Keeping Focus on the Commercial Strategy in Drug Development

Drug developers need to keep sight of the positioning and market opportunities for their products, both to ensure the right direction of their development efforts and to secure return on investment. Ole Wiborg, Managing Partner of Wiborg APS, and Søren Weis Dahl, Senior Consultant of Wiborg APS, discuss this in relation to a specific case of a new cancer supportive therapy for mucositis.

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Expanding New Developments and enlarging business into animal health

The common biological roots between animals and humans make knowledge-sharing between veterinary and human pharmaceutical companies a valuable commodity. In this article, Julian Braidwood and German Graff of Triveritas Limited explore the trend towards a “One Health” approach, identify the potential for new actives, and explain the roles that an exclusively veterinary product development contract research organisation (CRO) can play in building commercially effective bridges between the different disciplines and sectors.

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Tox and ecotox – What’s the Point?

Currently valid healthcare standards require that different chemical substances and compounds present on the market should not only be effective, but also safe. That also concerns pharmaceutical products used in human and veterinary medicine. Lucyna Kowalczyk, of the Institute of Industrial Organic Chemistry, explores why safety is a crucial concept in which the main, constantly raised question is the causal connection between chemical substances and compounds and the state of human health and the environment we live in.

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What’s the Buzz on Pharmaceutical Packaging?

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.

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In-Line QC – The Key to ‘Zero Fault’ Pharma Packaging Production

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.

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Recent Trends in Manufacturing Deals and Alliances

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.

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It’s a Risky Business

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.”

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Good Clinical Laboratory Practice: An Introduction

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.

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Dermatological Models: A Sound Basis for Early Decision-Making

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.

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