Children treated for cancer with approaches such as chemotherapy can develop therapyrelated myeloid neoplasms (a second type of cancer) with a dismal prognosis. Scientists at St. Jude Children’s Research Hospital have characterized the genomic abnormalities of 84 such myeloid neoplasms, with potential implications for early interventions to stop the disease. A paper detailing the work […]
Arctoris, an Oxford-based technology company operating a fully automated drug discovery platform, has – on the occasion of its 5th anniversary – unveiled its new and expanded, next-generation robotic platform, Ulysses.
Arctoris was founded in 2016 as the world’s first fully automated drug discovery platform. Through end-to-end automation, the company’s unique technology platform rapidly delivers reliable, reproducible, and fully auditable datasets enabling better decision-making early in the drug discovery process.
Commenting on the anniversary, the company’s CEO Dr Martin-Immanuel Bittner said: “The drug discovery ecosystem is evolving rapidly, and the key to success is having access to the right data at the right time, to progress the right projects towards the clinic. Arctoris plays an important role in enabling true data-driven drug discovery globally, by generating the data that powers decisions in biotech and pharma companies on three continents.”
Tom Fleming, COO of Arctoris, added: “Drug discovery is undergoing a rapid digital metamorphosis, and Ulysses plays a central catalytic role in that transformation. This success is the result of our amazing team’s dedication and hard work over these past five years, combined with guidance from experienced and insightful advisors and board members. We are looking forward to the next five years, which will see even greater change and accelerated growth, toward a future where treatments and cures can be generated at a fraction of the time and cost, and we are privileged to play our role in building that future.”
Having strengthened its team over the past few years with several high-profile hires and Advisory Board appointments, the company has recently announced partnerships with Insilico Medicine and Syntekabio, while further expanding its operations globally.
The Chairman of the Board, Dr Vishal Gulati, echoed the founders’ enthusiasm: “Five years ago, the founders set out with the idea to make it possible for any scientist in the world to run a biotech company with a laptop and a credit card – and thanks to Arctoris, this is now entirely possible, harnessing the power of automation for drug discovery. As Chairman of the Board of Arctoris, I am incredibly proud of where the Company stands today, and I am excited about what lies ahead, on our path to redesigning drug discovery from the ground up.”
Tecan has become one of the first companies to meet the requirements of the European Union’s In Vitro Diagnostic Regulation (IVDR) 2017/746 (Annex IX, Chapter I and III), successfully completing certification of its IBL International DHEA Saliva ELISA diagnostic assay kit through BSI Notified Body 2797. The valuable insights gained from this process will now be applied to the registration of Tecan’s complete portfolio of specialty IVD products – as well as to help its OEM partners ensure they are ‘IVDR ready’ – ahead of the May 2022 transition deadline.
The new IVDR is intended to increase the safety of all IVD products, including all innovations developed over the past decades. It represents a major regulatory overhaul, requiring reclassification and certification of all EU-registered IVD assays and devices. Introduced in 2017, it extends the scope of the outgoing IVDD to cover more devices and technologies – as well as supply chain and lifecycle management – and signifies a shift from a primarily ‘self-certification’ model to a requirement for notified body oversight. This greatly increases the regulatory burden for IVD manufacturers and notified bodies alike, making it essential to begin the certification process as soon as possible to avoid the risk of being forced out of EU markets.
Addressing the challenges of certification
Tecan is recognized as a global leader in quality and regulatory affairs (QARA), and is leading the sector in the management of the IVDD to IVDR transition. The company’s unique position as both an IVD and OEM manufacturer, combined with many years of expertise in IVD product registration globally, means that Tecan is ideally placed to address the challenges of certification for both its own products and those of its partners.
Guenter Weisshaar, Senior Vice President for QARA at Tecan, commented: “IVDR is a major business challenge for IVD manufacturers, requiring a significant investment of time and resources to ensure regulatory readiness. We are very pleased to be one of the first manufacturers to achieve product certification under the new regulations, and will be using our knowledge of this process to support and accelerate the certification of our IVD assays and devices, together with those of our OEM partners.”
Erica Conway, Global Head of IVD Medical Devices at BSI Notified Body 2797, added: “IVDR is a significant challenge to the in vitro diagnostic devices industry. It places greater regulatory requirements on everyone in the system, from manufacturers and notified bodies to importers and distributors. We are proud to continue to support our clients in the certification of devices under IVDR, ensuring that products remain available as we approach the May 2022 deadline.”
Arctoris, an Oxford-based research company operating a fully automated drug discovery platform, has appointed three distinguished experts as members of its Advisory Board: Beth J Hoffman PhD, Prof. Khusru Asadullah MD, and Stanley Lapidus.
In an exclusive agreement with Bionomics Limited, Australia’s Carina Biotech will create Chimeric Antigen Receptor T cells (CAR-T cells) and other adoptive cell therapies to the leucine-rich repeat-containing G-protein coupled receptor 5 (LGR5) using the first-in-class humanised antibody BNC101 developed by Bionomics.
BioMedion, a global Compliance Management Software company providing controlled content and raw data management solutions for the life science industry, has acquired the Compliance Division of arivis, a provider of regulatory software and biomedical 3D and big image data software solutions.
Nordic Capital and Astorg have jointly acquired acquire Cytel Inc. from New Mountain Capital. Cytel is one of the largest providers of statistical software and advanced analytics for clinical trial design and biometrics execution.
Seattle, US-based LSBio, a leading provider of antibodies and life science research reagents, has acquired UK-based Absolute Antibody and its sister company Kerafast. Terms of the transaction were not disclosed.
The new Open Research Europe (ORE) platform – funded by the European Commission – is now up and running.
Due to promising results, Porvair Sciences has agreed with its collaborative partners to make additional investment in the CEAT project which aims to dramatically improve the diagnosis and treatment of ovarian cancer.
November 2024
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