MarkLogic Launches Pharma Research Hub to Accelerate Drug Research and Results

dataversity | May 17, 2019

According to a recent press release, “MarkLogic Corporation, the next generation data platform provider for simplifying data integration, today announced the MarkLogic® Pharma Research Hub to enable pharmaceutical companies to lower drug trial costs and accelerate research. This is achieved by helping researchers quickly and easily find, synthesize and share high-quality data – including, genetic, proteomic, drug, textual, binary and clinical trial data – within a single cloud service. The MarkLogic Pharma Research Hub uses machine learning and other advanced technologies including semantics, fuzzy matching, relevance ranking and rich metadata to manage, organize and retrieve information. As a fully managed cloud service, the Pharma Research Hub can be set up in minutes and ingests data 10x faster than custom-developed solutions – with zero IT management burden.” The release goes on, “By working with five of the largest global pharmaceutical companies and other leaders in the healthcare ecosystem, MarkLogic has long used its Data Hub technology to help solve pharmaceutical companies’ business and data challenges by: (1) Enabling search and visualization of relationships: View, navigate, and search the graph of connections in data by leveraging all inherent relationships. Visualizing these relationships in data, such as how a researcher is connected to institutions and peers, or how a gene, drug target and metabolic pathway are related, can lead to faster discoveries. (2) Leveraging machine learning: Users get better search results on higher quality data. MarkLogic’s Smart Mastering feature uses machine learning to find and consolidate related and duplicate items and to construct a knowledge graph of all data. Data quality rules are applied as data is loaded. This high-quality, mastered data dramatically improves search results and enables better downstream bioinformatics and AI analysis.”

Spotlight

Understanding the most appropriate regulatory compliance solution extends beyond pure technological functionalities; it requires intimate understanding of policies and procedures required to achieve meaningful compliance with regulations, worldwide. The pharmaceuticals industry and related businesses are mandated to comply with diverse regulatory standards in different countries. This includes the Sarbanes-Oxley Act (SOX) in the U.S., and good manufacturing practice (GMP), good laboratory practice (GLP), good pharmacy practice, etc. in the U.S. and elsewhere. Hence, spending on governance, risk management, and compliance (GRC) tools is necessary

Spotlight

Understanding the most appropriate regulatory compliance solution extends beyond pure technological functionalities; it requires intimate understanding of policies and procedures required to achieve meaningful compliance with regulations, worldwide. The pharmaceuticals industry and related businesses are mandated to comply with diverse regulatory standards in different countries. This includes the Sarbanes-Oxley Act (SOX) in the U.S., and good manufacturing practice (GMP), good laboratory practice (GLP), good pharmacy practice, etc. in the U.S. and elsewhere. Hence, spending on governance, risk management, and compliance (GRC) tools is necessary

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PHARMACY MARKET

Jubilant HollisterStier LLC enters into cooperative agreement of $149.6 Mn with US Government to expand critical vaccine manufacturing capacity

Jubilant Pharmova Limited | May 31, 2022

Jubilant Pharmova Limited has announced today that Jubilant Pharma Limited, a wholly owned subsidiary of the Company, through one of its wholly owned subsidiaries, Jubilant HollisterStier LLC, (JHS) a leading US-based pharmaceutical contract manufacturer has entered into a cooperative agreement for $149.6 million (USD) with the Army Contracting Command, in coordination with the Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense (JPEO-CBRND) on behalf of the Biomedical Advanced Research and Development Authority (BARDA), within the US Department of Health and Human Services. The effort was funded under the American Rescue Plan, this agreement will enable the Company to double its injectable filling production capacity at a total cost of $193 million, at its Spokane, Washington manufacturing facility. This will be completed by 2025. This agreement is in addition to the $92 million filling line expansion announced in November 2021, which will be commercially available by the end of 2024. "Jubilant HollisterStier LLC is committed to making the US pharmaceutical supply chain more resilient with domestic manufacturing facilities and less reliant on foreign suppliers. Jubilant HollisterStier has a long history of supporting the US Department of Health and Human Services (HHS) and Department of Defense (DOD) biodefense and medical countermeasure programs, including production for national preparedness efforts. We are proud to support the US government in their efforts of making the US more prepared and ready for future pandemics." Speaking on the announcement, Pramod Yadav, CEO, Jubilant Pharma Limited "Jubilant HollisterStier LLC's expansion will target large Pharmaceuticals and Biotech companies for parenteral products as well as feature a flexible manufacturing platform able to produce several types of vaccines (live, mRNA and inactivated/subunit). We are committed to investing in capability and capacity. This investment will ensure our ability and flexibility to speedily produce quality vaccines and treatments for our customers and be better prepared for any future threats to the country," shared Amit Arora, President, Contract Manufacturing Organization (CMO), Jubilant HollisterStier LLC. About Jubilant HollisterStier LLC Jubilant HollisterStier LLC, a subsidiary of Jubilant Pharma Limited, is a leading integrated contract manufacturer of sterile injectables, ophthalmics, optics, sterile and non-sterile topicals and liquids. With facilities in North America, Jubilant HollisterStier LLC provides specialized manufacturing for the pharmaceutical and biopharmaceutical industries. Services include a full range of support to streamline manufacturing, from process qualifications through commercial release. About Jubilant Pharma Limited Jubilant Pharma Limited, a Company incorporated under the laws of Singapore and a wholly-owned subsidiary of Jubilant Pharmova Limited, is an integrated global pharmaceutical company engaged in manufacturing and supply of Radiopharmaceuticals with a network of radio-pharmacies in the US, Allergy Immunotherapy, Contract Manufacturing of Sterile Injectables and Non-sterile products, APIs and Solid Dosage Formulations through six manufacturing facilities that cater to all the regulated market including USA, Europe and other geographies. The Company has a team of over 4,600 multicultural people across the globe and is committed to delivering value to its customers spread across over 75 countries. It is well recognized as a 'Partner of Choice' by leading pharmaceutical companies globally. About Jubilant Pharmova Limited Jubilant Pharmova Limited is a company engaged in Pharmaceuticals, Contract Research and Development Services and Proprietary Novel Drugs businesses. Pharmaceuticals business through Jubilant Pharma Limited Singapore (JPL) is engaged in manufacturing and supply of Radiopharmaceuticals with a network of 48 radio-pharmacies in the US, Allergy Immunotherapy, Contract Manufacturing of Sterile Injectables and Non-sterile products, APIs and Solid Dosage Formulations through six manufacturing facilities that cater to all the regulated market including USA, Europe and other geographies. Jubilant Biosys Limited provides contract research and development services through two world class research centers in Bangalore and Noida in India. Jubilant Therapeutics is involved in Proprietary Novel Drugs business and is an innovative biopharmaceutical company developing breakthrough therapies in the area of oncology and auto-immune disorders. Jubilant Pharmova Limited has a team of over 6,000 multicultural people across the globe. The Company is well recognized as a 'Partner of Choice' by leading pharmaceuticals companies globally.

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PHARMACY MARKET

Inozyme Pharma Announces Partnership with Rady Children’s Institute for Genomic Medicine to Advance Newborn Screening for Genetic Diseases

Inozyme Pharma Inc. | June 17, 2022

Inozyme Pharma, Inc. a clinical-stage rare disease biopharmaceutical company developing novel therapeutics for the treatment of abnormal mineralization, today announced a partnership with Rady Children’s Institute for Genomic Medicine (RCIGM) to advance and evaluate a novel newborn screening technology to facilitate diagnosis of genetic diseases. The partnership includes several leading genomics, biotechnology companies and patient advocacy groups and focuses specifically on a diagnostic and precision medicine guidance tool called BeginNGS™, which incorporates rapid Whole Genome Sequencing (rWGS®) to currently screen newborns for approximately 400 genetic diseases. “Newborn screening will be essential to identifying and initiating timely intervention in children with rare genetic disorders like GACI (generalized arterial calcification of infancy) as we advance INZ-701 through clinical testing. We look forward to working with Rady Children’s Institute for Genomic Medicine, and with the BeginNGS consortium, to advance the use of this promising screening technology.” Catherine Nester, vice president, physician and patient strategies at Inozyme Pharma RCIGM is in a pilot evaluation that aims to supplement existing newborn screening protocols at birthing hospitals throughout the United States. The pilot program’s goal is for BeginNGS to become the genetic disease screening standard, with testing expanding to approximately 1,000 [disorders] and sequencing of 3.7 million newborns annually. Founding members of the public-private BeginNGS consortium include Inozyme, Alexion, Travere Therapeutics, and several patient advocacy groups that are helping to advance this program. “RCIGM helped pioneer the use of rWGS for diagnosis of genetic disease in intensive care settings,” said Stephen Kingsmore, MD, DSc, president and CEO of RCIGM. “With the proven clinical utility of diagnostic rWGS , we are using that experience to screen, diagnose, and help treat genetic conditions at or before onset of symptoms. Through a public-private consortium of leading organizations such as Inozyme, and advocacy groups in pediatrics, genetics, biopharma, biotech, and information technology, we aim to scale newborn sequencing to every life-threatening childhood genetic disease, RCIGM believes now is the time to end the diagnostic and therapeutic odyssey for all children with treatable genetic diseases.” BeginNGS developed through a research collaboration with Alexion; AstraZeneca’s Rare Disease group; Illumina, Inc.; TileDB; Fabric Genomics; and Genomemon, which uses rWGS to diagnose and identify treatment options for genetic conditions before symptoms begin. This approach represents an advance over current pediatric uses of rWGS that focus mainly on children who are already critically ill. Once a diagnosis is made, BeginNGS uses Genome-to-Treatment (GTRx™), a tool that provides immediate treatment guidelines to help physicians understand genetic conditions and their available treatment options. Addressing the Need for Enhanced Newborn Screening Tools Traditional newborn screening is one of the most successful public health programs in the United States. Of nearly 4 million babies born annually, 98 percent are tested in the first days of life. The BeginNGS test identifies serious childhood diseases that have effective treatments. States currently screen for only 31 to 76 of the hundreds of severe, childhood genetic diseases that have available treatments. Adding a new condition to the screening protocol is slow (5 to 6 years per condition), laborious, and costly. In the last decade, WGS has increased in speed, diagnostic performance, and scalability. BeginNGS will not replace the current biochemical newborn screening paradigm; rather, it is designed to complement the newborn screening processes and infrastructure that are already in place. “We are thrilled at the prospect of newborn screening to assist in early identification of infants affected by ENPP1 Deficiency and ABCC6 Deficiency via Inozyme’s collaboration with Rady Children’s Institute for Genomic Medicine. Early diagnosis is crucial to improving a baby’s chances of survival and long-term health if they have these rare and devastating diseases,” said Christine O’Brien and Liz Molloy, co-presidents of GACI Global. About Rady Children’s Institute for Genomic Medicine Rady Children’s Institute for Genomic Medicine is transforming pediatric critical care by advancing disease-specific healthcare for infants and children with rare disease. Discoveries at the Institute are enabling rapid diagnosis and targeted treatment of critically ill newborns and pediatric patients at Rady Children’s Hospital-San Diego and a growing network of more than 60 children’s hospitals nationwide. The vision is to expand delivery of this life-changing technology to enable the practice of Rapid Precision Medicine™ at children’s hospitals across the nation and the world. RCIGM is a non-profit, research institute embedded within Rady Children’s Hospital and Health Center. About Inozyme Pharma Inozyme Pharma, Inc. is a clinical-stage rare disease biopharmaceutical company developing novel therapeutics for the treatment of diseases of abnormal mineralization impacting the vasculature, soft tissue, and skeleton. Through our in-depth understanding of the biological pathways involved in mineralization, we are pursuing the development of therapeutics to address the underlying causes of these debilitating diseases. It is well established that two genes, ENPP1 and ABCC6, play key roles in a critical mineralization pathway and that defects in these genes lead to abnormal mineralization. We are initially focused on developing a novel therapy, INZ-701, to treat the rare genetic diseases of ENPP1 and ABCC6 Deficiencies. INZ-701 is currently in Phase 1/2 clinical trials for the treatment of ENPP1 Deficiency and ABCC6 Deficiency.

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BUSINESS INSIGHTS

Indegene Partners with Amwell to Empower Life Sciences Organizations with Unparalleled Patient Support Solutions

Indegene Inc | June 29, 2022

Indegene, a technology-led healthcare solutions provider, announced a partnership with Amwell®, a digital care delivery leader. This collaboration will facilitate life sciences organizations to connect patients to better quality care and drive better health outcomes. Digital patient engagement has disrupted the healthcare landscape. Patients are increasingly becoming more knowledgeable and involved in their health journeys. They want personalized support solutions that are available on the go. The technology partnership between Indegene and Amwell will enable life sciences organizations to transform their patient support capabilities and engage with patients across digital, virtual, and physical mediums. It will allow Indegene to include Amwell’s digital care platform Converge™ into its end-to-end patient support framework and enable life sciences organizations to offer a personalized care model. "Patient needs are rapidly evolving, and life sciences organizations often struggle to provide customized solutions that cater to them. By partnering with Amwell, we hope to equip life sciences organizations with customized patient engagement solutions that boost access to cutting-edge treatments and improve health outcomes," Nitin Raizada, Vice President, Enterprise Commercial at Indegen This partnership will facilitate Indegene to enable life sciences organizations to drive virtual care automation and patient companionship to advance longitudinal care, behavioral health, and other specialty and chronic care segments. It will help patients access treatments they need and receive continued support to remain adherent through their health journeys. “As the future of care becomes increasingly hybrid, we are excited to partner with Indegene to further expand access to our Amwell Converge Platform and help accelerate their path to market with access to our installed base of payer and provider customers,” said Rene Barron, VP Channel Management, Amwell. “Together with Indegene, we aim to ensure that all life sciences organizations can more easily connect patients to quality care to improve clinical and financial outcomes, as well as delight patients with personalized care experiences.” About Indegene Indegene is a technology-led healthcare solutions provider. It combines deep industry expertise with fit-for-purpose technology in an agile and scalable operating model. Many of the leading, global healthcare organizations rely on Indegene to deliver effective and efficient clinical, medical and commercial outcomes every day. From strategy to execution, Indegene enables healthcare organizations to be future ready. About Amwell Amwell is a leading digital care delivery platform in the United States and globally, connecting and enabling providers, insurers, patients, and innovators to deliver greater access to more affordable, higher quality care. Amwell believes that digital care delivery will transform healthcare. The Company offers a single, comprehensive platform to support all digital health needs from urgent to acute and post-acute care, as well as chronic care management and healthy living. With over a decade of experience, Amwell powers the digital health solutions for over 2,000 hospitals and 55 health plan partners with over 36,000 employers, covering over 80 million lives.

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