Oracle | September 16, 2021
Advances in DNA/RNA sequencing promise to revolutionize how medical communities identify, detect, and treat diseases and manage public health threats. To make this technology more accessible and increase its impact, Oracle has teamed up with Oxford Nanopore Technologies, the company behind a new generation of high-performance, rapid, scalable, and accessible sequencing technology.
Oracle and Oxford Nanopore have recently begun a collaboration to jointly explore several potential new solutions that would use genomic sequencing running on Oracle Cloud Infrastructure (OCI) to help speed medical breakthroughs and improve patient care.
Scientific researchers in more than 100 countries are already using nanopore sequencing to further their understanding of biology in a range of areas including human and cancer genetics as well as plant, animal, and environmental analyses. In addition, nanopore sequencing has been used for pathogen analysis, including the outbreak surveillance of tuberculosis, food-borne pathogens, Ebola, Zika, Lassa fever, dengue fever, influenza, and most recently COVID-19.
As part of the collaboration, Oxford Nanopore will be using OCI in applied and clinical markets. Leveraging the high performance, security, and extensive reach of Oracle Cloud, Oracle and Oxford Nanopore will have the ability to extend population-scale genetic sequencing across the globe.
The organizations will also take on several ambitious projects spanning epidemiology, whole-genome sequencing, and healthcare and drug discovery. This includes integrating Oxford Nanopore's DNA/RNA sequencing capabilities and data into Oracle's broad portfolio of healthcare and life sciences applications to strengthen the links between genomics, medical treatment, and drug development.
Oxford Nanopore's innovative sequencing technology is unparalleled in the market for its ability to generate rich, accurate genomic data at any scale, from handheld devices to ultra-high output installations, By integrating genomic data into our existing applications and cloud infrastructure solutions, we can get these powerful tools into the hands of more people to solve critical health issues faster and improve patient outcomes to usher in a new era of genomic breakthrough.
- Mike Sicilia, executive vice president of Oracle Vertical Industries.
In parallel, Oracle has committed to investing £150 million in Oxford Nanopore, subject to customary conditions.
Oracle offers integrated suites of applications plus secure, autonomous infrastructure in the Oracle Cloud.
CELL AND GENE THERAPY
Matica Biotechnology, Inc. | October 19, 2021
Matica Biotechnology, Inc, (Matica Bio) a contract development and manufacturing organization (CDMO) specializing in the clinical and commercial production of cell and gene therapies, today announced a joint research agreement (JRA) with Sartorius, a leading international partner of the biopharmaceutical industry. Under this agreement, Matica Bio and Sartorius will work on a number of studies together to streamline and optimize PAT technologies, automation software, and single-use platforms offered by Sartorius for large scale vector production.
Michael Stewart, Chief Technology Officer at Matica Bio explained, "The generation of in-line real-time process data is one of the most significant obstacles to achieving consistent, high-producing viral vector titers during development that can be translatable to large scale production. In many respects, what is going on inside a bioreactor or within downstream operations is still a black box to us." Mr. Stewart continued, "Matica Bio's development, manufacturing and quality teams have decades of viral vector production experience. Applying our expertise together with Sartorius' industry-leading single-use and PAT technologies will allow us to provide more robust, consistent results for our clients, guiding informed decision-making throughout the manufacturing process and accelerating the overall development timeline to the clinic and market."
"We are extremely excited to initiate this partnership with Sartorius. Our number one priority is to deliver for our clients. Our expert staff will be working to integrate more fully automated processes leading to an increase in the speed of information flow and a reduction in preventable errors. The end result will be increased product yields, higher quality as well as improved flexibility and responsiveness to our clients' ever-changing needs."
Dr. Yun Jeong Song, Chief Executive Officer of Matica Bio
The JRA with Sartorius underscores Matica Bio's commitment to applying integrated technology and bioprocess solutions to address production complexities like reduction of labor and risk while improving output efficiencies in the production of advanced therapies, including viral vector products. Together Sartorius and Matica Bio are dedicated to solving the challenges of large-scale cell culture and viral vector production, improving manufacturability and reducing the costs of novel cell and gene therapies, oncolytic vectors and vaccines.
About Matica Biotechnology, Inc.
Matica Bio is a contract development and manufacturing organization for gene therapies, cell therapies, vaccines, oncolytic vectors and other advanced biotherapeutic products. Our GMP facility in College Station, TX is designed for the rapid development, scale-up and production of clinical and commercial supply. Matica Bio offers process development, GMP production, product release and stability assessment, together with the quality oversight and regulatory guidance necessary to ensure our clients' success.
TransPerfect Life Sciences | February 16, 2022
TransPerfect Life Sciences, a leading provider of services and technologies to support global clinical trials and product development for the biopharmaceutical industry, today announced that Innovaderm will scale their implementation of Trial Interactive to further enable and optimize remote clinical operations.
Innovaderm, a North America-based contract research organization (CRO) that specializes in clinical studies for dermatology, leveraged Trial Interactive remote monitoring rooms to drive research forward and continue helping partners discover new therapies during the COVID-19 pandemic. By incorporating customized Trial Interactive remote monitoring rooms into its service offering, Innovaderm allowed customers to access Trial Interactive’s Study Document Collaboration solution, enabling successful remote trial execution.
Innovaderm’s partnership with TransPerfect began several years ago with language translation services. To eliminate its paper-based approach for clinical trial document management, Innovaderm then implemented Trial Interactive’s eTMF. As Innovaderm further optimized its clinical research strategy, TI Study Start-Up replaced the CRO’s manual process for distribution and collection of essential documents from sites, resulting in a more transparent, efficient path for site activation and reduced timelines for starting new studies.
Trial Interactive delivers user-friendly document and trial management solutions to help pharmaceutical, biotechnology, and CRO companies effectively streamline product development life cycles. A connected eClinical experience, Trial Interactive improves speed, quality, and compliance across site identification, selection, and activation, as well as study teams and site personnel training, content management, eISF, eTMF management, CTMS, and closeout. The platform offers industry-leading, fast-to-implement, cost-effective solutions in a secure 21 CFR Part 11-compliant environment.
“Trial Interactive worked with us to ensure our remote monitoring room configuration met our key requirements so we could conduct our studies without interruptions, delays, or significant changes. As we’ve faced unexpected shifts in the way we run and monitor studies, Trial Interactive has been key to enabling us to perform remote monitoring visits.”
Isabel Dorion, Director of Clinical Operations at Innovaderm
Michael Smyth, TransPerfect Life Sciences Solutions Division President, stated, “We’re moving into an era where decentralized clinical trials are becoming more common, and conducting clinical research processes remotely is key to keeping trials moving forward and getting life-saving products to market faster. With our solution of remote monitoring rooms, Trial Interactive has been able to help clients like Innovaderm shift to remote processes without losing momentum for their studies.”
About Trial Interactive
TransPerfect’s Trial Interactive is an industry leader in practical eClinical innovation that simplifies and automates clinical processes for sponsors, CROs, and sites around the world. The 21 CFR part 11 compliant unified platform delivers an author-to-archive collaboration experience with solutions for clinical document management, site selection, site activation, eLearning, compliance training, quality, and CTMS with seamless solution interoperability and indexing to the eTMF. Trial Interactive is consistently selected by clinical professionals for providing the most comprehensive yet intuitive experience with the most complete offering of technology and expert TMF services. Trial Interactive helps study teams streamline their operations by cutting unnecessary expenses, expediting timelines, reducing compliance risks, and improving operational excellence.
About TransPerfect Life Sciences
TransPerfect Life Sciences specializes in supporting global development and commercialization of drugs, treatments, and devices designed to improve and save lives. Our comprehensive solutions include eTMF and eClinical technologies, paper TMF migration, pharmacovigilance and safety solutions, translation and language services, and call center support. With offices in over 100 cities worldwide, TransPerfect is the ideal partner to ensure that your global launch makes a global impact.
About Innovaderm Research, Inc.
Innovaderm is a prominent contract research organization (CRO) collaborating with the biotech companies in the management of Phase 1 to 3 dermatology trials across many regions. Founded in 2000, the company provides a broad range of services including study design, protocol development, site selection, patient recruitment, regulatory and ethics submissions, clinical trial management, clinical monitoring, data management, biostatistics, medical monitoring, pharmacovigilance and medical writing. Committed to quality, Innovaderm is managing its activities in accordance to current Good Clinical Practice (GCP) from the International Conference of Harmonization (ICH), and being fully compliant with major international regulations such as the FDA (USA), Health Canada and EMA (Europe).