In this Q&A, Neil Ivey, Sales Development Manager, at Payne Security provides a brief history of Payne Security and answers questions such as: How big a problem is counterfeiting in the pharmaceutical industry? And how can covert technologies work in conjunction with overt technologies such as holograms?
Gonçalo Poças, the Marketing Manager at Neutroplast and the Director of Neutrodevices, explains that an important – if not essential – part of any pharmaceutical product is its packaging. Nevertheless, it has almost always been seen as an outsourcing need, due to its distance from the core business of pharmaceutical companies. This is ever more present if one takes into consideration that in the development of a new drug, the production of the drug itself, regulatory concerns and its marketing and commercialisation, there are already many physical infrastructures, human resources and other investment involved, which in turn form very heavy and costly structures.
Until five or ten years ago, companies supplying packaging to the pharmaceutical industry delivered their cartons several days or weeks before they were needed. The cartons went into the stores at the packing and filling plant, where white-coated quality control (QC) people would descend on the job to check that they met with the brand specifications. But this all changed with the arrival of leaner than lean, just-in-time manufacturing. Nowadays the same packaging is delivered not to a warehouse but straight to the filling line itself, and not days or weeks in advance but instead when it is actually needed, almost to the minute. Maryline Strasser of Bobst Group explains how In-Line QC is the Key to ‘Zero Fault’ Pharma Packaging Production.
Outsourced manufacturing has long been a key component of the pharmaceutical industry, whether it is to overcome internal capacity issues or exploit external expertise and cost advantages. Steve Poile of Wildwood Ventures Ltd explains that in recent years, the trend towards outsourcing manufacturing to India and China has increased, enabling significant cost savings. However, manufacturing is often just a component of a wider deal where the product or technology is being developed, and future manufacture for clinical or commercial use is anticipated within the agreement.
Sue Lee of World Courier (UK) Ltd examines the issues of risk. Risk is a part of life, and will never go away, as we might tell the small child finding out what happens if he sticks his fingers into the electric socket. However, we should remember that if companies decided to take no risks at all then the world of commerce would grind to a halt. It is possible to circumvent almost anything if you are prepared to spend a great deal of money on shipping, chartering flights, driving to the other side of Europe, using hand-carriers and flying people to remote destinations, but these are normally extreme measures. Perfection can be achieved but is a very expensive commodity, and so a balance must be struck. We should consider the advice of General Patton, who said: “Take calculated risks. That is quite different from being rash.”
Tim Stiles, Director of Qualogy Ltd, introduces Good Clinical Laboratory Practice (GCLP). GCLP is a quality system for laboratories designed to provide a strong framework to those individuals and organisations that undertake the analyses of samples from clinical trials, specifically on the facilities, systems and procedures that should be present to assure the quality, reliability and integrity of the work and results generated during the organisation’s/individual’s particular contribution to a clinical trial.
Betsy Hughes-Formella, the Director of Business Development and Consulting at Bioskin GmbH, explains that, in dermatological models, discrete evaluation of treatment effects may be possible following simultaneous application of multiple formulations/actives to small treatment areas in parallel in one individual, without risk of cross-over effects. By making intra-individual comparisons between treatments, the inter-subject variability is reduced, allowing meaningful interpretation of results with smaller panel sizes. Further, in these models non-invasive biophysical measurement and imaging methods to monitor skin function and structure provide alternative objective endpoints to support clinical evaluation, delivering additional information on structural and functional changes in the skin.
Thomas Zwingers, Chief Operating Officer for CROS NT, explains that, in the past few years, we have witnessed an exponential increase in costs for research and development of new cancer drugs: it has been estimated that the average expenditure in R&D for new drugs has doubled in the last decade. Consequently, the question pharmaceutical companies continue to face is: “How can we make a study more efficient while maintaining the validity and integrity?” Sponsors, clinical researchers and biostatisticians are becoming more interested in designs with greater flexibility than the standards and procedures that anticipate “go/no-go” decisions.
Traditionally, clinical trial application (CTA) approval in EU member states has been subject to national legislation. As a result, the assessment of a CTA that was filed simultaneously in several member states often resulted in varying final decisions and unnecessary delays. Country-specific modifications to the application often occurred due to changes requested by the different competent authorities and ethics committees. In some cases, a clinical trial might even be approved in one member state and rejected in another. The entire procedure could be extremely time-consuming and the country-specific modifications risk jeopardising the scientific value of clinical trial results. Dr Franz Josef Buchholzer, Vice President, Regulatory Operations Worldwide at PharmaNet, concludes in this article that in Europe, the voluntary harmonisation procedure (VHP) is a new method to obtain clinical trial approval across multiple European countries in a timely manner. In comparison to the traditional standard national submissions, which must be completed in parallel and submitted to each of the different European agencies, the VHP consolidates these activities into a single submission.
Michael Federico, Vice President at ePRO, ERT Inc., states in this article that increasing concerns regarding treatment-emergent suicidality have prompted the US Food and Drug Administration (FDA) to issue draft guidance for prospective assessment of suicidal ideation and behaviour in clinical trials. The Columbia-Suicide Severity Rating Scale (C-SSRS), a free-form clinician-administered interview, is an accepted instrument for meeting this requirement. However, procedural variance in the way this and all clinical assessments are performed by human raters has been a shortcoming for many years, negatively impacting the reliability of results. Electronic patient-reported outcome (ePRO) solutions can effectively address this limitation.