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European Biopharmaceutical Review
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Drug development is an arduous process punctuated by go/no-go decisions related to the efficacy and safety of drug candidates. When a new preclinical drug candidate with a reasonable profile of efficacy and safety is identified, it is still uncertain whether this new therapeutic agent will ultimately make its way to the patient and advance human health. In fact, ~90% of all compounds entering clinical trials fail, largely due to safety issues in clinical phases or drug efficacy issues in patients (1).
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Judi Wardwell is a Senior Application Scientist at InSphero, with more than 25 years of experience working in the pharma industry. Prior to joining InSphero, she was the Manager of a functional genomic group at Bristol-Myers Squibb, where she developed physiologically relevant cell models and conducted phenotypic screens to identify new drug targets in developing integrated approaches to target identification. Judi has also held scientific research positions at Wyeth and Hoffmann-La Roche.
Dr Radina Kostadinova is Lead Product Manager for InSphero 3D InSight™ Liver Toxicology and Disease Platforms. She has more than 17 years of research experience in industry and academic settings, working in the fields of molecular and cellular biology and preclinical mechanistic toxicology. At InSphero, her focus is to develop and establish liver tissue models for detection of drug toxicity, as well as 3D liver disease models for the study of fibrosis, inflammation, diabetes, and obesity.
Professor Armin Wolf is Chief Scientific Officer at InSphero and Professor of Toxicology at the Technical University of Kaiserslautern, Germany. An accomplished pharma R&D executive and board-certified toxicologist with more than 30 years’ cumulative experience at Janssen and Novartis, Armin offers a first-hand perspective on the challenges facing the pharma industry and the need for more physiologically relevant human models to improve efficiency in drug discovery and safety testing.
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Judi Wardwell |
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Judi Wardwell |
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News and Press Releases |
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CPI to showcase results from BioStreamline project developing novel biotherapeutics
CPI, a UK-based technology innovation centre and a founding member of
the High Value Manufacturing Catapult, announced today that it will host
an event in Darlington, UK on 26 June 2019 to disseminate the results
of the £11.2M BioStreamline project to optimise the development of novel
therapeutics. During the event, the project partners — Lonza Biologics,
UCB Celltech, Sphere Fluidics, Horizon Discovery Group plc (Horizon),
Alcyomics Ltd and CPI — will showcase the results and discuss the
potential impact on overcoming some of the most significant shortcomings
of the biologics supply chain.
More info >> |
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White Papers |
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Finding the Right End-to-End Safety Solution for Your Needs
Bioclinica
With upcoming changes, including the implementation of the International Conference on Harmonisation (ICH) E2B(R3) Electronic Transmission of Individual Case Safety Report and Identification of Medicinal Products (IDMP) standards, the current state of safety reporting can be confusing. Your existing safety system may not be flexible enough to accommodate these changing regulations, which are still moving targets regarding the details needed for a comprehensive solution with the right level of processes, company-to-company integrations and finalized regional rules.
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Industry Events |
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Clinical Trial Supply Europe
11-12 March 2020, Madrid, Spain
The 21st annual edition promises to grow on the success of 2019’s excellent conference which saw delegates from Europe’s largest pharmaceutical companies and biotech innovators come together to discuss, debate and unpack the latest trends in clinical supply chain innovation. 2020 will offer delegates the opportunity to address the growing need for agility within the supply chain in response to increasingly complex trial demands. With a stream dedicated to supply operations and another to innovative uses of technology in the supply chain, delegates will get the chance to gain practical take-aways that they can apply to their own studies.
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