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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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Humanigen Enters into Agreement with PCI Pharma Services as Part of Preparations for Commercialization in the United Kingdom
SHORT HILLS, NJ. June 16, 2022--(BUSINESS WIRE)-- Humanigen, Inc.
(Nasdaq: HGEN) (“Humanigen”), a late-stage clinical biopharmaceutical
company focused on preventing and treating an immune hyper-response
called ‘cytokine storm,’ today announced it entered into an agreement
with PCI Pharma Services (PCI), a leading integrated global contract
development manufacturing organization (CDMO), to provide importation,
release and commercialization services in the United Kingdom (UK) for
lenzilumab. Under the agreement, PCI will purchase lenzilumab for resale
and distribution in the event a Conditional Marketing Authorization is
received in the UK for use in patients hospitalized with COVID-19.
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What You Need To Know About Thermal Shipping Technologies
Temptime Corporation
This paper presents highlights from a thermal performance study conducted by Modality Solutions LLC. The study examined the performance of five shipping technologies commonly used by specialty pharmacies to transport high-value refrigerated specialty medicines against an industry accepted temperature profile standard.
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