Flexible Phase I Study Designs: Expediting Early Clinical Drug Development

Apr 28, 2012

Valerie Harding, Quanticate's Communications Account Director, explains that Phase I marks a significant milestone in the development of any new medicinal product. A target has been identified, a compound has been discovered that hits the target, and it has been refined to ensure it has good properties for development. In-vivo safety pharmacology and toxicology studies have been conducted and the compound has been tested in pre-clinical models of the disease. This process will have taken many years. A multi-disciplinary team has evaluated all the data, and decided to take the plunge and invest in clinical development. And now, the drug is ready ...

Read More

Promotion of aggregation via agitation as a Means of assessing the stability of antibody Molecules

Apr 28, 2012

Alison Turner, Principal Scientist at UCB (Celltech), explains in this detailed article how in the process of antibody candidate selection it is important that during manufacture and shelf-life the antibody shows aggregation stability. Hence it is necessary to be able to measure and predict the propensity of aggregation of different antibody molecules in a pre-screening assay. ...

Read More

Fighting rare Diseases

Apr 28, 2012

Shirley Johansson of Midfield Media estimates that 6%-10% of the world’s population will suffer from a rare disease at one point in their life, and approximately one out of five people personally know an individual suffering from a rare disease. She goes on to explain that finding a cure or improved treatments for such patients is fundamental, not only to their lives, but also to society as a whole. The journey has begun, and there is great potential to improve the work amongst all stakeholders: patient organisations, governmental authorities, health technology assessment organisations, payers, and orphan drug developers. On 14th–16th ...

Read More

RGCC: A Leading Company in Analysis of CSCs as Progenitors of All Cancer Relapses

Apr 28, 2012

Ioannis Papasotiriou explains in this article that RGCC Ltd is a leading company in analysis of circulating tumour cells (CTCs) as well as cancer stem cells (CSCs). Through their analysis, the organisation is able to offer services in the clinical field as well as in R&D in the pharmaceutical industry. By using the most advanced and innovative technologies of molecular and cellular biology, RGCC Ltd manages to overpass several restrictions and difficulties that the analysis of CTCs and CSCs involve. Through such an approach a massive amount of information and data has been generated in order to be used for ...

Read More

Improving the human relevance of Preclinical trials

Apr 28, 2012

A fundamental of drug development is the provision of safe and effective medicines. The safety and efficacy of a drug can only be demonstrated through large-scale trials in humans. However, as Emma Sceats, Business Development Manager at Zyoxel Ltd explains, using humans as test subjects for drugs whose safety is unknown would be unethical. Instead, legal and regulatory guidelines require a plethora of studies to be conducted prior to clinical trials, so that all reasonable steps have been taken to mitigate risk to trial participants. Drug developers are also expected to give evidence of the expected effectiveness of the drug ...

Read More