms encounter Standardization of Clinical Metadata Stringent Regulatory Compliance Increased Clinical Trial Complexity Mid-Study Changes Why Are Clinical Data Management Systems Garnering Popularity in the Biotech Industry? With the changing regulatory and clinical landscape, biotech and pharmaceutical companies are facing several obstacles in the management of clinical data and clinical trials. In addition, regulatory agencies are moving toward integrated electronic systems, which is making it more and more important for clinical laboratories to change the format of their submissions. Because of this, several biotech clinical labs are focusing on adopting innovative laboratory solutions, such as biotech clinical data management systems, to meet the need for standardized data inputs and replace all manual ways of working with electronic systems. A clinical data management system establishes the framework for error-free data collection and high-quality data submission, resulting in speedier drug discovery and shorter time-to-market. These solutions are gaining huge traction among biotech and pharmaceutical companies, owing to their ability to effectively manage clinical data, accelerate clinical trials, and ensure compliance. Let’s see some of the features of biotech clinical data management software that are most sought after by life-science companies Controlled, standardized data repository. Centralized data analysis and administration. Reduced operational expenditures for clinical data processes. Enhanced process effectiveness. Superior submission quality Compliance with predefined standards. Clinical Data Management Systems: The Future The role of clinical data management systems is evolving at a rapid pace as the life science and medical industries continue to incorporate digital solutions for diverse operations. These systems are being used in a variety of biotech clinical settings, ranging from clinical data compliance to data science and analytics, to help them analyze large and growing volumes of clinical data. Hence, a number of high-tech medical companies are aiming at integrating innovative technologies, such as artificial intelligence and machine learning, into clinical data management software to automate clinical data management tasks, improve clinical data submission, and enhance data quality. These new biotech clinical management technologies are anticipated to help life science laboratories gain a better understanding of diseases and speed up clinical trials in the coming years. FAQ What is a clinical data management system? A clinical data management system (CDMS) is a tool used in clinical research to track, record, and manage clinical trial data across medical establishments such as biotech laboratories. What are the key functions of the biotech clinical data management system? Some of the key functions of biotech clinical data management system are Documentation of Protocols and Regulations Patient Recruitment Real-time Clinical Study Analytics Reporting Investigator Relationship Management Electronic Visit Report Why is a clinical data management system needed for clinical trials today? A clinical data management system helps shorten the time from drug development to marketing by assisting in the collection of high-quality, statistically sound, and accurate data from clinical trials.

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MedTech

Data Analytics: A Groundbreaking Technology in Biotech

Article | July 20, 2022

Biotechnology is a vast discipline of biology that employs diverse biological systems to create solutions that can significantly alter the ways in which they operate across various domains. That said, biotechnology is not a new notion. It has existed for millennia, with ancient civilizations using its earliest incarnations to cultivate crops and create alcoholic beverages. Today, the biotechnology industry has developed by leaps and bounds and has amassed a vast quantity of scientific data through study and research. Given the importance of data in the biotechnology business, it is not difficult to understand why biotech companies utilize data analytics. Modern data analytics tools have made it possible for researchers in the biotech industry to build predictive analytics models and gain knowledge about the most efficient approaches to accomplish their desired goals and objectives. Data analytics is increasingly being adopted by biotech businesses to better understand their industry and foresee any problems down the road. How is Data Analytics Revolutionizing Fields in Biotechnology? Today's business and scientific fields greatly benefit from data. Without the analysis of vast information libraries that provide new insights and enable new innovations, no industry can really advance. Being highly reliant on big data analytics, biotech is not an exception in this regard. With the tools and methods that help scientists systematize their findings and speed up their research for better and safer results, data analytics is making deeper inroads into the biotechnology industry. It is emerging as a crucial link between knowledge and information and is extensively being used for purposes other than just examining the information that is already available. The following are a few of the cutting-edge biotechnology applications of data analytics Genomics and Disease Treatment Pharmaceutical Drug Discovery Drug Recycling and Safety Agriculture and Agri-products Environmental Damage Mitigation Data Analytics Possibilities in Biotechnology With data analytics becoming an integral part of how biotech businesses operate, biotechnologists and related stakeholders need to understand its emergence and crucial role. Data analytics has opened new frontiers in the realm of biotechnology. Thanks to developments in data analytics, research and development activities that once took years may now be accomplished in a matter of months. Also, now scientists have access to biological, social, and environmental insights that can be exploited to create more effective and sustainable products. By understanding the importance of data-related tools and techniques applications, biotech companies are aiming to invest in the popularizing technology to stay updated in the fast-paced biotechnology industry.

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Premier Healthcare Germany

Premier Healthcare Germany, with its head office in Germany ( Hamburg), specializes in organizing medical treatment and diagnostics in Europe. The expert case managers facilitate international patients’ access to high-quality medical care in many parts of Europe. The multilingual team has the necessary expertise to communicate with European doctors and international patients alike.

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Industrial Impact

TARA Biosystems Partners with Scipher Medicine®

TARA Biosystems | November 03, 2021

TARA Biosystemsa, biotechnology company harnessing human biology and data to transform cardiac drug discovery, today announced a collaboration with Scipher Medicine, a precision medicine company matching patients with the most effective therapy. The collaboration will address a critical unmet need for effective therapeutics in cardiac laminopathies. Cardiac laminopathies, associated with mutations in the LMNA gene, can result in electrical and mechanical changes in the heart. These changes can have profound clinical consequences, including cardiomyopathy, sudden cardiac death, and end-stage heart failure. At present, therapies that correct the underlying pathologies do not exist. “This collaboration demonstrates the transformative potential of combining biology-driven data with network biology to further drug discovery and development and unlock new medicines and therapeutics,” said Misti Ushio, PhD, CEO of TARA Biosystems Scipher will leverage human molecular data analyzed by its Spectra™ platform, which includes data from TARA’s BiowireTM II LMNA disease models, to identify novel targets for a stratified disease population. This approach aims to identify proteins upstream and downstream of LMNA signaling within the Spectra™ network model. The identified targets will be evaluated in TARA’s BiowireTM II platform, which consists of induced pluripotent stem cell-derived human cardiac tissue models, including a repertoire of healthy, gene-edited, patient-derived, and drug-induced phenotypes of human disease. “The Spectra platform uniquely integrates AI with the protein network of human cells to identify novel targets in highly complex and debilitating diseases such as laminopathy,” said Slava Akmaev, PhD, CTO, and Head of Therapeutics at Scipher Medicine. “By interrogating the network neighborhood of LMNA and its relationship with the proteins appropriate for targeted therapeutics we are confident that we can identify several novel and relevant drug targets.” “The TARA platform is highly versatile and can capture robust physiologic endpoints of human cardiac function, including contractility, electrophysiology, calcium signaling, structure, as well as genomic, proteomic, and metabolic profiles,” said Robert Langer, PhD, Board of Directors at TARA Biosystems. “We believe that TARA and Scipher combined efforts have the potential to lead to drug development that enables a truly personalized treatment for patients.” Under the terms of the partnership, TARA has the exclusive option to progress identified targets into drug discovery and clinical development. Scipher is eligible to receive milestone payments and royalties. TARA will retain the rights for the development, and commercialization of therapeutics for the selected targets. “The partnership with TARA is a further example of how our disease agnostic Spectra platform can be applied to where novel targets are most needed,” added Alif Saleh, CEO of Scipher. “The ability to quickly validate novel targets identified by Spectra on TARA’s human tissue model platform allows us to rapidly iterate to identify most effective targets.” About TARA Biosystems, Inc. Headquartered in New York City, TARA Biosystems harnesses innovations in stem cell biology and tissue engineering to generate in vitro biology that recapitulates human physiology with unprecedented fidelity. Our highly versatile and robust platform captures integrated physiologic endpoints of human cardiac function across a wide repertoire of cardiac disease phenotypes. Our data facilitates decisive evaluation of the efficacy and risk of novel medicines, increasing the probability of success and decreasing long timeframes associated with traditional drug discovery efforts. Safer and more effective new medicines that rapidly make it to market means better health and longer lives, and we believe that benefits people everywhere. About Spectra A platform deciphering the complexity of disease by analyzing large patient molecular datasets through the unique lens of the human interactome and AI. Built upon over a decade of experimental research, the platform’s backbone is the network map of human biology explaining how proteins expressed from the human genome interact to cause specific disease phenotypes, providing the wiring diagram needed to interpret dynamic individual patient molecular data to reveal actual disease biology. Spectra™ is not a model but a disease representation rooted in experimental human biology and proprietary patient molecular data, allowing us to identify a patient’s unique disease signature, predict drug response to approved drugs and identify novel drug targets in patients not responding to existing therapies. About Scipher Medicine® Scipher Medicine, a precision immunology company, believes that patients deserve simple answers to treatment options based on scientifically backed data. Using our proprietary Spectra Network Biology platform and artificial intelligence, we commercialize blood tests revealing a person's unique molecular disease signature and match such signature to the most effective therapy, ensuring optimal treatment from day one. The patient molecular data generated from our tests further drives the discovery and development of novel and more effective therapeutics. We partner with payers, providers, and pharma along the health care value chain to bring precision medicine to autoimmune diseases.

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MedTech

Outcomes4Me Partners with Invitae to Offer Genetic Testing to Breast Cancer Patients

Outcomes4Me | October 12, 2021

Outcomes4Me Inc., developer of a leading free mobile app and platform to navigate cancer treatment and care, today announced that it has partnered with Invitae Corporation (NYSE: NVTA), a leading medical genetics company, to expand education and access to genetic testing to breast cancer patients and survivors. The collaboration leverages the strengths of Invitae, which supplies clinical grade genetic testing, and Outcomes4Me’s 360-degree, validated and evidence-based cancer support and treatment options via its free and easy-to-use app. Initially and currently available in the United States, patients can now receive genetic counseling through Invitae’s partnership with Genome Medical, get testing, and upload their results within the Outcomes4Me app.There is a misconception that genetic testing is only useful as a preventative tool prior to a cancer diagnosis. According to Outcomes4Me patient data, almost half of users (46 percent) who qualified for testing (based on NCCN Guidelines®) did not receive testing or did not know if they had received testing. However, genetic testing can provide insights that can help inform and refine precision therapy use and clinical treatment trial enrollment. In addition, genetic testing results can be used to help prevent recurrence and reduce incidence of other inherited cancers. A cancer diagnosis is often overwhelming for patients and their families. Outcomes4Me demystifies cancer by providing the most up-to-date and validated research, support, and treatment options, all grounded in science and data and curated according to the patient’s specific diagnosis. Outcomes4Me partners with the researchers, doctors, and academics that set the rigorous standards of cancer care for all treatment providers, including the National Comprehensive Care Network® (NCCN®), Vanderbilt-Ingram Cancer Center (VICC) and Massachusetts General Hospital (MGH). The collaboration with Invitae expands access to genetic testing, a vitally important tool in the patient’s cancer care arsenal. “Outcomes4Me is an indispensable platform for patients with breast cancer, giving them the personalized knowledge and access to timely new trials and targeted therapies that could lead to better health outcomes. By providing access to our comprehensive genetic testing and counseling services, Outcomes4Me is adding a valuable resource that will empower patients to advance their knowledge, understanding, and therefore, self-advocacy during treatment and survivorship.” Ed Esplin, M.D., Ph.D., FACMG, FACP, Clinical Geneticist at Invitae Unlike popular direct-to-consumer genetic testing services, which test for a few specific genetic variants for certain genes, Invitae provides state-of-the-art clinical grade next-generation sequencing-based (NGS) genetic testing that comprehensively analyses more than 80 genes, including all known mutations of the important BRCA1/BRCA2 genes. This comprehensive approach, combined with associated genetic counseling, not only provides insights for cancer patients, but also for family members who may be at risk. “Our collaboration with Invitae reinforces Outcomes4Me’s mission to give patients back control. Because of this work with Invitae, our valued community now has rare direct access to a much-needed testing service. Outcomes4Me will proudly continue to democratize the best in cancer treatment, research, and support by removing barriers and bias in information flow.” Maya R. Said, Sc. D., Founder and CEO of Outcomes4Me About Invitae Invitae Corporation (NYSE: NVTA) is a leading medical genetics company whose mission is to bring comprehensive genetic information into mainstream medicine to improve healthcare for billions of people. Invitae's goal is to aggregate the world's genetic tests into a single service with higher quality, faster turnaround time, and lower prices. About Outcomes4Me Outcomes4Me is on a mission to improve health outcomes by empowering patients with understandable, relevant and evidence-based information. Outcomes4Me has developed a platform for shared decision-making between patients and providers. The platform harnesses regulatory-grade, real-world data and patient experiences generating deeper insights and better outcomes to improve care and accelerate research. The Outcomes4Me mobile app enables cancer patients to make decisions and take control of their care based on information that is personalized to their specific condition, including finding treatment options, matching to clinical trials, and tracking and managing symptoms. Based in Boston, Massachusetts, Outcomes4Me, a woman-led company, comprises seasoned healthcare, oncology, pharmaceutical, consumer and technology veterans.

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Machine learning programme used to predict stem cell growth

Drug Target Review | November 21, 2019

Researchers have used a computational model to learn how to manipulate stem cell arrangement, including those that may eventually be useful in generating personalised organs. According to the team, their discovery could be used to develop model organs grown from a patient’s own cells, which could ‘revolutionise’ how diseases are treated by increasing disease understanding or testing drugs. The study was conducted by a team from Gladstone Institutes, in collaboration with Boston University, both US. Induced pluripotent stem (iPS) cells, similar to the stem cells found in an embryo, have the potential to become nearly every type of cell in the body. Although researchers can prompt these cells into differentiating into specific organ cells, they cannot grow into functioning three-dimensional (3D) organs. “Despite the importance of organisation for functioning tissues, we as scientists have had difficulty creating tissues in a dish with stem cells,” said Ashley Libby, co-first author. “Instead of an organised tissue, we often get a disorganised mix of different cell types.”

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Industrial Impact

TARA Biosystems Partners with Scipher Medicine®

TARA Biosystems | November 03, 2021

TARA Biosystemsa, biotechnology company harnessing human biology and data to transform cardiac drug discovery, today announced a collaboration with Scipher Medicine, a precision medicine company matching patients with the most effective therapy. The collaboration will address a critical unmet need for effective therapeutics in cardiac laminopathies. Cardiac laminopathies, associated with mutations in the LMNA gene, can result in electrical and mechanical changes in the heart. These changes can have profound clinical consequences, including cardiomyopathy, sudden cardiac death, and end-stage heart failure. At present, therapies that correct the underlying pathologies do not exist. “This collaboration demonstrates the transformative potential of combining biology-driven data with network biology to further drug discovery and development and unlock new medicines and therapeutics,” said Misti Ushio, PhD, CEO of TARA Biosystems Scipher will leverage human molecular data analyzed by its Spectra™ platform, which includes data from TARA’s BiowireTM II LMNA disease models, to identify novel targets for a stratified disease population. This approach aims to identify proteins upstream and downstream of LMNA signaling within the Spectra™ network model. The identified targets will be evaluated in TARA’s BiowireTM II platform, which consists of induced pluripotent stem cell-derived human cardiac tissue models, including a repertoire of healthy, gene-edited, patient-derived, and drug-induced phenotypes of human disease. “The Spectra platform uniquely integrates AI with the protein network of human cells to identify novel targets in highly complex and debilitating diseases such as laminopathy,” said Slava Akmaev, PhD, CTO, and Head of Therapeutics at Scipher Medicine. “By interrogating the network neighborhood of LMNA and its relationship with the proteins appropriate for targeted therapeutics we are confident that we can identify several novel and relevant drug targets.” “The TARA platform is highly versatile and can capture robust physiologic endpoints of human cardiac function, including contractility, electrophysiology, calcium signaling, structure, as well as genomic, proteomic, and metabolic profiles,” said Robert Langer, PhD, Board of Directors at TARA Biosystems. “We believe that TARA and Scipher combined efforts have the potential to lead to drug development that enables a truly personalized treatment for patients.” Under the terms of the partnership, TARA has the exclusive option to progress identified targets into drug discovery and clinical development. Scipher is eligible to receive milestone payments and royalties. TARA will retain the rights for the development, and commercialization of therapeutics for the selected targets. “The partnership with TARA is a further example of how our disease agnostic Spectra platform can be applied to where novel targets are most needed,” added Alif Saleh, CEO of Scipher. “The ability to quickly validate novel targets identified by Spectra on TARA’s human tissue model platform allows us to rapidly iterate to identify most effective targets.” About TARA Biosystems, Inc. Headquartered in New York City, TARA Biosystems harnesses innovations in stem cell biology and tissue engineering to generate in vitro biology that recapitulates human physiology with unprecedented fidelity. Our highly versatile and robust platform captures integrated physiologic endpoints of human cardiac function across a wide repertoire of cardiac disease phenotypes. Our data facilitates decisive evaluation of the efficacy and risk of novel medicines, increasing the probability of success and decreasing long timeframes associated with traditional drug discovery efforts. Safer and more effective new medicines that rapidly make it to market means better health and longer lives, and we believe that benefits people everywhere. About Spectra A platform deciphering the complexity of disease by analyzing large patient molecular datasets through the unique lens of the human interactome and AI. Built upon over a decade of experimental research, the platform’s backbone is the network map of human biology explaining how proteins expressed from the human genome interact to cause specific disease phenotypes, providing the wiring diagram needed to interpret dynamic individual patient molecular data to reveal actual disease biology. Spectra™ is not a model but a disease representation rooted in experimental human biology and proprietary patient molecular data, allowing us to identify a patient’s unique disease signature, predict drug response to approved drugs and identify novel drug targets in patients not responding to existing therapies. About Scipher Medicine® Scipher Medicine, a precision immunology company, believes that patients deserve simple answers to treatment options based on scientifically backed data. Using our proprietary Spectra Network Biology platform and artificial intelligence, we commercialize blood tests revealing a person's unique molecular disease signature and match such signature to the most effective therapy, ensuring optimal treatment from day one. The patient molecular data generated from our tests further drives the discovery and development of novel and more effective therapeutics. We partner with payers, providers, and pharma along the health care value chain to bring precision medicine to autoimmune diseases.

Read More

MedTech

Outcomes4Me Partners with Invitae to Offer Genetic Testing to Breast Cancer Patients

Outcomes4Me | October 12, 2021

Outcomes4Me Inc., developer of a leading free mobile app and platform to navigate cancer treatment and care, today announced that it has partnered with Invitae Corporation (NYSE: NVTA), a leading medical genetics company, to expand education and access to genetic testing to breast cancer patients and survivors. The collaboration leverages the strengths of Invitae, which supplies clinical grade genetic testing, and Outcomes4Me’s 360-degree, validated and evidence-based cancer support and treatment options via its free and easy-to-use app. Initially and currently available in the United States, patients can now receive genetic counseling through Invitae’s partnership with Genome Medical, get testing, and upload their results within the Outcomes4Me app.There is a misconception that genetic testing is only useful as a preventative tool prior to a cancer diagnosis. According to Outcomes4Me patient data, almost half of users (46 percent) who qualified for testing (based on NCCN Guidelines®) did not receive testing or did not know if they had received testing. However, genetic testing can provide insights that can help inform and refine precision therapy use and clinical treatment trial enrollment. In addition, genetic testing results can be used to help prevent recurrence and reduce incidence of other inherited cancers. A cancer diagnosis is often overwhelming for patients and their families. Outcomes4Me demystifies cancer by providing the most up-to-date and validated research, support, and treatment options, all grounded in science and data and curated according to the patient’s specific diagnosis. Outcomes4Me partners with the researchers, doctors, and academics that set the rigorous standards of cancer care for all treatment providers, including the National Comprehensive Care Network® (NCCN®), Vanderbilt-Ingram Cancer Center (VICC) and Massachusetts General Hospital (MGH). The collaboration with Invitae expands access to genetic testing, a vitally important tool in the patient’s cancer care arsenal. “Outcomes4Me is an indispensable platform for patients with breast cancer, giving them the personalized knowledge and access to timely new trials and targeted therapies that could lead to better health outcomes. By providing access to our comprehensive genetic testing and counseling services, Outcomes4Me is adding a valuable resource that will empower patients to advance their knowledge, understanding, and therefore, self-advocacy during treatment and survivorship.” Ed Esplin, M.D., Ph.D., FACMG, FACP, Clinical Geneticist at Invitae Unlike popular direct-to-consumer genetic testing services, which test for a few specific genetic variants for certain genes, Invitae provides state-of-the-art clinical grade next-generation sequencing-based (NGS) genetic testing that comprehensively analyses more than 80 genes, including all known mutations of the important BRCA1/BRCA2 genes. This comprehensive approach, combined with associated genetic counseling, not only provides insights for cancer patients, but also for family members who may be at risk. “Our collaboration with Invitae reinforces Outcomes4Me’s mission to give patients back control. Because of this work with Invitae, our valued community now has rare direct access to a much-needed testing service. Outcomes4Me will proudly continue to democratize the best in cancer treatment, research, and support by removing barriers and bias in information flow.” Maya R. Said, Sc. D., Founder and CEO of Outcomes4Me About Invitae Invitae Corporation (NYSE: NVTA) is a leading medical genetics company whose mission is to bring comprehensive genetic information into mainstream medicine to improve healthcare for billions of people. Invitae's goal is to aggregate the world's genetic tests into a single service with higher quality, faster turnaround time, and lower prices. About Outcomes4Me Outcomes4Me is on a mission to improve health outcomes by empowering patients with understandable, relevant and evidence-based information. Outcomes4Me has developed a platform for shared decision-making between patients and providers. The platform harnesses regulatory-grade, real-world data and patient experiences generating deeper insights and better outcomes to improve care and accelerate research. The Outcomes4Me mobile app enables cancer patients to make decisions and take control of their care based on information that is personalized to their specific condition, including finding treatment options, matching to clinical trials, and tracking and managing symptoms. Based in Boston, Massachusetts, Outcomes4Me, a woman-led company, comprises seasoned healthcare, oncology, pharmaceutical, consumer and technology veterans.

Read More

Machine learning programme used to predict stem cell growth

Drug Target Review | November 21, 2019

Researchers have used a computational model to learn how to manipulate stem cell arrangement, including those that may eventually be useful in generating personalised organs. According to the team, their discovery could be used to develop model organs grown from a patient’s own cells, which could ‘revolutionise’ how diseases are treated by increasing disease understanding or testing drugs. The study was conducted by a team from Gladstone Institutes, in collaboration with Boston University, both US. Induced pluripotent stem (iPS) cells, similar to the stem cells found in an embryo, have the potential to become nearly every type of cell in the body. Although researchers can prompt these cells into differentiating into specific organ cells, they cannot grow into functioning three-dimensional (3D) organs. “Despite the importance of organisation for functioning tissues, we as scientists have had difficulty creating tissues in a dish with stem cells,” said Ashley Libby, co-first author. “Instead of an organised tissue, we often get a disorganised mix of different cell types.”

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