Religious beliefs shape our thinking on cloning, stem cells and gene editing

It is difficult to examine society’s acceptance or rejection of key biotech developments without considering the role played by the world’s major religions and their belief structures. Christianity, Judaism, Hinduism, Buddhism and Islam react to new technologies and concepts in their own way – though there is rarely universal consensus on every issue within those religions. Not surprisingly, the basis for modern day beliefs is often found in scripture and related lore. To better understand, for example,  how religions view the use of human embryonic tissue for research and treatment, consider the ancient Jewish tales of golemim — super beings created by humans for protection and tasks.

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Vical

Vical develops biopharmaceutical products for the prevention and treatment of chronic or life-threatening infectious diseases, based on our patented DNA delivery technologies and other therapeutic approaches.

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MedTech

Top 3 Biotech Clinical Data Management Trends to Watch in 2022

Article | July 11, 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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Research

AI and Biotechnology: The Future of Healthcare Industry

Article | July 11, 2022

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

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MedTech

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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Research

2022 U.S. Market Research Report with COVID-19 Forecasts2

Article | July 11, 2022

The global biotechnology market is expected to grow at a compound annual growth rate (CAGR) of 13.9 percent from 2022 to 2030, with a value estimated at USD 1,023.92 billion in 2021. The market is being propelled by strong government support in the form of initiatives aimed at modernizing the regulatory framework, improving approval processes and reimbursement policies, and standardizing clinical studies. The growing presence of personalized medicine and an increasing number of orphan drug formulations are opening up new avenues for biotechnology applications and driving the influx of emerging and innovative biotechnology companies, which is driving market revenue even further. The 2022 Biotech Research and Development Market Research Report is one of the most comprehensive and in-depth assessments of the industry in the United States, containing over 100 data sets spanning the years 2013 to 2026. This Kentley Insights report contains historical and forecasted market size, product lines, profitability, financial ratios, BCG matrix, state statistics, operating expense details, organizational breakdown, consolidation analysis, employee productivity, price inflation, pay bands for the top 20 industry jobs, trend analysis and forecasts on companies, locations, employees, payroll, and much more. Companies in the Biotech Research and Development industry are primarily engaged in biotechnology research and experimental development. Biotechnology research and development entails the investigation of the use of microorganisms and cellular and bimolecular processes to create or modify living or non-living materials. This biotechnology research and development may result in the development of new biotechnology processes or prototypes of new or genetically altered products that can be replicated, used, or implemented by various industries. This report was created using the findings of extensive business surveys and econometrics. The professionals follow reports with accurate and apt information on market sizing, benchmarking, strategic planning, due diligence, cost-cutting, planning, understanding industry dynamics, forecasting, streamlining, gap analysis, and other ana

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Vical

Vical develops biopharmaceutical products for the prevention and treatment of chronic or life-threatening infectious diseases, based on our patented DNA delivery technologies and other therapeutic approaches.

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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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