Minimising the immunogenicity of biopharmaceuticals: Current status of monitoring immunogenicity across the R&D value chain

At the 2014 Exploratory Clinical Development World Europe, Sylvia Julien, Principal Scientist, Senior Project Leader Global Scientific Affairs and Strategic Sourcing, Ipsen,  gave a presentation on “Minimising the immunogenicity of biopharmaceuticals: Current status of monitoring immunogenicity across the R&D value chain. Download and learn: Immunogenicity and influencing factors Immunogenicity risk assessment, stage-based Conclusion and perspectives Download Presentation. Found this interesting? Join us …

Enhancing the use of MedDRA in an intelligent online adverse event reporting portal

The process of drug development requires close monitoring of medical events experienced by patients both during clinical trials and post-marketing. Without this critical safeguard, patient safety is put at risk, as well as jeopardizing company reputation, loss of revenue and fall in share price if a product is subsequently withdrawn. Such diligent monitoring relies upon comprehensive reporting together with accurate statistical evaluation. …

Early Drug Development: Rationale for an effective organization model.

At the 2014 Exploratory Clinical Development World Europe, Isabelle Paty, Head of Clinical Pharmacology/Early Drug Development, Ipsen, gave a presentation on “Early Drug Development: Rationale for an effective organization model.” Download and learn: Introduction: Ipsen as a mid- size Pharma Challenges for Early Drug Development Conclusion and perspectives Download Presentation. Found this interesting? Join us in 2015 for the 9th annual …

3D bio printing human body parts

Japanese scientists from University of Tokyo Hospital has worked their way to develop an amazing technique in customisation of body parts via 3D printing technology. With 3D bio-printer, it is expected that cells can be “printed” in the way mimicking the native cells arrangements within organs. If successful, this discovery will fully eliminate the need for organ transplantation in current …

Using challenge models for early differentiation in respiratory diseases: Finding early signals for potential mechanism of action.

At the 2014 Exploratory Clinical  Development World Europe, Carol Astbury, Head, Early Development & Global Project Leader Respiratory TA, Almirall S.A, gave a presentation on “Using challenge models for early differentiation in respiratory diseases: Finding early signals for potential mechanism of action.” Download and learn: Background Key respiratory conditions Ultimate treatment goals COPD and asthma pathogenesis Bronchoprovocation models in asthma and …

Download White Paper : Translating Cancer Genomics for personalized approach to treating cancer

Over the past few decades, the approach to prevention, diagnosis and treatment of cancer has radically shifted from organ-based to morphology-based and most recently, to genetics-based. Personalized or precision medicine (tailoring a treatment for a patient’s particular disease at a precise time point) is being performed every day at different levels in the clinical setting.The study of cancer genomics has …

Singapore’s first FDA approval for novel drug

MerLion Pharmaceuticals, a joint venture between the Institute of Molecular and Cell Biology (IMCB) and GlaxoSmithKline, received the first FDA approval for a novel drug amongst the outstanding biotechs based in Singapore. MerLion’s finafloxacin was acquired after its merger withCombinature Biopharm AG and Athelas SA in 2006, and is targeted for acute otitis externa (also known as “swimmer’s ear”). Thanks …

Lessons learnt from unboiling an egg – Drug discovery

Scientist from UCI has recently published a study which shows methods to unboiling an egg. The 3D structure of a protein is essential in achieving its biological function. Typically, boiling a hen egg is typically used to illustrate the fragility of proteins three dimension structure and Gibbs free energy. This process is entropically driven and seemingly irreversible. Discovery of regaining …