Implementing Personalised Medicine in clinical settings

Dr James Sawyer, CEO of Prism Ideas, explores the effect of the completion of the human genome project in 2003, and how the field of personalised medicine has been advancing at a fast pace, with scientists and clinicians gaining critical insight into the biology of numerous medical conditions. This knowledge, combined with the long-known fact that risk of disease and response to treatment varies from person to person, has enabled the development of personalised medicine, with oncology being one of the fields reaping the greatest benefits.

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Antimicrobial Peptides: Therapeutic Potential

Bacterial resistance to traditional antibiotics over the last twenty years has reached unprecedented heights. For the first time since the discovery of penicillin, some bacterial infections such as MRSA can be considered untreatable. Other major pathogen species are displaying similar increases, which is causing considerable concern. Such a worrying scenario has fuelled the search for alternative antimicrobials. One such option is the development of cationic antimicrobial peptides (CAPs). John T George, D Rowley and R Zheng of University of East London (UEL) review the challenges that this class of antimicrobials face in order to become viable alternatives to the traditional antibiotics.

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Painful Transition from Paper to Electronic Submission Dossiers

For many years, submissions have been prepared in accordance with the specific national requirements of the countries where the medicinal products are to be marketed. Increasing co-operation among the regulatory authorities, spurred on by initiatives such as ICH, have looked at ways of reducing time-consuming reworking of data for each region and focused on producing a harmonised set of requirements. Tim Felgate, Regulatory Intelligence Consultant at Applied Regulatory Consulting Ltd portrays the sometimes painful transition from paper to electronic submission dossiers, and the potential future trends.

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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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Pharmacotherapy in older adults

Drug therapy plays a major role in healing or managing acute and chronic diseases to re-establish the health and wellbeing of individuals in our society. This has led to a significant increase in life expectancy over the past century, a fact acknowledged by the European Commission’s declaration of the “European year for active ageing and solidarity between generations 2012”. Sven Stegemann, Director for Pharmaceutical Business Development at Capsugel, takes a closer look at the future of drug therapy in older adults.

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Phage in therapy and Prophylaxis ?History and Future Prospects

Bacteriophages are well known in the biopharmaceutical industry, mainly due to their destructive impact on productivity of bacterial-based fermentations. However, it seems that their positive role may soon dominate their rather grim reputation in the biopharmaceutical industry. Marcin Los, CEO of Phage Consultants, explains the reasons for the failure of phages at the beginning of the 20th century and their rebirth, and speculates on the future prospects of use of phages in health protection.

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