Implementing Personalised Medicine in clinical settings

Apr 28, 2012

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

Apr 28, 2012

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 ...

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Painful Transition from Paper to Electronic Submission Dossiers

Apr 28, 2012

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

Apr 28, 2012

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

Apr 28, 2012

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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