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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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CPhI China opens with analysis pointing to a surge in growth in 2019
Shanghai, 23rd May 2019: New analysis released ahead of CPhI & P-MEC China (#CPhIChina and #PMECChina) – co-organized by Informa Markets, CCCMHPIE, and Shanghai Sinoexpo Informa Markets – forecasts that China will continue to grow strongly through 2019/20, thanks in part to a marked improvement in its global reputation.
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White Papers |
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Syringe siliconization
Gerresheimer AG
Ready-to-fill, i.e. sterile, prefillable glass syringes, are washed, siliconized, sterilized and packaged by the primary packaging manufacturer. They can then be filled by the pharmaceutical companies without any further processing. These days the majority of prefillable syringes are made of glass and the trend looks set to continue. The siliconization of the syringe barrel is an extremely important aspect of the production of sterile, prefillable glass syringes because the functional interaction of the glass barrel siliconization and the plunger stopper siliconization is crucial to the efficiency of the entire system. Both inadequate and excessive siliconization can cause problems in this connection. The use of modern technology can achieve an extremely uniform distribution of silicone oil in glass syringes with reduced quantities of silicone oil. Another option for minimizing the amount of free silicone oil in a syringe is the thermal fixation of the silicone oil on the glass surface in a process called baked-on siliconization. Plastic-based silicone oil-free or low-silicone oil prefillable syringe systems are a relatively new development. Silicone oil-free lubricant coatings for syringes are also currently in the development phase.
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Industry Events |
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2020 Avoca Quality and Innovation Summit
3-4 June 2020, Amsterdam, The Netherlands
The 2020 Avoca Quality and Innovation Summit will take place 3-4 June
2020, in Amsterdam, The Netherlands.
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