Patricia Moore
It is just another routine day in the office and then you receive the call that your company is scheduled for a pharmacovigilance inspection. What do you do? Panic? If that is your first reaction then hopefully this article will help to put your mind at rest by providing some advice and useful tips for how to survive an European Union (EU) pharmacovigilance inspection.
Kenneth I. Kaitin, Ph.D.
These are remarkable and challenging times for the research-based pharmaceutical and biotechnology industry.
Richard B. Toupence
In the search for new and efficient ways to discover and develop new drug candidates, many big pharma companies have utilized external partners for R&D services.
Dr. Vladimir V. Anisimov
Drug supply chain is very costly and is a well-recognized bottleneck at the design and managing of clinical trials. The innovative risk-based statistical approach to modelling drug supply demand for a single study is proposed. The approach uses the developed technique for predicting the number of patients randomized to different treatments in different regions, the notion of the accepted risk of stock-out of a required treatment for a patient and accounts for various uncertainties caused by randomness in patient recruitment, by randomization scheme and drug supply logistics. The advanced risk-based supply modelling tool based on this approach has been developed. The tool evaluates the upper prediction bounds for the amount of supply required to cover patient demand with a given risk of stock-out. Currently, the tool is undergoing implementation within GlaxoSmithKline.
Amelia Wall Warner, PharmD, RPh
Biosamples collected for future research provide a valuable source of material for the pharmaceutical industry to investigate new hypotheses related to drug efficacy and safety in a timely and efficient manner. However, collection of samples for future research remains a challenge for the pharmaceutical industry.
Sally Shorthose
Over the last few years, the way clinical trials have been conducted in Europe has developed rapidly. Not only is this because of the implementation of the Clinical Trials Directive 2001/20/EC, but also the Data Protection provisions in Directive 95/46/EC have needed to be reflected and the trials on biological Investigational Medicine Products, with novel forms, and modes of action has meant that there has been consideration and debate regarding how trials should be conducted.
Huifen Faye Wang, Ph.D.
Ligand binding assays (LBAs) are the primary methods used to quantify biotherapeutics, biomarkers and anti-drug antibodies to support biotherapeutics development. LBAs have been proven more difficult to outsource owing to their unique challenges such as high assay variability, nonlinear calibration, narrow dynamic range, more matrix interference, etc.
Jong Ran Kim is Director of Clinical Operations for North Asia (China, Hong Kong and Korea) at ICON. She has over 15 years of experience in the pharmaceutical, biotechnology, CRO industry as well as scientific research.