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Novartis Pharma AG - Articles and news items
Novartis to work with FDA on path forward for RLX030 for acute heart failure following Advisory Committee outcome
Advisory Committee members voted against RLX030 for the treatment of acute heart failure (AHF)…
In 2001, small interfering RNA (siRNA) was discovered as the mediator of RNA interference (RNAi), a transient and specific repression mechanism of protein expression1. After the pharmaceutical industry became aware of the intrinsic versatility and potential of this molecule, a race to develop the first siRNA based drug began. However, the initial hype was followed by the realisation that due to the specific properties of this very fragile molecule, stability and delivery issues might limit its application to certain niche indications.
siRNAs have been rushed into the clinics before fully understanding their biological effects. As a result, some of the big pharmaceutical companies such as Roche or Pfizer, who were initially committed to siRNA drug development, have meanwhile scaled back their efforts or entirely stopped their siRNA programs.
An important property of siRNA to be controlled during the drug discovery process is its potential off-target effect, which limits its specificity. The key to developing a successful drug based on a well characterised siRNA molecule is its formulation, since the molecule is relatively big, heavily charged and susceptible to degradation in the body fluids, therefore, the delivery vehicle has to provide protection as well as enable cell penetration and release. An overview of the delivery-enabling excipients which have progressed into clinics can be found elsewhere2. Although so far no siRNA based therapeutic product has been commercialised, several clinical trials have been conducted or are currently on-going.
Issue 6 2011, PAT & QbD, Supplements / 15 December 2011 / Terry McMahon (PAI Partners), Dr. Marianna Machin, Dr. Lorenz Liesum, Dr. Antonio Peinado (Novartis Pharma AG), Ravindra Dhumal, Tim Gough (Centre for Pharmaceutical Engineering Science, University of Bradford)
The historical development of the FDA’s PAT initiative and its present course.
Implementation of modelling approaches in the QbD framework: Examples from the Novartis experience.
Challenges in development and implementation of spectroscopic techniques as PAT Analysers.
Novartis studies show Onbrez® Breezhaler® & tiotropium provided greater increase in lung function than tiotropium alone
Patients with COPD treated with Onbrez® Breezhaler® & tiotropium notice improvements…
Participants: Dr Gordon R Alton, President and CEO, Altonyx Consulting / Dr Scott Bowes
Scientist, Novartis / Dr Sheraz Gul, Vice President and Head of Biology, European ScreeningPort /
Chris Molloy, Vice President of Corporate Development, IDBS
Thermal analysis techniques cover all methods in which a physical property is monitored as a function of temperature or time, whilst the sample is being heated or cooled under controlled conditions. Calorimetric methods measure the energy involved in every process. The quicker new developments attain the market, such as the progression of micro or nanotechnologies, combinations of different hyphenated techniques, as well as the development of high automated or high throughput systems, the faster new horizons will open in the industrial environment. In addition, the application of sophisticated kinetic software in DSC, calorimetry and reaction calorimetry gives better safety predictions.
High content imaging (HCI), the combination of automated fluorescence microscopy with quantitative image analysis, has been opening new dimensions in cytometry. This article gives an overview on the growing spectrum of applications and an outlook on the future use of this still rapidly developing technology.
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