Many countries have legislation that requires pharmaceutical and medical device companies to follow good manufacturing practice (GMP) and good distribution practice (GDP) guidelines to ensure the proper production and distribution of medicinal products for human use. In Europe, the EU GDP guidelines (94/C 63/03) offer companies guidance on personnel, documentation, premises and equipment, deliveries to customers, returns and self-inspections. Jim Hardisty of Goplasticpallets.com considers why guidelines fail to address one key element in the distribution process: the use of pallets.
Pharmaceutical packaging manufacturers have become the trailblazers of the packaging world when it comes to ensuring carton quality. In every pharma packaging plant, multiple checks are carried out right through the production process from sales, through design and print, to die-cutting, gluing, and beyond. Yet even this is not enough to ensure the ‘zero fault’ supply that brand owners increasingly require. Jacques Reymond from Bobst explains what carton makers can do from now on.
Recent Advances in Raman and Surface Enhanced Raman Spectroscopy: Pharmaceutical, Forensic and Biomedical Applications
Iqbal T Shadi from Imperial College London NHLI and Roy Goodacre, Professor of Biological Chemistry at University of Manchester, explore how Raman spectroscopy has advanced in recent years, and how its use in both industry and academia has increased significantly and is redrawing the landscape in many fields, such as biomedical and pharmaceutical R&D.
Big changes have occurred recently in the pharmaceutical industry – not unlike other industries and the wider economy in response to globalisation – notably, that smaller biotech and life science companies are struggling to access capital, whilst many big pharma companies have downsized and outsourced research in order to drive down costs. Torkel Gren of Recipharm Pharmaceutical Development AB discusses the best approach to take, while selecting the right contract development and manufacturing companies.
Sustainable High Technology Cooling Systems are Meeting the Need for Energy-Efficient Ultra Low Refrigeration
William B White, CEO, Offenberger & White, Inc highlights the reason why the process of purchasing ultra low temperature freezers and acknowledging impact on facility overhead budgets is forcing a transition in buying authority from a single user working on grant money to comprehensive evaluations by financial, environmental and sustainability departments throughout the institution.
Most recent research on clinical trials focuses on the outsourced research and development (R&D) activities such as data delivery, site conduct and development. This article, by Petra Bielmeier of F. Hoffmann-La Roche Ltd, Geert Crauwels and Jim Williams of Lodestone Partner, describes, for both sponsors and contractors, the clinical supply chain and manufacturing operations, from the manufacturing of active pharmaceutical ingredients (APIs) through to the delivery of investigational medicinal products (IMPs) at the clinical site and on to the patient.
The significance of biomarkers as diagnostic and predictive tools with clinical utility and for monitoring and judgment of study progress probably cannot be overestimated. Co-development and extended use of biomarkers throughout the entire drug development process, referred to as `companion diagnostics´, are considered to yield significant increases in study effectiveness. Ioannis Amarantos, Thomas Laufer and Thomas Brefort of Febit Biomed GmbH explain how integrative, combinatorial approaches assessing multiple genomic biomarkers will potentiate the power and complement cellular, protein and metabolic biomarker data.
“Comparative effectiveness” has become a popular phrase in political and health policy circles worldwide since the US Congress passed the Patient Protection and Affordable Care Act of 2010.
The current interest in comparative effectiveness research is driven by the desire to identify treatment options that are more effective than others and offer good “value for money”. While head-to-head research can yield valuable insights on effectiveness and cost-effectiveness, care must be taken to ensure comparability across the populations studied. Mason W Russell of PharmaNet discusses that once this data is collected, it can be used in conjunction with costs and other economic data within a modelling framework to estimate cost-effectiveness and budget impact of treatment options.
Clinical development plans require efficiency, expertise and agility in a rapidly changing regulatory and treatment environment. Meghann Smith and Kathy Burruss of Ockham explain the major points of consideration regarding the ability to strategically guide compounds through the clinical development process in a cost-effective manner by utilisation of a niche oncology CRO.
The cost of patient enrolment is now the single largest part of the total trial budget, representing 32% of the cost. Among CROs and sponsors, this expense has been accepted as the inevitable cost of trial management, but it no longer should be. Richard Malcolm of Acurian considers what impact the emerging CRO/sponsor strategic partnerships that represent the latest trend in the CRO industry will have on patient enrolment.