This is a very topical issue in both developing and industrialised countries, where commercial sites on the internet are increasingly used to buy consumer goods, including medicines – notably those not reimbursed by health insurance, and countless others issued without a prescription. The argument developed for leaving this responsibility to the patient alone is an acknowledgement that the whole distribution channel is corrupted, including the pharmacist and doctor, not to mention wholesalers or local manufacturers. Owing to this, we admit that having reliable intermediaries in such a crucial field as health is not possible and we “make do”. Roland Meylan, co-founder of AlpVision, expands further in this article.
In 2001 the EU launched a first directive in order to harmonise and regulate the European Medicines Supply Chain. However, that directive (2001/83/EC), which has now been in effect for several years through legislation of the European member states, has turned out to be too weak to efficiently safeguard European citizens. Dr Marietta Ulrich-Horn PhD, Cofounder and Manager of Securikett, provides a detailed insight into globally growing problems with counterfeited, diverted, falsified and expired drugs that have entered the European scene.
Decentral Automation at all Process Levels Intelligent Control Heads Enable Complete Decentral Automation of Hygienic Production Processes
In the food and beverage industry, and also in the production of medicines and cosmetics, excellent hygiene in processes and around the plant plays a key role. This is ensured by stringent legislative regulations. Dipl.-Ing. Sebastian Kundel, Global Marketing/Segment Hygienic Processing at Bürkert Fluid Control Systems, discusses how in an increasingly competitive global environment, companies in this industry are at the same time forced to make their production processes as efficient and cost-effective as possible.
Iqbal T Shadi, from the Faculty of Medicine at Imperial College, and Roy Goodacre, Professor of Biological Chemistry at The University of Manchester, explore why Raman spectroscopy is becoming an analytical tool employed in all areas of science, as shown by applications of both normal Raman and SERS (surface-enhanced Raman spectroscopy).
Understanding the intricacy of the cold chain distribution process, and the potential stumbling-blocks associated with conducting clinical trials in emerging markets, will help bio-practitioners more successfully safeguard product quality and chain of custody while dealing with a continuous stream of arms-length exchanges between local representatives, officials and vendors. Dr Rüdiger Lomb, Global Director, Quality & Technical Compliance at World Courier, outlines two effective strategies for securing the “non-science-based” part of the pharmaceutical supply chain equation while reducing both costs and risk.
Steve Healy and Karen Adams, from SCA Cool Logistics, discuss how supply chain partners provide specialised insights into the safe and effective transport of clinical trial materials around the globe, and are continuing to expand into the Middle East, the region which acts as a gateway from West to East, and which is also becoming more of a potential subject base.
Currently, the majority of clinical trial sites in the United States use paper cheques as their primary method of payment. Samuel Whitaker, Co-Founder & Chief Executive Officer at Greenphire, overviews the conventional subject payment process, identifies its shortcomings, and discusses how new electronic payment solutions are set to revolutionise subject payment in clinical trials.
Large molecule drugs are complex, biologically synthesised pharmaceutical compounds. Owing to their complexity, large molecule drugs, such as proteins and antibodies, can be efficiently analysed using indirect immunochemical/ligand binding techniques. However, these techniques are time-consuming, creating an additional burden for bioanalytical applications. Chris Beaver, Director of Immunochemistry Services at PharmaNet, summarises the challenges of managing commercially available research grade kits during clinical trials and outsourcing to contract research organisations.
With many thousands of experienced investigators globally, and innumerable completed studies, why do we need to be particularly concerned with assessing the feasibility of a clinical trial? Dr Guy Patrick MD PhD, Chief Executive Officer and Chief Medical Officer of Centrical Global Clinical Trials, explores significant pressures that have been building within the clinical trials industry to drive greater cost efficiencies and to ensure delivery of complete and quality data on time and on budget.
Twenty years ago, research sites alone would provide their total enrolment quota simply by reaching into their own database of patients. But in the last two decades, the clinical trial landscape has changed and the ripple effect has meant that sites need to go outside their practice for patients. Scott Connor, Vice President of Marketing, and Joe O’Rourke, Manager of Customer Solutions, at Acurian, consider the reasons why additive patient recruitment is no longer a nice-to-have or a rescue solution.